session one muhas_pm604-rational use of medicines recovered]

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MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES SCHOOL OF PHARMACY PM604: Session 1: Rational Use of Medicines

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Page 1: SESSION ONE MUHAS_PM604-Rational Use of Medicines Recovered]

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

PM604: Session 1:

Rational Use of Medicines

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Objectives

y Define Rational Use of Medicines (RUM)

y Explain the importance of RUM

y Describe the different types of irrational use of medicines

y Discuss the factors influencing the use of medicines

y Consequences of irrational use of medicines

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Session Outline

y Definition and dimensions of RUM

y Components of the Drug Use Cycle

y Importance of RUM

y Different aspects of irrational use of medcines

y Consequences of Irrational Use of Medicines

y Factors Influencing the Use of Medicines

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Buzz sessiony The term appropriate/rational drug use means different

things to different people. What does the term mean

from the perspective of:y Patient

y Prescriber

y Dispenser

y Health Service Manager

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Rational Use of Medicines

The rational use of drugs requires that patients receive

medicines appropriate to their clinical needs, in doses

that meet their own individual requirements, for an

adequate period of time, and at the lowest cost tothem and the community.

World Health Organization, 1988

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Dimensions of Rational Use of Medicines

yy Appropriate indication

y Appropriate drug

y Appropriate administration, dosage,

and durationy Appropriate patient

y Appropriate patient information

y Appropriate evaluation (estimate or cost)

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Components of the Drug Use System

Pharmacies/Pharmacies/Drug SellersDrug Sellers

Drug ImportsDrug Imports Local ManufactureLocal Manufacture

Public & PrivatePublic & PrivateHealth FacilitiesHealth Facilities Private MDs/Private MDs/Other ProvidersOther Providers

Manufacture, RegistrationManufacture, Registration

Procurement, SupplyProcurement, Supply

Provider &Provider &

Consumer InteractionConsumer Interaction

Epidemiology, Care SeekingEpidemiology, Care Seeking

Access, AffordabilityAccess, AffordabilityConsumersConsumers

Demand 

Supply 

C e ntr e H o spi tal 

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

WHY RATIONAL USE OF

MEDICINES?

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Importance of Rational Use of 

Medicines 1

y Irrational Drug Use can destroy all the benefits of careful, cost

effective selection, procurement and distribution of drugs.

y Resources spent on procurement are lost if the correct drugs are

not prescribed and dispensed to the patient, who in turn uses

them in a correct manner

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Importance of the Rational Use of Medicines

2

y Medicines constitute the largest household expenditures

in most developing countries

y A major percentage (at least 30%) of the budget onhealth care is spent on medicines

y

Medicines make health care delivery credible

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACYProblems of Irrational Drug Use 11

Common Patterns of Irrational Use of 

Medicinesy The use of drugs when no drug therapy is indicated

y The use of wrong drugs for a specific condition requiring drugtherapy

y The use of drugs with doubtful or unproven efficacy

y The use of drugs of uncertain safety status

y Failure to prescribe available, safe, & effective drugs

y Incorrect administration, dosages, or duration

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

The Medicine Use Process

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines

Diagnosis (1)

y Inadequate examination of client/patient

y Incomplete communication between client/patientand doctor

y Lack of documented medical history

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines

Prescribing 2a

Under-prescribing:

í Needed medications are not prescribed.

í Dosage is inadequate.

í Length of treatment is too brief.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines

Prescribing (2b)

Incorrect prescribing

Medication is given for incorrect diagnosis.

Wrong medication is selected for diagnosis.

Prescription is prepared improperly.

Adjustments are not made for coexisting medical,genetic, environmental, or other factors.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines

Prescribing (2c)

Extravagant prescribing:

Less-expensive medication provides comparable efficacyand safety.

Symptomatic treatment of mild conditions diverts funds

from treating serious illness.

Brand-name medicine is used when less expensiveequivalents are available

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines

Prescribing (2d)Over-prescribing

Medication is not needed.

Dose is too large.

Treatment period is too long.

Quantity dispensed is too great for current course of treatment.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines

Prescribing (2e)Multiple prescribing

Two or more medications are used when fewer wouldachieve same effect.

Several related conditions are treated when treatment of 

primary condition would improve or cure the other

conditions.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines (3)

y Dispensing

y Incorrect interpretation of the prescriptiony Retrieval of wrong ingredients

y Inaccurate counting, compounding, or pouring

y Inadequate labeling

y Unsanitary procedures

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines (4)

y Packaging

y Poor-quality packaging materials

yOdd package size, which may requirerepackaging

yUnappealing package

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Aspects of Irrational Use of Medicines (5)

y

Labeling/Counselingy Poor labeling

y Inadequate oral instructions

y Inadequate counseling to encourage adherence

y Inadequate follow-up or support of 

clients/patients

y Treatments or instructions that do not consider

the clients/patients beliefs, environment, orculture

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Problems with Irrational Drug Use:

Poor Compliance

Compliance is the degree to which the patient follows the

physicians instructions on how to take the prescribed drug and

treatment.

Many studies about outpatient compliance carried out in developing countries

indicate that only about 50% of patients follow the instructions given by the

 physician

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Problems with Irrational Drug Use:

Poor Compliance

Causes of poor compliance include:1. Improper labelling

Neither the name of the patient, nor the name of the drug is

on the container labels when dispensed. If two nor more

drugs are dispensed together, the patent does not know which drug he/she is taking

2. Inadequate instructions:

The instructions on dosage frequency must be written on the

drug label, or the patient could forget how to take it when

he/she arrives home and becomes involved in other activities

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Problems with Irrational Drug Use:

Poor Compliance

3. Treatment /instructions that do not consider the socio-

economic and cultural aspects of the patient

F or example, i n cases where the patient does not know how to

read, proper instructions would include graphic

symbols of how to take the drug.

F or a treatment of three days, for example, you could number 

the days 1 to 3, and then below each day, make a mark for each

time the drug must be taken that day 

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Some Examples of Drug UseStudies

