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NABP Commissions Task Force to Review CSA
Originally published in the October 2010 NABP Newsletter
Recommended Changes will Focus on Facilitating Provision of Patient Care and Protecting the Public Health
From policies guiding allowable Schedule II prescription changes by pharmacists, to regulations for secure disposal of unused medications, many of the Drug Enforcement Administration (DEA) regulations developed in the 1970s are in the process of being reviewed or studied by DEA and interested stakeholders, or amended through the legislative process. DEA regulations, promulgated to implement the federal Comprehensive Drug Abuse Prevention and Control Act of 1970 – generally referred to as the Controlled Substances Act (CSA) – have impacted the practice and regulation of pharmacy as pharmacies and pharmacists comply with its provisions and boards of pharmacy ensure compliance with federal and state laws. Recognizing that the practice of pharmacy has changed significantly since the CSA was first implemented and the CSA, therefore, could have the unintended effect of restricting the provision of pharmacist care, NABP members approved a resolution at the NABP 106th Annual Meeting held May 22-25, 2010, to commission a task force to review the CSA. The task force will meet October 5-6, 2010, and is charged with identifying provisions of the CSA that may require review and revision, and recommending legislative and regulatory changes to amend the CSA and accompanying administrative regulations.
Allowable Changes to C-II Prescriptions
One discrepancy in current guidelines, as DEA recognizes, is the confusion about federal regulations pertaining to changes that a pharmacist may make to a Schedule II prescription after oral consultation with the prescriber. DEA published in the Federal Register on November 19, 2007, the Final Rule titled “Issuance of Multiple Prescriptions for Schedule II Controlled Substances,” which contained instructions that conflict with prior DEA policy. Specifically, the more recent Final Rule states in its preamble that “the essential elements of the [Schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed) . . . may not be modified orally,” while prior DEA policy permitted the same changes to a Schedule II prescription that a pharmacist may make to Schedules III-V controlled substance prescriptions after oral consultation with the prescriber. Currently, DEA advises that pharmacists should adhere to state regulations or policy regarding changes that a pharmacist may make to a Schedule II prescription after oral consultation with the prescriber. DEA plans to resolve the issue through future rulemaking.
Transmitting of Prescriptions in LTCF
Some confusion also exists related to certain DEA policies addressing the authority to transmit prescriptions in long-term care facilities (LTCF). Recently, DEA has stated that nurses at LTCF may not act as agents of prescribers for purposes of transmitting prescription orders. The confusion arises from the term “agent,” which means “an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser,” (21 USC 802(3)) and it has been interpreted to mean that no legal agency relationship exists between the LTCF nurse and the physician, therefore this widely-used system is not in compliance with legal requirements. DEA solicited and is currently reviewing comments, which were due on August 30, 2010, from pharmacists and other stakeholders on issues related to the dispensing of controlled substances in LTCF.
Balancing Pain Management with Combating Abuse
Pharmacists and other health care providers have also been challenged with providing appropriate controlled substance pain medications to patients who need them, while maintaining compliance with DEA regulations enacted to prevent abuse and diversion. USC 21 1306.04(a) states “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 U.S.C. 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.” Boards of pharmacy do not encourage pharmacists to be inherently suspicious of all controlled substance prescriptions, as Jay Campbell, executive director, North Carolina Board of Pharmacy, noted in his continuing education presentation at the NABP 106th Annual Meeting, but pharmacists do have a responsibility for reasonable diligence. As Campbell noted, many pharmacists have heightened vigilance due to certain circumstances that fuel the rates of prescription drug addiction. These circumstances include the proliferation of pain clinics where illegitimate prescriptions are issued, weight loss centers issuing massive numbers of the Schedule IV drug phentermine, and various Schedule III steroids, and the proliferation of Internet-based prescriptions.
To address requests for a guidance document on treating patients for pain, DEA issued a policy statement, “Dispensing Controlled Substances for the Treatment of Pain,” on September 6, 2006. The statement reiterates DEA policy to prevent abuse and diversion without adversely impacting the legitimate need of patients to have full access to pain relief prescribed by their physician.
