Transcript Poster presentation

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
Abstract
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
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04.02.04
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
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04.02.04
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., Attributes of scoring
- Adequacy of facilities
- Information
- Qualification of medical staff - Databases
Process
What is actually done in
giving and receiving care e.g.,
- Technical style
Outcome Results of the care e.g.,
- Clinical end points
- Satisfaction with care
- Well-being, and etc.
Assessment of 2004 NLED selection
What is actually done in getting scores
- Transformation process from
information to scores
Results of scoring
- Satisfaction with scoring and outcome
- Compatibility of selected items with
NLED philosophy
- Amount of selected items
-Slide 3-
04.02.04
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
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04.02.04
Methods: Classification
15 Working Groups
Branch one: NLED Scoring
Branch two: Non-NLED
scoring
Consists of 11 working groups e.g.,
1. Neurology and Psychiatry
2. Cardiology
3. Infectious diseases
4. Dermatology
Consists of 4 working groups e.g.,
1. Occupational and Toxicology
2. Nutrition subgroup
3. Dentistry
4. Radiopharmaceuticals
Questionnaire A
Assessment of 2004 NLED selection
Questionnaire B
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04.02.04
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
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04.02.04
Results: Demographics
Factor
Classification
Career
Work
place
Branch two: non-scoring
Number
%
Number
%
46
56.1
10
38.5
Female
36
43.9
17
61.5
30-39
17
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
7.1
0
0
Physician
62
71.3
14
50.0
Non-physician
25
28.7
14
50.0
University
43
49.4
14
50.0
Non-university
44
50.6
14
50.0
Gender Male
Age
range
Branch one: Scoring
Responses from branch one are displayed for this presentation
Assessment of 2004 NLED selection
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04.02.04
Objective # 1: Overall opinions about NLED
Component
Items
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) 2.00 – 5.00
Other
opinions
Mean (SD)
Range
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) 2.00 – 5.00
Compatibility b/w selected items and NLED philosophy
3.51 (0.68) 2.00 – 5.00
Amount of drug items in the NLED (3 = appropriate)*
3.29 (0.74) 1.00 – 5.00
Compatibility b/w the selected items and one’s decision
3.30 (0.67) 2.00 – 5.00
Understanding about scoring system
3.70 (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
Assessment of 2004 NLED selection
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04.02.04
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. 2.40 (0.82)
74
0.55
0.587
Expert opinion vs. Combined approach
2.33 (0.92) vs. 4.32 (0.68)
74
14.88
0.000
NLED Scoring vs. Combined approach
2.40 (0.82) vs. 4.32 (0.68)
74
16.91
0.000
Factors used by the panel in NLED selection (1 = never used, 5 = used a lot)
Rank
1
2
Factors
Mean (SD)
Rank
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
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Factors
Mean (SD)
04.02.04
Objective # 3: Structure-Process-Outcome
relationship for the scoring approach
Information
characteristics
R2 = 0.08
 = 0.28**
 = 0.59*
Process of
scoring
transformation
R2 = 0.25
Evidence-based
 = 0.003
databases
 = 0.78*
Satisfaction with
scoring system
R2 = 0.32
Satisfaction with the
use of panel’s
judgment in score
adjustment
 = 0.15**
 = 0.56*
Satisfaction with
items in NLED
R2 = 0.29
Quality of
NLED
R2 = 0.36
 = 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
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04.02.04
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
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04.02.04
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 &of
DTC
advertising
Assessment
2004
NLED selection
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12-Slide
12-
04.01.04
04.02.04