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

% Prescribed as GenericsPublic Sector Indicator Studies, 19901994

0% 25% 50% 75% 100%

Sudan

Zimbabwe

Tanzania

NigeriaCameroon

Ghana

Uganda

Mozambique

Swaziland

Indonesia

Nepal

Ecuador 

Guatemala

El Salvador 

Jamaica

East. Carib.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

% Receiving AntibioticsPublic Sector Indicator Studies, 19901994

0% 25% 50% 75%

Sudan

Malawi

Zimbabwe

Tanzania

Cameroon

Ghana

Uganda

Nigeria

 Yemen

Indonesia

Bangladesh

NepalEcuador 

Guatemala

El Salvador 

Jamaica

East. Carib.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

% Receiving InjectionsPublic Sector Indicator Studies, 1990-1994

0% 25% 50% 75%

UgandaSudanMalawi

Zimbabwe

TanzaniaCameroon

GhanaMozambiqu

SwazilandNigeria

 YemenIndonesia

BangladeshNepal

Ecuador Guatemala

El Salvador Jamaica

East. Carib.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

f P ti ts K i g H t

T k Dr gsP lic S ct r I ic t r St i s, -

0% 25% 50% 75% 100%

Malawi

Indonesia

Bangladesh

Tanzania

Nigeria

Nepal

Eastern Caribbean

Ghana

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

% of ey Drugs in StockPublic Sector Indicator Studies, 1990-1994

0% 25% 50% 75% 100%

Malawi

Tanzania

NigeriaNepal

Ecuador 

Cameroon

Ghana

El Salvador 

Guatemala

Jamaica

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Impact of Inappropriate

Use of Medicines

ReducedReduced

quality of quality of 

therapytherapy

morbiditymorbidity

mortalitymortality

Waste of Waste of 

resourcesresources Risk of Risk of 

unwantedunwantedeffectseffects

patients rely onpatients rely on

unnecessaryunnecessary

drugsdrugs

PsychosocialPsychosocial

impactsimpacts

reducedreduced

availabilityavailability

increased costincreased cost adverse reactionsadverse reactions

bacterial resistancebacterial resistance

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Rational use

of medicines

Prescriber,

dispenser, and

their 

 workplaces

Pharmaceutical

supply system

Client/patient

and

community

Factors Influencing the Use of Medicines

Policy, legal, and regulatory

framework 

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of 

Medicines: Pharmaceutical Supply System

Pharmaceutical quality problems

Unreliable suppliers

Poor forecasting/poor quantifications

Inadequate inventory management (expired

medicines, shortages, and so forth) Pressure and lobbying from industry (promotional

activities and misleading claims)

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines:

Drug Regulation

Non-formal prescribers

Lack of regulation enforcement

Non-essential drugs available

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines:

Prescriber

Inappropriate role models Lack of objective pharmaceutical information

Limited experience

Outdated knowledge

Lack of skill or conscientiousness Unlicensed practitioners

Inadequate pharmacology training

Inappropriate prestige over-prescribing

Fear-induced prescribing (uncertain diagnosis) Misleading beliefs about drug efficacy

Incorrect generalizations from experience

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of 

Medicines: Dispenser

Inability to read or interpret prescription

Outdated knowledge about drugs

Inadequately trained dispensers Poor attitude about dispensing

Poor attitude about packaging

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines:

Workplace

Lack of adequate laboratory capacity

Lack of equipment or facilities

No packaging materials Adequate packaging thought to be too costly

Lack of continuing education

Pressure to prescribe

Pressure to dispense Insufficient staffing

Inadequate supervision of practitioners

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines

Economic Motivations of Providers and Consumers

Provider preference to earn more money

salaries independent of services provided

payment according to non-drug services provided (consultation fees, percapita payment)

profit from drug sales (dispensing doctors, dispensing pharmacist fees)

Patient preference to pay less for drugs

overuse of free drugs versus decreased access with full payment

Reimbursement of essential drugs and treatments compliant with guidelines

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines

Drug Financing Systems

y Public financing through central revenues

y good drug selection and quality control, but danger of limited access if govt. budget insufficient

y Health Insurance - sharing payment risky public compulsory

y private voluntary (community pre-payment, HMO)

y User fees - money paid by patients for drugs

y revolving drug funds run by govt. or community

y private purchase

y co-payments in insurance systems

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines

Drug Financing Systems

Public financing through central revenues

y good drug selection and quality control, but danger of limited access if govt. budget insufficient

y Health Insurance - sharing payment risky public compulsory

y private voluntary (community pre-payment, HMO)

y User fees - money paid by patients for drugs

y revolving drug funds run by govt. or community

y private purchase

y co-payments in insurance systems

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines

Sales profits and pricing policies

Lower prices for essential drugs & higher prices for non-essential drugsshould lead to greater use of essential drugs, but:

higher prices for non-essential drugs may lead to their greater use by dispensingprescribers who are motivated by profit

patients may prefer more expensive drugs if they feel that the cheaper drugs areless effective

dispensing fees that are % of the price of a drug may encourage the sale of more expensive drugs

flat dispensing fees irrespective of drug prices lower the cost to patients of expensive medicines but may lead to price increases for cheaper drugs

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines

Health Systems 1

Prescribers that sell drugs usually:

prescribe more drugs and less appropriately

Increased cost sharing is associated with:

reduced patient access to drugs and health care

reduced appropriate and inappropriate drug use with higher

fees

reduced inappropriate use only with lower fees

Increased drug availability associated with increased

use

availability of non-essential drugs leads to their use

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines

Health Systems 2

Flat fees per prescription are associated with drugoveruse and polypharmacy

Charging per drug item is associated with prescriptionof fewer drug items

Charging variable fees may lead to:

reduced use of expensive drugs, and

increased use of cheaper drugs

Strategies to promote rational use can be built intoinsurance systems and reimbursement

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Factors Influencing the Rational Use of Medicines

Clients/Patients and Community

Misinformation about medications

Misleading beliefs

Client/patient demands or expectations

Complex diseases or problems No labeling or labels clients/patients cannot understand

Inadequate oral instructions

Clients/patients misunderstanding of medicines and theiruse

Conflict between cultural values and therapy

Lack of client/patient trust

Poor client/patientdoctor communication

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Conclusionsy The promotion of RUM generally is crucial to maximize the

impact of health care delivery

y There are many challenges to RUM at the diagnosis, prescribing,dispensing, and client/patient-use levels.

y All stakeholders have key roles to play in promoting RUM at all

levels.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

PM604-Session Two:

Investigating Drug Use In

Health Facilities

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

Session Objectives

y Describe a model for defining and changing drug use

patterns

y Identify the importance of drug use indicators

y Know steps to implement an indicator study

y Understand different methods of sampling and data

collection

y Understand how to analyze a situation using indicatorsy Identify & evaluate sources of data for indicator study

y Introduce qualitative research methods

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCESSCHOOL OF PHARMACY

An Overview of the Process of 

Changing Drug Use

1. EXAMINE1. EXAMINE

Measure PracticesMeasure Practices

(Descriptive Quantitative(Descriptive Quantitative

Studies)Studies)

2. DIAGNOSE2. DIAGNOSE

Identify Problems & CausesIdentify Problems & Causes

(I n(I n--depth Quantitative &depth Quantitative &

Qualitative StudiesQualitative Studies ) )

3. TREAT3. TREAT

Design and ImplementDesign and Implement

InterventionsInterventions

(Collect Data t o Measure(Collect Data t o Measure

Outc omes)Outc omes)

4. FOLLOW UP4. FOLLOW UP

Assess Changes in OutcomesAssess Changes in Outcomes

( ( Quantitative & QualitativeQuantitative & Qualitative ) )

Im roveIm rove

InterventionIntervention

Im rove diagnosisIm rove diagnosis

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Changing Drug Use Problems:1. Examine

y Identify drug use issue of interest

y Highest clinical risk?

y Widely used or expensive drugs?

y Easiest to correct?

y Collect data to describe practices

y In all groups of interest

y Most important prescribers?

y High-risk patients?

