Case study Cephalexin is an expensive medicine that has been recently added to your hospital formulary list.

Widespread usage of this drug might have a significant impact on the drug budget according to recent ABC analysis conducted. It is well known that misuse of this antibiotic may lead to bacterial resistance, jeopardizing effectiveness when needed for future serious nosocomial infections. Additionally, it has been noted that celapheli in is fre!uently prescribed concurrently with other antibiotics such as erythromycin. "he hospital has decided to conduct #$% and you have been selected as technical lead. #evelop a summary procedure on how to address the problem, including listing the key aspects of medicines use and criteria that you will advise them to apply in evaluating the use of this medicine.

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ABBREVIATION DUR DTC DUE ADR RUD !T" drug use evaluation drug therapeutic committee drug use evaluation adverse drug reaction rational used o drugs standard treatment guideline

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#$% INTRODUCTION #$& 'ey De initions 1.2.1 Criteria are predetermined parameters of drug prescription and use established in #$( program for comparison to actual practice. Criteria should be developed or selected by !ualified health professionals. 1.2.2 Threshold is a percentage, establishes by #$( committee that identifies the point at which drug therapy problem e ists. )or e amples a threshold of *+, means the #$( committee has determine that problem a problem e ist if less than *+, of the data collected for a given criteria shows compliance 1.2.3 Interventions: are activities selected by #$( committee to correct drug therapy problems identified during #$( monitoring and evaluation. &$% DRU" U!E EVA(UATION #rug use evaluation -#$%. is a system of ongoing, systematic, criteria/based evaluation of drug use that will help ensure that medicines are used appropriately -at the individual patient level.. If therapy is deemed to be inappropriate, interventions with providers or patients will be necessary to optimize drug therapy. A #$% is drug/ or disease/specific and can be structured so that it will assess the actual process of prescribing, dispensing or administering a drug -indications, dose, drug interactions, etc... #$% is the same as drug utilization review -#$(. and terms are used synonymously. &$# Over vie) o drug use evaluation 0ince medicines have been used irrationally for as long as they have been available1 this reduces !uality of care, wastes resources and may cause harm to patients. "he first step to improving drug use is to investigate what kinds of problems there are and the e tent to which they occur. "his approach will makes it possible to design interventions relevant to a particular situation directed at improving the !uality of patient care. 2ere we will 3

describe a number of methods or tools to investigate drug use. 0o we may choose methods most suited to the type of problem to be investigated and the type of data available4 &$& "oal o the drug use evaluation "he goal of a #$% is to ensure that drug therapy meets current standards of care. Additional objectives may include4 5 creating guidelines -criteria. for appropriate drug utilization 5 evaluating the effectiveness of medication therapy 5 enhancing responsibility6accountability in the medicine use process 5 controlling medicine cost 5 preventing medication related problems, for e ample adverse drug reactions, treatment failures, over/use, under/use, incorrect doses and non/formulary medicine use 5 identifying areas in which further information and education may be needed by health/ care providers. 7nce the main problem areas have been identified, -from aggregate data, health facility indicators, and !ualitative studies, recommendations from #"C members can be established relatively !uickly.

*$% +ROCE!! O, C-AN"IN- DRU" U!E +ROB(E. *$# /uantitative method "his is the descriptive investigation of problem, the first step to addressing problems of irrational use of medicines is to measure the problem, analyze it and understand the causes underlying it. 9e may start with identifying broad areas of inappropriate use of medicines. "here are two main ways of doing this4 *$#$# Aggregate data methods4 9e may use data that are not collected at the individual patient level1 for e ample stock records, record from the manufacture or importer, drug procurement record and warehouse or pharmacy stock receipt. Aggregate data give an overview of drug use, which is useful in managing the formulary list. *$#$& Indicator study methods4 2ere we use data which are collected at the individual patient level, for e ample prescriptions or patient/provider interactions. "hese are collected specifically to investigate medicine use, but do not include sufficient information to make individual judgments concerning the appropriateness of a drug prescription for an individual diagnosis. 0uch data can therefore be collected by trained personnel who are not doctors, pharmacists or nurses. % amples of core drugs used indicators are, +rescri0ing indicators1 :easure performance of prescribers in the several key dimensions of appropriate use, +atient care indicators1 "hese measure what patients e perience in the 2) and how long it takes to be prepared to take the prescribed pharmaceuticals$ *$& /ualitative methods Is known as diagnose -identify problem and causes.. After the first step of identify an area of inappropriate medicine use ie1 ;uantitative methods of data can tell us if there is a medicine use problem, the nature of the problem and its size. 2owever, these methods do not tell us )hy there is a problem. ;ualitative methods are used to investigate the <why= of prescriber and patient behavior, this is essential to design effective interventions to

