Access to oxytocin, misoprostol, heat-stable carbetocin and tranexamic acid for management of postpartum haemorrhage in the Democratic Republic of the Congo, India and Kenya: a cross-sectional survey of drug availability and pricing

Abstract

Objectives

The aim was to assess point-in-time stock availability and pricing of drugs used for postpartum haemorrhage management (oxytocin, misoprostol, heat-stable carbetocin and tranexamic acid (TXA)).

Design

Cross-sectional point-in-time survey using an adapted version of the WHO/Health Action International methodology.

Setting

In public, for-profit and not-for-profit private health facilities and in pharmacies in the Democratic Republic of the Congo (DRC), India and Kenya.

Participants

211 health facilities in the DRC (n=63), India (n=76) and Kenya (n=72).

Primary and secondary outcome measures

Availability was calculated as a mean percentage of facility types where each medicine was observed on the day of data collection. Average procurement prices were calculated by obtaining the current purchase price per drug at each facility and then averaging prices across all facility types.

Results

Availability of the four medicines was limited, and only oxytocin in the DRC met the WHO’s benchmark of 80%. Across all countries, availability of oxytocin, misoprostol and TXA was lower in public health facilities than in other facility types, indicating an important gap. Where the four medicines were available, non-quality-assured products were predominant across the three countries. The average facility procurement prices in India and Kenya were reported to be lower than those in the DRC.

Conclusions

Availability of oxytocin, misoprostol, heat-stable carbetocin and TXA was suboptimal and varied by facility type and geography, and similar trends were found across the four drugs. This indicates that access strategies should be tailored to each drug, geographical area and facility type. Strategies to improve commodity access in public-sector facilities will be especially important, as well as improving the availability of quality-assured products, possibly through value-based procurement practices.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• The adaptation and use of a previously validated WHO/Health Action International methodology allows for the measurement of medicine availability and prices in a reliable and standardised way.

• This point-in-time cross-sectional survey evaluated availability of medicines within facilities as a binary variable (yes/no) only and was not intended to track inventory levels of postpartum haemorrhage drugs.

• These data refer to the availability of a given medicine in a particular dosage form and strength on the day of data collection at each outlet; therefore, trends in availability over time such as the average monthly, quarterly or yearly availability of medicines at individual outlets cannot be assessed.

• Certain types of facilities (ie, private not-for-profit facilities in the Democratic Republic of the Congo and India and pharmacies in India) were under-represented, although this reflects the actual geographic distribution of facilities within each survey area.

• Even though results are reported by country, they may not be generalisable as data were collected from a limited number of survey areas.

Introduction

Globally, postpartum haemorrhage (PPH) remains the leading cause of maternal mortality and morbidity, affects 5% of all deliveries and is responsible for nearly 27% of all maternal pregnancy-related deaths.¹ The risk of PPH and PPH-related morbidity and mortality disproportionately affects women in low- and middle-income countries (LMICs); more than 85% of deaths from PPH happen in South Asia and sub-Saharan Africa.² In 2020, the maternal mortality ratio was 138 per 100 000 live births in South Asia.³ In that same year, the maternal mortality ratio in sub-Saharan Africa was 531 per 100 000 live births, and this region alone accounted for approximately 70% of global maternal deaths.⁴ Efforts to reduce maternal morbidity and mortality due to PPH—including use of prophylactic uterotonics during the third stage of labour and timely, appropriate treatment to avoid the majority of PPH-associated deaths—can reduce the profound global inequities in maternal health outcomes.

For the prevention of PPH, WHO recommends use of intravenous oxytocin (10 IU) as the uterotonic of choice during the third stage of labour for all births.⁵ If intravenous oxytocin is unavailable, its quality cannot be assured or the bleeding does not respond to oxytocin, other uterotonic drugs, such as heat-stable carbetocin (HSC—100 µg via intravenous or intramuscular delivery) or misoprostol (400 or 600 µg by mouth), can be used, depending on country context. Furthermore, misoprostol for advance distribution to prevent PPH during community-based births can be used when no skilled personnel are available.⁵

