Introduction to Pharmaceutical Industry

Introduction to the Pharmaceutical Industry (Pharma/Big Pharma)

Pharmacy currently consumes about 13% of the overall health care dollar. The U.S. is the only country without some type of price control on pharmaceuticals. The main argument about this is: if there are price controls on drugs, Research and Development will be curtailed and that would be detrimental to the American people. This, of course, is the time-honored response from Big Pharma. It’s interesting that there are a lot of European and Asian drug companies that market drugs in non-U.S. countries (with price controls) for years before they ever come to the U.S. and they are doing quite well with enough funds to do R&D and produce new drugs. Big Pharma in America never seems to be able to explain that. This is so ingrained that a U.S. Congressional white paper came to the same conclusion. Of course, all of our legislators are getting huge sums of money from Big Pharma, so this is no surprise.

As has been the case since I was in Medical School in the 1970’s, the typical Pharma company spends more on sales and marketing than R&D. The Medical School I went to had a pie chart tacked up on the student lounge bulletin board showing this fact. But you don’t have to take my word for it, or presume that, since this is 40 years later, that this isn’t still the case. Here’s a recent analysis for you:

So, the whole R&D defense is a sham. DO NOT BELIEVE IT!

What really drives the price of drugs is what Pharma industry executives blatantly say: “What the Market can bear”. The CEO of Gilead, which markets Harvoni, a drug that cures Hepatitis C, for about $100,000 for a 12-week course, actually said this in an interview. The person who created the drug (using NIH grant money, yes, your tax dollars) says it only costs $1500 to make. It’s kind of like “Do you want to live? Pay the price!”. This is not like what most businesses do when they price a product. Usually it’s what it cost to develop, what it costs to manufacture the product, what, if any, warranty adjustment needs to be added, and then a reasonable margin (usually a fraction like 5%, 10%, even 50-100%), not 67 times the production costs, in order to create a price point that their target market can afford. By the way, Gilead bought the rights from the guy who developed the drug (with your tax dollars); they didn’t even do the R&D!!

A recent article in JAMA Internal Medicine has revealed that U.S. drug prices have no relationship to anything except what a Pharma company decides to charge. They consistently say they charge “what the market will bear”. Want to live? Pay $1 million. Or…die!

You’ve likely seen the recent TV and Newspaper articles about the Epipen (Mylan). The price has risen 6-fold in the last few years while the CEO’s salary has gone up a similar amount. So, now it is $600 for a pen. That’s because they are now the only U.S. company making it. So, they can charge whatever they want. The really interesting thing is, due to public pressure, they are saying they’ll market a “generic” version for about half the price. Really? Epinephrine is a brand drug? Not generic? Check this out:

“The active compound of epinephrine was isolated as an iron complex and marketed in 1900 by Farbwerke Hoechst as Suprarenin. In 1901, Parke-Davis began to market Adrenalin, the manufacturing of which was challenged by rival companies. Further analysis of the product revealed a lack of purity, and further chemical structures were proposed. In 1906, Hoechst began production of synthetic epinephrine, the introduction of which made the hormone more cheaply available on the market.”

Epinephrine has been generic for about 100 years!!

And as far as the “pen” is concerned:

“The injectable delivers a dose of epinephrine, otherwise known as adrenaline, to treat extreme allergic reactions. It’s been around for more than a century. And the pen that delivers the medication has been around since the 1970s, when it was first developed for the military. Since 2007, the price for a two-pack has gone up from $93.88 to $608.61, an increase of more than 500%.”

So, how does Mylan get away with this? And how can this be called a brand name when it has been generic for years (Patents expire in 14 years).

It’s due to your Pharma friendly FDA and USPTO (the Patent Office) and the rules they promote. That’s in another of my blog posts.

And, if you research the Canadian Pharmacy system, you’ll see that there are several companies marketing the epipen there and the costs are about $120 for a single and $170 for a dual pen prescription, OF WHICH MYLAN IS ONE OF THE MANUFACTURERS!!!

You see, the FDA and USPTO allows a Pharma company to keep marketing any drug as a brand drug no matter how old the drug is. Here’s an example:

Hydrochlorothiazide (HCTZ), a blood pressure medicine, has been around since 1959, and was first marketed by Merck and Ciba. So, it went generic around 1973. Here are the current prices ( for HCTZ:

Microzide by Actavis (a “brand” HCTZ)- $134.99 for 90 tablets of 12.5 mg

Generic hydrochlorothiazide – $44.97 for 90 tablets of 12.5 mg

Here’s another one. Sulfasalazine was developed and marketed in the 1950’s by Pfizer. It is an anti-inflammation drug:

Sulfasalazine generic – $29.56 for 120 500 mg tablets

Azulfidine (brand) – $131.99 for 120 500 mg tablets

Azulfidine EN (has a special coating)– $217.99 for 120 500 mg tablets

Here’s another Pharma game. A Pharma company is first to market for a drug either in a class of drugs or used for a specific condition. They price by “what the market will bear”. It has nothing to do with manufacturing or R&D costs. Six months later, a second company markets either a “me, too” drug in the same class, or a drug in a different class treating the same condition. What does the second company charge? THE SAME PRICE AS THE FIRST DRUG!! The rationale – the market was bearing the price of the first drug, so, why not price it the same?

Here’s an example:

Restasis is that eye drop that has a lot of ads on TV for several years. Recently another eye drop, Lifitegraf was approved for the same indication. Check out this table from The Medical Letter, a physician newsletter that gives physicians an unbiased review of drugs. It also shows you prices.

First, hydroxypropyl cellulose drops are just artificial tears, not an active drug. The new active drug costs exactly the same as the first drug. How likely do you think the R&D and manufacturing costs and the margin calculations are identical for both drugs? Well, I’m hear to tell you they aren’t. The second drug company knew people would pay $426.70 so that’s what they are charging.

Here’s another game they play. It’s supported by FDA/USPTO rules (which should be changed).

The FDA and USPTO allows a drug company to have exclusive rights to make and market a drug for 14 years so the drug company can recoup R&D costs. Here’s how drug companies abuse this.

There’s an aspect of organic chemistry that is at play with drugs because they are organic compounds. When the molecules are formed in the chemical reaction, you get two versions of the same compound, a right hand and a left hand version. Just like your own hands (and feet!) both your hands are hands but the spacial orientation is opposite. So you can’t put a right hand glove on your left hand, even though it is a hand. This is called a racemic mixture. It’s usually 50/50, just like your hands are 50/50. It turns out, in a lot of cases, one drug “hand” is not as active as the other “hand” or may not be active at all. However, you can separate the two. They are called “isomers”. One is the “D” isomer (right hand, “dexter”)and one is the “S” isomer (left hand, “sinister”). You can separate these from each other. Usually a simple process.

What drug companies do is, they market the racemic mixture for 14 years so they can call it a brand, have exclusivity, and price it as they want and no one else can make it and they can get their R&D and marketing costs paid for. Then, as the patent is running out, they submit to the FDA and USPTO the active isomer as a new and different drug AND THE FDA AND USPTO ALLOWS THEM TO CALL IT NEW AND DIFFERENT and gives them another patent for 14 years! So the drug company doubles their time of exclusivity WITH THE SAME DRUG! All they have to do now is convince prescribers and the general public that the “new” drug is better than the “old” one (this is the marketing costs you see in the above figure).

The classic example is omeprazole (Prilosec) originally developed by AstraZenica. When the patent for Prilosec was running out, AstraZenica got the FDA and USPTO to grant brand designation to the right hand version of omeprazole, esomeprazole (probably really desomeprazole or D-omeprazole) as Nexium. AstraZenica had been marketing Prilosec as the “Purple Pill” for 14 years. Overnight, Nexium became the “Purple Pill”. The only difference between Prilosec and Nexium is you only need half as much Nexium as you would need Prilosec, because the 50% non-active isomer was removed.

Here’s an excerpt from about Nexium:

“Nexium (esomeprazole) is AstraZeneca’s popular proton pump inhibitor used to block excess stomach acid. Nexium, also known as “The Purple Pill”, is used to treat heartburn and acid reflux, sometimes called GERD. In 2012 alone, Nexium had sales of over $5.6 billion, placing it solidly in the mega-blockbuster category.”

$5.6 billion in one year alone (remember they got another 14 years for the same drug)! At the same sales rate per year over 14 years that would calculate to $78 billion on basically the same drug as Prilosec! No R&D costs! A mega-blockbuster!

Guess what? You paid for this in your taxes (Medicaid and Medicare) and insurance premiums. Forty 20 mg Nexium prescription capsules cost $310.60 ( This was the cost for 14 years. Now, Forty-two 20 mg Over The Counter Nexium OTC cost $23.99 (Target, Wallgreens). The “market could bear” the prescription $310 cost for 14 years. Of course the doctors were 50% of the problem because they prescribed it. FYI, I never wrote a prescription for Nexium except when I saw someone else’s patient who was on it and they needed a refill when that physician wasn’t available.

OK, so I hope you’re getting the point about Pharma.

Take home messages:

  1. Pharma doesn’t care a whit about you.
  2. Pharma’s main goal is to make as much profit as possible. These are obviously stocks you want in your portfolio.
  3. Pharma contributes so much money to your legislators that they can get anything they want enacted, including FDA and USPTO influencing.
  4. Pharma prices drugs on “what the market can bear” irrespective of the ailment (I didn’t even get into things like cancer drugs but the games are the same) or the actual costs.
  5. FDA and USPTO rules allow perverse behaviors by Pharma.
  6. The R&D excuse for drug prices is totally absurd.
  7. Pharma spends more on sales and marketing than R&D.

By the way, 20 years ago, the main marketing approach for Pharma was convincing doctors to prescribe their drug. Many studies showed the biggest influencer of physician prescribing was not the medical literature but the extent of Pharma “detailing” (Pharma reps going to doctor offices with pizzas, holding evening dinners, sponsoring conferences, etc.). Then the court rulings related to the first amendment allowed drug companies to advertise drugs on TV to the general public. Sales jumped more with direct to consumer (DTC) advertising than advertising to the prescriber (doctor). Yes, doctors bent to the request of a patient who saw an ad on TV vs. going with the medical literature. And I guarantee the drug companies were pretty sure this was going to happen before they pumped tons of money into DTC advertising!

Also, this is one example of why the free market enterprise system doesn’t work with health care because the stakes are different. It’s your life at stake.

Because it’s all about the money.




The Fractured US Health Care System

The Fractured US Health Care System

Since the mid-80’s, the US Health Care system has slowly fractured into discrete pieces. The movement started with Emergency/Urgent Care and Family Practice physician specialties, then spread to all physician specialties.

The first Emergency Physician Training Program was started in 1970 at the University of Cincinnati, the first graduating “class” was in 1972. The American Board of Emergency Medicine was approved by the American Board of Medical Specialties in 1979. It took about 10 years for enough physicians in this specialty to be trained to create a tipping point in manning hospital Emergency Departments with Board Certified physicians. Before 1990, the majority of EDs were manned by community physicians “moonlighting” in EDs to get extra income, or, they were manned by community physicians who formed ED physician practices but were not board certified. By 2000, with the exception of some small rural hospitals, the vast majority of hospital EDs in the US were manned by Board Certified ED physicians with regional and national practices providing the supply to hospitals that didn’t directly hire their own ED physicians. Until the late 1980’s, if a patient presented to an ED, their primary care physician was called and was expected to come in and see the patient. The primary care physician could defer to the physician in the ED, but that didn’t occur often as, since the ED was manned by community physicians, primary care physicians were afraid they would lose their patient to the physician in the ED. Similarly, Urgent Care Centers pretty much failed in the 1980’s for the same reason, that is, the primary care physicians believed the physicians in the Urgent Care Centers were using that as an entry point into the community and would recruit their patients. The primary care physicians also felt that they knew the patients better and, for continuity of care reasons, it was better for the primary care physician to see their own patients. This was also expected by the health care system and the patients, as well as by the physicians themselves. It was the culture. Once board certified ED physicians became the norm in the EDs, the primary care physicians became more comfortable allowing ED physicians to see their patients. It wasn’t until around 2000-2005 that the primary care physicians began routinely referring acute care patients to Urgent Care Centers, due to reasons outlined below. This was the first step of the fracturing of the system. A physician now only had to go to the ED to see a patient if the ED physician either needed expertise to evaluate and treat a patient, or, the patient had to be admitted to the hospital. Some hospitals allowed ED physicians to write admission “holding” orders for the admitting physicians, so the admitting physician didn’t have to run to the hospital immediately.

This was Fracture #1 in the Health Care System.

The American Board of Family Practice was officially recognized in February 1969 by the Board of Medical Specialties. Before that, these physicians were called General Practitioners whose training was limited to Medical School plus one year of internship, usually a “rotating” internship (rotating through several specialties, e.g., Internal Medicine, Surgery, OB/GYN, etc.). At the beginning, there weren’t many Family Practice training programs, so, to get members into the specialty, you simply had to pass a “Family Practice” test to get certified. This was called being “grandfathered” in. The first Family Practice Residency Programs began in 1968. By the mid-1980’s, the “grandfathering” option was eliminated; you had to attend a Family Practice Residency Program to take the certification test. Initially, Family Practitioners could do anything related to the practice of medicine. They did surgeries, delivered babies, did ICU care, etc. Around 1985, this started to evolve into a more restricted (mostly self-chosen restriction) practice, eliminating surgery and OB. In some cases, hospitals started to restrict inpatient privileges for Family Practitioners, especially in urban areas where the board certified specialists in areas like surgery and OB were so plentiful, it was risky (malpractice risky) to the hospital to allow Family Practitioners to do these procedures since their depth and breadth of training was less then the specialists.

The second fracture in the system was due to the Family Practitioners. In the mid-1980’s Family Practitioners began eliminating their hospital practice entirely. They felt their training was more ambulatory biased and they began to feel “uncomfortable” with hospital-based medicine. I was in a medium sized city in 1986 when a Family Practitioner opened a practice in a town about 8 miles away from our city. His patients started showing up in the ED with the message that their primary care physician told them to go there to get admitted. The Family Practitioner had never applied for hospital privileges.

Back then, if you were a primary care physician with hospital privileges, you took “service call” in rotation with the other primary care physicians. Service Call was a quid pro quo for being allowed to care for your patients in the hospital. When you were on service call, usually a week at a time, you admitted any patient who presented to a hospital where the patient’s physician was not on the hospital staff. This could be a traveler or visitor to your city, someone who lived there but never chose a primary care physician, etc.

So, when a physician practicing within the service area of our hospital just started sending his sick patients to the hospital to be admitted by the service call physician, it created quite the stir, especially since the Family Physician didn’t even have the courtesy to inform the hospital that he would be doing this. The medical director and administrator of the hospital, at the request of the Medical Staff Executive Committee, met with this Family Physician who just said he wasn’t going to apply for privileges, he was still going to send his patients to the ED, and there was nothing the hospital or the Medical Staff physicians could do about it.

Over the next 20 years, the vast majority of Family Physicians stopped applying for hospital privileges and became 100% ambulatory/outpatient only practitioners. The Internal Medicine physicians began following suit, so that, by 2005, virtually 100% of urban and suburban primary care physicians were ambulatory practitioners only.

So, there is Fracture #2 in the Health Care System.

Now, just think about this for a minute. It used to be, primary care physicians went to EDs to care for their patients, did the urgent care in their offices and admitted not only their patients but unassigned patients to the hospital. Now, all of a sudden, they aren’t doing any of these things. The hospitals countered the ED issue by hiring ED physicians directly or contracting with ED physician practices. Now, with primary care physicians refusing to go to hospitals, the main question for the hospitals was, “Who in the heck is going to take care of the inpatients??!!”

Enter stage left, Fracture #3: The emergence of the hospitalist.

If your not keeping count, the hospitalist is the third physician type that is needed to do what one primary care physician did before 1990. Physicians were going into ED, and then, hospitalist practices, which subtracted them from the primary care base, and there wasn’t a decrease in the demand of patients who needed primary care. You can start doing the math as a preparation for the blog about why we need (or don’t need) 100,000 more physicians by 2030.

In a 1996 New England Journal of Medicine article, Dr. Lee Goldman and Dr. Robert Wachter coined the term “hospitalist.” By 2005 there were 5000 members of the Society of Hospitalist Medicine. As of 2014, there were 44,000 hospitalists in the United States. (The numbers are from the Society web page) It is the fastest growing medical specialty in history.

There is no official Hospitalist Residency Training program. The first hospitalists were mostly enterprising Internal Medicine or Family Practice physicians who saw a gap in care, a void, created by the primary care physicians. In a similar time frame, hospitals started directly hiring Internists as hospitalists, since Family Practitioners and some Internists had chosen to not do hospital medicine, and the hospitals couldn’t wait for hospitalist practices to form. The American Board of Hospital Medicine was founded in 2009, so you can see how young the specialty is. However, physicians acting as hospitalists are mainly Internal Medicine physicians who are adequately trained in hospital medicine. As a matter of fact, The American Board of Internal Medicine has a special certification, “Focused Practice in Hospital Medicine”.

