(4) Continuing Practitioner

Drug Education

A number of ways to involve practitioners and the public in the compliance investigation process were suggested. The most highly recommended was the continuing education of practitioners in the area of controlled substances.

4. SUMMARY OF FINDINGS

The findings obtained from the compliance investigative unit questionnaire are summarized below. Two major areas of concern involved the identification of Statewide problem areas and means to increase the effectiveness of the compliance investigative units.

(1) Major Drug Diversion and Abuse Problem Areas

The major drug diversion problems are drug theft, forged prescription orders, excessive prescription orders, and patients obtaining multiple prescription orders from a number of practitioners. The compliance inspection chiefs indicated that these areas can only be controlled through closer supervision of practitioner and stronger enforcement policies.

(2) Methods to Improve Effectiveness

of Compliance Investigative Unit

Not surprisingly, most of the compliance division chiefs felt that the number of compliance investigators should be increased to better handle the workload and that more lawyers should be provided to improve prosecution and legal support.

There is some concern that increasing the resources of compliance units without improving

their work scheduling, training, and support funding would increase their ability to reduce diversion, but cost more than necessary. Better allocation of existing resources with increases in support funds would be more productive.

Compliance chiefs support additional funds for practitioner drug education effort, but showed little enthusiasm for public drug education as a means of reducing drug diversion.

5. COMPILATION OF

DATA RESULTS

Data were collected throughout the States on compliance investigation activities. The sources include the results of the:

Legislative survey

• Field survey on three States

• Questionnaire survey of the 50 States and the District of Columbia.

(1) Legislative Survey

Table 2 summarizes the results of the statutory review relating to the provision of investigators for States licensing boards.

Statutory Provisions for Board Staff and Investigation

Up to 69 percent of the professional boards indicated that the statutes authorized employment of staff as needed. The pharmacy boards possess explicit statutory authority to employ investigators in 45 percent of the States. Comparatively, only 20 percent of the medical boards have such authority. The lack of such statutory authority imposes a limitation on the regulatory and enforcement function. This factor should be considered in assessing the State control of retail drug diversion.

(2) Field Survey in Three States

Based on the field survey of State boards and professional associations in the States of Maryland, New York, and Virginia, the following observations on compliance responsibilities and staff were made:

Responsibilities

The compliance inspection unit monitors and inspects drug distribution in all facets of the industry, from the manufacturer-wholesaler level to the community and hospital pharmacies.

The compliance inspection unit maintains liaison with the FDA in checking:

Outdated drugs

• Drugs without FDA approval

.. Mislabelling

• Erroneous packaging

• Erroneous drug quantities.

The unit collects evidence for the State attorney general's office to prosecute practitioners or pharmacies.

The unit collects evidence for the State attorney general's office to prosecute practitioners or pharmacies.

-In Virginia, nine investigators are assigned the task of investigating, monitoring, and enforcing the controlled substances laws within the State. Seven of the nine investigators are pharmacists. Their responsibilities cover drug manufacturers, drug wholesalers, and drug retailers. They are, by design and State policy, the major investigating body for all of the health professions' regulating boards.

Staffing Operations

In all of the States visited, compliance investigators are primarily pharmacists not in active practice.

The following questions and corresponding tables relate directly to the individual chiefs of compliance investigations and their jobs.

(1) Total Number of Compliance Investigators Maintained By Board

The number of compliance investigators maintained by the pharmacy board was four or less for 68 percent of the States responding. Of those, full-time investigators were two or less; part-time, one or less. In both cases, full-time and part-time, the number of unfilled positions averaged no more than one. These figures are based on Tables 3 and 4.

(2) Compliance Investigator Experience Requirement

In general, the most important requirements for compliance investigators are a background in

pharmacy and a college degree. It appears that 5 years experience in pharmacy is a significant requisite.

Although respondents from several States indicated they had an experience requirement for investigators, only seven State compliance representatives responded to this question, with five indicating a specific number of years. Those five responded with a range of 1 to 5 years and a mean of 3.2 years.

(3) Outside Employment for Compliance Investigators

In 54 percent (19) of the States surveyed, compliance investigators are not allowed outside employment. Of the 51 percent able to work elsewhere, 29 percent (8) were allowed in pharmacies; no restrictions exist in 43 percent (12) of the States. (See Table 5.)