Implementation of a pharmacist/physician-initiated voluntary program to curb amphetamine and methaqualone abuse

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Title:
Implementation of a pharmacist/physician-initiated voluntary program to curb amphetamine and methaqualone abuse
Physical Description:
xii, 172 leaves : ill. ; 29 cm.
Language:
English
Creator:
Bleidt, Barry Anthony, 1951-
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Subjects

Subjects / Keywords:
Amphetamines -- supply & distribution   ( mesh )
Methaqualone -- supply & distribution   ( mesh )
Substance-Related Disorders -- prevention & control   ( mesh )
Pharmacy thesis Ph.D   ( mesh )
Dissertations, Academic -- Pharmacy -- UF   ( mesh )
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bibliography   ( marcgt )
non-fiction   ( marcgt )

Notes

Thesis:
Thesis (Ph.D.)--University of Florida.
Bibliography:
Bibliography: leaves 168-172.
Statement of Responsibility:
by Barry Anthony Bleidt.
General Note:
Photocopy of typescript.
General Note:
Vita.

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University of Florida
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oclc - 09300932
notis - ABY0591
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IMPLEMENTATION OF A PHARMACIST/PHYSICIAN-INITIATED
VOLUNTARY PROGRAM TO CURB AMPHETAMINE AND METHAQUALONE ABUSE












By

BARRY ANTHONY BLEIDT


A DISSERTATION PRESENTED TO THE GRADUATE COUNCIL OF
THE UNIVERSITY OF FLORIDA
IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE
DEGREE OF DOCTOR OF PHILOSOPHY




UNIVERSITY OF FLORIDA


1982
































Copyright 1982

by

Barry Anthony Bleidt
















































The Pharmacists' Praiseworthy Initiative
Cincinnati Enquirer, October 24, 1976 [1L


I






















To my wife, Debe


This work of art is dedicated to you,

for your help and patience and all you do.

These words of wisdom from Kibran I must say

for they mean as much now as in his day.


"For even as love crowns you so shall he
crucify you. Even as he is for your growth
so is he for your pruning.

Even as he ascends to your height and
caresses your tenderest branches that
quiver in the sun,

So shall he descend to your roots and
shake them in their clinging to the earth."









ACKNOWLEDGEMENTS


I would like to acknowledge the guidance and support given to me

by my supervisory committee. I am particularly grateful to William C.

McCormick, Ph.D., chairman of the supervisory committee. He never seemed

to give up on me totally during my long long graduate career. His advice

and perseverence have been and will continue to be greatly appreciated.

I would also like to pay special homage to Richard A. Angorn, J.D.,

for his grammatical assistance. He kept my synecdoche in Schenectady.

His kindness, friendship and support have been needed and are also

greatly appreciated.

I would like to thank the other members of my supervisory committee;

William Kelso, Ph.D., for his knowledge and assistance in public adminis-

tration; Max A. Lemberger, M.S., for his patience and guidance in many

areas; Oscar E. Araujo, Ph.D., for his support and guidance; and Douglas

D. Bradham, D.Ph., for his assistance in the transition and evolution of

this document.

I would also like to thank Ron Marks, Ph.D., for his assistance in

deriving sample size calculations.

It is also appropriate to thank Edd H. Clouse for his assistance in

the data gathering process and Ramona W. Bryant for her typing of this

manuscript.

A special note of acknowledgement is extended to political cartoonist

H. Longfellow of the Cincinnati Enquirer and to satirist Rube Goldberg for

the use of their cartoons as a comic relief in this document.

Finally, I wish to extend my gratitude to all the pharmacists and

physicians whose leadership and ability made the Duval County program

possible and successful and to thank them for the cooperation that

provided the necessary data base for this evaluation.
V













TABLE OF CONTENTS
Page

ACKNOWLEDGEMENTS ... ...... ............. v

LIST OF TABLES .. .. .. . .. viii

LIST OF FIGURES . . x

ABSTRACT . . .. . .. xi

CHAPTER I INTRODUCTION .. . . 1

A History of Controlled Drug Regulations (1906-1982) 2
Control of Narcotics .. . 2
Control of Stimulants and Depressants . 3
Consolidated Federal Control . 5
Regulatory Control . ... 8
State and Local Control .. . 10
The Duval County Voluntary Program .... 11
The Florida Amphetamine Law. . .. 13
The Study .... ................. 14
The Significance of This Project .......... 14
Research Objectives . ..... 16

CHAPTER II POLICY IMPLEMENTATION LITERATURE REVIEW .. 19

Communication . .. 20
Resources . . .. . 23
Attitudes . . ... ....... .24
Organizational Structure . . .. 26
Factor Interaction . . 27

CHAPTER III SURVEY, SAMPLING METHODS AND QUESTIONNAIRE DESIGN 31

Study Development . . .. 32
Development and Pretest of Data Collection Instruments .. 32
The Telephone Interview . .. 34
Questionnaire Design . . 35
The Pharmacists' Questionnaire . .. 35
The Physicians' Questionnaire . .. 37
The Prescription Review . .. 39
Auditor Qualifications for Data Collection . .. 41
Sampling Methods . . .. 42
Randomization Process . . 44
Sample Attrition . . 45
Sample Representativeness . .. 46









Page


Study Period . .
Response Variable . .
Control Sample ..... ..
Summary of Data Collection Methodology .
Data Analysis Methodology . .


CHAPTER IV OUTCOMES OF THE DUVAL COUNTY PROGRAM .


Prescription Trends . .
Prescribing Behaviors . .
Verification Activities . .
Participation Level . .
Summary of the Prescription Review Results


CHAPTER V PRACTITIONERS' ATTITUDES AND KNOWLEDGE OF THE
DUVAL COUNTY PROGRAM . . .

Pharmacists' Responses .......
Respondent Characteristics ....... ...
Pharmacists' Attitudes Toward the Duval County Program
Pharmacists' Knowledge of the Duval County Program .
Pharmacists' Knowledge of the Florida Amphetamine Law
Physicians' Responses . . .
Respondent Characteristics........ .
Physicians' Attitudes Toward the Duval County Program
Physicians' Knowledge of the Duval County Program .
Physicians' Knowledge of the Florida Amphetamine Law
Comparison of Pharmacists' and Physicians' Responses .


83

84
84
87
94
99
101
101
104
113
116
118


CHAPTER VI SUMMARY AND CONCLUSIONS .

Program Development . .
Program Implementation .
Program Assessment . .
Policy Recommendations .
Areas for Future Research .
Conclusion . .

APPENDICES

I PHARMACISTS' COMMENTS . .
II PHARMACISTS' QUESTIONNAIRE .
III COVER LETTER TO PHYSICIAN QUESTIONNAIRE
IV PHYSICIANS' MAIL QUESTIONNAIRE .
V DRUG PRODUCT CODING SYSTEM .
VI DATA COLLECTION CODE SHEET .

REFERENICES . .

BIOGRAPHICAL SKETCH . .


123
125
127
132
136
138


140
147
154
156
163
167

168


. .


* .














LIST OF TABLES


Table Page

1 Cooperation Rate of Pharmacies by Ownership Type
and Participatory Status Category .... 47

2 Duval County Pharmacies and Study Sample by Ownership
Category-and Participatory Status .... 48

3 Participatory Status of Duval County Pharmacies and
Study Sample by Ownership Category .. 49

4 Characteristics of Pharmacies Participating in Study .. 55

5 New Prescription Volume by Year of Sample Pharmacies 56

6 Schedule II Prescriptions as a Percentage of
New Prescriptions . .... 57

7 Annual Rankings for Studied Drug Products in Duval
County . . .... 72

8 Stock-Size Package Prescribing Activities for
Methaqualone and Amphetamines in Duval County ..... 74

9 Verification Activities by Year for Experimental and
Control Counties .. ... 77

10 Participatory Dates for Sampled Pharmacies ... 79

11 Characteristics of Pharmacist Respondents ... 85

12 Pharmacists' Opinions on the Successfulness of the
Duval County Program. . 86

13 Pharmacists' Attitudes Toward the Duval County Program 88

14 Pharmacists' Perception of Their Customers' Attitudes
About the Program . .. 89

15 Pharmacists' Perception of Physician Responses to
the Program . . .. 91

16 Pharmacists' Perceptions Concerning Pressure Applied
to Participate in the Duval County Program 92

17 Pharmacists' Attitudes Regarding Issues Involving
Amphetamine Misuse . . .. 93


viii


~










OTable Page

18 Pharmacists' Attitudes Regarding Issues Involving
General Drug Abuse . ... 95

19 Pharmacists' Knowledge of the Duval County Program
and Florida Amphetamine Law . ... .96

20 Pharmacists' Answers on the Specifics of the Duval
County Program . . .. 97

21 Pharmacists' Answers on the Specifics of the Florida
Amphetamine Law .. . 100

22 Characteristics of Physician Respondents ... 102

23 Physicians' Responses by Degree Type and Specialty 103

24 Physicians' Attitudes Toward the Duval County Program 105

25 Physicians' Attitudes Regarding Issues Involving
Amphetamine Misuse . ........ 106

26 Physicians' Attitudes Regarding Issues Involving
General Drug Abuse . ... 107

27 Physicians' Perceptions of Their Patients' Difficulty
in Having Their Amphetamine Prescriptions Filled 109

28 Physicians' Perceptions of Pharmacists' Responses to
the Program . ... 110

29 Physicians' Perceptions of Pharmacist Verification of
Prescription Validity .. ... ..... .111

30 Physicians' Perceptions of Physicians' Responses to
the Program . .. ... ...... .112

31 Physicians' Knowledge of the Duval County Program
and Florida Amphetamine Law .. .. ... 114

32 Physicians' Answers on the Specifics of the Duval
County Program .. . .... .115

33 Physicians' Answers on the Specifics of the Florida
Amphetamine Law .. ..... .117

34 Pharmacists' and Physicians' Awareness of the Duval
County Program and the Florida Amphetamine Law 119

35 Comparison of Average Pharmacist's and Physician's
Ratings . .... .. .121















LIST OF FIGURES


Figure

1 Time-Frame Relationship of Duval County Program
and Florida Amphetamine Law . .

2 Does It Haveto Be This Complicated? A Comical Key

3 Interaction of the Four Critical Factors on the
Implementation Process . .

4 Time-Frame Relationship of Duval County Program,
Florida Amphetamine Law, Study Period and
Data Collection Period .

5 Drug Product Coding System An Illustrative Key .

6 Duval and Neighboring Counties A Geographical Key

7 Raw Data Tabulation for Duval County . .

8 Ampnetamine Prescriptions as a Percentage of
Schedule II Prescriptions . .

9 Methaqualone Prescriptions as a Percentage of
Schedule II Prescriptions . .

10 Methylphenidate Prescriptions as a Percentage of
Schedule II Prescriptions . .

11 Average Annual Amphetamine Prescription Volume
Per Pharmacy . . .

12 Average Annual Methaqualone Prescription Volume
Per Pharmacy . . .

13 Average Annual Methylphenidate Prescription Volume
Per Pharmacy . . .

14 Phenmetrazine Prescriptions as a Percentage of
Schedule II Prescriptions . .

15 Average Annual Phenmetrazine Prescription Volume
Per Pharmacy . . .


. 63


. 65


. 66


. 67


. 70


. 71


. .














