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• W3025268387 abstract "To assess the quality of antibiotics sampled from authorised sales outlets (ATs) (i.e. hospitals/health centres, pharmacies and licensed chemical shops) and unauthorised sales outlets (UATs) (mainly street vendors) in Ghana and to explore the health-seeking behaviour of medicine consumers. The contents of 14 active pharmaceutical ingredients (APIs) in 348 sampled products were determined using a validated liquid chromatography–tandem mass spectrometry (LC-MS/MS) method. Data on health-seeking practices were collected through entry and exit interviews and field observations from ATs and UATs. It was observed that 66.38% of all sampled antibiotic products were substandard; they either contained less (<90%) or more API (>110%) than the label claim. Medicines from UATs recorded substantially less API contents than those from ATs (F(2,419) = 43.01, P < 0.0001). For example, 90.54% of street vendor samples contained < 90% of the APIs. 75.93% of consumers often sought self-treatment with drugs without a prescription from UATs, as they perceived UATs as easily accessible, trustworthy and knowledgeable, and their medicines as inexpensive. These consumers rather thought of the formal healthcare providers as alternative sources. Consumers who purchase from UATs are at high risk of receiving substandard medicines. The quality of medicines in the national healthcare system, in the supply chain and in the distribution system needs to be monitored regularly to reduce the incidence of substandard medicines and their impact on antimicrobial resistance. The fight against substandard medicines needs to incorporate a full understanding of socioeconomic factors that drive consumer decisions regarding their health and choice of healthcare providers. Evaluer la qualité des antibiotiques prélevés auprès des vendeurs autorisés (VA) (c'est-à-dire les hôpitaux/centres de santé, les pharmacies et les magasins de produits chimiques agréés) et des vendeurs non autorisés (VNA) (principalement les vendeurs de rue) au Ghana et étudier le comportement des utilisateurs de médicaments en quête de santé. Le contenu de 14 principes actifs (PA) pharmaceutiques dans 348 produits échantillonnés a été déterminé à l'aide d'une méthode validée de chromatographie liquide et de spectrométrie de masse en tandem (LC-MS/MS). Les données sur les pratiques de recherche de santé ont été collectées par le biais d'entretiens d'entrée et de sortie, et d'observations sur le terrain des VA et des VNA. Il a été observé que 66,38% de tous les produits antibiotiques échantillonnés étaient inférieurs aux normes; ils contenaient soit moins (<90%), soit plus de PA (>110%) que ce qui était indiqué sur la notice. Les médicaments provenant des VNA ont enregistré une quantité de PA sensiblement inférieure à celle des VA (F(2,419) = 43.01, P < 0,0001). Par exemple, 90,54% des échantillons de vendeurs de rue contenaient <90% de PA. 75,93% des utilisateurs ont souvent cherché à se soigner eux-mêmes avec des médicaments sans ordonnance des VNA, car ils ont perçu les VNA comme étant facilement accessibles, fiables et bien informés, et leurs médicaments comme étant peu coûteux. Ces utilisateurs considéraient également les prestataires de soins de santé officiels comme des sources alternatives. Les utilisateurs qui s'approvisionnent auprès des VNA courent un risque élevé de recevoir des médicaments de qualité inférieure. La qualité des médicaments dans le système national de santé, dans la chaîne d'approvisionnement et dans le système de distribution doit être contrôlée régulièrement pour réduire l'incidence des médicaments de qualité inférieure et leur impact sur la résistance aux antimicrobiens. La lutte contre les médicaments de qualité inférieure doit intégrer une compréhension complète des facteurs socioéconomiques qui déterminent les décisions des utilisateurs concernant leur santé et le choix des prestataires de soins de santé. The emergence of microbial strains that are resistant to widely used antibiotics is a growing problem globally. Complicated by poor sanitation and weak infection control in low- and middle-income countries (LMICs) [1-3] and the rising problem of substandard antibiotics on the consumer markets [4-7], the fight against antimicrobial resistance (AMR) has become the more challenging. Poor-quality drugs are thought to result in potentially fatal treatment failures in individual patients [8, 9] with far-reaching implications for public health. Apart from that, exposing microorganisms to subtherapeutic drug doses leads to the emergence of resistant strains [10]. In Ghana, a low-income country with a weak medicines regulatory system that lacks routine drug quality surveillance systems, many local studies have shown a trend towards the development of microbial resistance to commonly used antibiotics [11-16]. Previous studies found substantial percentages of medicines acquired from ATs to be below quality standards, including