Availability of medical abortion medicines in eight countries: a descriptive analysis of key findings and opportunities

Registration and quality assurance

MA products that were registered by the national regulatory authority (NRA) in each of the eight program countries are shown in Table 1. For the assessment, the category of abortion law restriction was evaluated following a reading of each country’s abortion law, from low restriction (abortion upon request) to high (abortion only to save the life of the woman). For the purpose of these assessments, a quality-assured product is defined as one that is either WHO Prequalification (WHO-PQ)-listed or approved by a Stringent Regulatory Authority (SRA). Rwanda had no MA medicines registered whereas Bangladesh had the greatest number of registered MA medicines; given its domestic manufacturing capacity, however only one product was quality-assured (Misoclear®, Acme Pharmaceuticals). A quality-assured combi-pack (Medabon®, Sun Pharmaceuticals) was registered in only one country, Nepal. In four other countries, combi-packs that are neither WHO PQ-listed or SRA-approved were registered and were most commonly made by the Indian manufacturers Acme Formulations and Naari. We found that the WHO’s Collaborative Registration Procedure, which can enable accelerated regulatory approval, was underutilized in all countries assessed. We found that when reliance mechanisms such as this and other fast-track mechanisms are used, regulatory approval of MA products can take 90 days, but up to 5 years otherwise.

Table 1 Registration and quality assurance status of MA medicines by country and abortion law restrictionsPolicy and financing

Standard treatment guidelines (STG) indicate rational and judicious use of medicines for specific health indications and are recommended to be updated concurrently with national essential medicines list (NEML) which prioritize medicines to be procured for the public sector healthcare system [12]. National abortion care guidelines define who, when, where, and how safe abortion services are delivered in the country. The inclusion of combination regimen in NEML, STGs and abortion care guidelines varied across the countries assessed (Table 2). Mifepristone and misoprostol regimen for induced abortion was identified on the NEML/STG for South Africa (2019) as well as in specific abortion care service and delivery guidelines for Bangladesh, Nepal, Nigeria, and Rwanda [13,14,15,16,17]. Neither Liberia, nor Malawi included mifepristone and misoprostol combination regimen on its NEML/STGs but included misoprostol for postpartum hemorrhage (PPH) and postabortion care (PAC) management. Nigeria’s 2nd edition STG (2016) and Sierra Leone’s National Protocols and Guidelines for Emergency Obstetric and Newborn Care (2018) included misoprostol for PPH and PAC. At the time of the assessment, mifepristone’s inclusion was being considered for the Nigeria NEML and the combination regimen was added in 2020 [18]. In all countries, the use of misoprostol for PPH and PAC was included in the NEML/STG and/or service delivery guidelines.

Table 2 Extent to which MA commodities or protocols for their use were included in policy documentsProcurement and distribution

Procurement is the process by which a government acquires needed products and services by purchasing from commercial businesses, in this case, manufacturers and/or wholesale distributors of MA medicines. The government stores these products in their central medical stores departments at the national and/or provincial level and then distributes these products to public sector facilities. We identified whether public sector tenders and procurement of MA medicines had occurred at least once in the past 3 years preceding the assessment. Products that were listed on the NEML were also procured for the public sector at least once (Table 3). In all countries misoprostol had been procured for PPH and PAC at least once in the past 3 years for the public sector; in Nepal, Rwanda and South Africa, public sector tenders for either a combi-pack product or mifepristone were identified.

Table 3 Public sector tenders and procurement for MA medicines

MA was purely a private sector commodity in Liberia, Sierra Leone, and Nigeria, where social marketing organizations (SMOs) had registered and imported combi-pack but were limited in their distribution owing to a restrictive policy environment and/or lack of safe abortion service delivery guidelines (Table 2).

Rwanda and Nigeria illustrate ways in which the combination regimen was added to the NEML despite more restrictive abortion laws. In Rwanda, the government took the pragmatic step to add mifepristone and misoprostol to the 2015 NEML to align with the revised penal code of 2012 which permitted abortion resulting from rape, incest, forced marriage, or on medical grounds [19]. Rwanda wanted to have all WHO recommended abortion methods [2] available in such cases and the NEML application was accepted. In Nigeria, at the time of the assessment, a multi-stakeholder group of NGOs and researchers had engaged in consensus building with the NEML committee, presenting information on the safety, efficacy, stability, and pharmacodynamics of the MA medicines. During this time, the NRA had approved three MA products for registration, the government had approved the National Guidelines on Safe Termination of Pregnancy for Legal Indications, and the WHO had added the combination regimen to its Model List of Essential Medicines (2019). Bolstered by these events, it was added to the NEML in 2020 [18].

We found that adding a MA medicine to the NEML does not guarantee that once procured, distribution will happen readily. In both Rwanda and South Africa, key informants shared that central medical stores staff delayed distribution or locked up MA medicines citing concerns that MA medicines will be “misused.” In South Africa and Nepal, procurement is decentralized to the provincial level and determined by each provinces’ public health prioritization and budgets for commodities.

In all countries, funding for medicines was also an issue. In several countries, budget constraints required governments to re-prioritize procurement lists to a quarter of those deemed essential, and MA commodities were often eliminated, despite being on the NEML. As such, stock outs of MA medicines persist. In such cases, donors like UNFPA, or SMOs, were asked to procure misoprostol and/or combi-packs for public sector distribution.