change behavior and correct the problem. "he methods used here were the )ocus group discussion, In/depth interview, !uestionnaire and structured observation *$* Design and implementation o intervention Changing the use of medicines to ensure that they are used in the most effective way is the overall aim of a drug and therapeutics committee -#"C.. "here are three overall types of strategy to change the use of medicines4 %ducational strategies that aims to inform prescribers. "his involves training prescribers4 :anagerial strategies that aim to guide the decisions of prescribers. "his involve on selection, >rocurements and #istribution on the medicines (egulatory strategies that aim to restrict the decisions of prescribers. A comprehensive approach with a combination of interventions -preferably of different types. is always more effective than single interventions. *$2 ,ollo) up Assess Changes in Outcomes(Quantitative & Qualitative) 1After implementation of the interventions regularly monitoring and %valuation should be conducted ie4 In every #$%, follow/up is critical to ensure appropriate resolution of any problems. #id an intervention achieve its objective? If an intervention is not evaluated, or drug use problems are not resolved, then the #$% will have been of no use. As a part of a follow/up plan the #"C must assess the need to continue, modify or discontinue the #$%.

2$% !TE+! O, DEVE(O+IN" DUE 3 CE+-A(E4IN5 Basing on the overview of the #$% and the nature of the assignment which shows that the first analyzing method ie4 Aggregate data methods involve data that do not relate to individual patients -ABC analysis. methodology which is used to identify broad problem areas in medicines use was already conducted and find that Cephale in is an e pensive medicine that has been recently added to the hospital formulary list. 9idespread usage of this drug might have a significant impact on the drug budget. "he hospital technical team under my supervision will conduct the following procedure4/ 2$# Esta0lish responsi0ility "his will be included by appointing a responsible member of the #"C or a subcommittee to monitor and supervise the #$% process in the hospital or clinics. "he #"C should establish annual plans, outlining which medicines or clinical conditions will be a part of the #$% process. 2$& !cope o activities and de ine the o06ectives "he following are the areas6activities to be look for antibiotics such as -Cephale in. 4 7veruse of a Cephale ini when a cheaper e!uivalent is available, as revealed in aggregate data Incorrect use -indication, dosage, administration. of a particular drug, as revealed in patient charts, medication error reports, A#( reports Iinappropriate choices of antibiotic, as revealed in antibiotic sensitivity reports A poor dispensing process, as revealed by patient complaints or feedback.

2$* Esta0lish criteria and thresholds or the due "hresholds or benchmarks for !uality medicines should be defined and established by #"C using the hospital=s 0"Bs for use below which corrective action will be undertaken. 7nce the criteria are established, thresholds or benchmarks are decided for each criterion in order to define the e pectations or goals for compliance with the criteria. Ideally one would like &CC, of all cases to comply with the criteria, but in reality this may not be possible, and a #"C might decide to set a threshold of *C/*+, compliance below which they would instigate corrective action. "herefore the number of criteria established for this Cephale in for the #$% process were illustrated in the table below4/

After defining and establishing thresholds or benchmarks for !uality of medicines use above and comparing with actual data that corrective action will be undertaken, 2$2 .ethodology or Data collection #ata should be collected by using retrospective or prospective. But here we may used the retrospective which involve reviewing prescribe drugs after they are dispense to patients. 0ince almost all re!uired data elements are contained in case histories, data collectors typically work in cooperation with medical records departments. #ata should be collected from a suitable random sample of prescription records from the hospital, the treatment of &CC patients for common clinical conditions, should be reviewed per hospital, since the survey is undertaken to assess practices in individual health facility and the large number of prescription needed for review and analysis. #ata collection forms based on the criteria are configured into simple <yes6no= !uestions as shown in the form. 0ources of data include patient charts, dispensing records, medication administration records, laboratory reports, A#( reports, medication error reports, antimicrobial sensitivity reports, and documented staff and patient complaints. 2$7 Evaluate data and determine i drug use pro0lem e8ist$ #ata evaluation is one of the most critical steps in #$( program. If the threshold is less than *+, for specific condition, the #$( committee should review those cases that were not in compliance with the criteria. "he main purpose of any such review is to determine if there was justifiable reason for non compliance. 0o if threshold is not met again it indicate drug use problem. If the committee determines that drug use problem does e ist the data should be evaluated to determine if the problem

