1. Assessment of the Selection Process for the 2004 National List for Essential Drugs (NLED) of Thailand
Yoongthong W1, Kunaratanapruk S1, Sumpradit N1, Chongtrakul P2
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
Assessment of 2004 NLED selection Slide

3. Introduction 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
Assessment of 2004 NLED selection Slide

4. Quality of NLED (operationalization)
Study framework
Structure–Process–Outcome Model of Quality of Care
Introduced by Avedis Donabedian
Quality of care
Quality of NLED (operationalization)
Structure
Attributes of care setting e.g.,
Adequacy of facilities
Qualification of medical staff
Attributes of scoring
Information
Databases
Process
What 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
Outcome
Results 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

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

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

7. Methods: Study design 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
Assessment of 2004 NLED selection Slide

8. Results: Demographics
Factor
Classification
Branch one: Scoring
Branch two: non-scoring
Number %
Gender
Male 46
56.1 10
38.5
Female 36
43.9 17
61.5
Age range
30-39
20.0 2
7.1
40-49 27
31.8 11
39.3
50-59 35
41.2 15
53.6
60 or older 6
Career
Physician 62
71.3 14
50.0
Non-physician 25
28.7
Work place
University 43
49.4
Non-university 44
50.6
Responses from branch one are displayed for this presentation
Assessment of 2004 NLED selection Slide

9. Objective # 1: Overall opinions about NLED
Component
Items
Mean (SD)
Range
Structure
Appropriateness 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 databases
3.70 (0.65)
2.00 – 5.00
Process
Appropriateness of score transformation (5 items)
3.73 (0.52)
3.56 – 3.89
Outcome
Satisfaction with using panel’s judgment to adjust scores
4.07 (0.57)
Satisfaction with scoring as a selection tool
3.73 (0.73)
1.00 – 5.00
Satisfaction with the items selected in the NLED
3.84 (0.57)
Compatibility b/w selected items and NLED philosophy
3.51 (0.68)
Amount of drug items in the NLED (3 = appropriate)*
3.29 (0.74)
Other opinions
Compatibility b/w the selected items and one’s decision
3.30 (0.67)
Understanding about scoring system
3.70 (0.68)
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
Assessment of 2004 NLED selection Slide

10. Comparison of approaches Descriptive statistics
Objective # 2: Comparison of approaches and factors used in the NLED selection
Approaches used in the NLED selection (1=very inappropriate, 5=very appropriate)
Comparison of approaches
Descriptive statistics
t-statistics
Mean (SD) df t p
Expert opinion vs. NLED Scoring
2.33 (0.92) vs (0.82) 74
0.55
0.587
Expert opinion vs. Combined approach
2.33 (0.92) vs (0.68)
14.88
0.000
NLED Scoring vs. Combined approach
2.40 (0.82) vs (0.68)
16.91
Factors used by the panel in NLED selection (1 = never used, 5 = used a lot)
Rank
Factors
Mean (SD) 1
Community need
4.01 (0.99) 2
Ind. patient’s need
3.55 (0.97)
NLED philosophy
3.80 (0.89) 3
Reimbursement
2.99 (0.98)
Physician’s experience
3.68 (0.77) 4
Professional association
2.35 (1.11)
NLED Scoring
3.59 (0.74) 5
Family/friends’ need
1.55 (0.91)
Government budget
3.58 (0.85)
Drug company
1.52 (0.78)
Assessment of 2004 NLED selection Slide

11. Objective # 3: Structure-Process-Outcome relationship for the scoring approach
Information characteristics
R2 = 0.08
 = 0.78*
 = 0.59*
Satisfaction with scoring system
R2 = 0.32
 = 0.15**
Process of scoring transformation
R2 = 0.25
 = 0.56*
 = 0.28**
Satisfaction with items in NLED
R2 = 0.29
Quality of NLED
R2 = 0.36
Evidence-based databases
 = 0.003
Satisfaction with the use of panel’s judgment in score adjustment
 = 0.45*
* p < 0.001
** p < 0.05
Structure
Process
Intermediate Outcomes
Outcome
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.
Assessment of 2004 NLED selection Slide

12. Discussions 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
(R2 = 0.36).
Assessment of 2004 NLED selection Slide

13. Conclusions, Limitations & Recommendations
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.
Assessment of 2004 NLED selection Slide
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