This was a descriptive cross-sectional study design that assessed the availability, pricing, and affordability of 43 essential pediatric medicines in Malawi. Data were collected from public health facilities, Christian Health Association of Malawi (CHAM), private retail/community pharmacies and private clinics in selected districts across the country. We used the methodology developed by the World Health Organization (WHO) and Health Action International (HAI) on measuring medicine prices, availability and affordability in the development of the study design, data collection and analysis (World-Health-Organization(WHO), 2012). Data was collected from March to May 2023.

The study was conducted in five districts, three of which are in the northern region of Malawi (Mzimba, Nkhata-Bay and Rumphi) and the other two in the southern region (Zomba and Blantyre districts). Since the last study on availability and affordability of medicines (Khuluza and Haefele-Abah, 2019), there has been increased private health facilities being opened in the northern region, hence the inclusion of the same. We obtained a list of registered facilities from the Ministry of Health (public and CHAM facilities), Pharmacy and Medicines Regulatory Authority (retail pharmacies) and Medical Council of Malawi (for private clinics). We randomly pre-selected a total of 90 registered health facilities within the study districts, exceeding the minimum number of sites of 50 from the WHO/HAI methodology (World-Health-Organization(WHO), 2012).

Of the 90 randomly selected facilities, we collected data from 19 retail pharmacies and 11 medicine stores (giving a total of 30 in this sector), 20 public health facilities, 12 CHAM facilities and 14 private clinics giving us a total of 76 sites (Figure 1 showing distribution of study sites). The reduced number of study sites was as a result of some facilities (9 private/CHAM) declining to provide any data despite repeated visits to the sites even though confidentiality to the data was guaranteed. The other five sites could not be located, which could be as a result of closing their businesses. Despite having some challenges in some facilities, the response rate for the study was very good (84.4%) and above most studies (Fincham, 2008). The public health facilities included three central hospitals, five district hospital pharmacies, and 12 primary health centers.

We used Malawi Standard Treatment Guidelines (MSTG) 2015 that incorporated Malawi Essential Medicines List (MEML) as a main backbone in selecting pediatric medicines for the study (Ministry-of-Health, 2023). This was supplemented with information from World Health Organization Essential Medicines List for Children and Malawi Pediatric Handbook (World Health Organization, 2021). This resulted in the initial selection of 50 medicines for the study. However, during data collection, we realized that seven of the initially selected products are not stocked in any facility and as such were removed from data analysis. Table 1 is the list of the medicines that were included in the study while Supplementary Table S1 contains the details on why each medicine was included in the study.

Two trained teams of pairs (CCM and VM; and FA &TG) each were assigned to collect the data. We used WHO/HAI template for data collection with minor modification that was in line with previous studies (Khuluza and Haefele-Abah, 2019; World-Health-Organization(WHO), 2012). The modification concerned collecting prices regardless of branding of the medicines. This was done as Malawi has very few branded products on the market as such it was unlikely to collect three prices for each medicine (branded, most sold generic and lowest priced). The modified data collection form has been submitted as Supplementary Table S2. We recorded the medicine availability and price as provided by the responsible personnel, mainly the person in charge of the pharmacy (for public health facilities, CHAM, and retail pharmacies). While for private clinics, information was mainly provided by the owners of the facilities who in most cases were clinicians or nurses. Public health facilities provided availability information only as they provide medicines for free (Khuluza and Haefele-Abah, 2019).

We calculated medicine availability as the percentage of facilities which had stock of the respective medicine at the time of the visit, irrespective of the amount and pack size available, as recommended by the WHO/HAI methodology. The availability of medicines was compared among the different healthcare sectors: public, CHAM (faith-based) and private sectors. In terms of level of care, we conducted a sub-analysis on the availability of medicines that are supposed to be available in primary level facilities. All descriptive analyses were done in Microsoft Excel. We used 80% as a minimum target for assessing medicine availability in this study, that is in line with WHO, Tadesse T et al. and previous study in Malawi (World Health Organization, 2013; Bazargani et al., 2014; Khuluza and Haefele-Abah, 2019).

We collected medicine prices in local currency (Malawi Kwacha, MWK) that were converted to US $ using the average Reserve Bank of Malawi exchange rate for the month of April 2023 (1 US $ = 1036.25 MWK), in which the data were collected (Reserve_Bank_of_Malawi, 2023). The conversion to US Dollar allows international comparison of prices during the time of study as Malawian currency has been unstable since 2021. For example, the exchange rate of 1 USD was 1036.25 during the time of data collection (April 2023), but was subsequently devalued that by December of 2023, when 1 USD was equivalent to 1868.25 MWK (https://www.exchangerates.org.uk/USD-MWK-exchange-rate-history.html). For facilities where there was more than one price per product, we selected the cheapest one for inclusion in the data analysis. The lack of availability of originator brands, and thus lack of categorization, did not have an adverse impact on the results of the study. We also did a sub-analysis of medicine availability based on the level of health facility where the medicine should be available, as well as disaggregated data for private drug stores and retail pharmacies.

