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Quality Assessment of Some Essential Children's Medicines Sold in Licensed Outlets in Ashanti Region, Ghana.

1. Introduction

Children's medicines are generally intended for the diagnostic use, management, and treatment of diseases of children up to 12 years of age. Access to affordable and quality children's medicines in developing countries such as Ghana is important in reducing the high morbidity and mortality associated with malaria and other infectious diseases of children. To address the special medication needs of children up to age 12, the World Health Organization (WHO) in October 2007 introduced the WHO Model List of Essential Medicines for children (EMLc), with the current edition published in March 2017 (6th Edition). The EMLc consists of a core list and a supplementary list of medicines. The core list contains the most efficacious, safe, and cost-effective medicines for priority conditions and has the minimum medicines required for a basic healthcare system, while the supplementary list contains essential medicines for priority diseases which requires specialized medical care, specialized training or specialized diagnostic or monitoring facilities [1].

The presence of a medicine on the WHO EMLc is however not an assurance of the pharmaceutical quality of the medicine. It is therefore the responsibility of the relevant national and regional medicines regulatory authorities to ensure that medicines within their jurisdiction are of the right quality and stability through the application of integrated pharmacovigilance and drug surveillance systems [2]. The Standard Treatment Guidelines (STG) published by the Ministry of Health, Ghana, under the auspices of the Ghana National Drugs Programme are to ensure, among others, the availability of quality essential medicines for children and adults in all healthcare settings in the country [3]. The STG of Ghana incorporates some essential children's medicines contained in the WHO EMLc and others which are not on the list.

The healthcare system in Ghana has 5 levels of providers comprising health posts, health centers/clinics, district hospitals, regional hospitals, and tertiary or teaching hospitals. Most health facilities are found in the urban areas while the rural areas have poor health infrastructure. The country has 39.3% of the population below 15 years (2010 population census) with infant mortality and under 5 mortality in 2014 at 41 and 60 (per 1000 live births), respectively. In 2012, 5.2% of Ghana's gross domestic product (GDP) was spent on health. In 2014, the top 5 causes of death in all ages were malaria, anaemia, HIV/AIDS, hypertension, and pneumonia (The Health Sector in Ghana: Facts and Figures, 2015). The Ashanti Region is the most populous region of Ghana, with a projected population of 5,461,534 (GSS 2010 Census). The region has many health facilities including 141 health centers, 116 clinics, 119 hospitals, and 2,241 registered medicine outlets comprising hospital dispensaries, community pharmacies, and licensed chemical shops.

The quality of children's medicines available in medicines outlets in a country directly affects the quality of healthcare available to children in the country. Children are more vulnerable to the adverse effects of poor quality medicines due to their physiological differences from adults and the changes of their medicines disposition during maturation. The necessity of using quality medicines in health delivery systems cannot be overemphasized as poor quality medicines usage, particularly in children, can cause treatment failures, emergence of drug resistance, prolonged sickness, increased healthcare costs, and death [4]. Thus, the use of poor quality medicines in children will result in increased morbidity and mortality.

The quality of medicines can be compromised during manufacture, distribution within country, and storage at elevated temperatures and humidity conditions [5]. There is the need for regular quality assurance and postmarket surveillance of children's medicines by regulatory and allied authorities to ensure the quality of these medicines. However, medicines quality monitoring remains a big challenge in most developing countries due to inadequate facilities and trained personnel and poor regulatory mechanisms [6].

