Abstract

1. Abstract Impact of the National Healthcare Reform on Prescribing Patterns of Promotional Targeted Drugs among Thai Physicians Layton MR*, Chadbunchachai S*,Thinkhamrop B**,Tangcharoensathien V*** *Faculty of Pharmaceutical Sciences, Khon Kaen University, Thailand. **Faculty of Public Health, Khon Kaen University, Thailand. ***International Health Policy Program, Ministry of Public Health, Thailand. Problem Statement: Worldwide, the 1990’s witnessed the introduction of many promotional targeted drugs (PTD). Despite the fact that these newer drugs have been rapidly adopted in the global therapeutic practice, little is known about the prescribing patterns of PTD among Thai physicians, especially since the enactment of the national health care reform. Objective: To assess the impact of the reform on prescribing patterns of PTDs among Thai physicians at a teaching hospital. Design: Retrospective outpatient prescription records of PTDs between 1998 – 2003 were reviewed and compared with data of the established drugs in their respective categories. In addition, a qualitative study on how the PTD were enlisted in the hospital formulary was incorporated. The study was approved by the Institutional Review Board, Khon Kaen University. Setting: Outpatient department at a teaching hospital in Thailand. Study Population: Based on the PTD definition stated in the inclusion criteria, two new drugs – a Statin (PTD-M1) and a COX-2 inhibitor (PTD-O1) were identified as PTDs. The electronic outpatient dispensing data from the pharmacy department were retrieved. Qualitative data from in-depth interviews with the secretary team of the Pharmacy & Therapeutic Committee (PTC) including documents on the PTD drug approval process were also assembled. Outcome measures: The data of both PTDs and related drugs on daily dose prescribed, total numbers of prescriptions and days supplied, total sales volume and value, payment scheme, and descriptive information on the PTC approval process were compared with the respective prescribing departments. Results: The data of both PTDs showed significant increases in drug use even after the new healthcare policy was enacted. The majority of the drug costs was cash payment - either paid out-of-pocket by the patients or by other reimbursable insurance schemes. While there was evidence that many physicians complied with the cost containment policy, the data also reflected that some of the PTC’s prescribing restrictions were commonly violated. Conclusion: This exploratory study at a teaching and training hospital reveals an urgent need for further in-depth investigation on critical factors influencing physician prescribing behavior of a promoted drug. Ultimately, it may be necessary to consider any practical policies to curb the escalating drug cost and promote rational drug use in the country.

2. Background & Significance • The 1990’s witnessed the introduction of many promotional targeted drugs (PTD) worldwide with visibly increasing promotional budget • In October 2001, the Universal Coverage Reform was enacted and viewed as a threat to the pharmaceutical market, especially to the global-branded industry • Some prescribing restrictions such as requirement of authorized physicians’ signatures and license no., only designated list of specialists • In 2003, Thailand Total Pharmaceutical Market Value was 44,800 M.Baht (+13% growth),whichthe market shares of the global and local brands in the medical channel were 67% (+21%growth) and 33% (+9%), respectively

3. Objective • To assess the impact of health care reform on PTDprescribing pattern among Thai physicians at a teaching school hospital where the training site & modeling for the future doctors’ prescribing pattern is located • Based on the PTD inclusion criteria (ie. Relatively new and launched in both global and Thai markets, Global-branded product, Expensive,Visible/known promotional activities, Potentially cause some drug-related problems), a Statin (PTD-M1) and a COX-2 inhibitor (PTD-O1) were identified as PTDs

4. Methods • A retrospective review of electronic outpatient prescription records of the PTDs at a teaching hospital in Thailandbefore and after the enactment of the national healthcare reform was examined and compared with data of the established drugs in their respective categories e.g. (O2-Branded, M2-Branded, and M3-Generic) • In addition, in-depth interviews with the secretary team of the Pharmacy & Therapeutic Committee (PTC) including documents on the PTD drug approval process were also assembled • Approval from both the Institutional Review Board as well as the Director of the hospitalwere obtained prior to the study

