Article Text
Abstract
Objective To describe the price and affordability of key essential medicines for children in the private sector in Sri Lanka in 2017/2018, and compare the findings with 2009 data.
Design National cross-sectional descriptive survey using the WHO/Health Action International medicine price methodology.
Setting and participants Data were collected from a representative sample of 54 private sector pharmacies selected from all 9 provinces in Sri Lanka using a multistage clustered approach.
Main outcomes Median price ratio (MPR) and affordability of originator brand (OB) and lowest priced generics (LPG) of 25 key essential medicines for children.
Results The median MPR was 2.69 for OBs and 1.45 for LPGs compared with 3.7 and 1.35 in 2009. MPR of OB of all but one (chlorphenamine syrup) were higher than that of the LPG. MPR-OB>5 was observed for ceftriaxone injection, amoxicillin capsule, mebendazole chewable tablet and metronidazole tablet. This was documented in 2009 as well except for amoxicillin capsule. Prices of LPGs of seven medicines (amoxicillin capsule, amoxicillin suspension, clotrimazole cream, mebendazole chewable tablet, metronidazole tablet) were estimated as excessive (MPR ≥2.5) compared with chlorphenamine syrup, clotrimazole topical cream, ibuprofen syrup and paracetamol syrup in 2009. Compared with 2009, MPRs of OBs of 8 medicines and LPGs of 12 medicines were higher in 2017/2018. Compared with 2009, no change in affordability was noted except for asthma, which has been assessed as affordable in 2017/2018. Standard drug therapy for mild lower respiratory tract infections and acute gastroenteritis remained affordable, and treating epilepsy with carbamazepine syrup remained unaffordable.
Conclusion Economic access to key essential medicines for children has not improved in Sri Lanka in the 8 years’ time since the initial survey in 2009.
- CLINICAL PHARMACOLOGY
- Health policy
- HEALTH ECONOMICS
Data availability statement
Data are available on reasonable request.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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STRENGTHS AND LIMITATIONS OF THIS STUDY
The survey included a representative sample from the entire country.
The survey used the WHO/Health Action International medicine price methodology.
We were able to compare the findings with the data of our first survey in 2009, both followed the same methodology.
Median price ratio (MPR) was calculated based on the prices obtained from the survey pharmacies which had the survey medicines on the day of the survey. This might not be reflective of the prices over the year.
Although, the survey was done in 2017/2018, we had to use international reference unit price reported in 2015 in calculating MPRs as it was the nearest information we were able to access.
Background
The concept of essential medicines was introduced by the WHO with the intention of improving access to necessary medicines that would satisfy the priority healthcare needs of the population.1 The WHO launched the first model essential medicine list (EML) in 1977, and updates it regularly every 2 years. However, until 2007, the WHO model EML was mainly focusing on medicines and formulations meant for adults.2
Children differ significantly from adults in terms of pharmacotherapy mainly because of ongoing developmental processes substantially affecting the medicine exposure and response.3 4 Accepting this diversity, in 2007, the World Health Assembly passed the ‘Better Medicines for Children’ resolution which urged the 193 member states to promote access to essential medicines for children and devise measures to monitor prices.5
Embracing the challenge, the WHO launched the first model EML for Children (EMLc) in 2007 and spearheaded the ‘make medicines child size’ campaign.2 6 From 2007 onwards, the WHO updates EMLc also every 2 years together with the adult list, and the last version was published in 2021.7 Many countries including the low-income and middle-income countries (LMICs) introduced several initiatives to ensure better medicines for children.8 9
Despite these efforts, lack of physical (availability) and economic (affordability) access to key essential medicines for children had been reported from many LMICs.10–14 Although medicines are given free of charge in the public sector in many LMICs including Sri Lanka, patients are compelled to pay out-of-pocket to buy medicines from private sector because of low availability in the public sector.15 16 The WHO has estimated that up to 90% of the population had to pay out-of-pocket to buy medicines in LMICs.16
We conducted a national survey in Sri Lanka in 2009 and documented that the availability of key essential medicines for children was less in the public sector compared with private pharmacies.13 When we reassessed the situation in 2017/2018, the mean percent availability has been improved in public sector (from 52% to 68.1%) whereas a drop was observed in private pharmacies (from 80% to 65.4%).17 In both surveys, availability was surveyed in both public and private sectors, whereas prices and affordability were surveyed only in the private sector as medicines are supplied free of charge to the patients in the public sector
This paper describes the price and affordability of key essential medicines for children in the private sector in Sri Lanka in 2017/2018, and compares the findings with 2009 data.14
Methodology
Data on prices were obtained from a cross-sectional descriptive country survey conducted in 2017/2018 to reassess the availability, price and affordability of key essential medicines for children in Sri Lanka. The methodology of this survey was adapted from WHO/HAI medicine price methodology,18 and almost similar to our initial survey in 2009. Publications reported the findings of 2009 survey13 14 and the comparison of availability between 2009 and 2017/201817 give detailed account of the methodology.