There are very few reported studies on the quality testing of child-specific paediatric formulations [7-10]. Thus, most of the studies on the pharmaceutical quality of children's medicines reported in the literature are essentially subsets of larger medicines quality studies [2]. An evaluation of the physicochemical properties of four paediatric dihydroartemisinin-piperaquine powder for suspension revealed satisfactory drug content with pH: 3.19-4.65, moisture content: 2.6-4.4%, total solids: 86.2-97.2%, and viscosity: 78.5-125.8 mPa-s [11]. An assessment of the quality of artemether-lumefantrine preparations and artemether injections in Cape Coast Metropolis, Ghana, showed that 7 (87.5%) of the 8 brands (6 tablets, 2 suspensions) and all 2 artemether injections passed the International Pharmacopoeia content test [12]. A new validated high performance liquid chromatography method used to analyse the content of 24 artemether-lumefantrine tablets and powders for reconstitution into paediatric suspensions obtained in Ghana showed that all 4 samples which failed (16.7%) were powders for reconstitution into suspensions with two (8.3%) of the samples showing unacceptably higher levels of 222% and 756% artemether [13]. The analysis of microbial load of seven brands of multivitamin syrups marketed in Maiduguri, Nigeria, using the pour-plate method showed that one brand (14.3%) contained the pathogenic bacteria Salmonella spp. while the other 6 samples (85.7%) satisfied the microbial load limit of syrups [10].

A study in Kenya showed that 16 out of 23 amodiaquine suspensions (69.6%) sampled from the private retail sector passed the USP limits for content of amodiaquine of 93-107% while 7 samples (30.4%) failed. Also, out of 27 sulphadoxine (SDX)-pyrimethamine (PMT) suspensions analysed for content, 16 samples (59.3%) failed to meet the USP limits for content of SDX and PMT of 90-110% [14]. Eight percent of amoxicillin suspensions purchased from some Arab countries and analysed for drug content using validated chromatographic method after reconstitution failed the pharmacopoeial limits while 38% failed the drug content test after 7 or 14 days after reconstitution [15]. A quality evaluation of 10 metronidazole suspensions in Bangladesh found that 8 of the samples met the BP specification for potency while 2 brands were less potent. Also, all the 10 metronidazole samples satisfied the specification for pH of suspensions [16]. There have also been reports in Nigeria and India of diethylene glycol-induced renal failure and encephalopathy when it was substituted for propylene glycol in paediatric paracetamol formulations [17,18].

We have previously reported the low average availability of essential children's medicines in the Ashanti Region, Ghana of ~41.3% [19]. The objective of the current study was to evaluate the quality of some essential children's medicines (syrups, suspensions, and solutions) purchased from licensed medicine outlets in the Ashanti Region, Ghana, using the three quality parameters of content of active pharmaceutical ingredient (API), pH, and microbial load. From the study it would be possible to ascertain the proportion of children's medicines that are of good quality and/or substandard and the country of manufacture and level of unlicensed children's medicines available and their possible correlation with product quality.

2. Material and Methods

2.1. Chemicals and Analytical Reference Standards. Primary analytical reference standards with purity > 99% of ciprofloxacin (CPF), trimethoprim (TMP), sulphamethoxazole (SMZ), metronidazole (MTZ), amoxicillin (AMX), clavulanic acid (CLA), flucloxacillin (FCX), cefuroxime (CFX), arthemether (ART), lumefantrine (LUM), mebendazole (MBZ), albendazole (ALB), ferrous ammonium citrate (FAC), vitamin B1 (VB1), vitamin B3 (VB3), vitamin B6 (VB6), folic acid (FLA), griseofulvin (GFV), paracetamol (PCM), and ibuprofen (IBF) were obtained from the Food and Drugs Authority, Ghana. Analytical grade solvents including sodium hydroxide (BDH, UK), formic acid, methanol, chloroform acetic acid, glacial acetic acid (BDH, UK), ethanol, acetonitrile, ammonium hydroxide reagent ACS, sulphuric acid, ethyl acetate, holmium perchlorate, and potassium dihydrogen orthophosphate (BDH, UK) were used.

2.2. Microbiological Media and Test Strains. Buffered sodium chloride-peptone solution pH 7.0 (Sigma-Aldrich, USA), soybean-casein digest agar (Sigma-Aldrich, USA), tryptone soy agar (Fisher Scientific, USA), nutrient agar (BDH, UK), MacConkey agar (BDH, UK), mannitol salt agar (Fisher Scientific, USA), and sterile water were used. Clinical strains of Escherichia coli, Staphylococcus aureus, Candida albicans, Bacillus subtilis, Pseudomonas aeruginosa, Streptococcus pneumonia, and Haemophilus influenza were used for microbiological analysis.

