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1. BACKGROUND

The ultimate responsibility for the enforcement of the Controlled Substances Act at the retail level* has been delegated to the States through a memorandum of understanding between the individual States and DEA. DEA's activities concentrate on the manufacturer and wholesale levels. Professionals engaged in drug distribution at the retail level are shown in Exhibit V-1.

Each State is responsible for dealing with drug abuse problems relating to:

• Community and hospital pharmacies • Dispensing practitioners

• Nursing homes.

Characteristically, this involves the following activ

ities:

• Investigations of problems within these areas of responsibility

• Examination of records

• Compliance audits

• Coordination and reporting of the above activities with the DEA regional office.

Within the various States, the monitoring of retail points of diversion of controlled substances is usually accomplished by several separate agencies. The following are typical.

(1) State Boards of Licensure

The State regulatory boards for the concerned professions are primarily responsible for enforcing drug compliance. The boards usually have the sole authority to license the health professionals and, as a result, can remove an offender from a position of responsibility. Also, the boards have a mandate to ensure that licensees provide adequate health care to the public.

The mandate is satisfied by an investigation and regulation system specifically tailored to identify offending professionals. The means of detection

are:

• Board investigations

Other State investigations (e.g., compliance investigations, enforcement agencies)

• Peer review (including participation by the State association)

• Public complaints.

(2) State/Local Law

Enforcement Agencies

State and local law enforcement agencies are integral parts of the effort to regulate controlled substances at the retail level. Diversion of dangerous drugs will, in most cases, come to the attention of the enforcement agencies through:

• Intelligence sources maintained within the community

• Police contact with drug abusers (especially overdose cases)

• Complaints received from the public.

As a result, these agencies serve as a timely and useful source of information regarding diversion of controlled substances. If proper channels of communication are established, the licensing boards and other regulatory agencies concerned with health professionals can integrate this intelligence into their own program of enforcement.

Based on the field survey of three States, it was observed that police units are not involved in regulation of health professionals. Their efforts focus on the drug problem after the drugs have reached the streets.

The relationships among these agencies are shown in Exhibit V-2. While units usually maintain liaison with DEA regional offices, the degree of cooperation varies from State to State. Given the necessity for cooperation, some State organizations adopt a task force approach to dealing with drug diversion.

(3) Compliance Investigative Unit

Compliance investigators, commonly referred to as drug inspectors, enforce Federal and State drug laws. More specifically, this enforcement unit addresses the problem of drug diversion and/or abuse by health professionals and health institutions.

The compliance investigative units are usually affiliated with the State board of pharmacy. The investigators are usually pharmacists and most of their caseload relates to pharmacy practice. Investigators are also active in conducting compliance investigations of health professionals other than pharmacists.

Compliance investigators examine a profession

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Conduct undercover work to gain firsthand knowledge of a subject's practice as it relates to controlled substances

Survey related institutions and individuals to gain information on the subject's practice, including the subject's sources of supply of controlled substances.

The DEA offers a training program to State and local agencies involved in compliance activities. These training schools are located throughout the United States and are initiated either by the request of the State and local regulatory agencies or by DEA itself.

This training enables the DEA to provide information to the State and local personnel involved in compliance investigations at the retail level.

The level of activity assumed by this training is and will continue to be directly related to the DEA's effort to ensure that effective measures are being taken by responsible State agencies to minimize diversion of controlled drugs at the retail level.

2. DEA REGISTRATION AND THE DRUG DIVERSION ISSUE

On May 1, 1971, the Controlled Substances Act replaced a number of Federal laws. Briefly, the law requires that every person not specifically exempted who manufactures, distributes, prescribes, administers, or dispenses any controlled substance, or who proposes to engage in any activity utilizing controlled substances, must register annually with the Attorney General.

Table 1: Types of Registrants

(1) DEA Registration

The registration function is the responsibility of the DEA. Two types of registrants are involved: "Type A" includes community pharmacies, practitioners, hospitals and clinics, and teaching institutions

• "Type B' includes manufacturers, distributors, analytical laboratories, importers, and exporters. As of the end of the first quarter of 1974, there were 488,624 Type A registrants and 6,776 Type B registrants. Registrations by business activities are presented in Table 1.

Practitioners comprise 85 percent of total registrants handling controlled substances. For this reason, the practitioner/retail level remains a possible major source of drug leakages. Hence, the need for this study.

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Community Pharmacies

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Hospital/Clinic

Practitioner

Teaching Institutions

Manufacturer

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State-Local/DEA Regulation of Retailing of Controlled Substances for States not Having a Diversion Investigative Unit (DIU)

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Type of

Distributor

Exhibit V-3: BNDD Diversion Analysis: A Summary of Drug Arrest Data

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Source: Adapted from "Diversion Analysis," BNDD report covering the period 10/68 - 1/70.

Exhibit V-4: Regulatory Inspections and Compliance Actions by Registrant

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Available information from BNDD-DEA records led to the following observations:

• Retailers (pharmacies and practitioners) comprise a significant proportion of drug arrest data when compared to other distribution sources, such as wholesalers and manufacturers.

• Of arrests for drug diversion, the retail level accounts for 77 percent of illegal sales, 75 percent of recordkeeping violations, 72 percent of drug seizures, and 75 percent of prosecutions. (See Exhibit V-3.)

Exhibit V-4 presents a distribution of regulatory actions conducted by compliance inspectors on registrants. These data indicate DEA compliance efforts at the retail level.

(3) DEA Interaction with State Regulatory Agencies

The review of the DEA case files also disclosed the degree of involvement of State boards and professional associations with the DEA in the revocation of drug registration from practitioners. Exhibit V-5 leads to the following observations:

• In 69 percent of the cases, the State licensing boards initiated actions prior to DEA involvement.

• The professional associations are seldom if ever involved.

• In 63 percent of the cases, DEA investigators had no participation or involvement in the revocation of the drug registration.

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