For treatment of PPH, WHO recommends use of uterotonics together with uterine massage as soon as diagnosis is made, along with initial fluid resuscitation with isotonic crystalloids.⁵ Oxytocin (10 IU, intravenous or intramuscular) is the first-choice uterotonic, thus placing it in a central role in the treatment of PPH. The guidance specifically calls out the importance of using tranexamic acid (TXA) (1 g in 10 mL (100 mg/mL) delivered intravenously at 1 mL per minute) as part of the standard PPH treatment package. It should be administered as soon as possible after onset of bleeding and within 3 hours of birth in all cases of PPH, regardless of whether the bleeding is due to genital tract trauma or other causes.⁶ Updated guidance from WHO regarding best practices around PPH management includes objective quantification of blood loss and use of a treatment care bundle and implementation strategy for women experiencing vaginal birth.⁷ Medicines associated with this PPH management bundle include uterotonics and TXA.

Improving access to drugs that manage PPH is necessary to reduce PPH-related mortality in LMICs. HSC is a newer drug than oxytocin, misoprostol and TXA and was added to the WHO Essential Medicines List in June 2019. One HSC product (Ferring Pharmaceuticals, Switzerland) has been prequalified by WHO⁸ and approved through the European Union Mutual Recognition Procedure. This product had market authorisation in 19 countries as of the end of March 2024, and registration is in process in other LMICs (based on PATH’s conversation with Ferring Pharmaceuticals, 2024). No injectable TXA products are WHO prequalified for PPH treatment,⁸ although many are approved by stringent regulatory authorities (SRAs) and marketed globally (per PATH secondary research of regulatory authority databases in October 2022: European Medicines Agency; US Food and Drug Administration; and Ministry of Health, Labor, and Welfare of Japan). Five oral misoprostol products have been prequalified by WHO, manufactured by Acme Formulation Pvt. Ltd. (India), BIAL-Portela & Ca. SA (Portugal), China Resources Zizhu Pharmaceutical Co. Ltd. (China), Cipla Ltd. (India) and Senador Laboratories Pvt. Ltd. (India), as of July 2024. In addition, seven oral misoprostol tablet products have been approved by SRAs. Three oxytocin products have been prequalified by WHO, manufactured by JSC Grindeks (Latvia), Steril-Gene Life Sciences (P) Ltd. (India) and PT Sanbe Farma (Indonesia), as of July 2024.

However, it is challenging to address availability and pricing of quality-assured products—either approved by SRAs as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use or prequalified by WHO—particularly at facility levels in LMICs, due to lack of data transparency. The objective of this cross-sectional survey was to document point-in-time stock availability and pricing of oxytocin, misoprostol, HSC and TXA in public and private for-profit (PFP) and private not-for-profit (PNFP) health facilities and pharmacies in three countries. The evidence generated will be used to develop a strategy to facilitate introduction and adoption of quality-assured PPH medicines in LMICs.

Methods

Study design

This cross-sectional survey assessed point-in-time availability and pricing of four drugs used for PPH management (misoprostol, oxytocin, HSC and TXA) at public, PFP and PNFP facilities and at pharmacies in the Democratic Republic of the Congo (DRC), India and Kenya. Our survey method was adapted from the WHO/Health Action International (HAI) survey methodology,⁹ to collect point-in-time information on the availability and prices of essential medicines at public-sector and private-sector patient access points, including hospitals, clinics, pharmacies and dispensaries. Our survey focused exclusively on misoprostol (200 μg per tablet), oxytocin (10 IU/mL (or 5 IU/0.5 mL) per ampoule or vial), HSC (100 μg/mL per ampoule/vial) and TXA (500 mg/5 mL (or 1 g/10 mL) ampoule or vial). We collected price information on all four products stocked at survey sites regardless of whether they were originator or generic products. The specific dosage was selected based on the WHO recommendation for PPH management.

Survey areas and site selection

We selected the DRC, India and Kenya to leverage an ongoing project for data collection. These three countries had high maternal mortality ratios in 2020: 547/100 000 live births for the DRC;³ 103/100 000 live births for India³ and 355/100 000 live births for Kenya.¹⁰ These figures are much higher than 70 per 100 000 live births—the Sustainable Development Goal 3.1 target to reach by 2030—and represent a significant need for improved access to drugs for PPH management.