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

y Describe problem in detaily Specific problem behavior

y Define important providers or patients

y

Identify determinants of the problemy Knowledge and beliefs

y Cultural factors or peer practices

y Patient demand and expectations

y Identify constraints to change

y Economic constraintsy Drug supply

y Work environment

Changing Drug Use Problems:

2. Diagnose (dii)

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

y Select target and design intervention

y Which behaviors can be changed?

y Feasible interventions?

y Cost-effectiveness?

y Personnel required?

y Pilot test

y Acceptability

y Effectiveness

y Implement in stages

y Collect process and outcome data

y Evaluate impacts

Changing Drug Use Problems:

3. Treat

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

y Evaluate success in relation to intended outcomesy Was the intervention implemented as planned?

y What changes occurred

y Was the intervention cost-effective? Transferable?

y Consider unintended negative outcomes

y Feed back resultsy To managers and policymakers

y To staff 

y To providers and consumers

y Use results to plan future activities

Changing Drug Use Problems:

4. Follow Up

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Selecting Methods to Study Drug Use

y Depends on

y Nature of the problem

y Objectives of collecting data

y Resource availability

y Time available

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Methods to Study Drug Use.

y Quantitative Methods

y What? or How much?

y

Countsy Rates

y Classifications

y Qualitative Methods

y Why? or How strong?

y Opinions

y Descriptions

y Observations

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

DRUG USE INDICATOR STUDY

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 57

Purpose of Drug Use Indicator Studies

y Measure current medicines use practices

y Comparing the performance of individual facilities or

prescribers.

y Periodic monitoring of specific medicine use behavior to

assess change over time.

y To evaluate impact of intervention impact

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 58

Types of Indicatorsy Prescribing

y Patient Care

y Facility Indicators

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 59

Prescribing IndicatorsMeasure performance of prescribers in the several key

dimensions of appropriate use as per indicators listed

below:

1. Average number of medicines prescribed per

patient encounter

2. Average number of medicines prescribed by generic

name

3. Percentage of encounters with antibiotic

prescribed

4. Percentage encounters with injections prescribed

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 60

Patient Care Indicators1. These measure what patients experience in the HF and

how long it takes to be prepared to take the prescribed

pharmaceuticals

2. They do not capture quality of examination or RX

Example

1. Average consultation time

2. Average dispensing time

3. Percentage of prescribed medicines actually dispensed

4. Percent adequately labeled

5. Percentage of patients who could correctly explain on

how to take the prescribed medicines.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 61

Facility Indicatorsy Availability of national standard treatment guidelinesy Availability of key medicines

Complimentary indicators

� Percentage of medicines prescribed in consistence with

standard treatment guideline

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 62

Steps in an Indicator Study (oim gst -

pcff)y Specify objectives

y Define indicators to be used

y Develop Methods formeasuring indicators

y Select geographic area

y Select sample of facilities

y Select and train personnel

y Pilot test and revise proceduresy Collect data

y Feedback to facilities andmanagers

y Decide on follow-up studies

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 63

Scope of the Indicators Studyy Depends on:

y information needs of managers

y capabilities of record system

y types of providers

y resources available

y Minimum sample

y

20 facilities and 30 prescriptions / 30 patients per facility for cross-sectional study

y 100 prescriptions per facility if facilities will be compared

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 64

Preparing for a Survey (1)Prescribing Indicators

y Select a sample of facilities

y Decide on a source of data

for prescribing encountersy Define types of encounters

to include

y Define drugs to be counted

as antibiotics

y List drugs to be classified as

generic

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 65

Preparing for a Survey (2):Patient Care Indicators

y Observe logistics of patient care

y Determine how consulting anddispensing times will be measured

y Define criteria for adequate

patient knowledge

y Describe procedure for evaluating

patient knowledge

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 66

Preparing for a Survey (3):Facility Indicators

y Determine if national EDL 

or STG exists

y Prepare a short list of key

drugs to test availability

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 67

Indicator Sampling Methodsy Selection of Facilities

y Simple Random / Systematic

y Useful to Stratify -Government / Mission

y Retrospective Prescribing Data

y Systematic

y Random sampling

y Prospective Patient Encounters

y Convenience

h i d f l f

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Where Can We Find Useful Data for

calculating Indicators?

y Administrative offices, medical stores

y Clinical treatment areas and medical record departments

y Health facility pharmacies

y Private pharmacies and retail outletsy Households?

Where Can We Find Useful Data for

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

calculating Indicators?

Data Available at Health Facilities

y Retrospective

y Patient registers

y Treatment logs

y Pharmacy recordsy Medical records

y Prospective

y Observation of clinical encounters

y Patient exit interview

y Inpatient surveys

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Data from Drug Encounters

y FACILITY

y PATIENT

y PROVIDER

y INTERACTION

y DRUGS

y ID, characteristics, equipment, drugs

available

y ID, date, age, gender, symptoms

knowledge, beliefs, attitudes

y qualification, training, access to

information, knowledge, beliefs,

attitudes

y exams, history, diagnosis, time spent,

explanation about illness, explanation

about drugs

y brand, generic, strength, form, quantity,

duration, if dispensed, how labeled,

cost, patient charge

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 71

Undertaking the Survey:

Field Activitiesy Select a sample of encounters

y Fill in encounter forms

y Observe consultation and dispensing times

y Collect patient knowledge and dispensing

information

y Fill in facility summary forms

y Present results to staff 

10

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 72

Simple Prescribing

Indicators FormPRESCRIBING INDICATOR FORM

Location:

Investigator: Date:

Seq. Type Date Age # # Gen- Antib. Injec. # on Diagnosis

# (R/P) of Rx (yrs) Drugs erics (0/1) (0/1) EDL (Optional)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

11

1

1

1

1

11

1

1

0

1

0

Tot XXXXXXXX XXXXXXXXXXXXXX

Av g XXXXXXXX XXXXXXXX XXXXXXXX XXXXXXXX XXXXXXXX XXXXXXXXXXXXXX

nt g XXXXXXXX % % % % XXXXXXXXXXXXXX

of tota l of of tota l o f tota l  

d rugs ca se s ca se s d rug s

* 0=No 1=Yes

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 73

Detailed Prescribing

Indicators Form

Loca ion:

Inves i a or : Da e:

ID# Da e ame e ex rescri er  

Heal h Heal h r  oblem Descri ion Code

r oblems 1

2

3

Dr  s ame and rength Code Q antity

1

2

3

4

5

6

7

8,

9

Detailed rescribing

Indicators orm

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 74

Prescription 1

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 75

Prescription 2

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 76

Prescription 3

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 77

Prescription 4

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 78

Prescription 5

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 79

Prescription 6

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 80

Patient Care Indicators Form

Locat on:

