Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits

Anyakora, Chimezie; Oni, Yetunde; Ezedinachi, Uchenna; Adekoya, Adebola; Ali, Ibrahim; Nwachukwu, Charles Uchenna; Esimone, Charles Okechukwu; Abiola, Victor O.; Nwokike, Jude

doi:10.1186/s12884-018-1671-y

Cited by 39 publications

(60 citation statements)

References 29 publications

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“…Unfortunately, these medicines are very sensitive to environmental conditions like high temperatures (oxytocin, [8][9][10]) and humidity (misoprostol, [11,12]). Most oxytocin products should be stored at 2-8°C according to the labelling, and this can be challenging, especially in rural areas in LMICs [13][14][15][16]. Since misoprostol tablets can be stored at room temperature and can be administered orally, they offer an alternative to oxytocin injections in places where appropriate storage conditions for oxytocin cannot be ensured, or where no trained staff is available to administer medicines parenterally [17].…”

Section: Introductionmentioning

confidence: 99%

“…1 Structures of oxytocin (modified from [2]) and of misoprostol, and their typical degradation mechanisms. Commercial misoprostol is a mixture of the depicted structure at its epimer at C 16 , and of the enantiomers of both compounds. Corresponding stereoisomers are found for the degradation products of misoprostol Several previous studies have shown that the quality of oxytocics, especially in low and middle-income countries (LMIC), is often poor [8,11,15,16,[20][21][22].…”

Section: Introductionmentioning

confidence: 99%

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Quality, availability and storage conditions of oxytocin and misoprostol in Malawi

Hagen

Khuluza

Heide

2020

BMC Pregnancy Childbirth

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Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-and middle-income countries (LMICs). Oxytocin and misoprostol are used for the prevention and treatment of PPH. However, both medicines are chemically unstable and sensitive to environmental conditions. Previous studies reported a high prevalence of substandard oxytocin and misoprostol preparations in LMICs. Methods: In randomly selected health facilities of four districts of Malawi, the availability of oxytocin and misoprostol was determined, and the knowledge of health workers on storage requirements and use of oxytocics was assessed. Temperature loggers were used to record the storage temperature of oxytocics. Samples of oxytocin injections and misoprostol tablets were collected from the health facilities and from wholesalers. Oxytocin samples were analysed for identity, assay (= quantity of oxytocin) and for pH value according to United States Pharmacopeia 40. Misoprostol samples were analysed for identity, assay, dissolution and related substances according to the International Pharmacopeia 2017. Results: All visited hospitals and health centers had oxytocin available. At non-refrigerated storage sites, the recorded mean kinetic temperature exceeded the oxytocic's storage temperature stated on the labels in 42% of the sites. At refrigerated storage sites, the required temperature of 2-8°C was exceeded in 33% of the sites. Out of 65 oxytocin samples, 7 (11%) showed moderate deviations from specification, containing 82.2-86.8% of the declared amount of oxytocin. Out of 30 misoprostol samples, 5 (17%) showed extreme deviations, containing only 12.7-30.2% of the declared amount. The extremely substandard misoprostol was reported to the national authorities and to WHO, leading to an immediate recall of the respective brand in Malawi. The UK-based distributor of this brand closed its business shortly thereafter. Conclusion: Availability of oxytocin was excellent in Malawi, and its quality was better than reported in previous studies in other LMICs. However, storage conditions at the health facilities often did not meet the requirements. Extremely substandard misoprostol tablets were found, representing a serious risk to maternal health. This shows the need for continued efforts for quality assurance in medicine procurement and registration, as well as for postmarketing surveillance.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Quality, availability and storage conditions of oxytocin and misoprostol in Malawi

Hagen

Khuluza

Heide

2020

BMC Pregnancy Childbirth

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“…A major problem of oxytocin relates to heat-related degradation, inappropriate storage in the supply chain and at the health facilities. In most low-income countries these storage conditions are usually very difficult to maintain[9,10]. Surveillance studies have shown high prevalence of poor-quality oxytocin, particularly in Africa and Asia.…”

