Sensible Factors that Need Strategic Change to Improve the Medical Drug Availability across Healthcare Institutions in Sri Lanka

EXECUTIVE SUMMARY: Access to medicines remains a major obstacle for people across the world to maintain their health at a desired level. Ensuring an adequate supply of safe and effective drugs of acceptable quality is an integral part of the health policy of Sri Lanka. The medical supplies division is the sole organization responsible for providing all pharmaceuticals, surgical items, laboratory items, radioactive items, and printed materials for government sector healthcare institutions. The establishment of an independent drug regulation authority, the Declaration of a national essential drug list, the establishment of a separate drug procurement entity, Pooled procurement, digitalization of drug management, and expansion of drug storage capacity are key strategies that have been implemented by the Ministry of Health to minimize the drug shortages across the healthcare institutions of Sri Lanka. Despite the implemented strategies drug shortage continue to evolve from time to time as a public outcry in the media. This case study describes the critical issues that need to look at more strategically to improve drug availability.

Corporation (SPC) is functioning as the independent procurement agency for Medical Supplies Division (MSD). Further, MSD has the authority to procure some medical, surgical and laboratory items (n=236) from local drug manufacturers. MSD of the Ministry of Health Sri Lanka is the sole organization responsible for providing all pharmaceuticals (n = 1337), surgical items (n = 8600), laboratory items (n = 5639), radioactive items, and printed materials for government sector healthcare institutions. Medical Supplies Division is also responsible for supplying dangerous drugs and essential medical items to private medical institutions which are not available in the open market. MSD has a network of stores comprising central medical stores (storage volume = 7796 m3) five large other stores (total storage volume = 28136 m3) and 26 Regional stores at the district level. Annual drug estimation, ordering, monitoring, distribution, and accounting are the other vital functions carried out by MSD apart from the storing of drugs. In 2017 MSD officially launched its Medical Supplies Management Information System (MSMIS) to efficiently manage national medical supplies ensuring the availability of medical items in government health institutions. MSMIS has 16 modules covering all aspects of drug management at MSD. Despite all the measures taken to improve drug availability in healthcare institutions, the media highlight the public outcry on the unavailability of pharmaceuticals in healthcare institutions across the country.

Objective
To identify critical issues affecting the drug availability in government healthcare institutions of Sri Lanka.

METHODOLOGY
Following methods were used to identify problems affecting the availability of medicines in healthcare institutions of Sri Lanka. Secondary data related to the drug supply chain was obtained from databases and registers of MSD and relevant healthcare institutions and desk revive was carried out for a broad understanding of the drug supply chain. Notes of all KIIs were synthesized according to common words and coded into thematic areas. Each thematic area was then converted into the following information.

RESULTS
Problems related to government health care institutions 1. Irrational prescription of medicines by prescribers 2. Prescription of an unnecessary number of drugs to a simple health condition 3. The nonavailability of a scientifically agreed upon list of substitute drugs of the same efficacy to use when medicines are out of stock 4. Non-adherence of prescribers with the available treatment guidelines 5. Lack of reference to morbidity data in preparing annual drug estimates 6. Estimation errors such as over or underestimation 7. Unfavourable or inadequate drug storing conditions at healthcare institutions 8. Delayed receipt of drugs to healthcare institutions 9. Receipt of drugs less than the annual institutional estimate 10. Communication gaps between MSD & healthcare institutions 11. The nonavailability of MSMIS for some Base and all Divisional Hospitals 12. Quality failure of drugs

Problems related to MSD
1. Inadequate usage of drug utilization data for preparing the annual drug estimate 2. Less consideration of morbidity and mortality data for annual drug estimate 3. Inability to take real-time medicines stocks availability in most of the hospitals 4. Inadequate or over-estimation of pharmaceuticals 5. Considerable lead time in preparing order recommendations, prizing and order lists at the MSD level 6. Unacceptable lead time at SPC in procuring 7. Lack of e-procurement facilities for bidders 8. Lack of adequate and favourable storing facilities for consignments 9. Lack of adequate laboratory facilities for quality assurance 10. Inadequate store space due to delayed disposal of quality failed drugs 11. Lack of adequate and modern vehicle fleet to transport drugs to healthcare institutions 12. The delayed receipt of Financial Imprest to the MSD