Abstract of Dissertation Presented to the Graduate Council of the
University of FLorida in Partial Fulfillment of the Requirements for the
Degree of Doctor of Philosophy



IMPLEMENTATION OF A PHARMACIST/PHYSICIAN-INITIATED
VOLUNTARY PROGRAM TO CURB AMPHETAMINE AND METHAQUALONE ABUSE
By

Barry Anthony Bleidt

August 1982

Chairman: William C. McCormick
Major Department: Pharmacy

In 1976, local attention was drawn to the high per capital consumption

of amphetamines and methaqualone in the Jacksonville, Florida, area. To

help alleviate the problem, the Duval County Pharmacy Association, Medical

Society, and Osteopathic Society designed a voluntary program aimed at

discouraging unnecessary prescriptions for these drugs, reducing forged

prescriptions, and deterring pharmacy robberies.

The plan was to remove methaqualone and amphetamine products from

pharmacy inventories by establishing a 48-hour time delay in the dispens-

ing of prescriptions for these drugs and to allow pharmacists time to verify

prescriptions with physicians and to order the drugs from the wholesalers.

There were three phases to this evaluation of the Duval County program.

First, all Schedule II prescriptions for one year preceding and two years fol-

lowing initiation of the program were audited in random samples of thirty

Ouval County pharmacies and ten Alachua County pharmacies. Second, pharma-

cists in each of the thirty Duval County pharmacies and 396 Duval County










physicians practicing in the county during the entire time encompassed by

the study were surveyed to determine their opinions and knowledge concern-

ing the program. And third, the implementation process by which the volun-

tary program was executed was assessed for effectiveness and timeliness.

In the thirty Duval County pharmacies, amphetamine prescriptions de-

creased over 80 percent in the two years after program implementation

while methaqualone prescriptions were reduced more than 55 percent. A

positive spillover effect resulted in a 57 percent decrease in the pre-

scription volume of phenmetrazine since a majority of the practitioners

erroneously believed that it was also included in the program.

The survey results indicated that pharmacists and physicians thought

that the program had succeeded in accomplishing its goals and that it was,

in general, a good concept. The implementation assessment revealed a

weakness in the information dissemination process.

The Duval County program provided an excellent model for the imple-

mentation of similar programs. The program exhibited the highest degree

of peer review. More joint programs of a like nature are needed in order

to help solve the problem of drug abuse and drug misuse in our society.














CHAPTER I


INTRODUCTION


In 1977, the Duval County Pharmacy Association, the Duval County

Medical Society, and the Duval County Osteopathic Society, in response

to the serious problem of methaqualone and amphetamine misuse in Jack-

sonville, Florida, collaborated in an uncommon showing of interpro-

fessional cooperation and designed a program to alleviate the problem.

The basis for this program was a belief that excessive quantities of

amphetamine and methaqualone were being obtained pursuant, mostly, to

legitimate prescriptions, and possibly, to a lesser extent, pursuant

to forged prescriptions.

The joint program, which was wholly voluntary in nature, entailed

(1) a publicity campaign directed at the public, physicians and

pharmacists to familiarize them with the problem. This was

accomplished via the printed media and discussions at

professional meetings;

(2) the establishment of a 48-hour waiting period in the dis-
pensing of prescribed amphetamine and methaqualone to provide

adequate time for pharmacists to verify the prescription's

validity with the prescriber and to order the drug product

from the wholesaler; and

(3) prescribing of these drugs in stock-size container quantities
to prevent retention of partial packages in inventory.










It was anticipated that these activities would curb inappropriate

prescribing, aid in the detection of forgeries and aid in the preven-

tion of drug related robberies.

In conducting a proper evaluation of the implementation and out-

comes of the "Duval County program" to combat a portion of the overall

problem of drug abuse, it was essential to study the historical de-

velopment of drug abuse control and why it was necessary for these

health professionals to pioneer this type of voluntary drug control.

This chapter is divided into two sections: (1) a historical per-

spective on drug control, and (2) a description of the purpose and the

objectives of this evaluation of the Duval County program.

A History of Controlled Drug Regulation (1906-1982)

Control of Narcotics

Drug abuse is a problem that has plagued mankind for many centuries

[2]. Modern attempts to control this problem began with the enactment

of the Harrison Narcotic Act, [3] which went into effect on March 1,

1915. The Harrison Act controlled the distribution of "narcotic

substances"' through the federal government's power to levy taxes. The

administration of the law was under the control of the then Internal

Revenue Department. Narcotic drugs could be purchased only pursuant to

a special order form and be dispensed by the pharmacist only upon re-

ceipt of a practitioner's written order. The law placed tight controls

on all narcotics, but had less stringent controls on those narcotics

with a lesser degree of addiction potential. Narcotic preparations


"Narcotic substances" means cocoa leaves and opium and every sub-
stance neither chemically nor physically distinguishable from them [4].










in legitimate commerce under the Harrison Narcotic Act,as amended,were

eventually categorized accordingly:

Class A These narcotics could be dispensed only pursuant to a

practitioner's written order and were non-refillable.

This class included most single ingredient narcotic

preparations, e.g., opium, cocaine, and morphine;

Class B Originally, these narcotics could be dispensed only pur-

suant to a practitioner's written order, but the law was

later changed to permit oral orders. These were origi-

nally non-refillable. This class contained most com-

bination narcotic preparations, e.g., aspirin compound

with codeine and hydrocodone syrup;

Class X These were the "exempt narcotics" that could be obtained

in limited quantities by the patient upon signing the

narcotic register. These preparations included Elixir

Terpin Hydrate and Codeine (ETH and C) and paregoric;

and

Class M These narcotics were those opiate derivatives that showed
no addiction potential but were controlled because of

their natural origin from Papaver Somniferum (Opium

Poppy). These preparations included paperverine and

noscapine.


Control of Stimulants and Depressants

Stimulants and depressants were not regulated by the Harrison Act

because they were not classified as "narcotic drugs" and were subject

only to the requirements of the Pure Food and Drug Act of 1906 [5].










Amphetamines were first synthesized in the early twentieth cen-

tury. Methamphetamine was first prepared by Ortega, Inc., in 1919 [6:78].

Benzedrine3 (Amphetamine Sulfate) was synthesized by a California

pharmacist, Gordan Alles, in 1927 [7:183]. These were the first of the

amphetamines to be manufactured. The first amphetamine to be marketed

was Benzedrinea in 1932. It was introduced in an inhaler dosage form

for nasal decongestion and attained immediate wide-spread use [7:11]. It

was not until 1936 that the first misuse of amphetamines was reported

in the United States at the University of Minnesota among many of the

students studying for finals [6:96]. In 1938, amphetamines, along with

many other drugs, became subject to the provisions of the new Federal

Food, Drug, and Cosmetic Act (FD & C) [8].

The epidemic misuse of amphetamines was first reported among German

paratroopers in the Spanish Civil War, in 1939 [6:96], and later among.

American soldiers in the 1940's [6:97] and again in post-World War II

Japan [6:98]. By 1949, the Benzedrine inhaler had to be removed from the

market, because of extensive abuse [6:99]. The stimulants phenmetrazine

(Preludin) and methylphenidate (Ritalin) were first marketed in this

country in the early 1960's.

Methaqualone was first introduced as a somnifacient by M. L. Gujral

in India in 1950 [6:99], but was not marketed in the United States until

the early 1970's. It received wide acceptance and was marketed under

many trade names including Quaalude Sopor Parest and Somnafac .

During the mid-sixties, the public generally became aware of the

aouse of many non-narcotic substances. "Uppers," "Bennies," "Dexies,"

"pep pills," "downers," "dolls" and "yellow jackets" became household

words. In view of the growing recognition of wide-spread abuse of










stimulants and depressants, in addition to narcotics, Congress enacted

the Drug Abuse Control Amendments [9] (DACA) to the FD & C Act in 1965.

It was the first attempt by the federal government to control stimu-

lant and depressant drug abuse. The act was administered by the Food

and Drug Administration (FDA) Bureau of Drug Abuse Control (BDAC) [9].

All amphetamine-containing products and phenmetrazine were regulated.

The act required that an inventory of all regulated stimulants and de-

pressants be taken by pharmacists, manufacturers and wholesalers on

February 1, 1966. Thereafter, records had to be maintained for the

receipt and disposition of all regulated drugs.


Consolidated Federal Control

In 1968, BDAC was transferred from FDA to the Department of Justice's

Bureau of Narcotics and Dangerous Drugs (BNDD) when federal drug enforce-

ment operations were consolidated [10]. BNDD was succeeded in 1973 by

the Drug Enforcement Administration (DEA).

Increased public attention and federal regulation did not eliminate

amphetamines as a major drug of abuse. The continued recreational use

of amphetamines and other drugs by the "hippy movement" in the late

1960's was only one of the many examples of the failure of federal

legislation [11]. "Despite repeated raising of the regulatory ante,

FDA felt that too many Americans were taking too many 'uppers' for too

many of the wrong reasons." [11]
On October 27, 1970, President Nixon signed into law the Federal

Comprehensive Drug Abuse Prevention and Control Act of 1970 [12]. There

are three pertinent sections to the law: Title I establishes rehabili-

tative programs for drug abusers; Title II, commonly referred to as the










Federal Controlled Substance Act (CSA), is the mainstay of drug control;

and Title III regulates the importation and exportation of "Controlled

Substances." This Act superseded all of the more than 50 laws that

regulated narcotics and other dangerous drugs.

The CSA essentially establishes control through registration of all

persons in the "legitimate chain of procurement," except the ultimate

consumer. Congress exacted its authority to enact the CSA from Article

1, Section 8 of the United States Constitution, the power to regulate

interstate commerce, rather than from its power to levy taxes, which

it had previously used in controlling narcotics.

The CSA effectively consolidated all federal control over narcotic,

stimulant and depressant drugs in one agency. The BNDD was retained as

the controlling agency. The act differentiated between drugs according

to their potential for abuse and they were categorized accordingly:

Schedule I These drugs have a very high potential for abuse and

C-i have no currently accepted medical use in tne United
States. They may not be prescribed but they may be

used for research purposes under strict guidelines.

Examples of drugs included in this class are

heroin and marijuana;

Schedule II These drugs have a very high potential for abuse and

C-II have a currently accepted medical use in the United
States. They may be dispensed only pursuant to a

registered practitioner's written order and no

refills are permitted. Examples of drugs included

in this class are opium, cocaine and morphine;










Schedule III These drugs have a lower potential for abuse than do

C-III C-I or C-II drugs. Oral orders are permitted and not
more than five refills over a six-month period are

permitted, if authorized by the practitioner.

Examples of drugs included in this class are

glutethimide, aspirin compound with codeine and

methyprylon;

Schedule IV These drugs have a lower potential for abuse than

C-IV C-III drugs. Examples of drugs included in this
class are meprobamate and chloral hydrate; and

Schedule V These drugs have a lower potential for abuse than

C-V C-IV drugs. Refills are limited only by the pre-
scribing practitioner. Examples of drugs included

in this class are ETH & C and acetaminophen with

codeine elixir.

