Managerial and Regulatory Strategies to Improve Drug Use

Trainer's Guide

Managerial and Regulatory Strategies to Improve Drug Use

Managerial and Regulatory Strategies to Improve Drug Use

TRAINER'S GUIDE

OBJECTIVES

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).

3.  Develop and implement chosen strategies as successfully as possible within constraints of your program and environment.

MATERIALS AND 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.

TIME 3.5 hours plus. 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

VISUAL AIDS

1.  Title slide

2.  Objectives

3.  Managerial strategies

4.  Managerial strategies: Structure decisions (1)

5.  Managerial strategies: Structure decisions (2)

6.  Utilisation review and feedback to prescribers

7.  Audit and feedback in Uganda

8.  Impact of training and supervision on treatment according to STGs in Uganda

9.  Activity 1

10. Economic strategies: structuring decisions through economic incentives

11. Improving prescribing by changing the user fees

12. Polypharmacy and vitamin use on changing from a fee per prescription to a fee per drug item

13. Injection and antibiotic use on changing from a fee per prescription to a fee per drug item

14. Treatment cost and compliance with STGs on changing from a fee per prescription to a fee per drug item

15. Primary health care prescribing with and without Bamako Initiative in Nigeria

16. Prescribing by dispensing and non-dispensing doctors in Zimbabwe

17. Regulatory strategies

18. Regulatory strategies: Restrict decisions

19. Monthly proportions of Study Patients in Nursing Homes: Effect of Caps

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

21. Unintended effects of regulation

22. Choosing managerial and regulatory strategies

23. Activity 2

24. Conclusion

ORGANIZATION AND KEY POINTS OF SESSION

First Component

· 45 minutes 2 VAs 1-5

Overview of Management Strategies

After reviewing the objectives and the definitions of managerial and regulatory interventions, point out that managerial interventions are among the most consistently effective when compared to educational approaches.

The long list of managerial interventions on page 1 of the session guide and VAs 4-5 needs to be broken up and discussed in detail. Ask for experiences with the use of EDL’s for ordering. Discuss the strengths and weaknesses of morbidity based quantification as a basis for supply. Discuss the procedures which could be used for reviewing drug orders pointing out the danger of delays balanced against the value of external review. Discuss the value of leveled EDLs.

When discussing distribution controls point out the value of comparing reported morbidity patterns with the drug consumption by facilities. Calculating simple ratios such as chloroquin tablets per reported case of malaria by facility gives a wide range of practice for what should be standard. Other ratios that could be used could be tablets aspirin or paracetemol per outpatient seen etc. 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.

When discussing kits point out that many of the benefits and problems are well described in the MDS Chapter 27. Point out that while kit systems may improve distribution there are inevitably over and under supply with adverse effects on rational use.

When discussing prescribing and dispensing point out how important STGs are and what a powerful intervention is developing or revising these guidelines. The topic of STGs is discussed in a separate session so not too much time need be devoted to STGs. However, the opportunity may be used to stress the importance of ownership in the development of such guidelines. In this respect, on may ask for experiences and discuss the value of having low level health workers involved in the process.

Structured order forms are often a new idea to participants. Point out that this approach is suitable for large hospitals where a complex range of drugs are used. Course of therapy packaging may be in the form of blister packs or in pre-packs, which are often popular with patients and may save money.

Labelling and packaging are clearly important but often neglected. Discuss the needs of illiterate patients and point out that graphical labeling may be culturally mediated. Refer to pages 491-493 of MDS.

Second Component

· 30 minutes 2 VA 6-8

Examples of managerial interventions

A very 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 [VA 6-7] 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 chloroquin tablet use. Point out that there was a practice of starting malaria treatment with a 5ml chloroquin 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 study in Nepal point out that these activities occurred at health posts and showed consistent improvements - no VA for this study.]

In VA8 point out how STG distribution alone has little effect but that large impacts can be achieved if the STGs distribution is accompanied by training and supervision. Similar results - printed materials alone having little impact unless accompanied by training - have been found world-wide.