Now, when you go to the hospital, you never see your primary care physician. You are cared for by a hospitalist who is doing “shift work” (as a matter of fact, the ED physicians and Urgent Care physicians are also doing shift work). The usual schedule is 12 hours on, 12 hours off for a week, then a week totally off, then the 12 on 12 off, a week totally off, etc. A hospitalist, an ED physician, and an Urgent Care physician generally do ~14 12-hour shifts a month. That’s 42 hours a week on average, what most people consider “normal” work week hours (40 hour week!). A primary care physician in 1985 worked 60-80 hours a week. And, the primary care physicians are also doing shift work. The usual number of hours a week for a primary care physician now is 32-36 hours of direct patient care a week plus 4-6 hours of non-patient contact time. They only go to their offices. They expect the same income as the 60-80 hour physician from 1985 who went everywhere.

As noted above, there are now 44,000 hospitalists in the US. Internists used to be primary care physicians with patient panels of about 1800 ambulatory patients. 44,000 x 1800 = 79,200,000 people who would have had a primary care physician had primary care physicians still done both ambulatory and hospital medicine. Here’s a reason why there’s a doctor shortage because the Medical Schools didn’t ramp up admissions and graduations to produce 44,000 extra primary care physicians since 2000. We’re having to import them from foreign countries and the communities in the US still can’t keep up. Of course, the medical profession keeps blaming it on the aging population, which is a factor, but this fracturing is having more of an impact than the age wave. Plus other factors I’ll get into in a later post.

At this point in the discussion, there is now a need for four, count ‘em, four physicians to do what one primary care physician did before 1990.

And this now isn’t solely a primary care phenomenon. Since around 2005, every non-surgical specialty has adopted this model. Yes, there are now Cardiologist, Neurologist, OB/GYN, Gastroenterologist, etc. (you name it for non-surgeons) hospitalists! Surgeons haven’t totally converted because their income depends on the number of surgeries they do. But they do have APC’s (Advance Practice Clinicians) doing their hospital rounding and a significant proportion of their outpatient work. Surgeons want to be in the OR as much as possible, especially in the Fee For Service reimbursement model. Maybe that will change with capitation, value based reimbursement, bundled payments, etc.

Is there more? Well, yes! There is. Fracture #4!

Primary care physicians used to be obliged to follow their patients anywhere they ended up. Most people think about the above four venues, but there are more: Skilled Nursing Facilities and Nursing Homes. It now won’t come as a surprise to you to know that primary care physicians no longer go to Skilled Nursing Facilities (SNF) or Nursing Homes (NH), which the primary care physician in 1985 did. It was similar to admitting your patient to the hospital when they needed that level of care. It was expected that you would follow the patient to these facilities. If they were in a skilled level facility, you had to see them every 30 days. If they were in a nursing home you had to see them every 60 days. These regulatory time frames were moot if your patient was sicker and needed to be seen more often.

There were two separate movements that removed primary care physicians from going to SNFs or NHs. One was, they simply refused to go, just like the primary care’s refusal to go to hospitals. The other was, SNFs and NHs refused to let primary care’s see their patients, they hired “SNF-ists” and NH Medical Directors to see the patients. The main reason was, the primary care’s weren’t responsive enough when there were patient problems and they weren’t adhering to the regulatory time frames for response to urgent calls from the facilities or signing verbal orders. So, the primary care’s essentially removed themselves from these venues, one way or the other, the latter related to another of my blogs about their shift work mentality.

Now there are SIX physician FTE types who are doing what it took one primary care physician to do in 1985. And they are all doing shift work. Future posts will explain why physicians and APCs prefer shift work.

By the way, I was there in 1985 so I know what the 1985 reality was.

In 2016, according to the Kaiser Family Foundation, there were 441,735 primary care physicians in the US. There were 484,384 Specialists. The 44,000 hospitalists and 42,000 ED physicians are in the Specialist number. There are also 20,000 physicans in Urgent Care Centers. (All of these numbers come from their own society’s latest postings.) This adds up to 106,000 physicians out of the primary care practice arena. 106,000 x 1800 patients = 190,800,000 people! There are only 360,000,000 people in the USA! Wait, 441,735 x 1800 = 795,123,000 people! Of course, the 441, 735 probably included retired or semi-retired physician, but, doesn’t it look like there are enough primary care physicians? Unless, of course, they aren’t caring for 1800 patients each, or the way they practice limits their availability. The numbers say more like 800 patients each. More on this in later blogs.

[Interestingly, on May 16, over a month after this blog was written, an article on this exact subject was published in JAMA (“Reassessing the Data on Whether a Physician Shortage Exists”; JAMA May 16, 2017, Volume 317, Number 19). Here is an excerpt:

“The United States currently has more than 900,000 active physicians. Of these, 441 735 are primary care physicians and 484,384 are specialists. Approximately 12% of primary care physicians work part time, leaving slightly more than 388,000 full-time primary care physicians. Of these, nearly 80 000 are pediatricians. According to recommendations from the Agency for Healthcare Research and Quality, the average physician panel size—the number of unique patients under the care of an individual physician—should be between1500 and 2000. A recent Medical Group Management Association survey of primary care physicians found that the median panel size was 1906 and the average was 2184. Conservatively, if each of the 388,000 full-time primary care physicians cares for an average of 1500 patients, they could care for an estimated 583 million people. Today, there are 240 million adults in the United States. Even at the low panel size of 1500 patients, all adults could be cared for by 160,000 primary care physicians; at a panel size of 2000 patients, the United States would require an estimated 120,000 full time primary care physicians. Similarly, the 73 million US children younger than 18 years could be cared for by an estimated 49,000 pediatricians, assuming that each provides care for 1500patients, or by an estimated 36,500 pediatricians with panel sizes of 2000 patients. Add to these conservative calculations the care provided by the more than 50,000 part-time primary care physicians and there seems a significant surplus, rather than a shortage, of full-time primary care physicians.”]

The point of this post is, it’s the physicians who fractured the US health care system. The biggest problems from this are: 1. Lack of knowledge across the system about individual patients, 2. Lack of continuity of care, 3. Inadequate communication across the health care continuum, 4. The “too many cooks spoil the soup” concept (practitioners don’t agree with each other about how the patient should be managed and change care regimens set up by another physician), 5. Repeating tests and services, 6. Patient confusion over what their care plan is leading to deficient self-care, 7. Important things getting lost in the system, falling through the cracks, so to speak, 8. More opportunity for medical errors due to hand-offs.

To try to mitigate this, health systems (and health insurance companies) have added non-physician FTE’s (Full Time Equivalents, basically, a person who works 40 hours a week) to the system: Case Managers, Care Coordinators, Nurse Navigators. These will be discussed more in future posts, but, this is now NINE FTE doing what ONE primary care physician FTE and his practice nurse did in 1985.

And I haven’t even gotten into the Advanced Practice Clinicians (APC’s)(formerly called “mid-level providers): Nurse Practitioners, Physician Assistants and Pharmacist Clinicians. These APC’s do portions of what a primary care physician did in 1985, like, managing stable hypertension or diabetes, seeing same day acute patients (colds, sprains, etc.), adjusting meds for chronic illnesses like COPD and depression.

No one has decreased the number of physicians. All of these FTE’s are added to the functioning and cost of the health care system.

And the final, to me the craziest, FTE addition of them all is the “scribe”. What, you may ask, is a scribe?

A scribe is a person (now they are actually certified as a health care scribe! A new health care industry, scribe training and certification!) who enters information into the Electronic Medical Record (EMR) for practitioners. As you might have experienced, almost all physician practices, hospitals, SNFs, etc. are now on EMRs. The EMRs are so poorly designed for caregivers, there is now an FTE type, the scribe, who follows the practitioner around (physician or APC) and enters most everything into the EMR because it takes too much practitioner time. Yes, EMRs made practitioners less patient care productive.  As a matter of fact, there have been several articles published in 2016 and 2017 showing that practitioners spend 50% of their in office time on the EMR instead of seeing patients (i.e., 4 hours EMR, 4 hours seeing patients). Meaning they can’t see as many patients because of the unintuitive design of EMRs.

I don’t know what a scribe is paid, but, it is an additional cost to the system, not even counting the training and certification costs.

So, that’s 10 FTE doing what ONE primary care physician and their nurse did before 1990!

Anyone want to know why health care costs keep going up? And this is just one factor (no one wants to talk about)!

Why Physicians Prefer Doing Shift Work

Why Physicians Prefer Doing Shift Work

I graduated from college in 1972. It was a time when, if you wanted to be a doctor, you started the journey as a high school student and looked at college as a stepping-stone to medical school. Back then, going into medicine was considered a primary choice, a “calling”. That was the culture of the times going back to Hippocrates. You chose a “Pre-med” course for college, which was skewed towards the sciences. The medical schools had college course requirements you had to fulfill before applying. You already had your list of preferred medical schools before you were a junior in college. By the way, most college students completed their college studies in 4 years back then. If you didn’t you were considered a slacker or deficient in some way. More than 4 years in college on a medical school application was likely to get you an immediate rejection. Most medical schools would immediately reject anyone over 27 years old. You had to do well on the MCATs (Medical College Admission Test). You had to get stellar recommendations from your college professors and the college’s guidance office. When you interviewed, you had to prove you were “called”, that being a physician came first in your life. Everything else took second place. Intelligence wasn’t enough since the applicants were within a narrow intellectual bandwidth.

I know the above is true because:

1. I was 27 when I applied to Medical School and was rejected from several only because of my age (they weren’t afraid to tell you this). I asked one what the rationale was for this and the answer was, a large proportion of medical school costs were paid for by government subsidies and if you were older than 27, you didn’t spend enough years in practice to “pay that back” in taxes. Really?

2. A fellow I knew, who only got into one medical school, went to college to become a Medical Technologist (people who run the tests in a hospital laboratory) because he thought it would give him a better chance of getting into medical school since he would learn a lot about all of those tests and how they related to diseases. When he interviewed at medical schools they told him they weren’t likely to be interested in him because Medical Technologist was a “dead end” career and they didn’t want people in the school who had set their career sights so low. Really, they told him this!

When you got into medical school, on the first day they reminded you that many, many applicants would be thrilled to be in your place, that they felt “called”. If you didn’t commit to your patients coming first in your life, you might as well get up and leave now, there were plenty of others with that commitment who could fill your seat. Where I went to medical school, there were 70 applicants for every accepted student. Nobody got up and left.

Medical school was grueling. Between actual class hours (8 hours a day) during the first two years, and studying and reading tomorrows reading assignment until 10-11:00 at night, you were putting in a good 60 hours a week right from the get go. This got even higher when you got into the clinical rotations because you basically shadowed an intern, you were on call with them, you went to bed when they went to bed, etc. That was up to 100 hours a week for clinical floor work (regular hospital wards), then there was 36 on, 12 off for 6 weeks twice a year for ICU/CCU (126 hours a week) and then 28 on, 20 off for ED for 6 weeks twice a year (98 hours a week). You also got these hours as an intern and resident for three more years.

You never had the expectation that you would be working a 40-hour week when you got out into practice. Back in the 1980’s and 1990’s the average Internist worked 60-80 hours a week. Primary care was on the 80 hour end. At the same time, you were making 2-3 times the income everyone else in your neighborhood was. And there were (and are) careers where 80 hours was pretty normal but they made (and still make) half of what you made.

My medical school class graduated in 1979. This was the last class where just about everyone went into medicine as a calling. Beginning in 1980, it became apparent to me that there was a sea change starting. The students graduating in 1980 were generally born in 1955 or later. There were occurrences I personally experienced that foretold the phenomenon I am going to discuss in this post. Here are two examples.

Example #1:

When we were students, if an intern, resident or attending physician asked any of us to do something extra that would require more accountability than usual for a medical student, that would get you bragging rights! You never turned this down! You would be “da bomb” for days! Here’s what happened in 1980 that made me suspicious that things were changing.

I was the intern on the ICU/CCU medicine team (there was also a surgical team) along with a resident. Just the two of us were on call. The entire team was two interns and two residents who alternated nights on call. It was early in the morning, like, 1:00 AM. We were slammed. Both the ICU and CCU were full. We got a call from the ED that an acute heart attack patient had presented to the ED and we had to take him. We couldn’t transport him.

In these cases, we got busy looking over the charts of all of the patients in the ICU/CCU to see if anyone was stable enough to move to the floor to make room for the new critical patient. We found a patient 3 days post a heart attack. He was a VA eligible man. He still needed CCU care but was stable enough to be transported to the VA hospital about 8 miles away. We called the VA and they had a CCU bed available.

Given that this was a CCU to CCU transport, the attending physician advised us that more than an EMT had to be in the ambulance. There weren’t any paramedics on the ambulances. The attending and the resident felt that neither myself (the intern) nor the resident could accompany the patient to the VA because the patients in the units needed our attention. The attending suggested that we have the medical student accompany the patient in the ambulance.

I can tell you, if anyone in my class was asked to do this, there would be mucho boasting in the intern/resident’s quarters at lunch the next day! It would be the talk of the house staff for at least for a day or two. We thought this would be a great opportunity for our medical student!

We called our medical student and explained the situation and said we would like him to accompany the patient to the VA. (By the way, it also got him out of doing things like running units of blood from the blood bank, putting in IV’s etc.). To our astonishment, he looked us in the eye and said (exact words), “Sorry, I’m not doing your scut work for you.”


The resident had to order him to do it, at which point he sulked around for two days.

Example #2

There’s a process at the end of medical school called “The Match”. This process starts a year before graduation. You investigate training programs in the field you want to enter and line up interviews at those residency training programs. If you get invited, you spend a day at each program for a day-long formal interview session. After you’ve competed these, you make a list in order of your preference of the programs you would like to attend. Most students have 4-8 programs on their lists.

At the same time, the programs make a list of the students they want to attend their program in order of their preference.

During “Match Week”, a computer calculates the best alignment of which program you ranked against the lists of the programs who listed you in their order of preference. You are told you are going to the program with the best alignment of these lists (your one list against the 4-8 lists of the programs where you interviewed). On Match Day, you get a sealed envelope with the result and you must report to the one and only one program identified on the sheet of paper in the envelope. There are elated students and completely depressed students depending on how high on your list your assigned program matched. Then there is a big party that night to either celebrate or drown your sorrows, again, depending on where on your list the name of the program you were matched to was.

The students in the classes at my medical school before 1980 looked at the prestige of the program, the types of things you would be exposed to, the elective opportunities, what procedures you were allowed to learn and do, the types of cases the hospital saw, etc. We tried to pick the programs where we would get the best preparation for being out on our own when we graduated the program. I was particularly interested in this as I was going into the National Health Service Corps and would be “out in the middle of nowhere” with little peer support or mentors.

For the medical school graduating class of 1981, this changed.

Each hospital ward had a room called the “call room”. This was where the attending, residents and students met first thing in the morning, did sign outs at 4:00 each day and met to discuss cases during the day. One day, around 3 o’clock in the afternoon, I was approaching the call room to get ready for sign out and I stopped in the door as a half dozen students were in there talking. What they were talking about was The Match. They were discussing where they had interviewed and were telling each other which programs they were ranking high on their list and why. To a one, they were ranking the programs on:  1. The number of days on call a month (the less number of days on call, the higher the rank), and the number and type of services the program had that took work off of the intern/resident’s plate (did they have a 24/7 IV team? 24/7 blood draw team? 24/7 blood gas team?) The more services, the higher on the list. You see, we had none of these where I trained. We had to put in IVs, draw blood, do blood gases on our patients and, at night when on call, for all of the team’s patients. You might think having these services was a good thing, but, in the middle of an emergency situation (like a code blue), you, the doctor, are looked to to get done whatever needs to get done. If you are not proficient in doing them, and no one else there can do them, it affects the patient’s outcome.

I’ll give you an example of this. I was in the hospital. A patient was crashing. It wasn’t my patient. I ran to the room to help out. The nurses and a respiratory tech were working on the patient. The patient needed a blood gas pronto to correctly manage the patient. The respiratory tech was tasked with getting the blood gas. She tried 3 times and couldn’t get it. I told her, “Give me the set-up, I’ll get the blood gas”. She looked at me and said, “I’ve never met a doctor who could get a blood gas.” I said, “Please give me the set-up.” I got the blood gas the first time. The respiratory tech was shocked, but appreciative!

This observance of medical students choosing the program with the least work was the beginning of the slide from medicine as a calling and medicine as a job.

There are many studies documenting this shift. Some attribute it as a generational attitude. It’s basically this: Physicians graduating from Medical School after 1980 place their lifestyle first, being a doctor is second. The less they need to do the better. They will do things like go part time and take a lower salary to support their non-work (lifestyle) preferences. In a 2015 physician survey reported by the American Medical Association, 22% of male physicians and 44% of female physicians are part time (2015), up from 7% male and 29% female in 2005. “Twenty percent of male and 23% of female physicians in practices of 500 or more doctors worked part time. Meanwhile, only 6% of male and 4% of female physicians in practices of three to 50 physicians worked part time. In hospital-based practices, the total working part time was 5% of male and 7% of female physicians. 75% of groups in 2011 offered a four-day workweek, and 30% allowed job-sharing. The drive toward part-time medical practice is believed to be partially due to the fact that many more physicians are women of childbearing age looking to balance work and family life. ” ( FYI, in 2016 49.8% of medical school graduates were women. And the men also want lifestyle over work. It’s not just a women’s thing. It’s the generation. Want to know why we need more physicians?

