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Drug Use Review-A Manual System*
Drug Use Review-A Manual System* By David A. Knapp, Brenda M-.. Brandon, Sheila West and Dean E. Leavitt
A
manual system of drug use review has been developed as a means of beginning drug use review in organized health care settings. The system has been tested for several months in five Office of Economic Opportunity Neighborhood Health Centers differing in size, sophistication and type of pharmacy program. It has proven to be sound and versatile, yielding a moderately comprehensive picture of drug use trends and prescribing patternsinformation which is necessary to opI
increases sharply with age. Drug costs account for the third largest share of the medical care dollar. 3 It is clear that a system for reviewing the use of this important health care component is justified. Previous efforts have proved their worth. Maronde 4 developed and instituted a system of review for outpatient prescription orders at the Los Angeles County General Hospital and projected that ten percent of prescription drug costs could be saved if his
"The more we know about how specific drugs are used, the easier it is to determine how such use may be optimized." timize the quality and efficiency of the drug component of medical care. Principles and Objectives Drug use review, in its broadest sense, is defined as the review of physician prescribing, pharmacist dispensing and patient use of drugs. 1 The purpose of review is primarily educational; the more we know about how specific drugs are used, the easier it is to determine how such use may be optimized. In addition to the improvement of the quality of drug use, utilization review also may lead to cost savings for the program by uncovering situations in which less expensive therapy may be used with equal or better results. Thus, the twin goals of drug use review are (1) encouraging optimal drug use and (2) providing high quality drug therapy as economically as possible. The importance- of drug use review as a component of a health program's quality assurance effort should be evident because of the importance of drugs to patient care. Two of every three outpatient physician visits result in at least one prescription order; 2 the average American obtains over six prescription orders a year and the number
* Presented
at the American Pharmaceutical AssuciationOffice of Economic Opportunity Winter Conference, Dallas, Texas, February 1973. The project was supported by a contract to the University of Maryland school of pharmacy through the APhA project "Delivery of Pharmaceutical Services for Ambulatory Care Programs" funded by the Office of Economic Opportunity, grant number 31617.
system were adopted throughout the hospital. One of his review procedures involved setting guidelines for maximum prescription quantities which could be dispensed at one time. Applying these guidelines to outpatient prescribing in the hospital, he found that about 12.5 percent of all prescription orders written were for quantities above these limits and were judged excessive for any possible therapeutic indication. Another 3.7 percent of prescription orders surveyed were found to be in conflict with other medication currently being used by the patient. Maronde's review system was complex and used on-line electronic data processing equipment. While such computer systems are necessary for complete drug use review, they are not much help ·to most small neighborhood health centers or other organized health care systems which do not have the necessary equipment, personnel or finances. Therefore, compromises must be made in order to implement some sort of drug use review program. Overview of System
Recognizing the constraints operating in most centers, the drug use review system developed has the following characteristics• Requires no additional personnel • Can be used in either an in-house or a vendor program
• Does not employ electronic data processing equipment • Uses the dispensed prescription order as the data source • Uses a sampling procedure to save processing time • Offers model guidelines for reviewing data • Establishes review and analysis functions at the local level
Information is obtained from a representative sample of dispensed prescription orders rather than from every prescription order generated. In addition, since diagnosis or intended use is not routinely obtained, review must proceed without it, a.,lthough medical records may be consulted by authorized individuals when necessary. While f~r from perfect, such a procedure allows us to begin to deal with the issue of assuring drug use quality within present constraints of time and money. Review begins with a pharmacy technician (or other nonprofessional staff person) sampling dispensed prescription orders at a rate calculated to provide 15 to 20 a day as data sources. Selected information from the sampled prescription orders is copied by the technician onto specially prepared keysort data cards. The information includes the drug name and strength, quantity dispensed, directions, renewal instructions, prescriber and prescription number. The data cards used make possible the coding of selected information by notching the edge of the card with a hand punch in order to facilitate sorting at a later time. . Data cards are coded at the time of recording on two items-prescriber and selected drugs. This makes possible the easy monitoring of prescribing practices and the efficient access to data on drugs judged by the professional staff of the center to warrant attention. (Figure 1,page418). Coded cards are accumulated for periodic processing which includes the preparation of summary tables of prescribing patterns and the review of individual prescriptions. The pharmacist screens individual data cards, looking for potential problems. As an aid Vol. NS13, No.8, August 1973
417
David A. Knapp is professor, department of pharmacy administration, University of Maryland, Baltimore: He holds a BS in pharmacy and MS and PhD in pharmacy administration, all from Purdue University. Knapp has also taught at Ohio State University and was a visiting scholar at the University of Michigan school of public health. His memberships include APhA, APHA, AAAS, ASHP, Sigma Xi and Rho Chi. Knapp's research interests lie in the area of the application of the social sciences to medical care, particularly the drug component. In addition, he was project director of the APhA contract" Development ofa Drug Utilization Review System for OEO Neighborhood Health Centers."
Brenda M. Brandon is research assistant at the Health Services Research and Development Center, Johns Hopkins University, Baltimore. She holds a BS in pharmacy from the University of Maryland and is attending the Johns Hopkins school of hygiene and public health. Brandon has both community and hospital pharmacy experience and was project coordinator for the OEO-APhA Drug Use Review Project. She is a member of APHA and the Maryland Society of Hospital Pharmacists.
Sheila West is program director for pharmacy services, Health Services Research and Development Center; research associate in the department of medical care, Johns Hopkins University, Baltimore, Maryland, and adjunct assistant professor in the department of pharmacy at the University of Maryland, Baltimore. She holds a PharmD from the University of California at San Francisco. Her memberships include APhA, APHA and ASHP.
