Pacharaporn Phueanpinit1, Juraporn Pongwecharak2, Janet Krska3, Narumol Jarernsiripornkul4. 1. Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, 40002, Thailand. 2. Faculty of Pharmacy, Rangsit Center, Thammasat University, Pathumthani, Thailand. 3. Medway School of Pharmacy, Universities of Greenwich and Kent, Kent, UK. 4. Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, 40002, Thailand. narumol@kku.ac.th.
Abstract
BACKGROUND: The importance of promoting the use of patient-oriented medicines leaflets is recognized in many countries. Leaflets should include basic information plus specific warnings, and be provided with all medicines, but there is little attempt at enforcement of these requirements in Thailand. OBJECTIVE: To determine content and availability of Thai information leaflets for nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: Leaflets for all NSAIDs available for purchase from 34 pharmacies in a large city were evaluated against a checklist and number of leaflets assessed against number of medicine packs available in each pharmacy. RESULTS: Of the 76 leaflets for ten different NSAIDs, 67 (88 %) were for locally manufactured products. Only 22 % of 76 leaflets were sufficient in number for distribution with medicines, while only 4 % had patient-oriented leaflets. No leaflet covered all topics in the checklist. Less than half included safety information, such as contraindications (46 %), precautions (47 %), and adverse drug reactions (34 %). Locally-produced leaflets provided less information than those for originator products and no leaflet included all the warnings required by Thai regulations. CONCLUSION: This study illustrates the variable availability and quality of NSAID information leaflets. The lack of accessible essential information about medicines in Thailand requires urgent attention to enable patients to minimise adverse reactions.
BACKGROUND: The importance of promoting the use of patient-oriented medicines leaflets is recognized in many countries. Leaflets should include basic information plus specific warnings, and be provided with all medicines, but there is little attempt at enforcement of these requirements in Thailand. OBJECTIVE: To determine content and availability of Thai information leaflets for nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: Leaflets for all NSAIDs available for purchase from 34 pharmacies in a large city were evaluated against a checklist and number of leaflets assessed against number of medicine packs available in each pharmacy. RESULTS: Of the 76 leaflets for ten different NSAIDs, 67 (88 %) were for locally manufactured products. Only 22 % of 76 leaflets were sufficient in number for distribution with medicines, while only 4 % had patient-oriented leaflets. No leaflet covered all topics in the checklist. Less than half included safety information, such as contraindications (46 %), precautions (47 %), and adverse drug reactions (34 %). Locally-produced leaflets provided less information than those for originator products and no leaflet included all the warnings required by Thai regulations. CONCLUSION: This study illustrates the variable availability and quality of NSAID information leaflets. The lack of accessible essential information about medicines in Thailand requires urgent attention to enable patients to minimise adverse reactions.
Entities:
Keywords:
Drug safety information; Information leaflets; Non-steroidal anti-inflammatory drugs; Thailand
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