Amphetamines, originally categorized in Schedule III, were subse-

quently placed in Schedule II in order to further restrict their avail-

ability [13]. Methylphenidate and phenmetrazine, also originally

categorized as Schedule III drugs, were later placed in Schedule II in

late 1971 [14].

Methaqualone was not a controlled substance when it was first mar-

keted. However, in early 1973, pressure began to mount in Washington

for its control. After a scathing expose about the high abuse rates and

addictive potential of methaqualone, on "50-Minutes," The CBS news maga-

zine television show, the federal government moved quickly to control

the drug. After much debate, it was placed in Schedule II [15].











Regulatory Control

The DEA and FDA have attempted, by promulgating regulations, to fur-

ther limit the supplies of dangerous stimulants. The first effort re-

sulted in a regulation which established manufacturing production quotas

for amphetamines [16]. In 1970, the industry produced a sufficient

quantity of bulk amphetamines and methamphetamines to manufacture 1.5

billion 10 mg tablets (15,000,000 grams). This was the first year for

the quotas. The 1971 quotas were 5,870 kilograms of amphetamine and 2,782

kilograms of methamphetamines (8,652,000 grams) [17], a sharp reduction

from the 1970 quotas. Aggregate quotas are established for the entire

industry. They are based on the agency's estimate of "legitimate medical

needs."

In response to reports from the National Institute of Mental Health

(NIMH) [13] and lobbying by public pressure groups, the 1972 quotas were

set at 17.7 percent of the 1971 production and were only 8.8 percent of

the manufacturers' 1972 requests [19, 20]. The 1972 quota was 1,564 kilo-

grams of amphetamines and 969 kilograms of methamphetamines (2,533,000

grams) [20]. As the figures above indicate, the quota system alone was

responsible for reducing the availability of legitimately manufactured

amphetamines by over 80 percent.

The second effort to limit the supply of amphetamines was the FDA's

attempt to remove amphetamine-combination products from the market via an

"amphetamine class action" recall based on the DESI review2 recommendation


Drug Efficacy Study Implementation (DESI) review was the process
that the FDA followed to comply with the 1962 Kefauver-Harris amendments
to the FD & C Act. FDA contracted with the National Academy of Sciences/
National Research Council (NAS/NRC) to review for efficacy all drugs
marketed between 1938 and 1962.









That these drugs were "less than effective" for their indicated uses [21].

The FDA moved to remove parenteral amphetamines and amphetamine-combina-

tion products from the market on March 30, 1973 [22] by issuing an imme-

diate ban on their further distribution. Several large manufacturers3

filed suit to stop implementation of the ban. A stay was granted. There

was another "on-again-off-again" battle before FDA finally lost [23, 24].

Nevertheless, Smith, Kline and French (SKF), the largest manufacturer of

these products, eventually removed its Dexamyl and Eskatrolo from the

market because of disproportionate legal costs.4 [25, 26]

The third effort by the FDA was its attempt to remove the weight

reduction indication from product labeling [27, 28]. This indication

accounted for 88 percent of amphetamine usage in 1976 [29]. However,

after more than eleven years of effort, FDA has been able to require

only that the labeling regarding the period of effectiveness for these

drugs' anti-obesity indication be limited to two weeks [30].

A fourth effort, by the DEA and the FDA, to limit the availability

of stimulants, was the scheduling as controlled substances of non-

amphetamine anorectics that are legend drugs. The rationale in this

instance was to limit their potential for use as replacements for

amphetamines [11].


3The manufacturers involved in this law suit were: Smith, Kline and
French (Dexamyl, Eskatrol), Lederle (Bamadex), Obetrol (Obetrol-100
and -20'"), and Delco Chemical (Oelcobese").
4Joseph L. Rutledge, Vice President for Customer Affairs for SKF,
stated in a letter to pharmacists, "it became apparent that lengthy and
costly administrative and judicial proceedings lay ahead, and a great
deal of time and resources would be required to continue the controversy
....the decision was made to terminate the controversy and to discontinue
distribution of this product."









Federal attempts have reduced the annual number of prescriptions

for amphetamines to 25 percent of their annual average in the 1960's

decade [2]. Nevertheless, drug abuse remained a substantial problem

according to the latest reports from FDA [2] and National Institute

of Drug Abuse (NIDA) [31]. Of all categories of prescription drugs,

stimulants represent the therapeutic category most frequently abused

[2]. NIDA states that the non-medical use of stimulants is rapidly in-

creasing in the 18- to 25-year-old group. Amphetamines have rates of

abuse ten times those of other drugs relative to prescription sales [2].

Along with the "clamping down on 'uppers'" there has been a simul-

taneous "tightening up on 'downers'" [32]. The FDA is currently re-

evaluating its position regarding Schedule II sedatives and hypnotics

methaqualonee and certain barbiturates). An FDA-sponsored committee is

studying these drugs and their "use by the elderly, problems of chronic

use, cumulative effects of toxicity, the effects of statutes and federal

regulations on prescribing, and the possibilities of non-pharmacological

treatment of anxiety and insomnia, the two indications for which these

drugs are most often prescribed." [32]


State and Local Control

State officials dissatisfied with the lack of success of federal

efforts to curb amphetamine misuse have enacted legislation aimed at fur-

ther restricting their availability. In late 1977, Wisconsin became the

first state to prohibit the medical use of amphetamine for anorexia [33].

New Jersey [34], South Carolina [35], New York [36], Washington [37] and

Florida [38] have followed Wisconsin's example and have placed

restrictions on amphetamine prescribing for weight reduction.










Two separate and different approaches in limiting amphetamine usage

have been taken by Arkansas and Maryland. Maryland has restricted the

quantity of amphetamine products that may be legally dispensed [39].

In Arkansas, before an amphetamine prescription is considered valid, a

second physician's confirming signature is required [401.

The drug misuse problem has been attacked atthe local level also.

Several local professional associations have attempted to curb amphet-

amine misuse through voluntary means. The first of these efforts, under-

taken in Huntington, New York, in 1971, called for the verification of the

prescription by the pharmacist before dispensing [41]. Other actions

taken include calling for a 48-hour "cooling-off" period before dispens-

ing an amphetamine and restricting dispensing of amphetamines to stock-

size packaging [42, 43]. One such voluntary program is the subject of

this study and is detailed in the next section.


The Duval County Voluntary Program

In 1976, Jacksonville, Florida, had one of the highest per capital

consumption of amphetamines in the country.5 Cy Kothman, then president

of the Duval County Pharmacy Association, presented evidence to the city's

health department, local medical societies, and the local press that six

Jacksonville physicians were responsible for 90 percent of all amphetamine

and methaqualone prescriptions in the area [44, 45].


Although the basis, in fact, for this statement is elusive, it was
an important component of the overall effort by Cy Kothman to elicit the
support of the Duval County Medical Society, County Health Department,
the Ouval County Pharmacy Association and The Jacksonville Journal. Be-
cause all of them believed this to be a fact, it was included here.
This indictment was made in an article appearing in The Jacksonville
Journal on May 12, 1977.










By late 1977, the Duval County Pharmacy Association (DCPA), the

Duval County Medical Society (DCMS) and the Duval County Osteopathic

Society, had announced "plans to voluntarily remove amphetamines and

methaqualones from the shelves of local pharmacies" [46]. The position

of the DCMS, according to its president, Guy Selander, M.D., was that

the physicians wanted to be part of the solution, not part of the problem

by "seeking to reduce the amount of 'legally secured' drugs trafficked in

Jacksonville" [42, 46]. The program began on December 2, 1977 [42, 47]

as a totally voluntary cooperative attempt at self-regulation.

The Duval County program was modeled after a 1976 Kentucky program

in which the northern Kentucky Pharmacists' Association and three county

medical societies joined together to limit amphetamine distribution [48].

The Kentucky plan was divided into four parts. First, all amphetamine

products were removed from pharmacy .inventories. Second, the physicians

would indicate the diagnosis on all prescriptions for amphetamines. Third,

prescriptions would be written only for stock-size packages. And, fourth,

the physician would advise the patient that the pharmacist must order the

medication and there would be a delay before the prescription could be

filled [48].

Differing slightly, the Duval County plan was divided into three

parts. First, there was the removal of methaqualone and amphetamine drugs

from pharmacy inventories. Second, there was to be a 48-hour waiting

period in filling these prescriptions. This was to allow the pharmacist

time to verify the prescription's validity and to order the drug from a

local wholesaler. The delay would discourage forgeries and prescriptions

from "fat clinics" and "prescription-mill" physicians. And, third, the

prescriptions were to be written only for stock-size packages in order









to prevent the retention of partial packages in the pharmacy as a

deterrent to robberies and burglaries [49].

The Duval County program had several important aspects, the most

heartening of which was the pioneering of voluntary drug control by

pharmacists and physicians. This cooperative effort by health care pro-

fessionals to establish a voluntary compliance program would portend well

for the future control of drug abuse, if successful. Also heartening

was the enthusiastic cooperation of the local press in eliciting public

support. Twelve feature articles in The Jacksonville Journal and The

Florida-Times Union supporting the program were written in the six months

prior to the program's inception.

This collaboration of health care professionals to help solve part

of the problem of drug abuse attracted the interest of other Florida

pharmacists, DEA administrators and state legislators. Four other

Florida counties, Broward, Dade, Hillsborough and Orange, subsequently

initiated programs incorporating many of the features of the Duval County

experiment [50].


The Florida Amphetamine Law

Despite the fact that the national press was attributing great ap-

parent success to the Duval County program [1, 45, 51, 52], the Florida

Legislature decided to mandate amphetamine prescription reduction. In

late 1979, the Florida Legislature proposed severely restrictive drug

control legislation with many elements similar in nature to the Duval

County program [53]. A compromise bill which limited practitioners'

prescriptive rights was enacted amending the Medical, Osteopathic and

Dental Practice Acts [54] making it improper medical practice to prescribe,










dispense, sell, administer, or supply amphetamines or any Schedule II

sympathomimetic amines (e.g., phenmetrazine) for weight-control [55].

This law became effective October 1, 1980.

Figure i shows the time-frame relationship of the Duval County pro-

gram and the Florida Amphetamine Law. As can be seen from the figure,

this law superseded the Duval experiment.

The Study

As this review indicates, Florida has already chosen a different

method for restricting amphetamine availability, but national attention

continues to be focused on the problems of drug abuse, especially the use

of stimulant and depressant drugs. With the solutions to a continuing

problem through public policy unclear, there is an even greater need to

look at innovative programs in order to provide information on their im-

plementation, usefulness and effectiveness for consideration in future

policy efforts.


The Significance of This Project

Recently, the Florida Legislature has proposed legislation modeled

after the Duval County plan for methaqualone [56] and for all other non-

emergency Schedule II prescriptions [57]. Before legislation is enacted

which incorporates the salient features of the Duval County program, a

careful assessment should be made to evaluate the effectiveness and the

strengths and weaknesses of the program. The questions needing answers

include:

























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(1) Was the Duval County program successful in decreasing the

number of prescriptions for amphetamines and methaqualones?

(2) If there was a decrease, what was the actual percentage?

