I Remember When the Pharmacist Was Part of the Team

Every day I receive a phone call, email or text message from at least one of my patients saying they have been trying to refill a prescription at their local chain pharmacy for at least two weeks and they cannot get it done. The pharmacies all claim to have tried to contact “your provider” multiple times and “your provider has not responded.” 

The truth is, my staff and I have never received any of these requests from the pharmacy for a refill. Our office telephone lines are manned by human beings using no automated attendant during business hours when the office is open. After hours phone calls go directly to the physician’s cell phones. Both physicians in this office answer their cell phone calls twenty-four hours a day, seven days per week.

It is common for me to receive an email or text message after hours or on the weekend from a patient requesting a routine refill. If it is a controlled substance, I call it in myself. For nonscheduled prescription medications I will either call it in or send it by the computerized electronic health records software. If it is sent electronically, I receive a receipt for the completion of the transaction.

When I call by phone, I am commonly having to leave a detailed voice mail message because the pharmacy technicians and pharmacists are too busy to answer the phones. When the patient shows up to pick up those prescriptions, they are often told that the physician never called it in. That is usually because the pharmacy staff has not gotten around to listening to their messages on the electronic system they and/or their corporate ownership have set up. When patients are told that the doctor never called the script in, they call the office upset and annoyed that we haven’t honored their requests but, in fact, the prescription had been called in to the pharmacy hours earlier.

Years ago, the chain pharmacies decided to get into the health care business by setting up medical clinics within their pharmacies. They used their power and influence to have legislation and regulations passed to allow them to staff their clinics with nurse practitioners. At the same time, they lobbied heavily to take over and control the routine vaccination business – an important part of most primary care offices that brought patients back to the doctor periodically for a review of their health and preventive care plans.

Having clinics in pharmacies plays well with younger patients who don’t have a personal doctor and wish to perform every health evaluation and diagnosis and treatment over the screen on their smartphone. When they become significantly ill, they are left with running to emergency departments of hospitals or corporate walk-in clinics where typically a short-term solution is provided for a fee because they do not have a physician to guide them or see them.

The pharmacists I trained with were not experts on health insurance and drug benefit management programs. Those pharmacists mixed the medications and placed them in tubes, bottles or capsules. They were not just pill counters transferring pills or tablets from a stock bottle to a smaller bottle with a typed label. They were chemists and scientists. If you called them with a question, they answered your call or called you back. There was a mutual respect for the knowledge and experience they brought to the health care team that has since been lost.

The chain pharmacist is now my competitor, doing their utmost to make physicians in private practice look like inefficient, non-caring buffoons with office staff who are even less competent. There is no short-term solution to the problem.

If you contact your physician for a refill and they say they have called it in, they have done just that. If the pharmacist says the doctor never contacted them, please ask for the manager and ask if they have listened to their recorded messages or checked electronic submissions yet.

Zinc For Colds This Season?

Two weeks ago, my wife was doing her weekly childcare activity of love watching our two toddler grandchildren while our adult kids were on a business trip. The 3.5-year-old had brought home a viral respiratory infection the week before, gave it to his one-year-old brother and both kids were now in the tail stages of recovering from annoying but not serious illnesses.

In today’s world, coming home from school with a sore throat, runny nose and malaise means tea and honey, warm soup and a COVID-19 test. Both kids were negative but several days later my wife, then I, had similar symptoms. My wife’s symptoms settled in her sinuses and 10 days later her doctor put her on antibiotics and nasal spray. I was fortunately much less symptomatic but still have some nasal congestion and dry cough. We have a commercial preparation of a zinc product to prevent and reduce the symptoms of these infections but did not get around to taking them. In the past the literature wanted us to take these lozenges every two hours and I was not going to set an alarm at night to wake up to suck on a zinc tablet.

Jennifer-Hunter, PhD, from the Western Sydney University and associates studied the questions about zinc products’ effect on preventing and abating the common cold and published their findings in the online version of the BMJ Open on November 1, 2021. They looked at 28 randomized controlled studies with 5,456 patients. Their results showed that oral or intranasal zinc did prevent about 5 infections of those exposed per 100 persons when compared to a placebo. They found that if you challenged healthy individuals with a human rhinovirus inoculation the sublingual zinc did not prevent a clinical cold. Those who continued the zinc tended to have resolution of symptoms two days earlier than those who took placebo. For those who took the zinc prep there were more episodes of nausea and mouth and nose irritation.