Dean E. Leavitt is associate professor and chairman of the department of pharmacy administration at the University of Maryland school of pharmacy. He holds a BS and MS in pharmacy and a MBA in marketing, all from the University of Maryland, and a PhD in pharmacy administration from Purdue University. His memberships include APhA, Academy ofPharmaceutical Sciences, AACP and the Maryland Pharmaceutical Association. In addition, he is chairman of the Task Force on the Effect of Third-Party Programs on Maryland Pharmacy and Education.
to this undertaking, model guidelines for proper drug use have been developed. Summary tables and the results of the pharmacist's screen are presented to the center's drug use review committee, which is responsible . for taking whatever action is necessary in response to the findings.
From this discussion, it is obvious that certain prerequisites must be met before a system of drug use review can be implemented successfully. These include• At least one nonprofessional technician who can spend about 20 to 30
47693
Rx FILLED BY ( VENDOR )
Rx NUMB ER
Tetracycline DIRECTIONS:
250 mgm caps
One cap Qid
40 caps
Smith
-0TIMES REFILL,
COST
FIGURE l --In this example of a data card and coding, Dr. Smith is code number 28. The "2" is notched in the "tens" field of the prescriber code area and the "8" (7 plus J) is notched in the "units" field. The drug is coded and notched similarly. In this example, tetracycline is code number 06. A zero is coded by leaving the field blank. 418
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
minutes daily on the tasks of sampling, data recording and coding. • A pharmacist to be in charge of the overall review system. This individual must supervise the technician and take charge of the summary and analysis stages. • A set of drug use guidelines for use in the analysis. These guidelines must be agreed upon and supported by the health center professional staff. • A drug use review committee to take responsibility for final decisions related to drug use in the center and to take remedial action when necessary.
Sorting, Summarizing and Analyzing Data The pharmacist is responsible for periodically sorting, summarizing and analyzing the data collected for presentation to the drug use review committee. This should be done every few weeks to avoid the accumulation of large amounts of data and so that review may be reasonably current. The total number of cards analyzed at one time should be between 1,000 and 1,500. 1.
Sorting by Drug
During the collection of data certain drugs of interest to the center were coded by notching specified fields on the edge of the card. With the aid of a sorting needle and tray the data may be sorted into drug code order with uncoded drugs ending up at the rear of the pack. This sorting procedure facilitates the application of the guidelines since all cards for the same drug are grouped. 2.
Applying the Guidelines
Guideline~ have been prepared for over 50 of the most commonly used drugs which attempt to set conservative (that is, relatively narrow) limits around the acceptable dose and quantity of a drug in a given prescription order. The guidelines were developed by the clinical staff of the University of Maryland school of pharmacy. Examples of the guidelines are provided in Figure 2 (page 419). Since the intended use of a drug may vary widely, with concomitant variability in the dose or quantity required, the fact that a given prescription falls outside the limits does not necessarily indicate a problem. It does, however, alert the pharmacist that more information is required from the patient's medical record before a decision may be made. On the other hand, the mere fact that a given prescription order falls within the guidelines does not mean that no problem can exist. For example, completely inappropriate therapy may have been specified. Unfortunately no easy way exists to detect
this sort of problem and the approach used here was to minimize the pos-
detect potential problems in the use of less frequently prescribed drugs.
"These model guidelines are intended to provide a start for a local drug use review committee." sibility of its occurrence by setting conservative limits. The model guidelines are intended to provide a start for the local . drug use review committee. They must be studied, modified and expanded as required to meet the needs of individual centers. Keep in mind, however, that the guidelines must stand for justifiable therapy based upon generally accepted expert opinion and clinical literature rather than upon what local prescribers are used to doing. Although occasional compromises may be necessary, every effort should be made to prevent the guidelines from representing only empirical practices. To implement review the pharmacist compares each data card with the appropriate guideline. If the dose or quantity falls outside the guideline the card is marked for future reference. Explanatory comments may be added on the back of the card if desired. The model guidelines cover most of the drugs which will be routinely coded, as well as many others. The pharmacist should review every data card, however, even if guidelines are not included, relying upon his knowledge and professional judgment to
3.
Sorting by Prescriber
With the deck of data cards already arranged in order of drug code, the pharmacist should now sort by prescriber code, using the same procedure previously employed. When completed the deck will be arranged in order of prescriber codes and, within each group of prescriber data, by drug. 4.
Summarizing the Data
The number of data cards for each prescriber must be manually counted and recorded. Next, the deck should be arranged so that the set of data cards for the prescriber with the greatest number of cards comes first, followed by other prescribers in descending order of cards. A summary table may now be constructed as illustrated ' in Figure 3 (page 420). Column A indicates the rank order number of each prescriber followed by his code number (column B). Prescribers are arranged in descending order of data cards. Column C lists the total number of prescription orders or data cards for each prescriber; for example, in Figure 3, Prescriber Number 09 (ranked first) had 231 prescrip-
tion orders included in the sample. Column D includes the number of prescription orders for coded drugs by prescriber. Thus, Prescriber 09 had 40 prescription orders for drug products which were coded. Column E represents the total number of each prescriber's prescription orders falling outside of the guidelines. Prescriber Number 09 had 17 such prescription orders. Further tallying of the data cards is necessary to fill in the columns for individual drug products (columns F through G). In Figure 3, ' Ecotrin \yas the most frequently prescribed drug in the sample with 67 prescription orders from all prescribers, propoxyphene was second with 43, and so forth through erythromycin with only four. After the column headings have been filled in, totals for ·individual prescribers can be tallied and entered. The first number of each entry represents the number of prescription orders for a drug written by a given prescriber. The second number, following the hyphen, is the number of those prescription orders which fell outside the guidelines. For example, Prescriber 09 wrote four prescription orders for chlordiazepoxidediazepam, of which two fell outside the guidelInes. After all the coded drugs have been tallied, the residual or uncoded drugs should be divided into prescription orders for legend and nonlegend drugs
FIGURE 2
Sample Guidelines Ampicillin Note:
Any prescription calling for a regimen other than a dose every four to six hours for at least 10 days falls outside these guidelines.
