Trainer's Guide
Managerial and Regulatory Strategies

1. Recognize and understand the range of managerial and regulatory strategies which might be used to improve drug use.

2. Select for testing and possible implementation those strategies which appear best suited to your program's needs, circumstances, and resources based on consideration of expected magnitude of impact, likelihood of success, political and cultural feasibility, technical feasibility, and cost (economic feasibility).

Develop and implement chosen strategies as successfully as

Possible within the constraints of your program and environment.

PREPARATION

For this session the session notes, the overheads and the two activities are needed. Look through the session notes and think of examples of both managerial and regulatory actions that have been taken that you know about. Read through the case in Activity one and prepare your answers to the various questions.

This is a very full session if you are to discuss the examples in the notes and provide adequate time for the two activities. Allow at least 30 min for the first activity with 15 min for the second. Allow 15 min for debriefing on each activity. Plan to review managerial strategies and to start Activity one before the break. Allow time after the debriefing of Activity Two to summarize the key messages of the session. Review the Web posters from ICIUM so that you can discuss them at the end of the session as examples.

The main purpose of this session is to get participants to think of other interventions than training or educational ones when trying to change drug use behaviors. There are a number of key messages. These include:

Managerial interventions are likely to be effective but are a lot of work.

Both strategies require an understanding of the reasons for the problem behavior

Managerial interventions require continual revision and change to make them effective.

Regulatory interventions often have unintended effects and these should be expected and looked for

Combination or sequenced interventions are more likely to be effective

1. Title Slide
2. Objectives
3. Managerial Strategies
4. Managerial Strategies: Structure Decisions
5. Managerial Strategies: Structure Decisions
6. Audit and Feedback in Uganda
7. Regulatory Strategies
8. Regulatory Strategies: Restrict Decisions
9. Monthly Proportions of Study Patients in Nursing Homes: Effect of Caps
10. Choosing Managerial and Regulatory Strategies
11. Activity 1
12. Activity 2

First Component

· (30 minutes) 2 VA 's 1-5

Overview of Management Strategies

After reviewing the objectives discuss the VA reporting the results of the ICIUM review of well designed interventions. This has been previously presented in the Framework session. Point out that the managerial interventions were among the most consistently effective interventions when compared to educational approaches.

When discussing the definition compare the definitions for educational (guide) with regulatory (restrict) choices about drug use.

When discussing essential drug lists refer back to the session on Standard treatment guidelines and point out that the EDL can be used at many levels of the health system such as procurement, distribution, teaching examination, setting customs dues etc.

With regard to the use of the morbidity based quantification refer to the WHO manual and the MDS chapter 14 page 184. Give a simple example such as estimating the requirement for chloroquine based on the reported numbers of cases of malaria. You can also mention the value of calculating the consumption rates per outpatient seen for paracetemol and aspirin.

The role of supervisors in reviewing drug orders can also be discussed. Decision makers are often interested to know what percentage of drug expenditure is allocated to different therapeutic classes of drugs.

When discussing distribution interventions point out that data is frequently available at a central point and that generating comparative information of districts or similar hospitals can show dramatic differences which can reflect different practices.

Kit systems particularly in African countries generate heated discussions. Point out that while kit systems may improve distribution there are inevitably over and under supply with adverse effects on rational drug use.

For the discussion of prescribing and dispensing strategies reinforce the importance of STGs. This topic has previously been discussed in the session on STGs. Use this opportunity to stress the importance of ownership in the development of such guidelines. Structured drug order forms are often a new idea to participants. Point out that this approach is most suitable for large hospitals where a complex range of drugs are used. Automatic stop orders are often controversial. Generate discussion about possible sites for such an approach. Point out how frequently elderly patients receive many drugs or may have different providers each prescribing drugs. Course of therapy packaging may be in the form of blister packs or in pre-packs. These are popular with patients and may save money.

Labeling and packaging are clearly important but often neglected. Discuss the needs of illiterate patients. Refer to Pages 491-493 of MDS2. Discuss that graphical labeling may be culturally mediated and a new moon symbol may mean take monthly to some patients.