I appreciate the science and think I will pass on the zinc for now and stick with avoidance of sick individuals plus chicken soup, tea and honey when I catch the virus anyway.

Aspirin & Heart Disease Prevention Recommendations

In the 1950’s a research paper based on work done at a Veterans Administration Hospital found that men 45 years of age who took a daily aspirin tended to have fewer heart attacks and strokes. The VA patients were mostly male WWII and Korean War Veterans. That was the basis for most of the men in my Baby Boomer generation to take a daily aspirin.

Yes, we knew that aspirin gives us an increased risk of bleeding from our stomach and intestine. And we knew that if we hit our head while on aspirin the amount of bleeding on the brain would be much greater. It was a tradeoff – benefits versus risks.

Over the years the science has advanced to now distinguish those taking aspirin to prevent developing heart disease, cerebrovascular disease or primary prevention and those seeking to prevent an additional health event such as a second heart attack or stroke. To my knowledge there are no studies that examine what happens to someone in their 60a or 70s who has been taking an aspirin for 40 plus years daily and suddenly stops. It’s a question that should be answered before electively stopping daily aspirin.

Over the last few years researchers have hinted that the daily aspirin may protect against developing colorectal cancer and certain aggressive skin cancers. The downside to taking the aspirin has always been the bleeding risk. This data is now being questioned by the USPTF looking for more “evidence.”

The US Preventive Services Task Force was formed in 1984 with the encouragement of employers, private insurers selling managed health care plans and members of Congress to try and save money in healthcare. It is comprised of volunteer physicians and researchers who are supposed to match evidence with medical procedures to ensure that we are receiving high value procedures only.

In 1998 Congress mandated that they convene annually. Under their direction, recommendations were made to stop taking routine chest x rays on adult smokers because it didn’t save or prolong life and it took $200,000 of X Rays to save one life. They reversed their opinion decades later deciding that the math on that study wasn’t quite right and now recommend CT scans on smokers of a certain age and duration of tobacco use. I point this out to emphasize why I am not quite as excited today about their change in aspirin guidelines as the newspaper and media outlet stations seem to be.

I am a never smoker, frequently exercising adult with high blood pressure controlled with medication, high cholesterol controlled with medication and recently diagnosed non obstructive coronary artery disease. What does that mean? At age 45 my CT Scan of my coronary arteries showed almost no calcium in the walls. 26 years later there is enough Calcium seen to increase my risk of a cardiac event to > 10% over the next ten years. I took a nuclear stress test and ran at level 5 with no evidence of a blockage on EKG or films. The calcium in the walls of the arteries however indicates that cholesterol laden foam cells living in the walls of my coronary arteries and moving towards the lumen to rupture and cause a heart attack were thwarted and calcified preventing that heart attack or stroke. I am certainly not going to stop my aspirin.

My thin healthy friend who works out harder than I do told me he doesn’t have heart disease and is going to stop his baby aspirin. I asked him what about his three stents keeping several coronary arteries open? He told me he had heart disease before he got the stents but now he doesn’t. I suggested he talk to his internist or cardiologist prior to stopping the aspirin.

I may take a different path in starting adults on aspirin for cardiovascular and cerebrovascular event protection. I am certainly not going to withdraw aspirin from patients taking it for years unless they are high risk for falls and head trauma or bleeding. I suggest you ask your doctor before considering changing any of your medications.

Try an exercise by writing down all the prescription medicines and next to them list what condition you take them for. Once you have established that information, set up an appointment and talk about it with your physician. The decision-making is much more complicated than the USPTF and headline hungry media discussed and reported.

Some Health Issues Should Not Be Evaluated in the Office

I received a phone call from an elderly gentleman who was closer to ninety years of age than 80, was taking an aspirin and had just suffered a fall and hit his head. He did not know why or how he fell. He asked for an appointment the same day to “check me out.” 

My staff asked all the pertinent questions and immediately brought the information to me.  After reviewing it, I felt for his safety his best course of action was to immediately call 911 (or have us do it) and go to our local emergency department for evaluation. The patient takes daily aspirins to prevent a second heart attack or stroke.