By the way it costs just as much to train a physician who goes part time as a full time physician, and your tax dollars pay a significant portion of medical school and post graduate training. It effectively lowers the total number of FTE (Full Time Equivalents = a person working 40 hours a week) of physicians coming out of medical training, compounding the problem of increased physician capacity need. But hey, these folks need their lifestyle, patients don’t need their medical care, right?

Today’s physicians also want set hours in which to work so they can come and go to work on a set schedule. When the end hour of their shift comes they want to leave, no matter what is going on. They do not want work to interfere with the rest of their life. They want to hand off any ongoing cases to someone else at the end of their “shift”. In primary care this is “Go to Urgent Care” or “Go to the Emergency Room”.

Shift work fulfills their desire.

They also want a very predictable day. They have a low threshold to send their patients to Urgent Care or the ED rather than accommodate them into their schedule so their day doesn’t get “disrupted”. Thus the rise in the last decade of Urgent Care Centers. Remember, these failed in the 1980’s (see another post on my site about this, The Fracturing of the Health Care System).

I worked in an Urgent Care Center for the last 5 years of my career. This was a prevalent comment from patients…”My doctor’s office told me to go to urgent care”. In the 1980’s and 90’s we would never say this to a patient, we would squeeze them in or have slots in our schedules to accommodate these folks.

It’s even worse that that. Surgeons would sent patients, on whom they had done a surgical procedure and who were having a complication from the surgery, to urgent care if the patient called their office after 4:00 PM! Back in the day this would have been considered abandonment. Also, the surgeon is responsible for all post surgical care during what is called the “global billing period”, a specified time interval after a surgery for which the surgeon has already been paid (the global fee) for any follow-up care. I remember one case where you can see how bizarre this can get:

It’s 4:30 and I’m in the Urgent Care Center. An APC (Advance Practice Clinician) gets the next patient, who is still at the nurse intake station. The APC is called over there by the nurse and comes back saying the patient needs to go to the ED. The nurse is right behind the APC saying, “Are you sure we can’t do something here?” I asked what was gong on. The APC starts complaining that the patient had an orthopedic procedure on his left arm the day before and the patient’s arm is extremely painful. He called the Orthopedic office and they told him to go to urgent care. The APC is totally pissed off that the orthopedist wouldn’t see the patient and sent him to urgent care. She doesn’t want to touch the arm. The APC started filling out the ED transfer sheet. I asked the nurse if I could see the patient. He was sitting in a chair moaning. He had a bivalve cast with an Ace wrap around it. His fingers were cool and bluish. I told the nurse I could try something that I was pretty sure would work and personally took the patient to an empty room. What I perceived the problem to be was, his arm swelled between the surgery the day before and now and the cast was causing significant pressure on the arm impeding blood flow. Since he had a bivalve cast (the cast was in two pieces wrapped together), I determined I could just unwrap the Ace bandage and re-wrap it looser than before, but still firm enough to support the arm. So, that’s what I did. It took me five minutes. The patient had immediate relief and left the Urgent Care Center singing my praises. OK, I was a hero, but, his orthopedist or his nurse could have done the same thing, and actually the orthopedist was ethically obligated to do it because: 1. He did the surgery and was accountable for its outcome and, 2. He was already paid for it! And it took only five minutes!!

Here’s more related to shift work and not disrupting schedules.

I’m the Medical Director of a Staff Model HMO (all physicians are salaried with no productivity incentive). I’m at home at 6:00 PM and I get a call from our Urgent Care Department. The Physician Assistant there was upset and wanted me to know about a case.

A patient had presented to one of our outlying clinics, about 12 miles from our main site which housed our Urgent Care Department. He was complaining of chest pain. Now, chest pain is a diagnosis where you do an immediate assessment to make sure a patient isn’t having a heart attack or something else as life threatening (Pulmonary embolism, dissecting thoracic aorta, etc.). It was 4:45 PM. The only physician left in the clinic was a female internist. The nurse came back to the physician’s office to tell her this patient was at the front desk complaining of chest pain. The physician told the nurse to tell the patient to drive to Urgent Care 12 miles away because SHE HAD A NAIL APPOINTMENT at which point she left without seeing the patient. The man could have died on the way to Urgent Care.

Lifestyle before patients.

Here’s one about not wanting the day disrupted.

I was the Medical Director of the same Staff Model HMO. I had set up a system where I saw same day patients at every clinic in the Staff Model one half a day a week on a rotating basis. This way, I kept up my clinical skills and I got to know the staff and the systems at each clinic. I had let everyone know that patient care was more important than administrative meetings, so, at times when a clinic was unexpectedly short staffed, I cancelled all of my meetings and would go to the short staffed clinic to see patients. One Monday I got a call from a clinic where one physician was on vacation, another was at a conference and one of the two remaining physicians called in sick. That left only one physician at the clinic. I quickly told my secretary to cancel all of my meetings; I was on my way to see the scheduled patients of the sick physician.

Now, I had already been in four medical groups doing primary care. My usual schedule was to go to the hospital at 6:30 AM, see my inpatients and make it back to clinic by 8:00 AM to see my office patients. My morning schedule was 15 minute appointments (or 30 minutes for a physical exam) from 8:00-11:45 AM and the same in the afternoon from 1:00-4:45 PM. Since this was the case in four groups, I figured this was normal.

I got to the clinic to start my day seeing patients. I noticed in the schedule for the morning and afternoon that there were two 15 minute slots in each session labeled “phone time”. I asked the nurse what this was. She said it was time set aside for the doctors to return phone calls. This seemed odd to me, but I let it go. I saw two patients, then went to the door of the exam room with the third patient. I was looking at the chart. Just as I was about to open the exam room door, the nurse approached me and said a home health nurse called and was worried that a man with a double knee replacement, who had just been released from the hospital the day before, might have blood clots in his legs. He was on blood thinners but his legs were really swollen. I told the nurse to have him come in to be seen. She asked me when. I said, “Just have him come in, I’ll see him when he gets here.” She asked me again, when? I said, “Have him come in now, I’ll see him when he gets here. Put him in the procedure room and let me know when he gets there.” Blood clots are a serious problem, the sooner you figure things out, the better for the patient. My suspicion was, the physicians in this clinic didn’t squeeze patients into their schedule between scheduled patients, only into open slots no matter where they were. I had no morning slots in my schedule.

I kept seeing patients. Two patients later, I’m again at an exam room door getting ready to see a man complaining of shoulder pain. The nurse comes up to me and says the knee replacement patient is in the procedure room. I returned the shoulder pain patient’s chart into the rack by the exam room door and ran down to the procedure room. I asked the patient and the home health nurse some pertinent questions and examined the patient. He had swelling but no other clear-cut signs of blood clots. I ordered a test to make sure his blood thinner level was adequate and went back to see the man with shoulder pain. The entire encounter with the knee replacement patient took about 8 minutes.

To my surprise, the shoulder pain patient was gone and his chart was gone. I asked the nurse what happened to the patient and she said, “Since you saw the man with the knee replacements when you were scheduled to see the shoulder pain patient, I asked the shoulder pain patient to re-schedule.” WHAT!??!! I asked the nurse where the man was now. She said at the front desk re-scheduling. I ran out to the front desk, grabbed the patient and his chart, brought him back to the exam room and treated him. My guess was, making patients re-schedule in situations like this was normal in this clinic. Doing this fixed the total number of patients seen in a day.

A couple of patients later, the test for the knee replacement patient came back and was therapeutic, so I discharged him and gave instructions to the home health nurse. That took about 3 minutes.

Now I’ve finished the morning schedule, I’m charting with one hand and eating a sandwich with the other. (I quickly learned I should always bring my lunch to work because, as a physician, you never knew what was going to happen and you could go hungry!) The nurse brought in my afternoon schedule. To my astonishment, the man with the knee replacements was on my afternoon schedule at 3:00. I ran out and asked the nurse if the knee replacement man had called and was having more problems and needed to be seen again. To my…I’ll call it horror…she said, “Oh no, that’s to give you catch up time.” I said, “Catch up time?” She said, “Yes, here, if a doctor sees a non-scheduled patient we put their name in another empty slot so the doctor can catch up.” Really? In a session that started an hour after the “offending” session had ended? It was another way for the doctors to fix the total number of patients in their schedule. This on top of an hour of phone time built in their schedules. Believe it or not, the phone time slots became a standard with the new generation of physicians everywhere I went after that. In the above case, I could have seen five more patients had there been no phone or catch up time. That’s about 25% of an average primary care physician’s daily productivity (They are supposed to see at least 20 patients a day). Want to know why we need more doctors?

This is the consequence of the new generation of doctors. The orthopedist’s shift was about over, he didn’t want his day disrupted…send the patient to urgent care. Who cares about the patient’s lifestyle, convenience or pain? The doctor’s lifestyle overrules! Ethics? What’s that? And it didn’t impact the orthopedist’s pocketbook. He’s paid already! The primary care physicians were salaried and manipulated their schedules to minimize the number of patients they saw and they didn’t want their shifts extended by walk-ins even with potentially life-threatening conditions.

Because of the low threshold for today’s physicians and APC’s to send patients to Urgent Care Centers, there are now ~9000 successful Urgent Care Centers in the US (Urgent Care Assoc. of America website).

Here’s a couple more:

Primary Care Physicians in most practices only work four and a half days a week. They see patients for 32-36 hours in 4.5 days. If they worked 5 days and saw patients for 40 hours, you could immediately increase the physician capacity by 10%. An overnight fix. The sacred cow that physicians need at least a half-day off is a residual of the “old days” when PCPs went everywhere the patient went (hospital, skilled nursing facility, nursing home, emergency room, etc.) You needed time to see the patients in facilities other than the hospital, you had hospital obligations (you were required to sit on at least one hospital committee, you had chart work at the hospital, etc.). Today’s PCPs don’t do any of these. Why do they need a half-day off? The rest of the clinic staff doesn’t and they don’t get paid as well.

Primary Care Physicians complain about the insurance companies “forcing” them to see more and more patients. However, in more than one medical group I practiced in, there were PCPs who scheduled patients every 30 minutes. Really? That would fix the number of patients seen to 16 a day if they actually saw patients 8 hours a day, and that’s with no no-shows/cancellations. And they still sent their call-ins to Urgent care. The group had allowed the physicians to decide how long they would see patients. The vast majority of PCPs were 20 or 30 minutes per patient. When I practiced full time, the medical groups required you to see more patients than that. In this group, they finally calculated that a physician seeing a patient every 30 minutes couldn’t support the cost of the overhead required to support the physician FTE. The group began a program that penalized physicians who couldn’t or wouldn’t meet a benchmark based on MGMA (Medical Group Management Association) encounter data. The physicians in the group who were scheduling every 30 minutes quickly left the group, either “retiring” or finding another practice where they didn’t need to see more patients than they wanted (like the VA or another government position). I’m thinking every 20 minutes would be borderline for generating enough revenue to cover the clinic costs, unless your systems were really efficient, since every annual exam would be 40 minutes at a minimum. Under “value-based-reimbursement” (capitation) this low productivity could kill the budget.

As an example, when I was practicing in the 1980’s and 90’s, most physicians used a 15-minute block schedule. Your re-checks and minor acute condition visits were 15 minutes, annual periodic check ups or very complicated patients got two or three blocks (30-45 minutes). Another common method is the 10 minute method. 10 minutes for simple re-checks (like stable Blood Pressure visits), then you can combine 10 minute blocks depending on the circumstances (e.g., three blocks (30 minutes) for an annual exam, four blocks for complicated patients, etc.).

Want to know why we need more doctors?

There have been articles recently in the medical literature concerning physician burnout. BURNOUT?? I couldn’t figure out why physicians who are doing 1/8th of what I did and getting paid as well as I was were feeling burnt out! My reflex reaction was that these folks must be wimps! But, a recent article gave me some insight. Firstly, since being a doctor is a job now, not a calling, the doctor’s internal value system is not aligned with what it takes to be a caregiver. The article documents that physicians who consider being a doctor as a “calling” had less burnout that the ones who classified being a doctor as a “job”. Secondly, practicing medicine is not what it used to be from what I call the “wow” factor perspective. When I was a primary care and saw patients across the continuum I saw some and did some pretty amazing things. I did things that got my adrenaline pumping. I actually saved people’s lives in real time, right on the spot. It was like being a gambler with an intermittent unscheduled rewards pattern (Skinnerian theory) that is a strong reinforcer to keep someone doing the same thing (that’s what fuels gambling addictions). It made the hum drum of office work tolerable. Nowadays, the primary care’s don’t see any really sick patients, they don’t do procedures, they don’t pull someone out of the grave to live years longer. It’s day after day of preventive care and chronic care management. Actually, an APC can do at least 70% of what a physician does in primary care now. They are essentially tweaking care plans and medication doses against a guideline and doing counseling.

So, if it is just a job and it is relatively rote (following chronic care and preventative care guidelines), I can see why these folks get burnt out. To me, Borrring! That’s why I ended up in Urgent Care. Not as intense as ED but plenty of surprises and acutely ill patients requiring quick, high intensity action!!

But, hey, that’s just me!

Here’s some data about being a physician is now perceived by physicians as being more about it being a job than a calling. This data is from the 2017 Medscape physician survey.

Here’s the year over year trend in physician compensation:

In six years, the average salary went up 50%. That’s about an 8% increase a year. Anyone reading this (besides a physician) getting an 8% a year raise?

Here’s the number of hours a week they work:

Eighty-three percent work 55 hours a week or less. Sixty-four percent work less than 45  hours per week.

Here’s the number of hours they spend on “paperwork”:

Fifty-seven percent spend 10-20 hours on paperwork. Subtract that from the 45 hours or less hours worked per week (64% of physicians) and you get 25-35 hours a week or less on direct patient care.

Here’s, by specialty, how they feel about their compensation. For 55 hours or less a week, with an 8% raise a year.

Here’s what they are making “overall”:

So, first question is, how much do you make and how many hours a week do you work?

Here are the “rewards” they say they get from being a physician:

Notice how physician centric these rewards are. “Gratitude” from patients (egotistical?). Being good at what I do (self-serving?). Making good money (great job!) Knowing I’m making the world a better place (a little magnanimous, don’t you think?) Being proud of being a doctor (egotistical?). See anything in there about serving others? How about caring for patients? Nope, all are self-centered.

It gets worse with the challenges:

This list is just as self-centered as the rewards. Having to deal with rules and regulations is number one, not something like coordinating care for my patients. Having to work longer hours for less money. Really? They work 1/3 less hours than I did and they are getting 8% raises a year. Whining? Dealing with difficult patients (oh, poor me!), instead of dealing with the complicated and fractured health care system to get patients what they need. Difficulty getting fair reimbursement (while getting an 8% raise a year). Worrying about being sued (self-centered) instead of worrying that my uninsured or underinsured patients can’t get the care they need because they can’t afford it.

Finally, satisfied with their job enough to say they would go into that specialty again:

Notice where those PCPs are. One-third are disgruntled. This transfers to how physicians interact and relate to patients and how well of a “job” they do. I bet you’ve run into those physicians. It’s a known fact that disgruntled “employees” leads to lower patient satisfaction and employee productivity. Physicians aren’t different in that regard.

Summary of what I got out of this: It’s all about “me” and it’s all about the money.


Physicians first fractured the health care system and then backed out of putting in the time needed to care for the population and complain about their “plight”. Double whammy for patients!


Physicians put their lifestyles ahead of patients or work.

Being a physician to a current physician is more of a job than a calling.

Current physicians do everything they can to avoid “being overwhelmed” and minimize the number of   patients they see through schedule manipulations, deferring patients to others, and being part time.

Physicians’ behaviors exacerbate the “physician shortage” problem. There’s a difference between bodies graduating from medical training and the actual number of FTE (one FTE = a person working 40 hours a week) in the “workforce”. It’s the FTE’s that count.

The Opposite Ends of Universal Health Insurance Coverage

The Opposite Ends of Universal Health Insurance Coverage

I’ve been exposed to health care insurance in one shape or form since I was a child. My parents had Blue Cross Blue Shield (BCBS) beginning in the 1950’s. Back then, you had a deductible and then 80% coverage of the physicians’ bills. In 1965, a clause contained in the Social Security Act established the basis for Usual and Customary (UCR) fee schedules. BCBS changed from 80% of the physicians’ charges to 80% of the BCBS “allowable” (Which means, BCBS developed a “fee schedule” based on a formula that calculated a “usual and customary rate” for each thing a doctor did (UCR); this protected both the insurance company and the beneficiary from excessive charging by health care providers (Excessive charging by health care providers? I’m shocked!! LOL!). A future post will get into how providers, especially hospitals, determine their charges.).

In 1966 The American Medical Association developed its first edition of CPT codes (Current Procedural Technologies), which doctors could use to bill health insurance companies, who would, in turn, determine a UCR fee for each CPT code. I’ll get more into CPT and its perverseness in another post. In short, they describe a service a physician can provide and assign a weight to that service. The more complicated the service, the higher the weighting.

