1. PURPOSE OF THE STUDY

This study provides information for developing Federal policy to meet the objectives of Public Law 91-513, the Controlled Substances Act of 1970. Because several States have established goals and objectives in the area of drug abuse prevention and control, a detailed analysis of the roles of agencies and associations which address these goals and objectives, as well as background information and data, are also presented.

The objectives of this study, specified contractually, limit the inquiry to the available resources. These objectives were:

To analyze authorities, resources, practices, policies, and organization of State professional licensing boards and State professional associations, and their direct and indirect relation to the enforcement of the Federal Controlled Substances Act and similar State legislation • To explore and specify existing relationships between State professional societies and State licensing boards with reference to the boards' licensing, regulatory, and enforcement functions

• To recommend ways by which State licensing boards and/or professional associations can increase their effectiveness and cooperate in enforcement and regulatory activities

• To develop a model State professional practice act for the concerned professions, and to propose model objectives for the professional State licensing boards.

This volume provides an overall view of the roles of State agencies, State associations, and State regulatory boards with respect to controlled substances abuse prevention. It also provides a supporting logic and methodology for the study.

The Controlled Substances Act of 1970 assigns to the States and their licensing authorities the responsibility for determining who will be registered under the Federal Act. The States perform their traditional roles in preventing and controlling drug abuse, specifically, in the following areas of drug diversion at the practitioner level:*

• State licensing or regulatory boards exercise a major role in the enforcement of the Controlled Substances Act and equivalent State legislation. • The boards are responsible for the admission and continuation in public practice of health professionals under their jurisdiction.

• Disciplinary actions and licensure procedures represent one of the boards' primary mechanisms for regulating practitioners' and phar

The study team has defined this as the retail level.

macies' activities which relate to the prevention, control, and suppression of drug abuse. Through these mechanisms, the boards can regulate the licensees and protect the public against professional incompetence, unprofessional conduct, possible drug diversion, and leakages.

To a considerable extent, the authority, composition, and procedures of the boards determine how licensure laws are administered. Thus, State boards exert an important influence on the qualifications, discipline, ethics, professional performance, standards, and scope of professional practice of their licensees. Notably, the boards tend to make licensing procedures uniform within each State rather than within each profession.

This study included the following:

•Extensive literature review

tool to control and discipline practitioners who violate the Controlled Substances Act.

Further, efforts to improve the effectiveness and efficiency of the State boards and licensing agencies in resolving current problems with errant registrants should be carried out through the proposed model practice act.

Legislative recommendations are presented in Chapter II of this report, and the composition and characteristics of the proposed model act are summarized in Chapter VIII. Although the model practice act has been developed for submission to the National Conference of Commissioners on Uniform State Laws, a number of States may wish to take more immediate action. According to their circumstances, States may choose to adopt the basic substance of the act as it now reads simply by adding to, modifying, or deleting the appropriate provision(s) of existing legislation; or by adopting the basic jurisprudential philosophy underlying the act for developing a new model act.

4. SUMMARY OF

RECOMMENDATIONS

The following recommendations are based on the information received from all professional boards, professional associations, and compliance unit representatives. The objective was to improve board and compliance unit functions and activities. In most cases, the questionnaire survey was used to test both the desirability and feasibility of the recommendations.

(1) Exchange of Information Among the States, and the Clearinghouse Concept

Recognizing the problems of practitioner mobility and the resulting resource demands of licensure endorsement (reciprocity), professional regulatory board representatives supported the idea of a nationwide clearinghouse to exchange information on health care professionals' backgrounds. Three-quarters of the representatives indicated that the clearinghouse should include available information on all actions taken against a practitioner's license. A majority of the nurses and MD's indicated that such a clearinghouse should include information which would assist in evaluating the qualifications of graduates of foreign health care professional institutions and programs. Both the regulatory board and professional association respondents opposed Federal Government involvement in such a clearinghouse. Respondents felt data should be collected by the appropriate national association of health care professional regulatory or examining boards and that these groups should also disseminate the

data. The nursing and osteopathic medical professions, which do not have strong or independent national associations of boards, indicated less support for assigning their national association of State boards the role of administrative agency.

In view of the recommended courses of action on licensing, a program should be implemented whereby the clearinghouse will provide timely and accurate information on licensing actions. This program should provide the boards with information which will enable them to process licenses more accurately and rapidly, thereby releasing resources to improve the other board functions and activities. Associations should have access to clearinghouse information, but on a limited basis. There is a desire to consolidate and increase resources available to perform licensing functions which, if implemented, would improve drug abuse diversion control programs.

(2) Acceptability of Central Licensing

Using State centralized agencies for administrative tasks such as processing applications, handling renewals, and collecting and accounting for fees was felt by those using central licensing to be satisfactory; however, a substantial number of State professional board representatives indicated they are not considering such a central administration.

It is recommended that the States not be forced to adopt central licensing but that State committees on the healing arts be established. Such committees should consist of the presidents of the licensing and regulatory boards of the health care professions.