Minimum dose-Adults, 1 g/day Children, 500 mg/day
Minimum quantity- 40 capsules, 500 mg 40 capsules, 250 mg 100 ml, 250 mg/5 ml 200 ml, 125 mg/5 ml Maximum quantity-120 capsules,500 mg 120 capsules, 250 mg 200 ml, 250 mg/5 ml 400 ml, 125 mg/5 ml
Meprobamate, 200 mg and 400 mg tablets Minimum dose-200 mg/day Maximum dose-1600 mg/day
Minimum quantity-- ------- ------- -----Maximum quantity-240 tablet, 200 mg 120 tablets, 400 mg
Phenobarbital Minimum dose-as needed Maximum dose-200 mg/day
Minimum quantity- .-------------------Maximum quantity-120 tablets, 15 mg 120 tablets, 30 mg 90 tablets, 60 mg 60 tablets, 100 mg
Sulfisoxazole, 0.5 g tablets Minimum dose-2 g/day Maximum dose-4 g/day
Minimum quantity-32 tablets Maximum quantity-240 ta blets
Tetracycline Note:
Any prescription calling for a regimen other than a dose every four to six hours for at least 10 days falls outside ' these guidelines. Not indicated for use in children.
Minimum dose-1 g/day Maximum dose-2 g/day
Minimum quantity-40 capsules Maximum quantity-120 capsules, 250 mg 60 capsules, 500 mg
Vol. NS13, No.8, August 1973
419
FIGURE 3
Sample Summary Table I
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Analyzing the Data
Now that a summary table has been prepared, the pharmacist must study it carefully, analyze it and prepare a report for the drug use review committee. The table can be analyzed in several ways. First of all, patterns of drug use in the center as a whole are shown by the rank order of the coded drugs. Several positive prescribing patterns can be seen in Figure 3. For example, there is a low rate of prescribing of tetracycline and erythromycin. Tetracycline, a broad spectrum antibiotic, is frequently prescribed quite heavily, even though th~re exist few indications in which it is actually the drug of choice. Erythromycin, a fairly expensive antibiotic for which the major indication ' is in penicillin-allergic patients, tends to be used indiscriminately even when penicillin therapy will suffice. Neither of these problems is evident here since only nine prescription orders were found. Another positive finding is that very few sedative-hypnotic drugs, such as glutethamide, methaquaa:lude and pheno420
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(columns H and I). For example, Prescriber 09 wrote 133 prescription orders for uncoded legend drugs of which six were outside the guidelines. He wrote an additional 58 prescription orders for nonlegend drugs of which four were outside the guidelines. The last column in the table (J) contains the total number of uncoded drugs while the bottbm row contains the totals by drugs over all prescribers. 5.
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barbital were provided. The most widely used drug was Ecotrin, a nonlegend analgesic. The fact that an aspirin compound was so widely used is favorable, but the specific product, Ecotrin, indicates some problems. As an enteric coated aspirin, its use is sometimes attributed to the hypothesis that it will dissolve in the intestines, thus decreasing the amount of stomach irritation characteristic of aspirin. However, since the pH of the intestine is alkaline, aspirin will be present in the ionized state, markedly reducing its absorption. 5 Another frequently prescribed drug is propoxyphene, an expensive analgesic which has been reported to be no more effective than aspirin. 6 A second type of analysis is to examine the prescribing patterns of individual prescribers, taking note of the proportion of prescription orders which fall outside the guidelines. As can be seen in Figure 3 there is a considerable variation among prescribers. Those whose prescription orders continually tend to fall outside accepted . guidelines may be the subject of further investigation and/or educational efforts by the drug use review committee. A third type of analysis is to examine the proportion of prescription orders for certain drugs which fall outside the guidelines. In this way problem drugs can be isolated. In this center, 56 percent, or over half of the antibiotic prescription orders in the sample, fell outside the guidelines. The guidelines state a minimum of ten-day therapy as mandatory with antibiotics: In this
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
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center, a large number of prescription orders called for four- and five-day antibiotic therapy. This problem deserves attention by the drug use review committee. The example set forth in Figure 3 points out many kinds of information which can be abstracted from a summary table; however, there are specific limitations to these analyses. In most cases the information available will only suggest specific problems. Further data frequently will be necessary to clarify precisely existing problems. Specific data cards will be useful and in some cases the pharmacist will have to refer to the medical records of individual patients. The summary table also fails to point out trends or problems specific to uncoded drugs. However, the pharmacist, in running through all the data cards during his initial inspection, can easily get a general idea of possible prescribing problems among these drugs. At this point an interpretive report should be prepared by the pharmacist for the use of the drug use review committee. He should supplement the written report with supporting evidenc~ when required or desired by the committee. Drug Use Review Committee Activities The drug use review committee is a group of local physicians, pharmacists and other health center personnel charged with the responsibility for the monitoring of drug use in the program. (continued on page 433).