(3) What actions did pharmacists and physicians take in initiating

the program?:and'

(4) What are the attitudes of pharmacists and physicians (the

health professionals upon whom the success of such a program

relies) to this and other types of drug abuse control?

These four questions can be focused into two areas of primary con-

cern: first, the evaluation of the voluntary program's outcome and

second, the examination of the participants' attitudes and actions in

implementing the goals of the program. These foci will guide this

evaluation of the Duval County program.


Research Objectives

In seeking answers to the concerns outlined above, the researchable

objectives for the study of the Duval County program, divided by foci,

can be stated as follows:

A. First, evaluation of the program's outcome,

(1) to identify changes in the prescribing and dispensing

behaviors for amphetamines, methaqualone, phenmetrazine,

and methylphenidate in Duval County during the period

beginning one year prior to the program's initiation

and ending two years after its inception; and

(2) to determine the degree of participation by Duval County
pharmacies.









Accomplishment of these objectives will provide documentation on

whether the program succeeded in accomplishing its primary goals. The

dependent variables for the first objective will be amphetamine or metha-

qualone prescriptions as a percentage of all Schedule II prescriptions.

These ratios by pharmacy and county will indicate any decrease in the

level of prescriptions for these two drugs. The dependent variable for

the second objective will be the participatory percentage of pharmacies.

These results will be compared to an expected level of participation for

similar programs, either voluntary or mandatory. This participation

norm will be derived from the literature.

These two objectives are the mainstay of this study. In order to

accomplish an evaluation of the implementation of any voluntary program

it is necessary to evaluate the coverage level (degree of participation)

and the outcomes (successfulness of program in fulfilling its goals)

of the program. These evaluations are necessary, but to achieve a

more comprehensive evaluation of the program, additional foci are

required.

B. Second, examination of the participants' attitudes,

(1) to examine the pharmacists' attitudes toward the Duval

County program; and.

(2) to examine the physicians' attitudes toward the Duval
County program.

Accomplishing these latter objectives will sufficiently aid the

interpretation of the former objectives, to provide a comprehensive

evaluation. The dependent variables for these objectives are Accuracy

Rating (respondents' score on the knowledge questions) and Precision

(respondents' ability to differentiate specifics of the program). These






18



scores will provide a measurement of the participants' knowledge of the

various facets of the program.

The next chapter addresses the policy implementation literature

and its applicability to the Duval County program.














CHAPTER II


POLICY IMPLEMENTATION LITERATURE REVIEW


When the Duval County program was being formulated, the Duval County

Pharmacy Association, the Duval County Medical Society, and the Duval

County Osteopathic Society, by designing a program intended to alleviate

the problem of amphetamine and methaqualone misuse in Jacksonville, were

making policy. The voluntary program which they instituted was the re-

sult of joint policy decisions by members of each association. Implicit

in the adoption of the decision was the anticipation that the program

would achieve its goals. The primary goal of the program was to bring

about a reduction,in the number of legitimately prescribed amphetamine

and methaqualone prescriptions. If this goal could be attained, then a

substantial decrease in the availability of the two drugs "on the street"

might be expected [46]. Two secondary goals of the program were, one,

to effect a decrease in the incidence of forged prescriptions for these

drugs [47] and two, to effect a reduction in the incidence of drug-related

robberies [46].

Local policies, like federal and state policies, are rarely "self-

executing." Congress may legislate drug abuse control measures [9],

regulatory agencies may issue guidelines [58] or the President may order

the rescue of United States hostages held in Iran but in the absence of

effective implementation plans, it is unlikely that decisions of policy-

makers will be carried out with much success [59:xii]. The vast majority of










policy implementations require a combination of positive actions by many

people [60:10].

For the purposes of this study, implementation will have the follow-

ing definition: "fulfilling an obligation; giving effect to; carrying

out" [61:354]. Policy implementation will be considered as the stage be-

tween policy establishment such as the formulation of the Duval County

program and the final outcomes on the people or organizations which it

affects [62:1].

It is necessary that the outcomes of a policy decision be evaluated,

but evaluation alone is not sufficient unless an understanding is reached

as to why a particular outcome was achieved. "Information on implementa-

tion is critical for decision-making regarding future programs." [62:8]

There is a paucity of resource material available in the area of im-

plementation literature [59:xiii]. Therefore, most of the citations are

from one reference, Implementing Public Policy by George Edwards III.

This chapter is divided into four sections, corresponding to the four

critical factors in implementing public policy as detailed by Edwards

[62:10]:

(1) Communication;

(2) Resources;

(3) Attitudes; and

(4) Organizational Structure.

Communication

In order to achieve effective implementation of a policy or program,

the implementing personnel must have accurate knowledge of their expected

activities since the people who make the decisions are usually not the










ones who will implement it [63]. Faulty transmission of information or

inaccurate perception of implementation orders by the implementers are

but two of the obstacles that may hinder proper and effective implemen-

tation [62:17]. These potential obstacles highlight the necessity of

having an awareness of several key points to be considered in the es-

tablishment of an efficient communication system for implementation

activities. The key points are

(1) transmittance of concise, direct orders;

(2) transmittance of clear, but flexible directives; and

(3) consistency of objectives with goals [62:40].

The first key point concerns the transmission of directives. Be-

fore a decision can be implemented, the implementing personnel must have

knowledge both that the decision has been made and that the time is appro-

priate to begin implementation. There are several obstacles to efficient

transmission of information. First and foremost, is the barrier that the

implementers may not agree with their instructions [64]. This may result

in distortion or subversion of the decision and goals or a total blockade

of the implementation [62:18]. Second, the absence of direct, established

channels of communication may also result in the distortion of instruc-

tions [65]. Third, progress toward program fulfillment may be hindered

by the implementers' inability to accept the communications or the im-

plementers' lack of knowledge and understanding of the programs' goals [66].

Therefore, as a first step to ensure proper implementation, decision-makers

must transmit concise orders directly through established channels of com-

munication and be aware of the implemencers' attitudes toward the decision.

The second key point relates to the clarity of the instructions.

Vague orders provide implementers with the latitude to attach meanings to










policies different from those which were intended [62:26]. There are

several factors which may lead to a lack of clarity of directives. Among

these are complexity of the issue [62:26]; potential alienation of interest

groups [67:265]; consensus and priority-setting of competing goals [60:9];

and, accountability avoidance by implementers or decision-makers [68:265].

While it may be desirable to strive for a high degree of clarity in the

directives, overspecificity may reduce the degree of adaptability neces-

sary for tailoring a policy to meet changing situations [62:34]. A "disci-

plined flexibility" is needed to prevent red-tape bog-down and to avoid

rigid commitment to meeting the "letter of the law" rather than the

"spirit of the program." [69:82]

The last key point involves the consistency of the communications.

Contradictory directives are not only inefficient but also provide im-

plementers with opportunities to exercise their own interpretations of

the policy goals. "When implementers receive inconsistent instructions,

they will inevitable be unable to meet all the demands made upon

them." [62:45]

Accurate, concise, clear and consistent directives must be trans-

mitted to the implementers in a direct and timely manner. This can best

be accomplished by eliminating complexity, and by maintaining a small,

cohesive group responsible for implementation [62:43]. Substantial plan-

ning and knowledge of the implementers' attitude is necessary for the es-

tablishment of a communications base. Direct and established communication

links to the implementers are required to make the communication base both

an effective and an efficient channel for beginning the implementation pro-

cess. Inappropriate communications may mean that directives will not be









efficiently executed or that implementers will have the discretion to

execute them in a manner contrary to what was intended [62:43].


Resources

The second step in ensuring proper implementation of a policy is the

provision of resources adequate to perform the required tasks. Adequacy

of resources encompasses not only money, but also sufficient staff with

necessary skills, timely access to pertinent information, authority com-

mensurate with responsibility, and adequate facilities and supplies [59:xii].

Without the wherewithal to execute implementation directives, the process

most likely will be ineffective, even though the orders might have been

transmitted clearly and concisely.

The most fundamental resource is an adequately-sized staff which

possesses the necessary skills. Staff-size inadequacy is the principal

reason for implementation failures [62:54].. This type of personnel shortage

exists in every level of government, therefore, the delegation of imple-

mentation activities to other governmental levels rarely results in an

increase in efficiency [70]. Two consequences of inadequate staffing are;

one, a high degree of ineffectiveness in executing directives, and two,

limitations in regulating or monitoring implementation activities [62:79].

The second fundamental resource is information. Two types of infor-

mation are necessary for efficient implementation [69:114]. The first type

of information provides knowledge of how to execute a policy. The second

type is obtained from data generated from monitoring the compliance of

organizations or individuals affected by the guidelines of the policy.

The latter type of information is often very difficult to procure, usually

due to an insufficient number of staff [62:30].










Another resource that may be essential for implementation is authority

[71:276]. Implementers must be delegated sufficient authority to execute

their directives. It is not always necessary nor always desirable to

exercise such authority to its fullest extent. "One of the motivations

behind such an approach is the obvious one of obtaining the cooperation

of others through the creation of goodwill." [62:81]

The last important resource is physical facilities [62:77]. Facilities

include buildings, supplies and equipment. A deficiency in any of these

may impede efficient implementation [62:77].

Decision-makers must furnish those who will implement their policies

with necessary and sufficient resources. These resources include an ade-

quate staff with proper skills, pertinent and timely information as to

the manner of implementing decisions and monitoring compliance, sufficient

authority to make certain that directives are executed as originally in-

tended, and enough facilities, supplies and equipment to efficiently

implement policies. Inadequacy of resources may mean that directives

from decision-makers will not be properly executed.

Attitudes

The third step in ensuring effective implementation of a policy is

understanding how the attitudes of implementers toward a particular policy

affects their execution of directives concerning that policy [71:270]. A

positive or neutral disposition towards a policy by the implementers

usually poses no barriers to effective implementation. But policies that

conflict with the interests of the implementers or are opposed by them

for other reasons may have many obstacles blocking their effective imple-

mentation. When this occurs, policy-makers can take corrective measures










by manipulating the implementers' attitudes, by bypassing the implementers

or by limiting the implementers' discretion in executing directives.

The first option involves the use of incentives. Since people

usually act in their own best interest, augmenting the benefits to en-

hance the implementers' chances for advancement may influence their actions

[71:324]. The major disadvantage to this approach is the potential for

goal displacement [62:112]. If a standard of accomplishment is developed,

implementers may accentuate the element that is being measured without

any regard to its effect on the advancement of the policy's purpose.

The second option, bypassing the implementer,can be accomplished in

two ways. The first way is to replace the pervicacious personnel with

more responsive ones. Although this tactic may work in the private sector,

it is rarely possible in:the government bureaucracy where practically every

employee is protected under the civil service system [72:345]. One of the

few methods available in the public sector for overcoming such obstacles

is the transfer of the obstructive personnel elsewhere, but this will merely

shift the problem and not solve it. The second way involves the utilization

of different personnel to implement the policies. This method is seldom

viable as it would entail the creation of a new department [73:105].

The third option is to limit the implementers' discretion in execut-

ing directives. The problem is that this option is not always possible or

even desirable. Because decision-makers have little authority over career

bureaucrats in the government, it is not always possible to limit their

discretion [69:186]. Neither is it always desirable [72:345]. The dis-

advantage of too-rigid guidelines is that they often restrict adaptation

to changing environmental circumstances [62:34].