Survey settings
Survey was conducted in all nine provinces of Sri Lanka. From each province (survey area), data were collected from a representative sample of five private retail pharmacies and one Rajya Osusala Pharmacy (ROS) using multistage cluster sampling, which resulted in having 54 survey settings. The ROS pharmacies are retail arm of the State Pharmaceuticals Corporation (SPC) of Sri Lanka. As per the WHO/HAI methodology, in each province, public hospitals of different levels were used to select the private pharmacies.13 14 17 18 The pharmacies were the same ones we surveyed in 2009 except in Northern Province, which was not surveyed in 2009 and in few instances in other eight provinces where we could not locate the pharmacies surveyed in 2009 due to reasons beyond our control such as closure or relocation. In these instances, we followed the same principle and selected a private pharmacy that was closest to the particular public hospital.
Survey medicines
They were the same key essential medicines for children surveyed in 2009.13 14 Of the 25 medicines, 2 were excluded from price analysis; ferrous salt suspension as the preparations in the survey settings were of different strengths and had varying amounts of elemental iron, and domperidone syrup as it did not have an international reference unit price (IRP).
Data collection
Investigators or trained data collectors personally visited the survey settings and collected the required data, namely price of the originator brand (OB) and the lowest price generic (LPG) of the survey medicines if they were available on the day of data collection.
Data analysis
A detailed account of data analysis is given in our previous publication reporting the 2009 survey findings.14 Prices were converted from Sri Lankan rupees to US$ using the exchange rate (US$1=SLR150.97) on the first day of data collection.19 Median price ratio (MPR), ratio between median local unit price and IRP, was calculated for OB and LPG of each survey medicine. The supplier median unit prices given in 2015 International Medical Product Guide were taken as IRP.20 MPR ≤2.5 and ≤5 were considered as acceptable local price respectively for LPG and OB.14 21 High/low ratio was used to compare highest and lowest unit prices of LPGs.20 Per cent changes were determined to compare the prices between 2017/2018 and 2009.
Affordability was estimated using median local prices and the average salary of the lowest paid unskilled government worker (LPUGW),22 and expressed as ‘number of days’ wages that it would cost an LPUGW to purchase standard drug therapy. Affordability of treatment of common childhood diseases such as epilepsy, asthma, acute mild bacterial infections and acute gastroenteritis in a 5-year-old child of average body weight (18–20 kg) were calculated. Standard drug therapies that cost 1 day’s income or less for 7 days’ treatment for an acute condition and 30 days’ treatment for a chronic condition were considered as affordable.14 23 All the necessary precautions were taken to ensure accuracy of data collection, entry and analysis.
Patient and public involvement
No patient involved.
Results
Survey sample included 45 private and 9 ROS pharmacies: OBs of beclomethasone inhaler, clotrimazole cream, cloxacillin syrup, co-trimoxazole suspension, diazepam injection, diethylcarbamazine tablet, ORS and vitamin C were not available in the market whereas only the OB was available for carbamazepine suspension and mebendazole syrup. This was almost similar to 2009 survey.14 Table 1 shows the number of study pharmacies which had the OBs and LPGs of survey medicines.
Median MPR of survey medicines
Table 2 gives the MPR of OBs and LPGs of survey medicines. The median MPR was 2.69 for OBs and 1.45 for LPGs compared with 3.7 and 1.35 in 2009 (14). When private and ROS pharmacies were separately analysed, the median MPR was 2.44 (range 0.54–21.51) for OBs and 1.52 (range 0.14–4.59) for LPGs in private pharmacies compared with 2.54 (range 0.45–35.99) and 1.15 (range 0.13–6.70) in ROS pharmacies. To compare prices of the OBs and LPGs, the median MPR was recalculated considering only the medicines (N=13) which were available in both product types (OB and LPG). Median MPR of those 13 medicines was 3.27 for OBs and 1.45 for LPGs.
