Cross-sectional study of availability and pharmaceutical quality of antibiotics requested with or without prescription (Over The Counter) in Surabaya, Indonesia

Abstract

BackgroundAntimicrobial resistance is an increasing problem in developing countries and antibiotic use is widespread. Our previous surveys in Java, Indonesia, revealed that most antibiotic use was probably unnecessary or ineffective. The aim of this study was to explore a potential connection between resistance and substandard antibiotics sold in the area.MethodsA cross-sectional field study using the simulated client method was conducted in Surabaya. Five first-line antibiotics were requested with or without prescription (OTC). A certified laboratory analysed the drug content using validated methods. Possible determinants of substandard quality were explored.ResultsIn total, 104 samples from 75 pharmacies, ten drug stores and 39 roadside stalls (kiosks) were obtained. Pharmacy employees filled all OTC requests. Three quarters of kiosks sold antibiotics. Antibiotics were dispensed as single blister strips or repackaged (16%) without label. Ninety five percent of samples carried the label of 14 Indonesian manufacturers. The pharmaceutical quality did not meet BP standards for 18% of samples. Deviations (less active ingredient) were small. There was no association between low content and type of outlet, sold with or without prescription, registration type, price or packaging. Median retail prices of products carrying the same label varied up to 20 fold.ConclusionsAntibiotics were available OTC in all visited pharmacies and sold in the streets of an Indonesian city. Most samples contained an active ingredient. We urge to increase enforcement of existing regulations, including legislation that categorizes antibiotics as prescription-only drugs for all types of medicine outlets, to limit further selection of antimicrobial resistance.

Knowledge, Attitude and Behavior Related to Antibiotic Use in Community Dwellings

“…Fourteen percent of the respondents purchased antibiotics without a prescription at OTC or kiosk. This corresponded with Hadi et al 4 (2010) findings; this could occur because the regulations for antibiotic selling is not strong enough and there is no strong punishment for OTC or pharmacies selling the drug without prescription. 1 This study has certain limitations that merit discussion.…”

“…While behavioral factors are influenced by lack of information in antibiotic use and unawareness in antibiotic resistance. 3 In Indonesia, 4 antibiotic drugs can be purchased over the counter (OTC) or at the kiosk, whereas the Indonesian government regulation restricts antibiotic availability so that Antibiotic drugs can only be prescribed by doctors. The use of antibiotic drugs without prescription causes some problems in the community's behavior and attittude toward antibiotic use which are the use of inappropriate dosage and duration along with the use of left-over antibiotic.…”

Antimicrobial resistance in uropathogens and appropriateness of empirical treatment: a population-based surveillance study in Indonesia

“…Indonesia is the country with the highest population in the Asia–Pacific region and antimicrobial drug usage is common and often inappropriate 11 . Therefore, the Ministry of Health of Indonesia recognizes that surveillance of AMR is crucial to obtaining representative data that can serve as a basis for guideline development and policy planning, as well as steering clinical practice (http://www.lshk.or.id/uu).…”

Public Health Risks of Multiple-Drug-Resistant Enterococcus spp. in Southeast Asia

“…In this 1.9%, there was a significantly higher prevalence of VRE isolates in the inpatient department than in the outpatient department (10). In Indonesia, antibiotics can easily be obtained without a prescription from medical retailers despite existing regulations (69). According to the National Surveillance of Antimicrobial Resistance in Malaysia, antibiotic susceptibility testing was carried out on bacterial isolates from hospitalized patients whereby analysis was based on one isolate per patient (70).…”