Lao People Democratic Republic Peace Independence Democracy Unity and Prosperity ______OOOO______
Ministry of Health Food and Drug Department Tel : (856) 21 21 4013-4 Fax: (856) 21 21 4015
Final Report Pilot of Information Education Communication (IEC) Strategy for combating counterfeit and substandard medicines in Lao PDR
Supported by: United States Pharmacopeia (USP) through the promoting the Quality of Medicines (PQM) program, the United States Embassy Public Affair Office (US EPAO)
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Back ground: Counterfeit and substandard medicines are a major concern in Lao PDR, particularly where they affect medicines used for the treatment of acute life-threatening illnesses like malaria, and illnesses affecting mothers and children. The Food and Drug Department of the Ministry of Health has been working with the United States Pharmacopoeial Convention’s Promoting Quality Medicines program since 2003 in an effort to improve the standard of medicines available in Lao PDR. Over that time, significant gains have been made in reducing the number of poor quality medicines available in Laos. FDD has undertaken this pilot study to evaluate the effectiveness of IEC material in increasing public awareness of poor quality medicines, and providing education to pharmacists and the public about the dangers they pose. This project was supported by USAID/RDMA-PMI with a grant of 12,917 USD to conduct a two-phased assessment of the impact of IEC material placed in the pharmacies in Vientiane Capital. Objectives: IEC material including TV and radio programming, leaflets and posters permit contact with the public living in both rural and urban settings. Since the Lao public has limited knowledge about disease etiology, treatment methods, and the rational use of medicines, basic, easy-tounderstand information is needed to communicate the risks that poor quality medicines pose. In addition to more passive means of communication, pharmacist’s advices plays an important role in conveying the need for rational use of medicines, as well as awareness of the risks of counterfeit and substandard medicine. The objectives of this project were to: Increase awareness among pharmacy owners and residents of Vientiane capital, of the high risk of using counterfeit and substandard medicines. Enhance the ability of pharmacists aid the public in differentiating between high and low quality medicines Elevate the role of pharmacists, and general practitioners in combating counterfeit and substandard medicines in Lao PDR.
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I.
Activities A baseline assessment in pharmacies preceded the intervention, and was followed by an endline assessment to evaluate whether there was a change in knowledge, attitudes and practices relating to rational use of medicines, and awareness of the risks of counterfeit and substandard medicines. A. Initial Phase
A survey form was developed, printed and prepared for implementation in pharmacies in 6 districts of Vientiane Capital : Sisattanak, Chanthabuly, Sikhotabong, Saysettha, Saythany and Hatsaifong. Field surveys were conduct in the 6 districts by staff from FDD, led by the IEC division. Separate teams using identical structured questionnaires were assigned to each district. Following the survey, IEC material in the form of leaflets with the dispensing countertop box were designed and distributed to pharmacies throughout Vientiane Capital in March 2013 .
B. Follow up phase
Leaflets were distributed to 1 additional district, Nasaythong, as well as to the 6 original districts, Sisattanak, Chanthabuly, Sikhotabong, Saysettha, Saythany and Hatsaiphong. Fifty second-long radio and TV spots providing information on counterfeit and substandard medicines were broadcast in Vientiane Capital, twice per day, multiple days per week between the 1 June through 3 July, 2013 (33 TV broadcasts in total). Radio spots (FM 101.5) were broadcast twice per day for 80 days in June-August 2013 following the news, (160 radio broadcasts). A follow-up survey was conducted in 100 pharmacies in 6 districts of Vientiane Capital, Sisattanak, Chanthabuly, Sikhotabong, Saysettha, Saythany and Hatsaifong in September, 2013.
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II.
Results
A.
Initial Phase:
1.
The baseline survey was conducted in August, 2012 in 6 districts, with 100 pharmacies in total.
2.
Data was entered by the US Embassy Public Affairs Office.
3.
Eight thousand leaflets and 500 pharmacy countertop dispensing boxes were printed in January 2013 using content developed by the IEC division of the FDD and approved by USP.
