Adverse Drug Reactions in Selected Wards of the Yangon General Hospital and Yangon Specialty Hospital During the First Quarter of 2019 : An Active Pharmacovigilance Study in Myanmar

Previous studies in Europe and the USA have reported a high prevalence of adverse drug reactions (ADRs), but data on local ADRs in Myanmar are sparse. Our objective was to study ADRs in patients admitted to selected wards of Yangon General Hospital (YGH) and Yangon Specialty Hospital (YSH), Myanmar. This was a prospective observational study in three hospital wards during the first quarter of 2019. Suspected ADRs were carefully investigated in a face-to-face interview with each patient and via review of clinical records. Patients transferred to other wards or discharged were followed-up by the researchers until day 28 after admission. ADRs were divided into those that (1) led to the admission and (2) occurred during the hospital stay or after discharge (up to day 28 after admission). A total of 65 ADRs were identified, with 47 (29.4%) of 160 patients experiencing at least one ADR. Among these, 16 (24.6%) had led to hospital admission and 49 (75.4%) occurred in 31 patients during their hospital stay. Of 160 patients, 21 had taken at least one herbal remedy and six of these developed an ADR. Five ADR-drug associations (hypokalaemia with methylprednisolone, increased transaminase levels with standard antituberculosis drugs, upper gastrointestinal bleeding with nonsteroidal anti-inflammatory drugs, constipation with tramadol, and increased transaminase levels with herbal remedies) represented 18 (27.7%) of the 65 ADRs in this study. According to the Schumock and Thornton preventability scale, more than half of these ADRs (35 [53.9%]) were preventable. The present study highlights the existence of ADRs among patients attending these hospitals. The implementation of active pharmacovigilance in hospitals could be a helpful first step to improving the awareness of unwanted effects of medicines and patient safety, as well as a way to strengthen the national pharmacovigilance system in countries such as Myanmar. The online version of this article (10.1007/s40801-020-00180-0) contains supplementary material, which is available to authorized users

Programmatic definitions.

<p>Programmatic definitions.</p

Cascade of PMTCT program in Central Women Hospital, Mandalay, Myanmar.

<p>HIV; ^<b>¶</b>Human Immunodeficiency virus. *babies less than 9 months of age who were under regular follow-up and had not tested for HIV.</p

Low mother-to-child HIV transmission rate but high loss-to-follow-up among mothers and babies in Mandalay, Myanmar; a cohort study

<div><p>Introduction</p><p>Loss-to-follow-up (LTFU) throughout the Prevention of Mother-To-Child Transmission (PMTCT) cascade remains one of the major threats to the success of PMTCT programs. In this study, we aimed to determine the mother-to-child transmission rate in a programmatic setting and to determine factors associated with LTFU among enrolled mothers and unfavorable outcomes among HIV-exposed babies which includes being HIV positive, death and LTFU.</p><p>Methods</p><p>A retrospective cohort study reviewing routinely collected data in an Integrated HIV care program, Mandalay, Myanmar in June 2016.LTFU means mother/infant missing appointed visit for more than three months.</p><p>Results</p><p>Of 678 pregnant women enrolled in PMTCT program between March 2011 and June 2014, one stillbirth and 607 live births were recorded in this cohort. Of 457 HIV-exposed babies with HIV-test recorded at the end of the intervention, nine (2%) were HIV-positive. Pregnant women’s and exposed-babies’ LTFU rate was 7 per 1000 person-years, and 10 per 1000 person-years respectively. PMTCT option B protocol was found to be significantly associate with maternal LTFU [adjusted Hazard Ratio (aHR) 95% CI: 3.52 (1.38–8.96)] when compare to mothers receiving option B+/lifelong antiretroviral therapy (ART). Weight <2.5 Kg at enrolment, receiving mixed-feeding, vaginal delivery and option B PMTCT protocol were significantly associated with unfavorable outcomes among exposed babies [aHR(95% CI): 5.40 (1.66–17.53), 5.91(1.68–20.84), 2.27 (1.22–4.22) and 2.33 (1.16–4.69) respectively].</p><p>Conclusion</p><p>Mother-to-child HIV transmission rate in this public hospital-based program was lower than the 5% national target, which indicates a successful PMTCT intervention. However, a high proportion of HIV-infected mothers and exposed babies LTFU was recorded. Lifelong ART provision to HIV-positive pregnant women was shown to reduce exposed babies’ LTFU, death and transmission rate (unfavorable outcomes) in this setting. Lessons learned from this program could be used to inform policy and practice in the country, while the programmatic challenge of LTFU should be urgently addressed.</p></div

Characteristics and factors associated with unfavorable outcomes (HIV+ diagnosis, death and loss to follow up) among HIV-exposed babies in prevention of mother to child transmission program, Mandalay, Myanmar, March 2011-June 2014.

<p>Characteristics and factors associated with unfavorable outcomes (HIV+ diagnosis, death and loss to follow up) among HIV-exposed babies in prevention of mother to child transmission program, Mandalay, Myanmar, March 2011-June 2014.</p

Characteristics and factors associated with loss to follow up among HIV-infected mothers enrolled in prevention of mother to child transmission program Mandalay, Myanmar, March 2011- June 2014.

<p>Characteristics and factors associated with loss to follow up among HIV-infected mothers enrolled in prevention of mother to child transmission program Mandalay, Myanmar, March 2011- June 2014.</p

Uptake of antiretroviral therapy in HIV-positive women ever enrolled into ‘prevention of mother to child transmission’ programme, Mandalay, Myanmar—a cohort study

Abstract Background Early initiation and longer duration of anti-retroviral therapy either as prophylaxis (pARV) or lifelong treatment (ART) in HIV-positive pregnant women prior to delivery has a huge impact in reducing mother to child transmission (MTCT) of HIV, maternal morbidity, mortality and increasing retention in care. In this study, we aimed to determine the following in a ‘prevention of mother-to-child transmission’ (PMTCT) programme in Central Women Hospital, Mandalay, Myanmar: i) uptake of ART and factors associated with the uptake ii) duration of ART/ pARV received by HIV-positive pregnant women prior to delivery, iii) factors associated with ART/ pARV initiation after delivery and iv) factors associated with shorter duration of ART/ pARV (≤ 8 weeks prior to delivery). Method This was a retrospective cohort study using routinely collected data from PMTCT programme. We used multivariable Cox proportional Hazard model or log binomial models to assess the association between socio-demographic and clinical factors with a) uptake of ART/pARV, b) initiation of ART/pARV after delivery, c) shorter (≤8 weeks) duration of ART/PARV prior to delivery. Results Of the 670 ART naïve HIV-positive women enrolled to PMTCT programme between March 2011 and December 2016, 588 (88%) were initiated on ART/pARV. In adjusted analysis, only pregnancy stage at enrolment was significantly associated with initiation of ART/pARV. Of 585 who had delivered babies on or before the censor date, 522 (89%) were on ART/pARV. Women who lived outside Mandalay were more likely to be initiated on ART after delivery (i.e., delayed ART initiation in those on ART). Among women who were initiated on ART/pARV before delivery (n = 468), only 59% got ART/pARV for > 8 weeks before delivery. Women whose spouses’ HIV status was not recorded had 40% higher risk of short duration of ART/pARV. Conclusions This study shows high uptake of ART/pARV among those enrolled into the PMTCT programme. However, about one in eight pregnant women did not receive ART before delivery. Among those initiated on ART/pARV before delivery, nearly half of them received ART/pARV for less than 8 weeks prior to delivery. These aspects need to be improved in order to eliminate mother-to-child transmission of HIV