A total of 43 medicines were assessed for affordability based on the treatment regimens for common pediatric conditions in Malawi (Ministry-of-Health, 2023; IHMA, 2023). We used the Malawi Standard Treatment Guidelines (MSTG) 2015 supplemented by pediatric handbook for Malawi to calculate the amount of dosage units (bottles/tablets/capsules/vials) required for one course of treatment or for a monthly treatment in case of chronic conditions (Ministry-of-Health, 2023; Phillips et al., 2008). The majority of pediatric treatment are based on the weight of the child. In this study, we used a weight range of 15–20 kg in the calculation of the treatments. We multiplied the weights by the dosage per kilogram in order to find the course of treatment. The course of treatment was then converted to cost by multiplying it with the median price of a unit of medicine. A unit of medicine was the lowest unit that can be administered to the patient, which was either a tablet or capsule or a milliliter of medicine in cases of syrups. The total cost of the treatment was then divided by the minimum wage of Malawi to establish the number of days it would require for the worker to afford the treatment. Among other conditions, we included both complicated and uncomplicated malaria, sepsis, diarrhea, upper and lower respiratory tract infections including pneumonia, meningitis, seizures, and anemia. Supplementary Table S3) indicates the diseases condition that was considered for estimating the affordability of each medicine that was included in the study. For benzyl penicillin and gentamicin injections, a treatment duration of 3 days (before changing to oral medication) was chosen as stated in the treatment guidelines. For oral suspension or solutions, a bottle of 100 mL was used as a complete dose for the age range 0–2 years, and two bottles above 2 years while for any child above 10 years, we used available oral solid dosage forms (tablets or capsules). The daily minimum wage of the lowest-paid unskilled worker, as legislated by the Malawian government, was used to measure local affordability and the number of days’ wages needed to purchase a course of treatment (1923.08 MWK = 1.86 US$) (Wage_Indicator, 2023).

The Institution Review Board of Kamuzu University of Health Sciences-Malawi (College of Medicine Research and Ethics Committee (COMREC) under study numbers U.12/22/3900 and U.12/22/3903) granted approval. In addition, permission was sought from the hospital director or directorates of health and social services in Zomba, Blantyre, Mzimba, Rumphi and Nkhatabay before data collection. The study did not collect any patient data. The study was approved in line with the principles of the declaration of Helsinki.

We here present data for 43 medicines that were analyzed. The overall availability of pediatric medicines in all sectors was 38.1% for public health facilities, 53.7% for private retail pharmacies and drug stores, 49.5% for private clinics and 48.3% for CHAM facilities. Nalidixic acid, mebendazole and ferrous sulphate syrup had the lowest availability with zero availability in three of the four sectors. Artesunate injection had 100% availability in CHAM and public facilities, however its availability in private pharmacies and private clinics was very low. Artemether/Lumefantrine suspension had zero availability in CHAM and public facilities, with poor availability in private sectors (6.7% and 7.1% in private pharmacies and clinics respectively) Table 1.

We further analyzed the availability of medicines based on the level of health facility where they were supposed to be found. This was done in order to assess the adherence of the public sector to Malawi Essential Medicines List in their distribution of medicines. This analysis included CHAM and public health facilities only as in most cases CHAM facilities are at the level of primary care which is similar to most of the public facilities where the data were collected. A sub-analysis of 21 medicines that are supposed to be found in health centers (primary healthcare facilities) and throughout the system showed a higher medicines availability at 53.1% in public facilities, and 64.7% for CHAM facilities. While for those medicines that were not supposed to be at a health center (primary-level care) revealed a below 50% availability, Figure 2. Surprisingly, availability of artesunate injectable was 100% in public sector and CHAM, while amoxicillin plus clavulanic acid (a tertiary level medicine) was also available in some health centers, Table 2. In addition, there was presence of unclassified medicines in both CHAM and public health facilities, Table 2. Unclassified medicines are the ones that are not appearing in Malawi’s Essential Medicines List of both 2015 and 2023.

Pediatric medicine median prices were higher in the private clinics followed by retail pharmacies and drugs stores. CHAM had the lowest median prices of all the sectors. It should be noted that the public health sector in Malawi provides their services free of charge including medicines, as such there was no such comparison on prices in the public sector. In addition, certain categories of medicines like first line antimalarial medicines, are provided free of charge also in the CHAM sector, as such there was no comparison of their median prices. There was a wide variation in the median prices of certain medicines like albendazole among the sectors, with private retail pharmacies charging four times the price in the CHAM while private clinics charged six times the price in the CHAM, Table 3. The median price for paracetamol tablet was the same across all the sectors. Amoxicillin suspension, albendazole and metronidazole tablets had the lowest variation in median prices among the sectors (CHAM, Private Pharmacies. and Clinics).

For private retail pharmacies and drug stores, prescription only medicines (POM) are supposed to be found in retail pharmacies only and not drug/medicine stores. Drug stores are supposed to keep Pharmacy Only (P) and General Sales List (GSL) medicines category as mandated by the Pharmacy and Medicines Regulatory Authority (PMRA). However, a sub-analysis of 19 private retail pharmacies and 11 drug stores observed widespread availability of POM medicines in the drug/medicine stores. Overall availability of medicines in the retail pharmacies was 64.8% while the drug stores was 42.7%. We observed widespread availability of POM medicines in drug stores with as high as 54% for metronidazole suspension. Medicine median prices for retail pharmacies were lower than drug stores except for aminophylline tablet, Amoxicillin tablet/cap, benzyl penicillin and ORS (Table 4).

Affordability was assessed based on various weights as described in the methods section. The selected diseases on which the assessment was done have been attached as supplementary Table 3. Figure 3 provides details of affordability of medicines in which artesunate injection, clindamycin tablet, benzyl penicillin injection and carbamazepine tablet had the highest number of days for a family to afford treatment that required more than 2 days of work. Majority of the formulations were affordable, as they required less than a day to afford the treatment.

Of special note is that all antimicrobials (amoxicillin, cotrimoxazole Metronidazole and erythromycin) that are supposed to be found in primary health facilities were affordable as their number of days to purchase a course of treatment were less than or equal to 1 day in all the sectors. All paracetamol formulations had affordability below 1 day’s wage with the tablet requiring a tiny fraction of a day’s work. The pattern of paracetamol was similar with the non-steroid anti-inflammatory drugs (NSAIDs) ibuprofen, Figure 3 (and supplementary Table 3)