The front of the leaflet is shown below:
* Content only available in Lao Language
The back of the leaflet is shown below:
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* Content only available in Lao Language
B. Follow up Phase 1. All 8000 leaflets were distributed to 500 pharmacies in the 7 target districts in Vientiane Capital: Sisattanak, Chanthabuly, Sikhotabong, Saysettha, Saythany, Nasaythong and Hatsaiphong districts. 2. Radio and TV spots were developed and broadcast to the general public in both urban and rural parts of Vientiane Capital as described earlier. 3. An endline survey was conducted in 100 pharmacies in 6 districts matching the baseline survey. 4. Data was entered by Michael Pryor of the US Embassy Public Affairs Office. Sample Distribution: The table below shows that the proportion of the sample from Sikhotabong and Saysetta districts differed substantially between the initial and follow-up surveys. Small differences were seen in the remaining 4 districts. District Chanthabouly Sisatanak Sikhotabong Saythany Saysetta Hatsaifong No response Total
Before 23 17 20 15 22 3 100 Page 5
After 21 20 10 12 29 6 2 100 June 26, 2014
The appearance of the pharmacies showed a shift away from good to fair and poor appearance. There was also a slight decline in Class One Pharmacies from 52% of the sample to 49%. Pharmacy Appearance Excellent Good Fair Poor
Before After 5 1 53 43 42 52 1 4
Sample Demographics The table shows that female respondents represented 3 out of 4 pharmacies, and their average age was approximately 45 years of age, with slightly over 13 years of experience. No difference was seen in sample demographics, despite the substantial differences in sample distribution. Demographics
Before
After
% Female Respondents
74%
73%
Age
45.7
44.6
Experience
13.1
13.7
When asked about their role in the pharmacy, the following responses were given. The follow-up survey found fewer health professionals, but the same number of pharmacy owners. Occupation of Respondent
Before
After
Pharmacist
32
27
Pharmacy Assistant
29
26
MD
39
34
63*
63*
Owner Other
1
* Double counting with occupations
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Educational Training The baseline data showed a higher percentage of respondents who have medical training in the endline assessment despite fewer reporting their occupation as physicians. The proportion with pharmacy training was 42% in the baseline survey, and 34% in the endline. The proportion with training noted as “other” decreased from 20% to 12% of the sample. It is noteworthy that in the endline only 1/3 of respondents had pharmacy training.
Respondent Education (After)
Respondent Education (Before)
Nurse 4%
Nurs e 1%
Other 20%
Other 12%
MD 37%
MD 47% Pharmacist 37%
Pha rma cist 42%
An examination of the training identified by respondents in the baseline and endline surveys shows that many non-medically personnel are working in pharmacies in Vientiane Capital.
Other (Before) 25
Other (After) 14
20
Unknown
15
Physical Therapy IT Irrigation
10
12
Unknown
10
Lawyer
8 6
Finance 4 5
Trader No profession
0
2
Finance and Banking Tourist Guide Teacher Translator Dentist
0
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Awareness of Counterfeit Medicines Prior to the intervention, there was very high awareness of counterfeit medicines, although few respondents had seen one. In the endline survey, awareness remained very high (95%) and 14 of the 100 respondents had seen a counterfeit medicine, either through training by the FDD or district authorities, or in their practice. Similarly, nearly every respondent felt that counterfeit medicines were dangerous. However, in the endline survey, 2 respondents noted that since there was no active pharmaceutical ingredient, counterfeit medicines were not dangerous. Few respondents felt that the danger from counterfeit medicines is caused by resistance, rather they felt that they were harmful in ways not specified, or were ineffective. This may indicate a lack of understanding of the concept of resistance, and the mechanism by which counterfeit medicines might increase it, and a lack of sufficient understanding of other ways in which counterfeit medicines are harmful. Awareness of Counterfeit Medicines Yes
Before 97
Ever Seen Counterfeit Medicines
Before
After 95 After
Yes
2
14
No
98
86
Believe Counterfeits are Dangerous Yes
Before 100
Why are Counterfeit Medicines Dangerous?