This was generally how all the health insurance companies worked, with BCBS being the predominant payer. They were so dominant and had so much influence that, when I practiced in Massachusetts in 1985, a physician, by a law passed in Massachusetts, had to “accept assignment” for all Massachusetts BCBS beneficiaries. Medicare had mandated accepting assignment first. Accepting assignment means that a doctor, hospital, or other health care supplier agrees to or is required by law to accept the Medicare-approved amount as full payment for covered services, and the doctor, hospital or other health care supplier can’t “balance bill” (ask for more money from) a Medicare beneficiary. So, BCBS was so powerful in Massachusetts, they we able to lobby for this for themselves. No other insurance company in Massachusetts enjoyed this benefit. This seemed to offer an unfair market advantage to BCBS. I wonder how much BCBS paid to legislators in Massachusetts to pass such a bill. After all, it’s all about the money.

In the early 1970’s, Health Maintenance Organizations started up after the passing of the Health Maintenance Organization Act of 1973. This started the “co-pay” phase of health insurance. My version of the history of health care insurance will be detailed in another post. HMO’s got a bad reputation for a number of reasons, but they really weren’t as bad as what was going on in the “establishment” side of medicine. Then the PPO’s arrived as an alternative to HMOs. Recently, we now have high deductible health plans that are touted as a new consumer driven type of health plan, but, really, it is a throwback to the 1950’s-1960’s insurances like the BCBS plans described in the first paragraph. The health care insurance industry is re-packaging its 60-year-old core competency and making it look new. How uncreative.

Then came the Accountable Care Act, which is really a law trying to somewhat standardize benefit plans, revise some aspects of health care financing and promote universal coverage. The problem with the ACA is, a lot of health care industry stakeholders had to be placated to get their support to get the bill passed (like, the Pharmaceutical industry, hospitals, AMA and insurance companies). The ACA has some good things (e.g., no pre-existing condition clauses) and some not so good things (e.g., the health insurance exchanges and everything that goes with them).

Now, the Republicans are trying to repeal the ACA and replace it. Their first attempt failed, and, personally, I’m glad it did; it wasn’t a good proposal. It was mainly a combination of reversing everything in the ACA while adding in some political elements to get legislators to vote for it (like not funding Planned Parenthood for a year, which has nothing to do with anything except some congressmen’s personal paradigm).

There are a lot of folks giving their opinions about what the ACA replacement (or improvement) law should look like. I’m going to give you two that are on the opposite ends of the poles of current proposals that are my own personal coverage fantasies.

Having been in solo practice, physician medical groups, health insurance companies and integrated delivery systems, I have a broad experience with how the design of insurance plans affect people. Having continued seeing patients though it all, I’ve seen the personal impact on my patients. Mostly, not good. Being in the top level of insurance companies, I know how they think and act. One thing I learned was, there are so many stakeholders who benefit financially from the current system that making a true change would be monumental. And the stakeholder with the least leverage is YOU, the patient/beneficiary.

So, here is my “conservative” approach and my “liberal” approach. Both would actually work as long as both are founded in one essential rule: Coverage must be mandated for all US citizens. Any diversion from this will result in a system with the current, or worse, deficiencies that we see in the current prevailing models. I say this because not including every citizen of the USA will result in unsustainable costs per covered life. You need the people not consuming any or many resources to balance against people with serious medical conditions. It’s similar to the school system. We all pay for the public school system (through taxation in this instance) whether we have children in it or not. This keeps the cost for families in school at an affordable level. You could also make the case that Fire and Rescue systems are “insurance” against your house burning down or saving you at the time of a personal health emergency. You’re paying for this through your taxes, you don’t pay individually into the system and only those paying in get to have the fire truck respond to their house. You also don’t pay more or less depending on the number of children you have, the size of your house or the number of health conditions you have. Everyone pays the same. And most people never need those services. Everyone gets that service if an event occurs where Fire or Rescue is needed. And, those of us now paying taxes, are pre-paying for our Medicare Part A, which is “free” when you turn 65 y.o. (Not really free, right? You pre-paid for it). Look at your paystub for the Medicare withholding amount. You are paying 1.45% “tax” and your employer is also paying 1.45%. It’s mandated. Almost all other countries mandate some form of health care coverage. The US is an outlier in allowing discretionary coverage.

And for those of you who don’t like mandated insurance coverage, New Hampshire and Virginia are the only states that don’t mandate automobile insurance. I guess you will have to move there. In Massachusetts you have to show proof of insurance before you can register your car.

The descriptions that follow are high level versions. There would obviously be details that would need addressing.

The Conservative Approach

All citizens would be required to participate. If someone were indigent, they would be automatically enrolled in a government-funded program like Medicaid. If you were working and your income was at or below the poverty level (usually about $25,000 a year for a family of four, $12,000 a year for a single person), you would get a government subsidy.

In 2017, the average annual premium for a commercial family plan in the US is about $18,000. In most companies, the employee pays a portion and the employer pays a portion. The average annual premium for a single person is about $6500.

Now, most companies include the benefits they offer employees as part of what they call an employee’s “total compensation”. So, they will tell you your gross salary is, say, $100,000, but that your total personal cost to the company is $130,000 (i.e., you are really getting $130,000 from the company) because of the benefits for which they are paying. If you sign up for them, they cost about 30% of your salary. They don’t mandate that you sign up, of course, but they are willing to pay it if you do.

So, the employers are paying a certain percentage of the 30% for benefits on health insurance. As a theoretical example, let’s say it is ~50% of the 30% or 15% of your salary. If you are making $100, 000 that would be $15,000 and you would be paying $3,000 in premiums deducted from your paycheck. That percentage could be higher or lower depending on how much the health plan costs and what the cost sharing between employer and you are paying.

With my model, the employer would be mandated to pay either a set dollar amount based on actuarial formulas or a  percentage of your salary, approximating what they are paying now for health insurance, into a Health Savings Account (HSA) in your name, and you would be mandated to pay into the HSA (pre-tax dollars and not taxable if you spend it on health care) whatever your portion is. They are taking something like this out of your paycheck already. You would immediately have ~$18,000 tax-free dollars (using the example of the average family cost noted above) to pay medical bills. The employer portion could be a lump sum at the beginning of the year to get you started, then you could accrue your portion during the year from paycheck deductions, just like what happens now. There could be a rule that the employer must contribute at least 50% of the set dollar amount or percentage of salary described above. After all, they say they are really paying you ~130% of your gross salary. Let’s keep it that way!

In addition, you would be mandated to buy “catastrophic” insurance that only covers things like hospitalizations and other high cost care like cancer treatment, and they usually have a high deductible. The family premiums for these are currently about $175 a month and have an average deductible of about $6300. The premium for this would come out of your HSA.

If you are a young family of four who is healthy (which they generally are) you could amass almost $100,000 in your HSA in 5 years. If you are a twenty-something and single, you’d have about $60,000 in your HSA by the time you are 30.

And, IT IS YOURS! FOREVER! Unless you have to spend it. And you get interest on it! And the catastrophic insurance protects you from the really large bills, like cancer treatment or a heart attack.

You would pay for your “routine” and lower cost health care out of your HSA account with a credit card.

This model simplifies the administrative aspects of financing health care and significantly reduces administrative costs because it becomes mostly a cash business. You just swipe your HSA credit card. You have no idea how complicated and costly the current administrative system is now. (See my post about Administrative Costs)

With this model, there is no “single payer”. You don’t need insurance exchanges. The government isn’t intervening. It’s a conservative’s dream. And the employers are already paying this, so, it’s not a big hit to them. Since you are paying directly for most services, there could be more price competition, just like other markets (although, there is expert economist opinion that the health care market doesn’t operate the same way other markets do). It could likely spur more transparency in prices and quality.

The Liberal Approach

All citizens would be required to participate. If someone were indigent, they would be automatically enrolled in a government-funded program like Medicaid. If you are working and your income was at or below the poverty level, you would get a government subsidy.

If you were working, the “premium” for insurance would be a tax taken out of your paycheck and sent to the US Government. This is the model of most countries globally.

You get immediate coverage. There may or may not be co-pays. Everyone is in.

There are two ways the money gets disbursed from the government:

Option 1. A single payer gets the money. This could be a government run system (like the VA or Medicare or a combination of the two) or the government could contract with a single private insurance company to administer it. As a matter of fact, the CEO of United Health Group/United Health Care said in the 1990’s that he was positioning United Health Care to be the single payer when the time finally came. One of his goals was to have United Health Care operating in all 50 states.

You would still have the ability to go outside the single payer system at your own personal cost, but it wouldn’t affect your tax liability for the coverage. Everyone’s contribution is the same, just like your contribution to the school system is the same even if you send your kids to private school or don’t have kids.

Option 2. There would continue to be multiple competing health insurance companies. You get to choose which one you want. The government sends a standard premium amount to the company of your choice for a standardized  set of benefits. This is similar to Medicare Advantage where, as a Medicare beneficiary, you get to choose the insurance company and Medicare sends them a standard premium for a standardized set of benefits. The insurance company tries to manage the care so they make money. If you want more than the standard coverage, you pay an extra premium out of pocket. The government already has a system to disburse premiums to insurance companies, so it wouldn’t be a stretch for them to do it for everyone.

Since everyone would have the same benefit design, the administrative costs would be reduced. Since the premium would be dictated by the government, the costs would be more controllable. Since everyone working would be paying, the risk pool would be adequate. Insurance companies would be interested in the second option. The government could negotiate better prices with Pharma and other suppliers. Hospital payments would likely be lower, as the government could fix the fee schedules (like they do now with Medicare) and could allow negotiations between insurance companies and health care providers like physicians and hospitals if the price is lower than the standard fee schedule (back in the 1990’s I negotiated hospital and physician fee schedules to be Medicare rates minus 10-20%!). As you will see in a future post, prices for health care services is the number one reason why our health care costs so much (Commonwealth Fund data). So there seems to be room for lowering prices. Of course, someone would have to take a pay cut, like Specialists, Pharma and hospitals, for example. They would likely lobby aggressively against this model, since….it is all about the money.


All of this is kind of like Occam’s razor, the simplest solution is usually the best. Unfortunately, neither of these is likely to happen, since significant stakeholders are likely to lose business and they have legislators in their pockets or are willing to pay a lot to buy their votes. Remember, Money drives the decisions in our healthcare and political systems. And no one wants to lose his or hers.

The Rude Awakening about Hospitals and the US Healthcare System

My Rude Awakening about Hospitals and the US Healthcare System

It’s July 5, 1982. I arrived on July 3 for the start of my National Health Service Corps stint and, obviously, July 4 was a holiday. Yesterday I was invited to a small cookout where I met some local residents who were very nice and who told me that my physician counterpart at the clinic was on vacation that week, meaning, I was on my own. For the week. Me, a physician just graduating from the somewhat sheltered life of academic medicine with no transitional mentor.

I was now an LMD (Local Medical Doctor). LMD’s were routinely derided where I trained (and every other academic medical center, I learned from talking with other physicians my same age). They were essentially thought of as not knowing very much and the academic medical center had to fix their mistakes.

I was told clinic hours started at 0800h, so, I arrived at the clinic at about 0745h. I met the staff, Jane, LPN, Linda, LPN and Mary, the receptionist. Audrey, the clinic manager, who also managed two other clinics, wasn’t there. Jane showed me where everything was, what I was supposed to do with the encounter sheet, and said, “We have a full schedule today, 24 patients. Dr. Allen (the physician on vacation) has never seen that many in a day!” I said, “I guess we’ll have to put our roller skates on!” I’d never seen more than a half dozen patients in a session of “General Medicine Clinic” while in training.

The clinic had been taken over by a Community Health Care System from a Dr. Peterman. Dr. Peterman was used to seeing over 40 patients a day. Dr. Peterman turned out to be an impaired physician and was currently working for a blood bank in the Big City, but he still lived in Smalltown. He would stop by the hospital on his way home to see what was going on and he would often sneak into the OR area and sniff nitrous oxide. After reviewing his medical records, it was obvious that he wasn’t very thorough, with lots of chronic illnesses being uncontrolled.

I started seeing patients at 0800h. Blood pressure checks, a sprain, a Pap smear, a well child check, etc. Halfway into the morning, I got a call from the hospital. They wanted to know if I was going to round on the inpatients. No one had told me I was supposed to do that. There were 3 patients in the house. I told them I would see them during lunch. My next patient came in for a blood pressure check. He was on SerApEs, Dr. Peterman’s go-to BP med. While I was examining him, I noticed he was having runs of tachycardia. He also wanted me to check out a growth on his chest wall. The “growth” was a quarter inch irregular subcutaneous nodule that was rock hard. We did an ECG and he was having runs of ventricular tachycardia (V-Tach). I immediately had him ushered over to the hospital (which was only an alley way from the clinic back door). They had just installed a 2 bed “ICU” at the hospital across from the (only) nursing station. I had them put him on the monitor and checked a battery of tests. It turned out his potassium was below 2.0, likely due to the diuretic in SerApEs. I ordered runs of IV potassium.

I finished up my morning patients and went over to the hospital. The cardiac monitoring main-station was on the counter top of the main (only) nurse’s station. The hospital was a 20 bed one story hospital with a small OR area and one delivery room with a one bed labor room. I checked on the patient I admitted and rounded on the other three patients, who were divided between Dr. Allen and a long-time local physician who was in a clinic about 20 miles away in Farm City, Dr. Nixon, who I had never met. Everyone was stable so I ate a quick lunch from the hospital kitchen and went back to the clinic for the afternoon.

I saw the rest of my patients. Jane was impressed that I had seen the 24 patients plus all of the goings on of the day.

I went back over to the hospital. I saw my ICU patient. He still needed more potassium. He had no evidence for a heart attack, so this was mainly a metabolic problem. As I was writing my note on the patient, he had a 10-12 beat run of V-Tach. I asked the nurse to hit the button to get a strip so I could put it in the chart. But, by the time she hit the button, the V-Tach was gone and the strip was normal. This perplexed me because all of the monitoring stations I have been exposed to in training had a 10-15 second memory. The nurse said the one they were renting had no memory. This meant it was only possible to document a dysrhythmia if it lasted long enough for someone to notice and hit the button fast enough.

I asked the nurse if she knew what the rhythm was. She got up and walked over to a chart with rhythm examples that was tacked up on the wall. She scanned the chart and picked a rhythm that she thought matched the rhythm. “It looks like ventricular tachycardia”, she said. I asked. “What do you do if that rhythm doesn’t stop?” She said, “I call you.” I said, “I know you call me but what do you do while waiting for me?” She said, “ We just call you.” I asked, “Haven’t you had training on how to respond to things like this while waiting for me to arrive? I don’t have a phone yet, I’m only going to have the pager and I live two blocks from here. I won’t know why you paged me and I can’t give you phone orders.” She said, “The administration has decided they don’t have the money to train us. The Stockholm hospital (35 miles away) started an ICU and they trained the nurses, but we aren’t getting that.”

I sat there for about 45 minutes writing out protocols for the various scenarios the patient might get into during the night (and their immediate treatment) and went over them with the nurse. At night, there was only an LPN or an RN and a nurse’s aide in the hospital. Luckily, the patient made it through the night without incident and he had a normal potassium by the morning. We watched him one more day, through which he had no more runs of V-Tach and he was discharged. Unfortunately, his chest X-ray had a mass in his lung, and the excisional biopsy of the chest lesion was metastatic squamous cell lung cancer.

The next day, right after rounding on the inpatients, I went to the administrator’s office. The administrator, Harry, was at his desk. I explained to him that the rented monitor station had to be replaced with one with memory and that the nurses required training. He said they would look into changing out the monitoring station but, there was no money for nurse training. I said, “You can’t have an ICU and not have trained nursing staff”. He said, “We’re not shutting down the ICU, it’s a money maker for us. We need the revenue. You’ll just have to make do.” I said, “You’re putting people’s lives in danger. If you don’t train the nurses you either have to shut down the ICU or I’ll transfer all ICU patients to the Big City.” He said, “ We’ll be informing the staff to ignore your transfer orders. We are not shutting down the ICU. We need the patients here and in our ICU. We need the revenue, it’s a money-maker.”

This is the moment when I realized that healthcare/hospital systems do not primarily have the best interests of patients in mind. Money came first. It was a hard lesson to learn so soon out of training (first day!). Healthcare systems are “for” patients and “quality care” as long as there is a positive margin/profit involved. Otherwise, the decision favors the bottom line.

I had the nurses query the Stockholm Hospital nurses to find out how they were trained and what materials they used. I had the nurses purchase their own textbook, I purchased the instructor materials and text book, including ECG and rhythm-strip slides and spent the next six months every Wednesday night training the nurses in Cardiac Critical Care. At my and their expense. The hospital never kicked in funds. The nurses all passed their final exam and did excellent cardiac critical care going forward. They really cared about the patients.

The hospital, not so much.

The Real Story Behind the Opioid Epidemic

The Real Story Behind the Opioid Epidemic

There seems to be a news story about it almost every day. The statistics are horrifying. Since 1999, the rate of overdose deaths involving opioids—including prescription opioid pain relievers and heroin—nearly quadrupled, and over 165,000 people have died from prescription opioid overdoses. (HHS Bulletin The Opioid Epidemic: By the Numbers). Remember the year, 1999. We are spending 55 billion dollars a year in health and social costs related to prescription opioid abuse each year and $20 billion in emergency department and inpatient care for opioid poisonings. (Source: Pain Med. 2011;12(4):657-67.1 2013;14(10):1534-47.2).

How did this happen?

Three words: The Joint Commission. Yes, that accrediting agency that accredits your hospital.

Back before 1995, physicians were very judicious with their prescribing of opioids. The general opinion then was you should minimize prescribing of opioids and you were strongly discouraged to prescribe them for chronic pain. We were told they didn’t really work for chronic pain because the neural pathways were different between acute and chronic pain. The State Pharmacy Boards were monitoring your opioid use for anything but codeine containing pain medications.

Here are a couple of examples:

Example 1:

It’s 1983. About every 4 months or so, a male patient would come in to see me. He had a diagnosis of Migraine. This is the only thing I saw him for. He had no other active medical problems and, according to him, he generally used over the counter pain meds for most of his migraines. However, occasionally he got a really bad one and had been prescribed a small prescription of Dilaudid (hydromorphone, a pretty strong opioid) for those by a neurologist. He would ask for 10 of these. That meant he used about 2 a month. This didn’t seem like a problem to me, so I would refill this for him.

In early 1984, two people from the Board of Pharmacy visited my office in the middle of my afternoon session. They told me that they expected that I would not prescribe Dilaudid for this patient again. The reason was, the patient had been driving up and down about 200 miles of the Interstate, visiting multiple doctors asking for the same thing, 10 Dilaudid’s. No individual physician thought it was a problem, just like me. He was actually getting several hundred during a four month period. Yes, they were watching and they did something about it.

Example 2:

It’s 1985. I’m in a different state from Example 1. I saw a new male patient; I’d never seen him before. He comes in complaining of a bad cold and a really bad cough. It is keeping him up at night. This happens often when he gets a cold. He just moved here from California and his Primary Care in CA prescribed him Tussionex because it was “the only thing that worked”. I examine him, his exam is consistent with a cold. I prescribe him 200ml of Tussionex, which I had never heard of before that day, but it appeared to be a reasonable anti-tussive in the Physicians Desk Reference (PDR). There was no mention of anything like abuse potential in the PDR. Tussionex is comprised of hydrocodone and chlorpheniramine (an antihistamine) in time-release beads.

The next week, a fellow from the Board of Pharmacy comes in and tells me the patient to whom I had prescribed Tussionex was going around getting prescriptions from multiple physicians. He informed me that Tussionex was very addicting and I shouldn’t be prescribing it at all! Yes, they were watching and they did something about it.

Back then, before 1995, I rarely, if ever, prescribed anything stronger than Tylenol #3. That’s the way I was trained. Stronger opioids were for terminal cancer patients, not the acute pain we saw in the ER and in our offices. We mostly told patients to use aspirin, Tylenol or ibuprofen (which went over the counter in 1983). And, as I mentioned above, opioids were frowned upon for chronic pain. If anyone was on them for any period of time you worked to get them off. In my case, they got the opiates from surgeons after an injury or surgery, not initially from me.

Just to give you an idea about how reluctant we were to prescribe opioids, here’s a story from when I was in training. I was the Senior Resident in training. One of my and my intern’s patients was a fellow who was admitted with abdominal pain to the GI service. He was highly suspected of being a drug abuser and also of selling drugs. He was in the middle of a several day work up when a long holiday weekend “interrupted” his work up. The patient brokered a “weekend pass” from the attending since nothing was going to happen for three days (that’s the way it was back then!). The patient requested Percocet (oxycodone and acetaminophen) for pain control. The attending physician told me to write out a prescription for 30 Percocets. We argued with the attending that the patient was more likely to sell these than take them and we didn’t want to write the prescription for 10 Percocets a day (a lot). I finally told the attending that, if he wanted the patient to have the Percocets, he would have to write the prescription himself, which he did. When the patient came back, he had no leftover Percocets. So he either took 10 a day or he sold them. We always suspected that he sold most of them.

In 1996, The American Pain Society and other pain societies began advocating for the use of opioids for chronic pain and suggested that pain should be the “fifth vital sign”. This notion was based on only one journal letter (one paragraph with minimal details, not peer reviewed, no statistical analysis, no description of the study design, etc.) by one pain specialist without any credible data to support his recommendations (Jane Porter and Hershel Jick, MD, “Addiction Rare In Patients Treated With Narcotics”, NEJM, Vol. 302, No. 2, 1980). The Veteran’s Administration agreed with that approach and declared pain as the fifth vital sign. The Joint Commission picked up on this and in 2000 declared that all accredited hospitals had to adopt pain as the fifth vital sign and generated standards not only to that effect, but that all patients had to be assessed, treated and reassessed and that the medical record had to show decreases in the patient’s pain level reporting. They advocated that adequate pain management was a “patient right”. That’s how strongly The Joint Commission pushed this. Hospitals, including academic hospitals, were afraid of getting a “finding” (a ding) which would affect their accreditation status, so they advocated using whatever medication necessary to make sure patients’ pain scores decreased during their hospital stays. And the patient more than often went home on these medications. The Joint Commission also included that staff needed to be educated about pain and its treatment, which was aligned with the Pain Societies’ new guidelines promoting an increase in the use of opioids for acute pain and opioids for chronic pain. So, physicians in training were now being told to prescribe the more powerful opioids. Vicodin (hydrocodone and acetaminophen) became the drug of choice for most physicians. Since The Joint Commission was accrediting about 4500 of the 5500 hospitals in the US, the impact was incredible. (By comparison, the VA has only 168 hospitals). The Pharmacy Boards were no longer dogging opioid prescribing like it did before 1995 because, well, everyone thought it was the right thing to do.

For more detailed information about this see the JAMA supplement written by David W. Baker, MD, MPH from February 23, 2017.

Of course, none of this was lost on the Pharmaceutical Industry. They immediately began aggressively marketing their opioid drugs. Since The Joint Commission had mandated training and education in their standards, the Pharmaceutical companies started offering free education session to “help” the hospitals fulfill the standards. One opioid manufacturing drug company provided all-expense-paid “speaker training conferences” where they “trained” 5000 practitioners, then provided 20,000 “pain education programs” to hospitals trying to avoid a “finding” or loss of accreditation by The Joint Commission. The drug company revenue increased from $48,000,000 in annual sales of their drug to $1.1 billion. And this is only one example of this. The usual Pharma opportunistic behavior with total disregard to patient impact. I can hear them saying, “I don’t write the prescriptions. The doctor does. We just create the supply.”

All of this shifted the culture. But it started with the American Pain Society, the VA system and The Joint Commission (who had the largest influence by far).

I had to take a hiatus from seeing patients between 1996 and 2003. When I got back into practice in 2003, I was seeing same day appointments and I couldn’t believe how many patients were on Vicodin and Percocet! Especially Vicodin. I don’t think I ever prescribed Vicodin before 2003. Physicians now had a very low threshold for prescribing opioids. Understandable, since that was how they were trained. It was (maybe still is) so bad that, I know physicians who were prescribing Vicodin for coughs! (Remember Tussionex has hydrocodone in it, it is a cough suppressant). You can imagine what happened to those!

Here’s a personal example. I had a minor orthopedic surgical procedure. It was under general anesthesia in an outpatient surgery center. My wife took me home, then went to the pharmacy to fill the prescription the surgeon had written for me. It was 40 Percocets! I took one. I destroyed the other 39. There are studies showing that people use only about 10% of the opioids prescribed for them by surgeons. (“Prescription Opioid Analgesics Commonly Unused After Surgery”; Mark C. Bicket, MD, et al; JAMA Surgery Published online August 2, 2017)They frequently get 40-60 tablets and use only 4-6 tablets. Gee, what happens to the other 34-54 tablets? In the JAMASurgery systematic review, only 9% of patients disposed of their opioids according to FDA recommended disposal methods.

As the opioid epidemic evolved there was more and more concern that The Joint Commission (TJC) stance was leading to an over reliance on opioids and over prescribing by physicians. TJC started to back off on the strength and emphasis of its pain standards and eliminated them in 2009. Unfortunately, the damage was already done.

Now the trend is reversing again but not as fast and thorough enough yet. The recent recommendations in the US tend to still be medication based, not including alternatives to medication, or recommending not prescribing opioids at all (It’s hard to get addicted if you never get an opioid). People did relatively well before 1996 when we were discouraged from using opioids. Why not return to that? The Scottish recommendations/guidelines for pain control , for example, are predominantly non-medication based. Maybe the US efforts are more medication based because of the Pharmaceutical industry influence in the US, which is much stronger than other countries.

I took a chronic pain elective in 1981 while in training. That program was run by an internist. The main goal of the program was to eliminate opioids if they were being prescribed, and use non-medication interventions (like guided imagery, relaxation exercises, etc) instead of medications. He was specific with patients about the fact that the program would not eliminate their pain but make it manageable and they would live a normal life. I took a lot of notes and photocopied a lot of protocols and articles while in that program and used his techniques in my practice.

Since the opioid epidemic reaction by regulators (meaning, for example, I have to take an all day pain management course every three years to maintain my medical license) I have attended two mandatory pain management seminars. In both, 100% of the teaching is related to using medications. These seminars were led by a University medical school group of “pain specialists”. They never talked about the non-medication interventions I was taught and that are in the Scottish pain treatment guidelines. I actually spoke to them about this after the seminars and their answer was, there wasn’t anyone available to do the non-medication interventions, and they weren’t interested in building them at the University. I also emphasized that managing chronic pain is a PCP issue. Unfortunately, the PCPs nowadays have no idea nor do they have the support systems to do this so patients get referred to pain specialists who are mostly anesthesiologists who want to give everyone injections.

Anytime I described the way chronic pain should be managed, it fell on deaf ears. It is time and labor intensive for practitioners, but, it works. I Have many stories about how successful it is.

To my delight (but probably not of interest to others) an article came out on May 18, 2017 advocating for exactly what I’d been taught 30 years ago! (Primary Care of PatientsWith Chronic Pain, Jill Schneiderhan,MD, et al, JAMA, May 18, 2017). If we could swing the management of chronic pain as described in this article and stop prescribing opioids stronger than Tylenol #3, we’d actually be doing something that benefits the patients.

Anyway, if any of my loved ones died of an overdose that started with prescription drugs prescribed by a practitioner, even if the overdose drug was a different drug like heroin, I would sue The Joint Commission. My opinion is, they were negligent in adopting the standards they did; they were the major impetus to the current opioid epidemic. They did not do their due diligence relative to the strength of the literature/data or the consequences of their position and their standards, and their standards were ultimately the major influence on physician opioid prescribing behavior.

The FDA, the USPTO and the Pharmaceutical Industry

The FDA, the USPTO and the Pharmaceutical Industry 

There is enough evidence for one to be very suspicious relative to the relationship between the FDA, the USPTO (Patent Office) and the Pharmaceutical industry. One can only imagine how much money from the Pharmaceutical industry is influencing the FDA’s and USPTO’s decisions. But don’t take my word for it, just Google “collusion between the FDA and the Pharmaceutical industry”.

There are instances where the FDA has approved either human drugs or animal feeds that never should have been approved and there are allegations of collusion. There’s the fast tracking of drugs whose data doesn’t support approval. And more. I won’t repeat all of the concerns here. You can look those up.

The ones that irk me the most are:

  1. Allowing the same drug to be re-marketed as a new drug when it isn’t.
  2. Strongly supporting discarding all drugs according to an expiration date supplied by the manufacturer when studies show the expiration dates can be as long as 10-20 years.

All of the above result in Pharma making astronomical profits for no reason.

Remember, it’s all about the money.

Let’s look at these.

Allowing the same drug to be re-marketed as a new drug when it isn’t.

I’ve mentioned this one before. To recap, often, when a drug is synthesized it is a blend of two “isomers”. This means that the manufacturing process creates the exact same molecule except that the arrangement of the atoms in the molecule form in a right or left-handed arrangement. Test this out yourself. Hold up both of your hands. They both have a palm and five fingers and look the same except one has the thumb on the right and one has the thumb on the left, with the other fingers following suit. Your hands are “isomers”. They both do the same thing, they are just mirror images of each other.

Well, drugs do this, too. The mixture of the two isomers is called a racemic mixture. Depending on which naming method a company uses, the drug has R (rectus/right) or L (levo/left)or D (dextro/right) or S (sinister/left) isomers.

One major fact with most drugs is, one “hand” is often active and the other is inactive, whereas both your hands are active unless you had an accident, stroke or congenital anomaly. If you remove the inactive 50% (isomer), you only have to take ½ of the milligrams of the dose of the racemic mixture. It’s just third grade math.

Instead of the FDA and the USPTO having a rule that the drug company should submit the approval for the drug based on its active isomer, the FDA and USPTO approves the racemic mixture with exclusivity rights. The FDA and USPTO should reject the second applications for the active-isomer-only on the basis that the drug is not new, just “filtered” or “sorted”.

This goes hand in hand with patenting. A drug company gets a patent for the racemic mixture for 14 years. Then, as the patent is running out, the drug company separates the two isomers and the USPTO approves the active isomer as a new drug, giving the drug company another exclusivity period and the ability to call it something different and it is now a “new brand drug” for 14 more years! I wonder how much money changed hands there! Maybe they need an inservice from a PharmD!

With this new FDA and USPTO approval, the drug company can now legally market the drug as a new drug exclusively. And charge prices that are up to 10 times the cost of the drug going off patent and now called generic, even though it is the same drug.

The biggest offender is Nexium. Read about that in my first Pharmaceutical Industry post.

The latest is Xyzal. There’s an ad about it 2-3 times an hour on TV. It’s drug name is levocetirizine. It is the left-hand isomer of cetirizine which is Zyrtec. Heard of that? Thirty-five Xyzal at Walmart costs $17.96 or 51 cents a tablet. You can get 180 cetirizine at Walmart for $29.86 or 17 cents a tablet. The only difference is….the dose. Cetirizine/Zyrtec is 10 mg and Xyzal is 5 mg. Exactly as you would predict. Same drug, three times the cost. And people will buy it because they don’t know it is the same drug, they think it is new and “better” because that’s what the ad is saying. Terrible!!!

This should never be allowed. It’s a total rip off of the US population. Here’s some another examples.

Back before 2013, inhalers for Asthma and Chronic Obstructive Pulmonary Diseases (COPD) had CFC’s (Chlorofluorocarbons) as the propellant in them. These are inert and don’t affect the actual drug performance. They affect the ozone layer, so they were banned. CFC’s just push the drug out. Almost all of the CFC inhalers were generic and cost about $15 per canister.

After Dec 31 2013, the propellant had to be non-CFC. The drug companies switched the propellant to HFA’s (Hydrofluoroalkanes). Folks, this is merely the gas used to push the drug out of the canister! The FDA and USPTO allowed the drug companies to call these inhalers “new”, meaning they were again “branded” drugs with exclusivity. This allowed the drug companies to charge $30-45 a canister. The “generic” market completely disappeared because the CFC’s were banned. People with Asthma and COPD now either had to pay 2-3 times what they were paying or, if they had drug coverage with their insurance, they had to pay the “brand” co-pay, which generally went from $10 per canister to, generally, $40 per canister, a four-fold increase!! Overnight! Guess who made a lot of MONEY? Same active drug in the canister. 3-4 times the revenue for the drug company. Really? How does a propellant change warrant a 40 year old drug now becoming brand name again? For 14 years?

This should never be allowed. It’s a total rip off of the US population.

Expiration dates on drugs.

This is a sacred cow subject. As you all know, there is an expiration date stamped on every bottle of medications.

The USP says that the expiration date is “the time during which the article may be expected to meet the requirements of the pharmacopial monograph provided it is kept under the prescribed conditions.”

The dates are usually 1-3 years from the time of manufacture. This doesn’t mean that the day after the expiration date the drug is no good or is toxic. As a matter of fact, the vast majority of drugs in tablet form are good for ten or more years after manufacture. Using 1-3 years instead of 10-15 gives the drug company freedom from any liability due to a legal challenge of inadequate potency. Studies done by the US government and private research show that most drugs still have >90% of their potency after 10-20 years, depending on the study length. Interestingly, the drug companies themselves don’t test the potency of their drugs over time! Guess why? If they did and they determined their drugs were still clinically potent enough after 20 years, they would…guess what…MAKE LESS MONEY! (Remember, it’s all about the money)

I mean, really, how old are the major drug companies?:

Bayer founded 1863

Merck 1891

Pfizer 1849

Schering-Plow 1851

Bristol-Myer Squibb 1887

SmithKline 1715

Beecham 1842

Lilly 1876

Are you getting the picture?

You mean these companies couldn’t put a case or two of each of their medicines in a warehouse somewhere and tested them every 5 years until the potency was so low the drug wouldn’t be therapeutic anymore? Really? Of course not! People would keep their drugs longer and the drug company WOULD MAKE LESS MONEY!

