(11) Triplicate Prescription Orders Although proponents of triplicate prescription programs claim advantages such as reduction and detection of forgeries, ease of preparing criminal cases, deterence of practitioners who might be under pressure to prescribe excessive amounts, detection of practitioners and pharmacies who may be prescribing or dispensing an excessive quantity, and detection of "patients" who receive excessive amounts of controlled substances, many of the board and compliance investigation representatives did not favor triplicate prescription programs. (12) Continuing Education as a Part of Licensure Qualifications Making continuing education a condition of licensure qualifications could be a key factor in the regulation of concerned health professionals. The review of practice- or other experience-related qualifications cannot guarantee reduced drug leakages; however, if such qualifications were coupled with the requirement to understand the potential for abuse and misuse of drugs, the professional might help to reduce leakages and the incidence of drug violations. Most professional board and many association respondents felt that continuing education should be a primary requirement for relicensure. The boards should rely heavily upon the standards and recommendations of professional associations; the associations should regard their role in this matter as seriously as initial licensure. (13) Dedication and Specialization of Designees of the Attorney General The designation of legal staff from the Office of the Attorney General should be on a specialized basis. Further, it would be appropriate for the respective boards to have funds available for legal counsel for special purposes. In this instance, self-regulation refers to a professional licensing board composed solely of members of that profession; the term also has been used to mean informal regulation by a State professional association, and a board's compliance with a Federal agency regulation. (14) Development of Health Practice Standards by the State Professional Associations State professional associations must play an extremely active role in developing health care professional practice standards to achieve the basic objective of the regulatory environment, i.e., quality health practice. To determine qualification for licensure, the boards must have the tools to measure credentials and skills such tools are well-developed health care professional practice standards. While development of standards is related to the involvement of the State professional associations in continuing education, this role is more general. The standards should provide guidance to the practitioner and be capable of placing him "on warning" with respect to errant practices and/or neglect of practice that violations of the standards could subject the health care professional to review and possible disciplinary action by the appropriate health care professional board. (15) Problems and Advantages of Regulatory Boards Related to the Exclusive Membership of Professionals in Areas Being Regulated Those who favor the creation of boards which would include members from outside the regulated professions cite the following reasons: a "closed" board's reluctance to prosecute professional colleagues; the tendency to place the interests of the members of the profession ahead of those of the public or consumers; a lack of legal, administrative, and technical expertise on the part of the professional board members in areas where nonprofessional board members may possess that expertise, e.g., law; and the belief that self-regulation of a profession is the most effective way to regulate a profession. The last is a questionable theory at best.* The following reasons are given for not including nonprofessional members on professional licensing boards: the greater expertise of board members of the particular profession in matters relating to that profession; the existing use of legal expertise in staff and quasi-judicial roles; the desire of the members of the particular profession to keep professional standards high (such a desire allegedly would override problems of self-interest or reluctance to discipline colleagues); and the expenditure of considerable time and resources to explain subject matter readily comprehensible to members of the profession. ties This chapter examines the roles of the various Federal agencies in the regulatory functions of the State licensing authorities. It provides an overview of the responsibilities and duties of these Federal agencies. The major Federal agency and program activities in drug abuse prevention and control are described briefly. III. Legislative Survey This chapter summarizes the intensive review of the State statutes and regulations of the 50 States and the District of Columbia for each of the concerned professions. It serves as the groundwork for evaluating statutes governing the administrative boards of the concerned health professions. The purposes of the survey are to determine the operational structure of the State boards and to ascertain the overall authority exercised by the boards in conjunction with their regulatory function. IV. Regulatory Board Survey - This chapter presents the results of an in-depth analysis of the resources, methods, organizational policies, and practices of the regulatory boards. Findings contained in this chapter were obtained from data generated by the nationwide survey of State regulatory boards. V. Compliance/Enforcement Investigations This chapter defines the drug enforcement agency's roles in assisting State and local efforts to curtail drug traffic. It breaks down the various agencies involved in the control and prevention of drug abuse, and examines the functions of these agencies as they specifically relate to State and local enforcement agencies. II. Drug Control Agency and Program Activities The Controlled Substances Act of 1970 and its accompanying regulations reserve to the States and their health regulatory licensing agencies the authority to determine fitness to practice and the right to prescribe, administer, and dispense controlled substances by health care professionals. This authority includes the responsibility to provide resources for preventing drug abuse and control abuse, specifically drug diversion or leakages at the retail, or practitioner level. Because a Federal drug abuse strategy has also been developed, this strategy and its relationship to State drug abuse activities under the Act are also described in this chapter. The description of the roles of the various Federal agencies in conjunction with the regulatory function to be performed by the State licensing and/or regulatory agencies is also included. 1. PRIMARY AGENCIES WORKING TO COMBAT DRUG ABUSE (1) Special Action Office for Drug Abuse Prevention The Special Action Office for Drug Abuse Prevention (SAODAP) was established by Executive Order 11599 on June 17, 1971, to coordinate the Federal campaign against drug abuse. Its mission was to decide upon immediate steps to curb drug abuse and to develop a long-term Federal strategy. SAODAP also has been the coordinating agency for all programs dealing with drug abuse education, training, treatment, rehabilitation, and research. As a result of SAODAP's efforts, the number of Federal agencies involved in drug abuse prevention activities was reduced from 14 to 6, and each agency was given a clearly defined role. (See Exhibit II-1.) Since SAODAP's expiration on June 30, 1975, the National Institute on Drug Abuse has assumed responsibility for coordinating drug abuse programs. (3) Drug Enforcement Administration The management of Federal programs to reduce the supply of illicit drugs was strengthened by consolidating Federal drug investigation and intelligence resources into the Drug Enforcement Administration (DEA). Primary Responsibilities of DEA In the federal effort to combat drug abuse, DEA primarily is charged with: Development of an overall drug enforcement Regulation of the legal manufacture of drugs To achieve these objectives, DEA's responsibilities in the Federal campaign are to: Control all intelligence and investigation functions regarding drug law violations Provide technical and financial assistance for related state and local enforcement agencies Sponsor drug abuse prevention programs (providing speakers, information, literature, films, etc.) Assess the abuse potential of drugs, and recommend and promulgate schedules of controlled substances Register those who handle controlled substances Establish importation and manufacturing quotas for Schedule II drugs Regulate controlled substances in conjunction with the Food and Drug Administration (FDA). To meet this last responsibility and to reduce the amount of legally manufactured drugs being diverted for illegitimate use, the DEA established the Compliance Investigations Division (CID)*. To accomplish this objective, the CID implemented the regulatory functions described in the Controlled Substances Act. (4) Food and Drug Administration The Food and Drug Administration (FDA) works with the DEA to control the abuse of legitimately produced drugs. The FDA provides medical and scientific information and recommendations to the DEA. The FDA's major drug abuse control responsibilities and related activities are: To determine acceptable methods of treatment of narcotics addiction in conjunction with the DEA and NIDA • To advise the DEA on production and import quotas of scheduled drugs. 12 *EDITOR'S NOTE: CID was upgraded to Office status on September 3, 1976 by the U.S. Attorney General and is now the Office of Compliance and Regulatory Affairs. It has three Divisions: Regulatory Support, Compliance, and Regulatory Control. |