Decision-makers must be aware of the attitudes of the implementers

toward the policy to be executed. "If implementation is to proceed ef-

fectively, not only must implementers know what to do and have the capacity

to do it, but they must also desire to carry out a policy." [62:11]

Failure to consider this critical factor may mean that such obstacles will

effectively restrict efficient implementation, either directly through

implementers' actions in not faithfully executing directives with which

they disagree or indirectly through selective perception of communications.

Organizational Structure

The final step to ensure effective implementation of a policy is to

understand the impact of the organization's structure on the execution of

directives. Two different aspects of structure, operational procedures

and responsibility fragmentation, directly impact on the implementation

process. The first aspect, standard operating procedures (SOPs) assists

organizations in conserving time and resources for routine matters [71:133].

They are usually developed to compensate for a lack of resources. Ideally,

they are used to simplify complex situations and to allow for the inter-

change of personnel. Although SOPs can achieve these positive accomplish-

ments, they also can function as obstacles to the implementation of new

programs because they are designed for routine circumstances and not for

unusual situations [74:129]. SOPs can impede the implementation of new

programs, especially those that require different modi operandi from

established procedures [69:322].

The second aspect of organizational structure that impacts on imple-

mentation is fragmentation of responsibility. This is best exemplified

by the federal bureaucracy [62:134]. Fragmentation persists in the federal

system because three powerful entities, Congress, federal agencies and









special interest groups, advocate and continue to support the present

system. Congressional committees do not want to relinquish control over

their programs; federal agencies, likewise, are possessive about their

programs; and special interest groups do not want to lose control over

agencies they have "captured" or lose their special access to the other

two groups. Responsibilities may be so fragmented that implementation

functions are not executed, or are poorly executed.

Decision-makers must understand the structure of the organization

that is responsible for implementation. SOPs, although valuable tools

for making routine decisions, may be inappropriate for the different cir-

cumstances posed by novel programs. Fragmentation of responsibility may

result in directives from decision-makers falling in between the cracks

of agencies and never being executed. Figure 2 humorously illustrates

how simple tasks can be made complicated [75:18]. Effective implementation

requires an understanding of the organizational structure. Without this

understanding, the implementation responsibility can be lost through

organizational fragmentation or SOPs.

Factor Interaction

Goal setting or decision-making does not cease after the goals have

been set or the decision has been made. The effectiveness of the imple-

mentation process for these policies or goals may determine the final

outcome. After policy formulation, special attention must be paid to

resource availability, organizational structure, and to outside political

interests if effective implementation is to occur. The four critical

factors discussed in this chapter not only directly impact on the imple-

mentation process but they also indirectly impact by interacting with

each other. Figure 3 details this interaction. A decision-maker who


















































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desires to have his policies implemented in the most efficient manner must

understand how these factors affect that process.

To summarize, there are four critical factors which impact on the

implementation process. In order to have the most effective policy im-

plementation, decision-makers must understand the roles which communica-

tions, implementer attitudes, resource scarcity, and organizational

structure play and how to use this information to their advantage. These

factors were examined in depth to provide the necessary background for

understanding the impact of the implementation process on the final

outcomes of a policy.

Future chapters detail the data collection methodology, the results

obtained from the various data collection instruments, and the conclusions.

The final chapter discusses the implementation process of the Duval County

program and how it impacted on the final outcome of the voluntary program.

The next chapter addresses the methodology utilized for data collection

in this study of the implementation of the Duval County program.













CHAPTER III


SURVEY, SAMPLING METHODS AND QUESTIONNAIRE DESIGN


This evaluation of the Duval County program was divided into four

parts:

(1) a telephone interview with a pharmacist in every Duval County

community pharmacy in order to determine the degree of parti-

cipation in the voluntary program;

(2) a review of prescription records from a random sample of com-

munity pharmacies in the experimental (Duval) and control

(Alachua) counties in order to identify changes in prescribing

and dispensing behaviors for amphetamine, methaqualone,

phenmetrazine, and methylphenidate;

(3) a questionnaire completed by pharmacists in the sampled

pharmacies in order to examine their attitudes toward the

Duval County program; and

(4) a questionnaire mailed to those practitioners in the study

area categorized as potential amphetamine or methaqualone

prescribers in order to examine their attitudes toward the

Duval County program.

This chapter describes the procedures used in developing the data

collection instruments and the procedures used in the selection of

pharmacies, pharmacists and physicians. Also, sampling methods for the

experimental and control groups are explained.









Study Development

All of the data collection instruments used in this study were de-

veloped and pretested during the initial phase of this study. Both the

pharmacists' and physicians' questionnaires were pretested on a portion

of the population of Duval County pharmacists and physicians. The tele-

phone interviews were begun in November 1980 and were concluded in Janu-

ary 1981. The pharmacy data collection pretest was started in January

1981 and was concluded in February 1981. The pharmacy data collection

phase started in March 1981 and was completed in both the study and con-

trol counties by the middle of January 1982. The physician mail-question-

naire pretest began in August 1981 and finished in September 1981. The

physician mail-questionnaire data collection phase began in September

1981 and was concluded in November 1981.

Figure 4 shows the time-frame relationship of the Duval County pro-

gram, the Florida amphetamine law, the study period and the data collec-

tion period. As can be seen, the prescription review data is retrospec-

tive, therefore, these data were not influenced by the passage of the

Florida amphetamine law. However, the pharmacists' and physicians'

questionnaires were administered after the passage of the law, and there-

fore, may have been influenced by commentary about this and other laws

which appeared in the media.

Development and Pretest of
Data Collection Instruments

Implementation of the study began with the design and development

of questionnaires and prescription review techniques. The instruments

were tested and evaluated with regard to the time required for completion,

possible bias introduced by specific wording, and clarity of the meaning



























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of the questions. Only minor changes in wording in the instruments were

necessary after the pretest results were reviewed.


The Telephone Interview

The telephone interview was designed to accomplish two objectives:

(1) collection of descriptive information concerning the partici-

patory status of every Duval County community pharmacy; and

(2) acquisition of information detailing issues and response

categories for the development of both questionnaires.

In this manner the telephone interviews served a dual purpose. First,

that of a preliminary case study to enable the researcher to develop the

best possible instrument in the shortest amount of time. And second, the

interview achieved one of the study objectives, that of determining the

degree of pharmacists' participation in the voluntary program.

The interviewer telephoned every licensed non-hospital community

pharmacy in Duval County in 1979, asked for the pharmacist on duty,

identified himself and his purpose, and asked the following sequence of

questions:

(1) Are you familiar with the Duval County project regarding the

dispensing of amphetamines and methaqualone?

(2) Does your pharmacy participate in this voluntary program?

(3) What are your feelings or comments regarding this program?

The interviews were designed to be approximately five minutes in

length. However, because the discussion format gave the pharmacists an

opportunity to verbalize their opinions to someone interested and in

perceived authority, they lasted an average of twenty-five minutes. The

calls were made at random times throughout the day and week in order to









minimize any time-of-week or time-of-day bias in the data. As with all

other aspects of the study, the anonymity of the respondents was assured.


Questionnaire Design

One of the objectives of the interviews was to acquire information

for the development of the questionnaires. Several of the comments made

by the pharmacists indicated their reasons for choosing to participate

in the program. One pharmacist, who was vehemently against the program,

said he was "hassled to participate." Others hailed the program as "an

effective means to decrease the inventory of violence," a "way to decrease

robberies," and as "a tremendous success in eliminating forgeries." These

opinions were used to develop a Likert-scale instrument examining practi-

tioner attitudes as to the reasons pharmacists chose to participate in

the program and on the effectiveness of the program in decreasing amphet-

amine and methaqualone usage.

The telephone interview was useful in gathering initial information

about the pharmacists' opinions and perceptions of the Duval County pro-

gram. This information was important in the development of pharmacists'

and physicians' questionnaires. It also yielded an indication of the de-

gree of cooperation which could be expected from pharmacists in the sub-

sequent stages of this study. A compilation of the pharmacists' comments

appears in Appendix I.


The Pharmacists' Questionnaire

The pharmacists' questionnaire was designed to elicit information in

order to accomplish the following objectives:









(1) to determine the extent of knowledge, as measured by accuracy

and degree of precision, possessed by pharmacists regarding

the Duval County program;

(2) to identify factors which influenced the participatory status

of the pharmacies;

(3) to examine pharmacists' attitudes toward the Duval County pro-

gram and their perceptions regarding its success or failure;

and

(4) to determine the extent of knowledge, as measured by accuracy

and degree of precision, possessed by pharmacists regarding

Florida's amphetamine law.

The pharmacists' questionnaire included additional questions regard-

ing their perceptions as to why other pharmacists participated in the Duval

County program, physician responses to the program, expansion of the pro-

gram, and general drug abuse prevention measures. In addition, there

were several questions which classified pharmacists as to their number

of years in practice, association memberships, and pharmacy ownership.

A space for comments was provided.

Rough drafts of the questionnaire were pretested with Gainesville

pharmacists as respondents. The final draft was tested on nine pharma-

cists in a graduate seminar at the University of Florida College of

Pharmacy, where each person was asked to evaluate the draft for meaning

and clarity of the questions. The final questionnaire, which was ad-

ministered to the pharmacists, appears in Appendix II. The pretest

results were not included in the final data set.









The Physicians' Questionnaire

The physicians' questionnaire was designed to elicit information in

order to accomplish the following objectives:

(1) to determine the extent of knowledge, as measured by accuracy

and degree of precision, possessed by physicians regarding the

Duval County program;

(2) to identify the physicians' attitudes toward the Duval County

program;

(3) to determine the physicians' attitudes toward amphetamine

usage; and

(4) to determine the extent of knowledge, as measured by accuracy

and degree of precision, possessed by physicians regarding

Florida's amphetamine law.

The physicians' questionnaire contained inquiries about their drugs

of choice for five conditions for which amphetamines could be prescribed

during the following time periods; pre-Duval County program (1977), post-

Duval County program (1979) and after Florida's new amphetamine law be-

came effective (1981). The questionnaire also sought to identify

physicians' knowledge and understanding of the specifics of the Duval

County program.

Additionally, the survey included attitudinal questions regarding

the degree of success of the program, expansion of the program and gen-

eral drug abuse prevention measures. Many of the questions in the

physicians' survey were identical to those contained in the pharmacists'

survey, so that attitudes of these two groups of practitioners could be

compared. Also, several questions were included so that physicians could









be categorized as to age, degree designation (M.D. or D.O.), speciality

and gender. A space for comments was provided.

The questionnaire was mailed to fifty randomly selected Jacksonville

physicians as a pretest. Stamped return envelopes were included to in-

crease the response rate. Forty-two percent of the questionnaires were

returned, providing an estimate of the response rate which could be ex-

pected for the final survey. The two questions which the pretest showed

to be ambiguous or unclear, were modified. Only a few minor changes in

wording were necessary. The pretest results were included in the final

data set. The questionnaire in its final form is provided in Appendix IV.

A cover letter which accompanied the questionnaire explained its

purpose and importance and assured the anonymity of the respondents. The

cover letter is found in Appendix III.

