Stakeholders Consensus Document on Prescribing and Dispensing Controlled Substances
Prescribing and Dispensing Controlled Substances
Stakeholders:
American Academy of Family Physicians, American Medical Association (AMA), American Osteopathic Association, Cardinal Health, CVS Caremark, Federation of State Medical Boards (observer), National Association of Boards of Pharmacy (NABP), National Association of Chain Drug Stores, National Community Pharmacists Association, Pharmaceutical Care Management Association, Pharmaceutical Research and Manufacturers of America, Rite Aid, Walgreen Co.
Background:
The Stakeholders Meeting on Prescribing and Dispensing Controlled Substances was held on October 2, 2013, at NABP Headquarters in Mount Prospect, IL. The Stakeholders Meeting was convened to discuss the strategies employed by the stakeholder organizations to address the prescription drug abuse epidemic and the actions taken to ensure the validity of controlled substance prescriptions and verify that there is a legitimate medical need for the issuance and dispensing of such prescriptions. Representatives from the participating organizations provided their perspectives on the prescription drug abuse problem and described the challenges faced within their respective practice environments. On December 19, 2013, stakeholders met a second time at the AMA Offices in Washington, DC, to further discuss the issues and to finalize this Consensus Document on Prescribing and Dispensing Controlled Substances.
Consensus:
The participants agreed that stakeholder coordination and collaboration must be improved in order to combat the serious public health issue of prescription drug abuse and diversion, while also complying with the “corresponding responsibility ” requirements of federal and state laws and regulations. Such collaboration is essential to ensuring that this public health problem is addressed while at the same time ensuring that patients continue to receive responsible and effective patient care. The participants also recognized that the actions taken were not intended to intrude into the scopes of practice or authority of other stakeholders. Stakeholder representatives discussed the need for reviewing practices and policies they have implemented to help ensure that they comply with their legal responsibilities, with the intention of restoring and improving the collaboration and coordination between stakeholders. Stakeholder representatives agreed that two additional consensus documents will be drafted and finalized pending the group’s approval. The first document will identify the circumstances or “red flags” under which actions should be initiated to ensure the legitimacy of a controlled substance prescription.
The second document will provide guidelines on how to engage in and improve the dialogue and collaboration among stakeholders so as to address “red flags” in the issuance or dispensing of prescriptions and in the distribution of drugs to practitioners and pharmacies, with the intent of eliminating confusion caused by the diversity of current proprietary policies.
The following organizations contributed to the development of this Consensus Document and acknowledge their support:
American Academy of Family Physicians
American Medical Association
American Osteopathic Association
Cardinal Health
CVS Caremark
Federation of State Medical Boards (observer)
National Association of Boards of Pharmacy
National Association of Chain Drug Stores
National Community Pharmacists Association
Pharmaceutical Care Management Association
Pharmaceutical Research and Manufacturers of America
Rite Aid
Walgreen Co.
[1] 21 CFR 1306.04 Purpose of issue of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 USC 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
