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Self care group supports researching non-prescription access by patients to urgent and chronic care drugs
On March 22 and 23, 2012, the U.S. Food and Drug Administration (FDA) held a public hearing to explore the idea of switching some medications to treat chronic conditions and health emergencies from prescription to over- and behind-the-counter status. Representing a group of academic health professionals, called The Self Care Collaborative, R. William Soller, PhD, a faculty member in the UCSF School of Pharmacy, Department of Clinical Pharmacy, testified in support of the concept as long as research could predict that expanded access and use of these drugs by patients was safe. He comments here on behalf of The Self Care Collaborative.
The nation reached a quiet health milestone this spring far removed from the Supreme Court considerations on health reform. In a public hearing hosted by the Food and Drug Administration (FDA), and attended mainly by medication experts, we moved one step closer to giving consumers greater access to—and we hope far better use of—medications to treat chronic conditions and health emergencies.
At hand is a new plan the FDA is considering to switch certain widely used prescription medications from prescription (Rx) to nonprescription status, provided that specific conditions of safe nonprescription use are met.
Traditionally nonprescription medicines have been given over-the-counter (OTC) status. Exceptions to this are Plan B, an emergency contraceptive, and pseudoephedrine, a nasal decongestant, which were given non-prescription, behind-the-counter (BTC) status for safety reasons.
“With new conditions of use, certain prescription medications could become OTC or BTC…”
With new conditions of nonprescription use, certain prescription medications could become BTC or OTC when accompanied by mandatory pharmacist consultation and/or the use of information technologies (IT) to make product self-selection safer. New technologies open wide this possibility. As well, U.S. pharmacists graduate with doctoral degrees and are clinically trained experts in the safe product selection and use of medications by patients.
As a coalition of medication experts that has studied consumers’ use of OTC medications for several decades, we strongly support FDA’s intention to pursue expanded access of prescription medications. Having the Centers for Medicare and Medicaid Services (CMS) on the FDA hearing panel was a key milestone, but the ultimate vision is to have the Department of Health and Human Services, to which FDA and CMS report, visibly embrace self care as a national priority—indeed, as a foundational pillar of health care in the United States.
Millions of Americans suffer, and some die, from allergies, asthma, diabetes, and drug overdoses. Highly effective prescription rescue medications exist to meet the emergency care needs of these consumers—glucagon for low blood sugar, albuterol for emergency asthma attacks, epinephrine for severe allergic reactions, and naloxone for drug overdoses. The time is now to consider giving consumers safe, nonprescription access to these medications to bridge the time needed to reach the emergency room.
Medications to treat certain chronic diseases are also potential targets for easier access through technology under new conditions of safe use. For example, an attempt was made to switch prescription statins to nonprescription OTC status but failed because the FDA found the OTC label too complex for safe self-selection by consumers. What if information technologies in pharmacies could help the consumer safely select statins while the pharmacist carefully documents the selection?
In other situations where a diagnostic test is a condition of safe use, a pharmacist could be the intermediary before sale to interpret test results, make physician referrals if needed, or determine if the product is suitable for that consumer. In the United Kingdom, pharmacist counseling is required for dozens of medications to ensure consumer safety, including those for recurring or chronic conditions such as Chlamydia infections, eczema, and migraine.
“Over the past 40 years, Rx-to-OTC switch has been an important step in empowering consumers through access to safe and effective medications.”
Over the past 40 years, Rx-to-OTC switch has been an important step in empowering consumers through access to safe and effective medications. Both pharmacy-based IT technologies to aid consumer self selection of certain OTC medicines and mandatory medication consultation for more complex BTC medicines have the potential to ensure medication safety in the community setting. The result would be a sea change in how we deliver care to Americans who need easier access to medications to treat emergency conditions and certain chronic diseases.
We urge the FDA to develop new study designs that will provide the needed evidence to predict that new conditions of use are safe. Also, all those in involved in the development and delivery of medications have a responsibility to collaborate and find ways to overcome barriers to self care imposed by language, literacy, and IT competence so that self care equity can be achieved.
A national plan to identify and switch suitable prescription medications to non-prescription availability, ensure consumer safety at the point of sale in new ways, and leverage the expertise of the pharmacist can lead to a new era of responsible self care in America. On behalf of The Self-Care Collaboration, The Self Care Collaborative is a group of academic health professionals with direct experience in the Rx- to-OTC switch and a sustained interest in FDA’s approach to redefining this medication landscape. Members include Schools of Pharmacy at UCSF, the University of Arizona, University of Pittsburgh, and the University of Texas.
- Safe Use Conditions proposed by FDA may re-open door for switch in US: Has the OTC Drug Facts Label fallen victim to the Peter Principle? - SelfCare
- [Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs] [link defunct] - FDA
- FDA Considers Expanding Definition of Nonprescription Drugs
About the School: The UCSF School of Pharmacy aims to solve the most pressing health care problems and strives to ensure that each patient receives the safest, most effective treatments. Our discoveries seed the development of novel therapies, and our researchers consistently lead the nation in NIH funding. The School’s doctor of pharmacy (PharmD) degree program, with its unique emphasis on scientific thinking, prepares students to be critical thinkers and leaders in their field.