Assessment of Effectiveness of Quality Failure Recall Procedure in Government Medical Supplies Using Western Province in Sri Lanka

Abstract

Background: Government has a free medical supply system but frequent quality failures are reported. Though there is a recall procedure, the general impression is that, when the quality failure circulars are received by the hospitals most of the drugs have been used. There could be major consequences as health risk and financial lost due to that. The health risk could be of two ways. One risk is the disease will not control or cure as they will not get the therapeutic effects with the poor quality drugs. Secondly it will produce unwanted side effects due to bad quality. Earlier, government policy of claiming for quality failed drugs needed to produce the amount of quality failed items physically in order to reimburse for that quantity from the manufacturer. Objectives: To assess the quantity of consumed quality failed drugs in last 2 years (2017-2018) in Western Province health institutions and to analyze the primary consequences using ABC and Vital, Essential and Non-essential (VEN) system as indirect methods. Methodology: Study setting is above the Base Hospital level health institutions in Western Province (10 institutes). All the quality failure recall circulars (n=56) were considered. Hospital data and a format were used to analyze the quantity of quality failed drugs used at the time recall circular received. Results: Out of 56 circulars to recall a particular batch/product of drug, the relevant drug has been used 100% for 24 circulars (nearly 50% circulars). On average 54% drugs have been used when the notification reach the institution. Some vital drugs (life-saving drugs) have been used 83%. Averagely it was more than 25% for all vital drug circulars. The category A drugs (the unit cost if high the overall purchased quantity is comparatively low) have been used more than 53%. Conclusions: A greater percentage of quality failed drugs have been used when the health institution received the circular to recall/withdraw the product. Vital drugs have been used more than 50%, could have resulted major health risks. Category A drugs have been used more than 50% showing a significant lost as their unit cost is very high. Therefore a proper quality failure recall procedure should be established as soon as possible. Further studies should be also carried out to find out the issues and the best options.