Task Force Recommends CSA Revisions Aimed to Support Patient Care and Safety

July 12, 2011 12:39 pm

Originally published in the June-July 2011 NABP Newsletter

To address public health and patient safety issues, such as escalating rates of prescription drug abuse and medication errors, federal legislators have adopted laws amending the Controlled Substances Act (CSA), such as the Secure and Responsible Drug Disposal Act of 2010. In addition, Drug Enforcement Administration (DEA) has implemented new rules, such as the interim final rule on electronic prescriptions for controlled substances. While pharmacy regulators await the implementation of the drug disposal laws and follow guidance to facilitate implementation of the e-prescribing rule, the need for additional CSA amendments that will support the provision of pharmacist care is recognized. With this need in mind, and with an eye toward future technologies and pharmacy practice changes, the NABP Task Force to Review and Recommend Revisions to the Controlled Substances Act has made 21 recommendations calling for amendments to the CSA itself or the related regulations. The task force also reviewed 20 additional amendments advised by its subcommittees, and ultimately recommended that these changes were unnecessary, or, in a few cases, made alternative recommendations.

Recognizing that the practice of pharmacy has changed significantly since the initial implementation of the CSA in 1970 and that current provisions of the CSA could have the unintended effect of restricting and inhibiting the provision of pharmacist care, member boards of pharmacy approved NABP Resolu­tion No. 106-6-10, which called for a Task Force to Review and Recommend Revisions to the Controlled Substances Act, at the 2010 Annual Meeting.

The Task Force to Review and Recommend Revisions to the Controlled Substances Act convened in October 2010 and accepted the following charge:

1. Review selected provisions of the CSA and accompanying administrative regulations;
2. Identify those provisions that may require review and revision; and
3. Recommend legislative and regulatory changes to amend the CSA and accompanying administrative regulations.

At this first meeting of the task force, members identified provisions that needed to be addressed and assigned each to a task force subgroup. Four subgroups were formed to focus on provisions related to the following areas: community pharmacy, hospital pharmacy, long-term care pharmacy, and a variety of CSA issues under miscellaneous provisions. Each of the four subgroups met via teleconference during the month of November. The task force then reconvened in January 2011 to review the recommendations of each subgroup and make final recommendations.

Recommended Definition Revisions

With current pharmacy practice issues and potential future practice issues in mind, the task force has recommended that several definitions in the CSA and its implementing regulations be added or revised to address pharmacy practice issues. For example, it was recommended that CSA be amended to include separate definitions for “administer,” “dispense,” and “prescribe.” Members recommended that the definition for “administer” use the following language: “The term ‘administer’ means the direct application of a Drug to the body of a patient or research subject by injection, inhalation, ingestion, or by any other means.” It was also suggested that language referring to the “prescribing and administering of a controlled substance” be cut from the definition of “dispense,” and that, instead a separate definition should be provided for “prescribe.” The following definition is recommended: “The term ‘prescribe’ means a direction or authorization, by prescription, permitting an ultimate user lawfully to obtain controlled substances from any person authorized by law to dispense such substances.” The task force aimed to develop recommended definitions that are functional in nature and broad enough to encompass future practices.

The task force also recommended that pharmacists should be included in the CSA definition of “practitioner.” Members discussed how the revision of the term would be appropriate as DEA now registers pharmacists as mid-level practitioners pursuant to DEA regulations. In addition, members recommended the definitions of “individual practitioner” and “mid-level practitioner” be amended to conform with the recommended definitions for “dispense” and “prescribe.”

LTCF Related Revisions

Revisions to several definitions related to long-term care facilities (LTCFs) were also recommended. To allow for flexibility, particularly at the state level, it was indicated that the term “long-term care facility” should be defined broadly as “an institution which provides extended health care to resident patients.” Additionally, the revision of definitions for the terms “agent” and “prescription” were recommended, as these changes would help lay groundwork for clarifying the role of agents in LTCFs. First, the task force recommended the term “agent” be defined as “a person authorized to act on behalf of a practitioner as provided by state law or written agency agreement.” Second, the task force recommended that medical record orders should be included in the term “prescription” to allow for what have historically been called “chart orders.” Members also recommended that a medical record order without a quantity should be limited to a seven-day supply. Revising these definitions, along with amending applicable regulations regarding the manner of issuance of prescriptions, would continue to allow designated agents to call in prescriptions to pharmacies.

The task force also recommended that the sections of CSA pertaining to the administering or dispensing of narcotic drugs to maintain or detoxify a patient be revised to allow for the detoxification or maintenance treatment of LTCF patients. This change is advised due to the increasing need to dispense detoxification medications in LTCFs to patients being treated for other conditions.

Prescription Elements and Allowable Changes

The task force also recommended several amendments to the CSA related to requirements for the manner of issuance of prescriptions, medical record orders, and allowable changes. Recognizing that certain prescription elements can be made readily available by the pharmacy, members recommended that the elements to be required on a prescription should include full patient name, drug name, strength, quantity prescribed, directions for use, and practitioner name. Members recommended adding language specifying that “the address and date of birth of the patient and the address and registration number of the practitioner are not necessary on the face of the prescription if made readily available by the pharmacy and attached to the electronic record of the prescription.” Further, members recommended amending the language to indicate that a pharmacist may add or change the following elements: drug strength, drug quantity, directions for use, or issue date after consulting with prescriber. Since it is recommended that medical record orders be included in the definition of prescriptions, members advised amending the manner of issuance section to also indicate the requirements for medical record orders and to include language specifying that a medical record order without a discernable quantity will be limited to a seven-day supply.