Third Component

· 30 minutes, plus 15 minutes debriefing 2 VA 9

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

For this activity allow 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 the participants' countries, drug utilization evaluation (DUE) actually occurs and what reasons there may be for this lack of interest.

Fourth Component

· 30 minutes 2 VA 10-16

Economic strategies

Another very important part of this session is to stress the value of economic strategies to improve prescribing. Use the example in VAs 11-14 to discuss the effect of user fees on prescriber and patient behaviour. Explain the different kinds of user fee. The flat fee is a single-rate fee covering all the drugs prescribed to a patient in whatever amounts. As such, it is similar to registration fees or consultation fees which cover all treatment. In this study the flat fee was 5 Nepali Rupees (NRs) per patient and charged in all districts in 1992 (pre-intervention) and NRs. 7 in the control district in 1995 (post-intervention). Two different systems for charging a fee per drug item were introduced in 1993-4 in the intervention districts. One system (1-band item fee), introduced into one of the intervention districts, involved charging a single rate of NRs.3 per drug item. Thus a patient receiving two drugs paid NRs.6 and a patient receiving three drugs paid NRs.9, irrespective of the type of drug given or in whatever quantity. The other system (2-band item fee), introduced into the other intervention district, involved charging two rates, NRs.5 for an expensive drug such as an antibiotic or an injection and NRs.2 for a cheaper drug such as paracetamol, aspirin or mebendazole. Thus a patient receiving an antibiotic and paracetamol paid NRs.7 (i.e. 5+2=7) irrespective of the quantity of each drug (number of tablets) given. The different user fee types were set such that the average patient treated with two drugs (the maximum recommended in the national STGs for the majority of common diseases) would pay a total of NRs.6-7 irrespective of fee type. It was found that there was more rational prescribing with both types of item fee as compared to the flat fee in terms of fewer drugs per patient, fewer patients prescribed antibiotics and vitamins, more patients treated in compliance with standard treatment guidelines, and relatively less average drug cost per prescription. The 2-band item fee, where a higher fee was charged for injections, was associated with reduced injection use as compared to the flat fee. All changes were statistically significant. This study was accompanied by qualitative investigation that showed that the reason for these prescribing changes was that both patients and prescribers felt less inclined to have more medicines, when they had to pay more for them. In other words, a flat fee per patient encouraged polypharmacy because everyone felt "Why have one medicine when one can have more medicines for the same total fee?"

VA 15 shows the impact of the Bamako Initiative in Nigeria. Explain that the Bamako Initiative is a system where patients are charged the full cost of the drugs that they receive and that this money is used to procure more drugs and to improve the services at the primary health care facility. Point out that in this study the facilities operating the BI were compared to those not operating the BI where drugs were dispensed free and there was no extra money to purchase extra drugs. The study clearly shows that in the BI facilities, as compared to the non-BI facilities, drug availability was much better and prescribers used more generic drugs and drugs belonging to the Essential drug list. Unfortunately, the prescribing in the BI facilities was much poorer in terms of the number of drugs per patient and the % patients receiving antibiotics or injections. Furthermore, the effect of the BI on utilization of the health facility was not measured. Point out that in other studies, user fees charging the full cost of the drugs have been associated with greatly reduced utilization of health facilities i.e. decreased access due to patients being unable to pay the fees.

The graphic [VA 16] compares prescribing by dispensing and non-dispensing doctors in Zimbabwe. Point out that the dispensing doctors gain profit from dispensing the medicines they prescribe while the non-dispensing ones do not. The study shows quite clearly that the dispensing doctors prescribed more drugs, more antibiotics and more injections and spent less time with their patients as compared to the non-dispensing doctors. Similar findings have been found world-wide and it was recommended at the 2nd international conference on improving the use of medicines in 2004 that prescribing and dispensing functions be separated through regulation.

Fifth Component

· 30 minutes 2 VA 17 - 21

Regulatory Strategies

When discussing regulatory strategies [VA 17-21] reinforce the point - both at the beginning and end of the session - that regulatory interventions may have unintended consequences. 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.

The graphic [VA 19] 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.