NCPA Outlines Community Pharmacy Priorities as FDA Considers Risk Evaluation and Mitigation Strategies

July 28, 2010

 

The National Community Pharmacists Association (NCPA) offered recommendations to the U.S. Food and Drug Administration (FDA) at a two-day public meeting that concluded today and was held to solicit input as the agency designs and implements Risk Evaluation and Mitigation Strategies (REMS) intended to promote drug safety.

"Pharmacists take seriously their role as the primary source of drug information for their patients," said NCPA Acting Executive Vice President Douglas Hoey, RPh. "Pharmacists provide both life-saving medications to their patients, as well as critical written and verbal drug information and counseling that allow medications to be used most appropriately and safely. Going forward, we urge the FDA to leverage the value that community pharmacists offer related to the proper use of medications and avoidance of costly mistakes down the road."

NCPA's Vice President for Policy and Regulatory Affairs, Ronna Hauser, PharmD, presented the following views and recommendations to the FDA:

  • "To date, community pharmacy's experience with REMS continues to be challenging due to the lack of a common design or platform surrounding such programs. Medication Guides have not provided the solution some had hoped. That is why NCPA is a strong advocate for the creation and use of a single, FDA-approved plain language document to replace existing written information distributed by pharmacies. We greatly appreciate the Agency's movement in this direction, and additionally we support the Agency's seeking a way around imposing REMS when only a Medication Guide is required.
  • "Any state- and DEA-licensed pharmacy should be eligible to dispense specific REMS products. Not only do restricted distribution programs interfere with patient access to prescribed therapies, they may limit legitimate access to certain therapies and shift illegitimate use to other products.
  • "NCPA does not support REMS such as the FOCUS program for Onsolis. Based on studies and experience we know that direct face-to-face counseling is more effective than this program's method of shipment via courier service to the home and counseling provided by a call center phone bank.
  • "NCPA contends that many independent pharmacists can meet stringent REMS requirements such as being 'on call' 24 hours a day, as this is the level of service many of our members offer patients on a daily basis, regardless of REMS.
  • "NCPA cannot stress enough that any REMS system be created using a standard platform. Workflow standardization is an important component of safely filling prescriptions. A standardized REMS process that can be integrated within existing pharmacy workflow is critical to the successful execution of the program.
  • "NCPA strongly supports the use of metrics by FDA to evaluate the effectiveness and outcomes of a given REMS and its individual components."

NCPA's full statement to the FDA regarding REMS is available here. In addition, NCPA's statement to the FDA concerning a class-wide opioid REMS can be found here.

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The National Community Pharmacists Association (NCPA®) represents America's community pharmacists, including the owners of more than 22,700 independent community pharmacies, pharmacy franchises, and chains. Together they represent an $88 billion health-care marketplace, employ over 65,000 pharmacists, and dispense over 40% of all retail prescriptions. To learn more go to www.ncpanet.org or read NCPA's blog, The Dose, at http://ncpanet.wordpress.com.

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