∞∞Most countries inspect importers, manufacturers, distributors and pharmacies.Site inspection is somewhat less frequent in low-income countries.86 Andrea Gardellin, Abraham Gebre GiorgisTable 5. Monitoring of adverse drug reactions (ADRs)Table 5. Monitoring of adverse drug reactions (ADRs)∞∞Most countries inspect importers, manufacturers, distributors and pharmacies.Site inspection is somewhat less frequent in low-income countries.Table 5. Monitoring of adverse drug reactions (ADRs)∞Few • low-income Few low-income countries countries monitor monitor ADRs, ADRs, and the and median the median number number of ADR of ADR reports reportsin thesecountries isinverytheselow.countries is very low.2.3 In EthiopiaRegarding2.3 IntheEthiopiapresence of the following legislation and regulation: pharmaceuticalsector legislation, Regarding the legislation presence and of the regulation following on legislation registration and medicines, regulation: site pharmaceuticalinspection∞ Few low-income countries monitor ADRs, and the median number of ADR reports in theseof establishments countriessector as is requirement legislation,very low.legislation of licensing, monitoring regulation of on adverse registration drug medicines,and legislation site inspection prescribing of establishments and substitution as requirement of generic of licensing, medicines monitor-in publicreactions(ADRs)and private ing of sectors adverse in drug Ethiopia, reactions the(ADRs) drug authority and legislation (Drug Administration prescribing and substitutionControlAuthority 2.3 – InDACA) Ethiopiaof generic has elaborated medicines standard, in public directives and private and sectors guidelines in Ethiopia, for most the of theactivitiesRegardingdrug related authority withthe presence(Drug the sector.of the following legislation and regulation: pharmaceuticalsector legislation, legislation Administration and regulation and on registration Control Authority medicines, – site DACA) inspection hasThe following elaborated documents standard, are directives available and also guidelines in the web for site most (www.daca.gov.et)of establishments as requirement of licensing, monitoring of of adverse the activities drug reactions related(ADRs) with the and sector. legislation prescribing and substitution of generic medicines in publicof the DACA: Policies, Legislation Regulation, Standards, Directives andguidelines, and private List ofsectors drugsin and Ethiopia, formularies, the drug Treatment authority (Drug guidelines, Administration other and documents Control andThe following documents are available also in the web site (www.daca.gov.et)Bulletins Authority – DACA) has elaborated standard, directives and guidelines for most of theof activities the DACA: related Policies, with the Legislation sector. and Regulation, Standards, Directives andguidelines, The Table following 6. Some List documents of indicators drugs are and available of formularies, thealso pharmaceutical in the Treatment web site (www.daca.gov.et)guidelines, sector in Ethiopia other documentsof theand DACA: Bulletins Policies, Legislation and Regulation, Standards, Directives andguidelines, List of drugs and formularies, Treatment guidelines, other documents andIndicator descriptionResultBulletinsEstimated total value of drug imports (CIF), 2003/20041.1 billion ETBTotal number of drug Importers and/or wholesalers,126Table2003/20046. 6. Some indicators of the pharmaceutical sectorin in EthiopiaTotal number of drug Manufacturing firms in the13:Indicator descriptionResultCountry, 2003/2004Estimated total value of drug imports (CIF), 2003/20041.1 billion ETBTotal number of drug Importers and/or wholesalers, 9 Drug Manufacturers, 126 1 Syringes2003/2004Manufacture, 2 Bandage and GauzeTotal number of drug Manufacturing firms in the manufactures, 1Hard 13: Gelatine capsule shellCountry, 2003/2004manufacture9 Drug Manufacturers, 1 SyringesManufacture, 2 Bandage and Gauzemanufactures, 1Hard Gelatine capsule shellmanufacture
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