antibiotics such as penicillins and macrolides [17-22]. In 2010, the Ghana Food and Drugs Authority (FDA) tested samples from a number of ATs and found 14% of three antibiotics to be of substandard quality [23]. A medicine is said to be substandard if it is produced by a legitimate manufacturer but does not meet indicated quality specifications [24]. For example, such a medicine may contain less (or more) active ingredient than the label claim. There may not necessarily be an intention to cheat or an issue of fraud with such occurrences; they may be due to problems with the manufacturing processes or distribution challenges within the supply chain [25] or to accidental errors and negligence [26]. As in other LMICs, UATs such as street and internet vendors supplement the formal healthcare market in Ghana [27]. They offer regulated medicines, including antibiotics, directly to consumers without prescriptions [4, 5, 28, 29]. While the precise market share of street vendors in Ghana is not known, previous studies in neighbouring LMICs such as Nigeria have suggested that drugs sold by street vendors are used by more than 40% of people in rural communities for treatments against illnesses such as childhood fevers [30]. When children exhibit symptoms such as cough, fever, vomiting, diarrhoea and convulsion, their mothers reportedly consult street vendors more often than formal healthcare facilities [31]. Thus, although some of these outlets are not legally registered and mandated by law to render such services, consumers keep on patronising them [32]. Due to this phenomenon, it has become particularly important to monitor the state of quality of medicines procured from medicine sales outlets; whether ATs or UATs, because irrespective of the source of obtaining the medicines (in this case, antibiotics), the outcome of their use has a significant impact on national attempts in fighting AMR. This project was thus carried out to evaluate the quality of antibiotics acquired from street vendors, pharmacies and licensed chemical shops and hospitals from small and large cities using LC-MS/MS method. The project also sought to investigate consumer behaviour regarding contact to healthcare providers at all levels and to study why, how and when consumers use medicines such as antibiotics [33-38]. The study was conducted using an explanatory mixed method approach [39]; the first part consisted of a cross-sectional study designed to sample 14 types of antibiotics from 35 ATs and UATs in different parts of the country, in accordance with WHO Guidelines on the conduct of surveys of quality of medicines (WHO TRS 996 Annex 07) [40]. A convenience sampling technique was adopted to collect the samples from the above-mentioned sites depending on their availability at the time of visit (N = 348). The quality of the samples was then accessed by determining the contents of the active pharmaceutical ingredients in each product. The second part of the study constituted the use of a qualitative study design tool to establish community perceptions and practices with regard to medicine purchasing and use, especially antibiotics, in three phases. Semi-structured interviews and systematic observations were the tools used in collecting the qualitative data. After initial consultations with representatives from WHO-Ghana, Ministry of Health, FDA and academia in Ghana, antibiotics selected constituted the widely used ones to treat common and/or life-threatening infections or for pre-surgery prophylaxis. Thus, 14 antibiotics, comprising amoxicillin, amoxicillin and clavulanic acid combinations, ampicillin, metronidazole, sulphamethoxazole and trimethoprim combinations, ceftriaxone, cefuroxime, tetracycline, ciprofloxacin, benzylpenicillin (penicillin G), phenoxymethylpenicillin (penicillin V), erythromycin and gentamicin, were selected. All (except ampicillin oral formulations) are included in the Medicines List in Ghana [41, 42]. Samples of different dosage forms (including tablets, capsules, syrups, suspensions, injectables, ear or eye preparations) and from different manufacturers (foreign, local) were included. Sampling, testing and retesting of the samples were carried out between 2011 and 2018. It was ensured that the included samples (Figure 1) tested and retested were always within their shelf lives and were duly registered with the FDA. We selected 25 ATs and 10 UATs in urban and rural communities in four central and southern parts of Ghana (Greater Accra, Eastern, Ashanti and Brong-Ahafo), including two large cities (Accra and Kumasi) reported to have many pharmaceutical retail services [27]. These regions together represented 56% of the Ghana population [43]. Medicine sales outlets were selected purposively, targeting outlets that had higher client base in major hospitals and commercial centres in the geographic area. Sampling covered pharmacies (including dispensaries of healthcare facilities and government-licensed, private, stand-alone pharmacies), licensed