Invest ator  Date:

Pa t ent Consult ng D spensing # Drugs # Drugs # Ade- Knows

Seq. Identif ier Time Time Pre- Dis- qua tely Dosage

# (if needed) (mins) (secs) scribed pensed Labe lled ( )

PATIENT CARE FORM

Count 

TotalAverage XXXXXX XXXXXX XXXXXX XXXXXX

Percentage XXXXXXXX XXXXXXXX XXXXXX % % %

* 0=No 1= es

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 81

Health Facility Summary FormLoca

 

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R Y F   

RM

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 82

Facility Indicator Reporting FormF ility Indi t r r ting For 

Lo ti n

In tig t r  te

Thi  

  

  

ti  

n  

l

F   

ility   

tandard  

u   

ber ! " 

 #  

ases Pr escribing

Patient  #   ar e

A$  

er age    

u   

ber ! " 

dr ugs %  

r escribed

Per centage ! " 

dr ugs %  

r escribed by generic names % %

Per centage ! " 

 enc!  

unter s with an antibi!  

tic %  

r escribed % %

Per centage ! " 

 enc!  

unter s with an in jecti!  

n %  

r escribed % %

Per centage  ! "  dr ugs  %   r escribed !   n  &   ssential '   r ug List % %

A$  

er age  # !  

nsulting Time mins mins

A$   er age   '   ispensing Time secs secs

Per centage ! " 

dr ugs actua lly dispensed % %

Per centage ! " 

dr ugs adequate ly labelled % %

Per cent c!  

rr ect patient (  nowledge  

! " d

!  sage % %

A$  

ailabili ty ! " 

 essential dr ug List !  

r For mular y Yes /  

!  %

Per centage a$  

a ilabili ty ! " 

 (  

ey indicat!  

r dr ugs % %

)   

  

mments

Signatur es

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 83

Indicators Consolidation FormIndicator  onsolidation For 

ocation: Date:

Av0  

. dr 1 0  

s Per cent Per cent Per cent Per ce nt Consult Dispens e % Dr ugs % Adequate %Ade quate Im par tial % Dr ugs

Date Facility Pr es cr ibed gener ics antibiotics Injections on EDL time time dispensed label knowledge Infor mation in stock

Mean

Maximum

Minimum

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 84

Graphs of Indicators Data (1)

Sample-Wide Distribution of Antibiotic Use

0

2

4

6

8

10

12

Under 30% 30% - 40% 40% - 60% Over 60%

Percentage Antibiotic Use

NUMBER OF FACILITIESNUMBER OF FACILITIES

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 85

Graphs of Indicators Data (2)

Sample-Wide Distribution of Consulting Times

01

2

3

4

5

6

7

8

Under 2 2 - 3 3 - 4 Over 4

Average Consulting Time (mins)

NUMBER OF FACILITIESNUMBER OF FACILITIES

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 86

Graphs of Indicators Data (3)Facility-Specific Antibiotic Use

0

10

20

30

40

50

60

70

80

U0 U1 U3 U3 U5 U6 U7 U8 U9 R0 R1 R2 R3 R4 R5 R6 R7 R8 R9

Health Facility

Urban

Rural

Percentage of PatientsPercentage of Patients

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 87

Graphs of Indicators Data (4)Facility-Specific Consultation Times

0

1

2

3

4

5

6

7

U0 U1 U3 U3 U5 U6 U7 U8 U9 R0 R1 R2 R3 R4 R5 R6 R7 R8 R9

Health Facility

Urban

Rural

AVERAGE TIME (MINS)AVERAGE TIME (MINS)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Implementing a Drug Use

Indicators Study 88

Conclusiony Undertaking a Drug Use

Indicators Study is

possible in nearly allenvironments

y The more attention to

detail the greater the

value and accuracy of the survey.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

PM604: Session Three:

Qualitative Methods

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Session Objectives (2)

y Identify four methods used to investigate reasons

underlying drug use and prescribing behavior

y Understand use of qualitative methods to identify why

documented drug use problems occur

S i O li (2)

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Session Outline (2)

y Introduction

y Applying qualitative methods to drug use studies

y Qualitative methods

y

Focus group discussionsy In-depth interviews

y Structured observations

y Structured questionnaires

y Activities

y Summary

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Introduction

y Quantitative study methods identify presence of drug

use problems

y Indicator studies

y Aggregate data: DDD, ABC, VEN

y

Record review and DUE

y What else do we need to plan an intervention?

y We need to know why the problem exists: i.e.,

qualitative methods

Introduction (2)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Introduction (2)

yFour qualitative study methods:

y Focus group discussions

y

In-depth interviews

y Structured observations

y Questionnaires

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Applying Qualitative Methods

y Complement results of a quantitative study

y Explore a topic about which little is known

y Provide background data prior to developing training

materials for a planned educational intervention and for

developing managerial and regulatory interventions.

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Applying Qualitative Methods (2)

y Example of the use of qualitative methodsy Prescribing by brand name was very popular at the district

hospital. Despite numerous interventions including face-to-

face discussions, in-service education, policy and procedures

changes, physicians continued to prescribe by brand name.

y Utilizing qualitative methods it was discovered that physicians

were receiving educational benefits from drug companies in

exchange for their prescribing of branded products. This

problem was then corrected once the reasons for the drug usebehavior became known.

i i ( )

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Focus Group Discussions (1)

y A short discussion (1-2 hours) led by a moderator in which a

small groups of respondents (6-10) talk in depth about a list of 

topics of interest.

y A trained moderator leads the discussion and encourages

participants to reveal underlying opinions, attitudes, and

reasons for the problem being studied

y The discussion is recorded and analyzed to identify key themesand issues

F G Di i (2)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Focus Group Discussions (2)

y 6-10 homogeneous participants i.e. they should share similar

characteristics (e.g., age, gender, type of work)

y Local convenience to participants

y Number of focus groups discussions should be sufficient to

gain the views of all the various target groups involved in the

drug use problem

y Moderator and recorder must be skilled and trained

F G Di i (3)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Focus Group Discussions (3)

y A

dvantagesy Relatively cheap and easy to organize

y Identifies a range of beliefs and ideas

y Disadvantagesy Group may not represent the larger population

y Success depends on the skill of the moderator

In-depth Interview (1)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

In-depth Interview (1)

y An extended discussion between a respondent and an trained

interviewer (who is knowledgeable about the topic) based ona brief interview guide that usually covers 10-20 topics

y The interview is flexible and often unstructured

y The questions are open ended to encourage the interviewee

to talk at length on the topic of interest

y 5-10 interviews with each important subgroup, often opinionleaders and key informants

I d th I t i (2)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

In-depth Interview (2)

yAdvantagesy Can develop trust between interviewer and interviewee

y Possible to probe deeper and therefore gain

unexpected insights or new ideas

y Disadvantages

y Generates lots of data and analysis may be difficult

y Interviewees may give answers they think the

interviewer wants to hear

y time consuming

Structured Observation (1)

