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A New Class of ..

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The U.S. Food and Drug Administration (FDA) has proposed a new strategy for increasing access to medications for common, and sometime undertreated, chronic conditions. The idea is to make certain prescription agents for chronic disease states such as diabetes, hypertension, elevated cholesterol, asthma and migraines available without a prescription “under conditions of safe use.” “Safe use” would depend on the drug and would include considering if the product should be sold under certain stipulations, such as within a pharmacy. The drugs would be considered part of a new class of “OTC-plus” drugs. Increasing access would include such scenarios as a patient being able to obtain the drug after discussion with the pharmacist or after viewing information via various technology platforms to determine if the drug is appropriate and safe for the individual. Another proposed situation is that the pharmacist could refill a prescription used for treating a chronic condition without consulting or gaining approval from the physician after determining from the patient that the drug is being used appropriately. 

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The FDA held a 2-day public hearing on March 22-23, 2012 to obtain input from key stakeholders, including pharmacy and technology vendors, to determine the feasibility and possible benefits and costs of the initiative.1 

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A hope, with the new proposal, is that it would allow physicians “to spend time with more seriously-ill patients, reduce the burdens on the already-overburdened health care system, and reduce health care costs.”1 Various groups have cited the potential benefits of a new “OTC-plus” class which could include increased access to treatment and care for chronic conditions and health care cost savings related to office visits and prescriptions. Examples of successful Rx to OTC switches are current access to heartburn medications (histamine-2 receptor antagonists and proton pump inhibitors), second generation antihistamines, vaginal yeast infection medications, and nicotine replacement therapies.

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One consideration is that this proposal to treat chronic conditions with “OTC-plus” drugs is a shift from using OTC products to treat conditions that are self-limiting and can be self-diagnosed and self-treated.  Care of chronic disease usually requires objective evidence and interpretation from a qualified health care professional to determine the best way to manage and evaluate appropriateness of therapy. For instance, high blood pressure is asymptomatic. Patients would need to measure their BP, know when therapy is effective or not, and then determine if the medication is safe for them based on their other health conditions, medications and laboratory values. That is considerably different from self-treating a cough or nasal congestion. The prior Rx to OTC switches have been for conditions where self-diagnosis is possible based on symptoms. While some chronic conditions can be diagnosed by symptoms, selection of an appropriate therapy is more complicated and individual patient factors, i.e. other medical conditions, laboratory values, concomitant medications and follow-up monitoring, need to be considered.

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This proposal could be a good thing for pharmacy. If the position is taken that pharmacists will be the gatekeepers for “OTC-plus” medications, then new opportunities for patient care and advanced services in community pharmacies will be created. This would allow community pharmacists to truly put their education and skills ...

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