Dispensing of Prescriptions

Regarding the dispensing of prescriptions, members agreed that there should be a uniform time limit for the validity of all controlled substances prescriptions. Members recommended that the CSA be amended to allow a six-month time limit for the validity of Schedule II and Schedule V prescriptions to be consistent with Schedule III and Schedule IV prescriptions. In addition, it was recommended to remove the “unable to supply” provision relating to partially filling prescriptions, and to increase the time limit for the partial filling of prescriptions from 72 hours to 30 days. The latter changes are intended to address patient care issues such as expense, tolerability to a drug, and patient choice.

Prescription Labels and Electronic Storage

With the aim of keeping prescription label content patient-focused, two changes to provisions regarding labeling were recommended. First, members recommended removing the requirement that the well-known warning statement prohibiting patients from giving controlled substances to others be affixed to the prescription label or revising the warning to state “It is unlawful to share this medication.” Second, members recommended removing the requirement that central fill pharmacy identification information be included on the label.
The task force also made several recommendations regarding storage of records. Many of these suggested amendments are made in light of current technology, which can securely store records electronically. With current technology capabilities in mind, it was also recommended to remove the requirement that transfers of Schedule III, IV, and V prescriptions must be made by pharmacists if the pharmacies share a real-time, online database.

Call for Commentary

A few recommendations called for NABP to issue commentary to DEA as appropriate, or for encouraging other stakeholders to submit commentary to DEA. For example, DEA is currently developing regulations to implement the Secure and Responsible Drug Disposal Act signed into law on October 12, 2010. At the recommendation of the CSA Task Force, NABP will comment as appropriate on the DEA Notice of Rulemaking upon its publication. Task force members also recommended that industry stakeholders be encouraged to comment upon the need for streamlining the Automation of Reports and Consolidated Orders System (ARCOS) database.
 

Other task force recommendations addressed modernizing the language of the CSA.

Task force members included Jack “Jay” Campbell, RPh, JD, chairperson; Ross Brickley, RPh, MBA, CGP; Patricia “Trish” D’Antonio, RPh, MS, MBA, CGP; Kristi R. Dover, PharmD; Danna Droz, RPh, JD; Virginia “Giny” Herold, MS; Suzan Kedron, JD; Susan Ksiazek, RPh; Lawrence “Larry” Mokhiber, MS, RPh; Suzanne Neuber, RPh; Jeanne Waggener, RPh; and Brenda Warren, DPH. Lloyd K. Jessen, RPh, JD, and Cathryn J. Lew, RPh served as Executive Committee li­aisons.

The following guest participants were present to advise the task force on the first day of the meeting: Daniel Bellingham, Healthcare Distribution Management Association; Kevin Nicholson, RPh, JD, National Association of Chain Drug Stores; Susan Janeczko, PharmD, National Community Pharmacists Association; Charles Thomas, RPh, FAPhA, National Association of State Controlled Substances Authorities; Rebecca Snead, RPh, National Alliance of State Pharmacy Associations; and Kelly C. Alfred, MS, Federation of State Medical Boards.

In addition, the following individuals were appointed to serve on each subgroup.

Community pharmacy subgroup members included W. Benjamin Fry, RPh, FIACP, FACA, chairperson; Donald Casar, RPh; Lenna Israbian-Jamgochian, PharmD; Heather Pasquale, RPh; William Prather, RPh; Joanne Trifone, RPh; and Dennis Wiesner, RPh. James T. DeVita, RPh, served as Executive Committee liaison.

Members of the hospital pharmacy subgroup included Susan Ksiazek, RPh, chairperson; Kevin Borcher, PharmD; Rebecca Deschamps, RPh; Paul Limberis, RPh; Alice Mendoza, RPh; Anne Policastri, PharmD, MBA, FKSHP; and Michael Romano, RPh. The Executive Committee liaison was Cathryn J. Lew, RPh.

The long-term care pharmacy subgroup members were Patricia D’Antonio, RPh, MS, MBA, CGP, chairperson; William Fitzpatrick, RPh; Elizabeth Gregg, RPh; and Stanley Weisser, RPh. Gary A. Schnabel, RN, RPh, was the Executive Committee liaison.

Members of the subgroup for other pharmacy environments included Gay Dodson, RPh, chairperson; Robert Giacalone, RPh, JD; William Harvey, RPh; Randall Knutsen, RPh; Kendall Lynch, RPh; Rich Palombo, RPh; Michael Podgurski, RPh; Walt Slijepcevich, RPh,; and Frank Whitchurch, RPh. The Executive Committee liaison was Michael A. Burleson, RPh.

The recommendations of the task force were re­viewed and amended by the Committee on Law Enforcement/Legisla­tion in March 2011 and subsequently approved by the NABP Executive Committee during its May 2011 meeting. The full report of the task force is available in the Members section of the NABP Web site.