The antiplatelet action of the aspirin, plus his age and the head trauma necessitate an immediate and thorough evaluation with imaging. I do not have an X Ray unit, CT Scan unit or MRI unit in my internal medicine office. If I bring this gentleman into my office, he must transport himself, wait until I have time later in the day and probably will then have to wait to be scheduled by an imaging facility for a non-contrast CT scan of the brain to make sure doesn’t have a bleed between his brain and skull or a bleed in the brain. The delay in evaluation can threaten his survival and recovery. 

The patient was quite angry at the suggestion – quoting my concierge practice contract that says we will bring you in for a visit same day for an acute condition. The non-stated content is that we will bring you in same day for a condition that is appropriate for evaluation in an office setting. The same can be said for someone calling with acute substernal chest pain which could be a heart attack or sudden inability to breathe.  Add in excessive bleeding that does not respond to compression or loss of consciousness as conditions that are best evaluated and treated in an emergency department. These are all conditions that require a call to EMS via 911 and an immediate evaluation in an Emergency Department where the equipment exists to quickly evaluate and treat these problems safely. 

The patient was worried about the wait in the ED and COVID-19 exposure. Both concerns are understandable despite little transmission of Covid recorded in ED visits or in patient hospitalizations.

This patient has emailed me twice now demanding a full refund of his membership fee due to violation of the contract. The reasoning and concern have been explained to him several times already. My concern is that his new onset short temper and grumpy demeanor are the result of the fall and head trauma which still has not been evaluated.

Patients need to know that there are times a health issue requires evaluation and treatment in an emergency department.  It has nothing to do with a contract.  It has everything to do with making the right clinical recommendation for the patient.

Safety & Efficacy of Lowering Lipids in the Elderly

I am bombarded regularly by older patients, their adult children and various elements of the media with complaints that elderly are taking too many medicines. Poly pharmacy is the word they use and the first prescription medications they want eliminated are their cholesterol lowering drugs – either a statin (Lipitor, Zocor, Pravachol, Crestor , Livalo or their generic form), Zetia ( Eztimebe) or the newer injectable PCSK9 inhibitors Repatha and Praluent. Is there an age that we should stop these medications? Is there benefit in the elderly to continue taking them? Should we start these medications in the elderly if we discover they have high cholesterol and vascular disease?

A recent study was published in the prestigious Lancet medical journal. The authors looked at 29 trials with 244,090 patients. From this pool there were 21,492 patients who were at least 75 years old. Half of them were on oral statin drugs and the others were on Eztimebe or PCSK9 inhibitors. They were followed from 2 – 6 years.

The results showed that for every reduction of LDL cholesterol of 1mmol/L there was a 26% reduction of in major adverse vascular events. These numbers were similar to those in younger patients. The data also pointed out that these patients had a significant reduction in cardiovascular deaths, myocardial infarction (heart attacks), strokes and the need for heart surgical revascularizations. It was extremely clear that if you are on a cholesterol lowering drug you should stay on that medication despite your age!

A study in JAMA internal medicine, authored by LC Yourman, answered the question of whether you are too old to start on a cholesterol lowering drug. They found that it took 2.5 years before the cholesterol lowering medicine reduced your risk of a major cardiovascular event. Their conclusion was that if you are 70 or older, and your lifespan appears to be greater than 2.5 years, you should start the medicine.

Foreign Dependence on the Drug Supply Chain

I have written often about the problems we have as a nation being dependent on foreign nations for the raw materials and manufacturing of common everyday drugs and supplies. The COVID-19 pandemic has only amplified that problem as the U.S. compete for supplies against nation states for needed drugs to treat the infected and prevent transmission. I have addressed how many common drugs are manufactured in China, India and Israel and, due to financial cutbacks for FDA inspections, production plants have not been inspected for years.

I have also addressed how a hurricane that destroyed Puerto Rico left the only intravenous solution producing factory in North or South America unable to function – leaving hospitals and the military short of vital materials for health care. We witnessed the shortage of personal protective materials including masks, face shields, gloves, sanitizers, etc. as the coronavirus spread through the Americas with businesses and states bidding against nations for a limited supply of products, preferentially kept in the nation they were manufactured in.