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Structured Observation (1)

y Systematic observations by trained observers of a series of 

encounters between health providers and patients

y Observers record behaviors and impressions they witness

during the encounters in structured manner or they record a

score for each observed interaction

y Data may be recorded as coded indicators and scales or lists

of behaviours and events, and then frequency of behaviours

may be calculated

St t d Ob ti (2)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Structured Observation (2)

y To prepare for the study the observer shouldintroduce a non-threatening explanation and spend

time blending in

y At least 30 encounters should be observed to

calculate the frequency of behaviours

y At least 10 sites should be visited to observebehaviour

Structured Observation (3)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Structured Observation (3)

yAdvantagesy Best way to study the complex provider-patient interactions,

including patient demand and quality of communication

y Can learn about provider behaviour in natural setting

y Disadvantages

y Observed providers may modify their behavior because of 

observers presence

y requires skilled patient observersy inappropriate for infrequent behaviours

S d Q i i (1)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Structured Questionnaire (1)

y A fixed set of questions asked to a large sample of respondents

selected according to strict rules to represent a larger

population

y The questions have a fixed set of responses or options in order

to collect the desired information in a standard way from all

respondents

y The questionnaire may be administered by an interviewer or

filled out alone by the respondent

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Structured Questionnaire (2)

y At least 50-75 respondents from each target group

y Respondents should be chosen randomly

y Training and supervision of interviewers required

y Questions always asked in a standardized way, with no

leading questions

y Useful for attitudes, beliefs and opinions as well as facts

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Structured Questionnaire (3)

y Advantages

y Best for measuring strength & frequency of attitudes,

beliefs, knowledge, and population characteristics

y Can generalize to a wider population

y Disadvantages

y Do not uncover the unexpected

y Sensitive to the way questions are phrased leading to

possible bias and respondents may answer even when theyhave no true opinion

y Large surveys are expensive

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Summary

y Before an intervention can be designed to correct poorpractice or irrational use of drugs, we need to know why thatbehavior is occurring

y Qualitative methods should be used to investigate thebehaviour from different perspectives and with regard todifferent actors (patients, staff, etc.)

y Triangulation of results using different methods should bedone to identify the major reasons underlying a particularbehaviour.

MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

SCHOOL OF PHARMACY

PM604-Session IV:Drug Use Evaluation

Session Objectives 1 (DUE)

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Session Objectives 1 (DUE)

y

Understand the concept of drug use evaluation (DUE)

y Understand the process for implementing and

performing a DUE

y Discuss the use of a DUE program for improving drug

therapy

ey Definition:

D l ti (DUE)

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Drug use evaluation (DUE)

yy Ongoing, systematic, criteriaOngoing, systematic, criteria--based program of drugbased program of drugevaluations that will ensure appropriate drug use.evaluations that will ensure appropriate drug use.

InterventionsInterventions are necessary when inappropriate therapy isare necessary when inappropriate therapy is

identified.identified.

yy A DUE will:A DUE will:

yy DefineDefine appropriate drug use (by establishing criteria)appropriate drug use (by establishing criteria)

yy Audit  Audit criteria against what is being prescribedcriteria against what is being prescribed

yy

GiveGive feedback  feedback to prescribers on all identified problemsto prescribers on all identified problemsyy Monit or Monit or to see if criteria are followed and prescribing isto see if criteria are followed and prescribing is

improvedimproved

Drug Use Evaluation (DUE)

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Drug Use Evaluation (DUE)

y When drug use problems are identified, corrective

action with providers will be necessary and required

to optimize drug therapy

Obj i f DUE

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Objectives of a DUE

y Ensure that drug therapy meets current standards

y Promote optimal medication therapy

y Prevent medication-related problems

y Identify areas in which further evaluation is needed

y Create criteria for drug use

y Define thresholds for quality of drug use below whichcorrective action will be undertaken

y Enhance accountability in drug use

y Control drug costs

I di t ti d f DUE

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Indicators suggesting need for DUE

y Over-use or under-use of medications

y Problems indicated from WHO/MSH indicator studies

y High number of adverse drug reactions

y Signs of treatment failures

y Excessive non-formulary medications used

y Use of high-cost drugs where less expensive alternatives exist

y Excessive number of drugs within a therapeutic category

Step ise Approach to DUE

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Stepwise Approach to DUE

1. Establish responsibility

2. Develop scope of activities

3. Establish criteria and Thresholds for the DUE

4. Collect data and organize results

5. Analyze data

6. Develop recommendations and plan of action

7. DUE follow-up

S 1 E bli h R ibili

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Step 1Establish Responsibility

y Drug and Therapeutics Committee is a logical choice

y Multidisciplinary committee dealing with all facets of drug

therapy has the necessary expertise

y Subcommittees of the DTC

y Must include representation of practitioners whose drug

prescribing will be assessed

Step 2Develop Scope of Activities

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Step 2Develop Scope of Activitiesy I dentify drug therapy problems to be addressed

y Using ABC/VEN analysis, ADR reports, AMR reports

y Concentrate on drugs with highest potential for problems

y High volume

y Low therapeutic index

y High ADR ratey Expensive drugs

y Critically important drugs

y Antimicrobials

y Injections

y Drugs used for non-labeled indications

y Drugs used for high-risk patients

Step 3Establish Criteria and thresholds defining correct

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

p g

drug use (using evidence-based medicine)

yAppropriate drug for medical condition

y Correct dose

y Quantity to be dispensed

y Preparation for administration

yMonitoring is appropriate (e.g. lab test)

y Contraindications

y Drug interactions

y Drug administration (especially for injections)

yPatient education (written and oral instructions)

y Patient outcomes (e.g., blood glucose, Glyosyl.Haem.)

y Pharmacy administrative indicators (correct cost, billing)

Step 3 Establish Criteria and Thresholds

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(2)

y Define and establish thresholds or benchmarks for

quality of drug use below which corrective action will be

undertaken

y Thresholds define the expectations or goals for

complying with the criteria (e.g. 90% of 

prescriptions for 3rd generation cephalosporins

are for predefined serious infections).

Example: Ciprofloxacin DUE criteria &

thresholds (1)

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thresholds (1)

Criteria Threshold

Use 90%y Complicated, chronic, or relapsing UTI,

y Gonorrhea

y Resistant respiratory tract infections

y Bone and joint infections

y Prostatitis

y GI infections

Dose 95%y Complicated or recurring. infections: 500-750mg bid

y GI infections: 500mg bid

y Gonorrhea: 250mg in 1 dose

y renal disease decrease as follows:

Creatine Clearance 30-50ml/min 250-500 q 12 h

5-29ml/min 250-500 q 18 h

Hemodialysis 500mg q 24 h

pro oxac n cr er a res o s(contd.)