As new rules are developed and the CSA is further amended, stakeholders and government agencies will likely continue to consider the balancing act between ensuring that patients are treated appropriately for pain and helping to prevent activities that fuel prescription drug abuse.
Multiple C-II Prescriptions
Though action on the aforementioned issues is still pending, in recent years DEA rules and developing federal legislation have begun to address other issues related to the CSA.
Effective December 19, 2007, a DEA rule amended regulations to permit practitioners to issue multiple prescriptions for Schedule II controlled substances. In effect, the new rule allows practitioners to prescribe up to a 90-day supply of a controlled substance. Each prescription must be issued for a legitimate medical purpose with specific written instructions by the practitioner indicating the earliest date on which a pharmacy may dispense each prescription. This rule is intended to “address patients’ needs for schedule II controlled substances while preventing the diversion of those substances,” as explained in the Final Rule published in the November 19, 2007, Federal Register.
e-Prescribing Rule
The interim final rule on electronic prescriptions for controlled substances went into effect June 1, 2010, and allows prescribers the option to write prescriptions for controlled substances electronically, and pharmacies to receive, dispense, and archive these electronic prescriptions. The regulations are an addition to existing rules and will maintain a closed system of controls on controlled substance dispensing. The regulations will reduce paperwork for pharmacies registered by DEA and have the potential to reduce prescription forgery. Additionally, the regulations have the potential to reduce the number of prescription errors and will help integrate prescription records into other medical records. The process of implementing this rule requires that prescribers and pharmacies utilize systems that have been certified as meeting the requirements of the rule and thus the implementation process will take time.
Secure Drug Disposal
As boards of pharmacy and pharmacists are well aware, current DEA regulations effectively make it unlawful for ultimate users, ie, patients, to return unused controlled substances to pharmacies or other entities for destruction. Regulations stipulate that entities or individuals distributing or dispensing drugs be registered with DEA. The law does state, in USC 21 1307.21(a), that “Any person in possession of any controlled substance and desiring or required to dispose of such substance may request assistance from the Special Agent in Charge of the Administration in the area in which the person is located for authority and instructions to dispose of such substance.” The code also states, in section 21 CFR 1307.21(d), “This section shall not be construed as affecting or altering in any way the disposal of controlled substances through procedures provided in laws and regulations adopted by any State.” Drug take-back programs have been careful to follow the federal law by ensuring that a DEA agent or other authorized law enforcement officer is present if accepting unused controlled substances. Many programs, however, opt to not accept unused controlled substances for disposal.
Various legislation has been introduced to the United States Congress to address the need for patients to securely dispose of unused medications. The Secure and Responsible Drug Disposal Act of 2010, (S 3397) passed in the Senate on August 3, 2010. This act would amend the CSA to give the attorney general authority to promulgate regulations to allow patients to deliver unused controlled substances “to appropriate entities for disposal in a safe and effective manner consistent with effective controls against diversion.” The law would also allow for the authorization of controlled substance disposal by longterm health care facilities on behalf of patients. A similar bill, the Safe Drug Disposal Act of 2010 (HR 5809), has been introduced in the House, and referred to a house subcommittee. This act would similarly amend the CSA and also would require the implementation of a public education campaign, government studies to assess the effectiveness of take-back programs, and an Environmental Protection Agency study on the environmental impact of existing drug disposal systems.
Rescheduling Drugs
Proposals for scheduling or rescheduling certain drugs with a high potential for abuse are also currently being considered. For example, DEA held a hearing in May 2010 regarding the proposed placement of carisoprodol into Schedule IV based on recommendations from the US Department of Health and Human Services and an evaluation by DEA.
NABP Actions
To address such issues, as previously mentioned, NABP members passed Resolution No. 106-6-10 at the NABP 106th Annual Meeting held in May 2010, which states that NABP should “commission a task force of interested stakeholders to review the provisions of the CSA and accompanying administrative regulations, identify those provisions that may require review and revision, and recommend legislative and regulatory changes to amend the CSA and accompanying administrative regulations.” See the October Newsletter for more details on this task force. The report of the task force will be available by Spring 2011.