Three to five subnational administrative survey areas in each country (eg, provinces, districts, counties) were purposively selected and included the country’s main urban centre and two to four other urban or rural areas. In all three countries, administrative survey areas that were part of ongoing project implementation were included to leverage logistics and relationships with local health departments. All survey areas were reachable within 1 hour of travel time from the main urban centre using a car or bus. Only two counties (one urban and one rural) were selected in Kenya due to the time necessary to obtain permission for facility visits; data were collected primarily from two subcounties in each of these counties. We selected the main public hospital in each survey area first, followed by random selection of at least four public-sector health facilities (district hospital, health centre or dispensary) that provide maternity services. Additionally, we selected at least five private pharmacies, five PFP health facilities and three to five PNFP health facilities that provide maternity services—with the exception of India, where fewer than three to five PNFP health facilities were selected due to the low number of this facility type in the survey area.

Trained data collectors with experience in conducting medicine surveys administered a semistructured questionnaire to pharmacists to determine the point-in-time availability and pricing of surveyed medicines. The availability and labelling information of surveyed medicines (eg, product names and manufacturers) were additionally confirmed via observation. For each medicine surveyed, data collectors recorded the product name, manufacturer, unit size of the product, the price at which facilities and pharmacies procured the medicine, the price to patients and the organisations from which the product was procured, using a paper-based data collection tool (online supplemental file 1). Product names and manufacturers/marketers were confirmed by labelling information on the product package. The names of distributors or local representatives were not confirmed consistently.

Data analysis

All data were entered into a Microsoft Excel database and data inputs were independently checked for errors. The availability of each of the four products was calculated as the percentage of surveyed sites where the drug was observed to be physically present at the time of the survey compared with the total number of surveyed sites. The percentages were calculated separately for public, PFP or PNFP health facilities and pharmacies.

Procurement price data were obtained in the local currency (Congolese francs in the DRC, Indian rupees and Kenyan shillings) and converted to US dollars using the OANDA exchange rate on 31 July 2023 (https://www.oanda.com/currency-converter/en/?from=EUR&to=USD&amount=1), to standardise the dataset. In India, prices of oxytocin products were provided for 5 IU/0.5 mL ampoules, and we doubled the prices per ampoule to obtain the prices for 10 IU/mL for comparison across the three countries. For TXA, although 1 g/10 mL products were globally available, all procurement prices in our survey were provided for 500 mg/5 mL ampoules. To calculate the average procurement price for each medicine, we obtained the current procurement price at each facility that shared the information and then calculated a simple average across all facility types. Where possible, we compared prices between quality-assured and non-quality-assured products.

Patient and public involvement

As this was solely a cross-sectional survey of drug pricing and availability, patients or the public were not involved in design, conduct, reporting or dissemination plans.

Results

A total of 211 health facilities in the DRC (n=63), India (n=76) and Kenya (n=72) were surveyed from June through July 2023, as shown in table 1.

Table 1. Facilities sampled, by location and facility type.

Country	Survey area	Public HF	PFP HF	PNFP HF	Pharmacy	Total
DRC	Kimpese	6	7	4	4	21
	Kinshasa	7	7	3	3	20
	Kisantu	6	6	5	5	22
	Subtotal	19	20	12	12	63
India	Khargone	5	5	0	5	15
	Indore	7	5	3	6	21
	Jalgaon	5	7	2	7	21
	Mumbai	7	6	1	5	19
	Subtotal	24	23	6	23	76
Kenya	Nairobi	10	11	6	10	37
	Makueni	12	8	5	10	35
	Subtotal	22	19	11	20	72
Grand total		65	62	29	55	211

DRC, Democratic Republic of the Congo; HF, health facility; PFP, private for-profit; PNFP, private not-for-profit.

Availability of drugs for management of postpartum haemorrhage

Overall point-in-time availability of misoprostol did not meet the WHO benchmark of 80% in any country (figure 1A). Misoprostol was available in more facilities in India (57%) and Kenya (63%) than in the DRC (38%). In India, misoprostol was most available in public health facilities (26%) and least available in PNFP health facilities (5%) and pharmacies (5%). In the DRC, PNFP health facilities had the highest availability (11%), and PFP health facilities had the lowest (8%). In Kenya, misoprostol was most available in PFP health facilities (25%), while it was lowest in pharmacies (7%).

