Doctors of Pharmacy and Their Role in the Health Care Team

My patient, a mental health professional, was sent for an MRI of her hips and back by her orthopedic surgeon. He was in surgery when she called him for an antianxiety medication to help her get through her claustrophobia in the MRI machine.

She waited seven hours for a response and when a repeat phone call resulted in no response she called me. I asked her if she was driving herself to or from the procedure and she answered no that her husband was taking her. I phoned in a small supply of a longer acting antianxiety medication called lorazepam 0.5 mg one tablet 30 minutes prior to the procedure. It was called in at 4:00 p.m. after we first accessed the in-state narcotic prescribing line Eforsce to make sure our patient was not pill or doctor shopping.

I received a phone call at 9:00 p.m. that evening from the patient who was at the pharmacy saying they didn’t have lorazepam in stock. It was unclear to me why, if they did not have the medication in stock, no one was responsible enough to call me and request an alternative prescription? I called the pharmacy in response to the patient calling me and ordered another product. However, they did not respond to my question “Why didn’t you call me if the medicine I ordered was not available?”

This week a 63 year old woman with three days of painful urination came to my office. Her urine suggested an infection. I called her pharmacy to phone in a prescription for ampicillin until her culture and sensitivity results were known. The pharmacist said she was too busy to take the call and asked me to leave a message. I waited for the beep and left the message. Thirty six hours later I received a fax to my office telling me that they were out of ampicillin and did not offer an alternative. I immediately called the pharmacy, furious at the delay and prescribed an alternative medication. Once again, if they did not have the ampicillin then why did it take them 36 hours to inform the patient or me? Why was this done by facsimile and not a phone call? The potential for complications of an untreated gram negative urine infection is frightening and life threatening. This should never occur. Then again why isn’t a common inexpensive antibiotic available in South Florida?

This is not very different than the blood pressure medicine Valsartan recall due to production induced impurities. When the recall was announced, I searched my computer and contacted my patients taking this medication to discuss options. For those demented and cognitively impaired patients I first called the pharmacy to ask if their supply was part of the recall. Much to my surprise much of it was under recall but the pharmacy had no intention and felt no professional responsibility to inform the customers who they had sold the tainted product to.

Pharmacists continually stress their professionalism as part of the health care team. These are three recent local examples of their need for improvement.

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Statin Related Muscle Pain and Coenzyme Q 10

Statins are used to lower cholesterol levels in an effort to reduce the risk of developing cardiovascular disease. They are used after a patient has exhausted lifestyle changes such as changing their diet to a low cholesterol diet, exercising regularly and losing weight without their cholesterol dropping to levels that are considered acceptable to reduce your risk of vascular events.

Patients starting on statins often complain of muscles aches, pains and slow recovery of muscle pain after exercising. In a few individuals the muscle pain, inflammation and damage becomes severe. One of the known, but little understood, negative side effects of statin medications are the lowering of your Coenzyme Q 10 level. CoQ10 works at the subcellular level in energy producing factories called mitochondria. Statin drugs, which inhibit the enzyme HMG-CoA Reductase lower cholesterol while also lowering CoQ10 levels by 16-54 % based on the study reporting these changes.

The November 16, 2018 edition of the Journal of the American Medical Association published a review article by David Rakel, MD and associates that suggested that supplementing your diet with CoQ 10 would reduce muscle aches and pains while on statin therapy. Twelve studies were reviewed and the use of CoQ10 was associated with less muscle pain, weakness, tiredness and cramps compared to placebo. The studies used daily doses of 100 to 600 mg with 200 mg being the most effective dosage. Finding the correct dosage is important because the product is expensive with forty 200 mg tablets selling for about $25.

Since CoQ10 is fat soluble, you are best purchasing formulations that are combined with fat in a gel to promote absorption. As with all supplements, which are considered foods not drugs , it is best if they are UPS Labs certified to insure the dosage in the product is the same as listed on the label and that it contains no unexpected impurities.

Vitamin D Supplements Do Not Reduce Falls, Fractures or Improve Bone Density

Much has been written about the benefits of supplementing Vitamin D in patients. The World Health Organization sets its normal blood level at 20 while in North America it is listed at over 30. Under normal circumstances when your skin is exposed to sunlight your kidneys produce adequate amounts of Vitamin D.

Over the last few years low vitamin D levels have been associated with acute illness and flare-ups of chronic illness. The Vitamin D level is now the most ordered test in the Medicare system and at extraordinary expense. Supplementing Vitamin D has become a major industry unto itself.

The October 4th edition of the Lancet Diabetes and Endocrinology contained an article written by New Zealand researchers that looked at 81 randomized research trials containing almost 54 thousand participants. “In the pooled analyses, researchers found that Vitamin D Supplementation did not reduce total fracture, hip fracture, or falls – even in trials in which participants took doses greater than 800 IU per day.” Vitamin D supplementation did not improve bone mineral density at any site studied (lumbar spine, hip, femoral neck, forearm or total body).

They concluded that there is little justification for the use of Vitamin D Supplements to maintain or improve musculoskeletal health, and clinical guidelines should reflect these findings.

Sleep and Cardiovascular Health

Several recent publications and presentations of data on the relationship between sleep patterns and vascular disease occurred at the recent meeting of the European Society of Cardiology. The PESA (Progression of Early Subclinical Atherosclerosis) study performed by Dr Fernando Dominguez, MD, of the Spanish National Center for Cardiovascular Research in Madrid talked about the dangers of too little or too much sleep.

The principal researcher, Valentin Fuster, MD PhD, looked at 3,974 middle-aged bank employees known to be free of heart disease and stroke. They wore a monitor to measure sleep and activity. Interestingly, while only about 11% reported sleeping six or fewer hours per night, the monitor showed the true figure was closer to 27%. They found those who slept less than six hours per night had more plaque in their arteries than those people who slept six to eight hours. They additionally looked at people who slept an average of greater than eight hours.

Sleeping longer had little effect on men’s progression of atherosclerosis but had a marked effect of increasing atherosclerosis in women. Researchers then adjusted the data for family history, smoking, hypertension, hyperlipidemia, diabetes and other known cardiovascular risk factors. They found that there was an 11% increase in the risk of diagnosis of fatal or non-fatal cardiovascular disease in people who slept less than six hours per night compared to people who slept 6-8 hours per night. For people who slept an average of greater than eight hours per night they bore a 32% increased risk as compared to persons who slept 6-8 hours on average. Their conclusion was distilled down into this belief: “Sleep well, not too long, nor too short and be active.”

In a related study, Moa Bengtsson, an MD PhD student at the University of Gothenburg in Sweden presented data on 798 men who were 50 years old in 1993 when they were given a physical exam and a lifestyle questionnaire including sleep habits. Twenty one years later 759 of those men were still alive and they were examined and questioned. Those reporting sleeping five hours or less per night were 93% more likely to have suffered an MI by age 71 or had a stroke, cardiac surgery, and admission to a hospital for heart failure or died than those who averaged 7-8 hours per night.

While neither study proved a direct cause and effect between length of sleep and development of vascular disease, there was enough evidence to begin to believe that altering sleep habits may be a way to reduce future cardiovascular disease.

Inflammation and Increased Risk of Cardiovascular Disease

For years, experts have noted that up to 50% of men who have a heart attack do not have diabetes, high blood pressure, high cholesterol, do not smoke and are active. This has led to an exploration of other causes and risk factors of cardiac and cerebrovascular disease.

In recent years, studies have shown an increased risk of cardiovascular disease in patients with rheumatoid arthritis, in untreated psoriatic arthritis and in severe psoriasis. We can also add atopic eczema to the list of cardiovascular risk factors.

In a publication in the British Medical Journal, investigators noted that patients with severe atopic eczema had a 20% increase risk in stroke, 40 – 50% increase risk of a heart attack, unstable angina, atrial fibrillation and cardiovascular death. There was a 70% increased risk of heart failure. The longer the skin condition remained active the higher their risks.

The study looked at almost 380,000 patients over at least a 5 year period and their outcomes were compared to almost 1.5 million controls without the skin conditions. Data came from a review of medical records and insurance information in the United Kingdom.

It’s clear that severe inflammatory conditions including skin conditions put patients at increased risk. It remains to be seen whether aggressive treatment of the skin conditions with immune modulators and medications to reduce inflammation will reduce the risks?

It will be additionally interesting to see what modalities cardiologists on each side of the Atlantic suggest we should employ for detection and with what frequency? Will it be exercise stress testing or checking coronary artery calcification or even CT coronary artery angiograms? Statins have been used to reduce inflammation by some cardiologists even in patients with reasonable lipid levels? Should we be prescribing statins in men and women with these inflammatory skin and joint conditions but normal lipid patterns?

The correlation of inflammatory situations with increased risk of vascular disease currently raises more questions with few answers at the present time.

Concierge Medicine – My 15th Anniversary

I practiced general internal medicine from June 1979 until November 2003. Immediately after training I became an employed physician of an older internist covering my employer’s patients and building my practice for two years before embarking on my own.

I saw 20 or more patients per day in addition to providing hospital care and visiting patients as they recovered in nursing homes. As managed care made its clout felt by kidnapping our patient’s and trying to sell them back to us at 50 cents on the dollar, I helped form a 44 doctor multi-specialty group with its own lab, imaging center and after hours walk-in center. The hope was that a large group might have some negotiating leverage with insurers allowing us to take more time with our patients for more reasonable fees. They laughed at us.

