By David A. Galardi, PharmD, EVP commercial operations for Apogenics Inc.
Author Disclosures: Through his work at Apogen ics Inc., Dr. Galardi regularly consults within the pharmaceutical and biotechnology industry regard ing REMS. His clients include a significant number of manufacturer/sponsors, service organizations and specialty pharmacy/distribution companies.
Universal Program Number: 401000 10001H03P Activity Type: Knowledgebased Initial Release Date: Jan. 9, 2010 Planned Expiration Date: Jan. 9, 2013 This program is worth one contact hour (0.1 CEUs).
Target Audience
Pharmacists in communitybased practice or specialty pharmacy.
Program Goal
To improve the pharmacist’s ability to explain risk evaluation and mitigation strategies, or REMS, and counsel patients on the changes they may see.
Learning Objectives
Upon completion of this program, the pharmacist should be able to:
1. Recall federal regulations that pertain to risk management affecting distribution and retail pharmacy.
2. Explain the evolution of risk management from RiskMAPs to REMS.
3. Compare the varying degrees of REMS and their implication on access to certain drugs or biologics.
4. Educate patients on the basics of REMS as they relate to changes the patients may see, such as medication guides, patient package inserts, etc.
To obtain credit: A minimum test score of 70% is needed to obtain a statement of credit. Submit your answers online at CEdrugstorenews.com, and receive your statement of cred it in your CE account folder immediately. Submit by mail or fax using the answer sheet found in your issue, and receive your printed statement of credit within seven days of receipt.
Questions regarding statements of credit and other cus tomer service issues should be directed to Angela Sims at (800) 9339666. If you are a paid enrollee, there is no cost to participate in this lesson. The fee for participants who are not enrolled is $13.95.
TO LINK DIRECTLY TO THIS LESSON, VISIT: CEdrugstorenews.com/40100010001H03
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The specialty pharmaceutical industry has been placed in the middle of an emerging trend to reduce the amount of severe adverse events experienced by patients. The safe use of drugs has become a primary consideration of the Food and Drug Administration through the use of new legislative authority to develop systems that can reduce the risk and improve the benefit of drug use. Pharmacists rapidly are being introduced to the post-marketing drug surveillance universe through these changes and the intersection of pharmacovigilance (avoidance of adverse events) and pharmacoepidemiology (the incidence of adverse events). This lesson focuses on this new administrative mandate on the FDA, the emergence of risk evaluation and mitigation strategies, or REMS, and its impact on the pharmacy marketplace.
Federal regulations govern
most aspects of the pharma-
ceutical markets in the United
States. Over the past five years,
significant legislation has been
implemented to address the con-
cerns of Congress related to drug
safety and the risks associated
with drug use. On Sept. 27, 2007,
President Bush signed into law
the Food and Drug Administra-
tion Amendments Act of 2007,
or FDAAA. The FDAAA cre-
ated a number of new authori-
ties by adding to the Federal
Food, Drug and Cosmetic Acts
by granting the authority to the
FDA to require people submit-
ting certain applications (ap-
plicants) to submit a proposed
REMS as part of that application
— if the FDA determined that a
REMS was necessary — to en-
sure that the benefits of a drug
outweighed the risks of the use
of the drug. REMS may be ap-
plied to all “covered” new drug
applications, abbreviated new
drug applications and biologics
license applications. 1
Before the FDAAA was enacted, the International Conference on Harmonization released its E2E Guideline for Pharmacovigilance Planning in November 2004. This was adopted by the European Medicines Agency, and subsequently by the FDA, as the first organized attempt to address risks associated with the use of medications. In 2005, the FDA provided greater guidance on 1) Good Risk Management Practices through its definitions on pre-marketing risk assessments, 2) the development and use of a Risk Minimization Action Plan, or RiskMAP, and 3) Good Pharmacovigilance and Pharmacoepidemiologic Assessment.
In each of the three guidance documents provided by the FDA, a system of ongoing surveillance was emphasized that could identify aberrant patterns of drug use that had the potential to increase risk to the patient. Since that time, the FDA approved a small number of drug and biological products with risk minimization action plans. Many pharmacists have been exposed to RiskMAPs, as they often are identifiable by a patient or product registration model. They are widely regarded as providing the tactical components of the safety program designed to meet specific goals and objectives in minimizing known risks of a product while
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