2.3. Sample Collection. Sixty-eight samples of 15 different essential children's medicines employed in the treatment of prevalent diseases in the region and falling into therapeutic groups of antibiotics, anthelmintics, antimalarials, analgesic/anti-inflammatory agents, and antifungals were purchased from hospital dispensaries (24), community pharmacies (24), and licensed chemical sellers shops (35) in the 27 administrative districts of the Ashanti Region, Ghana [19]. Stratified sampling was employed to allocate three paediatric medicines to each district, except the Kumasi Metropolis which, being the best endowed with medicines outlets, was allocated 5 medicines. Random sampling was then used to determine the specific medicine outlets to visit to purchase the medicines in each district for the study from a list of 2,241 registered medicine outlets in the region. The same investigator purchased all the medicines from the selected licensed medicine outlets. For each selected drug, one proprietary product and two or more generics (n = 3), depending on availability, were purchased from the medicine outlet for the study. The characteristics of the sampled children's medicines are shown in Table 1. The samples were collected between June 2014 and August 2016 and quality assessment studies were conducted at least six months before their expiry dates.

2.4. Determination of Content of API by Ultraviolet Spectroscopy. The percentage content of APIs of cotrimoxazole suspension (trimethoprim TMP and sulfamethoxazole SMZ), metronidazole suspension, cefuroxime suspension, mebendazole suspension, ferrous ammonium citrate solution, paracetamol suspension, and griseofulvin suspension (n = 3) was determined by ultraviolet spectrophotometry (UV-VIS spectrophotometer 3000+, Labindia Instruments Pvt Ltd., India) using the standard British Pharmacopoeia methods [20]. The suspensions were shaken to make sure that there were no cakes at the bottom of the bottles. Powders for reconstitution into suspensions were constituted with distilled water as recommended and shaken to ensure content uniformity before samples were taken. The API contents of the paediatric medicines were determined by measuring the absorbance of the appropriately diluted medicines at the following absorbance values: TMP: 204 nm; SMZ: 257 nm; metronidazole: 277 nm; cefuroxime: 274 nm; mebendazole: 305 nm; ferrous ammonium citrate: 472 nm; paracetamol: 257 nm; and griseofulvin: 291 nm.

2.5. Determination of Content of API by High Performance Liquid Chromatography. Standard United States Pharmacopeia high performance liquid chromatography (HPLC) methods [21] were used to determine the percentage content of APIs in the suspensions of ciprofloxacin, amoxicillin, flucloxacillin, albendazole, ibuprofen, artemether-lumefantrine, and syrups of multivitamin and folic acid (n = 3). The HPLC analyses were undertaken on an Agilent 110 HPLC system (Agilent Technologies, UK) with a stainless steel Agilent Zorbax C18 column (25 cm x 4.6 mm), packed with octadecylsilyl silica gel. The injection volume, flow rate, and wavelength of detection were, respectively, as follows: ciprofloxacin: 10 [micro]l, 1.5ml/min, 278 nm; amoxicillin: 10 [micro]l, 1.5ml/min, 230 nm; flucloxacillin: 10 [micro]l, 1.0ml/min, 225 nm; albendazole: 20 [micro]l, 2.3ml/min, 308 nm; ibuprofen: 10 [micro]l, 2.3ml/min, 220 nm; artemether-lumefantrine: 20 [micro]l, 1.0 ml/min, 210 and 380 nm; multivitamin: 20 [micro]l, 1.5 ml/min, 275 nm; and folic acid: 20 [micro]l, 2.0 ml/min, 283 nm. Column temperature was maintained at 25-40[degrees]C.

2.6. Determination of pH of Drug Samples. The pH of each sample, diluted according to the manufacturer's instruction, was determined with a calibrated Hanna pH meter (model HI 2210, Hanna Instruments, UK). The results were compared with the British Pharmacopoeia [20] pH specifications of each sample.

2.7. Microbial Limit Tests. The pour-plate method was used to determine the microbial load of the samples according to British Pharmacopoeia specifications [20].