MPR of OBs
MPR of OB of all but one (chlorphenamine syrup) were higher than that of the LPG. MPR >5 was observed for ceftriaxone injection, amoxicillin capsule, mebendazole chewable tablet and metronidazole tablet (table 2). This was documented in 2009 as well except for amoxicillin capsule.14 MPR <1 indicating that the median local unit price is cheaper than IRP was observed for OB of salbutamol respiratory solution and amoxicillin+clavulanic acid suspension in 2017/2018 compared with only salbutamol MDI in 2009. MPR of OBs of all but three survey medicines were the same in private and ROS pharmacies; mebendazole syrup and salbutamol respiratory solution had a higher MPR in private pharmacies whereas carbamazepine suspension had a higher MPR in ROS pharmacies. Compared with 2009, MPR of OBs has increased for eight medicines and decreased for seven medicines with mean percentage change of 7.4% (table 3), indicating a rising trend in prices of OBs.
MPR of LPGs
For each medicine, LPG varied from one pharmacy to other with wide interpharmacy variability in price. This has resulted wide range in the MPR especially in private pharmacies. This was noted in 2009 as well. Prices of the LPGs of majority of medicines were more than the IRP (ie, MPR >1) in both private and ROS pharmacies except amoxicillin+clavulanic acid suspension, beclomethasone MDI, cloxacillin syrup, diethylcarbamazine citrate tablet, salbutamol respiratory solution and vitamin C tablet. In 2009 also, prices of the LPGs of majority of medicines were more than the IRP. The MPR of the LPG was considerably higher in private than ROS pharmacies for clotrimazole cream (4.27 vs 0.98), mebendazole tablets (4.59 vs 1.80) and metronidazole tablet (3.00 vs 0.88).
Prices of LPGs of five medicines (amoxicillin capsule, amoxicillin suspension, clotrimazole cream, mebendazole chewable tablet, metronidazole tablet) in private and two (ceftriaxone, diazepam) in ROS pharmacies were estimated as excessive (MPR ≥2.5). In 2009, prices of LPGs of chlorphenamine syrup, clotrimazole topical cream, ibuprofen syrup and paracetamol syrup were estimated as excessive.14 High/low ratio was 1.0–49.7 in private compared with 1.0–30.9 in ROS pharmacies. Maximum variation was noted with mebendazole chewable tablet in both private and ROS pharmacies. Compared with 2009,9 MPR of LPGs has increased for 12 medicines and decreased for nine medicines with a mean percentage change of 54.2% (table 3) indicating a rising trend in prices of LPGs.
Only 13 medicines were available in both product types (OB and generics) in the survey sample. Mean per cent difference in price between OB and LPGs of these 13 medicines was 149.6% (range −15.31 to 437.16). In 2009, 15 medicines were available in both product types, and the mean per cent difference in price between OB and LPGs of those 15 medicines was 365% (range −21 to 2343).
Table 4 shows affordability calculation. Daily wage for the LPUGW in 2017/2018 was LKR1053.17 compared with LKR400 in 2009. Standard drug therapy for the included conditions was deemed to be affordable (for both OB and LPGs in private and ROS pharmacies) except epilepsy treated with carbamazepine syrup. This was documented in 2009 as well. For a child on 150 mg carbamazepine/day, purchasing 1 month supply of syrup carbamazepine cost 2.3 and 5 days’ wages for the LPUGW, respectively, in 2017/2018 and 2009. No change in affordability was noted from 2009 except for asthma. Purchasing one inhaler each of salbutamol and beclomethasone cost between 1.5 (LPG) and 2.17 (OB) days for the LPUGW in 2009 compared 0.72 days in 2017/2018 (beclomethasone OB was not available in the market in 2017/2018).
Discussion
In this paper, prices of key essential medicines for children in a lower-middle-income country in 2017/2018 are compared with the prices we have reported from a similar survey in 2009. To the best of our knowledge, no prior studies have reported such a comparison. Passage of ‘Better Medicines for Children’ resolution by the World Health Assembly and subsequent launch of the first model EMLc by the WHO happened in 2007. The resolution categorically urges the member states including Sri Lanka to promote access to essential medicines for children and to devise measures to monitor prices.5 Documenting the changing trend in prices from 2009 to 2017/2018 would provide the required data to monitor prices of key essential medicines for children in Sri Lanka.