Drug Use Review (continued from page 420)
It may be created especially for this
purpose or may be an already existing group also serving other functions (for example, the pharmacy and therapeutics committee).
Summary
, To review and summarize, the stepby-step drug use review procedure is as follows1. Sample daily prescription orders at a rate suitable to produce 15 to 20 data cards each working day. 2. Copy data from sample prescription orders onto the data card.
"The pharmacist is unquestionably the key person in the drug l:Ise review process." The committee receives the report presented by the l?harmacist which summarizes prescribing patterns in the center and pinpoints potential problems. Because.of his specialized knowledge, the pharmacist is in a position to assist the committee in properly interpreting the data. Additional information related to patterns of practice of individual practitioners and specific patient data will often be required to permit the committee to make informed judgments about the current quality and economy of drug use in the center. When problems are identified they must be dealt with. The interprofessional makeup of the ideal committee should help to deal with such problems and to assure the support of the entire center staff. The primary . tools available to the committee are education and communication, although in some cases specific prescribing policies may have to be established.
3. 4. 5. 6.
Code drug name and prescriber name. Accumulate daily data cards. Every few weeks, sort by drug code. Screen data cards by applying guidelines. 7. Further sort the data cards by prescriber code. 8. Prepare summary table of prescribing practices. 9. The drug use review committee considers the data and takes appropriate action when necessary
The strength of this system of drug use review is that the data collected represent current prescribing patterns in the center alone, and problems detected are dealt with by center personnel without external interference. The objectives of quality assurance and cost control may thus be approached with a minimum of difficulty. The pharmacist is unquestionably the key person in the drug use review process. He is the best person to initi-
APhA andAACP Form Task Force on Continuing Competence The American Pharmaceutical Association and the American Association of Colleges of Pharmacy have agreed to form a joint Task Force on Continuing Competence in Pharmacy. It will consist of nine members, six pharmacists and three members of the general public. The objective of the Task Force will be to prepare a statement of basic principles and policies with respect to the continuing competence of pharmacists. The statement should assist the profession in developing a basic guide for planning and implementing programs to assure that pharmacists maintain professional competence. The continuing competence of professionals to practice is influenced by various factors, including the numerous scientific and technological developments in the past several decades; the increasing number of persons seeking health care; the changing patterns and the management and delivery of health care; and the growing recognition of the need to protect the public from unqualified personnel, a recognition that is shared by an increasing proportion of health professionals themselves, includ-
ing members of the profession of pharmacy. In the development of the statement on principles and policies, the Task Force will be expected to seek observations and suggestions from pharmacy organizations, including those responsible for licensure, as well as from individuals and organizations in other health fields. Drafts of the statement will be made publically available for comment before the Task Force presents its statement to the APhA and the AACP. In initiating this project, the twosponsoring groups believe they are not only fulfilling the desires of the pharmacy profession, but also are meeting the needs of society.
Programmed Learning Courses
A detailed step-by-step explanation of the entire drug use review system, complete with instructions for pharmacist and aide, examples of data summary and analysis, and sample guidelines is presented in the Drug Use Review Manual, available for $5.00 a copy from Wiggins Jones, OEO Project Director, American Pharmaceutical Association, 2215 Constitution Avenue, N. W., Washington, DC 20037.
ate the program and only through the application of his profes~ional talents can it succeed. The benefits to patient care and the personal satisfaction obtained are well worth the relatively small effort required . • References 1. Brodie, D.C. , " Drug U tiliza tion Review/ Planning, H ospitals, 46, 103 (June 1, 1972) 2. Stolley, P .D ., a nd L a sagn a, L. , " Prescribing Patterns of Physicia n s," J . Chron. D is. , 22, 395 (1969 ) 3. Socia l Security Administr ation , Office of Research a nd Sta tistics, Prescription Drug Data Summary, 1972, W ashington , D .C ., 5 (1972) 4 . M a ronde, R. F ., Drug Utilization R eview with On-Line Computer Capab ility , W ashington, D.C ., Socia l Security Administra tion, Office of Research a nd Statistics, S taff P ap er N o . 13 (1973 ) 5. L eon a rd s, J. R ., a nd L evy, G. , " Absorption and M e ta bolism of Aspirin Administered in EntericCoated T a ble ts," J A MA , 19~, 93 (July 12, 1965) 6. Miller , R. R ., et al., "Propoxyphene H ydrochloride, A C ri tical R eview," J A M A , 213, 996 (Aug. 10,1970 )
Aldosterone, Anxiety, Depression, Diabetes, Gout, Hyperactive Child, HypertenSion, Infection, Immunology, Iron Therapy, Oral Contraception, Parkinson's Disease, Schizophrenia, Steroids, Ulcer, Venereal Disease
John Wiley and Sons Inc. 605 Third Avenue New York, NY 10016 Medical Terminology (excellent) $ 5.95 There are programs available in addition to the ones listed that pharmacists can use to continue their education. The listing makes it obvious that programs are available in a wide variety of topics at various levels of difficulty. I would highly recommend pharmacists to add programmed learning to the other methods available for continuing their education. •
(continued from page 416)
M iscella neous The Medcom Inc. 2 Hammarskjold Plaza New York, NY 10017 Have film-monogram-test programs in the following-
References 1. Y o ung, J.A. , " P r ogr ammed Instruc tion," J. Chem . E d. 40, 11 (Ja n . 196 3) 2 . " T he M a n agem en t of Dia betes Insta llment 5 : Using the Ora l H ypoglycemic Agents," AFP/ GP (Sept. 1970) 3. Blizard, P .J ., A Bibliography of Programmed Learning Publications in the H ealth Sciences, 2, University of N ew S . W a les, Austra lia
Vol. NS13, No.8, August 1973
433
A
manual system of drug use review has been developed as a means of beginning drug use review in organized health care settings. The system has been tested for several months in five Office of Economic Opportunity Neighborhood Health Centers differing in size, sophistication and type of pharmacy program. It has proven to be sound and versatile, yielding a moderately comprehensive picture of drug use trends and prescribing patternsinformation which is necessary to opI
