Does Drug Use Evaluation Required by National Policy Improve Use of Medicines?

1. Does Drug Use Evaluation Required by National Policy Improve Use of Medicines? Akaleephan C*, Muenpa R**, Sittitanyakit B***,Treesak C#, Cheawchanwattana A$, Limwattananon S$, Limwattananon C$, Tangcharoensathien V* *International Health Policy Programme

2. Abstract Akaleephan C*, Muenpa R**, Sittitanyakit B***,Treesak C#, Cheawchanwattana A$, Limwattananon S$, Limwattananon C$, Tangcharoensathien V* *International Health Policy Programme-Thailand, **Lumpang Hospital, ***KhonKaen Hospital, Srinakharinwirot University#, $KhonKaen University Problem Statement: Drug Use Evaluation(DUE) was first introduced to Thailand’s Ministry of Public Health (MoPH) hospitals in 1991. Annual surveys of pharmacy activities in 92 MoPH hospitals during 1995-1999, indicated that DUE existed in 30-50% of them, however only 7.5% was continuous DUE monitoring. DUE was strengthened by the policy statementin the 1999 National Essential Drug List (NEDL) and the 1998 MoPH post-economic crisis drug management reforms under Good Health at Low CostPolicy. Objectives: To assess the DUE situation in Thailand regarding policy implementation and outcomes on rational drug use; to assess health professionals’ perspectivestowards and experienceon DUE and its constraints since the program was strengthened in 2000. Design: Prospective, time-series design Setting: 100 MoPH hospitals,1 university hospital, and 4 defense hospitals. Intervention: Four antimicrobialsand two cardiovascular drugswere selected as tracers. DUE package for the 6 drugs, (consist of evaluation criteria of 6 drugs use, guideline on DUE procedure, drug order forms, data collection forms and report forms) were developed by researcher. A national meeting of the chairpersons and secretariat of hospitals’ DTC was organized to disseminate the policy messages and DUE package for the 6 drugs in 2000. A self administered questionnaires survey of hospital pharmacists’ perspective, experience and constraints was conducted and another survey of physicians’perspective in 2 regional hospitals with 10-year experiences in DUE was also conducted at the end of 2002. Outcome Measures: %hospitals having DUE in pre- and post-policy implementation; %appropriateness of indication and dosage regimen; incidence of adverse events; %self evaluation competency of hospital pharmacists; and %DUE perspective of physicians. Results: The survey of pharmacy activities showed increasing proportionamong 92 MoPH hospitals having aqualitative or quantitative DUE program, from 19.7% in 1999 to 82% in 2000. Qualitative DUE data were spontaneously reported with an average 30% reporting rate. The rate decreased over the 3 six-monthly period during June 2000 to December 2001. The rates of appropriate indication for using pentoxiphylline and statin (primary prevention) tablets were 30-57%, higher rates of 44-90% were found among other drugs. A questionnaire survey of 450 hospital pharmacists indicated that 32% had insufficient knowledge to set up DUE criteria, while 47% was able to analyse data. The constraints in conducting DUE were described. It was found that 94% and 44% of physicians in hospital 1 and 2, respectively, misunderstood that DUE is the compulsory use of drug order forms for restricted drugs. Conclusions: The national policy was effective in encouraging DUE; however, there is room for improvement. Therapeutic outcomes of drug use should be assessed. Current lack of proper understandings on DUE illustrated existing problems.

3. Background • Drug Use Evaluation(DUE) was first introduced to Thailand Ministry of Public Health (MoPH) hospitals as a component of clinical pharmacy package in 1991. In 1995-1999 annual surveys of pharmacy activities of all 92 provincial and regional hospitals indicated that DUE was existing in 30-50% of these hospitals, however, 7.5% had a continuous DUE program. During 1992 to 2002, most (74%) DUE conducted were qualitative studies, focusing on antimicrobials and the rest were quantitative evaluation and prescribing pattern review. • Since 1998, DUE has been addressed within the framework of two key policies. • First, the high cost or high risk drugs in sub-list D in the 1999 National List of Essential Drug (NLED) enforced a mandatory DUE program if a hospital adopt this list. • Second, DUE was advocated in the MoPH post-economic crisis drug management reforms under Good Health at Low Cost Policy banner.

4. Objectives • To assess the DUE situation in Thailand regarding policy implementation and outcomes in term of rational drug use • To assess health professionals’ perspectives towards and experiences on DUE and programmatic constraints since its strengthening in 2000 Methodology 1. Six drugs, namely, ceftazidime injection, imipenem plus cilastatin injection, ciprofloxacin injection and tablet, statins tablet and pentoxiphylline tablet were selected as tracers. • Selection criteria of tracers included in: • The sublist D classification in the 1999 NLED • The top 50 drug expenditure of MoPH hospitals (latest figures in 1998, 1999) • The list of top 100 drug manufactured domestically and imported value (latest figure in 1997, 1998)

5. Methodology (cont.) 2. DUE package: Drug use criteria were set up mainly based on NLED recommended indication. Guideline on DUE procedure, drug order forms, data collection form and report forms were also developed. 3. A national meeting of chairpersons and secretariats of hospital drug and therapeutic committee(DTC) was organized to disseminate the policy messages and DUE package of tracers in March 2000. 4. The voluntary reports of qualitative DUE of tracer drugs (June 2000 to December 2001) were analyzed. 5. Self administered questionnaire survey of hospital pharmacists’ perspectives, experience and constraints were conducted in a national academic meeting on pharmaceutical care in November 2002. 6. Self administered questionnaire survey of physicians’ perspectives in two regional hospitals with 10-year experiences in DUE was conducted in December 2002.

6. Discussion 1. Average voluntary reporting rate was 30%, with a decreasing trend over 3 six-monthly periods during June 2000 to December 2001. 2. The high percentage of appropriateness in most tracers in this study, does not represent a national picture. Voluntary reporting may biased towards good performance hospitals. Thus, there is room for strengthen DUE program to cover more hospitals. 3. According to NLED 1999 recommended indication, pentoxiphylline tablet had the lowest appropriateness. It needs further verification and specific intervention. 4. Therapeutic outcomes of drug use should be assessed and strengthened, for example adverse drug reactions in general and lipid blood level for lipid lowering drug.

7. Conclusion & recommendation 1. The national policy encourages DUE in hospitals, however, continual enforcement and concomitant monitoring and technical support are recommended. 2. Current lack of proper understandings on DUE concept illustrated existing problem. Insufficient knowledge and skill in clinical pharmacy or pharmaceutical care, and coordination among pharmacists and physicians were also found. This prompts to increase awareness and training needs to strengthen DUE.

8. Result 1. Percentage of regional and provincial hospitals responded to DUE policies Policy introduction

9. 2. Percentage of indication appropriateness

10. 2. Percentage of indication appropriateness statin-1 = statin primary prevention, statin-2 = statin secondary prevention

11. 3. Appropriateness in dosage regimen • Dose appropriateness: more than 70% in patients without renal problem but 27-78% in patients with renal insufficiency due to lack of confidence to adjust dose in severe and serious infection • Dosage interval appropriateness: more than 90% 4. Incidence of adverse drug reaction unable to estimate because of insufficient data

12. 5. Hospital pharmacists’ self evaluation (n = 450, 64% response rate) • 32% had insufficient knowledge to set up drug use criteria • 48% was able to modify the MoPH standard criteria • 47% was able to analyze data • constraints in conducting DUE were described: difficulty in patient profile evaluation, inadequate skill in clinical pharmacy, lack of coordination among physicians and pharmacists

13. 6. Physicians’ perspectives in 2 regional hospitals (n = 110)