ALEXANDRIA, Va. — Written testimony submitted by the National Association of Chain Drug Stores underscored chain pharmacies’ commitment to patient safety as part of the next Prescription Drug User Fee Act reauthorization, and emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies.
NACDS submitted the testimony to the U.S. House of Representatives Energy and Commerce Subcommittee on Health ahead of Thursday’s hearing, titled “FDA User Fees 2012: Hearing on Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain.”
NACDS supports several drug safety reforms included in the proposed PDUFA reauthorization, including the use of drug industry fees to review drug applications for sound-alike proprietary names and factors that could contribute to the likelihood of medication errors, such as unclear label language or package designs.
NACDS also supports the proposal to standardize Risk Evaluation and Mitigation Strategies and further incorporate these risk mitigation plans into the healthcare system. As Congress considers the REMS program, the U.S. Food and Drug Administration should include the development of methodologies to assess the effectiveness of REMS and obtain pharmacy input, as these strategies could impact drug store operations, according to NACDS.
“NACDS and the chain pharmacy industry are committed to partnering with policy-makers and the supply chain stakeholders on viable effective strategies to enhance the safety and security of the U.S. prescription drug distribution supply chain,” NACDS stated in the written testimony for the hearing record. “Our members have invested significant resources and efforts toward this goal, including changes in purchasing practices and actively supporting state legislation that strengthened the supply chain integrity. Nothing is more important to our industry than the health and safety of our patients.”
NACDS emphasized in the testimony that the U.S. drug supply chain is proven safe — if not the safest in the world. Chain pharmacy has supported the development of state-level chain of custody “pedigrees” for medicines distributed outside normal distribution channels, which have demonstrated some marked improvements in supply chain security. However, premature drug “track and trace” models unnecessarily would increase healthcare costs while imposing burdensome technologies that have not demonstrated an ability to enhance supply chain security, NACDS noted.
“As lawmakers, we urge you to consider approaches that are feasible and workable for the supply chain, and to recognize the importance of not requiring untested costly mandates such as a prescription drug ‘track and trace’ system for supply chain stakeholders,” NACDS stated in the written testimony. “Such requirements would add billions in additional costs to the healthcare system and take time and resources away from pharmacies’ ability to provide pharmacy services to their patients.”
Underscoring NACDS and chain pharmacies’ commitment to drug safety, NACDS and several of its members joined the Pharmaceutical Distribution Security Alliance and support many of its policy recommendations, including the adoption of uniform federal wholesale drug distributor licensure requirements to help ensure consistency in regulations across the country and prevent bad actors from avoiding stringent laws by crossing state lines. NACDS also supports the PDSA proposal to implement lot-level tracing, and is providing recommended edits to the alliance’s policy Discussion Draft to address various concerns.
Separately, community pharmacist-provided medication therapy management services help patients understand their medications and avoid costly complications. Proper reimbursement of pharmacists for providing MTM services could further incorporate this counseling into the healthcare delivery system to improve patient safety while reducing costs.
NACDS also supports the development of a registry of safe online pharmacies to help consumers distinguish between legitimate pharmacy websites and illegitimate drug dispensers that often provide adulterated medicines to patients.
Further, NACDS supports the FDA’s development of a “one document solution” to replace the multiple existing drug information inserts, which are duplicative, incomplete and difficult to understand. The creation of a single patient medication information document, which NACDS had called for, could help ensure that an accurate, comprehensible and balanced assessment of drug risks and benefits are communicated to patients, NACDS stated.