In Sri Lanka, private and ROS pharmacies are pivotal source of medicines for children because significant proportion of children receive outpatient treatment from general practitioners and specialists in the private sector.24 In Sri Lanka, the public health system is free of charge. However, even if the children receive treatment in the public sector, parents had to buy medicines from private sector as the prescribed medicines are often not available in the public sector.13 15 17 We selected the survey settings as per the WHO/HAI methodology for monitoring prices.18 Survey medicines were also carefully selected.13 Findings of this survey could be considered as a valid, reliable and generalisable indicator of economic access to key essential medicines for children in Sri Lanka.
Although, the median MPR of OBs was lower in 2017/2018 compared with 2009, this was not evident with LPGs. In 2017/2018, not only the median MPR of LPGs has increased, MPR of the LPG of 12 of the 23 medicines also showed an increase (table 3). Generics are generally cheaper than the OB; this was evident in our survey as well. Owing to this price difference, generics are commonly purchased. Hence, increase in the prices of generics impedes access to essential medicines for children. Although the median MPR of OBs showed a considerable drop in 2017/2018, it was still higher than the median MPR of the LPGs. In addition, MPR of the OB of 8 of the 23 medicines showed an increase in 2017/2018 (table 3); hence a drop in the median MPR of the OBs would not have contributed to ease the economic access.
A recent (2021) systematic review of accessibility of medicines20 has pooled the results of 18 surveys published between 2011 and 2018, including our 2009 survey.13 14 Similar to our surveys, medicines have been selected based on the WHO model EML in 15 out of the 18 surveys. The median MPRs of both OBs (2.69) and LPGs (1.45) in 2017/2018 in Sri Lanka are lower than that was reported in the systematic review (3.8 and 1.54). This suggests that the prices of key essential medicines for children in the private sector in Sri Lanka are reasonable when compared with the countries reported in the systematic review.
A survey of some key paediatric essential medicines from Odisha State in India reported that the largest contributor to add-on costs was at the level of retailer shop.25 The survey further reported that for branded products, the MSP was the largest contributor to final price (around 65%) whereas for the branded generic, the retail markup was the largest contributor (61%–67%), with the Manufacturer Selling Price (MSP) only accounting less than a third of the final price. This observation could explain the discrepancy noted in the trend between OBs and LPGs in our survey: Since, generics are in higher demand than OB, wholesale and retail markets could have increased the add-on costs to boost the profits. On the other hand, as market for OB is limited, add-on prices could have been kept to a minimum to increase the sales.
The National Medicine Regulatory Authority introduced maximum retail Prices of 48 selected medicinal product formulations in October 2016.26 Only four survey medicines, amoxicillin-clavulanic acid suspension, beclomethasone MDI, paracetamol tablet and salbutamol MDI were within the 48. Of these four medicines, price of OBs of three were same as the controlled price, and price of LPGs of all four were slightly lower than the controlled price. This shows that some form of price control for key essential medicines for children would improve the economic access and affordability. However, with the current, economic crisis, the controlled prices have been considerably increased in Sri Lanka. We have not analysed the price components (MSP, taxes, mark ups at different levels) in our survey. Add-on prices at the different levels of supply chain of these medicines therefore remains unknown. Monitoring the price components, and regulating add-on prices are two initiatives that would ease economic access to essential medicines.
When individual medicines were considered, MPR of LPGs of all but one (chlorphenamine syrup) was lower than that of the OB (table 2). This is a common phenomenon and reported in many studies.16 22 27 28 The MPR of OBs was the same in private and ROS pharmacies for majority of medicines. This is an expected observation as there is only one OB for a medicine. Prices of the LPGs tend to be lower in ROS than private pharmacies with narrower H/L ratio. Better performance in ROS pharmacies was observed in our 2009 survey as well.13 14 17 In addition, the prices of both OBs and LPGs are same in all ROS pharmacies, irrespective of their geographical location since they come under the same organisation (SPC). Knowing the prices from one ROS pharmacy allows the patients to buy from any branch without worrying about any difference in prices. Rajya Osusala pharmacies are the retail arm of the SPC which sell medicines in reasonable prices. The SPC tends to market few generics and promote the generics manufactured locally by the State Pharmaceutical Manufacturing Corporation. This accounts for the narrow variation in the H/L ratio and consistently lower MPRs compared with private pharmacies. However, in Sri Lanka, the total number of ROS pharmacies is 5029 compared with about 2000 private pharmacies.30 In addition, the ROS pharmacies are mostly located in main cities compared with PPs, which are located all over the country. Contribution of ROS pharmacies towards improving economic access to essential medicines needs to be expanded and strengthened.