is wide spread or limited to a few individuals, if the problem localized to a particular department 6 ward and if the problem occurs on one particular hospital shift. 2$9 Determine drug use pro0lem$ In order to have a comprehensive analysis, ;ualitative methods should be conducted to compliment the !uantitative data. "his method will be used to investigate the <why= of prescriber and patient behavior -feelings, beliefs, attitudes or motivations that underlie an observed problem., and help to understand why cephale in is being misused. 9e may used one of the four methods to collect relevant information which can be focus group discussion or in/depth interview or structured observation or structured !uestionnaire 2$: ,eed0ac; to the prescri0ers and ma;ing a plan o action After information is presented regarding inappropriate cephale in use, the #"C should develop conclusions about the differences between actual and desired results. As #$( data analysis=s are completed, the results should be reported to phyisician and other relevant staff such as pharmacist and nurses. (esults can be disseminated using any of the following mechanism. 9eekly prescriber conference, news letter, ad hoc meeting or posting the results in meeting places such as nurses= station on each ward. 2$< Design and implement intervention Basing on the findings we would get from !uantitative and !ualitative analysis on how and why there is cephale in misuse in the hospital, intervention should be designed and implemented for changing the use of the medicines to ensure that they are used in the most effective way is the overall aim of a drug and therapeutics committee -#"C.. 9e may choose one or more interventions that will results in improve drug use

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2$<$# Educational strategies1 aims to in orm prescri0ers$ This involves training prescri0ers1 2ere formal education -preservice., Continuing education -in/service., 0upervisory visits group lectures, seminars and workshops, approach based on face/to/face contact will be conducted by technical member=s from #"C, on additional to these >rinted :aterial concerned on how to prescribe Cephale in should be prepared and disseminated to all prescribers and dispensers at the hospital 2$<$& .anagerial strategies1 aim to guide the decisions o prescri0ers$ This involve on selection= +rocurements and Distri0ution on the ollo)ing1 Eimited procurement list, drug utilization review and feedback, hospital and regional drug committees, Cost information, >rescribing and dispensing approach, )inancing 2$<=* Regulatory strategies1 aim to restrict the decisions o prescri0ers= )hich involved the ollo)ing process1 #"C should ensure that regulatory strategies like drug registration, limited drug list, prescribing restrictions, dispensing restriction are in place and monitored regularly 2$7 ,ollo)>up After implementation of the interventions regularly monitoring and %valuation should be conducted ie4 In every #$%, follow/up is critical to ensure appropriate resolution of any problems. #id an intervention achieve its objective? If an intervention is not evaluated, or drug use problems are not resolved, then the #$% will have been of no use. As a part of a follow/up plan the #"C must assess the need to continue, modify or discontinue the #$%. 2$9 Disseminate result o re>evaluation #isseminate results of the re/evaluation #$( to the medical staff

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7$% CONC(U!ION #rug use evaluation -#$%. is a system of ongoing, systematic, criteria/based evaluation of drug use that will help ensure that medicines are used appropriately -at the individual patient level.. "he first step to improving drug use is to investigate what kinds of problems there are and the e tent to which they occur and why they occur. "his approach will makes it possible to design interventions relevant to a particular situation directed at improving the !uality of patient care. "he goal of a #$% is to ensure that drug therapy meets current standards of care. #esign and implementation of intervention should be conducted after the problem has been identified. After implementation of the interventions regularly monitoring and %valuation should be conducted ie4 In every #$%, follow/up is critical to ensure appropriate resolution of any problems.

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9$% Re erences &. http466apps.who.int6medicinedocs6en6d6Fs8DD'e6D.html '. :anagement 0cience for health. :anaging drug supply1 the selection, procurement, distribution and use of >harmaceuticals. Gumarian >ress, &**, 0econd edition, revised and e panded. 3. Class review notes6handouts

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