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( )

Criteria Threshold

Duration 95%y Complicated UTI10-21 days

y Respiratory7-14 days

y Osteomyelitis4-6 weeks

y GI5 days

Contraindications 100%y Pregnancy

y Children less than 18

Drug interactions 90%y Theophylline, antacids, iron, sucralfate, probenecid

y Food: decreased absorption with milk

Outcome 90%y Negative cultures

y Improved symptomatology

Step 4Collect Data

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Step 4 Collect Data

y Prospective evaluation

y done as drug is prepared or dispensed to the patient

y pharmacist can intervene at the time the drug is dispensed

y Retrospective evaluation

y requires access to medical records

y Sources of data

y patient charts, medical records, prescriptions, laboratory files

y manual systems versus computerized systemsy needs minimum of 50-75 records

Step 5Analyze Data

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p y

yTabulate results for each indicator

y Analyze to see what % of prescribing episodes comply with

the criteria and whether the threshold is met, e.g.:

y 70% of patients prescribed 3rd generation cephalosporins

were given it for predefined criteria 20% short of threshold

y Determine why thresholds (benchmarks) are not met

y Analyze data quarterly or more frequently

Step 6Develop Recommendations and

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Plan of Action

y Recommendations to address

y Inappropriate drug use

y Unacceptable patient outcomes

y Interventions to resolve any drug use problems

y Interventions to resolve drug use problems

y Education

y Drug order forms

y Prescribing restrictions

y Formulary manual changes

y STG changes

Step 7DUE Follow-up

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Step 7DUE Follow-up

y Check to see that recommendations have been

implemented

y Re-evaluate DUE to see if problems with drug therapyhave been resolved

Problems that can arise in DUEs

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ob e s t at ca a se U s

y Lack of authority

y Poor prioritization of drug use problems

y Poor documentation of findings

y Inadequate follow-up

y Overly intrusive data collection and evaluation

y Failure to obtain buy in from medical staff 

Summary (1)

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Summary (1)

y DUE is an audit and feedback intervention where drug use canbe reviewed against approved criteria and thresholds

y Requires establishing criteria and thresholds and then reviewing

drug use to determine if therapy is appropriate

y Feedback to prescribers is necessary to improve prescribing

(educational, managerial, regulatory interventions may be

required)

Summary (2)

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Summary (2)DUE will help improve drug use by

y Ensure that drug therapy meets current standards

y Promote optimal medication therapy

y Prevent medication-related problems

y Identify areas in which further evaluation is needed

y Create criteria for drug use

y Define thresholds for quality of drug use below which correctiveaction will be undertaken

yEnhance accountability in drug use

y Control drug costs

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INTERVENTIONS STRATEGIES

Decision Making for Rational Use

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Decision Making for RDU

Interventions 129

Decision Making for Rational Use

Interventions: Objectivesy To review intervention strategies

y Choose between interventions

y Develop a plan to undertake an intervention

Developing Strategy

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y Identify the problem & recognize the need for action-

meet consensus about the problemy Identify underlying causes and motivation factors using

posters to promote generic prescribing will fail if doctors

dont know generic names

y List possible interventions educational, managerial andregulatory

y Assess resources available for action- who will

implement? Do they have enough time?

y Choose an intervention or interventions to test-

effectiveness, costs, sustainability

y Monitor the impact & restructure the intervention

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Decision Making for RDU Interventions

131

Choosing Strategiesy Expected magnitude of impact

y Likelihood of success

y Risk of unintended effect

y Political and cultural feasibility

y Technical feasibility

y Cost (economic feasibility)

y Potential for donor support

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Decision Making for RDU

Interventions 132

Framework for Intervention StudiesFORMA IVE

S UDIES

IN ERVEN ION

S UDIES

FOLLOW U

. D fin ro l wi h

Dr ug U r n

. Id n ify Mo i ing

Factors/Und r lying Caus s

. List  ossibl

Interventions

. Choose Intervention s) to 

test

5. Conduct controlled study

of Intervention s)

REVISE & RES UDYpar tially eff ective or  costly

interventions

IMPLEMENcost eff ective interventions on a 

lar ger  scale

DROPineff ective, uneconomical

interventions

lprescribingldispensinglpatient use

linformationalleconomic

lsocial, culturallsupply logistics

leducationallmanageriallregulatory

lcultural acceptancellikelihood of success

lpotential impact

lfeasibility

Source: Quick et al. 1991.

l i i

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Decision Making for RDU Interventions

133

Selecting an InterventionStage 1: Choosing a Target

y Characterize situation (indicator study)

y Clarify problem (follow-up quantitative studies)

y Investigate underlying factors (qualitative studies)

y motivations of prescribers

y patient expectations

y constraints of system

y Synthesize data to choose targets

y key behaviors to change

y target group

Selecting an Intervention

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Decision Making for RDU Interventions

134

gStage 2: Choosing an Intervention

y List possible interventions

y Consider available resources

y financial

y human

y administrative structure

y Choose an intervention (or interventions)

y feasibility

y likely to change target behaviorsy no absolute constraints

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Decision Making for RDU Interventions

135

y Post Only:

y after the event

yPre-Posty before and after

y Randomized Trial

y random assignment of study

& control group

y Time Series

y multiple measures before

and after

Types of Study Design

Not Recommended

Not Recommended

Recommended

Recommended

Principles of Good Intervention

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Decision Making for RDU Interventions

136

Testingy Use a relevant comparison group

y randomly assigned if possible

y data collected like study group

y Measure outcomes at multiple time points

y before and after intervention

y time series?

y Focus on key outcome measures

y behaviors targeted by interventiony feasible to measure

Choosing Useful Outcome

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Decision Making for RDU Interventions

137

Measuresy Focus on key behaviors to be changed

y Consider likely substitute behaviors

y Focus on several important outcomes, not all changes

y

Choose outcomes:y that can be clearly defined

y that can be reliably measured

y Measure more than one dimension, for example

y changes in knowledge

y changes in prescribing

y changes in patient knowledge

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Decision Making for RDU Interventions

138

Issues and Sampling Methods

y

Simple Random Samplingy Systematic Sampling

y Stratified Sampling

y Cluster Sampling

y Multistage Sampling

Uni n y i m b in b mp in b in .Uni n y i m b in b mp in b in .

S mp iz m b n h xp h nS mp iz m b n h xp h n

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Decision Making for RDU Interventions

139

Using Samples to Collect Datay A sample should be typical of the overall group of 

interest.

y The accuracy of a study depends on the sample size.

y If sample units are drawn in clusters, the size of the

clusters should be small, and the number of clusters

should be large.

Involving Decision Makers at

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Decision Making for RDU Interventions

140

Involving ecision Makers at

Design Stagey By involving decision makers at design stage increases

chances of implementation if the intervention is

successful

y Opportunities for involving decision maker should be

actively sought

y Asking for input at the design stage increases chances

of cooperation and success

Planning an Intervention

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Decision Making for RDU Interventions

141

gy Decide what kind of study to use to test the intervention

yDefine study and control groups

y Define sampling process and size

y Define outcome variables to measure success

y Plan how to collect data

yDecide who will analyze the data, how, and when*

y Plan how to present the data, and to whom

y Decide how to monitor the project

* R m mb : i y n n yz by h n , mp m y h p.I y n' , mp n y m k hin w !  