“Adding another product to the EML is like creating a wish list for shopping. As a government we don’t even have the funds to procure everything that is already on the list, why add another item? It would cost $22 million to purchase everything on the EML to meet the entire country’s need.” – Key informant, Liberia

Provider knowledge

Provider knowledge was assessed using proxies such as availability of ministry-approved training manuals and curricula and documented training efforts of healthcare workers (Table 4). In Bangladesh, Nepal, Rwanda and South Africa, provincial and/or national governments had supported a limited number of in-service trainings of public sector providers on abortion care, including MA. In Liberia, Malawi and Sierra Leone—countries with highly restrictive abortion laws and no abortion service delivery guidelines or training curricula—no government-supported training on medical abortion for public sector providers had occurred. Instead, training on MA was either limited in scope to selected private sector providers and pharmacists, or prohibited. This created a bottleneck to service provision and also meant that the product risked expiring before use. Nigeria proved to be an exception; following the development of ministry-approved guidelines on abortion provision within the legal framework in 2019, the Society of Obstetricians and Gynecologists of Nigeria trained 18 master trainers on comprehensive abortion care (CAC), across all six country zones, with future cascade trainings planned. CAC includes the provision of information, abortion management (including induced abortion), and care related to pregnancy loss/spontaneous abortion and PAC [2].

Table 4 Provider training efforts on MA medicines

Where trainings had occurred in the public sector (Bangladesh, Nepal, Nigeria, Rwanda, and South Africa), key informants reported poor coordination between government training efforts and central medical stores’ distribution supply chain. This sometimes resulted in a lack of MA medicines at the facilities with trained staff. In the case of Rwanda, this situation was exacerbated by no registered MA products in the private sector. Once initial donated program drug stocks were depleted in the facilities, trained providers lacked access to MA drugs because a prescription was unable to be filled at an outside pharmacy.

We found a paucity of nationally approved pre-service curricula including MA in schools of medicine, midwifery and nursing (Table 4). Training on mifepristone and misoprostol for medical students was also limited. For instance, in 2010 in Nigeria, Ipas supported pre-service education on CAC in ten medical colleges, which included medical methods, but pre-dated the registration of combi-pack or mifepristone in Nigeria. In Nepal, pre-service training on abortion is mixed across healthcare cadres and schools. At the time of the assessment, WHO Nepal was reviewing existing curricula on abortion care to inform the development of government-approved standardized pre-service curricula on CAC, including MA for medical, midwifery and nursing schools. Few countries assessed were maximizing WHO healthcare worker guidance related to abortion service provision which limited abortion services to only doctors and specialists at the highest-level facility in their country.

Interviews with key informants, some of whom were providers themselves, suggested that some healthcare providers lacked knowledge of their country’s abortion law. Lack of awareness about the medical indications that would permit therapeutic abortion, fear of litigation, and deeply entrenched abortion-related stigma influenced providers’ willingness to offer services and commercial distributors’ interest to stock or promote MA products. In some of the countries assessed, providers in positions of influence at teaching and referral hospitals and professional associations held negative views of abortion.

“Here we have many issues of heads of hospitals not always being aware of the conditions whereby women and girls can get a legal abortion. I was at a site visit at a large district hospital once and the midwife in charge of the maternity ward was unaware that a court order was no longer required in cases of rape and incest, and that any girl under 18 years old can receive abortion on demand with presentation of her ID. This was more than 6 months after the revised penal code had been in the Gazette.”—Key Informant, Rwanda

End-user knowledge

A review of the literature showed that even in settings where abortion is broadly legal, most women do not know that it is an option. This was the case in Bangladesh, Nepal and South Africa, where less than half of women surveyed knew abortion was legally available in their country [20,21,22]. For those that did, they sought abortion through a variety of means, including at health facilities, traditional healers, pharmacies, and clinics [5, 23,24,25]. In South Africa, women were also accessing pills online [25].

In countries where abortion was more restricted (Liberia, Malawi, Nigeria, Sierra Leone), there was little data on the incidence of unsafe abortion and women’s knowledge of the abortion law or services. In these countries, key informants widely believed that abortion stigma was common and driving the practice towards less safe methods, contributing to preventable death and disability, particularly among adolescents and rural populations. Private sector pharmacists interviewed often expressed that they were the first point of contact for those seeking assistance with an unwanted pregnancy.

“Education levels are low, the population is young and the government doesn’t realize we are doing them a favor by making family planning, emergency contraception and MA products available in pharmacies—because that is where the youth will go first, not a facility, not their parents.” -Key Informant, Liberia

Community awareness activities on MA have been limited in scope across the countries assessed. Small-scale efforts to utilize mobile health and/or sensitize communities on abortion services via helplines and community health workers were being utilized in Bangladesh, Nepal, Nigeria, Rwanda, and South Africa. It was also loosely understood that informal networks, hotlines, pharmacies, and word of mouth play a role in women’s knowledge and access to abortion, including MA in the private sector. We found that SMO’s typically included helpline numbers on MA product inserts as a strategy to educate women on correct use and management.

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