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FRONTESPIZIO - Cooperazione Italiana allo Sviluppo

FRONTESPIZIO - Cooperazione Italiana allo Sviluppo

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6. Using indicators to measure the pharmaceutical sector in Ethiopia 87Total Number of Drug Retail Outlets (Pharmacies, Drug3238Shops and Rural Drug Vendors), 2003/2004Number of Registered Drug Products, 2003/20044000 (400 chemical entities)No of drug product tested by the quality control376laboratory during the past Fiscal Year, 2004/2005Percentage of drugs/batches that failed quality controltests, out of the total number of drugs/batches tested pastFiscal Year, 2004/2005 11.2%Adverse drug reactions (ADRs) cases reported last26Fiscal year 2003/2004Ethiopia does not export medicines and the importation market share is 80-85% of theEthiopiatotal. Onlydoes15-20%notofexportthe marketmedicinesneeds isandlocallythe importationproduced. Themarketfactoriessharethemselvesis 80-85% do not of the meettotal. Good Only Manufactory 15-20% Practice of the market (GMP) needs requirements. is locally Theproduced. computerized Thefactories registration themselves system of medicines do not meet is available Good butManufactory not fully utilized. Practice (GMP) requirements.The authorityThe has acomputerized web site even ifregistrationnot well updated.system of medicines is availablebut not fully utilized. 3. Quality Control of PharmaceuticalsThe authority has a web site even if not well updated.Why is this important?Quality control is important to ensure that patients receive medicines that are safe andeffective. Quality control extends beyond testing whether medicinal products contain3. Quality Control of Pharmaceuticalsthe right ingredients in the correct amount, to ensuring that they are properly storedand have not passed the expiry date. The latter measure is intended to ensure that, atthe final distribution point, patients are getting high quality and efficacious drugs.Why is this important?Prevailing conditions of high temperature and high humidity; common storageQualityproblems,controlsuch asis importantstorage ontotheensurefloor; lackthat patientsof systematicreceivearrangementmedicinesofthatstock;aresafe presence and effective. of dust and Quality pests; inadequate control extends protection beyond from testing direct sunlight; whether and medicinal lack ofproducts provision contain of temperature the right monitoring ingredients chartsin and the facilities correct to amount, monitor room to ensuring temperature thattheycan leadare properlyto degradationstoredof drugs.and have not passed the expiry date. The latter measure3.2 is What intended is the current to ensure situation? that, at the final distribution point, patients are gettinghigh quality and efficacious drugs. Prevailing conditions of high temperatureand high Table humidity; 7. Productcommon samples collected storage for problems, regulatory such purposes as storage on thefloor; lack of systematic arrangement of stock; presence of dust and pests; inadequateprotection from direct sunlight; and lack of provision of temperaturemonitoring charts and facilities to monitor room temperature can leadto degradation of drugs.∞Low-income countries tend to collect fewer samples and of those that were tested, theyreport higher rates of products failing testing.Table 8. Presence of expired medicines in health facilities and warehouses

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