Professional Advice / Opinions:

Risk versus Benefit: Prescription to Over the Counter Medications

By: Maria A. Sorbera, Pharm.D. Candidate c/o 2013

  Maria Sorbera was the 2011-2012 President of the Rho Chi Beta Theta Chapter at the Arnold & Marie Schwartz College of Pharmacy at Long Island University (LIU). She is a strong advocate of networking with fellow pharmacists regardless of their area of expertise, as well as the need for more unity in our profession. Ms. Sorbera would like to work with the Beta Delta chapter to promote interprofessional cooperation and further foster unity. The Rho Chi student editors would like to thank Maria for her contributions, and for being a strong, progressive voice in our profession.

“I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.”  As part of the code of ethics within the Oath of a Pharmacist, this statement is made annually by both third year pharmacy students during their “White Coat Ceremonies” and sixth years who graduate with Doctor of Pharmacy degrees.  The promise and duty of a pharmacist is to provide optimal patient care to achieve pharmacological and non-pharmacological goals, while minimizing drug interactions and adverse side effects.  Since pharmacists are the last healthcare professionals who patients speak with before receiving their medications, these goals are achievable.  Through patient counseling and profile reviews, pharmacists play key roles in preventing adverse drug reactions.  Where would we be if we had no such prospective drug utilization reviews from pharmacists?  Could patients really medicate themselves for chronic medical conditions without the counseling provided by pharmacists?

Recently, I came across an article in Pharmacy Times discussing movements by the Food and Drug Administration (FDA) to switch many prescription medications for chronic disease states such as hyperlipidemia, hypertension, and asthma to over-the-counter (OTC).1  As I read this article, not one positive outcome crossed my mind.  How could present and future pharmacists provide optimal healthcare to patients if they are no longer dispensing and counseling on medications for these chronic disease states?  One point of discussion is how and when the patients know to begin taking these medications.  The article mentioned the idea of kiosks in pharmacies, in which patients answer a series of questions to receive a diagnosis.  The problem is that not every patient who walks into a pharmacy is a text-book case; thus hard-coded guidelines would only aid a percentage of the population.  It takes evidence-based medicine and a clinician’s experience to diagnose patients properly.

Furthermore, many of these medications have serious adverse effects that healthcare providers need to discuss with patients before they begin their treatments.  For example, if a woman of childbearing age receives an HMG-CoA reductase inhibitor (also known as a “statin”), she must be aware that it is a teratogenic category X drug (not for use in pregnancy, as the fetal risks clearly outweigh any benefit of taking the medication).  If statins were to become OTC medications, patients must also be aware of the risk of myopathy and the blood monitoring required to avoid this side effect.  If more patients begin taking this class of medications without proper counseling, there may be an increased incidence of myopathies.

For antihypertensive medications, there are also several monitoring parameters patients must hear about.  Hypertension is a silent killer, and vital signs with laboratory data are necessary.  There is a risk of hypotension with all medications used to treat hypertension, and this side effect is prevalent specifically with the elderly population.

Like hyperlipidemia and hypertension, asthma is a chronic disease state that should not be self-treated.  If a patient is filling their albuterol rescue inhaler too often, the pharmacist could intervene, speak to the patient, and contact the physician about the possibility of the patient’s condition not improving or actually worsening. If that patient is able to purchase inhalers OTC without ever speaking to a pharmacist, such a beneficial intervention would never be made and the patient may remain on a suboptimal asthma regimen.

Although I have only listed a few examples regarding these three chronic disease states, there are several more reasons as to why these should remain prescription-only medications.  These reasons, as well as the overall risks versus benefits of prescription-to-OTC regulation changes, have been a topic of discussion by the FDA and regulatory agencies around the world.  In 2004, the United Kingdom (UK) was the first country to approve statins for OTC use.  The National Health Service, supported by the Department of Health and the Committee of Safety Medicines in the UK, believed that the benefits outweighed the possible risks of statin OTC use.The decrease in the risk of cardiovascular events with only a modest decrease in LDL was the overall benefit that gave this argument the push that it needed for approval.  Nonetheless, the FDA is still debating this topic.

As present and future healthcare professionals, we should strive to provide optimal patient care.  Members of the healthcare team should work together to manage patients’ acute and chronic disease states, as well as select individualized treatment regimens.  In the end, our efforts will lead to comprehensive health care management and innumerable benefits for our patients.


  1. Weiss D. FDA plans next round of Rx-to-OTC switches. Website. Available online: Mar 20, 2012. Accessed Apr 20, 2012.
  2. Abrams J. Over-the-counter statins: a new controversy. Nat Clin Pract Cardiovasc Med. 2005 Apr;2(4):174-5.
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