Objectives

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					   Managerial and
Regulatory Strategies to
  Improve Drug Use



                           1
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   2
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   3
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   4
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   5
 Utilization Review (Audit) &
 Feedback to Prescribers
                 Establish Criteria

                   Collect data on
                   prescribing (audit)


Feedback                            Comparison
• To individuals or groups          • with standards
• Using letters or in person        • with peers
                                    Managerial and Regulatory Strategies   6
Audit and Feedback in Uganda




                    Managerial and Regulatory Strategies   7
Impact of training & supervision on
treatment according to STGs in Uganda

                   60

                   50
% STG compliance




                   40

                   30

                   20

                   10

                   0
                        Control   STG           STG+train         STG+train+sup

                                   Pre   Post
                                                      Managerial and Regulatory Strategies   8
Activity One




    Managerial Strategies to Change Generic
       Drug Use in a Teaching Hospital
                                Managerial and Regulatory Strategies   9
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   10
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   11
Polypharmacy & Vit use on changing from a
fee per Px (PxF) to a fee per drug item (IF)


     Av. no. drugs per patient               % patients pres vitamins, tonics
4                                       30
3                                       20
2
                                        10
1
0                                       0
    PxF       1-band IF     2-band IF           PxF           1-band IF           2-band IF

            1992 1995                                      1992 1995
                                                      Managerial and Regulatory Strategies    12
Injection and antibiotic use on changing
from a fee/Px (PxF) to a fee/drug item (IF)


     % patients prescribed injections           % patients pres. antibiotics
25                                         80
20                                         60
15
                                           40
10
 5                                         20
 0                                         0
        PxF       1-band IF    2-band IF        PxF           1-band IF           2-band IF
                 1992 1995                                  1992 1995
                                                      Managerial and Regulatory Strategies    13
Treatment cost and compliance with STGs
on changing from fee/Px (PxF) to a fee/drug
item (IF)

     % patients treated according to STGs           Av. drug cost per patient (NRs)
60                                             40
40                                             30
                                               20
20
                                               10
0                                              0
        PxF         1-band IF      2-band IF        PxF            1-band IF           2-band IF
                  1992 1995                                       1992 1995
                                                          Managerial and Regulatory Strategies     14
   PHC prescribing with & without Bamako
   initiative in Nigeria Scuzochukwu et al, HPP, 2002

 no.EDL drugs avail                15.3
                                                 35.4
  % pres EDL drugs                   21
                                                                                               93
% Px with antibiotics                     25.6
                                                                     64.7
% Px with injections                              38
                                                                             72.8
   no.drug items/Px         2.1
                             5.3

                        0          20            40          60                 80             100

             21 Bamako PHCs             12 non-Bamako PHCs
                                                        Managerial and Regulatory Strategies   15
Prescribing by dispensing and non-
dispensing doctors in Zimbabwe Trap et al 2000


consultation time (mins)             13
                                  8.65

   % Px with antibiotics                                               48
                                                                                   58
    % Px with injections              9.5
                                                 28.4

       no.drug items/Px        1.67
                               2.31

                           0     10         20   30       40          50          60      70

           dispensing doctors          non-dispensing doctors
                                                  Managerial and Regulatory Strategies   16
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   17
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   18
Monthly Proportions of Study Patients
in Nursing Homes: Effect of Caps




                         Managerial and Regulatory Strategies   19
Impact of enforcing a presciption-
only policy for antibiotics in Chile
                                                                                      0.4




                                                                                              DDD / 1000 inhabitant days
                                                                                      0.35



                                                                                      0.3



                                                                                      0.25



                                                                                      0.2
 1996        1997        1998        1999       2000         2001              2002

        Source: Ballesteros and Cabello, ICIUM2004
                                                       Managerial and Regulatory Strategies                          20
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   21
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   22
Activity Two




       Regulatory Strategies in
        Use in Your Countries




                            Managerial and Regulatory Strategies   23
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   24