Managerial and Regulatory Strategies to Improve Drug Use

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 1993-4 • 1 control area continued with the fee per Px during 1992-5 • 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. 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