This past Wednesday, President Biden issued and signed an Executive Order directing Federal agencies to study ways to secure the supply chain for pharmaceutical goods and manufactured goods. The Executive Order will direct 100-day reviews for supply chains for pharmaceutical goods, computer chips, large capacity batteries like those used in electrical cars to prevent dependence on foreign governments. The studies call for “consulting with experts in private industry, academia, workers and communities”.

The hope is we will create manufacturing diversity and redundancy bringing some manufacturing home but insuring that one nation or one site will not be responsible for the total production of any vital product. In my view, this is a long overdue step in the right direction based on what has transpired in the recent past.

Do Cipro and Levaquin Cause Abdominal Aortic Aneurysms?

Melina Kibbe, MD, of the University of North Carolina Medical Center at Chapel Hill published an article in JAMA Surgery reviewing any possible relationship between taking fluoroquinolones antibiotics such as Cipro or Levaquin and the subsequent development of an abdominal aortic aneurysm.  An aneurysm is a weakening in the wall of a blood vessel that balloons out like the defect on a damaged tire or basketball and has the potential to rupture causing exsanguination and sudden death. Dr Kibbe is also the editor of JAMA Surgery.

The study looked at health insurance company data on antibiotics and aneurysm diagnosis and repair.  They found that 7.5 aneurysms formed per 10,000 fluoroquinolone prescriptions filled at 90 days. This was significantly higher than the 4.6. per 10,000 aneurysms formed after patients took non-fluroquinolone antibiotics.  Patients filling fluroquinolone prescriptions were more likely to undergo repair of aneurysms than those who took other types.

The study used data from IBM MarketScan health insurance claims from 2005 to 2017 in adults aged 18-64.  The study included data on 27,827,254 individuals. The data did not include smoking or hypertensive history or family history of vascular disease. The authors were hoping the FDA would require a warning or caution to high-risk individuals for developing an aneurysm.

We already see an increase in ruptured tendons in patients taking fluroquinolones – especially women who have taken corticosteroids. They are also associated with C difficile colitis, nerve damage, emotional health issues and low blood sugar events. 

Despite these known draw backs to these medications, patients continually demand to have Cipro or Levaquin on hand in case they develop a urine infection or upper respiratory infection or are travelling and concerned about traveler’s diarrhea. 

More research is needed to determine the exact risk of prescribing these medications. Should we be doing scans on patients with hypertension and or smoking history who frequently use these drugs to screen for an abdominal aortic aneurysm?  This is a question that will be addressed by a study soon.  While the research is in process, we need to make sure that our prescribing of these antibiotics is the safest choice for our patients.

Cholesterol Lowering Statin Drugs DO NOT Encourage Cognitive Decline

Statin drugs are used to lower cholesterol levels in the hope of preventing vascular disease including heart disease, strokes, peripheral arterial vascular disease. They have been safely prescribed to millions of people for years showing great effectiveness.  However, a cloud hangs over them over side effects glorified in the lay media and on the internet.  Oftentimes patients don’t even fill their prescriptions due to their concerns. One of the myths is that statins lead to a premature decline in cognitive function and dementia.

This concern was addressed in the Journal of American College of Cardiology highlighting a study authored by Katherine Samaras, MBBS, PhD of St. Vincents Hospital in Sydney Australia.  They looked at adults aged 70 – 90 over a period of seven years.  Over 1,000 subjects in the study included individuals who did not take statins, individuals who were already using statins and individuals who were started on statins during the study period. The subjects first took a standard mini mental status test which allowed them to exclude anyone already showing signs of dementia. They then did state of the art cognitive testing and memory testing on the subjects over a seven-year period.

They found that there was no difference in the rate of decline of memory or intellectual function between statin users and non-users.  In a small subgroup of patients, they used imaging techniques to look at the brain volume comparing it over time between statin users and non-users. They found that users had more brain volume at the six-year mark than non-users.  They found that users with heart disease who took statins had a slower rate of decline of learning memory than non-users.  This also included users and non-users who have the APOE-4 genotype associated with cognitive decline.

While statins may not be a perfect class of drug, the study clearly demonstrated that the idea that they encourage cognitive decline and dementia at an accelerated rate is completely false.

Who Is Addressing the Availability, Safety & Efficacy of our Medications?

I watched all three presidential debates this summer with health care being a time-consuming topic for all. Universal health care and Medicare-for-All, with or without an option for private insurance, were debated and discussed at length.