Figure 1. Availability, by country and facility type, of misoprostol (A), oxytocin (B), heat-stable carbetocin (C) and tranexamic acid (D). DRC, Democratic Republic of the Congo; HSC, heat-stable carbetocin; HF, health facility; PFP, private for-profit; PNFP, private not-for-profit; TXA, tranexamic acid.

Oxytocin products stocked at the surveyed facilities in the DRC and Kenya were 10 IU/1 mL ampoules, and 5 IU/0.5 mL ampoules were stocked in India. The overall point-in-time availability of oxytocin in the DRC (92%) met the WHO benchmark of 80% (figure 1B). Kenya (72%) did not meet this benchmark due to the exceptionally low availability of oxytocin in pharmacies. Lower point-in-time availability of oxytocin in India (51%) than in the DRC and Kenya can likely be attributed to expiry of the rate contract at the time of this survey and dispensing restriction at the pharmacy level.

Overall point-in-time availability of HSC did not meet the WHO benchmark of 80% in any country (figure 1C). No HSC was observed in the DRC since it was not included in the National Essential Medicines List at the time of this survey, and extremely limited point-in-time availability was observed in India (12%) and Kenya (6%). HSC was not available in the public health facilities in India as it is not included in the National Health Mission’s PPH management guidelines.

For TXA, although 1 g/10 mL products were globally available, TXA products stocked at the surveyed facilities were 500 mg/5 mL ampoules. Overall point-in-time availability of TXA did not meet the WHO benchmark of 80% in any of the three countries (figure 1D). Overall availability of TXA was relatively high in India (75%) and Kenya (71%) compared with the DRC (29%). In India, point-in-time availability of the drug is highest in the public health facilities (32%), whereas in Kenya, it is highest in PFP health facilities (22%), and in the DRC, it is highest in pharmacies (10%).

Most frequently observed brands of drugs to manage postpartum haemorrhage

The most frequently observed brands of the four drugs are shown in online supplemental file 2. In the DRC and Kenya, all product names of the four medicines were imported, most from India. A wider variety of product names was observed in India, which might suggest a more fragmented market than in the other two countries.

We observed nine different product names of misoprostol across 24 facilities in the DRC, 15 different product names across 42 facilities in India and 4 different product names across 45 facilities in Kenya. In India, two public health facilities stocked misoprostol with two different product names, while the other facilities in India and all facilities in the DRC and Kenya reported only one product name of misoprostol per each facility. Most of the misoprostol products stocked were generic; one quality-assured product (Cytotec, Pfizer Inc.) was stocked at 14 facilities in Kenya, and another quality-assured product (Misoprost, Cipla Ltd.) was stocked at one PFNP health facility in the DRC.

We observed eight different oxytocin product names at 58 facilities in the DRC, ten at 39 facilities in India and eight at 52 facilities in Kenya. In the DRC, 37 facilities stocked two different product names of oxytocin per facility, and in India, one pharmacy stocked two different oxytocin products. The majority of oxytocin products were generic. One quality-assured oxytocin product was stocked at one PFP facility in Kenya (Syntocinon, Novartis), and another quality-assured product (Pitocin, Pfizer Inc.) was stocked at nine facilities in India.

In terms of HSC, four facilities in Kenya had only the Pabal brand from Ferring Pharmaceuticals in stock. Pabal HSC is marketed for private-sector use; however, the brand was observed in public, PFP and PNFP health facilities in Kenya. In India, 14 facilities had six brand names of HSC products in stock. Two Ferring Pharmaceuticals products, Caritec and Riligol, were marketed by Sun Pharmaceuticals Industries Ltd. and Abbott, respectively. Three additional HSC brand name products were observed in India, marketed by three different Indian pharmaceutical companies.

We observed 5 different TXA brand names at 18 facilities in the DRC, 18 different TXA brand names at 57 facilities in India and 7 different TXA brand names at 51 facilities in Kenya. While most of these products were non-quality-assured, one quality-assured product, Exacyl (Cheplapharm Arzneimittel GmbH), was stocked at five facilities in the DRC, and another quality-assured product, Pause (Emcure Pharmaceuticals Ltd.), was stocked in nine facilities in India.

