Role of Medicines of Unknown Identity in Adverse Drug Reaction-Related Hospitalizations in Developing Countries: Evidence from a Cross-Sectional Study in a Teaching Hospital in the Lao People’s Democratic Republic

Abstract

IntroductionThe health dangers of medicines of unknown identity (MUIs) [loose pharmaceutical units repackaged in individual bags without labelling of their identity] have been suspected in L/MICs. Using visual and analytical tools to identify MUIs, we investigated the frequency of, and factors associated with, adverse drug reaction (ADR)-related hospitalizations in a central hospital in Vientiane Capital, Lao People’s Democratic Republic (PDR).MethodsAll unplanned admissions, except for acute trauma and intentional overdose, were prospectively recorded during a 7-week period in 2013, leading to include 453 adults hospitalized for ≥24 h. The patients or their relatives were interviewed to complete the study questionnaire. MUIs suspected of being involved in ADR(s) were identified through comparison of visual characteristics of tablets/capsules with that of reference medicines (photograph tool), and by proton nuclear magnetic resonance and mass spectrometry analyses. Factors associated with ADRs were identified by multivariate logistic regression.ResultsThe frequency of hospitalizations related to an ADR was 5.1% (23/453, 95% confidence interval [CI] 3.1–7.1). Forty-eight (12.8%) patients used MUI(s) in the last 2 weeks preceding hospitalization. They were more likely to be hospitalized because of an ADR (adjusted odds ratio 4.5, 95% CI 1.7–11.5) than patients using medicines of known identity. MUIs were mainly involved in bleeding gastroduodenal ulcers. The photograph tool led to the misidentifications because of look-alike pharmaceutical units in the medicines photograph collection.ConclusionAccording to the results of this study, there is a need to ensure appropriate labelling of medicines at dispensing and to provide well-suited tools to identify MUIs in clinical settings to improve drug safety and patients’ care in developing countries with limited capacities for drug analysis.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-017-0544-z) contains supplementary material, which is available to authorized users.

Retracted and Republished: A random survey of the prevalence of falsified and substandard antibiotics in the Lao PDR

“…Tetracycline is easily degraded under unfavourable storage conditions, resulting in potentially noxious degradation products 31 , 34 . Even if clinical consequences are relatively rare, they would be very difficult to detect and manage in rural Laos 67 …”

Laboratory evaluation of twelve portable devices for medicine quality screening

“…Falsified FCM were collected during earlier studies (see [ 23 ] and references therein). Look-alike FCM were visually indistinguishable from genuine medicines, and contained APIs not evaluated in this study [ 24 ]. Five brands of FCM were sold in transparent packaging such as clear plastic blister packs or clear glass vials.…”

Prevalence of Substandard Amoxicillin Oral Dosage Forms in the National Capital District of Papua New Guinea

“…The dispensing of loose tablets and capsules in plastic bags, a practice common in many in low-and middle-income countries which hinders the detection of falsified medicines, is additionally problematic in tropical climates as this packaging does not afford sufficient protection against moisture. 20 A South African study simulating local conditions in Durban (30-35°C and 75% RH) reported amoxicillin loss of 11-16% from capsules that were stored in plastic bags and flip-top bottles for 1 day. 21 The focus of this study is Papua New Guinea (PNG), a lowermiddle-income country with a population of more than seven million at the last conducted census (2011).…”