3. Results

Sixty-eight out of 83 samples of children's medicines allocated to the 27 administrative districts of the Ashanti Region, Ghana, were evaluated in the three quality parameters of content of API, pH, and microbial load. Thus, the quality of 68 samples of 15 different essential children's medicines comprising both locally manufactured and imported products were evaluated. The products studied fell into the therapeutic areas of antibiotics (29), antimalarials (4), anthelmintics (13), antifungals (3), haematinics (7), and analgesic/anti-inflammatory agents (12). The imported products were sourced mainly from India and the United Kingdom, showing the importance of these countries as the primary source of imported paediatric medicines in the region. Only one (1.5%) of the samples studied was sourced from another African country, South Africa. This observation could be attributed to the low production capacity for children's medicines by the nascent pharmaceutical manufacturing industries in Africa.

Thirty-six (52.9%) of the products possessed the Food and Drugs Authority, Ghana, or foreign product manufacturing license (PML) numbers while the remaining 32 (47.1%) had no product registration numbers. Thus, a large proportion of the essential children's medicines sampled had not been properly licensed by the national medicines regulatory authority for use in Ghana. Some prescription-only children's medicines were available in some licensed chemical sellers shops even though they are licensed to supply only over-the counter medicines. All the products had the product strength, country of manufacture, manufacturing date, and expiry date on the product labels (Table 1). The shelf lives of the products ranged between 1 and 5 years. All the products had batch numbers except CPF2 (1.5%).

The results of the quality assessment of the sampled children's medicines in terms of percentage content of active pharmaceutical ingredient(s), pH, and microbial load and content are shown in Table 2. The percentage drug contents were determined using either high performance liquid chromatography or ultraviolet spectroscopy methods and were calculated relative to the labelled amount of the drug. The retention times of samples assayed by HPLC varied with the type of drug analysed and were similar for different brands of the same children's medicine. This observation confirms the authenticity of the API(s) contained in the medicines. The two samples of ciprofloxacin oral suspensions (retention time 8.73 min) had drug contents far below the minimum of the official specification of 98-102% and are therefore substandard. One ciprofloxacin sample passed the pH test while the other failed. However, both ciprofloxacin samples passed the microbial limit test and could pose no microbial health hazard.

All the cotrimoxazole suspensions sampled failed the official drug content test but were compliant with specifications for pH and microbial load and content. Cotrimoxazole suspensions contain the APIs trimethoprim (TMP) and sulphamethoxazole (SMZ) with specifications of 92.5-107.5% for the two drugs. Cotrimoxazole suspensions CTX1, CTX2, and CTX4 contained the right amounts of SMZ but had amounts of TMP higher than the specified upper limits. Samples CTX3 and CTX5, however, had both TMP and SMZ above the upper limits. Thus all the cotrimoxazole suspensions sampled are substandard products. Metronidazole oral suspensions are specified to contain 95-105% of the drug. Only sample MTZ4 (16.7%) passed the test while MTZ7 failed marginally. All the six samples, however, passed the pH and microbial limit tests. Samples MTZ2, MTZ3 and MTZ5 contained much lower amounts of the drug than stipulated and their use could result in serious underdosage and possible therapeutic failure.

The amoxicillin suspensions analysed by HPLC had retention times of 3.65-4.04 min. All the six amoxicillin suspension samples, including four locally manufactured products, satisfied the compendial requirements for drug content, pH, and microbial quality and are thus deemed to be good quality. The flucloxacillin suspension samples were analysed by HPLC and had retention time of 2.36 min. All the flucloxacillin samples failed the content of API test but passed both the pH and the microbial limit tests. The samples had their contents of API far below the specified lower limit and are substandard. Only one cefuroxime suspension sample passed the content of API test while the remaining samples failed the test. Cefuroxime suspension CFX1 failed the content of API, pH, and microbial limit tests while samples CHX2-CFX6 passed both the pH and the microbial limit tests. Sample CFX1 contained the pathogenic bacteria Staphylococcus aureus which could adversely affect the health of children. This observation clearly shows that the cefuroxime suspensions available in the region are of poor quality and unsuitable for use.