A roster of licensed physicians in Duval County was obtained from

the Department of Professional Regulation for the years 1977 and 1979.

The final survey instrument was mailed to every osteopathic and allo-

pathic physician who had been identified as potential amphetamine or

methaqualone prescribers during the entire time period covered by the

study and who were not included in the pretest. Potential prescribers

included general practitioners and most physician specialists. However,

urologists, radiologists, anesthesiologists, opthalmologists, orthopedic

surgeons, dermatologists and plastic surgeons were excluded from the

study on the basis that they would seldom, if ever, need to prescribe

the drugs in question. Because the issues involved were most likely not

relevant to the practice of these physicians, they were excluded from

the study population. The potential prescriber group totaled 346

additional physicians.










The Prescription Review

The prescription review of Duval and Alachua County community pharma-

cies was designed to collect data necessary to accomplish the following

objectives:


(1) to describe and to compare dispensing behaviors for amphetamines,

phenmetrazine, methylphenidate, and methaqualone in Duval

County prior to and during the Duval County program; and

(2) to describe and to compare dispensing behaviors for the same

four drugs during the same time period in a control county.

An audit form was designed to collect the following information

pertaining to the prescription:

(1) the month the prescription was filled;

(2) the year the prescription was filled;

(3) the identity of the drug product prescribed (use of a two-

digit code);

(4) the quantity of the drug product prescribed;

(5) the selling price of the drug product prescribed; and.

(6) the verification of the prescription's validity (if present).

The identity of the drug product prescribed was recorded through the

use of a two-digit coding system developed by the researcher (see Figure

5). The complete list of codes for all pertinent drug products appears

in Appendix V. The drug product coding system provided a means for quickly

categorizing the products dispensed. Each different class of drug was

assigned a chemical category code (e.g., dextroamphetamine = 7, amphet-

amine-combination products = 5). Specific product codes were included

within each chemical category for identification of each of the different

products. For example, 3 was the chemical category code for



























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methaqualone and within this class were the following specific products;

32-Quaalude 300 mg, 34=Sopor 300 mg, 36=Parest 400 mg.

An easily read form for keypunching was developed as the most ef-

ficient means for expediting the data processing. A copy of this form

appears in Appendix VI.


Auditor Qualifications for Data Collection

The data was collected by two graduate students who were registered

pharmacists, each with at least six years of practical pharmacy experience.

Each had skills in evaluative research methodology. These qualifications

were deemed necessary for the accurate and reliable collection of the

technical information required for this project.

Both auditors had previously completed an auditors' training program

for a related project and had many hours of data collection experience.

To assist the auditors and to assure complete data collection, a procedural

guide for data collection was developed.

The review method employed had been used by both auditors in previous

audits. They also had prior experience in auditing pharmacies of varying

ownership categories in Jacksonville. These included independents (one-

store pharmacies), small chains (two to ten pharmacies) and large chains

(ten or more pharmacies).

In order to minimize inaccuracies due to auditor fatigue, not more

than two pharmacies were audited in any one day. In addition to gathering

data from prescription files, the auditor was also responsible for making

sure that the pharmacist on duty completed the questionnaire. The audits

were performed at random times throughout the day and week in order to

minimize any time-of-day or time-of-week bias in the data.









The audit process was fully explained to all pharmacists when the

initial telephone contact was made. They were assured that the identity

of the participating pharmacies, as well as the information collected

from the patient records, would remain anonymous.

Sampling Methods

An evaluation of the experience under the Duval County program first

required that the pertinent prescriptions and Schedule II prescriptions

be sampled in order to extrapolate the analysis to a county-wide finding.

Since the total number of amphetamine, methylphenidate, phenmetrazine,

and methaqualone prescriptions dispensed in Duval County and their distri-

bution among pharmacies was not known, the sampling unit became the indi-

vidual pharmacy. Because only licensed community pharmacies are authorized

to dispense prescriptions to out-patients, only non-hospital community

pharmacies were included in the sample. Hospital pharmacies that had a

combination Institutional Class II/Community Pharmacy permit were deleted

from the sampling list because the program was not designed for their

category and because they traditionally dispense an insignificant number

of prescriptions for the drugs included in the study.

A list of community pharmacies was obtained from the Department of

Professional Regulation. There were 104 licensed community pharmacies in

Duval County in 1979 (Duval County and its neighboring counties are shown

on a map in Figure 6). Ownership of these pharmacies was classified

according to the following guidelines: (1) independent when only one

pharmacy was owned, (2) small chain when two to ten pharmacies have a

common ownership, and (3) large chain when more than ten pharmacies have

a common ownership. Participatory status of each of the 104 pharmacies

was determined from the telephone interviews and was classified as follows:



















DUVAL


Baker


Clay


Alachua


Figure 6. Duval and Neighboring Counties -A Geographical Key










(1) participating pharmacist stated that the pharmacy participated in

the Duval County program, (2) non-participating pharmacist stated that

the pharmacy had not participated in the Duval County program, and (3)

partially participating pharmacist stated that the pharmacy only

participated for its non-regular customers.

These ownership and participatory parameters were established to

control for these potentially important factors and are not sampling

strata. It might be that the levels of these factors would impact on the

evaluated success of the Duval County program. They are characteristics

of respondents independent non-varying factors.

In this study, we are examining an overall effect, not the differences

among the groups defined by ownership or participation. But to guarantee

that the county-wide effect was examined, it is important that all clas-

sifications are represented. The differences between the policies of

large corporations and single entrepreneurs could be reflected by differ-

ent levels of prescription reduction, as could the participatory status

of the individual pharmacies.

Pharmacies selected for the sample had to meet the following inclusion

criteria:

(1) the pharmacy must have been in operation from December 1, 1976

to December 31, 1979; and

(2) the auditor had to have access to the original Schedule II

prescription records for that period of time.


Randomization Process

A simple random sample of thirty pharmacies was chosen. All Duval

County pharmacies were sequentially numbered and a random number table









was used to select the sample pharmacies. A pretest of five of the ran-

domly selected pharmacies was performed in order to test the audit pro-

cedure and to gather preliminary data for use in the sample size determina-

tion. These results are included in the final results. The sample size

was based solely on calculations using finite population correction factors

and pretest statistics of variance and mean. The decrease in the number

of amphetamine prescriptions as a percentage of Schedule II prescriptions

from 1977 to 1978 was 67.8 percent with a variance (S2) of 368.91 and a

standard deviation (a) of 19.2. The goal was to be able to calculate the

actual percentage of decrease to within five percent. Therefore, the

range of meaningful difference (8) to be detected was seven percent.

According to The Basics of Biomedical Research Methodology by Marks [76:221]

the calculations for sample size determination required the following

calculation:

Delta .36458 where: B = meaningful difference
a
a = standard deviation

Using this value of Delta, the sample size required to estimate the

mean percentage decrease in amphetamine prescriptions with a confidence

coefficient of 0.95 was determined from Table 9.3 in Marks' text [76:350].

The desired sample size calculated was twenty-eight, two additional

pharmacies were sampled to ensure against the pretest pharmacies being

non-representative of the population. Therefore, the universe is all

non-hospital community pharmacies in Duval County (N = 104].


Samoi Attrition

All thirty pharmacies were initially contacted by means of telephone

solicitation. The large chains often required a telephone consultation









with their District Supervisors and, where requested, an explanatory letter.

Follow-up telephone calls were used to establish audit appointments. Only

one of the thirty pharmacies did not meet established criteria. Of the

remaining twenty-nine pharmacies, only one declined to participate. Two

replacement pharmacies were chosen at random to return the total to thirty

pharmacies.

Table 1 shows the cooperation rate of sampled pharmacies as categor-

ized by ownership and participatory status. Of the thirty-one eligible

pharmacies, thirty (97 percent) agreed to be audited. Because of the

very high response rates in all six categories, bias due to non-response

can be considered negligible.


Sample Representativeness

Table 2 presents the universe (Duval County pharmacies) and study

sample by ownership category and participatory status. The percentage

for both the study sample and the universe are very close. Table 3 de-

tails the participatory status of the universe and the study sample by

ownership category. Both tables indicate the similarity between the two

groups when comparing these characteristics. Thus, all cells in Table 3

for the universe are adequately represented in the sample. This indication

of the representativeness of the sample to the population allows us to

extrapolate the results of this study to the entire county.

Study Period

For every pharmacy audited, all Schedule II prescription records were

reviewed within the defined study period. The study period was defined

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(1) December 1, 1976 to November 30, 1977; and

(2) January 1, 1978 to December 31, 1979.

Detailed data were collected from this sample of prescriptions.

December 1, 1976 to November 30, 1977 was the year prior to the initia-

tion of the program. The study period included the first two years after

the program's beginning in order to measure any changes in the practi-

tioner's responsiveness over time. December 1, 1977 to December 31, 1977

was specifically excluded because it was the month in which the Duval

County program was initiated and because compliance was deemed to be

minimal during the phase-in period.

The total number of Schedule II prescriptions dispensed within this

period of time was tallied.6 The legal requirement calling for the

separate filling of Schedule II prescriptions made the task of counting

them quicker and more accurate.


Response Variable

The response variable for this study is number of prescriptions (for

amphetamines, methaqualone, phenmetrazine and methylphenidate) as a per-

centage of Schedule II prescriptions. This value was chosen instead of

a comparison of the total numbers of prescriptions for these drugs for

the three survey years, because this ratio adjusts the data by volume,

thereby preventing any exaggerated weighting by high volume pharmacies.


In some instances, there was a misfiling of non-Schedule II pre-
scriptions with the Schedule II prescriptions. These were not counted
in the total. For those cases where Schedule II prescriptions might be
misfiled in the regular files, it was deemed to be an unimportant and
negligible event because if a legal authority (DEA or Board of Pharmacy)
were to audit the same pharmacy, these misfiled prescriptions would be
considered as missing inventory.









Control Samole

Because of the large decreases in amphetamine prescription volume

demonstrated by the pretest, it was decided to include a control county

in the sample. This was necessary to control for any historical effects,

other than the Duval County program, which might have impacted on the de-

crease found in the number of prescriptions. A non-contiguous county,

Alachua County, was selected because of similar demographics, profes-

sionally active pharmacists, similar urban-rural blend, and large medical

community. Economy of collection costs was also a consideration. There

are twenty-eight community pharmacies licensed in Alachua County. Of

these, twenty-two met the criteria established for Duval County pharmacies.

A simple random sample of ten pharmacies was chosen because of time and

resource constraints. All Alachua County pharmacies were sequentially

numbered and a random number table was used to select the sample

pharmacies.

For every control pharmacy audited, all Schedule II prescription

records were sampled within the defined study period. Detailed data

were collected from the control sample. For each prescription included

in the control sample, information was obtained regarding the specific

drug prescribed (strength, quantity, notations indicating verification).

The total number of Schedule II prescriptions dispensed within the study

period was tallied for each pharmacy.

For both the control sample and the Duval County sample, the total

number of new prescriptions in each pharmacy for each of the three years

of the study was documented.