Prices of LPGs of many key essential medicines for children remain above the acceptable local prices in private pharmacies both in 2009 and 2017/2018. This is in agreement with other studies.11 21 27 31–33 In addition, MPRs of many OB and LPGs have increased in 2017/2018. Majority of population in Sri Lanka had to depend on private pharmacies for their medicines as ROS pharmacies are mainly located in cities. Our findings confirm that the economic access to key essential medicines for children has room for improvement in Sri Lanka. This survey was done before the COVID-19 pandemic and the current economic crisis in Sri Lanka.34 Therefore, the economic access would have further deteriorated denying the children’s access to key essential medicines.
Despite the daily wage has doubled, affordability has not changed except for inhaler therapy for asthma. Improvement in the affordability for inhaler therapy for asthma is a welcome observation. Since the WHO has removed salbutamol tablet and syrup from its model EML in 2007, availability of inhaled medications has increased in the public hospitals13 17 though the last version of Sri Lankan EML still has the tablet and syrup. This could have contributed for the reduction in prices and improvement in affordability in private pharmacies. However, treatment of seizure disorders, the other major childhood non-communicable disease, remains unaffordable. This definitely needs the intervention. Although tablets of carbamazepine and sodium valproate26 were included in the 48 medicines that were subjected to price control, liquid dosage forms of these medicines were not included. Children’s access to medicines has not been prioritised in the decision-making processes. Price surveys from other LMICs have shown varying findings depending on the local determinants: For example, an Ethiopian study11 reported MPRs similar to ours, but differed in affordability whereas a Mongolian study31 has reported a comparable affordability with relatively higher MPRs.
The WHO has classified antibacterials into three categories, access, watch and reserve (AwaRe): Antibacterials in the access group are expected to be available at all times in all places to minimise irrational use of watch and reserve category antibacterials and to ensure successful treatment of common infections at primary care level.35 Seven out of the eight antibacterials included in our survey come under access category. Their physical availability was not 100%13 17 though it has improved in 2017/2018. MPRs of the LPGs of five of these antibacterials have increased in 2017/2018 with three having excessive local price. Improving physical and economic access to these access category antibacterials is an important step in combating antibacterial resistance.
Despite many initiatives, both globally and nationally, taken place during this period to improve the access to essential medicines for children, it appears that there was not much effect on economic accessibility to key essential medicines for children in Sri Lanka. Even increased availability of the medicines in the public sector13 reducing the demand for these medicines in the private sector has not produced much impact on prices of medicines in the private sector. Although, the price data are not very recent, we feel reporting the changing trend before the pandemic and economic crisis is important to plan sustainable initiatives to improve access to essential medicines for children in Sri Lanka.
MPR was calculated based on the prices obtained from the survey pharmacies which had the survey medicines on the day of the survey. This might not be reflective of the prices over the year. Although, the survey was done in 2017/2018, we had to use IRPs reported in 2015 in calculating MPRs as it was the nearest information we were able to access. We have used standard treatment plan in calculating affordability, however, this may not be the case in real-time practice.
Data availability statement
Data are available on reasonable request.
Ethics statements
Patient consent for publication
Ethics approval
Even though there are no human participants in this study, as per our Country’s research regulations, the proposal was submitted to the Ethics Review Committee, Faculty of Medicine, Colombo. The study was exempted from ethics review by the Ethics Review Committee, Faculty of Medicine, Colombo (EC-17-027).
Acknowledgments
We acknowledge the University of Colombo, Sri Lanka for the funding support (AP/3/2/2017/SG/10), Authorities of the Ministry of Health and State Pharmaceuticals Corporation of Sri Lanka for approving the survey, Provincial Health authorities and hospital administrators for granting permission to collect data, pharmacists in the respective survey settings for providing the data, Dr T Rameshkumar, Dr GPSG Senadheera and Ms Layanthini Somasundaram for assisting data collection, Mr S Thayaparan for assisting data entry, and Ms Inoka Gammune for secretarial assistance.
References
Footnotes
Contributors SSR conceptualised the research. SSR, RB and HB planned the methods and developed the proposal. SSR, TSN, RB and HB collected the data. TSN, SSR and RB entered and analysed the data. RB and TSN deigned the Tables. SSR and TSN wrote the first draft. HB and SSR provided expertise to write the discussion. All authors reviewed the different manuscript drafts and approved the final version for submission. SSR is responsbile for the overall content
Funding This study was funded by University of Colombo (AP/3/2/2017/SG/10).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.