chemical shops (licensed to vend over-the-counter medicines) and street vendors as the most important suppliers of antibiotics (Figure 2). In the category of ATs, eight public tertiary and district hospitals (including the country’s two largest tertiary hospitals, i.e. Korle-Bu Teaching Hospital, Accra and Komfo Anokye Teaching Hospital, Kumasi), one health centre dispensary and 16 private registered pharmacies and licensed chemical shops were sampled. In the category of UATs, one in Greater Accra, two in Eastern, three in Ashanti and four in Brong-Ahafo were sampled with the help of local collaborators recruited in the course of the study. This was to limit the potential barrier of mistrust. Most vendors were approached at busy lorry and bus terminals and carried drugs in leather bags and/or ‘Ghana-must-go’ polyethylene (GMG) bags. At each site, 20–50 dosage units of tablets and/or capsules and 5–10 bottles and/or vials of suspensions/syrups/sterile products were purchased. Products were sampled among those displayed for sale without any interference from shop attendants/street vendors. Immediately following collection, samples were photographed, coded and stored under conditions as recommended by their respective manufacturers. All samples were analysed at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark, using a validated LC-MS/MS method [44] between 2011 and 2018. Homogenous mixtures of the products (tablets, capsules, suspensions/syrups, intravenous (IV) and eye and ear drops were prepared and analysed in triplicate. Analyses of freshly prepared solutions of the samples were performed blindly to the packaging. The LC-MS/MS set-up comprised of an Agilent 1100 series HPLC system (Agilent Technologies, Palo Alto, CA, USA) hyphenated to a Sciex API 3000 triple quadrupole mass spectrometer with electrospray ionisation (Applied Biosystems, Foster City, CA, USA). Data were collected and analysed using Analyst software 1.4 (Applied Biosystems). Data obtained were processed using GraphPad Prism (version 6.01) and Statistical Package for Social Scientists (IBM SPSS Statistics version 20). Descriptive and inferential statistics were used to analyse the data. The results from the descriptive statistics were presented in tables. Comparisons of sample results were statistically analysed using Student’s t-test and analysis of variance (ANOVA), followed by Tukey’s post hoc test. Statistical significance was inferred in comparisons where P values ≤ 0.05. This part of the study sought to document behaviour of medicine consumers towards the use of antibiotics and understand factors influencing their use. Observations were made at medicine sales points and interviews held with patients prescribed with antibiotics at healthcare facilities, owners/dispensers at pharmacies and chemical shops, street vendors and heads of households. The study was carried out in the Eastern Region exclusively, during the same time period as the drug sampling. Eastern Region was chosen strategically for the qualitative component as it has communities that are less likely to be ‘over-researched’ [45] and is convenient due to its proximity to Accra, the capital of Ghana. Koforidua, the capital city of Eastern Region, was selected purposively to represent urban settings in southern Ghana. Rural communities in Atiwa, a close-by district, were selected for convenience. In Phase I, semi-structured exit interviews were conducted with 58 outpatients who had been prescribed antibiotics at six primary healthcare facilities. Health facilities were selected by type and patient attendance rate in 2010. Sampled facilities were two government-owned, two private not-for-profit and two private-for-profit. Four facilities were located in an urban setting and two in a rural one. Patients prescribed with antibiotics were approached for interview as they exited the dispensary. After each interview, the interviewer returned to the dispensing area to recruit the next eligible participant. Interview topics included what symptoms patients perceived; actions taken to address them before reporting to the health facility; a narration of conversation and procedures in the clinical consultation; an account of the interaction with the drug dispensing staff; perceptions of all interactions, procedures and outcomes; and knowledge and experiences with antibiotics. Phase II covered 12 households in three rural communities. Communities were already divided into suburbs for community health outreach purposes and households perceived to be at the centre of suburbs were selected to participate. Community entry and household selection were done with the help of community volunteers. All selected households contained both national health insured and non-national health insured members. For a period of eight weeks, health events and therapy/management choices were recorded in bi-weekly visits. Data obtained through informal interviews and observations were recorded in detailed field notes. Information obtained included