Audit and feedback is a technique which should be promoted though the difficulties should be noted. Refer to pages 472-475 in MDS2.

Second Component

· (20-30 minutes) 2 VA 's 6

Examples of Managerial interventions

The most important part of this session is to stress the value of audit and feedback as an effective tool to improve prescribing. Use the example of the Uganda study to discuss the process and to point out how easy it can be to evaluate the effect of an intervention. On the overheads and charts in the notes point out that the final three facilities were the intervention facilities showing the effect of reducing injection use and increasing or maintaining chloroquine tablet use. For the study in Nepal point out that these activities occurred at health posts and showed consistent improvements For the Uganda intervention point out that there was a practice of starting malaria treatment with a 5ml chloroquine injection which is an inadequate dose with significant side effects. Discuss the results of the study and point out that at Mulago hospital a regulatory approach was used with a limited and negative long term effect.

For the Nepal study stress that in this study they measured the effect of supervision on drug use indicators. The impact of the supervision was greater in public than private facilities. For the Gunung Kidul study ….

 

Third Component

· (60 minutes) 2 VA 's 11

Activity One Managerial strategies to change generic drug use in a teaching hospital

For this activity allow about 40 minutes for discussion and 20 minutes for debriefing

Make it clear that if a group finishes their questions they should move on to the next questions.

At the end of the debriefing session ask whether in participants countries Drug Utilization Evaluation (DUE) actually occurs and what reasons there may be for this lack of interest.

Fourth Component

· (45 minutes) 2 VA 's 7-9

Regulatory Strategies

Discuss the definition of regulatory (restrict) in relation to the definitions of educational (inform) and managerial (guide)

When discussing regulatory strategies reinforce the unintended consequences message both at the beginning and end of the session. Point out the effect of the WHO pink manual on antidiarrheals had the effect of reducing antidarrheal drug use (GOOD) but also had the effect of increasing metronidazole use in some countries (BAD). For each of the examples given point out possible unintended effects. For example for level of use restrictions may lead to blank prescriptions being signed. A three drugs per prescription regulation may lead to patients receiving two prescriptions etc etc.

The graphic of the nursing home restriction needs discussion. In this example the effect of the cap was to dramatically increase nursing home admissions at a cost of about $3,000 per month while making very limited savings in drug costs.

 

When discussing the Norway "medical need" clause point out that it was only because Norway joined the EU that they dropped their need clause. The banning of drugs always elicits fierce discussion. Use the Pakistan and Bangladesh example to report that when anti-diarrheals were banned the use of metronidazole increased dramatically. This was a an unintended effect which could have been predicted. When discussing the Level of use restrictions example from Zimbabwe point out that this approach can be combined with managerial approaches related to distribution. Level of use prescribing controls may work when health workers accept the need for restrictions. For example most doctors accept that cancer should be treated by specialists. For cytotoxics pharmacists may be limited to dispense only specialist prescriptions.

Dispensing controls e.g. three day rule or three drug rule are likely to have adverse effects. The three day rule may be used to bring patients back to boost attendance numbers. A three drug per prescription limit may result in two prescriptions being issued. Use the New Hampshire example to show the unintended effect of a drug "cap" on hospital admissions.

Fifth Component

· (10 minutes) 2 VA 's 10

Choosing Strategies to Test and Implement

This is a short component that feeds into the next session on Decision making. Go through the factors to consider quite quickly. Conclude by pointing out that frequently managerial and regulatory interventions will be combined with educational or other interventions.

Sixth Component

· (20 minutes) 2 VA 's 12

Regulatory Methods used in Different Countries

For this activity ask each group to list the regulatory measures used in each country. In the debriefing highlight how many regulations exist.

Conclude by summarizing that many managerial and regulatory strategies exist and that a manager must choose between a range of options. Remind participants that managerial interventions are likely to be effective but are a lot of work and that regulatory interventions may have unintended effects.

VISUAL AIDS WITH NOTES

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