At the same time NBC Nightly News presented a story documenting that all our antibiotics come from production in China. With globalization policies, which promote moving production to lower cost overseas factories, there is no longer any production of antibiotics in the USA. A former member of the Joint Chief of Staffs, citing the current trade conflicts and China’s aggressive military stance in the Pacific, considers this a security issue. I have heard not one question or comment on this topic in the debates?

This week, once again, the blood pressure medicines losartan and valsartan were recalled because they contained potential carcinogens. These generics were produced in India, Asia and Israel. These same drugs have been recalled multiple times in the last few years for similar problems.

Due to reduction in funding for FDA inspections, many of these foreign plants have not been inspected for years. We can add recalls of generics to drug shortages. We suffered a shortage of intravenous fluids for hydration because the primary production site in Puerto Rico was destroyed in a hurricane. We had shortages of morphine and its derivatives for treatment of orthopedic trauma and post-surgical pain. They substituted foreign-produced short acting fentanyl. I saw pediatric ER physicians unable to administer the most effective treatments for sickle cell crisis in children because it required the use of a narcotic drip to offset the dramatic pain the treatments induce as they stop the crisis.

Then there are the psychiatric patients on antidepressant generics who are paying hundreds of dollars per month for products that wear off in 16 hours rather than 24 as the brand product did. Their symptoms creep back in allowing them to tell time based on the reduced efficacy of these products. By law, generics are required to provide 80% of the “bioavailability” of the brand product but what does that mean and who is testing?

This all began when the Reagan Administration closed the FDA research lab. Prior to that, all new products were sent to that lab for approval prior to being released in America. On their watch, a pharmaceutical product never had to be recalled. Big Pharma complained they took too long as did some consumer groups. This resulted in the defunding and closing of the lab. Products are now outsourced to private reference labs and their reports are sent to the FDA for review. The frequent drug recalls contrast to the success of promoting safety when the FDA did it themselves.

Isn’t it time for the health care debate, especially the presidential debates, to discuss the safety, efficacy, supply and cost of pharmaceutical products? I am all for bringing production home to the USA, restoring the FDA funding for the reopening of their lab as an impartial test site and putting the cost of repeatedly testing the generics for efficacy even after approval and release on the backs of Big Pharma. Let’s see these topics introduced to the health care debate too.

Antibiotic Use – Independent of Physician Prescribing

A recent article in the Annals of Internal Medicine looked at individuals who took antibiotics without them being prescribed by physicians at a visit.  The authors looked at 31 published studies between January 2000 and March 2019.  The medications came from family and friends, online distribution sites, drugs prescribed for their animals by their veterinary doctors and those stored after a previous indicated use.   When asked about it, and the reasons why these patients took these medications, the main factors cited were lack of health insurance or lack of healthcare access, cost of physician visits or medications, long waiting times in clinics, embarrassment for needing antibiotics, lack of transportation and/or easy availability of antibiotics  from other sources.

We are currently going through an antibiotic resistance crisis in the world.  Most of the fault lays with agricultural industry feeding livestock tons of antibiotics to fatten them up. Patterns of resistance develop on the farms and are passed species to species.

To remedy this, the US agriculture industry, especially in chicken production, has cut back drastically on this process.  At the same time, we are requesting physicians to work with infectious disease doctors in stewardship programs to reduce their use of ineffective antibiotics and to prescribe with precision when these medications are needed.  It works. Studies are beginning to show the benefits of these programs.

Despite this, the pressure from patients to be given something when they pay for, and invest in, a medical evaluation for an infection is overwhelming. In the setting of telemedicine, as well as walk-in and urgent care centers, reviews and patient satisfaction survey results are tied to whether the patient was given an antibiotic whether it was indicated or not.

As bacteria become resistant to common and inexpensive antibiotics, pharmaceutical manufacturers are not being incentivized to produce newer more efficacious medications.  At the same time, older useful antibiotics which do not generate much of a profit are not even being ordered and stored by chain pharmacies that lose money each time the older generics are prescribed.

To begin solving this problem, an improvement of our health literacy is required. Education in schools and in public health announcements, both in print and social media, need to realistically address the issue. This education will not replace the need for access to health care and health, but it is a beginning to make individuals understand how, when and why these “miraculous” medications can and should be used.