a list of household members who were ill during review period, illness suffered, any treatment given, treatment outcome, any use of medicine(s) and a look at the medicine or empty package, how the medicine(s) was/were administered, source of advice on treatment and source of medicine(s). In Phase III, systematic observations were made at three registered retail pharmacies located in the commercial centre in the urban settings and three licensed chemical shops located in the rural communities in the study site (we found no registered pharmacies in rural settings). To minimise the effect of the possibility of dispensers changing practices during observation, the first day of data collection was used to observe practices and engage in informal unstructured interviews with dispensers without recording. Dispensing practices were documented on the second day, but these were not included in the final analysis [46]. A total of 1548 client–dispenser interactions were observed in the six medicine sale outlets, 1040 in pharmacies and 508 in chemical shops. Information documented included medicines dispensed to clients (name, strength and quantity), the dosage, the source of advice (prescription, over-the-counter or dispenser advised) and a narration of the interaction between the client and dispenser. Product delivery and handling, and storage practice were also documented. Interviews were transcribed verbatim, field notes incorporated and imported into NVivo 10 for analysis. Codes were identified inductively from the data and grouped to produce higher order themes [47]. Data were then recoded using the thematic codes to ensure themes, and findings were systematically evidenced in the data [48]. Conclusions were drawn based on thorough contrasting and comparison of the data [49]. The drug dispensing data from medicine sale outlets were analysed quantitatively. A list of variables analysed was generated, and a data master sheet was developed in Microsoft Excel for each variable. Straight counts were then performed to know how frequently variable options occurred. The data gathered addressed a host of issues such as perception of illness and medicines, treatment-seeking behaviour, disease management and medicine sources, dispensing practices and medicine-related community customs. In this paper, we include only data that contextualised consumers’ choice of treatment and medicine outlets, issues relating to medicine quality and insight on how consumers interact with different suppliers. The study was approved by the Ghana Health Service Ethical Review Committee with an approval ID of GHS-ERC 05/11/10. In the drug quality survey, informed consent was obtained from all medicine outlets (pharmacies, licensed chemical shop operators and street vendors) based on an introductory letter from the Department of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana, describing the study’s purpose and scope. Written or verbal consent was then obtained from the outlet. In the qualitative study, informed consent was obtained from all persons interviewed highlighting that participation was completely voluntary and that there would be no negative consequences for declining to participate. Participants were also assured that information obtained from them would be rendered anonymous. No incentive was given for participation. Products were sampled based on availability at the time of the visit. Most products were dispensed from their original blisters, containers, packaging bottles or vials (injectables). Some tablet blisters were dispensed by street vendors in paper or plastic zip envelopes. Overall, 348 samples were collected. Some products had one active pharmaceutical ingredient (API) (n = 274, 78.74%); others had two APIs (n = 74, 21.26%), notably amoxicillin plus clavulanic acid (n = 42, 56.76%) and sulphamethoxazole plus trimethoprim (n = 32, 43.24%). Consequently, there were more products containing single APIs than combination products (N = 348, χ2 = 114.943, P < 0.0001). Amoxicillin was the most frequently observed API identified in the samples (n = 93, 26.7%) (Table 1). It was shown either to be present alone in a monotherapy (n = 51, 54.84%) or combination with clavulanic acid (n = 42, 45.16%). This was followed by metronidazole (12.36%), cefuroxime (41, 11.80%) and phenoxymethylpenicillin (41 = 11.80%). The least frequently encountered API was ceftriaxone (n = 3, 0.90%) (Figure 1). These samples were collected from hospitals/health centres (n = 138, 39.70%), private pharmacies and licensed chemical shops (n = 136, 39.10%) and street vendors or medicine peddlers (n = 74, 21.30%). Most outlets offered both imported and locally produced antibiotics. There were significantly more locally manufactured medicines (n = 200, 57.50%) than foreign-origin ones (n = 148, 42.50%) sampled for the study (N = 348, χ2 = 7.77011, P = 0.005). This was evident with samples from street vendors (n = 56, 75.68%) and private pharmacies/licensed chemical shops (n = 86, 