Editorial - SAGE Journals

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specialty pharmacy operations because of the cost of the medica- tions and the various requirements for participation, initial prescrib- ing, monitoring, special ...
Hospital Pharmacy Volume 44, Number 3, pp 208–209 2009 Wolters Kluwer Health, Inc.

Editorial Awareness of Risk Evaluation and Mitigation Strategy Program for New Drugs Danial E. Baker, PharmD, FASHP, FASCP*

ealth care professionals are very aware of the risks and benefits associated with drug therapy. The public also is concerned about drug safety, particularly after some well-publicized drug withdrawals (eg, rofecoxib) and safety-related changes in drug product labeling (eg, rosiglitazone). Although health care professionals are familiar with the approval process for new drugs that is used by the US Food and Drug Administration (FDA), how many are familiar with the Risk Evaluation and Mitigation Strategy (REMS) and Risk Minimization Action Plan programs used by the FDA? According to a study recently published in the Journal of the American Pharmacists Association, awareness of these types of programs varies with each affected drug.1 This is not a surprise. Some of these drugs are distributed by restricted distribution systems and specialty pharmacy operations because of the cost of the medications and the various requirements for participation, initial prescribing, monitoring, special equipment, and adverse reaction mitigation. Pharmacists should become more aware of REMS, the newest program, and the reasons for its existence; it was required by the FDA Amendments Act of 2007.2-4 This amendment to the FDA Act provides the legal framework

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for requiring risk management plans, such as REMS, as a component of all New Drug Applications and Biologic License Applications and also for previously approved drugs if new safety concerns emerged after their approval. It also allows the FDA to impose civil monetary penalties for violations of the REMS provision and/or to declare a drug or biologic product as misbranded and take appropriate legal action for this type of infraction.2-6 Examples of drugs already affected by this program are Cimzia, Entereg, Nplate, Advair, Enbrel, Intron A, and PegIntron/ Rebetol Comb Pack.7 These changes in the drug approval process are important for assuring the monitoring of drug safety and providing health care professionals and patients with more information about the potential risks associated with the use of particular pharmaceutical products. The elements of REMS that are required for a particular pharmaceutical product depend on the associated risks of that product.2,5 The strategies used within REMS may include special labeling requirements, medication guides, communication planning, postapproval studies, and/or restricted distribution systems (sometimes referred to as performance-linked access systems). The hope is that this type of safety-focused program will improve patient outcomes and minimize

patient harm. Periodic assessment of the impact of these programs on patient safety and pharmaceutical products will be important to determine their worth and whether modifications to the system are necessary. Until these data are available, we must work with manufacturers to ensure that patient access is not negatively affected and that good patient care is provided for those patients who need these important, albeit riskier, pharmaceutical products. We also must continue to report adverse reactions associated with all pharmaceutical products to the FDA’s Safety Information and Adverse Event Reporting Program (MEDWATCH; https://www.access data.fda.gov/scripts/medwatch/med watch-online.htm). REFERENCES 1. Lee LY, Kortepeter CM, Willy ME, Nourjah P. Drug-risk communication to pharmacists: assessing the impact of riskminimization strategies on the practice of pharmacy. J Am Pharm Assoc (2003). 2008;48(4):494-500. 2. Questions and answers on the Federal Register notice on drugs and biological products deemed to have risk evaluation and mitigation strategies. US Food and Drug Administration Web site. www.fda.gov/cder/regulatory/FDAAA/F R_QA.htm. Updated March 27, 2008. Accessed January 11, 2009. 3. Office of Surveillance and Epidemiology; US Food and Drug Administration. An overview of RiskMAPs. www .docstoc.com/docs/573628/An-Overview-

*Associate Dean for Clinical Programs, College of Pharmacy, Washington State University, Spokane, Washington

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of-RiskMAPs. Published June 25, 2007. Accessed January 10, 2009. 4. Post-approval frequently asked questions (FAQ). Pharmaceutical Product Development, Inc, Web site. www .ppdi.com/services/post_approval/faq.ht m. Published 2009. Accessed January 11, 2009. 5. Segligman PJ. FDA Amendments Act (FDAAA): New regulatory authorities [presentation]. Paper presented at: Royal Danish Embassy Conference; November

4, 2008; Copenhagen, Denmark. www .ambwashington.um.dk/NR/rdonlyres /60B9CA25-FF37-4B89-93D7-959D 9F9F24BB/0/915FDAAmendmentsAc tandNewRegulatoryAuthorityPaulSelig man.ppt. Accessed January 10, 2009. 6. Jenkins J, Dal Pan G. Memorandum of agreement between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research. US Food and Drug Administration Web site. www.fda .gov/cder/drug/DrugSafety/OSE_OND_

MOA.pdf. Published October 15, 2008. Accessed January 11, 2009. 7. Approved risk evaluation and mitigation strategies (REMS). US Food and Drug Administration. www.fda.gov/cder /drug/DrugSafety/REMS.htm. Published October 28, 2008. Accessed January 11, 2009.

Dr. Baker serves on the Specialty Advisory Board for Accredo Health Group, Inc. 

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