Summary of Data Collection Methodology

To summarize, thirty randomly selected community pharmacies (29 per-

cent) in Duval County were sampled along with ten randomly selected con-

trol community pharmacies (45 percent) in Alachua County. All Schedule

II prescriptions were reviewed and all amphetamine, methylphenidate,

phenmetrazine, and methaqualone prescriptions for the three year period

were noted. Finally, questionnaires were distributed to thirty Jackson-

ville pharmacists and 396 Jacksonville physicians.

Data Analysis Methodology

In order to fulfill the stated objectives of this study, data and

descriptive information were collected through the use of the following

instruments:

(1) telephone interviews;

(2) practitioner questionnaires; and

(3) a prescription review.

These results were sorted and categorized into variables in order

to analyze and to compare them in accordance with the data analysis

plan. A brief synopsis of this two-part plan follows:

(1) Evaluation of the program's outcome. This was accomplished

through the utilization of the results from the prescription

review. The primary variables studied in this section are

the number of pertinent drug prescriptions as a percentage

of Schedule II prescriptions and the annual average of

pertinent drug prescriptions per pharmacy; and

(2) Examination of the participants' attitudes. This was accom-

plished through the utilization of the results from the










practitioner questionnaires and the telephone interview.

The primary variables studied in this section are accuracy

ratings for each practitioner and attitudinal ratings derived

from the Likert-type questions.

The next chapter addresses in detail part one of this plan, the

evaluation of the program's outcome, and discusses the results obtained

from the prescription review. Part two, the examination of the partici-

pants' attitudes and actions in implementing the goals of the program,

is discussed in detail in Chapter V.













CHAPTER IV


OUTCOMES OF THE DUVAL COUNTY PROGRAM


As noted in Chapter II, the first step in an implementation study

is an evaluation of the program's outcome. Accordingly, prescription

records were audited in the sample pharmacies in Alachua and Duval counties

for a three-year period which began one year before the program went into

effect. This chapter discusses the results obtained from the review and

summarizes the outcomes of the Duval County program.

One objective of the prescription review was to retrieve information

so that the dispensing patterns for amphetamines, methaqualone, phenmetra-

zine, and methylphenidate during the study period in both the experimental

and control counties could be described and compared. Other objectives in-

cluded the examination of pharmacist-initiated verification activities and

the voluntary program's coverage level (participation percentage).

The sample of pharmacies from both counties is a random one. Table 4

describes the sample by location, practice setting, ownership category and

pharmacists' gender. Table 5 presents volume characteristics for new pre-

scription and Table 6 presents the Schedule II prescription volume as a

percentage of new prescription volume for the sampled pharmacies.

The results of the prescription review are presented in the following

four sections:

(1) Prescription Trends;

(2) Prescribing Behaviors;
















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(3) Verification Activities; and

(4) Participation Level.


Prescription Trends

The first part of the Duval County program's outcome evaluation en-

compasses an examination of the trends in prescription dispensing which

occurred during the study period. The two drugs which were included

within the scope of the Duval County program, amphetamine and methaqualone,

are the major focus of the outcome evaluation. Methylphenidate was not

included in the program, but because it is a Schedule II sympathomimetic

agent and legally is considered to have an abuse potential similar to

that of the amphetamines [77] it was included in the study so that its

dispensing patterns could be examined and compared with those of the

other two drugs.

Figure 7 shows the raw data tabulations for the experimental county.

These figures provide the basis for all further analysis and discussion.

The first set of variables that was used to document the program's

outcome is amphetamine or methaqualone prescriptions as a percentage

of Schedule II prescriptions. Figure 8 provides a graphic representa-

tion of amphetamine prescriptions as a percentage of Schedule II pre-

scriptions. In 1978 amphetamines accounted for only 3.5 percent of the

Schedule II prescriptions, which represents a decrease of 73.3 percent

from the year prior to the initiation of the Duval County program, (1977).

The decrease for the control county over the same period of time was

27.3 percent, which indicates that the voluntary program alone could have

been responsible for a decrease of up to 46.0 percent in legitimate

amphetamine prescriptions in the experimental county after its initiation.











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The dramatic decrease in amphetamine prescriptions exhibited in Duval

County when compared to the decrease in Alachua County, indicates that

the program was successful in reducing the number of prescriptions for

amphetamines. The figures for 1979 were lower than those for 1978 in

both counties. These figures indicate that the program's effect was not

temporary, but rather that it had a lasting behavioral modification effect

on both pharmacists and physicians in regard to the dispensing and

prescribing of amphetamine and methaqualone drug products.

The variable, methaqualone prescriptions as a percentage of Schedule

II prescriptions, is presented in Figure 9. For Duval County, the 1978

results showed a 67.2 percent decrease from the 1977 results, while in

Alachua County, the decrease was only 36.7 percent. Again, as with the

amphetamine variable, the 1979 results in both samples were below those

for 1978.

The variable, methylphenidate prescriptions as a percentage of

Schedule II prescriptions, is compared with the first two variables,

amphetamine and methaqualone prescriptions, inasmuch as iethylcnenidate

was subject to the same federal and state controls as the other two drugs,

but it was not included in the Duval County program. Figure i0 details

the results for methylphenidate. There was no significant difference7

between the results for any two years of the study period, however, the

slight increase in the percentage of methylphenidate prescric:' 3s can be

attributed to a concomitant decrease in the total number -: Sc-ecule II

prescriptions. These results help confirm the findings :.a3 -.:= jval


Unless otherwise noted, all references to findinG :- -s _-iical
significance in this chapter are based on the Z-test.
















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County program was the Aalcon. d;tAte behind the decrease in the number

of methaqualone and amphetamine prescriptions.

The second set of variables that was used to document the success of

the program was the average annual prescription volume for amphetamines

and methaqualone per pharmacy. Figure 11 presents the average annual

amphetamine prescription volume per pharmacy for Duval and Alachua

Counties. There was a 76.8 percent decrease for amphetamines between

1977 and 1978 in Duval County, as opposed to a 32.5 percent decrease in

the control county. There was a further, but slight, decrease in 1979

which again indicates that the Duval County program had a lasting effect

on physicians and pharmacists.

The annual methaqualone prescription volume per pharmacy appears in

Figure 12. The results were identical to those presented by the first

variable for methaqualone and show a decrease between 1977 and 1978 both

in Duval County (67.2 percent) and in Alachua County (36.7 percent). The

results obtained for 1979 demonstrated a continuing decrease from the

1977 figures.

For the second set of variables, methylphenidate again was used as a

control, since it was not included in the voluntary program. Figure 13

presents the average annual methylphenidate prescription volume per

pharmacy. There was very little change from year to year for either

county. Methylphenidate prescription volume has remained constant during

the study period.

To summarize, there was a significant decrease in the number and
0 9
volume of both amphetamine' and methaqualone prescriptions, as measured


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by the average volume per pharmacy and as a percentage of Schedule II

prescriptions, after the initiation of the voluntary program. The de-

crease for amphetamine products was 76.8 percent and for methaqualone,

67.2 percent. The volume decreases in Duval County were significantly

different from those in the control county, which were 32.5 percent and

36.7 percent,10 respectively. The decrease in volume, which came about

during 1978, continued throughout 1979.

The control drug, methylphenidate, was also monitored during the

study period. Methylphenidate was subject to the same federal and state

controls as amphetamine and methaqualone, but was not included in the

Duval County program. The number of prescriptions for methylphenidate

varied very little in either county during the study period. The reduc-

tion in the number of amphetamine and methaqualone prescriptions observed

in the experimental county was much greater than that observed in the con-

trol county. The reduction in the volume of amphetamine and methaqualone

prescriptions when compared with the static prescription volume for the

control drug, methylphenidate, leads to the following conclusion:

The Duval County program was successful in decreasing
the availability of legally procured amphetamine and
methaqualone prescriptions.

Prescribing Behaviors

The second part of the program's evaluation entails an examination

of physicians' prescribing behaviors during the study period. Phenmetra-

zine is the fourth drug which was included in the prescription review.

It is included in this section because of the interesting results that

were observed. Phenmetrazine, like amphetamine and methylphenidate, is


p < .0001 and p < .001, respectively.









a Schedule II sympathomimetic agent and is subject to the same federal

and state controls and, like methylphenidate, was not included in the

Duval County program. Nevertheless, as Figures 14 and 15 demonstrate,

there was a large reduction in the number of phenmetrazine prescriptions

dispensed in the experimental county after the program's initiation

and an unexpected increase in phenmetrazine prescriptions in the control

county. The results for 1979 showed a continuation of this unexpected

trend for Duval County.

One explanation for this phenomenon is found in the results obtain-

ed from the pharmacists' and physicians' questionnaires: thirty-nine

(32.3 percent) of the physicians and twenty-one (72.4 percent) of the

pharmacists in Duval County believed that phenmetrazine was included as

part of the voluntary program. The results of the questionnaires are

discussed in detail in Chapter V.

Table 7 shows the annual rankings for the drug products being

evaluated. Major changes in rank position are exhibited by amphetamine

products: there were five products listed in 1977 and only two products

each in 1978 and 1979. Methylphenidate (Ritalin ) products, moved up

in rank between 1977 and 1978. These positional changes do not reflect

an increase in the number of methylphenidate prescriptions, but rather,

they reflect a substantial decrease in the number of prescriptions for

amphetamine and methaqualone products. The 1979 rankings exhibited no

major changes from those of 1978. Therefore, the findings that the pro-

gram had brought about lasting behavioral modifications for both physi-

cians and pharmacists regarding amphetamine, methaqualone and phen-

metrazine drug products was reinforced.


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Under the guidelines of the Duval County program, physicians were

requested to prescribe amphetamines and methaqualone in stock-size pack-

aging in order to minimize the retention by pharmacies of partially

filled containers. Table 8 presents stock-size package prescribing

activities for Duval County during the study period. Although there was

a decrease in the total number of prescriptions for stock-size packages

between 1977 and 1978, there was a significant increase in the percentage

of prescriptions for stock-size packages of amphetamines2 and methaqua-

lone.13 There was a 62.0 percent increase in stock-size package pre-

scribing activities in 1978 and this trend continued for both drugs

during 1979. The program participants should have been aware of the

status of each drug as a list of the products included in the program

and information regarding stock-size packaging was available and could

be attained by all pharmacists and physicians from their respective

professional associations.

In summary, it was found that the prescribing behaviors of physicians

were altered after the initiation of the Duval County program. First,

there was a substantial change in the prescribing of phenmetrazine in

Duval County that parallelled the results obtained for amphetamine and

methaqualone. These results can be attributed to the belief held by a

substantial number of pharmacists and physicians (including the President

of the Duval County Medical Society) that phenmetrazine was included

within the program's scope. The Duval County decrease contrasted sharply

with the increase in phenmetrazine prescriptions in the control county


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during the study period. Second, there was a dramatic rearrangement of

the rankings of the most frequently prescribed drugs in the experimental

county, with amphetamine and methaqualone drug products dropping from the

top three positions as a result of the large decrease in the number of

prescriptions for such drugs after the program began. And third, there

was a significant increase in the prescribing of stock-sized packaging

for amphetamine and methaqualone in Duval County during the program.

These results lead to the following conclusion:

The Duval County program successfully altered the
prescribing behaviors of physicians. This be-
havioral modification continued after the first
year of the program.