63.24%). However, imported products were predominant in hospitals/health centres (n = 80, 57.97%). Most of these products were tablets (n = 181, 52.00%), followed by suspensions (n = 61, 17.50%), then capsules (48, 13.80%) and parenteral or intravenous (n = 41, 11.80%) formulations. The least observed dosage form was eye ointment (n = 1, 0.30%). All hospitals/health centres except one reported that drugs were being stored in air-conditioned rooms. However, some of the pharmacies and the dispensaries in hospitals/health centres had turned off their air conditioners at the time of visit, in an attempt to reduce the cost of electricity. None of the licensed chemical shops visited had air-conditioned premises. Pearson’s Chi-Square (χ2) P-value (2 sided) Hospitals (n = 138) Street Vendors (n = 74) Pharmacy/LCS (n = 136) Drug quality was assessed in terms of percentage content of API(s) per label guarantee and compliance with the British Pharmacopoeial standard [50] on content assay (percentage content) for the respective products (Figure 3). In all, only 117 (33.62%) of all 348 sampled products had adequate or expected content, that is they contained between 90% or more and ≤ 110% of active ingredient as guaranteed by the product label and conformed with the British Pharmacopoeia standard [50]. In effect, 66.38% (n = 231) of the sampled products were substandard; they either contained less (<90%) or more (>110%) API than expected. The mean percentage content of samples with a single API (n = 274, 78.74%) was 72.50% (68.70 – 76.29), whereas that of samples containing two APIs (n = 74, 21.26%) was 68.40% (63.47 – 73.33). The contents of both classes of products were thought to be comparable (t = 1.281, df = 420, P = 0.2009; Figure 4). A relatively higher proportion of single-component samples (n = 176, 64.23%) that did not comply with the percentage content specification compared to those samples which did (n = 98, 36%). Among samples which did not comply (N = 176), 160 (90.91%) recorded either low (50% - 89.99%) or very low contents (<50%), whereas 16 (9.09%) recorded either high (111.00% - 140.00%) or very high contents (>140.00%) (Table 2). Similarly, among samples containing two APIs (N = 74), there were more products which did not comply with the compendial standard (n = 55, 74.32%) than those which did (n = 19, 25.68%). All non-compliant samples had either low or very low content (n = 55, 100%). Pearson’s Chi-Square (χ2) P-value (2 sided) Very high (>140%) N = 2 High (111−140%) N = 14 Expected (90–100%) N = 117 Low (50–89.99%) N = 129 Very Low (<50%) N = 86 There were more samples from hospitals with the expected contents (n = 68, 49.28%) than from pharmacies/LCS (n = 42, 30.88%) and street vendors (n = 7, 9.46%) (Figure 4). Generally, there were comparatively more samples from each of the collection sites with contents either above or below the expected levels (n = 231, 66.38%, χ2 = 78.321, P < 0.0001) than those with expected levels. In terms of the formulation types, intravenous preparations recorded the highest proportions with expected contents (n = 26, 63.41%), followed by suspensions (n = 32, 52.46%), syrups (n = 1, 50%) and eye and ear drops (n = 2, 40%). Most of the eye drops (n = 8, 88.89%) and tablets (n = 144, 79.56%) did not contain the right percentage content of their APIs (Table 2). The breakdown of the contents of the respective APIs in the sampled products is described in Table 3. With a mean of 69.34% (65.53–68.28) for samples with local origin and a mean of 73.06% (68.28–77.84) for samples with foreign origin, their contents were comparable (t = 1.215, df = 420, P = 0.2250) (Figure 4). Pharmaceutical Ingredient The findings of the qualitative study were summarised under the following themes: (1) self-treatment practices, (2) over-the-counter dispensing of antibiotics, (3) street vendors as sources of biomedicines and (4) storage practices and perceptions of drug quality. Text quotes from interviews were also presented to enhance transparency. The data from the Phase I showed that self-treatment of illness was a very common practice. Although most study participants (n = 54, 93.10%) who sought care at primary healthcare centres were insured under the National Health Insurance Scheme (NHIS), several (n = 41, 75.93%) had earlier engaged in self-treatment. The household interviews in the Phase II also revealed similar practices: only 31.58% (n = 30) of cases of medicine use were informed by visits to ATs. The reasons given for self-treatment were (1) a concern by the non-insured about cost of biomedical care, (2) waiting time, drug unavailability, poor quality of care and unprofessional attitude of some staff at health facilities, (3) the limited range of biomedical services offered by peripheral facilities that often result in referrals and (4) reports by the insured that they feel a need to possess some funds before seeking care at facilities because requests for out-of-pocket payments were common. Self-treatment was also considered if the