Hospital Pharmacy - March 2013 - (Page 198)

Hosp Pharm 2013;48(3):198–199 2013 Ó Thomas Land Publishers, Inc. www.thomasland.com doi: 10.1310/hpj4803-198 RxLegal Expanding the Definition of Nonprescription Drugs: Potential Impact on Pharmacists Michael Gabay, PharmD, JD, BCPSp I n March 2012, the US Food and Drug Administration (FDA) held a public hearing regarding a proposed ‘‘new paradigm’’ where the FDA would move toward approving certain medications that normally require a prescription to nonprescription status under conditions of safe use.1 These conditions of safe use, which could involve pharmacybased kiosks or other aids that lead the patient through an evidence-based algorithm for a particular drug product, performance of simple diagnostic tests by pharmacists, or some other type of pharmacist intervention, may signiﬁcantly expand the current role of pharmacists in retail and clinic pharmacy settings. Over 240 million individuals self-treat with nonprescription medications annually and approximately 60 million of these would not otherwise seek treatment; therefore, the potential impact of expanding the deﬁnition of nonprescription drugs is enormous.2 Currently, medications are approved by the FDA either as prescription or nonprescription.1 The FDA requires a medication to be dispensed under a valid prescription if, ‘‘because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such drug.’’ The agency has wide latitude to decide whether or not data submitted as part of a new drug application are sufﬁcient to ensure that a drug is safe for use under its proposed labeling and if the new medication should be prescription-only. The FDA has begun to consider expanding the deﬁnition of nonprescription medications for a variety of reasons, not the least of which is the sometimes burdensome process of obtaining a prescription. Oftentimes, patients must see a prescriber in person to obtain an initial prescription and, in some cases, for additional reﬁlls. The time and cost associated with prescriber visits can discourage patients from receiving needed medications.3 In addition, undertreatment of a variety of common disorders (eg, hypertension, dyslipidemia, asthma) is a well-recognized problem in the United States.1 By making certain prescription medications widely available without a prescription, but with standardized conditions for safe use, the FDA hopes to address this public health issue. The FDA is considering multiple potential approaches to the expanded deﬁnition of nonprescription drugs, including the following1: requiring an in-person visit to a prescriber for an initial prescription, but then allowing a speciﬁc number of reﬁlls to be authorized under conditions of safe use without a return visit (most beneﬁcial for rescue medications such as asthma inhalers or epinephrine injection for allergic reactions), allowing some medications to be available simultaneously as both prescription and nonprescription medications under conditions of safe use (allowing for greater ﬂexibility in obtaining needed medications), approving medications that generally have required a prescription as nonprescription products in conjunction with some sort of pharmacist intervention. The FDA believes that reducing or eliminating the number of ‘‘required’’ prescriber visits through some of the above mechanisms may not only allow prescribers to focus care on the more seriously ill, but may also decrease overall health care costs. All of these approaches, if adopted, would have an impact on the role of the pharmacist, particularly in the retail setting where pharmacists are the most accessible to patients. Some diseases or conditions might require conﬁrmation of a diagnosis or routine monitoring using a diagnostic test that could be available in a pharmacy.1 Pharmacists may then use the results *Director, Drug Information Group and Prior Authorization Services, Clinical Associate Professor, Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, Chicago, Illinois 198 Volume 48, March 2013 http://www.thomasland.com

Table of Contents for the Digital Edition of Hospital Pharmacy - March 2013

Hospital Pharmacy - March 2013
Editorial
ISMP Medication Error Report Analysis
ISMP Adverse Drug Reactions
Cancer Chemotherapy Update
Off-Label Drug Uses
RxLegal
Integrating Precepting Into Your Daily Practice
Reduction in Surface Contamination With Cyclophosphamide in 30 US Hospital Pharmacies Following Implementation of a Closed-System Drug Transfer Device
Comparison of the Efficacy and Safety of Two Different Insulin Infusion Protocols in the Medical Intensive Care Unit
Publication Rates of Abstracts Presented at Five National Pharmacy Association Meetings
Case Report: Dabigatran-Associated Gynecologic Bleeding
Formulary Drug Reviews
Continuing Education Case Study Quiz (0.15 CEU)
Current FDA-Related Drug Information
Director’s Forum
Pharmacy Automation and Technology
Index to Advertisers

Hospital Pharmacy - March 2013