Before
After 98 After
Resistance
38
13
Use more
23
9
Pay more
20
6
Ineffective
68
56
Harmful
65
59
Don't Know
1
For those 14 respondents in the endline survey who had seen counterfeit medicines, their responses indicate they have some awareness of what action to take. How did you know it was counterfeit?
Respondents
Authorities/Analysis
5
From pamphlet explanation, training
3
No registration number
3
Colour, taste, form
2
Price very low
1
Where did the counterfeit medicine come from? Sales rep
Respondents 4
District Authorities
2
Don't know
2
Vietnam China
2 2
Neighbouring pharmacy
1
Korea
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What did you do with the counterfeit medicine when it was identified
Respondents
No buy, no sell
4
Inform sales rep to not come again, won't buy again
3
Never saw [demonstration only]
2
Inspector came to collect it
2
Unknown
2
Did not use
1
Rational Use of Medicines Respondents were asked about their practices in providing patients with information on the appropriate used of medicines they sold, and also on the patient’s demand for information on counterfeit medicines. In the baselines survey, fewer than half of the respondent aways provided full instructions to patients. This increased to 76% in the endline survey. Those warning patients about counterfeit medicines decreased, with those who always or sometimes warned patients declining from 62% to 43% of respondents, and those who never warn patients increasing from 14% to 39% of respondents. Almost no patients (4-5%) request information about counterfeit medicines. Always
Sometimes
Rarely
Never
Before
48
44
8
Do you give patients full instructions?
After
76
22
2
0
Do you warn them about counterfeit medicines
Before
6
56
24
14
After
7
36
18
39
Do patients ever ask about counterfeit medicines
Before
1
3
23
73
After
0
5
14
80
Communication about Counterfeits Respondents were asked what the best ways to communicate with the public regarding the risks of counterfeit medicines. Prior to the intervention, television was recommended by 62% of repondents. In the endline survey, television was clearly the leading method recommended to communicate about the dangers of counterfeit medicines. Best ways to Communicate About Counterfeit Medicines
Before After
Television
62
84
Radio
49
42
Publication/Print Material
48
45
Notice Letter/Alert
35
15
Training
17
11
Outreach
29
8
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Knowledge and Practices on Preventing Counterfeit Medicines In the baseline survey, respondents focused on their experience with the company and the actions of regulatory authorities to communicate, enforce and train people. How do you prevent purchasing counterfeit medicines?
Before
Purchase from a Trusted/Registered Company
75
Communication to the public
11
Reporting to the District Authorities/FDD
5
Training for Pharmacists
5
Enforcement by Drug Authorities
4
Respondents in the endline survey provided information on how they would prevent purchasing counterfeit medicines in their pharmacy including checking the registration status of the product, and it’s expiry date, and comparing its packaging and tablets to high quality medicines. How do you prevent purchasing counterfeit medicines? Check the Registration Number/Expiry Date on the package Compare tablet/packaging with previous purchases Check Invoice Other
III.
After 82 57 7 8
Lesson learned and suggestions. The activities were implemented according to the program plan. Coordination with the United States Embassy Public Affairs Office was an effective means of completing the data entry for the 200 surveys. The endline survey found that some pharmacies had closed or moved and there were changes in interview respondents so it was not possible to maintain a consistent sample. This may have influenced the results. Awareness of counterfeit medicines was high prior to the survey, and counterfeit medicines were perceived to be dangerous both before and after the intervention, suggesting there was no impact, nor need to influence awareness. The reasons why counterfeit medicines are dangerous do not appear to be well understood by the respondents before or after the intervention, so further communication regarding the concept of resistance is needed, and an evaluation of the training that physicians and pharmacists receive on the impact of non-rational use of medicines, and the risks of poor quality medicines should be completed to ensure there is improved understanding of these concepts. There was an increase in the proportion of patients who received full prescribing information. There are some pharmacies that are not being staffed by pharmacists. Enforcement by FDD to ensure pharmacies are staffed by pharmacists with adequate pharmacy training is warranted. Page 10
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Expansion of this program to other provinces is requested by FDD but the impact of IEC material on patient knowledge, awareness or practices was not evaluated in these surveys. Further assessment of the public awareness of counterfeit medicines should be undertaken prior to expanding the IEC material distribution. Remote area access, preference for type of media distribution, and ethnic language translation will be important for programs targeting the public Acknowledgements The Food and Drug Department would like to thank the US Embassy Department of Public Relations for the generous assistance in completing the data entry for this project. The Department would also like to thank the United States Pharmacopoeial Convention for financial and technical assistance which made this work possible and the Analytic Department of the Food and Drug Department, and the Food and Drug Unit of Vientiane Capital Health Office who assisted with the field work.
