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Assessment of the Selection Process for the 2004 National List for Essential Drugs (NLED) of Thailand Yoongthong W 1, Kunaratanapruk S 1, Sumpradit N 1,

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Presentation on theme: "Assessment of the Selection Process for the 2004 National List for Essential Drugs (NLED) of Thailand Yoongthong W 1, Kunaratanapruk S 1, Sumpradit N 1,"— Presentation transcript:

1 Assessment of the Selection Process for the 2004 National List for Essential Drugs (NLED) of Thailand Yoongthong W 1, Kunaratanapruk S 1, Sumpradit N 1, Chongtrakul P 2 1 Thai Food and Drug Administration 2 Chulalongkorn University

2 Abstract Assessment of 2004 NLED selection -Slide 1- 04.02.04 Problem Statement: Essential drugs (ED) satisfy the healthcare needs of the majority of the population. They must be effective, safe, and accessible. Careful selection of ED is important because it leads to a higher quality of care, better management of medicines/diseases, and more cost-effective use of health resources; and therefore ultimately improves public health as a whole. To achieve the goal, the ED selection process in Thailand dramatically changed from the use of an implicit system in 1999 (i.e., primarily relying on expert opinions) to an explicit system in 2003 (i.e., evidence-based medicines). In the explicit system, the evidence regarding characteristics of information (I), safety (S), administration restriction (a), frequency of use (f), and efficacy (E) of each medicine is calculated to form an ISafE score. The ISafE score divided by cost per patient per day generates a final score for that medicine. Although a majority of experts in NLED working groups appear to agree on the benefit of the scoring system in ED selection, it is important to evaluate this new method objectively. This study focuses on further understanding the system and how to improve its quality, as well as to promote the system’s sustainability. Objectives: To assess the NLED working groups’ opinions regarding the NLED selection. Specifically, we examine how the working groups think and feel about structure, process, and outcome associated with the establishment of the NLED. Design/Setting/Population: The study is based on a mailed survey with a self-administered questionnaire.Questionnaires were mailed to a total of 270 participants who are physicians and pharmacists officially appointed as experts and secretariats in in the 15 working groups for the NLED selection. Data collection has been conducted during Jan – Feb 2004. Outcome Measures: The questionnaire includes three major domains. The first set of questions relates to the assessment of structure, i.e., informational components and databases used in the NLED selection. The second set of questions involves the evaluation of process, i.e., the transformation of evidence-based drug information into scoring. The third set of questions involves the appraisal of outcomes, i.e., the composition (amounts and items) of the NLED. Responses will be recorded using a five-point scale from 1 (very inappropriate/ dissatisfied) to 5 (very appropriate/satisfied). Personal background will be requested as possible factors affecting opinions. The questionnaire was pre-tested for its validity. Results and Conclusions: The preliminary analyses (N = 67) showed that participants thought that publication quality, severity of drug’s risks, efficacy information, and cost is appropriate to use for the NLED selection process (mean scores equal 4.4, 4.2, 4.6, and 4.1, respectively). However, they were not sure about the appropriateness of the use of number of publication/drug’s risks, databases, and scoring transformation (mean scores of 3.7, 3.8, and 3.7, respectively). Overall they were moderately satisfied with the use of scoring system (3.7). Community’s need, NLED philosophy, physician’s experiences, and scoring were major factors that participants mostly used in the NLED selection, whereas influences from drug companies, family/friends, and medical professional association were least likely to be used. Submitted: February 15, 2004

3 Introduction Assessment of 2004 NLED selection -Slide 2- 04.02.04 Importance of the National List of Essential Drugs (NLED) –Promote rational use of medicines The NLED selection is changed. –In 1999, it mostly relied on scoring system that is based on expert opinions. –In 2004, the scoring system was exclusively based on evidence-based materials. However, consensus from the expert panels can modify scoring as appropriate. NLED Score is a tool to enhance objectivity and systematic approach to the ED selection process. NLED Score = ISafE score / Cost of treatment ISafE score is derived from an integration of data regarding Information, Safety, administration restriction, frequency of use, and Efficacy