Facility procurement prices of drugs for management of postpartum haemorrhage

A total of 85 procurement prices for misoprostol were provided (19 in the DRC, 39 in India and 27 in Kenya) by facilities that had the drug in stock on the day of the survey. In India, one facility in Khargone had two different misoprostol products in stock and they provided the price of each product. The facility procurement price for misoprostol ranged from a low of US$0.03 per tablet in the public health facilities in India to a high of US$0.80 per tablet in the PNFP health facilities in the DRC. The average facility procurement price was lower in India than in the other two countries because of the low facility procurement price by the public health facilities in the country. In the DRC, the public health facilities paid higher procurement prices than any other facility types on average. In the DRC, one of the two public health facilities in Kimpese that provided product prices procured misoprostol at a very high price (US$1.20 per tablet), which drove the average procurement price for public health facilities in the DRC upward. In Kenya, the PNFP health facilities paid a lower price than the public health facilities on average for the drug (figure 2A).

Figure 2. Average facility procurement price, by country and facility type, of misoprostol (A), oxytocin (B) and tranexamic acid (C). DRC, Democratic Republic of the Congo; HF, health facility; PFP, private for-profit; PNFP, private not-for-profit; TXA, tranexamic acid.

A total of 139 procurement prices for oxytocin were obtained from 115 (42 in the DRC, 35 in India and 38 in Kenya) facilities that had the drug in stock on the day of the survey. 25 facilities in the DRC (11 in Kimpese, 7 in Kinshasa and 7 in Kisantu) and 1 facility in Jalgaon, India, provided prices for the two different oxytocin products they had in stock. The facility purchase prices for oxytocin ranged from a low of US$0.03 per ampoule in public and PFP health facilities in the DRC to a high of US$0.48 per ampoule in PFP facilities in India. Overall, the average facility procurement price was lower in the DRC compared with the other two countries. Public health facilities paid the lowest price in Kenya and India, while those in the DRC paid slightly higher prices in the DRC (figure 2B).

A total of 93 procurement prices for TXA were provided by 93 (12 in the DRC, 47 in India and 34 in Kenya) facilities that had the drug in stock on the day of the survey. The purchase prices for TXA ranged from a low of US$0.11 per ampoule/vial in public health facilities in India to a high of US$2.90 per ampoule/vial in PFP health facilities in the DRC. Overall, average facility procurement prices in India and Kenya were lower than in the DRC. In Kenya and India, public health facilities paid lower average prices than any other health facilities (figure 2C).

Only nine facilities (two in Kenya and seven in India) reported the prices they paid to procure HSC. The average facility procurement price for HSC ranged from a low of US$0.77 per vial in a PFP health facility in India, to a high of US$18.90 per vial in a PNFP health facility in Kenya. In Kenya, the average facility procurement prices were higher than those in India, although direct comparison was not feasible since public and PNFP health facilities reported procurement prices in Kenya and PFP and pharmacy facilities reported procurement prices in India.

Facility procurement prices of quality-assured medicines versus non-quality-assured medicines

We compared the average facility procurement prices for quality-assured versus non-quality-assured products for a subset of products.

For misoprostol in Kenya (figure 3A), the average facility procurement prices of the quality-assured product Cytotec (US$0.35 to US$0.59) were higher than those of the non-quality-assured product Isovent (US$0.11 to US$0.21). Likewise, for oxytocin in India (figure 3B), the average facility procurement prices of the quality-assured product Pitocin (US$0.16 to US$0.45) were generally higher than those of the non-quality-assured product Evatocin (US$0.11 to US$0.18). For HSC in India (figure 3C), the prices of the quality-assured products (US$2.58 to US$5.00 for Caritec and Riligol) were not very different from the non-quality-assured products (US$3.92 to US$4.64 for Carbitex and Ecbosure (Ecbosure is spelled ‘ecbosuere’ in some manufacturer documentation but not on product packaging)). We observed no notable price difference between quality-assured and non-quality-assured TXA products in India (figure 4A): US$0.69 to US$0.74 for Pause compared with US$0.43 to US$0.82 for Trenaxa and Klotin. But, in the DRC (figure 4B), there was a large difference between quality-assured Exacyl (US$2.24 to US$2.90) and non-quality assured Exaceal (US$0.53 to US$1.87).

