NSURE; Expanded non-prescription drug class
Objectives: There has been considerable debate over the last few decades about creating a third class of drugs that would not require a prescription or not be available freely over the counter, but require a pharmacist’s consultation upon purchase. These debates reignited again in 2012, when the Food and Drug Administration (FDA) held a hearing about a third class of drugs positioned as an expanded nonprescription drug class under the FDAs Nonprescription Safe-Use Regulatory Expansion (NSURE) Initiative. The objective of this study was to determine which prescription drugs community pharmacists believe are acceptable additions to an expanded definition of nonprescription drugs that would be available pending pharmacists’ consultation with a patient.
Methods: This cross-sectional study was conducted using a self-report, web-based survey administered to a national panel of community pharmacists. The survey contained a list of 24 current “prescription-only” drugs which may be potential candidates for an expanded nonprescription drug class, based on criteria outlined by the FDA, and questions related to respondent demographic and practice characteristics. The respondents were asked to indicate whether a particular drug should be marketed as a prescription drug, nonprescription drug or as part of an expanded non-prescription drug class. Descriptive analyses were conducted to determine the drugs that community pharmacists believed would be suitable additions to an expanded non-prescription drug class under the NSURE initiative.
Results: 462 completed surveys were received. Most respondents indicated that clopidogrel bisulfate (85.3%) and zolpidem (86.6%) should continue to be dispensed as prescription drugs. Atorvastatin, metformin, and sildenafil (among others) were considered appropriate to be marketed as an expanded nonprescription drug, in other words, dispensed without a prescription but upon pharmacist consultation. Desloratadine (64.6%) and pre-natal vitamins (50.2%) were considered appropriate for nonprescription status (over-the-counter, without pharmacist intervention).
Conclusions: Respondents suggested that 18 out of 24 drugs (75%) on the list provided could be categorized into an expanded class of nonprescription drugs. Adding more drugs to an expanded nonprescription drug class has the potential to expand pharmacists’ provision of patient care under the FDA’s proposed NSURE program.
Conflict of Interest
Shah RM, Holmes ER, West-Strum DS, Patel A. Community Pharmacists’ Classification of Prescription Drugs into an Expanded Class of Nonprescription Drugs under the FDA's Proposed NSURE Initiative. Inov Pharm. 2017;8(4): Article 6. https://pubs.lib.umn.edu/innovations/vol8/iss4/6.