Conclusion

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Decision Making for RDU Interventions

142

Conclusion

Which Method to Usey Best method depends on:

y nature of the problem

y objectives of collecting data

y available resources and timey local capacity and experience

y Use multiple methodsy quantitative + qualitative

y

triangulate findingsy each method can look at different aspects of a problem

Conclusion 2

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Decision Making for RDU Interventions

143

Conclusion 2

Points to Consider when Developing Strategyy Specific intended changes in behavior

y Possible unintended outcomes due to the intervention

y How both intended and unintended changes will be

measuredy Choice of intervention (or combination of interventions)

y Why this is likely to achieve desired changes

y Other information needed to design the intervention

General Recommendations to Improve the

Rational Use of Medicines

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Reference:

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y

TEN RECOMMENDATIONS TO IMPROVE USE OFMEDICINES IN DEVELOPING COUNTRIES

RO LAING,1 HV HOGERZEIL2 AND D ROSS-DEGNAN3

1

Boston University School of Public Health, Boston, USA,

2

World HealthOrganization Action Programme on Essential Drugs, Geneva, Switzerland and 3Harvard Medical School and Harvard Pilgrim Health Care, Boston, USA

HEALTH POLICY AND PLANNING; 16(1): 1320 © OxfordUniversity Press 2001

1

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-1-Establish procedures for Developing,

Disseminating, Utilizing and Revising

National (or hospital-specific)

Standard Treatment Guidelines

-2-

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y Establish procedures for developing and revising an

Essential Drug List (or hospital formulary) based on

treatments of choice

3

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-3-y Require hospitals to establish representative Pharmacy

and Therapeutics Committees with defined responsibilities

for monitoring and promoting quality use of medicines

-4-

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y Implement problem-based training in pharmacotherapy

in undergraduate medical and paramedical education

based on national STGs

-5-

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y Encourage targeted, problem-based in-service educational

programmes by professional societies, universities and theMinistry of Health

y Require regular continuing education for licensure of health

professionals

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-6-

y Stimulate an interactive group process among health

providers or consumers to review and apply information

about appropriate use of medicines

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-7-y Train pharmacists and drug sellers to be active members

of the health care team and to offer useful advice to

consumers about health and drugs

-8-

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8y Encourage active involvement by consumer

organizations in public education about drugs, anddevote

government resources to support these efforts

9

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-9-

y Develop a strategic approach to improve prescribing in

the private sector through appropriate regulation and

long-term collaborations with professional associations

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-10-

y Establish systems to routinely monitor key

pharmaceutical indicators in order to track the impact of 

health

sector reform and regulatory changes

Conclusions

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Conclusions

y The promotion of RUM generally and in the context of Antiretroviral Treatment is crucial to maximize the impact of 

health care delivery

y There are many challenges to RUM at the diagnosis, prescribing,

dispensing, and client/patient-use levels.

y All stakeholders have key roles to play in promoting RUM at alllevels.

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

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PM 604: Module 2

Intervention to Promote

Rational Use of Medicines

Learning About Factors Underlying

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Framework for Changing Drug Use Practices

159

Drug Use

Use qualitative methods to 

identify motivations and

incentives of pr escr ibers and

patients

Components of the Drug Use

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY 160

SystemDr ugDr ug Impor tsImpor ts

LocalLocal

Manuf actur eManuf actur e

HospitalHospital or or 

Health Center Health Center 

Pr ivate Physician or  Pr ivate Physician or  

Other Other Practitioner Practitioner Pharmacist oPharmacist or  r  

Dr ug rader Dr ug rader 

The Dr ug SupplyThe Dr ug Supply

ProcessProcess

Provider  andProvider  and

Consumer Consumer Behavior Behavior 

Illness Patter nsIllness Patter ns

++

PubliPublicc

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY 162

Strategies to Improve Drug Use

Manager ial:

t o st ruc t ure or guide decisions

Regulator y:

t o rest ric t or limi t decisions

Educational: t oinform or persuade

inform or persuade

Educational Interventions

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY 163

Educational InterventionsGOAL: to inform or persuadey Training

y changes in formal education

y in-service training seminars

y face-to-face persuasive outreach

y

clinical supervision or consultationy Printed Materials

y clinical literature and newsletters

y formularies or therapeutics manuals

y persuasive print materials

y Media-Based Approaches

y postersy audio tapes, plays

y radio, televisions

Prescriber Training

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY Framework for Changing Drug Use Practices164

Prescriber Training

y WHO has produced a

Guide for Good

Prescribing

y Developed in Groningen

y Field tested in 7 sites

y Suitable for medical

students, post grads &nurses

Printed Educational Materials

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY Framework for Changing Drug Use Practices165

Printed Educational Materials

y Cover range of materials

including journals,

newsletters, adverts, STGs

etcy Most useful when

combined with other

methods

y

Should include keymessages and have

attractive graphics

Face to Face Education

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY Framework for Changing Drug Use Practices 166

Face to Face Education

y Very effective method in both developed and

developing countries

y Need to target prescribers

y Have key messages to convey

y Should reinforce messages

Yogyakarta Diarrhea Study

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

167

A Comparison of Two Educational Interventions

y Study Designy Randomized controlled trial

y 2 districts randomly assigned to each of 3 study groups

y 15 random health centers per district

y Study Groupsy Face to face training in health centers (staff from single

unit)

y Large training seminar at district office (120 per seminar)

y Control group with no training

 Yogyakar ta Diarr hea Study

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY Framework for Changing Drug Use Practices168

gy yA Compar ison of Two Educational Interventions

�� Data CollectionData Collection ± ± Pr ePr e--post knowledge testpost knowledge test

 ± ± Retrospective pr escr ibing auditRetrospective pr escr ibing audit

 ± ± 3 months pr e vs. 3 months post3 months pr e vs. 3 months post�� Outcome measur esOutcome measur es

 ± ± Knowledge about diarr heaKnowledge about diarr hea

 ± ± % r eceiving ORS% r eceiving ORS

 ± ± % r eceiving antibiotics% r eceiving antibiotics ± ± % r eceiving% r eceiving antidiarr healsantidiarr heals