increases sharply with age. Drug costs account for the third largest share of the medical care dollar. 3 It is clear that a system for reviewing the use of this important health care component is justified. Previous efforts have proved their worth. Maronde 4 developed and instituted a system of review for outpatient prescription orders at the Los Angeles County General Hospital and projected that ten percent of prescription drug costs could be saved if his
"The more we know about how specific drugs are used, the easier it is to determine how such use may be optimized." timize the quality and efficiency of the drug component of medical care. Principles and Objectives Drug use review, in its broadest sense, is defined as the review of physician prescribing, pharmacist dispensing and patient use of drugs. 1 The purpose of review is primarily educational; the more we know about how specific drugs are used, the easier it is to determine how such use may be optimized. In addition to the improvement of the quality of drug use, utilization review also may lead to cost savings for the program by uncovering situations in which less expensive therapy may be used with equal or better results. Thus, the twin goals of drug use review are (1) encouraging optimal drug use and (2) providing high quality drug therapy as economically as possible. The importance- of drug use review as a component of a health program's quality assurance effort should be evident because of the importance of drugs to patient care. Two of every three outpatient physician visits result in at least one prescription order; 2 the average American obtains over six prescription orders a year and the number
* Presented
at the American Pharmaceutical AssuciationOffice of Economic Opportunity Winter Conference, Dallas, Texas, February 1973. The project was supported by a contract to the University of Maryland school of pharmacy through the APhA project "Delivery of Pharmaceutical Services for Ambulatory Care Programs" funded by the Office of Economic Opportunity, grant number 31617.
system were adopted throughout the hospital. One of his review procedures involved setting guidelines for maximum prescription quantities which could be dispensed at one time. Applying these guidelines to outpatient prescribing in the hospital, he found that about 12.5 percent of all prescription orders written were for quantities above these limits and were judged excessive for any possible therapeutic indication. Another 3.7 percent of prescription orders surveyed were found to be in conflict with other medication currently being used by the patient. Maronde's review system was complex and used on-line electronic data processing equipment. While such computer systems are necessary for complete drug use review, they are not much help ·to most small neighborhood health centers or other organized health care systems which do not have the necessary equipment, personnel or finances. Therefore, compromises must be made in order to implement some sort of drug use review program. Overview of System
Recognizing the constraints operating in most centers, the drug use review system developed has the following characteristics• Requires no additional personnel • Can be used in either an in-house or a vendor program
• Does not employ electronic data processing equipment • Uses the dispensed prescription order as the data source • Uses a sampling procedure to save processing time • Offers model guidelines for reviewing data • Establishes review and analysis functions at the local level
Information is obtained from a representative sample of dispensed prescription orders rather than from every prescription order generated. In addition, since diagnosis or intended use is not routinely obtained, review must proceed without it, a.,lthough medical records may be consulted by authorized individuals when necessary. While f~r from perfect, such a procedure allows us to begin to deal with the issue of assuring drug use quality within present constraints of time and money. Review begins with a pharmacy technician (or other nonprofessional staff person) sampling dispensed prescription orders at a rate calculated to provide 15 to 20 a day as data sources. Selected information from the sampled prescription orders is copied by the technician onto specially prepared keysort data cards. The information includes the drug name and strength, quantity dispensed, directions, renewal instructions, prescriber and prescription number. The data cards used make possible the coding of selected information by notching the edge of the card with a hand punch in order to facilitate sorting at a later time. . Data cards are coded at the time of recording on two items-prescriber and selected drugs. This makes possible the easy monitoring of prescribing practices and the efficient access to data on drugs judged by the professional staff of the center to warrant attention. (Figure 1,page418). Coded cards are accumulated for periodic processing which includes the preparation of summary tables of prescribing patterns and the review of individual prescriptions. The pharmacist screens individual data cards, looking for potential problems. As an aid Vol. NS13, No.8, August 1973
417
David A. Knapp is professor, department of pharmacy administration, University of Maryland, Baltimore: He holds a BS in pharmacy and MS and PhD in pharmacy administration, all from Purdue University. Knapp has also taught at Ohio State University and was a visiting scholar at the University of Michigan school of public health. His memberships include APhA, APHA, AAAS, ASHP, Sigma Xi and Rho Chi. Knapp's research interests lie in the area of the application of the social sciences to medical care, particularly the drug component. In addition, he was project director of the APhA contract" Development ofa Drug Utilization Review System for OEO Neighborhood Health Centers."
Brenda M. Brandon is research assistant at the Health Services Research and Development Center, Johns Hopkins University, Baltimore. She holds a BS in pharmacy from the University of Maryland and is attending the Johns Hopkins school of hygiene and public health. Brandon has both community and hospital pharmacy experience and was project coordinator for the OEO-APhA Drug Use Review Project. She is a member of APHA and the Maryland Society of Hospital Pharmacists.
Sheila West is program director for pharmacy services, Health Services Research and Development Center; research associate in the department of medical care, Johns Hopkins University, Baltimore, Maryland, and adjunct assistant professor in the department of pharmacy at the University of Maryland, Baltimore. She holds a PharmD from the University of California at San Francisco. Her memberships include APhA, APHA and ASHP.
