Hospital Pharmacy - February 2012 - (Page 110)

Hosp Pharm 2012;47(2):110–111 2012 Ó Thomas Land Publishers, Inc. www.thomasland.com doi: 10.1310/hpj4702-110 RxLegal Drug Importation: Where Do We Stand? Michael Gabay, PharmD, JD, BCPSp n October 2011, Senator David Vitter introduced an amendment to Congress allowing for the importation of US Food and Drug Administration (FDA)–approved prescription medications from Canada either through the mail or the Internet.1 The Vitter amendment went down in defeat in the United States Senate, capturing only 45 of the required 60 votes. Senator Vitter’s amendment is not the ﬁrst, nor will it be the last, attempt to legalize some form of drug importation in the United States. With persistent public pressure to somehow address the ever-increasing costs of prescription medications, the issue of drug importation continues to be one of importance. Currently, the importation of unapproved new drugs, whether for personal use or otherwise, violates the Federal Food, Drug, and Cosmetic Act (FDCA).2,3 Under the Act, unapproved new drugs include ‘‘any drugs, including foreign-made versions of U.S. approved drugs that have not been manufactured in accordance with and pursuant to an FDA approval.’’ The burden of proof regarding whether an imported drug is actually an approved medication falls on the importer of the medication; the FDA may deny importation of any drug that ‘‘appears’’ to be unapproved. In addition, imported medications must follow FDA requirements with regard to labeling and dispensing in order to not be in violation of the FDCA.3 Despite the wording within the FDCA, the FDA does exercise enforcement discretion with regard to drug importation. In fact, the FDA generally refrains from taking legal action against consumers who import medications for personal use under its personal importation policy as long as the following requirements are met3: ‘‘the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; I the product is considered not to represent an unreasonable risk; and the individual seeking to import the product afﬁrms in writing that it is for the patient’s own use (generally not more than 3 month supply) and provides the name/address of the licensed physician in the U.S. responsible for his/her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.’’ Beyond the personal importation policy, several states have developed drug importation programs for their citizens despite the clear wording within the FDCA. The FDA has acknowledged that these programs are in direct conﬂict with federal and sometimes state laws4; however, it has not taken speciﬁc enforcement action to close them down. Some of these prescription drug importation programs have shut down on their own due to lack of use by consumers. For example, in October 2004, Former Gov. Rod Blagojevich of Illinois announced the creation of ‘‘ISave Rx,’’ a state-sponsored program that allowed for the importation of prescription drugs from select pharmacies in Canada and Europe. Other states including Wisconsin, Kansas, Missouri, and Vermont signed on to participate in ‘‘I-Save Rx’’; however, the program ended in 2009 when its Canadian supplier, Pegasus Health Services, withdrew citing inadequate promotion of the program.5 Although many consumers view drug importation as a win-only proposition that allows for wider access to affordable prescription medications, there are risks including concern regarding the integrity of the imported drug product and the impact on patient care.6 The current US drug distribution system was designed to prohibit unapproved and potentially unsafe medications from entering the hands of consumers. Allowing for drug importation of unapproved new drugs would create another opportunity for mislabeled, mishandled, subpotent, or counterfeit drugs to access *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. 110 Volume 47, February 2012 http://www.thomasland.com

Table of Contents for the Digital Edition of Hospital Pharmacy - February 2012

Hospital Pharmacy - February 2012
Editorial
ISMP Medication Error Report Analysis
ISMP Adverse Drug Reactions
Cancer Chemotherapy Update
Off-Label Drug Uses
RxLegal
Key Considerations in Pharmacy Outsourcing: Understanding Risks and Managing Liability
Using the National Poison Data System to Detect Mistaken Oral Ingestions of Medication Capsules Designed for Use in Pulmonary Inhalers
Apparent Epinephrine Toxicity in the Treatment of Anaphylaxis: A Patient Case of Prolonged Hypotension
Formulary Drug Reviews
Continuing Education Case Study Quiz (0.15 CEU)
Current FDA-Related Drug Information
Pharmacy Automation and Technology
Director’s Forum
Hospital Pharmacy Pulse
Index to Advertisers

Hospital Pharmacy - February 2012