As House Panel Reviews DEA, NACDS Provides Recommendations in Combatting Prescription Drug Abuse, Protecting Patients

In its statement, NACDS emphasized chain pharmacy's initiatives to comply with DEA's "cradle-to-grave" regulation structure.

Arlington, Va. — Urging transparency, collaboration and prioritization in working with pharmacy and other healthcare stakeholders to help protect patient access and fight prescription drug abuse and diversion, the National Association of Chain Drug Stores (NACDS) submitted a statement to a House panel as it reviews the work of the Drug Enforcement Administration (DEA). The U.S. House Subcommittee on Crime, Terrorism, Homeland Security and Investigations held a hearing today titled “Oversight of the Drug Enforcement Administration.”

In its statement, NACDS emphasized chain pharmacy’s initiatives to comply with DEA’s “cradle-to-grave” regulation structure, including loss prevention and internal security systems to help ensure safety and prevent diversion from the prescription drug distribution center to the point of dispensing the medication to the patient.

“Chain pharmacies are committed to ensuring that prescription drugs remain under tight control for the purposes of providing care to their patients, and are not diverted for nefarious purposes. Our members’ efforts are evidence of this commitment,” NACDS said in its statement.

In its continuing efforts to work cooperatively in the best interest of patients while ensuring compliance with DEA regulations, NACDS stressed the importance of ensuring that public policy reflects the operational realities of pharmacies.

One area where greater transparency would be helpful is clarification of the diverse and sometimes conflicting roles of pharmacists under DEA’s policies.

“On the one hand, pharmacists have a strong ethical duty to serve the medical needs of their patients in providing neighborhood care. On the other hand, community pharmacists are also required to be evaluators of the legitimate medical use of controlled substances,” NACDS said in its statement.

Another area of concern is the quickly-approaching implementation date (October 6) for rescheduling hydrocodone products into a Schedule II classification. NACDS has and continues to cite implementation challenges with only 45 days that was provided for pharmacies to become compliant with the DEA’s final rule on this rescheduling. NACDS had previously requested 180 days to allow pharmacies to become compliant with the rule.

Under DEA’s final rule, patients may face challenges in refilling their hydrocodone prescriptions. Prescriptions for these products that are issued on or after October 6 must comply with requirements for Schedule II prescriptions and refills of these prescriptions will be prohibited.

Prescriptions issued before October 6 that have authorized refills may be dispensed in accordance with DEA rules until April 8, 2015. However, state law, insurance limitations and some pharmacy quality and safety operations and processes may not allow for these prescriptions to be refilled.

Citing efforts to work with healthcare stakeholders, including prescribers and patient groups, to help prevent any potential disruptions to healthcare delivery, NACDS expressed concern in its comments stating, “Most states have not provided clarity with respect to whether such refills will be valid under state law. Moreover, most pharmacies will not be able to process such refills due to existing quality and safety operations and processes; such pharmacy operations and processes cannot be modified in a mere 45-day time frame,” NACDS said in its statement.

NACDS has consistently supported policies urging federal agencies to work together to help ensure that patients can access medications and prevent diversion and abuse of prescription drugs. NACDS has endorsed H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement Act, which would establish a framework to foster collaboration among health and enforcement officials and other stakeholders to consider abuse and access issues simultaneously.

“We believe that bringing together stakeholders to address the problems associated with prescription drug abuse would provide better solutions than have been developed to date. Improved collaboration and coordination among federal agencies and other stakeholders would benefit all, including the patient, whose legitimate access must be preserved in order for any potential solution to be successful,” NACDS stated in its comments.

Prioritization of DEA’s resources was also cited by NACDS in its comments to help refocus government resources on solving the problems of prescription drug abuse and ensuring that legitimate patients are not harmed. NACDS also cited better utilization of electronic prescribing and prescription drug monitoring programs in combatting prescription drug abuse and diversion.

This release can also be found on the NACDS website.

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NACDS represents traditional drug stores and supermarkets and mass merchants with pharmacies. Chains operate more than 40,000 pharmacies, and NACDS’ 125 chain member companies include regional chains, with a minimum of four stores, and national companies. Chains employ more than 3.8 million individuals, including 175,000 pharmacists. They fill over 2.7 billion prescriptions yearly, and help patients use medicines correctly and safely, while offering innovative services that improve patient health and healthcare affordability. NACDS members also include more than 800 supplier partners and nearly 40 international members representing 13 countries. For more information, visit www.NACDS.org.