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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
ion¡
In¢
es
iga
or £
a
e¡
¤
ontact¥
Pr oble¦
s or ¤
o¦
plaint¥
# Cases Fr o¦
To
Retr o¥
pecti¢
e co¢
er ing dates
Pr o¥
pecti¢
e co¢
er ing dates
Patient Care co¢
er ing dates
Essential Dr ug Li¥
t/For ¦
ular §
a¢
ailable at f acilit§
? (0 /1 ̈
©
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in Stock to Treat I¦
por tant Condition¥
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(0 /1 ̈
% in¥
tock
thi¥
f acilit§
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CILIT Y SU
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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MUHIMBILI UNIVERSITY
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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MUHIMBILI UNIVERSITY
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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MUHIMBILI UNIVERSITY
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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MUHIMBILI UNIVERSITY
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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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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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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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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SCHOOL OF PHARMACY
SCHOOL OF PHARMACY
PM604-Session IV:Drug Use Evaluation
Session Objectives 1 (DUE)
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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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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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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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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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MUHIMBILI UNIVERSITY
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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MUHIMBILI UNIVERSITY
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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SCHOOL OF PHARMACY
(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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OF HEALTH AND ALLIED SCIENCES
SCHOOL OF PHARMACY
( )
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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OF HEALTH AND ALLIED SCIENCES
SCHOOL OF PHARMACY
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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SCHOOL OF PHARMACY
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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OF HEALTH AND ALLIED SCIENCES
SCHOOL OF PHARMACY
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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MUHIMBILI UNIVERSITY
OF HEALTH AND ALLIED SCIENCES
SCHOOL OF PHARMACY
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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OF HEALTH AND ALLIED SCIENCES
SCHOOL OF PHARMACY
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
MUHIMBILI UNIVERSITY
OF HEALTH AND ALLIED SCIENCES
SCHOOL OF PHARMACY
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SCHOOL OF PHARMACY
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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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
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Prophylaxis in a Teaching Hospital
,
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JanJan Apr Apr JulJul OctOct JanJan Apr Apr JulJul OctOct JanJan Apr Apr JulJul OctOct8484 8585 8686
00
0.10.1
0.20.2
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0.50.5
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Perce t f all -secti s DiscussiDiscussi
withwith
hief f hief f
Obstetr icsObstetr ics
-- Cef az li
rec mme ded
² Cef xiti
t rec mme ded
Managerial Strategies 1
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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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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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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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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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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
8/4/2019 SESSION ONE MUHAS_PM604-Rational Use of Medicines Recovered]
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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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MUHIMBILI UNIVERSITY
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