Examining characteristics, knowledge and regulatory practices of specialized drug shops in Sub-Saharan Africa: a systematic review of the literature

A wide variety of SDSs were encountered, including pharmacies and non-pharmacy outlets. Non-pharmacy SDSs included accredited drug dispensing outlets (ADDOs) and the older part II drug stores (also referred to as ‘duka la dawa baridi’ in Swahili) in Tanzania, licensed chemical sellers (LCSs) in Ghana, patent medicine vendors (PMVs) in Nigeria, rural drug vendors in Eritrea, and drug shops in Uganda among others. Pharmacies were found mainly in urban areas, with the non-pharmacy SDSs operating more in rural areas [16‐19]. Specialized drug shops were more likely to be found in affluent and highly populated areas overall. In Tanzania and Eritrea, for instance, a positive correlation was reported between the number of medicine outlets and village or town size [20, 21]. As distribution of health facilities follows similar patterns, there is danger of low density areas having neither a health facility nor an SDS; indeed, half of ADDOs in Tanzania were located less than one kilometer from a health facility [22].

Shop ownership varied across studies, but rural SDSs were more likely to have owners or relatives working as staff, whereas urban shops had a higher likelihood of having employees. This phenomenon, seen in Kenya and Nigeria [9, 23, 24], may explain Greer et al’s observation of relatively low staff turnover among rural PMVs in Nigeria, where over half of staff had worked at the same shop for over 4 years [25]. Although staff qualification varied substantially, those working in pharmacies and part II drug shops generally held higher qualifications compared to those working in PMVs. In Kenyan pharmacies for instance, nearly all staff were found to have tertiary health-related training [24]; similarly, nearly all staff working in Tanzanian part II drug stores and Ugandan drug shops were reported to have some health-related training [11, 26, 27]. The majority of staff were nurse aides. In Nigeria on the other hand, PMVs were found employing children under the legally mandated age for dispensing (21 years), most being school going children [9, 28]. However, pharmacies in some areas were also guilty of hiring staff with no qualifications after obtaining registration; in Mali, for instance, majority of individuals dispensing in pharmacies were found to have no professional qualifications [15]. Although pharmacies usually require pharmacy-trained staff, Somaliland was a notable exception; there, medical doctors and nurses were allowed to run pharmacies due to an acute shortage of pharmaceutical staff [29].

SDSs were well stocked overall, although urban pharmacies were generally better stocked compared to their rural counterparts. In Somaliland for instance, urban and rural pharmacies had 70% and 40% of specified essential medicines respectively [29]. Drug shops were found to have good availability of a narrower range of medicines, usually fever and malaria drugs [20, 30]. However, good availability did not always mean good geographical access to recommended treatments. This was particularly seen in the case of antimalarials, where the more widely available drugs were not the recommended first-line treatments. This trend was seen in Kenya, Uganda, Tanzania, Madagascar, Nigeria, Zambia, Somalia and the Central African Republic [13, 14, 31‐39]. In Tanzania, pharmacies were more likely to stock non-recommended antimalarials if they were located near health facilities that stocked the recommended drugs [40]. Drug expiry was a problem in some areas but not others. In Uganda, nearly half of the shops reported cases of drugs expiring, whereas only one case was observed in Somaliland [17, 29]. Generic substitution was rarely done; in South Africa for instance, only 14% of pharmacists substituted branded drugs, despite the fact that nearly half of prescribed medicines had generic equivalents [41].

Staff knowledge was assessed at two broad levels; knowledge specific to treatment, and knowledge on wider aspects of practice such as treatment policies. Knowledge on drug specific aspects was found to vary substantially, although certain patterns were consistent across studies. Majority of staff knew what drugs to give for tracer conditions, but had less knowledge on appropriate dosing. This was seen in Tanzania [7, 26, 27, 42‐44], Uganda [25, 45], Eritrea [21], and Nigeria [31, 46]. Misconceptions were also reported: for instance, most South African pharmacists erroneously believed that emergency contraceptive pills (ECPs) posed health risks if used repeatedly [47], majority of Nigerian PMVs believed fever medicines could cure malaria on their own [48], and that white colored medicines were less efficacious overall [49], and nearly one-fifth of Tanzanian drug sellers thought that antibiotics could cure viral infections [50]. Where pharmacies and non-pharmacy SDSs were compared, the former performed better overall. In Ghana for instance, three quarters of pharmacy staff knew symptoms of complicated malaria compared to 43% for LCSs [51]. A few studies went further and compared knowledge to practice. In Nigeria, 70% of pharmacies and PMVs knew oral rehydration therapy (ORT) to be the treatment of choice for diarrhea and yet a vast majority sold antidiarrhoeals and antibiotics instead [52], whereas only 10% of Eritrean rural drug vendors gave correct diarrhea treatment, despite the fact that 63% knew the correct treatment [21]. Similarly, amodiaquine and quinine were sold as much as sulphur medicines in Tanzanian drug stores, despite staff knowing that only the latter was recommended for uncomplicated malaria at the time [26]. Discordances between knowledge and practice extended beyond treatment; in another Tanzanian study for instance, only a few ADDOs advised malaria clients to sleep under an ITN, despite the majority knowing about the effectiveness of bednets as a preventive strategy [22]. Similarly, although 55% of Nigerian pharmacies knew about pharmacovigilance, only one fifth of pharmacies had actually made an attempt to report an ADR to relevant authorities [53]. Knowledge on broader policy issues was good overall, with all PMVs in a Nigerian survey knowing about prescription-only medicine status [28], and majority of Tanzanian drug stores being aware that they were only allowed to sell certain medicine categories, although there was considerable confusion on which malaria medicines fell in this category [54]. There were rural-urban differences in knowledge on policy issues in Somaliland, with rural pharmacies being less aware of the difference between prescription and non-prescription drugs, and rationale behind restricting the former [29].

Dispensing practices were grouped into three categories; treatment practices, communication, and client referral. Most studies touched on more than one category, with some exploring associations between dispensing practices and factors such as shop location, staff qualification, and client characteristics (age, sex, level of education and familiarity to the attendant).

Studies assessing treatment practices looked at a wide range of factors, including drug selection, adherence to treatment protocols and dispensing without prescription. The degree to which SDSs adhered to treatment guidelines was varied but low overall. Adherence to national guidelines when managing STI clients was low in Kenya (27% adherence) [55], Ghana (20-23%) [56, 57], and Uganda (8-14%) [16, 25]. Inappropriate dispensing was also observed for diarrhoea in Kenya [58], Tanzania [43, 59], Nigeria [9, 52] and Sudan [60]. However, good performers were also noted; in Tanzania for instance, 80 - 90% of drug stores dispense drugs recommended in national guidelines for STIs, although the authors noted the irony in the fact that the shops were not allowed to stock the medicines in the first place [27]. It appeared that some respondents were not completely honest in their responses, possibly because they knew that they were engaged in unlawful behavior. In another Tanzanian study for instance, three-quarters of drug stores reported not having medicines for sexually transmitted infections (STIs) in stock, and yet these drugs were dispensed to 63% and 78% of female and male mystery shoppers respectively [27].

Like treatment practices, communication with clients gave mixed results. Shops were more likely to communicate basic medication instructions after selling medicines than take patient history before treatment, or offer advice on alternative management strategies. Basic advice and treatment instructions (how and when to take medicines) were given in Ghanaian pharmacies (89% of clients), and Tanzanian drug stores and ADDOs (89 and 93% respectively) [22, 27, 61], but rarely done in Kenyan pharmacies (17%) and Nigerian PMVs (10-13%) [9, 55]. More technical aspects such as side effects and contra-indications were rarely discussed among drug stores in Tanzania and PMVs in Nigeria [22, 27, 48]. Clients who requested specific drugs, or those who failed to disclose the purpose of purchasing medicines were less likely to receive advice in Nigeria and Uganda [16, 62]. Pharmacies on the other hand performed relatively well in counseling, with nearly two-thirds of South African pharmacies discussing prevention of pregnancy with contraception clients [47], and majority of Ghanaian and Kenyan pharmacies counseling STI clients on the importance of partner treatment (81 and 84% respectively) [55, 61]. Pharmacies also offered more privacy during counseling, as seen in Zimbabwe, Kenya and Somaliland [29, 63, 64]. In Ghana, three quarters of pharmacies had designated counseling areas compared to 19% of LCSs [65]. Patient history taking was observed to be poorly done in a number of studies. This was seen in Ghana, Nigeria and Sudan [9, 56, 60]. Nigerian PMVs were more likely to ask questions about illness if the shop was located in a rural setting, if the attending staff was the owner, or if the client was buying the drug for another person [62].