5. Results 1: PTD-O1 and Other COX-2 Inhibitors PTD - O1 O2 • Date of PTC approval Nov 2001 Jul 2000 • Duration of data analysis 2001-2003 2000-2003 • Drug category Non ED ED • Current unit price 30 Baht 17 Baht • Total no. of prescriptions 1,760 11,902 • Total sales volume (Tab/Cap) 84,198 438,049 • Total sales value (Baht) 1,830,225 5,601,125 • Average daily dose prescribed 1.3 1.2 (Tab/Cap) • Avg. quantity prescribed / visit 34.3 27.5 • Avg. no. of days supplied 27.6 23.0 • Avg. price per prescription 1,030.50 468.50 • Payment type: Cash 70.8%67.4% Social Security 3.4% 3.8% 30 Baht Scheme 0.2% 3.0% CSMBS 28.6% 24.2% Others - 1.6%

6. ฿ 350 , 000 ฿ 300 , 000 October 2001: Starting Healthcare Reform ฿ 250 , 000 ฿ 200 , 000 PTD – O 1 O 2 ฿ 150 , 000 Sales Value (Baht) ฿ 100 , 000 ฿ 50 , 000 ฿ 0 2000 2000 2001 2001 2002 2002 2003 2003 2000 2000 2001 2001 2002 2002 2003 2003 Apr Apr Apr Apr JAN Jul Jul Jul Jul Oct Jan Oct Jan Oct Jan Oct Months/Years - Figure 1: Total Sales Value of Cox-2 (2000-2003)

7. Results 2: PTD-M1 and Other Statins PTD - M1 M2 M3 20mg 40mg 10mg • Date of PTC approval 7/2001 11/ 2001 11/2001 • Duration of data analysis 2001-2003 1998-2003 2001-2003 • Drug category ED ED ED • Current unit price 60 Baht 42 Baht 3.50 Baht • Total no. of prescriptions 5,556 9,857 13,690 • Total sales volume 193,975 438,049 1,779,044 • Total sales value 13.3 M 16.0 M 4.3 M • Average daily mg prescribed 709.2 796.1 1,301.5 • Avg. quantity per visit 40.2 34.3 77.4 • Avg. no. of days supplied 55.1 48.0 56.5 • Avg. price per prescription 2,426 1,631 318.9 • Payment type: Cash 73.4% 66.4%70.5% Social Security 0.6% 1.5% 3.1% 30 Baht Scheme 0.3% 0.1% 8.4% CSMBS 25.7% 31.7% 16.2% Others - 0.3% 1.8%

8. ฿ 700 , 000 October 2001: Starting Health Care Reform ฿ 600 , 000 ฿ 500 , 000 Baht ) ฿ 400 , 000 M2 M3 Sales Value ฿ 300 , 000 PTD-M1 ฿ 200 , 000 ฿ 100 , 000 ฿ 0 1998 1999 2000 2001 2002 2003 Year Figure 2: Total Sales Value of Statins (1998 – 2003)

9. 90 80 70 60 Ratio to O-2 50 40 Trend line of PTD-O1 to O2 30 20 10 0 15 10 Ratio to M2 Ratio to M3 5 Trend line of M3 0.5 Trend line of M2 2000 2003 2000 2001 2001 2001 2002 2002 2002 2003 2003 2002 2003 2001 May May May Aug Aug Nov Aug Aug Feb Nov Nov Nov Feb Feb 0.2 Figure 3: Ratio of Adjusted Sales Volume PTD-O1 to O2 (2001-2003) Figure 4: Ratio of Adjusted Sales Volume PTD-M1 to M2 & M3 (2000-2003)

10. Summary • Both of the observed PTDs showed significant increases in drug use even after the new healthcare policy was enacted. • Except comparing with the generic ED, the PTDs showed higher rate of sales off take than the traditional existing drugs • The majority of the drug costs were cash payment and CSMBS ie. either paid out-of-pocket by the patients or by other reimbursable insurance schemes, thus could be burdensometo the society as a whole • While there was evidence that many physicians complied with the hospital’s cost containment policy, the data also reflected that some of the PTC’s prescribing restrictions were commonly violated

11. Limitation & Discussion • An exploratory study at only one site, a teaching hospital in Thailand. Other setting ie. Regional and Private hospitals may reflect different outcomes due to different nature of both patients and hospital policy management • Using OPD dispensing data at the hospital pharmacy only with lack of records on prescribers and diagnosis

12. Conclusion & Implication • Various marketing strategies and promotional efforts have been successfully exercised by multinational companies to sustain the drug product life cycle even facing the market threat like the national healthcare reform • Out of pocket payment by UC members for ambulatory care is not uncommon if UC beneficiaries perceived low quality of generic products • It may be critical to consider any practical policies to curb the drug cost and promote rational drug use in the country