Inspection of the Compliance to the Ministerial Rule on Licensing and Requirements on Premises, Instruments and Good Pharmacy Practice among Drugstores in Lamphun

Abstract

Objective: To inspect the compliance to the Ministerial rule on licensing, premises, and good pharmacy practices (GPP) BE 2013 among type1 drugstores in Lamphun province. Method: The officer responsible on drugstore inspection interviewed type1 drugstore licensees to collect the data on their opinion on the Ministerial Rule using the instrument developed by the researcher, and then inspected 72 type1 drugstores according to the assessment form in the Ministerial Rule. Results: Nearly all type1 drugstores licensees (98.61 %) had heard the Ministerial Rule and 93.06 % supported it. About 55.56% of drugstores reported that it was possible to comply with the Rule, while 44.44% said they could partially comply to the rule. 54.17% of drugstore licensees estimated that they could completely comply to the Rule within 2 years. The inspection of drugstores revealed that more than 95% of drugstores satisfied the standard on premises by passing 7 from the total of 9 criteria. 45.83% of drugstores were able to control the store conditions to be appropriate for drug storage. More than 95% of drugstores passed 2 out of 6 criteria in space allocation. Less than half of the drugstores could satisfy the other 4 criteria in this standard. For the standard on signs and instruments, More than 90% of drugstores passed 2 out of 6 criteria. About 65-76% passed the other 3 criteria in this standard. Only 11 drugstores (15.28%) had a complete set of instruments as required by law. The majority had no measuring scales for height and fire extinguishers. The passing rate in this standard was low because it was a new requirement not appearing in the earlier Ministerial Rule, and, in addition, there were barriers in satisfying the standard due to the use of existing layout of drugstores and budget constraints for renovation.   For the standard on GPP, 85% of drugstores passed 4 out of 6 criteria. Less than 50% of drugstores had report forms and medication bags with a complete set of information as required by law. Conclusions: Drugstores in Lamphun could comply with many criteria in the Ministerial Rue, but also need an improvement in many criteria especially those in space allocation. The officers should inform drugstore licensees on the Rule and related declarations, and give feedback on the result of assessment to them. Moreover, the officers should arrange the consultation, drugstore visit and supervision in order to give advice on how to improve the compliance with legal requirements.