And, the FDA is very adamant that no one should take any medication beyond its expiration date, even though they must know the literature on this. They’ve developed “take-back” programs and scare the bejesus out of the general public into throwing their drugs away.

The available research data supports expiration dates farther into the future than any drug company determines. And, except for one form of tetracycline from 1963 which is no longer on the market, there are no reports of a drug “going toxic”, which the FDA also proposes can be the case.

So what’s going on? Well, the FDA is, first, covering its ass. Secondly, they are promoting discarding and destroying perfectly good drugs so drug companies can make as much money as possible. In the hospitals I worked at, in the nurses’ med rooms, there are these big flushing sinks where the nurses would purge expired drugs. The cost to the global population is huge. Of course, the drug companies are MAKING A TON OF MONEY because of this. (Remember, it’s all about the money)

A USA Today article cited that we throw away about 250 million pounds of drugs a year because they “expire”.

Now, there are some drugs you don’t want to take after their expiration dates. Some degrade quickly. These are mostly drugs in liquid form, like epinephrine, certain IV antibiotic drugs or drugs that have to be reconstituted from a powder. Insulin is another one.

Another category is drugs with narrow therapeutic indices or unique handling in the body. For example, if you have to have a blood test to measure the levels of a drug in your body, you shouldn’t take these after their expiration date. Not because it definitely isn’t good anymore, it’s because the drug company hasn’t tested its degradation rate and you don’t know. And even a 10% reduction in a drug like Dilantin (for seizures) or digoxin (for heart problems) or warfarin (Coumadin) (for blood thinning) could get you in trouble.

So, this issue is clearly due to the Pharmaceutical industry refusing to do these studies so people know the truth. And the FDA doesn’t mandate that the drug company needs to provide that data. They should, as part of the approval process, mandate potency and, I guess, toxicity testing for at least 20 years from the initial manufacture date, i.e., the first couple of cases of the drug should be saved and tested. But, Noooo! Let’s just throw the stuff out so the drug companies make money from providers and patients disposing of and re-buying drugs to sustain the drug companis’ double-digit profits.

After all, it’s all about the money, not the truth.

Addendum September 21, 2017: So, if you think this is just me ranting here’s a reference for you backing up whatever I’ve written in this blog-site. “Strategies That Delay Market Entry of Generic Drugs”, Kerstin Noëlle Vokinger,MD, JD, et al; JAMA Internal Medicine Published online September 18, 2017. Pretty much saying the same things I am, but more eloquently. The FDA and USPTO facilitates Pharma making as much money as possible.

Clinical Quality, the #4 priority in health care.

Clinical Quality, the #4 priority in health care.

If you refer to the front page of this website, you’ll see that I am placing Clinical Quality #4 on the list. This is referring to the quality of the care that is being delivered to you, the patient. In a series of upcoming posts, you will see why this is #4.

The Institute of Medicine (IOM) defined quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”

My definition is simpler: The right thing happens at the right time, in the right place and without defects.

Do you notice how relatively ambiguous the IOM definition is? Sort of sounds like political gobbledy-gook, doesn’t it? Yup, that’s how the medical community and industry talk about quality.

Before delving into the details, it’s helpful to know some of the history.

Before 1965, there were no organized quality programs in medicine anywhere. Nope, not even in hospitals. The quality of care was dependent on the culture of a health care entity, like The Mayo Clinic. At the same time, no one was measuring anything, so, clinical quality was mainly based on anecdotes (“ my local doctors weren’t making me better so I went to The Mayo Clinic and I’m better now”).

So, let’s go way back.

There were some historical events that improved clinical quality which were based on one really smart clinician figuring something out and aggressively championing an improvement. It wasn’t generally a group activity or promoted by “the administration” or the “medical community”. Here are two examples:

In 1850, Ignaz Semmelweis noticed that post partum women cared for by obstetricians were dying of infections. He noticed that the incidence of these infections was a lot lower in the wards attended by midwives. The difference he noted was, the doctors were tending to other ill patients and doing autopsies, and the midwives only delivered babies. The physicians would come to the labor and delivery rooms or the post-partum wards immediately after working on the ill or dead patients without washing their hands. He theorized that there was something on their hands that was spreading the infections. He didn’t know what that was. (Louis Pasteur figured that out later.) Semmelwies tested his theory by having physicians wash their hands with a chlorinated lime solution. The infection rate plummeted dramatically.

Here’s a sentence you’ll see again…His ideas were rejected by the medical community.

Florence Nightingale noticed that soldiers did worse in facilities where the conditions were poor and unsanitary. She championed making things as clean as possible, improving hygiene and improving working conditions for caregivers. The death rates plummeted. She also created and promoted standards of care for nurses. Interestingly, she was criticized.

Semmelweis and Nightingale were what some people call “heroic” leaders. They worked tirelessly to maintain the improvements they believed were critical to good patient care despite resistance from the medical community. A lot of what Nightingale proposed became ingrained in nursing. Interestingly, except for surgery and OB, Semmelweis’ hand washing went by the wayside. Doctors and nurses and other staff went from room to room without washing hands. I was never trained to wash hands in between patients unless you touched something obviously contaminated or infected. No one wore gloves unless you were doing a sterile procedure. It wasn’t until 1995 that the CDC officially proposed that clinical staff wash hands before entering and upon leaving hospital rooms and outpatient exam rooms. To this day, getting everyone to consistently wash his/her hands is an issue, despite a national call to action about it. Yes, centuries after Semmelweis figured that out, medical staff still don’t consistently wash their hands.

These notable heroic leaders pretty much promoted or dictated tasks. Wash your hands, sanitize hospital wards, etc. They didn’t really look at the process of care longitudinally. It was more insert a task or change a task. The task-oriented culture is the Achilles heel of the medical industry. We’ll get to that later.

Anyway, with heroic leaders, when they leave, things mostly fall apart unless someone equally passionate about the subject stays behind to sustain it. What is really needed is a “non-heroic” leader.

Ever heard the sentence, “Give a man a fish and he will eat for the day, teach him how to fish and he will never be hungry”? How about “some people tell time and some people are clock builders”?

A non-heroic leader teaches people to fish, and they build clocks so when they leave, people won’t go hungry and they have a way to tell time.

The first real non-heroic-type leader in medicine was Ernest Codman. He was the first to propose measuring things and setting up systems to mitigate errors. This is different than promoting tasks. Codman was a Harvard trained surgeon who was one of the founding fathers the Society of Surgeons, a precursor to the American College of Surgeons. He was practicing successfully at Massachusetts General Hospital when he came up with the idea of what he called “The End Result”. In Codman’s words, The End Result was, “The common sense notion that every hospital should follow every patient it treats, long enough to determine whether or not the treatment has been successful, and then to inquire, ‘If not, why not?’ with a view to preventing similar failures in the future”. This was the first known suggestion that the process of taking care of people should be examined and improved. Codman started keeping ledgers of all of the surgeries performed at Mass General. The other surgeons didn’t like this. The idea was met with a lot of resistance. He was actually hated by other doctors. Codman presented his End Result idea at a Surgeon’s Society meeting where he portrayed surgeons as greedy surgeons grasping for wealthy people’s money. (See, even back then, it seems, it was all about the money). The medical community at Mass General went ballistic. He was asked to resign and was ostracized. Some stories about his leaving Mass General say the other doctors burned his surgery ledgers. Codman opened his own hospital and applied his End Result idea. He wrote books about it including case reports. But, the medical community of the time never adopted his approach. He also was a champion of hospital efficiency, and actually wrote a book about that. But for a long, long time, his ideas were rejected by the medical community.

As a matter of fact, the exact opposite of what Codman championed occurred. Medicine became veiled in secrecy and no one wanted to talk about anything that didn’t go well. Unless a doctor did something so egregious that it was criminal or near criminal, doctors were pretty much left alone. Believe it or not, there is still a large component of this going on today. People only knew about medical “misadventures” when someone filed a medical malpractice lawsuit. State Medical Boards were pretty impotent, acting more like the “good old boy” system. I commonly heard, “We can’t really do something about this because this could have been me.”

It wasn’t until 1965 that some sort of organized quality program began, and only in hospitals. And it was only because of when the Medicare and Medicaid laws were passed. The laws called for certain standards to be met to ensure beneficiaries were getting appropriate care. Medicare called this Conditions of Participation. It was mostly utilization review, not quality improvement. There weren’t a lot of prescribed details. There weren’t any significant improvements. So Medicare mandated quality programs and started PSRO’s (these were committees of physicians and largely failed to make any impact) and QIO’s (these exist today). In the beginning, the hospitals, searching for something structured on which to base quality programs, chose the malpractice insurance companies’ risk triggers, like, unexpected transfer to an ICU, unexpected death, return to the ER within 2 weeks of discharge, etc. So, the hospitals essentially built their quality programs on events, and did reviews of cases that met the trigger events. This was the bulk of what quality programs did, case reviews. The result was a headhunting culture. The reviews look for who did the wrong thing or the things that resulted in the trigger event occurring. It was a culture of fear, so, clinicians and staff were always trying to hide their involvement in these events. People would be fired, embarrassed, admonished, etc.

What was really needed was an analysis of the processes of care within a culture that didn’t start with finger-pointing.

It wasn’t until about 1990 that people started to realize that 1. Human beings are error prone and 2. Processes can promote or mitigate errors.

This was due to two things, 1. A book called Human Error by James Reason and 2. The emergence of an awareness in the medical community of Statistical Process Control (SPC is based on the premise that 80% of defects and inefficiencies are due to the process, only 20% is due to individuals’ actions).

The event that seemed to spur more interest in the above was the beginning of the Patient Safety Movement, which occurred in 1998. Really, it wasn’t until 1998 that the medical community thought you ought to be kept safe from harm from medical “institutions”! As a matter of fact, before WW II hospitals were referred to “pest houses” because you were more likely to die in the hospital from something that happened in the hospital than the disease you had if you had stayed home!

Here’s a real story about this.

It was 1998. (two years before the IOM’s treatise: To Err is Human) I was the Chief Medical Officer (CMO) of a medium-size regional Managed Care Organization/Health Maintenance Organization (MCO/HMO). (I’ll use MCO from now on for these insurance companies) Once a year, just about all of the MCO’s in the country descended on Washington, DC for a large weeklong conference. There were tracks for different “positions” in MCO’s. There was a CMO track, a CEO track, a CFO track, an Employer CEO track, etc. Near the end of the week, there was a combined MCO CMO-Employer CEO 2 hour session. There had never been a track session like that before.

We were ushered into a large conference room with just about equal parts Health Plan CMO’s and Employer CEO’s. It seemed an odd combination for us CMO’s. We were wondering why it wasn’t MCO CEO and Employer CEO.

There was a long low stage set up with about 8 “panelists” sitting at a long table. The moderator said the subject of the session was Patient Safety. None of us really knew what that meant, having never heard that term before. I’m sure the Employer CEOs were thinking the same.

The moderator said the first thing they were going to do is play a video for us.

The video was about a ~11 year old boy. It was December; Christmas was approaching. The child had a “growth” on his ear that the surgeon had recommended to be removed. It was a procedure to be done under local in a same day surgery suite at the hospital. The parents were waiting in the waiting room. Suddenly the surgeon came out and told the parents that the surgery went wrong, there was a complication and the child did not survive the event. The Quality Nurse conducted an investigation and determined that the local anesthetic that was used had 10 times the amount of epinephrine than it should have, and that the anesthesiologist had given the operating surgeon the wrong bottle.

The video was stopped and four individuals gave accounts of the events including how they felt about what happened: The mother, the surgeon, the anesthesiologist and the Quality Nurse. It was extremely emotional, the mother obviously still grieving, the surgeon and anesthesiologist guilt ridden, the Quality Nurse compassionate.

The bottom line reached by the panelists was, the process, or lack of it, was the cause of this boy’s death. The participants in the process were well-trained and doing what they thought was right. The moderator went through statistics from studies from 1990-1995 about harms and deaths from “medical adverse events”. The moderator then opened the dialogue to those of us in the audience. Of course, we were all stunned.

The first utterance was from an Employer CEO. His exact words were, “What are you health plan CMO’s doing all day long that you are allowing something like this to happen?”

Well, we thought, they actually had the wrong CMO’s in the room. They should have had the Health Care Delivery Systems’ CMO’s. How would we know what was going on day to day in hospitals? The Employer CEO’s said we should be holding the Health Care Delivery Systems accountable, sort of like the Patient Safety Police.

The start of the Patient Safety Movement was really a watershed event in medical quality. Although there were some (vast minority) health care systems that had started to adopt and train their staff in SPC (using The Improvement Model or FOCUS-PDCA), there was little evidence that anyone could do it well except for one or two institutions, like Intermountain Healthcare in Salt Lake City.

I recall being at a management meeting of a health care system that had hospitals, a medical group and a health plan in 1999 where I presented this emerging Patient Safety Movement. I was sitting next to the Chief Operating Officer of the hospitals. After some inquiry dialogue by the group, the COO said (exact words), “Well, we don’t have to do anything about this right away since this stuff has been going on for years.” Really? Seriously? See why your quality care is #4?

Sidebar: I actually took a year of the agendas for the highest management team meetings in an integrated health care system. 95% of the time spent by the most senior management team had nothing to do with patient care. It was mostly budgets, growth, HR issues, IT, marketing, etc. When I showed this to them the CEO said, “Well, we have Quality Committees that deal with that, we don’t need to go over that here.” Really? Want to know why Clinical Quality is #4?

Here’s another true story. Remember, I was the CMO of a health plan. I really took this Patient Safety Movement to heart, since, as a physician, this sentence was pounded into our brains, “First, do no harm.” It’s part of the Hippocratic Oath we all took. I started looking at whether a health plan and its processes could create a patient safety event. A case occurred that required a “root cause analysis” that confirmed my suspicion. Here’s a synopsis of that event.

A Medicaid member of our Medicaid Health Plan was admitted to a hospital with a ruptured appendix. She was a minor. She had the surgery and post-op was put on two antibiotics since ruptured appendices can cause an abdominal infection. The patient was discharged on the two antibiotics. One of them was not on the health plan formulary, so it required a “prior-authorization”. Error #1 – The hospital surgeon didn’t know which antibiotics were on the formulary (health plan based error).

The patient was discharged at 3:00 PM on a Friday. Her mother went to the drug store and handed in the prescriptions from the hospital. The Pharmacist told the mother that one of the antibiotics was not on the formulary and her primary care physician (PCP) would have to get an authorization from the health plan or the patient would have to pay out of pocket for the antibiotic, which cost more than $100. Since Medicaid folks can rarely afford $100 for a medicine, the mother left without the antibiotic, requesting the pharmacist notify the PCP. Error #2 – The Pharmacist didn’t access the health plan’s telephonic expedited authorization process. (health plan based and pharmacy based error). Error #3 – The Health Plan didn’t have an emergency Pharmacist driven prior-authorization override policy (health plan based error). The Pharmacist used the routine process to get the authorization…he faxed a request to the PCP office, assuming the PCP would send the authorization form to the health plan, who would then put an edit in the computer system to allow payment for the antibiotic. (Notice, none of the clinical folks talked to each other. This was a totally fax based communication system)

Well, it was about 4:00 before the fax was sent. Now, if you’ve ever been in a “modern” PCP office on Friday afternoon, you’d know that the PCP and staff were focused on getting out on time, which, nowadays is as close to 4:00 as possible. No one in the office checked the Fax stack that day. Error #4 – Inattention of the Office Staff to incoming notices. (PCP office based error) In fact, the office staff didn’t find the fax until Tuesday morning. The PCP sent the authorization request to the health plan at 2:00 PM that day. Error #5 – Delay in processing the authorization at the PCP office. (PCP office based error)

The big problem was, the Medicaid member had been re-admitted to the hospital with an abdominal infection at 9:00 AM Tuesday morning, five hours before the authorization request was sent to the health plan.

The root cause found by the quality staff was: the need for a prior –authorization for a critical medication for a patient being discharged from the hospital. We changed our policy to: anyone with a prescription coming from a hospital (inpatient, ER or Urgent Care) would have that prescription filled regardless of whether it needed a prior-authorization or not. Meanwhile we worked on figuring out how to make sure discharging physicians would be able to know whether a drug was on the formulary or not. Believe it or not, to this day, even with an Electronic Medical Record and a national system like Surescripts, knowing what is on a health plan’s formulary is very problematic.

Here’s the kicker. I wrote up a proposal to start up a health plan based Patient Safety Committee that not only looked at patient safety cases from the delivery systems, but that also looked at and tried to mitigate health plan patient safety events. That had to go to the Board of Directors. They couldn’t understand how a health plan could cause patient safety events. I had to go back to the Board meeting two more times with case reviews like the above to convince them that we should have a Patient Safety Committee and that a health plan could cause patient safety events. As I went to conferences after this and talked about our Patient Safety Committee and that we were looking at cases where the health plan policies and actions caused adverse patient safety events, none of the other health plans would agree to or admit that a health plan could cause patient safety events. To them it was a delivery system problem, and the role of the health plan was to hold them accountable. My ideas were rejected by the medical community. To this day I don’t know of any other health plan that looks at or thinks they have an active hand in causing patient safety events and I’m pretty sure the health plan in the above story has abandoned their committee (I left there 8 years ago).