Dean E. Leavitt is associate professor and chairman of the department of pharmacy administration at the University of Maryland school of pharmacy. He holds a BS and MS in pharmacy and a MBA in marketing, all from the University of Maryland, and a PhD in pharmacy administration from Purdue University. His memberships include APhA, Academy ofPharmaceutical Sciences, AACP and the Maryland Pharmaceutical Association. In addition, he is chairman of the Task Force on the Effect of Third-Party Programs on Maryland Pharmacy and Education.
to this undertaking, model guidelines for proper drug use have been developed. Summary tables and the results of the pharmacist's screen are presented to the center's drug use review committee, which is responsible . for taking whatever action is necessary in response to the findings.
From this discussion, it is obvious that certain prerequisites must be met before a system of drug use review can be implemented successfully. These include• At least one nonprofessional technician who can spend about 20 to 30
47693
Rx FILLED BY ( VENDOR )
Rx NUMB ER
Tetracycline DIRECTIONS:
250 mgm caps
One cap Qid
40 caps
Smith
-0TIMES REFILL,
COST
FIGURE l --In this example of a data card and coding, Dr. Smith is code number 28. The "2" is notched in the "tens" field of the prescriber code area and the "8" (7 plus J) is notched in the "units" field. The drug is coded and notched similarly. In this example, tetracycline is code number 06. A zero is coded by leaving the field blank. 418
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
minutes daily on the tasks of sampling, data recording and coding. • A pharmacist to be in charge of the overall review system. This individual must supervise the technician and take charge of the summary and analysis stages. • A set of drug use guidelines for use in the analysis. These guidelines must be agreed upon and supported by the health center professional staff. • A drug use review committee to take responsibility for final decisions related to drug use in the center and to take remedial action when necessary.
Sorting, Summarizing and Analyzing Data The pharmacist is responsible for periodically sorting, summarizing and analyzing the data collected for presentation to the drug use review committee. This should be done every few weeks to avoid the accumulation of large amounts of data and so that review may be reasonably current. The total number of cards analyzed at one time should be between 1,000 and 1,500. 1.
Sorting by Drug
During the collection of data certain drugs of interest to the center were coded by notching specified fields on the edge of the card. With the aid of a sorting needle and tray the data may be sorted into drug code order with uncoded drugs ending up at the rear of the pack. This sorting procedure facilitates the application of the guidelines since all cards for the same drug are grouped. 2.
Applying the Guidelines
Guideline~ have been prepared for over 50 of the most commonly used drugs which attempt to set conservative (that is, relatively narrow) limits around the acceptable dose and quantity of a drug in a given prescription order. The guidelines were developed by the clinical staff of the University of Maryland school of pharmacy. Examples of the guidelines are provided in Figure 2 (page 419). Since the intended use of a drug may vary widely, with concomitant variability in the dose or quantity required, the fact that a given prescription falls outside the limits does not necessarily indicate a problem. It does, however, alert the pharmacist that more information is required from the patient's medical record before a decision may be made. On the other hand, the mere fact that a given prescription order falls within the guidelines does not mean that no problem can exist. For example, completely inappropriate therapy may have been specified. Unfortunately no easy way exists to detect
this sort of problem and the approach used here was to minimize the pos-
detect potential problems in the use of less frequently prescribed drugs.
"These model guidelines are intended to provide a start for a local drug use review committee." sibility of its occurrence by setting conservative limits. The model guidelines are intended to provide a start for the local . drug use review committee. They must be studied, modified and expanded as required to meet the needs of individual centers. Keep in mind, however, that the guidelines must stand for justifiable therapy based upon generally accepted expert opinion and clinical literature rather than upon what local prescribers are used to doing. Although occasional compromises may be necessary, every effort should be made to prevent the guidelines from representing only empirical practices. To implement review the pharmacist compares each data card with the appropriate guideline. If the dose or quantity falls outside the guideline the card is marked for future reference. Explanatory comments may be added on the back of the card if desired. The model guidelines cover most of the drugs which will be routinely coded, as well as many others. The pharmacist should review every data card, however, even if guidelines are not included, relying upon his knowledge and professional judgment to
3.
Sorting by Prescriber
With the deck of data cards already arranged in order of drug code, the pharmacist should now sort by prescriber code, using the same procedure previously employed. When completed the deck will be arranged in order of prescriber codes and, within each group of prescriber data, by drug. 4.
Summarizing the Data
The number of data cards for each prescriber must be manually counted and recorded. Next, the deck should be arranged so that the set of data cards for the prescriber with the greatest number of cards comes first, followed by other prescribers in descending order of cards. A summary table may now be constructed as illustrated ' in Figure 3 (page 420). Column A indicates the rank order number of each prescriber followed by his code number (column B). Prescribers are arranged in descending order of data cards. Column C lists the total number of prescription orders or data cards for each prescriber; for example, in Figure 3, Prescriber Number 09 (ranked first) had 231 prescrip-
tion orders included in the sample. Column D includes the number of prescription orders for coded drugs by prescriber. Thus, Prescriber 09 had 40 prescription orders for drug products which were coded. Column E represents the total number of each prescriber's prescription orders falling outside of the guidelines. Prescriber Number 09 had 17 such prescription orders. Further tallying of the data cards is necessary to fill in the columns for individual drug products (columns F through G). In Figure 3, ' Ecotrin \yas the most frequently prescribed drug in the sample with 67 prescription orders from all prescribers, propoxyphene was second with 43, and so forth through erythromycin with only four. After the column headings have been filled in, totals for ·individual prescribers can be tallied and entered. The first number of each entry represents the number of prescription orders for a drug written by a given prescriber. The second number, following the hyphen, is the number of those prescription orders which fell outside the guidelines. For example, Prescriber 09 wrote four prescription orders for chlordiazepoxidediazepam, of which two fell outside the guidelInes. After all the coded drugs have been tallied, the residual or uncoded drugs should be divided into prescription orders for legend and nonlegend drugs
FIGURE 2
Sample Guidelines Ampicillin Note:
Any prescription calling for a regimen other than a dose every four to six hours for at least 10 days falls outside these guidelines.