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Appendix 1 – Survey Form The target of survey form I. To understand what pharmacists currently know about substandard medications II. To understand what practices pharmacies use to promote quality medication use III. To gather data to direct efforts to raise awareness and prevent substandard medication use SURVEY QUESTIONAIRE I. 1. 2. 3. 4.
Profile Survey number District Class of pharmacy: ☐ Class 1 ☐ Class 2 ☐ Class 3 Gender ☐ Male ☐ Female, Age _____years JOB: ☐ Pharmacist ☐ Pharmacy assistant ☐ Owner ☐ Other 5. Interviewee - How long have you been on job (experience) 6. Degree
Date
☐ Doctor years
II. Counterfeit medications 1. Have you ever heard about counterfeit medications? ☐ Yes ☐ No If yes, By Whom? ☐ hearsay ☐ TV ☐ Radio ☐ newspaper ☐ brochure/poster ☐ authority notice/inspection ☐ Training, When was your last training (month/year)? ☐Other 2. Have you ever seen counterfeit medications? ☐ Yes ☐ No (skip to III) What kind of medicines was it? ☐antibiotics (including anti-malarias and TB) ☐vitamin ☐analgesic ☐hormones ☐infusion medicines ☐steroid ☐ Other_________________________________________________________________ 3. How did you know it was counterfeit? _____________ 4. Where did it come from? 5. What did you do about it? ☐ other
☐ tell authority ☐ destroy ☐ nothing _______________________________________
III. Knowledge about counterfeit medicine 1. Do you believe counterfeit medicines are dangerous? ☐ Yes if yes why? ☐ resistance if yes, ☐ use more medicines ☐ will not cure ☐ can hurt me ☐ don’t know Page 12
☐ No
☐ pay more money
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☐ other 2. If no why? IV. problem of counterfeit medicines 1. How big a problem are counterfeit medicines (circle a number on the scale, with zero being no problem and 10 being a huge problem)?
0 1
2
3
4
5
6
7
8
9
10
2. Are counterfeit medicine problem to social-economics? ☐ Yes, (Why?), ______________________________________________________ ☐ No, (Why not?), _____________________________________________________ V. Medication Safeguards 1. Where do you get your medications from? ☐ Company/Factory ☐Pharmacy ☐Sale Person ☐Others________________________________________________________________ 2. When you get your medicine, how do you inspect them?
3. Which medicine do you store in refrigerator? (Have to store under 8 Celcius) ☐Vaccine ☐Suppositoire ☐Insert(Gyneaco) ☐Others________________________________________________________________ 4. Do you provide instructions to the patients on how to take medicines? ☐ always ☐ sometimes ☐rarely ☐ never 5. Do you warn them about counterfeit/substandard medications? ☐ always ☐ sometimes ☐rarely ☐ never 6. Do patients ever ask you about counterfeit medications? ☐ always ☐ sometimes ☐rarely ☐ never 7. What do you think the best way to prevent counterfeit medication use is?
VI. Observation of pharmacy (for interviewer) Location, Cleaning, Good storage of medicine and others. ☐ Excellent ☐ Good ☐Fairly ☐Poor Page 13
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