Anyway, if you noticed, it always takes an outside force to get the medical community to do something. First, Medicare, and then, the Patient Safety Movement in this story. Employers got in the act and created Leapfrog, which rates hospitals on safety, but, it’s voluntary and not all hospitals participate. Leapfrog gives non-participating hospitals a failing grade.

So, you’re getting some idea why Quality is #4. More to come.

Why The United States Health Care System Costs So Much – Part One – Failures of Care Delivery

Why The United States Health Care System Costs So Much – Part One

You’ve heard this before. The health care costs in the United States costs a lot more than other countries. Here’s a couple of charts from the Commonwealth Fund’s U.S. Health Care from a Global Perspective publication:


Here is their conclusion in the executive summary:

“Higher spending appeared to be largely driven by greater use of medical technology and higher health care prices, rather than more frequent doctor visits or hospital admissions. In contrast, U.S. spending on social services made up a relatively small share of the economy relative to other countries. Despite spending more on health care, Americans had poor health outcomes, including shorter life expectancy and greater prevalence of chronic conditions.”

So, what’s going on here?

Well, the root cause of the two main drivers cited by The Commonwealth Fund is the fact that the United States Health Care Industry is based in the US economy, which is a free enterprise/capitalism economy. Health care service providers take advantage of that fact. You’ll see how technology company marketing and health care service provider pricing behavior, which is consistent with free enterprise, significantly drives healthcare costs.

The best way to delve into why these two factors are the main drivers and why other lesser factors are driving health care costs is to use the analysis and conclusions from an article by Don Berwick, MD and Andrew Hackbarth, MPhil entitled, Eliminating Waste in US Health Care published in the Journal of the American Medical Association (JAMA, April 11, 2012—Vol 307, No. 14).

Berwick and Hackbarth categorize excess health care costs into categories of waste. Overuse of technology and high prices are imbedded in those categories, as you will see.

Here are the categories of waste:

  1. Failures of Care Delivery
  2. Failures of Care Coordination
  3. Overtreatment (overuse of technology is in this one)
  4. Administrative Complexity
  5. Pricing Failures (higher prices are in this one)
  6. Fraud and Abuse

Failures of Care Delivery

Berwick and Hackbarth define this as “the waste that comes with poor execution or lack of widespread adoption of known best care processes.” Notice the emphasis on “processes”.

So what does this mean?

Of course “poor execution” Seems obvious. Someone fundamentally did things wrong, like a surgeon operating on the “wrong side” (e.g., cut off the wrong leg; yes, this still happens) or leaving a sponge or instrument in a person during a surgery (yes, this still happens). It turns out that at least 80% of “poor execution” is actually due to poorly designed health care processes that either don’t prevent human error effects or that create errors of their own. About 20% is due to people either doing things for which they aren’t adequately trained or they are just malpracticing.

This “process” orientation, poorly designed processes being the reason for the vast majority of failures in this category, is still a difficult concept to grasp for health care administrators and workers.

Here’s an example.

It’s 2007. I’m at a conference for Medical Directors. The last session before lunch is by a national expert on high blood pressure (hypertension). He stresses the point that for many years now, the national statistics on hypertension have been just about the same: only 50% of people who have hypertension have been diagnosed with hypertension, and, for the 50% who have been diagnosed, only 50% of them have a controlled blood pressure (< 140/90).

So, now I’m at lunch and I mention to the fellow on my right that this statistic has been frustrating for many years. He was the Medical Director for the Internal Medicine department of one of the premier medical systems in the US. He said that, last year, he was at a similar conference with a similar hypertension session quoting the same statistics. He said to himself, “I’m the Medical Director of one of the most prestigious Internal Medicine departments in the US. My statistics on hypertension can’t be as bad as that.” So, he returned to his institution and had his assistant pull all of his hypertension patient charts and do the same statistical analysis. He said, “Lo and behold, I had the same statistics! Only about 50% of my hypertension patients had a controlled blood pressure!” So then, he had the entire department do the same analysis. Yes, several dozen Internists. And again, they all had pretty much the same statistics, only about 50% of their hypertensive patients had a controlled blood pressure! “The internist we all believe is the best Internist in our institution and the internist we feel is ‘less skilled’ than the others had the same results, a 50% hypertension control rate!” he said.

I looked at him and said, “Since the national, departmental and your own personal statistics and your “best” and “worst” internist have exactly the same statistics, what does that tell you?” He just looked at me without an answer. I gave him about 5 seconds to respond then said, “To me, it’s obvious that the process for treating blood pressure that we’ve all been trained to do is creating this result, since everyone has the same outcome, no matter whether an individual is considered excellent or not or where they live.”

I’m not sure what he did with that piece of information, but it was interesting that he hadn’t figured that out.

Of course, not controlling blood pressure leads to excess costs for higher incidences of heart attack, strokes, kidney failure, etc.

Several years later I was tasked with improving the blood pressure control rate at a large medical group. The groups overall blood pressure control rate was about 60%. We held a “rapid redesign” session using Lean techniques (basically a version of the Toyota Production System) incorporating what were considered best practices. We found out some interesting things:

  1. Some patients were misdiagnosed or over-treated because the testing to diagnose and treat hypertension (HTN) wasn’t being followed. This was because some PCPs weren’t taking blood pressures (BP) correctly or weren’t using home BP readings (which have been shown to be more accurate than office BP’s if taken correctly). The standard for office BP is, a BP is taken on admission and, if elevated, taken again at least 10 minutes later, since the act of signing in and being taken into a doctors office can falsely elevate someone’s BP.
  2. There was some variation in the cost of the medications being used, up to a 5 fold difference, among physicians because some physicians weren’t following the published guidelines and were prescribing second and third line drugs for people instead of first line drugs.
  3. PCPs were referring patients to Cardiologists and Nephrologists before going through the published guidelines.
  4. Generally speaking, patients have little knowledge of their condition and what the long-term effects of uncontrolled BP are.
  5. There was no consensus or systematic method for having patients come in when they should for follow-up visits. Like, how often should patients with uncontrolled BP be seen? What about controlled?
  6. Stable BP patients needed little “care”. Follow-up visits could be done by Advance Practice Clinicians (APC’s) instead of a physician, freeing up physician time for more complicated patients.

The team changed the process of care and was able to measure the components. We knew, for example, what percent of a PCP’s patients with initial high BPs got a second BP at least 10 minutes later. We knew if a patient was supposed to come back within 60 days, what percent did. Etc. APC’s saw the majority of patients, spent more time with them. A formal standardized patient education module was administered to every HTN patient.

Within 2 years, the BP control rate was 82%! The process redesign had worked. The Medical Group actually got an award for this.

Unfortunately, most improvement efforts in health care don’t create impact because they aren’t following effective process improvement methods. Here’s why.

First, the medical industry is steeped in a task orientation of improvement and management. The classic way the medical community “changes” something is to have an “inservice” (a classroom type activity that can range from a couple of hours to several days). It’s mostly a didactic session. Sometimes there are some simulations and 30-60 minutes of “practice”. Then everyone is given a binder or a CD-ROM and “certified” and sent out to do what they were “trained” to do. The problem is, that isn’t “training”. And there isn’t any follow-up to prove that the “training” actually worked. There are ways to do this. One is called the Kirkpatrick Model of training effectiveness, to which I subscribe. It has four levels of assessment. Level 1 is an assessment by the participant that the training was well-organized, challenging, etc. Level 2 is, did the participant actually learn something (you do a pre-and post-test to figure this out), Level 3 is, did the training actually change the way they did work, i.e., did the employee retain the information and was he/she using the new way of doing things, and Level 4, was there actually a positive impact on the business results.

Training requires daily oversight by an expert until the trainee can do the work correctly. A Medical Director I know once said, “You don’t give a 2 hour 100 slide presentation to an army recruit on how to handle a gun and consider him trained.” They spend hours on the shooting range with a drill seargent. There’s no similar situation in health care.

I’m here to tell you that, unless I was running a project and did these four things, they were never used by health care managers or the HR departments that ran the trainings. Consequently, when people left the trainings, they pretty much went back to the old way of doing things.

And remember, the way medical systems do improvements is they teach staff a new task, usually without subtracting a task, so, the new task is just more work. Since no one is measuring, there is no accountability. The actual process of care isn’t examined or changed.

Here’s an example.

A hospital had a consultant group come in to train surgeons and OR staff on “Team Training” based on the aviation industry practice. This consisted of a pre-op briefing (what do the staff need to be aware of), a “time-out” before starting surgery where the team ran through a checklist, and a de-brief (what went well, what didn’t go well) after the procedure. The consultant did multiple week-long sessions for all the surgeons and hospital OR staff. Everyone was high-fiving when everyone was “trained” and leaders got kudos at management meetings. Six months later, no one could report on what the adoption rate was and the frequency of “never events” (those wrong side surgeries and articles left in patients) hadn’t changed. The consultants had added three tasks. The process of doing procedures didn’t change. No tasks were subtracted to “make time” for the new tasks.

And here is a truism about the “Failures of Execution”. For centuries, medical personnel have fixed things by adding tasks, resulting in a task oriented management system. This is so ingrained, and there is such a lack of process awareness that, even if you send a Lean or Six Sigma consultant in to re-design the process, and the new process is proven to be significantly better then the old one, the managers in the work area aren’t proficient in process management, only task management, so the process degrades back to the old task oriented way. Most managers’ days are executing a list of tasks: scheduling staff, monitoring budgets, managing overtime, etc. not walking the floors and ensuring staff are running the process correctly or monitoring for efficiency or defects. Forget about monitoring a dashboard and acting when a measure performed worse than expected. It’s actually not these poor managers’ fault, since they have never been trained to be process managers. They are kind of victims of the legacy health care management system. The other thing is, management training for new managers in health care is woefully inadequate. Often non-existent. It’s not unusual for a line staff employee to be promoted to a manager with no training, and they never get it.

So, care systems and patient safety systems aren’t generally working well in health care. You have dedicated, conscientious workers trying to make do with error prone, inefficient systems by creating “workarounds” that can actually make things worse.

In an ER in a hospital at which I had privileges, there was a fellow whose only job was to do workarounds for the processes that didn’t work well. They called him a gopher (he was actually a certified Medical Assistant) and he was held in high regard by the staff because he “fixed” the things that weren’t working. Like, if a department didn’t deliver what they were supposed to on time, he went down to the department and got the stuff and brought it up to the ER. That was his entire job. No one tried to hold the non-performing department accountable. Just add an FTE to do workarounds, who was a hero! Yikes!

Another Health Care cost sub-category is what is called Undertreatment. This means, treatments that should be given or should be utilized aren’t given or utilized as often as they should be. Like, vaccines aren’t given when they should be (this is especially true with children). Preventive health maintenance care (colonoscopies, mammograms, cholesterol levels, etc.) isn’t done when it should be. You get the idea. Secondly, sometimes there are practitioner misperceptions (“You can’t give a vaccine to a child with a cold”). Sometimes a practitioner doesn’t believe the test or treatment is useful despite literature data or expert opinion. Sometimes a practitioner just can’t keep track or doesn’t have a good reminder system. At any rate, the patient doesn’t get what they should when they should. That’s Undertreatment. And Undertreatment increases costs because of the cost of treating conditions that could have been prevented or detected early.

Most of the undertreatment problems are rooted in process deficiencies. And the blame is placed on the practitioner for not “doing what they should”. But both the practitioner and the patient are victims of the systems operating around them.

Ok, enough for this post. We got through Waste Category #1! In future posts, I’ll go through the rest of them.


The United States’ health care costs more than other countries mainly due to the use of technology and higher prices

There are six categories of waste.

Failures of health care delivery are mainly due to error prone and inefficient health care processes

The fundamental health care management system is task oriented, which is a mismatch given most of the problems in Failures of Care Delivery are process oriented.

Training in health care is really education, not training, and it is not very effective.

The Swiss Cheese Model

The Swiss Cheese Model

In 1990, James Reason proposed a relatively simplistic model for understanding errors and defenses against errors resulting in defects.

Definitions: Errors = something went wrong. Defects = errors have an impact on the customer, in our case, the patient.

So, an error can be a mistake or mishap that is blocked by a “defense mechanism” so that the customer/patient never feels any impact (the defect). If the error in a process is blocked near the customer/patient it is called a “near miss”.

Example: A patient is in a same day surgery center and requires a medication. A nurse hands the doctor a syringe full of the medication. The doctor asks a verifying question about the dose amount. The nurse double checks the medication vial and says, “Oops, the syringe has 10 times the requested dose” and takes back the syringe. This is a blocked error (wrong dose) and a near miss (since the next step in the process would have been injecting the medication into the patient which would have caused a defect).

James Reason’s model assumes that every step in a process has inherent errors and is like a slice of Swiss cheese. The first trick is to have as few holes and the smallest holes in the cheese as possible. As the process steps line up, each step/slice of cheese has holes, but the next trick is to have none of the holes line up, so each step “blocks” the previous step’s “holes” (errors). Problems occur when holes line up in the slices of cheese creating an “error conduit” allowing an error effect to pass through the holes resulting in a defect event impacting the customer/patient. Often this defect event has catastrophic consequences. If you Google “Swiss Cheese Model” you will be able to see Reason’s drawings of the model.

In the example above, the holes might be: There is no training regarding call-back between nurse and doctor (where the doctor says “ten milligrams valium IV”, the nurse says “ten milligrams Valium IV”), maybe the bottle of Valium delivered by the pharmacy is 100mg per cc instead of 10mg per cc, the nurse didn’t read the bottle for concentration amount, etc. You get the point. All of these errors added up to the nurse giving the doctor a syringe with ten times the requested dose. If the doctor just took the syringe and injected it, the patient would have had a respiratory arrest. A catastrophic event.

Well, it turns out, health care processes have a lot of holes in the Swiss cheese and it isn’t uncommon for the holes to line up.

But, you don’t have to take my word for it. Here is an excerpt from a study of Medicare beneficiaries. An “adverse event” is a “defect”.

Department of Health and Human Services





“An estimated 13.5 percent of hospitalized Medicare beneficiaries experienced adverse events during their hospital stays. Of the nearly 1 million Medicare beneficiaries discharged from hospitals in October 2008, about 1 in 7 experienced an adverse event that met at least 1 of our criteria (13.5 percent). This rate projects to an estimated 134,000 Medicare beneficiaries experiencing at least 1 adverse event in hospitals during the 1-month study period. We calculated incidence rates for adverse events that met our three criteria: 0.6 percent of beneficiaries had an NQF Serious Reportable Event, 1.0 percent had a Medicare HAC event, and 13.1 percent experienced an adverse event resulting in the four most serious categories of patient harm. An estimated 1.5 percent of Medicare beneficiaries experienced an event that contributed to their deaths, which projects to 15,000 patients in a single month.

An additional 13.5 percent of Medicare beneficiaries experienced events during their hospital stays that resulted in temporary harm.

Temporary harm events are those that require intervention but do not cause lasting harm. Although many cases represent fairly minor occurrences, such as hypoglycemia, others were classified as temporary harm only because the patients were in the hospital for lengthy periods as a result of other, more serious, diagnoses, allowing hospitals enough time to address the harm prior to discharge. Additionally, 28 percent of beneficiaries who experienced adverse events also had temporary harm events during the same stay.

Physician reviewers determined that 44 percent of adverse and temporary harm events were clearly or likely preventable.

Physicians determined that 44 percent of all events were preventable and 51 percent were not preventable. (For the remaining 5 percent of events, physicians were unable to make determinations.) Events related to surgery or procedures were less likely to be preventable than other types of events, such as hospital-acquired infections. Preventable events were linked most commonly to medical errors, substandard care, and lack of patient monitoring and assessment. Physician reviewers assessed events as not preventable when they occurred despite proper assessment and care or when the patients were highly susceptible to the events due to health status. Nearly all events on the NQF and Medicare lists were assessed as preventable, a key criterion of both lists.”

One thing is, the VAST majority of studies on medical adverse events is in hospitals, which are relatively controlled environments. Some experts estimate that outpatient adverse events are at least 20 times higher than hospital events, but, up to the date of this post, I don’t know of any well-designed study that quantifies outpatient adverse events. I proposed doing this when I was a Medical Director of a large integrated delivery system (IDS) (Hospitals, Ancillaries, Health Plan and Physician Group) and they wouldn’t fund or allow the activity. We could have done it because we had huge amounts of outpatient data, including non-IDS-physician group providers and pharmacies. We could have made a positive impact with the information. The main problems with getting the activity funded were: 1. Since the prevalence and types of adverse events weren’t known, a financial return on investment (ROI) estimate couldn’t be made (remember, it’s all about the money) and, 2. Fixing things would have meant applying the IDS’s resources to address things outside of the “four walls” of the IDS, i.e., it would cost the IDS money to improve these non-IDS systems. This was tantamount to heresy by the Finance Department, I mean, spend the IDS money on non-IDS providers and processes that would result in better and safer patient care? Yeah, right, that would never happen.

