A number of issues were considered in determining how to collect the survey data. Simply accumulating the responses would have expended a considerable amount of staff resources and would not have provided DEA, NIDA, FDA, or the study staff with an opportunity to explore interesting avenues apparent only after the initial descriptive analysis had been completed. The results of the questionnaires were therefore tabulated and integrated using a time-shared computer-based approach. This method facilitated thorough analysis of the survey results.

The following procedures were used in the data analysis:

• Survey data from the questionnaires were reviewed for completeness and face validity. Where respondents specifically stated that the same questionnaire was to be used for more than one respondent from the same State organization, that questionnaire was duplicated. In addition, review of responses from the same State organizations showed that the responses were identical in a great many cases.

• Questionnaires were coded for keypunching into machine-readable format.

• Data coding sheets were checked and machinereadable cards were keypunched, keyverified, and edited.

Using these cards, an on-line data base was created using SURVEY, a commercial software package available from Tymshare, Inc.

Critical cross-tabulations were selected and executed using the SURVEY software package. These tabulations were analyzed, conclusions drawn, and recommendations made.

The questionnaire and legislation data bases were available for ad hoc cross-tabulations, histograms, and other statistical analyses.

5. LEGISLATIVE SURVEY

The legislative survey reviewed and evaluated current ideas and trends in the State statutes and regulations relating to licensing and regulation of health care professionals. Highlights of this review included the following:

• Evaluation of Present Trends in Institutional Licensing

One part of the literature review and interviews with health care authorities focused upon the concept of self-regulation by institutional groups (hospital internal review). The objective was to identify an approach to controlled substances abuse through an institutional licensure system.

• Review of Case Law for Challenges to Existing Statutes, Policies, and Procedures

Case laws reviewed under this effort were analyzed for possible application to State laws and regulations. The rights of individuals under regulation were weighed vis-a-vis the authority vested in the State to regulate health care professionals. The results of this endeavor were integrated into the other parts of the legislative survey.

• Review of Trends in Licensing

This effort reviewed licensing procedures, particularly the procedures of temporary and restrictive licensing by the State, and the effect such practices have on access to controlled substances. This analysis was intended to provide further insight into the relationship of licensing, regulation, and drug control.

• Review of Programs Conducted by Health Care Professionals

In addition to the regulatory procedures of the States, the professional associations sponsor continuing education programs. This effort involved a collection and review of position papers and model statutes concerning licenshing and drug control. The effort also included a review of the nature and extent of continuing education, with special reference to those programs which relate to drug abuse control and prevention.

Review of Activities of Legal Societies, Government Associations, and Licensing Associations After the activities of the professional associations had been reviewed, was collected and reviewed similar data from such related groups

Council of State Governments and the National Conference of State Governors. The influence of these organizations upon regulatory activity and legislation required that their opinions be considered.

Compilation of Pending and Recent Federal and State Bills, Regulations, Procedures, and Policies

Data on current trends and developments in the governmental approach to licensing and drug regulation were collected. Recent legislation and proposed regulatory actions were compiled to enable a thorough and complete approach to the development of the Model Practice Act. • Summary of the Pending Legislation, Regulations, Policies, Procedures, and Trends

The results of this summary were incorporated in the earlier legislative survey to obtain a cohesive description of existing laws and trends in licensing and drug regulation and enforcement.

6. ANALYTIC APPROACH

Analysis, integration, and evaluation of data were the critical components of the research process. The findings can be used directly by DEA, NIDA, and FDA in their basic policy formulation and program evaluation roles.

To perform the analysis, the study staff used all the resources of existing data; assessed the capabilities of the licensing boards to control, monitor, and enforce the federal and substantially equivalent State laws and regulations related to controlled substances; identified problem areas in control, monitoring, and enforcement of Federal and equivalent State laws and regulations; and recommended procedures for their improvement.

Analysis of the completed data included a number of specific procedures and activities.

(1) Statistical Analysis of Data

Using data generated from statistics on the professions and each of the 50 States and the District of Columbia, the analysis began with an extensive computer-based effort in which each step in a sequential pattern was designed to support further analysis. The statistical analysis consisted of the following:

• Tabulation of Survey Data

Data collected from the questionnaires and the legislative review of the States were reviewed for completeness and entered into separate data files. The survey data was keypunched, keyverified, and edited to ensure that the data entered into three study data bases were pro

The first step provided for development and organization of the information for each profession and State.

The second step generated basic statistical measures, including frequency distributions for major data items for each profession. In the final step, matrices were developed to investigate relationships of the influencing variables for individual elements, professions, and States. Identification and Development of Summary Statistical Descriptors

Specific information was identified and analyzed to describe the impact of the critical study factors. The analysis team prepared a separate set of question titles for each of the three previously described data bases. In performing analysis and obtaining tabulations of data from the various data bases, it was necessary to obtain summary statistics, cross-tabulate responses, obtain statistical measures, apply conditional statements to select respondents meeting specific desired conditions, and apply other analytical techniques and statistical tests (chisquare and contingency tables) to the data.

(2) Comparison of Existing Statutes to Existing and Proposed Model Statutes, Policies, and Procedures

Comparison of the data collected as a result of the legislative analysis determined the changes and trends occurring in licensing and drug regulation.

(3) Legislative and Organizational

Analysis

The existing legislation and proposed models were organized to permit identification, by point of regulation or issue, of the current trends in law, regulations, and procedures. Organizational relationships of the various licensing boards, professional associations, compliance agencies and units, and drug enforcement agencies were analyzed. The purpose of this correlation procedure was to validate the provisions of the model statutes.

(4) Integration of Information

Models were developed for preparation, integration, and documentation of individual methods of analysis.

Assessment criteria (including qualitative judgments) and measures for assessing components of a given program and the attainment of its subobjectives were developed for specific program activities. In this manner, data were provided which allowed analysis of compliance, enforcement, and licensing activities, additional statistical significance tests, and identification of external factors which might affect leakages of controlled substances.

The project team used a "comparative evaluation" of programs method. The objectives of this method included the following:

Provision of a basis for comparative analysis of licensing and compliance enforcement successes and impact

Cataloging of various objectives, subobjectives, program activities, etc., involved in programs

• Provision of common measures for comparison among individual State efforts, statutes, regulations, and agencies.

(5) Evaluation and Interpretation of Findings

In evaluating each activity or project, the project team used a logical progression of steps to ensure achievement of more advanced goals.

A number of issues addressed by the questionnaire have not been included in the comprehensive report. These issues were not included because of insufficient or invalid data. The respondents were frequently unable to respond accurately to some questions or did not have the information close at hand. Instructions for filling out the questionnaire were such as to assure a high degree of response by requiring only a nominal amount of time to complete and return it. The likelihood of receiving some invalid information was therefore anticipated.

(6) Development of Criteria for Model Statutes, Policies, and Procedures Criteria were developed prior to the production of the model statutes for two reasons;

• To permit thorough analysis of major issues as they appear in statute, regulation, procedure, and implementation, so that the models developed would mesh with one another in workable fashion To permit review of the intended criteria by the project officers prior to actual construction of the models.

(7) Preparation of Model Acts, Regulations, and Procedures

Actual production of the model statutes, administrative regulations, and enforcement procedures required special legal skills. This effort was therefore undertaken as a separate task; the study team was then used to research specific background materials and prepare explanations and comments.