(3) Information Network on Drugs of Abuse

Consideration should be given to developing a network similar to the existing federally sponsored poison control network which would provide practitioners and pharmacists with information on drugs of abuse, forgeries, stolen prescription orders, and patient attempts to obtain controlled substances. It might be possible to utilize either fully or partially the existing poison control apparatus. But this alternative properly should be explored by the concerned Federal agencies.

(4) Timing of Implementation of the Model Practice Act

Immediate efforts should be undertaken to obtain participation and review by the National Conference of Commissioners on Uniform State Laws. The DEA should form an external task force of selected Federal officials, State officials, representatives of national associations of professional

regulatory boards, and national professional association officials to review the model practice act and prepare an implementation program.

(5) Convicted Drug Theft Participants

Because the board, association, and compliance investigation representatives felt that drug theft was a major, if not the most important, source of drug diversion (leakages), studies of convicted drug theft participants should be undertaken. These studies should focus on the types of drugs stolen, the source of location of the drugs within the pharmacy, how the individual was detected or apprehended, and how the individual was able to locate the controlled substances within the pharmacy.

(6) Triplicate Prescription Orders

Because of the large number of responses indicating that it would not be acceptable and could not be implemented, a requirement of triplicate prescription orders should not at this time be forced upon those States which do not have constitutionally sound statutes. If an evaluation of the use of triplicate prescription orders proves this to be a successful drug control mechanism, incentives could be developed for other States to develop similar programs.

(7) Methods to Improve Effectiveness of State Compliance Investigative Units Efforts to increase resources of compliance units should focus on improving investigator scheduling, training, and funding, and increasing legal counsel to improve prosecution and legal support.

Additional funding to continue the practitioner drug education effort was viewed as appropriate, but there was little enthusiasm for public drug education to reduce drug diversion.

(8) Registration of Exempt Practitioners

Because the number of health care practitioners exempt from licensure requirements due to Federal or State agency affiliation was identified as a potential problem, registration without licensing or certification should be undertaken by States where such individuals form a significant proportion of the practitioner population. The actual registration document should not have the issuing lay agency's name in large letters and/or should have a colored overlay indicating that the holder does not have a license to practice in that State. These exempt individuals would be allowed to practice within a facility under Federal or State supervision. The license would be provided for a nominal (less than $5) fee.

(9) The Newsletter as a Drug Diversion and Abuse Control Mechanism

Strong group pressure against errant practitioners (for example, those who overprescribe controlled substances) is reportedly effective in some of the States surveyed. Mere publication of the names of such practitioners in newsletters appears to be sufficient to deter them from future such actions. In all but the very largest States, this may be a very effective tool. It is recommended that this practice be encouraged and evaluated in those States using the practice.

(10) Continuing Education as a

Voluntary Compliance Tool

It is recommended that both the boards and their compliance investigation representatives participate in sponsoring continuing education programs for practitioners on problem drugs, means to reduce leakage, and recognition of patient and colleague drug abuse. Such programs should focus on proper recordkeeping, overprescribing of controlled substances, cooperative pharmacypractitioner efforts, security techniques, and recent trends or fads among drugs of abuse. Given the continuing changes in drug abuse patterns, diversion techniques, and DEA/FDA regulations, practitioner continuing education on drug-related matters is preferable to the less rigid and more individualized college and university health care professional curricula.

(11) Operational Manuals

Financial support for developing and improving operational guides and manuals for State compliance investigation units and board members is recommended. Topics which would improve board and compliance unit handling of drug-related issues should include: drug theft prevention, improving pharmacy and drugstore security, compliance and conduct of audits, selection and training of compliance staff, improving physicians' office security and prevention of forgeries, evaluating the State's compliance effort, disciplinary and administrative hearings, drug problems under the Controlled Substances Act, and board organization and operations. There should also be a board member's training handbook and prosecutor's handbook on experts, case preparation, and Federal assistance.

ices at a "reasonable cost." Practitioner boards must be sure that regulation pertaining to these paraprofessionals contains sufficient incentives to monitor properly any contact the paraprofessionals have with controlled substances. However, the wide variation in State health care practice acts makes it more difficult to initiate and develop training, education, and accreditation programs for them.

5. SUMMARY OF FINDINGS

The major areas of concern in the abuse and diversion of controlled substances involve the sources of drugs, the role of the professional associations in regulation, continuing education, legislative changes, and the effectiveness of the complaint review process. Each finding obtained from the surveys is summarized below, and is discussed in detail with supportive analysis and tabulation in the individual chapter findings and recommendations sections.

(1) Major Drug Diversion and Abuse Problem Areas

The major causes of drug diversion problems cited include drug theft, forged prescriptions, excessive prescriptions, and the acquisition, by patients, of multiple prescriptions from a number of practitioners. The compliance inspection chiefs and board representatives indicated that these areas can be controlled only through closer supervision of practitioners and stronger enforcement policies.