I’m going to get more into preventing errors and defects in future posts. There are ways to do it. Unfortunately, the US health care system doesn’t have the will to implement and maintain the ways to do it. Even Don Berwick is skeptical about the will of the health care industry to improve things. (Berwick, D., Vital Directions and National Will, JAMA, March 21, 2017)

So, here are three personal examples of outpatient errors. They didn’t result in a defect only because of my and my wife’s persistence. These are the stories of three consecutive prescription refill requests. I’m convinced that, if a person not as knowledgeable in health care systems as I am had these experiences, these would have been adverse events.

Here are my tales:

Twenty-first Century Medical Office

So, here’s an example of how a “next-generation” medical office system works. The issues were shared between the pharmacy and the physician office, but predominantly there were physician office systems errors.

My primary care physician (PCP) of 16 years is in a 650 “provider” (Physicians, Advance Practice Clinicians, Pharmacist Clinicians) multispecialty group. In August 2016, I had a periodic health check-up. My primary care told me he was moving to a government corporate position in October and I should call on October first and get a new PCP.

On October 1, I called the customer service department. They had no knowledge of the PCP leaving the medical group. I asked how they determine how the PCPs patients are re-distributed. They don’t know. I ask if there is any system or process involved that tries to match a patient’s conditions with an appropriate provider and… they don’t know. They tell me I’ll get a letter in the mail about it, but they don’t know when. I had to file a complaint to get the information about the available PCPs, their training, and any areas of clinical interest or enhanced training, etc.

I agreed on a PCP at the same clinic. Since I had just had my annual check up, there was no need for an appointment.

I moved from one side of town to the other side of town. Now my new PCP was about 12 miles away. The medical group opened a new clinic 3 miles from my new home. I called to transfer to the new site. I got a call from the medical group explaining that the new site was a new model, you weren’t signing up for a PCP, but a primary care site that was manned by one physician and five Advanced Practice Clinicians. I said that was OK with me as I supported that model. I also had transferred all of my prescriptions to a new pharmacy (same chain) near my home.

Two months later, I needed a prescription refill. I’d been on this medication for more than 10 years. I used the Pharmacy chain’s online refill request system. I had refilled the prescription 60 days before, and was, at the time, a little perplexed that they gave me 60 because the usual amount was 90. Here’s the 24-hour chain of events:

March 12: Submitted refill request online.

March 13, 9:00 AM: I get a text message from the Pharmacy saying my prescription was delayed. The message said click on the link to see details. I clicked on the link and it brought me to a page that said, in order for me to see my prescription status, input your birthdate into the field below. I used their calendar function to input my birthdate. The birthdate showed up but it was grayed out and when I clicked “continue”, it reverted to an empty field and said it was a required field and I hadn’t filled it out. I tried to input the date 3 more times, got the same cycle back to an empty field with the same message and finally gave up on it.

March 13, 11:11 AM: I call the pharmacy asking what is the cause of the delay. The answer was, I have no more refills, that the reason I only got 60 the last time was there were no refills on the prescription the last time I requested a refill. This seemed odd as the process should have been requesting the refills from the PCP at that time and I should have gotten 90. [ERROR #1, not following standard process] – A prescription with no refills was refilled instead of the pharmacy requesting refills from the PCP. [ERROR #2, not following standard process] – The pharmacy never notified me that there were no refills.

Then they tell me they sent the refill request to the old PCPs office for the refill request. However, my new PCP is not in that practice since I moved to the new site. They suggest I call the old PCP office to make sure it would be refilled, since I wasn’t technically their patient anymore.

March 13, 11:18 AM: I call my old PCP office. The woman there tells me the prescription refill should come from the providers at my new site. She takes down all of the information and says she is sending a note to the new site to have it renewed.

March 13, 11:37 AM: I get a voicemail call from my new PCP site saying the prescription was renewed on March 1 at my old pharmacy 15 miles away and I should call my new pharmacy and have the refill transferred to my new pharmacy.

March 13, 11:44 AM: I call my new pharmacy and tell them what the last caller told me. The woman there searched their system and said there were no active requests for this medication for me in their system.

I started thinking, the March 1 date may have been incorrect and the last caller may have misstated the date. Maybe my old PCP site had sent it in and now there was also a request from the new site and there could be two requests going in at the same time.

March 13, 12:31 PM: I call back the old PCP site and voice my concerns that there could be two requests, and I request that they make my new pharmacy the default pharmacy in their Electronic Medical Record. The woman there said the default pharmacy was changed previously but there is no evidence of a prescription being sent in.

March 13, 1:05 PM: I call my new PCP site and inform them that there apparently is no refill request issued by them, because they think there was one called in on March 1, and my old PCP’s site hadn’t sent one in. I told the woman there that there was no evidence of a request in the pharmacy’s system, either. She said she would go over all of the info in the Electronic Medical Record (EMR) and put me on hold. She came back on and said she would get back to me.

March 13, 3:29 PM: I get a call back from a different woman from my new PCP site who tells me they misread the EMR and the March 1 refill was one year old, in 2016! [ERROR #3, inattention] – Misreading the EMR led to a potential gap in my having my medication (a “near miss” because of my persistence). She tells me that my new PCP may not refill the prescription because she has never seen me, that she would ask the “provider of the day” to renew it if the PCP wouldn’t but if he also declined, they would send the request to the old PCP’s site because they should be responsible for renewals until I can be seen by the new PCP. This is the exact opposite from what the first woman told me at my old PCP’s site. Also, this didn’t make sense because no provider at either site has seen me and they both have the same medical record to refer to since they are in the same group. [ERROR #4, lack of standardization or lack of adequate training] – Inconsistent staff information led to delay and bouncing accountability back and forth within the same medical group. [ERROR #5, lack of standardization] – A provider in the same medical group, seemingly the same medical practice, being unwilling to refill a continuous medication because they had never seen that person, but was willing to defer that to another provider who had never seen me and would never see me.

March 13, 3:47 PM: I get a call back from the new PCP office. The woman tells me that the new PCP will refill the prescription but wouldn’t approve any more refills until I was seen. I asked for an appointment and she gave me an appointment for 6 weeks hence.

When I got to the pharmacy, I only got a 30 day supply phoned into the pharmacy, two weeks less than needed to get to my appointment! [Error #6, inattention]

Does anyone think this is patient friendly?

Retail Pharmcy – this was mainly a pharmacy set of issues

I had a medication that needed to be refilled. With Big W Pharmacy, you can create an account and manage your medications online and with a smartphone app. So, I went online on my computer, signed in and went to the “Refill Prescriptions” page in the dropdown menu.

In the Refill Prescription page, all of your prescribed medications are listed. You can click on a button that activates automatic refill if you want. My medication is one that runs out variably so I didn’t activate that function for this particular medication. To the right of the auto-refill button is a check box that you check to refill a prescription. I checked the box next to the medication I wanted refilled. There is a button at the lower right that says “Request Refill”. I click on that button and I get a page that says my medication refill request is sent to my Big W Pharmacy, including the pharmacy’s address and telephone number.

Now I wait. The process should be, the request is sent to my pharmacy and the pharmacy either refills the prescription or, if all of the refills have been used, the pharmacy faxes a refill request to the doctor’s office. The doctor’s office is expected to review the faxes daily and send a doctor’s decision (refill or not refill) back to the pharmacy. If the doctor orders a refill, the pharmacy notifies the patient one of three ways: 1. A robo-phone call, 2. An email, 3. A text message.

Seven days later, I’m suspicious that something went wrong. I went into the online account and clicked on “Prescription status”. It’s an empty page. I called the doctor office, they hadn’t gotten a fax from the pharmacy. I called the pharmacy. They said they never got a notification from the online system. [Error #1, IT system malfunction] The woman who answered the phone said , “This happens all the time.” I asked, “Who do I talk to, to file a complaint?” She said I have to call corporate, the local pharmacies have nothing to do with the IT stuff. The woman entered my refill request into the system for me and said they would send a fax to the doctor’s office.

I called the corporate office and filed a complaint. They told me they would call me within 48 hours to tell me why the system didn’t work.

The next day, I got a text message that says my refill has been delayed and I should click on a link to see the status of my request. I clicked on the link and it took me to a page that said I must enter my date of birth in the field in order to access my prescription status. Since I’m on my smartphone, I poke at the field. It is totally dead. I try this 10 times, and it won’t work. The check box next to “I agree with the terms and conditions” works, but the birthdate field doesn’t. This was actually the second time in a row this happened. [Error #2, IT System malfunction]

I called the Big W Pharmacy’s corporate office again and filed another complaint. I get the same answer that someone will call me within 48 hours with what went wrong, but, I should use the online or smartphone app as they will be accurate. I told the person on the phone that I didn’t believe that those would be accurate since nothing I’ve used so far had been accurate.

I called the doctor’s office and got a voice mail. I left a message saying that Big W Pharmacy’s system has been problematic in getting a refill request to them and could they check their fax pile and see if something has come in. The voice mail says I will hear from them within 24 hours.

30 hours later, I’d heard nothing from either the pharmacy or the doctor’s office. [Error #3 Physician Office process delay] My wife checked the prescription status and it said Big W Pharmacy had sent the request twice to the doctor’s office.

At that point my wife called and left a long angry message. Now, it is nine days trying to get the refill and I’m out of the medication. Two hours later I get a call from the doctor’s office that they sent in the refill request. Fifty minutes later I got a Big W Pharmacy text saying my refill was ready. I got in the car and drove to the pharmacy drive-through window. There was a sign on the window saying the staff was on lunch from 1:30-2:00 and the pharmacy was closed. It was 1:35. [Error #4, Delay due to wait time]

I had to go home, and then drive back to the pharmacy after 2:30. [Error #5, customer required to over process]

I’ve never gotten a call from Big W Pharmacy IT people.

Does anyone think this is patient friendly?

Mail Order Pharmacy

My health plan has a contract with RxMO Pharmacy for mail order prescriptions. I had a visit with my Primary Care Physician (PCP) and asked her to send a prescription for a 90 day supply to the mail order pharmacy after I notified her through the patient portal that I was registered for mail order (I had never gotten mail order medications before).

I went to the health plan website and looked up how to get mail order prescriptions. What they had was a brochure .pdf from RxMO Pharmacy. The brochure had thee options: 1. Online registration, 2. Telephonic registration, and, 3. Paper registration through snail mail. I chose the online method.

I went to the URL on the brochure and clicked on “create new account”. I filled out all of the required fields and clicked “submit”. I got a page that said check my email to activate my account. I went to my email and there was the RxMO Pharmacy email. I opened the email and clicked on the activation link provided. That brought me to a page with a box that said, “click to activate”. I clicked on that box and it changed to “Your account has been activated.” Below that there was a button that said, “continue”. I clicked on continue and it brought me back to my health plan member pharmacy portal page, where I had started. I went to the RxMO Pharmacy website and signed in. It brought me back to my health plan member pharmacy portal page. [Error #1, IT malfunction]

So, I called the health plan member services telephone number. The customer service rep listened to my tale and then said, “I have to transfer you to someone who knows more about this.” She transferred me and I got another woman who told me the IT link between the health plan and RxMO Pharmacy wasn’t working and they were trying to fix it. She gave me the telephone number for the telephonic registration. [Error #2, re-processing]

I called the number and got a nice woman who looked in the system and said that the only two fields that had “taken” were my name and date of birth. I had to go through all of the fields again with her verbally. I also arranged for payment to be made by credit card. She said that all that needed to be done now was for my PCP to send them the prescription and they would process it, send it and charge my credit card. She said I would get a call within two days of their getting the prescription from my PCP notifying me when the package would arrive.

I messaged my PCP to send the prescription.

Two days later I got a message from the PCP office that they had sent in the prescription.

The next day, my phone rang with an 866 number. When I answered it, it was a robo-call fromRxMO Pharmacy. It said before they could send me the prescription they needed to verify that I was the person they should be sending it to. They asked me to input my date of birth. While I was doing that, my phone double struck one of the numbers and my phone doesn’t have a delete function for this, so, now I was stuck with a wrong date of birth. The robo-caller finally said it couldn’t understand my date of birth and it was transferring me to a live person. The phone rang twice and I got another robo-caller asking for my date of birth. I put it in correctly. Then it asked for my zip code. I put that in correctly. Then it asked for my phone number. I put that in correctly. Then it asked for my prescription number, also saying if I didn’t have the bottle with me, it would hold until I found the bottle.

Now, since this was totally new, I had no prescription number. The robo-caller finally said, if I didn’t input the prescription number, it couldn’t help me. [Error #3, Delay in process] I hit Zero on the phone. I got another robo-caller asking me if I was calling about Medicare Part D. I hit zero again and the robo-caller started talking again. I hit zero before I could even understand what it was saying. I hit zero five times and finally got a “transferring to a customer service representative. [Error #4, Over-processing]

A woman came on the phone and asked me the same questions the robo-caller did. [Error #5, Over processing] Then she said she had my account pulled up, why was I calling? I told her the above story, also adding that there should have been an opt out of the robo-caller (like, dial 0 at anytime to get to a live person) and asking me for a prescription number was really stupid for a first time prescription (yes, I used the term stupid!) and they should have had another opt out command, like, “if you don’t have a prescription number dial 0”.

She said, “I’m sorry, I can’t help you with filling a prescription. I’m going to live transfer you to the correct person” and put me on hold. I was on hold for almost 10 minutes. [Error #6, Delay on processing] The customer service rep came back on three times telling me she was still trying to transfer me. Finally, she said she had the person on the line and was now transferring me.

The person who received the transfer started with something like, “Hi, I hope I can help you but I may be the wrong person.”


So, I told her my story (again). [Error #7, Over-processing] She said she was the right person but didn’t know before I told her the story because the person who transferred me to her didn’t say why the transfer was occurring. [Error #8, inaccurate communication] She pulled up my account, verified the medication and asked if I wanted them to send me the drug (REALLY?!?). I said, yes. She verified the address and told me the medication would be arriving in eight days.

Does anyone think this is patient friendly?

You can see how these errors can line up like holes in Swiss cheese and result in a defect impacting a person. Luckily, my medications weren’t “life-saving” and I knew how to work the system. Not true for most people. And it could have been catastrophic for people on medications treating their cardiac disease or diabetes where their life is at stake. Read my Clinical Quality Part 1 post dated April 29, 2017 to see a more serious consequence of  Pharmacy/Health Plan/Physician Office processes creating a serious adverse event.

And these examples are only relating to getting a medication!

This has to be what the majority of patients go through on a daily basis. I can’t imagine that these stories are specific only to me. And this is only the tip of the iceberg. There are studies of patients who get re-admitted within 30 days of a hospital discharge that show that process issues like the above related to multiple health care service providers (doctors not responding, durable medical equipment companies not showing up, pharmacies’ processes causing delays or not filling prescriptions correctly, home health agencies arriving 3-5 days late, etc.) are significant contributing factors for those 30-day re-admissions, which are adverse events.

There are similar error prone experiences that patients are going through related to other health care systems. Tests that don’t get reported, test results that are never reviewed (cases like an imaging study shows a cancer but is never reviewed, the physician office policy is “if you don’t hear from us everything is normal” and 6-12 months later, the patient comes in for a re-check and now has an untreatable cancer…this actually happened…), etc.

Here’s another scarier true story.

I’m seeing same day patients at a primary care site. It’s Thursday afternoon. I see an elderly woman being treated for a cancer, undergoing chemotherapy. She presented to the ER four days earlier with fever and a bad sore throat with swelling on the left side of her face and neck. They do a bunch of tests. Her white blood cell count is low due to the chemotherapy. As a matter of fact, she says her chemo was delayed because her counts were so low. They do a CT scan of the face and neck. It shows a 0.5 cm stone obstructing the salivary gland duct and the salivary gland is very swollen. There is no mention of this in the ER physician’s notes. They give her a prescription for amoxicillin and advise her to follow-up with her PCP if she is not better, and the final diagnosis is pharyngitis.

Now, I have to assume they missed the salivary duct stone reported on the CT scan report. FYI, you can’t clear a salivary gland infection caused by a stone stuck in the duct without removing the stone. And, this patient was significantly immunocompromised and could have gone into full sepsis with the degree of  leukopenia (low white blood cell count) she had.

I call our medical group’s Ear, Nose and Throat (ENT) department, giving them the story and requesting an immediate appointment to have the stone removed before the patient became septic. They said they couldn’t see her until the next Tuesday. I told them this was unacceptable, she needed the procedure ASAP. They said, send her to the ER. Since that was where she had been and that hadn’t gone well, I wanted the specialist who could treat her to see her. They said sorry, Tuesday was the best they could do.

I hung up and called a non-medical group ENT, a physician in solo private practice. He advised me to change her antibiotics to cover more bugs, and he would see her first thing in the morning. She made it through the night and had her procedure in the morning and did fine, no thanks to the health care system she was in.

I bet you can relate a similar story. Most people can, either for themselves or someone they know. Sad! But true!

Now, the thing is, there are ways to make these systems more reliable and they are used by industries like the aviation and nuclear reactor industries. They are also used by companies like Toyota and Hyundai. These “ways” to make systems and processes more reliable and reduce errors and defects have been tried by some health care systems but most abandon them, spending their money on things like  building new shiny buildings. They like spending money on tangible things that you can touch rather than improving care processes that actually benefit the patient by improving outcomes or creating a safer environment.