4 Study framework Structure–Process–Outcome Model of Quality of Care Introduced by Avedis Donabedian Quality of careQuality of NLED (operationalization) StructureAttributes of care setting e.g., - Adequacy of facilities - Qualification of medical staff Attributes of scoring - Information - Databases ProcessWhat is actually done in giving and receiving care e.g., - Technical style What is actually done in getting scores - Transformation process from information to scores OutcomeResults of the care e.g., - Clinical end points - Satisfaction with care - Well-being, and etc. Results of scoring - Satisfaction with scoring and outcome - Compatibility of selected items with NLED philosophy - Amount of selected items Assessment of 2004 NLED selection -Slide 3- 04.02.04

5 Objectives Goal: To explore how experts in the NLED working groups think and feel about the 2004 selection process of NLED Objectives: Objective # 1: To examine overall opinions about scoring used in the NLED selection Objective # 2: To explore opinions about approaches and factors used in NLED selection Objective # 3: To investigate relationships between structure, process, and outcome components of the scoring approach used in the NLED selection Assessment of 2004 NLED selection -Slide 4- 04.02.04

6 Methods: Classification 15 Working Groups Branch one: NLED ScoringBranch two: Non-NLED scoring Questionnaire AQuestionnaire B Assessment of 2004 NLED selection -Slide 5- 04.02.04 Consists of 4 working groups e.g., 1.Occupational and Toxicology 2.Nutrition subgroup 3.Dentistry 4.Radiopharmaceuticals Consists of 11 working groups e.g., 1.Neurology and Psychiatry 2.Cardiology 3.Infectious diseases 4.Dermatology

7 Design –Exploratory study based on mailed survey of self-administered questionnaires Data collection procedures –Questionnaires were mailed to all staff members –Follow-up telephone calls were made to non-respondents –Overall response rate was 43% Measures –Structure: Appropriateness of information and databases –Process: Appropriateness of transformation from information to scoring –Outcome: Satisfaction: Satisfaction with scoring, Satisfaction with the selected items NLED Quality: Compatibility b/w the selected items with the NLED philosophy, and Amount of the selected items in NLED Methods: Study design Assessment of 2004 NLED selection -Slide 6- 04.02.04

8 Results: Demographics FactorClassificationBranch one: ScoringBranch two: non-scoring Number% % GenderMale4656.11038.5 Female3643.91761.5 Age range 30-391720.027.1 40-492731.81139.3 50-593541.21553.6 60 or older67.100 CareerPhysician6271.31450.0 Non-physician2528.71450.0 Work place University4349.41450.0 Non-university4450.61450.0 Assessment of 2004 NLED selection -Slide 7- 04.02.04 Responses from branch one are displayed for this presentation

9 Objective # 1: Overall opinions about NLED Assessment of 2004 NLED selection -Slide 8- 04.02.04 Component ItemsMean (SD)Range StructureAppropriateness of ISafE and cost information (12 items) 3.96 (0.43)3.46– 4.55 Appropriateness of evidence-based databases (6 items)3.82 (0.52)3.63 – 3.96 Satisfaction with evidence-based databases3.70 (0.65)2.00 – 5.00 ProcessAppropriateness of score transformation (5 items)3.73 (0.52)3.56 – 3.89 OutcomeSatisfaction with using panel’s judgment to adjust scores4.07 (0.57)2.00 – 5.00 Satisfaction with scoring as a selection tool3.73 (0.73)1.00 – 5.00 Satisfaction with the items selected in the NLED3.84 (0.57)2.00 – 5.00 Compatibility b/w selected items and NLED philosophy3.51 (0.68)2.00 – 5.00 Amount of drug items in the NLED (3 = appropriate)*3.29 (0.74)1.00 – 5.00 Other opinions Compatibility b/w the selected items and one’s decision3.30 (0.67)2.00 – 5.00 Understanding about scoring system3.70 (0.68)2.00 – 5.00 -Appropriateness/Satisfactory is measured with a 5-point bipolar scale: 5 = very appropriate/satisfied to 1 = very inappropriate/dissatisfied -* Amount of selected items is measured with a 5-point bipolar scale: 5 = too many to 1 = too few. -Compatibility/Understanding is measured a 5-point unipolar scale: 5 = very compatible/well understood to 1 = not at all compatible/understand