Pharmacy theft represented the most serious source of controlled substances diversion. The most desired control response for drug diversion was increased enforcement. However, both MD's and DO's considered both of these methods effective.

ers and pharmacies are certified for registration to handle controlled substances under the various State and Federal laws. As a result, the boards can remove an offender from a position of responsibility. The boards also have a mandate to ensure that licensees provide adequate health care to the public. Because these State boards and their investigative arms initiate most license and revocation actions, it appears that the most appropriate way of affecting the registrant/practitioner is to improve monitoring, disciplinary, and related investigative activities. These board activities should focus upon more careful handling by practitioners, reduced vulnerability to theft, and the recognition of potential abuse and diversion of controlled substances. These improvements can play a key role in reducing diversion of controlled substances at the retail level.

(3) State Regulatory-DEA Responsibilities for Controlled Substances

An analysis of DEA interaction with State regulatory agencies suggests that on a nationwide basis, State boards and compliance units have initiated and conducted those regulatory functions relating to DEA registrants on their own. Intervention by Federal agencies was necessary in a small proportion of the cases. This approach by DEA is consistent with the primary federal statutes and regulations relating to the control of substances of abuse. The statutes clearly reserve to the States authority to determine fitness to practice, and hence the right to prescribe, administer, and dispense controlled substances. This leaves the primary responsibility for control of diversion at the retail level to State agencies. DEA may revoke a practitioner's Federal controlled substances registration only if (1) the practitioner has been convicted of a drug-related felony, (2) the license was revoked or suspended, or (3) the practitioner has materially falsified his application for DEA registration. DEA does not have-nor does Congress believe it should have the resources to pursue extensive numbers of violations at the retail level. Therefore, it relies very heavily on State drug investigation, law enforcement, and regulatory agencies.

(4) Complaint Handling Process

Although board representatives and compliance inspection chiefs believe consideration should be given to increasing the compliance inspection staff to improve the complaint review process, there is some concern that increasing their resources without improving investigatory scheduling, training, and support funding would increase their ability to pursue diversion (leakage) reduction goals at a higher cost than necessary. Better use and allocation of existing resources and in

creased funds would be a more productive way to achieve objectives. To be more effective, boards and compliance units will require increased regulatory and statutory authority, as well as the additional support of legal counsel.

(5) Centralizing Disciplinary Activities for Investigation

Use of central disciplinary activities for investigations cannot be assessed properly from the survey results. Although the boards' respondents recognize the need for staff whose responsibilities extend beyond pharmacy inspection, the boards do not have sufficient resources to provide for such investigators. If the States are pressed into developing central disciplinary units for investigation, this may in many States increase costs and result in the assignment of investigators who do not possess the supervisory qualifications or capabilities of the practitioner board members.

(6) Centralizing Activities

A number of States have a central agency which controls the licensing functions for the various health professional boards. The result is a consolidation of administrative functions.

Apparently, there is extensive duplication of functions among the professional boards within a State. Centralizing and consolidating the boards' functions will increase efficiency and uniformity of procedure, while decreasing costs.

Administrative aspects of licensing are centralized in California, New York, and Virginia.

Some argue that many of the functions of the different professional boards do not relate directly to the profession and can be performed by one unit. The functions most frequently mentioned as susceptible to consolidation are: investigative work; administration of examinations; maintenance of all records of examinations, suspensions, revocations, and other disciplinary actions; collection of fees; compilation of a register of licensees; purchase of supplies; and provision of hearing commissioners for all hearings.

This system would alleviate the most time-consuming and burdensome tasks of the boards, and would provide the boards with time to attend to more important tasks. The system also might provide a central investigative body which the individual boards could utilize as their needs require.

(7) Changing Legislation

To a considerable extent, State boards and associations exert considerable influence on new legislation relating to the qualifications, discipline, ethics, professional performance, standards, and

scope of professional practice of their member licensees. Licensing procedures tend to be more uniform within each State than within each profession. This eases the operational problems of State prosecutors, enforcement agencies, and other governmental units, while exposing the multi-State practitioner to a wide variety of legislation and regulations.

(8) Problems in Assessing the Extent of Controlled Substances Diversion

A main impediment to the proper assessment of the extent of diversion and leakage of controlled substances is the lack of measurable definitions of drug diversion. This, in turn, leads to a lack of data, problems with comparing data, and an inability to use existing investigative data to estimate the extent of drug abuse by source.

(9) Association Roles in the Board Appointment Process

With the partial exception of the pharmacy profession, the substantial majority of the health care professional associations exercises a very high level of review and control over the recommendation and nomination processes for board member appointments. This condition and the almost universal lack of public or lay members on the health care regulatory boards has led to a decrease in public credibility regarding the manner in which these professions regulate themselves.

(10) Development of Model of Model Policies,

Practices, and Objectives

In order to implement the model practice act properly and achieve a functioning regulatory environment for professional practices, certain goals, and the policies and practices necessary to meet these goals, should be established. While the boards are the principal actors, the courts, the attorney general's office, and the respective professional associations in each State influence the professional health practice regulatory process as they interact with the boards.

It is critical that particular observations and topics be studied thoroughly by appropriate members of each group and agency. For example, a board's requirement for the continuing education of licensed practitioners as a condition of license renewal gives new meaning and importance to the development of health care practice standards by the appropriate professional association; this is a reciprocal relationship because the boards certainly will wish to evaluate and use the association's standards.