NCPA Provides Support, Roadmap for Proposed Nonprescription Class of Drugs

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ALEXANDRIA, Va. (May 8, 2012) – The National Community Pharmacists Association (NCPA) has submitted formal comments to the U.S. Food and Drug Administration (FDA) following the March 22nd public hearing about the proposed creation of a nonprescription class of drugs with conditions for safe use. NCPA expanded further upon the testimony provided during the hearing by NCPA member and Katterman's Sand Pharmacy owner, Beverly Schaefer, RPh; which expressed support for the policy, while ensuring certain concerns are met.

"We believe such a class will have a positive impact in enhancing public health, if used appropriately with pharmacist intervention," said NCPA in its comments. "As one of the most trusted and available health care providers, pharmacists are in the optimal position to simultaneously provide access to patients and place safeguards for the new nonprescription drug class. This is especially so for drugs designated for acute and short-term conditions, and other drugs deemed appropriate by the FDA on a case-by-case basis."

NCPA added, "Despite the unanswered questions and ambiguity that still remain related to the logistical details of the new paradigm, NCPA is excited for the significant opportunities it creates for pharmacists and the patients they serve. NCPA is committed to working closely with the FDA and other key stakeholder as this process evolves."

In its comments, NCPA offered several fact-based reasons for why the nonprescription class of drugs is sound policy:

  • According to the IMS Institute for Healthcare Informatics, the down economy and cost-sharing requirements are causing patients to ration their visits to doctor's offices and their use of prescription drugs. That results in more emergency room visits, which means a new nonprescription class of drugs that increases public access to affordable health care should be viewed as an acceptable solution.
  • A new nonprescription class of drugs may benefit patients seeking immediate symptomatic relief for acute conditions and will reduce the burden on emergency rooms and other health care providers by utilizing clinically-trained medication experts—pharmacists.
  • A new nonprescription class of drugs would allow pharmacists to continue demonstrating their well-chronicled ability to improve public health and provide increased access to health care, especially for those with chronic conditions.
  • The challenge of poor medication adherence is a growing public health concern that pharmacists are well-positioned to help alleviate thanks to their frequent interaction with patients, and the use of services such as medication reconciliation and medication therapy management (MTM).

However, NCPA comments seeking to ensure an efficient implementation process and proper compensation for pharmacist services, sought to have the following concerns addressed:

  • In response to doctor concerns about a new nonprescription class making it more difficult to monitor their patients, we propose that products with conditions of safe use be made available in pharmacy settings only so a stop point to document the medication and care process, as determined by the FDA on a case-by-case basis, is established.
  • Standardized best-practice algorithms developed for dispensing the nonprescription products should be put in place.
  • As the FDA establishes the guidance, it is essential that sufficient insurance coverage and appropriate reimbursement compensation for pharmacists be considered as part of the equations, despite the logistical challenges that exists.

The National Community Pharmacists Association (NCPA®) represents the interests of America's community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent a $93 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 315,000 people, including 62,400 pharmacists. Independent community pharmacists are readily accessible medication experts who can help lower health care spending. They are committed to maximizing the appropriate use of lower-cost generic drugs and reducing the estimated $290 billion that is wasted annually by improper medication use. To learn more go to or read NCPA's blog, The Dose, at

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