1. Managerial and Regulatory Strategies to Improve Drug Use

2. Managerial and Regulatory Strategies to Improve Drug Use: Objectives
Recognize the range of managerial and regulatory strategies
Identify strategies best suited to program need
Successfully develop and implement strategies
Managerial and Regulatory Strategies

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

4. Managerial Strategies: Structure Decisions
Selection and Procurement
Essential Drug Lists
National Formulary
Morbidity-Based Quantification
Drug Procurement Review and
Feedback to Decision-Makers
Distribution
Distribution Review Process
Kit Supply Systems
Managerial and Regulatory Strategies

5. Managerial Strategies: Structure Decisions
Prescribing and Dispensing
Standard Diagnostic and
Treatment Guidelines
Structured Drug Order Forms
Automatic Stop Orders
Course-of-Therapy Packaging
Effective Labeling
Audits plus "Feedback" to Providers
Required Consultations or Justifications
Financing
Pricing Drugs According to Health Impact
Patient Cost-Sharing (e.g., $0.20 per prescription)
Managerial and Regulatory Strategies

6. Utilization Review (Audit) & Feedback to Prescribers
Establish Criteria
Collect data on prescribing (audit)
Feedback
To individuals or groups
Using letters or in person
Comparison
with standards
with peers
Managerial and Regulatory Strategies

7. Audit and Feedback in Uganda
Managerial and Regulatory Strategies

8. Impact of training & supervision on treatment according to STGs in Uganda
Managerial and Regulatory Strategies

9. Activity One
Managerial Strategies to Change Generic Drug Use in a Teaching Hospital
Managerial and Regulatory Strategies

10. Economic strategies: structuring decisions through economic incentives
Economic strategies are managerial strategies that use economic incentives to influence the decision process of prescribers and patients such that they use medicines in a more cost-effective manner.
Providers may be induced by budgets and financial incentives and patients by cost sharing.
Unfortunately many health systems include perverse financial incentives.
Managerial and Regulatory Strategies

11. Improving prescribing by changing the user fees (Holloway, Gautam & Reeves 2001)
Pre-post study with control
All 3 areas using flat fee per prescription in 1992
2 areas changed to a fee per drug item in
1 control area continued with the fee per Px during
Prescription (Px) surveys done in pre-intervention (1992) and post-intervention (1995)
10-12 health facilities per area, >30 prescriptions per facility
Managerial and Regulatory Strategies

12. Polypharmacy & Vit use on changing from a fee per Px (PxF) to a fee per drug item (IF)
Managerial and Regulatory Strategies

13. Injection and antibiotic use on changing from a fee/Px (PxF) to a fee/drug item (IF)
Managerial and Regulatory Strategies

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

15. PHC prescribing with & without Bamako initiative in Nigeria Scuzochukwu et al, HPP, 2002
Managerial and Regulatory Strategies

16. Prescribing by dispensing and non-dispensing doctors in Zimbabwe Trap et al 2000
Managerial and Regulatory Strategies

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

18. Regulatory Strategies: Restrict Decisions
Market Controls
Banning unsafe or Ineffective Drugs
Limits on Product Selection
Registration Based on Medical Need
Distribution Controls
Prescribing and Dispensing Controls
Level-of-Use Prescribing Restrictions
Restricting Who Can Prescribe or Dispense
Limits on Number of Different Drugs per
Patient (e.g., "3-drug rule")
Limits on Quantities of Each Drug (e.g., "3-Day Rule)
Managerial and Regulatory Strategies

19. Monthly Proportions of Study Patients in Nursing Homes: Effect of Caps
Managerial and Regulatory Strategies

20. Impact of enforcing a presciption-only policy for antibiotics in Chile
Source: Ballesteros and Cabello, ICIUM2004
Managerial and Regulatory Strategies

21. Unintended Effects of Regulation
Getting around restrictions
Changes in record keeping (“diagnosis creep”)
Creation of a black market
Shifts from public to private sector
Substitution effects
Alternate drugs may not be safer, more clinically appropriate, or less costly
Restricting drugs may increase other services
Managerial and Regulatory Strategies

22. Choosing Managerial and Regulatory Strategies
Expected Magnitude of Impact
Likelihood for Success
Potential for Unintended Effects
Political and Cultural Feasibility
Technical Feasibility
Cost (economic feasibility)
Potential for Donor Support
Managerial and Regulatory Strategies

23. Regulatory Strategies in
Activity Two
Regulatory Strategies in
Use in Your Countries
Managerial and Regulatory Strategies

24. Conclusion
Managerial, economic and regulatory strategies are more consistently effective as compared to educational ones
Regulatory interventions may be associated with unintended effects
Many health systems include perverse financial incentives such as inappropriate user fees and dispensing doctors
Managerial and Regulatory Strategies