 Yogyakar ta Diarr hea Study

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use

Practices 169

gy yImpact of Tar geted Tr aining on Health Wor ker  Knowledge

Face to Face Seminar 0

4

6

8

10Knowledge ScoreKnowledge Score

Pre

Post

Significant  

increase pre

vs. post 

Imp T T inin n H h W k Kn w  

Yogyakarta Diarrhea Study

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

170

 Yogyakar ta Diarr hea StudyImpact of Tar geted Tr aining on Pr escr ibing of ORS

Face to Face Seminar Control

4

60

80

100

% Cases Receiving ORS

Pr e

Post

Di nDi n

mm

n nn n

i ni i ni ni i n

 Yogyakar ta Diarr hea Study

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use

Practices 171

gy yImpact of Tar geted Tr aining on Pr escr ibing of Antibiotics

Face to Face* Seminar * Control0

20

40

60

80

100

% Cases Receiving Antibiotics

Pr e

Post

Si ni i n y  

i n

m

n , p<0.001

 Yogyakar ta Diarr hea Study

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

172

Impact of Tar geted Tr aining on Pr escr ibing of Antidiarr heals

Si ni i n y  

i n

m

n ,

 p<0.001

Face to Face* Seminar * Control0

20

40

60

80

100

% Cases Receiving Antidiarr heals

Pr e

Post

Impact of Small Group Tr aining on ORSS l i K R t il Ph i

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

173

Sales in Kenyan Retail Pharmacies

Pr e Post Pr e Post0

20

40

60

80

100

Per centage Pr escr ibing ORS

Phase 1

N air bi  

Intervention

Control

Phase 2 

Ot her Ci t ies

Impact of Patient-Provider Discussion Groups on

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

174

Injection Use in Indonesia PHC facilities

Intervention Control0

20

40

60

0

Per centage Pr escr ibing Injections

Pr ePr e

PostPost

Effects of Opinion Leader on Choice Antibiotic for

Prophylaxis in a Teaching Hospital

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

175

Prophylaxis in a Teaching Hospital

,

,

,

,,

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,

,

,

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,

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,

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JanJan Apr    Apr JulJul OctOct JanJan Apr    Apr JulJul OctOct JanJan Apr    Apr JulJul OctOct8484 8585 8686

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0.10.1

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Managerial Strategies 1

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use

Practices 176

Managerial Strategies 1GOAL: to structure or guide decisions

y Changes in Selection, Procurement,

Distribution

y essential drugs lists

y morbidity-based quantificationy kit system distribution

y Changes Aimed at Prescribers

y utilization review (audit) and feedback

y diagnostic and treatment guidelines

y structured drug order forms

y peer group monitoring

Managerial Strategies 2:

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use

Practices 177

Managerial Strategies 2:GOAL: to structure or guide decisions

y Changes Aimed at Dispensers

y allowing generic substitution

y improved labeling

y course of therapy packaging

y Changes in Economic Incentives

y patient cost-sharing

y revolving drug funds

y cost controls

Standard Treatment Guidelines

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY Framework for Changing Drug Use Practices 178

Standard Treatment Guidelines

y STGs lead prescribers to

most cost-effective

treatments

y Particularly useful for lowlevel workers

y Can be used for training,

examinations and audit

y Used for procurement

Prescribing Audits plus "Feedback"

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY Framework for Changing Drug Use Practices179

to PrescriberE st a lishCri t eria & Guidelines for Review 

 AUDIT(COLLECT DATA ON)

RESCRIBING

 AUDIT

(COLLECT DATA ON)

RESCRIBING

· Comparison withGuidelines

· Comparison with eers

NOTIFY RESCRIBERS

OF RESULTS

· Individuals or Groups

· Letters or atient Notes or 

in erson

Rati onal Use o f Medicine I ndicat ors:

1--Prescribing indicators

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

g

y Average No. drugs per encounter

y % drugs prescribed by generic name

y % encounters with antibiotic prescribed

y % encounters with injection prescribed

y % drugs prescribed from EDL or formulary

Regulatory Options

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY Framework for Changing Drug Use Practices181

g y pGOAL: To Restrict Decisions

y Market Controls

y Limiting Drug Registration

y Banning Previously Registered Drugs

y

Rx - only to OTCy Controlling Content in Drug Advertising

y Prescribing and Dispensing Controls

y Limiting Drugs Supplied in Public Sector

y Restricting Specific Drugs to Higher Levels of Care

y

Required Generic Prescribingy Allowing Generic Substitution

y Limits on Number or Quantity of Drugs per Patient

C i I t rv ti Str t gy

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use

Practices 182

gyPr scri i g f r Ac t Di rr i M xic City

00

2020

4040

6060

8080

100100

% cases tr eated in line with algor ithm% cases tr eated in line with algor ithm

Stud Ph siciansStud Ph sicians

Control Ph siciansControl Ph sicians37 /5237 /52

79 /11579 /115

20 /8420 /84

Baseline StageBaseline Stage(n = 20)(n = 20)

Af ter  Af ter  Wor kshopWor kshop

Af ter  Peer  Af ter  Peer  

ReviewReview

(n = 20)(n = 20)

1818--months months 

FollowFollow--upup

11 /4611 /46

31 /11031

 /110

16 /7016 /7025 /10225 /102

42 /8242 /82

Impact of Training on Use of Diarrhea

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use

Practices 183

Impact of Training on Use of Diarrhea

Treatment Algorithm in Three Mexico Settings

S : M n z, , np b i h (1993)

Intervention

given by:

"Exper ts" in 2 clinics(San Jeronimo)

"Leaders" in 18 clinics

(Coyoacan)

"Coor dinators" in 124

Pr escr ibers

31

65

157

Baseline

%

24.5%

17.7%

24.7%

Post

%

71.2%

43.4%

31.2%

Change

%

+46.7%

+ 25.6%

+ 6.5%

clinics (Tlaxcala)

Conclusion: Interventions to

Change Drug Use

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

184

Change Drug Usey Best evidence in PHC area

y Focused, problem oriented repeated training

y Supervision or self monitoring with simple indicators

y Peer group oriented guideline development

y Evidence lacking for :y Private sector, adults, and chronic diseases

Conclusion: Interventions to

Change Drug Use (2)

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MUHIMBILI UNIVERSITY

OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

185

Change Drug Use (2)y Few interventions in hospitals in developing

countries but based on experience in developed

countries great potential exists for hospital

interventions to be successful

y Consumers need to be involved. Experience is

lacking but interactive, context specific programs

using a mix of communication channels are likely tobe effective

Conclusion: Interventions to Change Drug

U (3)

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OF HEALTH AND ALLIED SCIENCES

SCHOOL OF PHARMACY

Framework for Changing Drug Use Practices

186

Use (3)

y Drug retailers sales practices can be improved!

y Studies on impact of economic and drug sector

policy changes sorely lacking

y Need for more indicators for adequacy of 

diagnosis, guideline compliance, quality of care,

cost, inpatient drug use, success of P&T

committees and community programs

Characteristic of effective

intervention

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interventiony Identify key influence factors: why people behave the way

they do qualitative methods

y Target individuals/group with worst practices

y Use credible information sources: decision makers,

authoritative materialsy Use credible communication channel

y Use personal contact whenever possible: face to face

y Limit the number of messages & repeat key message usingdifferent media

y Provide better alternative: encourage people to dohi di h i h ORS A idi h