Problem prioritization
The Pareto Principle of Vilfredo Federico Damaso Pareto was used to prioritize the critical problems causing the unavailability of medicines in healthcare institutions and is discussed in detail in the discussion. Similar issues were collated together to make the discussion more understandable.    Cabinet Procurement Committeefor bids with a value of more than 100 million (LKR) and usually takes more than 24 months.  Ministerial Procurement Committeefor bids with a value from 10 to 100 million (LKR) and usually take 15 -18 months.  Departmental level After the process of evaluation, the bids will be offered to the most substantially responsive bidders. Finding a minuid deviation in the given drug specifications will result in referring those bids back to the MSD for further clarifications which is an additional delay. After all, the successful bidders will be given three months to supply the consignments to the MSD. Further, almost all steps of the procurement process are manual and this has resulted in adding extra duration to the lead time. Figure  3 shows the order quantities placed in the year 2020 and their delays beyond the usual lead time (11 months). Further, it shows only 13 consignments have been received within the expected lead time. Apart from the procurement process delays for some items have occurred due to a narrow supplier base to compete for bids. Sometimes no supplier bids have been received for orders due to reasons such as small quantity, bidding price, delayed payments of previous orders, and pharmaceutical standards-related issues. This situation leads to calling new bids from unregistered suppliers and that causes an unprecedented delay as these suppliers need to get registration or no objection letter from NMRA.

Quality failure of drugs and lack of adequate laboratory facilities for quality assurance of drugs
A pharmaceutical product should not be contaminated and must deliver the properties described on the label. NMRA and NMQAL ensure the quality of drugs in two steps; Pre-market and Post-market quality assurance. Appearance, identity, purity, uniformity, packaging, and labelling are the main characteristics considered in quality assurance. Pre-market quality assurance focus on the quality of drugs during the registration process, bidding, and pre-consignment samples. Post-marketing Quality Assurance is carried out by random checks for drug samples collected from government healthcare institutions, private healthcare institutions, and the market. In addition, government healthcare institutions and MSD directly send their samples of suspected quality for analysis. The laboratory owned by SPC also carries out quality checks of consignments. However, the final decision on quality is made upon the results released by NMQAL. Annually, due to several reasons, a considerable number of drugs are removed from usage due to quality failure. Clinicians suspect that the quality failure occurs due to the purchase of low-quality products and in return drug suppliers argue it is due to inappropriate storing and transport conditions. Discussions held with pharmacists revealed that both the quality of drugs and the storage conditions may have attributed to the quality failure. However, the inadequate capacity of the NMQAL is hindering the evaluation of the quality of each consignment at the time of delivery to MSD drug stores. The ambient store capacity has increased significantly from 2019 to 2021 ( Figure 5). However, the airconditioned store capacity needs to be increased considerably to reach the required storage capacity.

Lack of adequate and modern vehicle fleet to transport drugs to health care institutions
MSD has its vehicle fleet for the timely transportation of drugs to healthcare institutions across the country. At the end of every quarter, MSD prepares an advanced program for distributing drugs to the RMSDs and other healthcare institutions. The date and mode of dispatch of the drugs are also indicated in this document. However, frequent breakdowns of vehicles disturbed the continuous supply of drugs and led to a shortage of drugs in healthcare institutions. The age of the vehicle fleet, substandard preventive maintenance, poor quality corrective maintenance, incomplete vehicle record keeping, and excessive delays in getting approvals for vehicle repairs have attributed to a greater extent to increasing vehicle off-road time. . Despite the ongoing expansion, this project has contributed to identifying additional system-related issues such as less user-friendliness, slowness of software and inadequate bandwidth. Further, it was identified that the opportunities available for further improvement and customization of MSMIS are limited to being a virtual private network. In addition, functions like preparing annual drug estimates and monitoring real-time stock availability also have been affected due to the unavailability of MSMIS beyond the drug stores of the healthcare institutions.

Delayed reception of Financial Imprest to the MSD
WHO reports that the pharmaceutical expenditure in most South East Asian countries is less than US$ 25 per person per year, and it has almost no change during the last decade [12]. The availability and expenditure on drugs mostly depend on the receipt of