illness was considered mild and/or it was perceived that the condition could be treated without medical advice because of previous experiences. Where cost was an issue, self-treatment was sometimes considered because medicines could be obtained on credit from community drug sellers. One mother whose child was insured explained her decision to purchase medicines and self-treat her child’s fever without visiting a health facility: ‘…sometimes after going through all the processes, then you are told the medicine the child needs is not available and you have to go to the drug store to buy it’. Another informant without health insurance complained: ‘…. now that there is health insurance, the health facilities have increased the cost of services forgetting that not everybody has health insurance to absorb the cost’. Out of the 1548 client–dispenser interactions observed at medicine outlets in the Phase III, only 2 (0.13%), both in rural settings, resulted in no medicine dispensed and clients being referred to a hospital/health centre. 168 (16.15%) transactions in pharmacies and 139 (27.36%) in chemical shops led to the dispensing of antibiotic(s). All antibiotics dispensed in chemical shops were without prescriptions, while in pharmacies, the figure was 140 (83%). Most medicine sale transactions (73.0% in chemical shops and 67.8% in pharmacies) took place without prescription or advice from the dispenser. Clients often came, knowing beforehand what product(s) they wanted to buy. Street vendors visited rural communities regularly, and 3 households (25%) reported seeking care from them. Vendors had formed relationships of trust with community members, and some informants perceived them to be knowledgeable about the medicines they sold. Below is a quote from an interview with an informant who compares the street vendor with the chemical shop in her community: ‘The owner [of the licensed chemical shop] is retired from a non-health profession. He runs the shop himself. Sometimes his wife or children attend to the shop. None of them are trained. They are not able to advise on medicines procured like [name of street vendor] does’. Other reasons why people bought medicines from street vendors included a perception that the per-unit cost of drugs sold was lower than in pharmacies and chemical shops. The units of drugs sold could also be tailored to suit the client’s budget and even offered on credit. Community members believed that due to high patronage, there was a high turnover of medicines sold by vendors, and therefore, medicines offered were unlikely to be expired. Street vendors moved from house to house, bringing medicines to the doorstep of clients, and this was welcomed by community members. One informant also indicated how a street vendor helped her to fill a prescription at a pharmacy in the city since the vendor did not have the medicine in stock and it was also not available in local shops. Issues of drug quality emerged naturally in the interviews. Some patients attending healthcare facilities believed that medicines dispensed to persons on the NHIS were of inferior quality compared to those obtained through out-of-pocket payment in private medicine shops. Pharmacy and chemical shop attendants mentioned that they secured the quality of the medicines stocked by buying from ‘credible’ suppliers. One chemical shop attendant, sharing his experience in sourcing medicines for his shop, said ‘the difference between the good drugs and the fake ones is very subtle. It is difficult to tell. Sometimes when we go for our meetings, they bring it [things to lookout for to differentiate the good product from the falsified] to our attention’. In shops, medicines were arranged on shelves and in cabinets. Extras were left in cardboard boxes, sometimes on the bare floor. In one of the three pharmacies studied, medicines were on the floor, touching the walls and stacked up to the ceiling. Room temperatures in the medicine shops were not always regulated. All three pharmacies had air conditioners, but were switched on only in the afternoons when the weather was perceived to be hot as a cost-saving measure. Chemical shops did not have air conditioners. During the period of the study, suppliers that delivered medicines to pharmacies and chemical shops used enclosed vans with no temperature regulation. Street vendors carried their wares in GMG bags that expose medicines to heat. In this study, authors report that 66.38% of all products sampled were substandard (i.e. containing less than 90% or more than 110% of active ingredient compared to pharmacopoeial specification on content assay). Previous studies on antimalarials in the country had put the incidence rate at 35% [51, 52]. Another study on an" @default.
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• W3025268387 title "Exposure of consumers to substandard antibiotics from selected authorised and unauthorised medicine sales outlets in Ghana" @default.
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