10 Objective # 2: Comparison of approaches and factors used in the NLED selection Assessment of 2004 NLED selection -Slide 9- 04.02.04 Comparison of approachesDescriptive statisticst-statistics Mean (SD)dftp Expert opinion vs. NLED Scoring2.33 (0.92) vs. 2.40 (0.82)740.550.587 Expert opinion vs. Combined approach2.33 (0.92) vs. 4.32 (0.68)7414.880.000 NLED Scoring vs. Combined approach2.40 (0.82) vs. 4.32 (0.68)7416.910.000 RankFactorsMean (SD)RankFactorsMean (SD) 1Community need4.01 (0.99)2Ind. patient’s need3.55 (0.97) NLED philosophy3.80 (0.89)3Reimbursement2.99 (0.98) 2Physician’s experience3.68 (0.77)4Professional association2.35 (1.11) NLED Scoring3.59 (0.74)5Family/friends’ need1.55 (0.91) Government budget3.58 (0.85)Drug company1.52 (0.78) Factors used by the panel in NLED selection (1 = never used, 5 = used a lot) Approaches used in the NLED selection (1=very inappropriate, 5=very appropriate)

11 Objective # 3: Structure-Process-Outcome relationship for the scoring approach  = 0.28**  = 0.15**  = 0.003  = 0.56*  = 0.45*  = 0.78*  = 0.59* Information characteristics R 2 = 0.08 Evidence-based databases Process of scoring transformation R 2 = 0.25 Satisfaction with the use of panel’s judgment in score adjustment Satisfaction with scoring system R 2 = 0.32 Quality of NLED R 2 = 0.36 StructureProcessOutcome Satisfaction with items in NLED R 2 = 0.29 Intermediate Outcomes Assessment of 2004 NLED selection -Slide 10- 04.02.04 The panel thought that NLED scoring approach could increase the NLED quality. - Appropriate information increases the appropriateness of the scoring transformation. - When the scoring transformation is appropriate, satisfaction with the scoring system increases. - Satisfaction with scoring system and panel’s judgment in score adjustment leads to the satisfaction with items selected in the NLED - Satisfaction with the items selected into the NLED increases participants’ evaluation of NLED quality. * p < 0.001 ** p < 0.05

12 Discussions Assessment of 2004 NLED selection -Slide 11- 04.02.04 Objective 1: Participants had favorable opinions about the 2004 NLED scoring approach (i.e., majority of responses had mean scores >= 3.5). This is probably because: NLED scoring approach may simulate panel’s thinking process of drug evaluation It is based on well-established clinical evidence, and therefore it is accepted by the panel The magnitude of favorability may be improved if: the panels understand NLED scoring approach better (mean score = 3.7) revisions are made to address the panel’s concerns about NLED scoring approach Objective 2: NLED Scoring approach with expert opinion is viewed as the most appropriate way. This is probably because: The combined approach may minimize limitations of each other. Objective 3: Structure-Process-Outcome relationship NLED Scoring approach partially addresses participants’ views of the NLED quality ( R 2 = 0.36).

13 Conclusions, Limitations & Recommendations Conclusions –The 2004 NLED scoring approach is useful for the establishment of the national list of essential medicines. Limitations –Data collection was conducted during different stages of selection process among working groups –Adoption level of scoring approach is different among working groups Recommendations –NLED scoring system needs further revisions. –Intensive training for the panel is necessary. Motivation & DTC advertising -Slide 12- 04.01.04 Assessment of 2004 NLED selection -Slide 12- 04.02.04


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