Patterns of oxytocin use for induction and augmentation of labour among healthcare providers in Nigeria.

Background: The practice of intrapartum use of oxytocin for induction and augmentation of labour is increasing worldwide with documented wide variations in clinical use, especially dose administrations. There is also evidence of intrapartum use by unauthorized cadre of staff.

Aim: This study assessed the patterns - frequency of intrapartum use of oxytocin, the doses and routes of administration for induction and augmentation of labour, and identified the predictors of oxytocin use for induction and augmentation of labour by healthcare providers in Nigeria.

Modeling the Health and Economic Impact of Substandard and Falsified Medicines: A Review of Existing Models and Approaches.

Substandard and falsified medicines are harmful to patients, causing prolonged illness, side effects, and preventable deaths. Moreover, they have an impact on the health system and society more broadly by leading to additional care, higher disease burden, productivity losses and loss of trust in health care. Models that estimate the health and economic impacts of substandard and falsified medicines can be useful for regulators to contextualize the problem and to make an economic case for solutions.

A descriptive study of healthcare-providers' experiences with the use and quality of oxytocin for the prevention of post-partum hemorrhage in Nigeria: A nation-wide survey.

Background: Oxytocin is recommended as an affordable and effective drug in the prevention of postpartum hemorrhage-one of the leading causes of maternal morbidity and mortality in low- and middle-income countries, however, there are concerns about its proper use and quality. This study builds on earlier work conducted in a South-Western state in Nigeria.

Objective: The study assessed the knowledge around oxytocin, usage, storage practices and perceived quality of oxytocin used by healthcare providers that directly administer oxytocin for the prevention of postpartum hemorrhage across Nigeria.

Importance of medicine quality in achieving universal health coverage.

Objective: To assess the importance of ensuring medicine quality in order to achieve universal health coverage (UHC).

Methods: We developed a systems map connecting medicines quality assurance systems with UHC goals to illustrate the ensuing impact of quality-assured medicines in the implementation of UHC. The association between UHC and medicine quality was further examined in the context of essential medicines in low- and middle-income countries (LMICs) by analyzing data on reported prevalence of substandard and falsified essential medicines and established indicators for UHC.

Registration timelines of antiretroviral medicines in Ghana and Kenya.

: This study examines registration timelines of antiretroviral medicines (ARVs) in Ghana and Kenya, to assess whether prior reviews by the US Food and Drug Administration Tentative Approval or WHO prequalification (WHO/PQP) affect in-country approval timelines. Data were collected from online and national databases. Median in-country review period in Ghana was 9 months compared with 25 months in Kenya.

Clinical experiences with the use of oxytocin injection by healthcare providers in a southwestern state of Nigeria: A cross-sectional study.

Background: Postpartum hemorrhage (PPH) is a leading cause of maternal mortality in Nigeria and in most low- and middle-income countries. The World Health Organization (WHO) strongly recommends oxytocin as effective, affordable, and the safest drug of first choice in the prevention and treatment of PPH in the third stage of labor. However, there are concerns about its quality.

Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials.

Background: This research reviewed major Clinical Trial Registries (CTRs) and assessed the availability of fields on quality assurance for approved medicines used as Investigational Medicinal Products (IMPs) in phase IV clinical trials.

Methods: Two reviewers independently assessed CTRs of the International Committee of Medical Journal Editors (ICJME) and of World Health Organization (WHO) platforms. Each CTR was checked by two reviewers on availability of fields on brand name, manufacturer's name, approval status, approving authority, compliance with Good Manufacturing Practices, and quality testing.

Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems.

Access to quality-assured medical products improves health and save lives. However, one third of the world's population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient.

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

Background: The high level of maternal mortality and morbidity as a result of complications due to childbirth is unacceptable. The impact of quality medicines in the management of these complications cannot be overemphasized. Most of those medicines are sensitive to environmental conditions and must be handled properly.

Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

Background: Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity.

Actions of the National Regulatory Authorities in 10 Low- and Middle-Income Countries Following Stringent Regulatory Authority Safety Alerts on Rosiglitazone.

On September 23, 2010, the US Food and Drug Administration and the European Medicines Agency issued safety alerts for medicines containing rosiglitazone. The authors monitored the actions of national regulatory authorities (NRAs) from 10 low- and middle-income countries to identify the time lag between the issuance of safety alerts by these two stringent regulatory authorities and any actions by these select NRAs. Two NRAs outside Africa took regulatory actions related to safety of rosiglitazone within 2 weeks of stringent regulatory authority safety alerts.

A framework for assessing the economic value of pharmacovigilance in low- and middle-income countries.

Pharmacovigilance (PV) programs are an essential component of national healthcare systems. Well-functioning PV programs can improve population health by identifying and reducing medicines-related problems (MRPs). Many low- and middle-income countries lack functional PV systems, but this deficiency has not been described in terms of the potential economic value of strengthening PV systems.

Pharmacovigilance and global HIV/AIDS.

Purpose Of Review: This review focuses on current status, progress, challenges and opportunities in global pharmacovigilance for HIV/AIDS treatment.

Recent Findings: Over 6 million HIV-infected individuals worldwide are on treatment with more than 150 innovator and generic antiretroviral drug products. This achievement is made possible through sponsorship of HIV/AIDS programs [The Global Fund to Fight AIDS, Tuberculosis and Malaria; the President's Emergency Program for AIDS Relief (PEPFAR)] and the availability of generic fixed-dose combination products.

Records linkage of electronic databases for the assessment of adverse effects of antiretroviral therapy in sub-Saharan Africa.

Purpose: In 2009, the Ministry of Health and Social Services in Namibia decided to conduct a confirmatory assessment of the risk of anemia associated with zidovudine (AZT)-based highly active antiretroviral therapy (HAART) using records contained in three electronic databases. These records did not share a unique identifying number. The first step was to apply probabilistic record linkage methods to link records in the three databases.

Global pharmacovigilance for antiretroviral drugs: overcoming contrasting priorities.

Jur Strobos and colleagues describe the deliberations of a recent multi-stakeholder meeting discussing the creation of a sustainable global pharmacovigilance system for antiretroviral drugs that would be applicable in resource limited settings.

A situational analysis of pharmacovigilance plans in the Global Fund Malaria and U.S. President's Malaria Initiative proposals.

Background: Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals.