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Expanding the availability of OTC medication
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All readers of Infectious Diseases in Children are aware of the speed at which medical care advances, including the use of technology and our knowledge of disease diagnosis and treatment.
Although new pharmacologic agents and medication products are introduced each year, one area of the drug use process that has not recently changed is the availability of certain drugs, with respect to their categorization. This may change in the near future.
Prescription and OTC
Medications are available as two main categories: prescription and over-the-counter. In past years, some drug products have changed categories, from availability by prescription only to availability without prescription — OTC. Recent examples that have affected children include ranitidine (an H2 antagonist) and omeprazole (a proton pump inhibitor). The FDA has the authority to determine whether a drug product should be available by prescription only or whether it can be more widely available OTC.
To be available OTC, the FDA considers whether a medication treats conditions that can be self-diagnosed (without interaction with a prescriber); not associated with adverse effects deemed significant enough to require prior evaluation by a prescriber; and does not require a prescriber’s direction for use. Certainly, many pharmaceutical manufacturers would like their products to be available OTC as a way to increase sales. For example, the FDA recently denied conversion of several statin (HMG-CoA reductase inhibitors) drug products to OTC status because the agency said most consumers cannot yet independently and adequately determine their blood lipid values.
The availability of several OTC drug products are more controlled and are known as “behind-the-counter,” although this is not a standardized class of medication availability. These drugs do not require a prescription, but their use must be requested at a pharmacy counter, where their availability can be controlled and monitored. Several years ago, pseudoephedrine availability in pharmacies became more controlled to limit its use in the production of methamphetamine. Plan B, a product containing levonorgestrel to prevent postcoital pregnancy, is also available without a prescription to females aged 17 years and older. A specific request is necessary at a pharmacy to obtain Plan B and pseudoephedrine.
Increased product availability
Long recognized difficulties associated with prescriptions and OTC include under-treatment of common conditions, lack of continued pharmacotherapy of chronic conditions (ie, due to need for continual prescriber visits and prescription refills), and the generally overburdened health care system. Allowing some medications, under very specific circumstances, to be available without the necessity of seeing a prescriber may allow prescribers to spend more time with seriously ill patients. The FDA is considering allowing the establishment of some medications (that are now available by prescription) to be available OTC, after use of specific electronic diagnostic measures or algorithms; or after consultation with a pharmacist; or by other additional means.
Discussion of this medication availability paradigm is just beginning, and a public hearing was held near FDA headquarters in March. Public comment is sought by the FDA and is open until May 7 (www.regulations.gov; specify Docket # FDA-2012-N-0171). Discussion is beginning with this concept and has not yet advanced to specific medications and scenarios.
Examples that have been used to illustrate this concept include adults and children with chronic conditions, such as hyperlipidemia, diabetes, hypertension, migraine headaches and asthma. As under-treatment of common diseases is a well-recognized problem in the United States, these conditions may represent suitable health problems in which easier access to prescription medications — once an accurate diagnosis is made and appropriate patient characteristics can be determined (eg, patients who can be relied upon to use the medication properly) — may be beneficial.
Once an accurate diagnosis is made and the patient receives and benefits from pharmacotherapy, medication refills may potentially be made through electronic pharmacy kiosks or Internet-based questionnaires. Pharmacists could additionally assist in verifying appropriate use of, and clinical benefit, from the medication. An important component of this concept includes expanded availability — and flexibility — of medications under “conditions of safe use.” Proper procedures, such as advanced electronic systems or additional use of pharmacists, would assist in ensuring that patients continue to receive high-quality medical care.
Potential benefits of this new concept of increased medication availability include increased appropriate use of medications, improved access to health screening, increased and easier access to medications, and decreased health care costs. As health care has rapidly advanced in years, the FDA has described that it may be time for the procedures of determining which medications should be more widely available OTC to modernize with advances in technology.
As this new paradigm receives more attention and scrutiny, many questions will no doubt arise to ensure that medications are used safely. These include the health conditions most likely to benefit from increased OTC medication availability, the technology necessary to ensure the safe and effective use of expanded medication availability, and specific characteristics of patients most likely to benefit.
References:
- FDA. FDA considers expanding definition of nonprescription drugs, 2012. Available at: www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm297128.htm.
- Kux L. Using innovative technologies and other conditions of safe use to expand which drug products can be considered nonprescription. Federal Register. 2012;77(39):12059-12062.
Edward A. Bell, PharmD, BCPS, is professor of clinical sciences at Drake University College of Pharmacy, Blank Children’s Hospital, in Des Moines, Iowa. He is also a member of the Infectious Diseases in Children Editorial Board. Disclosure: Dr. Bell reports no relevant financial disclosures.