Figure 3. Average facility procurement price comparison of quality-assured and non-quality-assured products—misoprostol in Kenya (A), oxytocin in India (B), and heat-stable carbetocin in India (C). DRC, Democratic Republic of the Congo; HF, health facility; PFP, private for-profit; PNFP, private not-for-profit; QA, quality-assured.

Figure 4. Average facility procurement price comparison of quality-assured and non-quality-assured tranexamic acid products—in India (A) and in the DRC (B). HF, health facility; PFP, private for-profit; PNFP, private not-for-profit; QA, quality-assured; TXA, tranexamic acid.

Discussion

As noted in WHO’s A roadmap to combat postpartum haemorrhage between 2023 and 2030,¹¹ making PPH medicines more accessible and affordable is a key action to ensure effective and coordinated efforts towards eliminating preventable deaths from PPH. Our data document point-in-time availability and pricing of oxytocin, misoprostol, HSC and TXA in public and private health facilities and pharmacies in the DRC, India and Kenya. Overall, availability of the four medicines was limited, and only oxytocin in the DRC met the WHO benchmark of 80%. One hypothesis to explain this result in the DRC is that the 2018 WHO recommendation⁵ that stipulates oxytocin as the first choice for PPH management was well understood by all stakeholders, and procurement of oxytocin was well integrated into the existing supply chain systems with financial support provided by either the government or international aid organisations.

Oxytocin and misoprostol availability were shown to meet the WHO benchmark in both Kenya and Uganda in 2017.¹² Yet, results from our survey showed a lack of availability of both drugs—particularly, a lack of misoprostol at private pharmacies in Kenya. Previous findings showed that the availability of misoprostol was poor in rural settings in Kenya, possibly due to fear and stigma associated with its use for abortion.¹² Similar results from our study suggest that in rural areas such as Makueni county, pharmacists may be reticent to stock misoprostol since it can be used as an abortifacient as well as for prevention of PPH. In Kenya, building the awareness and capacity of pharmacists in terms of knowledge on uses of misoprostol beyond abortion is critical. This may be especially timely given the 2022 High Court ruling that affirmed abortion as a fundamental right under the country’s constitution¹³ even though Kenya does not permit abortion unless the mother’s life or health is in danger. The results from our study showed that availability of oxytocin¹⁴ and misoprostol^{15 16} was also limited in India, particularly in PNFP health facilities and pharmacies, due to laws limiting their distribution and use. A similar lack of availability has been documented for oxytocin in private retail outlets in Maharashtra¹⁷ and for oxytocin and misoprostol in private pharmacies in Karnataka.¹⁸

Across all countries, point-in-time availability of misoprostol, oxytocin and TXA was generally lower in public health facilities than in other sectors, indicating an important gap in equitable access. In many LMICs, such as Kenya, where the latest national household health expenditure and utilisation survey¹⁹ indicated that public health facilities were used by 59% of people seeking care, access to these lifesaving drugs must be improved.

Data from the 2024 Landscape and Projection of Reproductive Health Supply Needs (LEAP) global report²⁰ as well as from various countries in sub-Saharan Africa^{21 22} show that PPH drugs are not available to all women who might need them. A qualitative evidence synthesis²³ concludes that inconsistent availability of drugs and other medical supplies causes delays in the timely management of PPH and suggests the development of a new procurement audit tool to identify low stock or stock‐outs as one way to counter this inequity. An institutional-based cross-sectional study conducted in 10 district hospitals in Rwanda demonstrated the criticality of using inventory management tools such as bin cards and electronic software (e-LMIS),²⁴ to maintain adequate medicine inventory. Other approaches to achieving a sustainable supply chain for PPH medicines such as HSC include the use of human-centred design as in Nigeria^{25 26} and the introduction of a public-private partnership model in India.²⁷ End-to-end planning for introduction of essential maternal health products has also been noted as a pathway to increase access to these life-saving medicines.²⁸

Non-quality-assured misoprostol, oxytocin and TXA products were observed to be widely available at the time of this survey across the three countries. The facility procurement prices of non-quality-assured oxytocin and misoprostol were lower than those of quality-assured drugs. Awareness of value-based procurement will also be critical as countries consider allocation of domestic resources to quality-assured drugs for maternal and newborn health. Reflection on the usefulness of frameworks²⁹ around resource allocation that incorporate a value-based care perspective may also be useful. Ultimately, adopting procurement practices based on the total value of the drugs rather than just price will be an important avenue towards achieving cost-effectiveness.

