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FDA considers prescription drug switch to OTC
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The FDA held a public hearing to obtain information and comments from the public on the feasibility of a new paradigm that would allow certain drugs for nonprescription use and its potential benefits and costs.
During this 2-day public hearing, presentations focused on the pros and cons of switching certain prescription drugs to over-the-counter status. The classes of drugs included:
- Cholesterol.
- Hypertension.
- Diabetes.
- Migraine.
- Asthma.
- Influenza.
- Allergy.
- Insomnia.
- Smoking cessation.
“Over-the-counter drugs have had great success with providing consumers with excellent self-care options and at the same time providing significant health care savings from averted prescriber and emergency department visits,” said Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA. “The question we are addressing is: Can we broaden the assistance that the consumer gets and, thus, increase the types of medicines that could potentially be available nonprescription.”
Pharmacist involvement
Involvement of pharmacists in consumer diagnosis was a key topic in this new paradigm. Besides providing the consumer with a specific medication, they could also help interpret test results for diagnosis and decide which medication is right for the consumer.
“Research has shown that approximately one-third to one-half of all patients in the United States do not take their medications as prescribed by their providers,” said Eric Juhl, director of federal public policy for the National Association of Chain Drug Stores. “Pharmacy services administered by pharmacists in chain pharmacies have been proven to improve patient health and prevent unnecessary hospitalization caused by nonadherence.”
Another idea generated included an algorithm available through a store kiosk or the Internet that would allow consumers to find out whether a specific medication would be right for them. The algorithm would include questions about sex, age and chronic disease history and provide information about the medication that would help consumers with self-diagnosis.
The other side
However, not every presenter agreed that help from pharmacists and algorithms is the best solution for consumers. Many said consumers should still receive advice on taking certain medications from a physician.
“Lack of oversight from a practitioner is a serious concern. This is especially true for patients with chronic disease,” said Sandra Adamson Fryhofer, MD, MACP, FRCP, chair-elect of the Council on Science and Public Health at the American Medical Association. “Not having a physician involved can delay change in treatment and can harm the patient. This is especially concerning for older patients who might be seeing multiple doctors and taking multiple medications.”
Disclosure: Drs. Fryhofer and Woodcock and Mr. Juhl report no relevant financial disclosures.
Perspective
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Rhonda Cooper-DeHoff, PharmD
As with all comprehensive programs, like this would be, the devil is in the details. I think coming up with criteria for oversight and management of all the different diseases specified and classes of drugs that could be involved will be a huge task. I am a firm believer that properly trained and experienced pharmacists are capable of contributing to patient care through monitoring of laboratory parameters, as well as assessing patient outcomes and patient adverse outcomes. However, one has only to turn to the experience in the United Kingdom when statins (simvastatin) went OTC and pharmacists were relied upon to monitor cholesterol levels and refill statin requests. At least in the early years post-implementation, this program was significantly underutilized by patients, and there may be a number of reasons for this, not the least of which is cost. Once a drug goes OTC, then all costs associated with the purchase of the drug are out-of-pocket. There is no longer a co-pay for the drug, which in the case of a statin can be as little as $4 per month or $10 every 3 months. An OTC version of a statin would likely be much more expensive. I am also concerned about the potential for increased risk of drug-drug interactions, which may become much more complex to understand when some medications are purchased OTC and not tracked within a comprehensive medication records system and others are filled by one or more pharmacies.
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