Minimum dose-Adults, 1 g/day Children, 500 mg/day
Minimum quantity- 40 capsules, 500 mg 40 capsules, 250 mg 100 ml, 250 mg/5 ml 200 ml, 125 mg/5 ml Maximum quantity-120 capsules,500 mg 120 capsules, 250 mg 200 ml, 250 mg/5 ml 400 ml, 125 mg/5 ml
Meprobamate, 200 mg and 400 mg tablets Minimum dose-200 mg/day Maximum dose-1600 mg/day
Minimum quantity-- ------- ------- -----Maximum quantity-240 tablet, 200 mg 120 tablets, 400 mg
Phenobarbital Minimum dose-as needed Maximum dose-200 mg/day
Minimum quantity- .-------------------Maximum quantity-120 tablets, 15 mg 120 tablets, 30 mg 90 tablets, 60 mg 60 tablets, 100 mg
Sulfisoxazole, 0.5 g tablets Minimum dose-2 g/day Maximum dose-4 g/day
Minimum quantity-32 tablets Maximum quantity-240 ta blets
Tetracycline Note:
Any prescription calling for a regimen other than a dose every four to six hours for at least 10 days falls outside ' these guidelines. Not indicated for use in children.
Minimum dose-1 g/day Maximum dose-2 g/day
Minimum quantity-40 capsules Maximum quantity-120 capsules, 250 mg 60 capsules, 500 mg
Vol. NS13, No.8, August 1973
419
FIGURE 3
Sample Summary Table I
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Analyzing the Data
Now that a summary table has been prepared, the pharmacist must study it carefully, analyze it and prepare a report for the drug use review committee. The table can be analyzed in several ways. First of all, patterns of drug use in the center as a whole are shown by the rank order of the coded drugs. Several positive prescribing patterns can be seen in Figure 3. For example, there is a low rate of prescribing of tetracycline and erythromycin. Tetracycline, a broad spectrum antibiotic, is frequently prescribed quite heavily, even though th~re exist few indications in which it is actually the drug of choice. Erythromycin, a fairly expensive antibiotic for which the major indication ' is in penicillin-allergic patients, tends to be used indiscriminately even when penicillin therapy will suffice. Neither of these problems is evident here since only nine prescription orders were found. Another positive finding is that very few sedative-hypnotic drugs, such as glutethamide, methaquaa:lude and pheno420
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(columns H and I). For example, Prescriber 09 wrote 133 prescription orders for uncoded legend drugs of which six were outside the guidelines. He wrote an additional 58 prescription orders for nonlegend drugs of which four were outside the guidelines. The last column in the table (J) contains the total number of uncoded drugs while the bottbm row contains the totals by drugs over all prescribers. 5.
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barbital were provided. The most widely used drug was Ecotrin, a nonlegend analgesic. The fact that an aspirin compound was so widely used is favorable, but the specific product, Ecotrin, indicates some problems. As an enteric coated aspirin, its use is sometimes attributed to the hypothesis that it will dissolve in the intestines, thus decreasing the amount of stomach irritation characteristic of aspirin. However, since the pH of the intestine is alkaline, aspirin will be present in the ionized state, markedly reducing its absorption. 5 Another frequently prescribed drug is propoxyphene, an expensive analgesic which has been reported to be no more effective than aspirin. 6 A second type of analysis is to examine the prescribing patterns of individual prescribers, taking note of the proportion of prescription orders which fall outside the guidelines. As can be seen in Figure 3 there is a considerable variation among prescribers. Those whose prescription orders continually tend to fall outside accepted . guidelines may be the subject of further investigation and/or educational efforts by the drug use review committee. A third type of analysis is to examine the proportion of prescription orders for certain drugs which fall outside the guidelines. In this way problem drugs can be isolated. In this center, 56 percent, or over half of the antibiotic prescription orders in the sample, fell outside the guidelines. The guidelines state a minimum of ten-day therapy as mandatory with antibiotics: In this
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
5-2
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center, a large number of prescription orders called for four- and five-day antibiotic therapy. This problem deserves attention by the drug use review committee. The example set forth in Figure 3 points out many kinds of information which can be abstracted from a summary table; however, there are specific limitations to these analyses. In most cases the information available will only suggest specific problems. Further data frequently will be necessary to clarify precisely existing problems. Specific data cards will be useful and in some cases the pharmacist will have to refer to the medical records of individual patients. The summary table also fails to point out trends or problems specific to uncoded drugs. However, the pharmacist, in running through all the data cards during his initial inspection, can easily get a general idea of possible prescribing problems among these drugs. At this point an interpretive report should be prepared by the pharmacist for the use of the drug use review committee. He should supplement the written report with supporting evidenc~ when required or desired by the committee. Drug Use Review Committee Activities The drug use review committee is a group of local physicians, pharmacists and other health center personnel charged with the responsibility for the monitoring of drug use in the program. (continued on page 433).
Drug Use Review (continued from page 420)
It may be created especially for this
purpose or may be an already existing group also serving other functions (for example, the pharmacy and therapeutics committee).