Section: Introductionmentioning

confidence: 99%

“…Surveillance studies have shown high prevalence of poor-quality oxytocin, particularly in Africa and Asia. [10–12] Most common problems were insufficient or no active ingredient[10,11]. Safe medicines supply is fundamental to public health[13].…”

Section: Introductionmentioning

confidence: 99%

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Clinical experiences with the use of oxytocin injection by healthcare providers in a South-Western State Nigeria: A Cross sectional study

Ejekam

Okafor

Anyakora³

et al. 2018

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26Background: Post-Partum Hemorrhage (PPH), is a leading cause of maternal mortality in 27 Nigeria and most low and middle income countries (LMIC). The World Health 28 Organization(WHO) strongly recommends oxytocin as effective, affordable and the safest 29 drug of first choice in the prevention and treatment of PPH in the third stage of labor. 30 However, there are concerns about its quality. Very high prevalence of poor-quality oxytocin, 31 especially in Africa and Asia has been reported in literature. Excessive and inappropriate use 32 is also common with oxytocin in low-resource settings. 33 Objective: To assess clinical experiences with quality of oxytocin used by healthcare 34 providers in Lagos State Nigeria. 35 Methods: It was a descriptive cross-sectional study done in 2017. Seven hundred and five 36 respondents (doctors and nurses) who use oxytocin for obstetrics and gynaecological 37 services were recruited from 195 health facilities (public and registered private) across 38 Lagos State. Data collection was quantitative, using a pretested self-administered 39 questionnaire. Data analysis was done using IBM SPSS version 21. Statistical significance 40 was set at 5%( p<0.05). Ethical approval was obtained from Lagos University Teaching 41 Hospital Health Research Ethics Committee. Results: Only 52 percent of the respondents knew oxytocin should be stored at 2°C to 8°C.45 About 80% of the respondents used oxytocin for augmentation of labor; 68% for induction of 46 labor, 51% for stimulation of labor and 78% for management of PPH. Forty-one percent used 47 3 49 over a third (36%) of the respondents had an available means of documenting or reporting 50 perceived ineffectiveness of drugs in their facility. Of these, only about 12% had 51 pharmacovigilance forms available in their facilities to report the ineffectiveness. 52 Conclusion: The inappropriate and inconsistent use of oxytocin especially overdosing likely 53 led to the spuriously high perception of medicine effectiveness among respondents. This is 54 also coupled with lack of suspicion of medicine ineffectiveness by clinicians as a possible 55 root cause of poor treatment response or disease progression. Poor knowledge of oxytocin 56 storage and consequent poor storage practices could have contributed to the ineffectiveness 57 reported by some respondents. There is need for the establishment of a unified protocol for 58 oxytocin use with strict compliance to the guidelines. Continued training of healthcare 59 providers in medicines safety monitoring is advocated. 60 Pharmacovigilance and Lagos State.62 63 Background 64 Poor maternal and child health indices have remained a recurring public health challenge in 65 Nigeria. Obstetric haemorrhage especially post-partum haemorrhage (PPH) is a leading cause 66 of maternal mortality in Nigeria [1,2]. According to the world health organisation (WHO) 67 post-partum haemorrhage (PPH) is defined as a blood loss of 500 ml or more within 24 hours 68 after birth and it is said to affect approximately 2% of ...

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Keeping up with the medical abortion revolution: The Marie Stopes International abortifacient quality assurance system

Stewart

Perera

2020

Intl J Gynecology & Obste

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Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits

Cited by 39 publications

References 29 publications

Quality, availability and storage conditions of oxytocin and misoprostol in Malawi

Quality, availability and storage conditions of oxytocin and misoprostol in Malawi

Clinical experiences with the use of oxytocin injection by healthcare providers in a South-Western State Nigeria: A Cross sectional study

Keeping up with the medical abortion revolution: The Marie Stopes International abortifacient quality assurance system

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