Majority of staff interviewed in Ethiopia, Tanzania, Somaliland, Nigeria and Ghana expressed willingness to refer clients when necessary [26, 29, 48, 61, 66]. However, actual referral practices were rarely investigated, and where this was done, the practice was scarcely reported. In Nigeria and Uganda for instance, nearly all staff failed to refer clients when required [11, 62]. What made referral particularly hard to assess was poor record keeping, an observation made in Ugandan and Tanzanian drug stores, as well as Ghanaian LCSs [22, 65, 67]. Pharmacies kept better records , although it was not clear whether this included referral records [65].

So, what factors influence dispensing behavior among SDSs? A number of studies explored determinants of SDS practices across different countries. In Nigeria, 3 separate studies found demand to be an important influence, with 40% of pharmacists and 62-69% of PMVs selling medicines at the request of clients [48, 62, 68]. Similarly, Ugandan and Tanzanian drug shops sold whichever medicines clients requested [11, 43, 69], whereas in Kenya and Somaliland, demand was reported to influence pharmacies’ choice of medicines to stock [24, 29]. Another important determinant of dispensing practices was shop location, with shops situated in urban and affluent areas providing better services overall. This was seen in Zimbabwe and Kenya for instance. In Zimbabwe, pharmacies located in the capital had a higher likelihood of dispensing correct STI treatments, whereas clients visiting pharmacies located in urban or affluent areas were more likely to receive appropriate treatment in Kenya [58, 64]. Additionally, shops located near towns, those operating close to other shops, and shops situated in more populous areas were found to have a higher likelihood of stocking the first line antimalarial treatments in Tanzania, meaning individuals staying within such localities had better geographical access to policy recommended treatments [40]. The same study also found shops operating in remote areas to have a higher likelihood of selling antipyretics in place of antimalarials for fever (the policy at the time was to treat all fevers as malaria cases in high transmission areas). Shop location was associated with medicine prices and credit facilities. In Tanzania, ADDOs operating in more rural areas were found to have higher mark-ups compared to those in urban locations [42], whereas medicines prices were higher in pharmacies operating in more affluent parts of Mozambique’s capital [19]. In Somaliland, four-fifths of rural pharmacies offered credit facilities compared to only half in urban locations [29]. Prices also varied with shop type, with non-pharmacy drug shops having lower prices compared to pharmacies in Nigeria, Uganda, Benin and Zambia [14, 31, 33, 70]. Regulation of retail mark-ups was only encountered in Mali and Mozambique [19, 71, 72]. Age and sex of client also had some association with dispensing, with women receiving correct diarrhoea treatment more often than men in Kenya, and drug shops expressing higher willingness to sell medicines for sick adults than infants in Tanzania [26, 58]. Finally, familiarity with the clients influenced dispensing in Zimbabwe, where one-fifth of pharmacy staff admitted they could sell an antibiotic to an acquaintance without asking for a prescription [64].

Regulatory practices were rarely reported overall. Frequency of regulatory visits varied across countries, with only a third of PMVs in Nigeria reporting visits over the last 2 years in contrast to drug stores in Tanzania, majority of whom had received visits over the last year [28, 54]. Low frequency of regulatory inspection was blamed for poor regulatory compliance among pharmacies in Zaire (now the Democratic Republic of Congo), where 87% of drugs were sold without prescription [8]. The sale of unregistered medicines was fairly common in Kenya and Ghana. In Kenya for instance, only 5 out of 12 brands of amodiaquine syrup were registered by the regulatory authority [35], whereas 6-29% of pharmacies and 11-23% of LCSs were found selling various brands of unregistered antimalarials in Ghana [73]. In Tanzania, different patterns were observed across different shop cadres; whereas 19 of 30 drug stores were found stocking unregistered antimalarial imports, nearly all pharmacies were reported to only stock registered malaria medicines [54, 74]. Other forms of regulatory infringement included providing clinical management without authorization in Uganda, and failure to display practice permits in Tanzania [54, 75]. Drug policy issues were poorly communicated in Tanzania overall, with three-quarters of dispensers reporting that they heard about malaria treatment policy changes over the radio and other news media [7]. This may partly explain the high availability of unrecommended treatments such as artemisinin monotherapies in Tanzanian pharmacies and drug stores [74, 76].