Summary
, To review and summarize, the stepby-step drug use review procedure is as follows1. Sample daily prescription orders at a rate suitable to produce 15 to 20 data cards each working day. 2. Copy data from sample prescription orders onto the data card.
"The pharmacist is unquestionably the key person in the drug l:Ise review process." The committee receives the report presented by the l?harmacist which summarizes prescribing patterns in the center and pinpoints potential problems. Because.of his specialized knowledge, the pharmacist is in a position to assist the committee in properly interpreting the data. Additional information related to patterns of practice of individual practitioners and specific patient data will often be required to permit the committee to make informed judgments about the current quality and economy of drug use in the center. When problems are identified they must be dealt with. The interprofessional makeup of the ideal committee should help to deal with such problems and to assure the support of the entire center staff. The primary . tools available to the committee are education and communication, although in some cases specific prescribing policies may have to be established.
3. 4. 5. 6.
Code drug name and prescriber name. Accumulate daily data cards. Every few weeks, sort by drug code. Screen data cards by applying guidelines. 7. Further sort the data cards by prescriber code. 8. Prepare summary table of prescribing practices. 9. The drug use review committee considers the data and takes appropriate action when necessary
The strength of this system of drug use review is that the data collected represent current prescribing patterns in the center alone, and problems detected are dealt with by center personnel without external interference. The objectives of quality assurance and cost control may thus be approached with a minimum of difficulty. The pharmacist is unquestionably the key person in the drug use review process. He is the best person to initi-
APhA andAACP Form Task Force on Continuing Competence The American Pharmaceutical Association and the American Association of Colleges of Pharmacy have agreed to form a joint Task Force on Continuing Competence in Pharmacy. It will consist of nine members, six pharmacists and three members of the general public. The objective of the Task Force will be to prepare a statement of basic principles and policies with respect to the continuing competence of pharmacists. The statement should assist the profession in developing a basic guide for planning and implementing programs to assure that pharmacists maintain professional competence. The continuing competence of professionals to practice is influenced by various factors, including the numerous scientific and technological developments in the past several decades; the increasing number of persons seeking health care; the changing patterns and the management and delivery of health care; and the growing recognition of the need to protect the public from unqualified personnel, a recognition that is shared by an increasing proportion of health professionals themselves, includ-
ing members of the profession of pharmacy. In the development of the statement on principles and policies, the Task Force will be expected to seek observations and suggestions from pharmacy organizations, including those responsible for licensure, as well as from individuals and organizations in other health fields. Drafts of the statement will be made publically available for comment before the Task Force presents its statement to the APhA and the AACP. In initiating this project, the twosponsoring groups believe they are not only fulfilling the desires of the pharmacy profession, but also are meeting the needs of society.
Programmed Learning Courses
A detailed step-by-step explanation of the entire drug use review system, complete with instructions for pharmacist and aide, examples of data summary and analysis, and sample guidelines is presented in the Drug Use Review Manual, available for $5.00 a copy from Wiggins Jones, OEO Project Director, American Pharmaceutical Association, 2215 Constitution Avenue, N. W., Washington, DC 20037.
ate the program and only through the application of his profes~ional talents can it succeed. The benefits to patient care and the personal satisfaction obtained are well worth the relatively small effort required . • References 1. Brodie, D.C. , " Drug U tiliza tion Review/ Planning, H ospitals, 46, 103 (June 1, 1972) 2. Stolley, P .D ., a nd L a sagn a, L. , " Prescribing Patterns of Physicia n s," J . Chron. D is. , 22, 395 (1969 ) 3. Socia l Security Administr ation , Office of Research a nd Sta tistics, Prescription Drug Data Summary, 1972, W ashington , D .C ., 5 (1972) 4 . M a ronde, R. F ., Drug Utilization R eview with On-Line Computer Capab ility , W ashington, D.C ., Socia l Security Administra tion, Office of Research a nd Statistics, S taff P ap er N o . 13 (1973 ) 5. L eon a rd s, J. R ., a nd L evy, G. , " Absorption and M e ta bolism of Aspirin Administered in EntericCoated T a ble ts," J A MA , 19~, 93 (July 12, 1965) 6. Miller , R. R ., et al., "Propoxyphene H ydrochloride, A C ri tical R eview," J A M A , 213, 996 (Aug. 10,1970 )
Aldosterone, Anxiety, Depression, Diabetes, Gout, Hyperactive Child, HypertenSion, Infection, Immunology, Iron Therapy, Oral Contraception, Parkinson's Disease, Schizophrenia, Steroids, Ulcer, Venereal Disease
John Wiley and Sons Inc. 605 Third Avenue New York, NY 10016 Medical Terminology (excellent) $ 5.95 There are programs available in addition to the ones listed that pharmacists can use to continue their education. The listing makes it obvious that programs are available in a wide variety of topics at various levels of difficulty. I would highly recommend pharmacists to add programmed learning to the other methods available for continuing their education. •
(continued from page 416)
M iscella neous The Medcom Inc. 2 Hammarskjold Plaza New York, NY 10017 Have film-monogram-test programs in the following-
References 1. Y o ung, J.A. , " P r ogr ammed Instruc tion," J. Chem . E d. 40, 11 (Ja n . 196 3) 2 . " T he M a n agem en t of Dia betes Insta llment 5 : Using the Ora l H ypoglycemic Agents," AFP/ GP (Sept. 1970) 3. Blizard, P .J ., A Bibliography of Programmed Learning Publications in the H ealth Sciences, 2, University of N ew S . W a les, Austra lia
Vol. NS13, No.8, August 1973
433