managerial and regulatory strategies to improve drug use

1

Managerial and Managerial and Regulatory Strategies to Regulatory Strategies to

Improve Drug UseImprove Drug Use

Managerial and Regulatory Strategies 2

Managerial and Regulatory Managerial and Regulatory Strategies to Improve Drug Use: Strategies to Improve Drug Use: ObjectivesObjectives

• Recognize the range of managerial and Recognize the range of managerial and regulatory strategiesregulatory strategies

• Identify strategies best suited to Identify strategies best suited to program needprogram need

• Successfully develop and implement Successfully develop and implement strategiesstrategies


Managerial StrategiesManagerial Strategies

Managerial Strategies structure information, Managerial Strategies structure information, information flow, and the decision process to information flow, and the decision process to achieve more cost-effective use of achieve more cost-effective use of pharmaceutical resources.pharmaceutical resources.


Managerial Strategies:Managerial Strategies:Structure DecisionsStructure Decisions

• Selection and ProcurementSelection and Procurement– Essential Drug ListsEssential Drug Lists– National FormularyNational Formulary– Morbidity-Based QuantificationMorbidity-Based Quantification– Drug Procurement Review andDrug Procurement Review and– Feedback to Decision-MakersFeedback to Decision-Makers

• DistributionDistribution– Distribution Review ProcessDistribution Review Process– Kit Supply SystemsKit Supply Systems


Managerial Strategies:Managerial Strategies:Structure DecisionsStructure Decisions

• Prescribing and DispensingPrescribing and Dispensing

– Standard Diagnostic andStandard Diagnostic and

– Treatment GuidelinesTreatment Guidelines

– Structured Drug Order FormsStructured Drug Order Forms

– Automatic Stop OrdersAutomatic Stop Orders

– Course-of-Therapy PackagingCourse-of-Therapy Packaging

– Effective Labeling Effective Labeling

– Audits plus "Feedback" to ProvidersAudits plus "Feedback" to Providers

– Required Consultations or JustificationsRequired Consultations or Justifications

• FinancingFinancing

– Pricing Drugs According to Health ImpactPricing Drugs According to Health Impact

– Patient Cost-Sharing (e.g., $0.20 per prescription)Patient Cost-Sharing (e.g., $0.20 per prescription)


Utilization Review (Audit) & Utilization Review (Audit) & Feedback to PrescribersFeedback to Prescribers

Establish CriteriaEstablish Criteria

Collect data on Collect data on prescribing (audit)prescribing (audit)

ComparisonComparison• with standardswith standards• with peerswith peers

FeedbackFeedback• To individuals or groupsTo individuals or groups• Using letters or in personUsing letters or in person


Audit and Feedback in UgandaAudit and Feedback in Uganda


Impact of training & supervision on Impact of training & supervision on treatment according to STGs in Ugandatreatment according to STGs in Uganda

0

10

20

30

40

50

60

% S

TG

co

mp

lian

ce

Control STG STG+train STG+train+sup

Pre Post


Activity OneActivity One

Managerial Strategies to Change Generic Drug Use in a Teaching Hospital


Economic strategies:Economic strategies:structuring decisions through economic incentivesstructuring decisions through economic incentives

• Economic strategies are managerial strategies Economic strategies are managerial strategies that use economic incentives to influence the that use economic incentives to influence the decision process of prescribers and patients decision process of prescribers and patients such that they use medicines in a more cost-such that they use medicines in a more cost-effective manner. effective manner.

• Providers may be induced by budgets and Providers may be induced by budgets and financial incentives and patients by cost sharing. financial incentives and patients by cost sharing.

• Unfortunately many health systems include Unfortunately many health systems include perverse financial incentives.perverse financial incentives.


Improving prescribing by changing the Improving prescribing by changing the user feesuser fees (Holloway, Gautam & Reeves 2001)(Holloway, Gautam & Reeves 2001)

• Pre-post study with controlPre-post study with control• All 3 areas using flat fee per prescription in 1992 All 3 areas using flat fee per prescription in 1992 • 2 areas changed to a fee per drug item in 1993-42 areas changed to a fee per drug item in 1993-4• 1 control area continued with the fee per Px during 1 control area continued with the fee per Px during

1992-51992-5• Prescription (Px) surveys done in pre-intervention Prescription (Px) surveys done in pre-intervention

(1992) and post-intervention (1995)(1992) and post-intervention (1995)• 10-12 health facilities per area, >30 prescriptions 10-12 health facilities per area, >30 prescriptions

per facilityper facility


Polypharmacy & Vit use on changing from a Polypharmacy & Vit use on changing from a fee per Px (PxF) to a fee per drug item (IF)fee per Px (PxF) to a fee per drug item (IF)

