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The Benefits Versus Side Effects of Medications

I have been practicing pharmacy for 37 years and flying for 33 years. I understand as a healthcare professional that a pilot’s first thought will often be, “Can I fly with this medication, because all I remember is what it is used for and all the published major side effects.” Fear of harm seems to be a bigger concern than how a medication can increase a person’s lifespan and quality of life. This fear is very unnecessary. Let me share with you some valuable information that should allay this fear.

Pilots’ biggest fears are stalls and seeing their aviation medical examiner. When ready to get or renew their pilot certificate, they must go to MedXPress and complete FAA Form 8500-8. Calmly reviewing the form, our diligent pilot stares at Item 17.a. Do You Currently Use Any Medication (Prescription or NONprescription)?  (And, incidentally, the same question is also found on the BasicMed CMEC, the Comprehensive Medical Examination Checklist.) If the pilot is taking, on a regular basis, an over-the-counter non-sedating antihistamine for allergies, the medication should be listed along with any other currently used prescription medications. Antihistamines often result in increased heart rate, rising blood pressure, and profuse sweating. Sounds like a medication side effect, does it not?

I have been practicing pharmacy for 37 years and flying for 33 years. I understand as a healthcare professional that a pilot’s first thought will often be, “Can I fly with this medication, because all I remember is what it is used for and all the published major side effects.” Pilots have been known to not be completely forthcoming with Item 17(a), fearing that the medication(s) are not allowed by the FAA because of the potential adverse side effects or because of the underlying medical condition being treated by the medication. Fear of harm seems to be a bigger concern than how a medication can increase a person’s lifespan and quality of life. This fear is very unnecessary. Let me share with you some valuable information that should allay this fear.

Prescribing medications is always about benefits versus risks. If the benefits outweigh the risks, the medication could be prescribed. If the risks outweigh the benefits, it’s a no-go decision. The physician will also evaluate if the medication meets standardized guidelines for the disease state that is being treated. My role as a pharmacist is to ensure the medication is guideline- and evidence-based. The thought I have when I check a prescription order for a patient is, if this was my mom or dad, would this medication be a good choice for her or him? Will it prolong life and hopefully quality of life?

Every medication since the Food, Drug and Cosmetic Act of 1938 has been monitored for safety, quality, and effectiveness. Before a medication gets prescribed it must be studied in a clinical trial. The pharmaceutical company that discovered the medication will conduct such trials. The medication must go through three phases of study. The last phase of the trial is studying the medication in the patient population it is to be prescribed for. This phase usually has thousands, or even tens of thousands, of patients being studied for how well they do on the study medication. The endpoints of these trials are commonly mortality, hospitalizations, and safety. Side effects of the medication are reported and documented during the trials. Once the trial has been completed and assuming the results are positive, the medication is submitted to the Food and Drug Administration (FDA) for evaluation of approval. The FDA will approve the medication for use by the public if it meets the standards for safety and efficacy, and defines the claims the company makes regarding the medication’s utility.

As a general rule, once over 50 years of age, there is a higher likelihood that we will require a chronic medication to lower blood pressure, prevent heart attacks, improve kidney function, decrease the risk for stroke, keep cholesterol levels low, and prolong life.

 

A great example of why you should know the wonderful benefits a medication provides to a patient is ramipril, a medication used in patients with hypertension and heart failure. The side effects of ramipril are a risk of a high potassium level, change in kidney function, and a tickle cough. There was a study called the HOPE Trial, The Heart Outcomes Prevention Evaluation Study, published in the New England Journal of Medicine on January 20, 2000 (Volume 342, pages 145-153), where ramipril was studied in low or high doses versus placebo (an inactive comparator) in 9,541 patients. These patients had a history of heart disease, diabetes, stroke, or peripheral vascular disease. The study was set up to see if heart attack, death, or stroke would be decreased in patients taking ramipril. Treatment with ramipril reduced rates of death, heart attack, stroke, cardiac arrest, and heart failure. It also reduced the risk of complications from diabetes. The quote I heard a cardiologist say was, “Ramipril does everything but keep your mother-in-law away.” Heart attacks, stroke, complications from diabetes, and death will all keep you from flying, especially death.


If you already know the benefits of taking your prescribed medications, then this is not news to you. If this concept is new to you, then adopt this new paradigm of medication knowledge and thinking. My goal and mission is to inform you of the huge benefits of your medications and not to think about the side effects as a reason to not take a medication. Most side effects happen very rarely. Every side effect, from feeling dizzy to causing mortality, must be reported to the FDA starting from the original trial to the present. It is not investigated to see if the side effect was due to other causes such as stomach flu, infection, or dehydration. It is just reported and may not be due to the medication. When taking your medications on a daily basis, think about the positive effects on your health. That mindset keeps you healthy and flying. It also keeps you flying longer to enjoy a journey that very few people get a chance to do. For me, every moment of flying is a joy and a privilege. If I require a prescribed medication for a malady or disease state, my immediate thought is how the medication will benefit me, my family, and my flying career. If you have any questions concerning safe medications allowed or disallowed by the FAA go to: https://www.aopa.org/go-fly/medical-resources/medications-database.

Larry M. Diamond, PharmD, CFII

Larry Diamond has a Doctor of Pharmacy Degree and has been a pharmacist for 37 years. Larry’s pharmacy practice has been as a Clinical Pharmacy Specialist in Cardiology, Orthopedic Surgery Specialist and most recently Clinical Pharmacy Coordinator. He is a CFII, a pilot for 33 years and has been an AOPA member since 1984.

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