Verification Activities

In addition to the other restrictive measures, the forty-eight hour

waiting period in the dispensing of amphetamine and methaqualone prescrip-

tions also was of major importance in the Duval County program. One rea-

son for providing a "cooling off" period was to afford the pharmacist

an opportunity to confirm the prescription's validity. One of the pieces

of information retrieved during the prescription review was whether a

notation of the pharmacists' verification activities was present. For

the purpose of this study, a verification activity is defined as:follows:
A pharmacist-initiated activity which verifies or
substantiates the validity of a prescription with
the prescriber.

It should be noted, however, that under the guidelines of the voluntary

program, pharmacists were not required to make any notation when a

verification activity was performed.









Table 9 presents the tabulation of verification activities by year

for both Duval County and Alachua County. Only 335 prescriptions of a

total sample of 14,730 prescriptions (2.3 percent) for the three-year

period bore notations of verification by a pharmacist. However, there

was a significant increase14 in such activities in Duval County after the

initiation of the program, while in the control county, a decrease was

observed.

In the experimental county, 270 (90 percent) of the verifications

pertained to amphetamine and methaqualone prescriptions, as compared to

only sixteen (46 percent) in the control county. These activities re-

mained relatively constant for 1978 and 1979 in Duval County. The fig-

ures indicate that the Duval County program had a significant impact on

the pharmacists' verification activities.

To summarize, one of the purposes of the Duval County program was to

decrease the potential for the forgery of prescriptions for amphetamines

and mrethaqualone. In order to accomplish this purpose, a forty-eight

hour moratorium was established to encourage the pharmacists to corro-

borate the validity of the prescriptions with the prescriber. In the

experimental county, there was a significant increase in such activity,

while in the control county, there was a decrease. Duval County showed

an increase in verification activities of 93.6 percent after the program's

inception, while Alachua County showed a 36.8 percent decrease.

The large increase in the verification activities in Duval County

after the program began, when taken in conjunction with the decrease

observed in the control county, leads to the following conclusion:


14 001
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The Duval County program was successful in
heightening the pharmacists' awareness of the
potential for prescription forgeries and sub-
sequently, in increasing his verification
activities.

Participation Level

The last part of the evaluation of the program's outcome is an ex-

amination of the program's level of coverage (i.e., the number of pharma-

cists and physicians who participated). The number was obtained by asking

the respondents, via interviews and questionnaires, if they participated

in the Duval County program. Table 10 presents the participation status

and dates for the sampled pharmacies. Twenty-two (73.3 percent) of the

pharmacies in the sample participated in the Duval County program. This

compares very favorably with the results obtained for the population

during the telephone interviews, where 73.1 percent of the pharmacies

indicated that they had participated in the program to some degree

(see Table 3).

The prescription audits indicated no significant differences be-

tween the pharmacies which had participated in the voluntary program and

those which had not. Both groups showed a substantial decline in the

number of prescriptions for amphetamines and methaqualone.

The physicians' participation level will be discussed in the next

chapter under Physicians' Responses section.

In summary, the participation level for pharmacies was seventy-three

percent. However, there was no significant difference in the percentages

of decreases in prescription levels for amphetamines and methaqualone

between pharmacies of different participatory status. These decreases

indicate that there was a sufficient number of physicians and pharmacists







79













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participating in the Duval County program to bring about the successful

outcome that has been demonstrated by these results.


Summary of the Prescription Review Results

The Duval County program had several goals, the most important of

which was to impede accessibility of amphetamine and methaqualone drug

products in legitimate channels. Two secondary goals which have been

identified for the program are: (1) to effect a decrease in the incidence

of forged prescriptions for the drugs, and (2) to effect a decrease in the

incidence of drug-related robberies. A prescription review was employed,

which examined the two drugs, amphetamine and methaqualone, over a three-

year period of time beginning one year prior to the program's initiation.

Also included within the prescription review were two amphetamine-like

drug products, phenmetrazine and methylphenidate, which were subject to

similar federal and state controls but were not included within the scope

of the Duval County program. Additionally, data for the four drugs were

contemporaneously gathered in the control county in order to control for

other historical occurrences (with the exception of the Duval County pro-

gram). The prescription review was designed to gather other data regard-

ing quantities prescribed and the incidence of verification activities.

The data obtained from the prescription review provided a basis for

examining the outcomes of the Duval County program as measured by the

degree of successfulness of the program in fulfilling its goals.

Attainment of the primary goal was measured directly through the use

of the operational variables, Amphetamine, Methaqualone, Methylphenidate

and Phenmetrazine Prescriptions each as a Percent of Schedule II pre-

scriptions and their annual per pharmacy mean volume. The results were









in accord. The Duval County program was successful in decreasing the

availability of amphetamines and methaqualone.

Attainment of the secondary goals was measured by using different

operational variables. The first goal, to effect a decrease in the in-

cidence of forged prescriptions, required the use of verification activi-

ty as a measure of its attainment. It was assumed that without a

validity check by the pharmacist with the prescriber, forgery detection

*would be difficult and presumptuous. A significant increase in such

activity was noted after the Duval County program began. This highly

publicized activity could be expected to discourage the presentation of

forged prescriptions. The next chapter details the physicians' per-

spectives regarding forged prescriptions.

The second goal, to effect a decrease in the incidence of drug-re-

lated burglaries and robberies, was more difficult to document. Physicians

were requested to prescribe amphetamines and methaqualone in stock-size

packages in order to reduce the inventory of these items and thereby

lessen the incentives for theft. The stock-size package prescribing

activity showed a dramatic increase after the program began. The final

chapter details the pharmacists' perceptions regarding the incidence of

robberies.

All of the positive actions described in this study exhibit the high

degree of success which the Duval County program had attained in fulfilling

its mission. The outcomes for 1979 remained consistent with those for

1978. The sustained positive results indicate that the voluntary program

exceeded its goals, by achieving a permanent change in the prescribing

and dispensing behaviors of the pharmacists and physicians in Duval County.










The final part of the outcome's examination of the Duval County pro-

gram involves an evaluation of the coverage level. The program was

wholly voluntary in nature. Nevertheless, the results showed that seventy-

three percent of Duval County pharmacies participated in the program to

some degree.

The literature reveals a wide range of compliance with the goals of

various programs. The range extends from 13.0 percent [78] to 93.6 per-

cent [79]. One of the major factors which accounts for the disparities

in levels of compliance is the process whereby the program is to be im-

plemented [62:1]. The participation level of the voluntary program (73

percent) compares favorably with the upper range for other programs.

The implementation process of the Duval County program is detailed in

the final chapter.

The next chapter discusses the attitudes of the pharmacists and

physicians toward the Duval County program.













CHAPTER V


PRACTITIONERS' ATTITUDES AND
KNOWLEDGE OF THE DUVAL COUNTY PROGRAM


The second focus of this evaluation is an examination of the parti-

cipants' attitudes and actions in implementing the goals of the program.

This chapter examines that aspect.

One objective of this study is the collection of descriptive infor-

mation concerning the pharmacists' and physicians' attitudes toward the

Duval County program. Other objectives include the elicitation of know-

ledge as measured by accuracy and degree of precision, possessed by

pharmacists and physicians regarding both the Duval County program and

the Florida amphetamine law, their attitudes toward amphetamine usage,

and the collection of descriptive information concerning factors which

influence the participatory status of the pharmacies. Attitudes and know-

ledge are considered by most social scientists to be of extreme importance

to the extent that they may characterize behavior in regard to the actions

taken in implementing policy decisions [62:90].

The sample of pharmacists is not a random one, but rather it repre-

sents the pharmacists who are associated with the pharmacies involved in

this study. The population of physicians comprises the osteopathic and

allopathic physicians who were identified as potential amphetamine or

methaqualcne prescribers and who were practicing in Duval County in 1977

and 1979. The entire population (396) was sampled.

This chapter is divided into three sections:










(1) pharmacists' responses;

(2) physicians' responses; and

(3) a comparison of pharmacists' and physicians' responses.

Pharmacists' Responses

Resoondent Characteristics

Table 11 describes characteristics of the pharmacist respondents.

Twenty-five (36.2 percent) were male. Most (79 percent) had been prac-

ticing pharmacy for at least six years. Eighty-three percent of the

pharmacists surveyed held memberships in at least one professional

association, 52 percent in two, and 41 percent in three.

When asked how they perceived the Duval County program for success

in decreasing amphetamine availability, 65 percent of the respondents

replied that they felt that the program had succeeded, 14 percent felt

that it had failed, and 21 percent did not respond to the question (see

Table 12). These results compare favorably with the results obtained

from the telephone interviews of the entire population of Duval County

pharmacists, in which 54 percent of the respondents felt the program had

succeeded in decreasing amphetamine availability and eight percent felt

the program had failed.

Since no statistical evidence was found of a relationship between

the gathered characteristics of gender, years in practice and profess-

ional association membership and the results obtained from the pharma-

cists' questionnaire, presentation of demographic information was limited

to descriptive detail of the sample and the population.15


1Unless further noted, all references to findings in this chapter
of statistical significance are based on the Chi Square (X2) test.









TABLE 11

Characteristics of Pharmacist Respondents


Gender


Femal e


Male

25

(86.2%)


4

(13.8%)


Years in Practice

0 5 6 15 over 15 Did Not Respond
6 5 18 0

(20.7%) (17.2%) (62.1%) ( 0%)
Professional Affiliations

American Pharmaceutical Association

Yes No Did Not Respond

12 15 2

(41.4%) (51.7%) ( 6.9%)
Florida Pharmacy Association

Yes No Did Not Respond

15 12 2

(51.7%) (41.4%) ( 6.9%)
Duval County Pharmacy Association

Yes No Did Not Respond


24

(82.3%)


4

(13.8%)


1

( 3.4%)








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In summary, it was found that the typical respondent was a male, who

had been in practice at least six years. He was a member of at least one

professional association and believed that the Duval County program had

succeeded in decreasing amphetamine availability.


Pharmacists' Attitudes Toward the Duval County Program

A Likert-type instrument was used to evaluate pharmacists' attitudes

toward the Duval County program. Pharmacists were asked to indicate the

extent to which they agreed or disagreed with statements concerning the

Duval County program. Table 13 shows that most pharmacists believed the

program had succeeded and that it should be expanded to a state-wide level.

The respondents were evenly divided in their opinions as to whether the

program should be made mandatory and whether they believed that most

pharmacists were limiting participation in the program to only those per-

sons not considered to be regular customers. There were no provisions in

the program for excluding regular patrons of an establishment.

Table 14 presents the pharmacist respondents' perceptions concerning

their customers' attitudes toward the Duval County program. Two state-

ments concerned the customers' willingness to accept the delay period in

obtaining amphetamine or methaqualone prescriptions. Customers had the

opportunity to find a non-participating pharmacy in Duval County or to

go outside Duval County where the voluntary program was not in effect.

There was a slight disagreement with the statements that the delay has

caused numerous customers to go elsewhere and that a significant number

of patients had crossed county lines to get their amphetamine prescrip-

tions filled as a result of the program, and slight agreement that most

customers accepted the program as a necessary means of controlling drug







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