Av. no. drugs per patient

0

1

2

3

4

PxF 1-band IF 2-band IF

1992 1995

% patients pres vitamins, tonics

0

10

20

30


1992 1995


Injection and antibiotic use on changing Injection and antibiotic use on changing from a fee/Px (PxF) to a fee/drug item (IF)from a fee/Px (PxF) to a fee/drug item (IF)

% patients prescribed injections

05

10152025


1992 1995

% patients pres. antibiotics

0

20

40

60

80


1992 1995


Treatment cost and compliance with STGs Treatment cost and compliance with STGs on changing from fee/Px (PxF) to a fee/drug on changing from fee/Px (PxF) to a fee/drug item (IF)item (IF)

% patients treated according to STGs

0

20

40

60


1992 1995

Av. drug cost per patient (NRs)

0

10

20

30

40


1992 1995


PHC prescribing with & without Bamako PHC prescribing with & without Bamako initiative in Nigeria initiative in Nigeria Scuzochukwu et al, HPP, 2002Scuzochukwu et al, HPP, 2002

5.3

72.8

64.7

93

35.4

2.1

38

25.6

21

15.3

0 20 40 60 80 100

no.drug items/Px

% Px with injections

% Px with antibiotics

% pres EDL drugs

no.EDL drugs avail

21 Bamako PHCs 12 non-Bamako PHCs


Prescribing by dispensing and non-Prescribing by dispensing and non-dispensing doctors in Zimbabwedispensing doctors in Zimbabwe Trap et al 2000 Trap et al 2000

2.31

28.4

58

8.65

1.67

9.5

48

13

0 10 20 30 40 50 60 70

no.drug items/Px

% Px with injections

% Px with antibiotics

consultation time (mins)

dispensing doctors non-dispensing doctors


Regulatory StrategiesRegulatory Strategies

Regulatory Strategies limit access to Regulatory Strategies limit access to drugs or constrain choices in order to drugs or constrain choices in order to save money or prevent improper use save money or prevent improper use of drugs. Sanctions are often defined of drugs. Sanctions are often defined for non-compliance.for non-compliance.


Regulatory Strategies: Restrict Decisions

Market ControlsBanning unsafe or Ineffective DrugsLimits on Product SelectionRegistration Based on Medical NeedDistribution Controls

Prescribing and Dispensing ControlsLevel-of-Use Prescribing RestrictionsRestricting Who Can Prescribe or DispenseLimits on Number of Different Drugs perPatient (e.g., "3-drug rule")Limits on Quantities of Each Drug (e.g., "3-Day Rule)


Monthly Proportions of Study Patients Monthly Proportions of Study Patients in Nursing Homes: Effect of Capsin Nursing Homes: Effect of Caps


Impact of enforcing a presciption-Impact of enforcing a presciption-only policy for antibiotics in Chileonly policy for antibiotics in Chile

0.2

0.25

0.3

0.35

0.4

1996 1997 1998 1999 2000 2001 2002

DD

D /

10

00

in

ha

bit

an

t d

ays

Source: Ballesteros and Cabello, ICIUM2004Source: Ballesteros and Cabello, ICIUM2004Source: Ballesteros and Cabello, ICIUM2004Source: Ballesteros and Cabello, ICIUM2004


Unintended Effects of RegulationUnintended Effects of Regulation

• Getting around restrictionsGetting around restrictions– Changes in record keeping (“diagnosis Changes in record keeping (“diagnosis

creep”)creep”)– Creation of a black marketCreation of a black market– Shifts from public to private sectorShifts from public to private sector

• Substitution effectsSubstitution effects– Alternate drugs may not be safer, more Alternate drugs may not be safer, more

clinically appropriate, or less costlyclinically appropriate, or less costly– Restricting drugs may increase other servicesRestricting drugs may increase other services


Choosing Managerial and Choosing Managerial and Regulatory StrategiesRegulatory Strategies

• Expected Magnitude of ImpactExpected Magnitude of Impact

• Likelihood for SuccessLikelihood for Success

• Potential for Unintended EffectsPotential for Unintended Effects

• Political and Cultural FeasibilityPolitical and Cultural Feasibility

• Technical FeasibilityTechnical Feasibility

• Cost (economic feasibility)Cost (economic feasibility)

• Potential for Donor SupportPotential for Donor Support


Activity TwoActivity Two

Regulatory Strategies in Regulatory Strategies in Use in Your CountriesUse in Your Countries


ConclusionConclusion

• Managerial, economic and regulatory Managerial, economic and regulatory strategies are more consistently effective strategies are more consistently effective as compared to educational onesas compared to educational ones

• Regulatory interventions may be Regulatory interventions may be associated with unintended effectsassociated with unintended effects

• Many health systems include perverse Many health systems include perverse financial incentives such as inappropriate financial incentives such as inappropriate user fees and dispensing doctorsuser fees and dispensing doctors

managerial and regulatory strategies to improve drug use

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