In India, at least four brands of HSC were marketed in the private sector, all manufactured by two companies, Ferring Pharmaceuticals and Precise Biopharma. All HSC products were registered with the regulatory authority in India, but the Ferring HSC product is the only product prequalified by WHO. Our survey did not find substantial price differences across the four brands overall. In all three countries, available oxytocin products were often generic and not quality assured. The average facility procurement price for oxytocin for all facility types in all survey areas in the DRC and Kenya and most facility types and areas in India was lower than the ex-works price of US$0.31±10% per ampoule of 100 µg HSC being offered by Ferring Pharmaceuticals to public-sector buyers in LMICs. Strategies for demand generation for HSC might need to focus on reducing switching costs from oxytocin to HSC for prevention of PPH, including further reduction of the price of HSC to the public sector. In addition, attention must be paid to the leakage of Pabal HSC into public and PNFP health facilities in Kenya. An innovative strategy might be needed if the manufacturer intends to continue two-tier pricing for public and private health facilities.

All medicines included in our survey in the DRC and Kenya were imported. In India, many PPH medicines were manufactured by and sourced from Indian companies, although a large portion of the market share was occupied by only a few oxytocin, misoprostol and TXA products. As seen with oxytocin, domestically sourced medicines are not necessarily linked to lower procurement prices. When countries are considering improving local production capacity of essential medicines, they will need to take into account various factors and determine whether local production of medicines could lead to lower prices.³⁰

Our adapted WHO/HAI study design was cross-sectional in nature, so historical data trends could not be analysed. The number of facilities surveyed was less than the minimum number of 30 facilities per sector recommended in the WHO/HAI standardised sampling methodology. However, adapting the sample size to a smaller number of facilities per sector was amenable to our exclusive focus on four drugs for PPH management as opposed to the broader range of medicines covered by the WHO/HAI survey. Other limitations of this assessment include the varied number of facility types in the survey areas. The low number of certain types of facilities (particularly PNFP facilities in the DRC and India and pharmacies in India) represents a gap in reporting. Furthermore, some facilities were hesitant to share procurement pricing data due to the sensitive nature of the request; this occurred most often at pharmacies, where management did not want to release pricing information that might allow revenue margins to be calculated. Additionally, prices were not confirmed by documentation (eg, invoices). Last, data limitations impacted reporting on any affordability analysis. We were unable to calculate out-of-pocket spending accurately due to only very limited responses to questions relating to price of medicines to consumers. We imagine this is because facilities did not want to disclose their profit margin by providing both their procurement prices and prices that they charge to patients/consumers. In Kenya, maternal medicines are theoretically covered by the Linda Mama programme³¹ of the National Health Insurance Fund, so affordability should not be an issue, particularly in the public sector. However, a recent study reported that Kenyan patients have incurred out-of-pocket expenses for maternal healthcare in some cases.³² Our survey did not identify the availability and use of each drug based on different clinical indications. Further investigation into the quantity of each medicine prescribed by indication for use will help national governments develop better quantification and national introduction plans. In addition, the optimal route of advance distribution of misoprostol for community births could be further investigated where private pharmacies are prohibited from providing the drug directly to consumers.

Conclusion

In general, the availability of PPH medicines in the three countries was suboptimal. Stock availability, facility procurement prices and price ranges of oxytocin, misoprostol, HSC and TXA varied by facility type and geography, and similar trends were found across the four drugs. Future efforts to develop strategies to increase access to PPH drugs should be tailored to each product, geographical area and facility type. Strategies to improve commodity access in public-sector facilities will be especially important, as well as improving availability of quality-assured products, possibly through value-based procurement practices.

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.