Three years later, my associate and I went to the bank, took out a big personal loan and started our concierge practice. We did this primarily to be comfortable providing excellent care to patients. The system was broken and no medical leader, insurer, employer or politician was going to fix the broken system.

Year after year as our patient’s survived and grew older and more complicated, private insurers including CMS (Medicare) asked us to see them quicker, in shorter visits, but be more comprehensive. The insurers essentially wanted us to place a square peg in a round hole. Switching to a Concierge practice meant I would be caring for a small group of patient’s well at the cost of finding a new medical home for 2,200 existing patients. Switching to Concierge Medicine was our response to a broken system being pushed in a direction of more money and profits for administrators and insurers at the expense of patients and doctors.

In retrospect, I should have made this change five years sooner. The financial rewards are not very different – caring for a small patient panel that pay a membership fee as compared to an enormous panel of patients. The rewards to the patients’ and the doctor for doing a job well done are priceless.

We increased our visit time to 45 minutes from 10 minutes. We set aside 90 minutes for new patient visits. We made a point of continuing to care for our hospitalized patients while all our colleagues were turning that over to hospital employed physicians with no office practices. We provided same day visits and access to the doctor 24 hours a day, seven day a week with accessibility by phone or email. We had the time to advocate for our patient’s as they weaved their way through a bureaucratic mind numbing health care system that made filling a prescription as difficult as the science of launching a rocket into space.

The results of the change are striking. There are very few emergency admissions to the hospital. Falls and trauma, which are mostly not preventable, replaced heart attacks, strokes and abdominal catastrophes as reasons for hospitalizations. There are many fewer hospitalizations. There are fewer crises because we learn about the problems immediately and see the patient’s quickly. If necessary, we help them get access to specialty services.

We have the time and staff now to battle with insurers and third party administrators to get our patient’s what they need to regain their health and independence. When they need specialty care we get them the best; the people we go to ourselves both locally and nationally. We send them equipped with all the information and questions they need to ask about their health problem.

Concierge Medicine has additionally given us the time to teach future doctors. While this stewardship of the profession and launching of future physicians is immensely satisfying, it also makes us stay current and on top of the latest literature and advances.

I look forward to this coming celebration of my 15th year in concierge medicine. I see Direct Pay Practices developing which deliver concierge services to the masses for lower fees. It is a spin-off of “boutique “medicine” or Concierge Lite” as my advisor calls it. It is an attempt by young physicians to reestablish the doctor patient relationship and deliver care in a broken health system.

I am thankful to my patients, who took a chance and came on this journey with me. I look forward to caring for them for years to come.

Prostate Cancer, Digital Rectal Exams, PSA and Screening

The PSA blood test, to detect prostate cancer, clearly has saved lives according to numerous studies. The United States Preventive Task Force (USPTF) recognizes this but has decided that screening for prostate cancer is not a great idea in men aged 55-69. They point out the PSA can be elevated from an enlarged prostate, an inflamed or infected prostate, a recent orgasm while having sex and other causes.

Elevated PSAs led to trans-rectal ultrasound views of the prostate and biopsies of the prostate. These biopsies were uncomfortable, even painful, and often followed by inflammation and infection of the prostate. Many times the prostate biopsy was benign with no cancer detected. The USPTF felt the cost, worry, and potential side effects were a risk far outweighing the benefits of screening. They consequently came out against screening men in this age group.  Naturally this position produced a tidal wave of criticism from urologists and other.

So, the USPTF has produced new recommendations calling for patient education and making a shared decision whether or not to obtain a PSA measurement before you send it out. This is a bit confusing because we always discuss the pros and cons of a PSA before we draw it. Adult men are entitled to hear the pros and cons so they can make their own informed decision.

To complicate matters, a study out of McMaster University in Canada reveals physicians are poorly trained in performing a digital rectal exam. They cite the lack of experience coming out of school and going into training and cite numerous research studies showing a rectal exam is a low yield way to detect prostate cancer. They do not recommend performing digital rectal exams for prostate cancer screening.

This received much media hype and the blur between the efficiency of detecting prostate cancer via a rectal exam and the use of the rectal exam to detect rectal and colon disease has been lost. We perform digital rectal exams to detect prostate cancer and look at the perirectal area for disease. We test the strength and performance of the anal sphincter muscle. We feel for rectal polyps and growths and, in certain situations, test the stool for the presence of blood.

During my internal medicine training my teachers always required a digital rectal exam, stool blood test and slide of the stool as part of the exam. As trainees, we realized the invasiveness of the exam and did our best to be polite, gentle and caring. I always asked for permission first, and still do. How can you tell if something is abnormal if you haven’t performed normal exams?

Last but not least, Finesteride, a medicine used to shrink an enlarged prostate by inhibiting male hormones, has finally been shown to be protective against developing prostate cancer. A study published in the journal of the National Cancer Institute found that men taking it for 16 years had a 21 % lower incidence of prostate cancer.