The retention times of artemether and lumefantrine analysed by HPLC ranged from 3.23 to 4.07 min and from 3.91 to 14.21 min, respectively. None of the artemether-lumefantrine suspensions satisfied the official specifications for content of artemether and lumefantrine of 90-110%. Sample ATL1 passed the drug content test for lumefantrine but failed the test for artemether. The other artemether-lumefantrine suspensions failed the content tests for both artemether and lumefantrine. All the samples passed the microbial limit test but only sample ATL1 passed the pH test while the rest were noncompliant. Only one mebendazole sample (MBZ3) complied with specifications for drug content, pH, and microbial load and is of good quality for use. Sample MBZ5 failed the microbial limit test with the total aerobic microbial count far exceeding the official limit of 1000 cfu/ml. Also, while sample MBZ2 failed the pH test the remaining samples passed the test.

The retention times of the albendazole suspensions analysed by HPLC ranged from 7.23 to 7.28 minutes. Six of the samples (75.0%) passed the content of API test while the rest which failed had drug contents above the upper limit of the official range of 90-110%. All the albendazole suspension samples complied with the microbial load test but only half the number of samples passed the pH test. Only albendazole samples ABZ3 and ABZ4 complied with official specifications for content of API, pH, and microbial load. Two of the three griseofulvin oral suspensions failed the content of API test, with one of them GS V3 failing marginally. All the griseofulvin samples passed the microbial limit test but two of the samples failed the pH test. All the three ferrous sulphate syrups analysed complied with the content of API and microbial limit tests but one sample failed the pH test.

The two multivitamin syrups analysed by HPLC had the following retention times: Vitamin B1 (2.06-2.75 min), Vitamin B2 (6.84 min), Vitamin B3 (2.74-3.17 min), and Vitamin B6 (1.97 min). Multivitamin syrup MVM1 was noncompliant for the requirements of content of vitamins B1, B2, B3, and B6. Multivitamin syrup MVM2 complied with specifications for content of vitamin B1 but was noncompliant for content of vitamins B3 and B6. Samples MVM1 and MVM2 contained unacceptably low amounts of vitamin B1 and vitamin B6, respectively. However, the two multivitamin syrup samples passed both the pH and the microbial limit tests. The two folic acid syrups analysed (retention time: 3.83 min) failed both the content of API and the pH tests but passed the microbial limit test. Three (42.9%) paracetamol oral suspension samples analysed passed the content of API test, with three of the samples failing marginally. All the seven paracetamol samples passed the microbial load test while six (85.7%) passed the pH test. Four ibuprofen oral suspensions analysed by HPLC (retention times: 19.56-20.43 min) complied with the official specification for content of API while all the samples passed the microbial limit test. However, three of the samples failed the pH test while two passed.

Table 3 presents a summary of the results of the drug content determination, pH, and microbial limit tests for the children's medicines studied. In all, 26 (38.2%) of the samples studied complied with official specifications for content of API(s) while 42 (61.8%) were noncompliant. Also, 49 (72.1%) of the samples passed the pH test while 19 (27.9%) failed the test. Two (2.9%) of the children's medicines sampled were noncompliant with specifications for microbial load and content while 66 (97.1%) were compliant. In all, eighteen (26.5%) samples passed all the three quality evaluation tests while one sample (CFX1) failed all the tests. Table 4 shows a comparative analysis of the quality of locally manufactured children's medicines versus foreign-produced samples. Thirteen (36.1%) of the locally manufactured children's medicine samples passed the content of API test while twenty-three (63.9) failed. Also, thirteen (40.6%) of the foreign-manufactured products passed the content of API test while nineteen (59.4%) failed. Thus the failure rate of the foreign-manufactured products was similar to the locally manufactured products. In terms of compliance with pH, the LMP performed marginally better than FMP. All the FMP sampled were compliant with the microbial load and content test while two (5.6%) of the LMP failed. Table 5 shows the effect of registration status/licensing on the quality parameters assessed. Whereas the registered products had higher pass rates for pH and microbial load, the unregistered products showed higher pass rates for content of API. Also, the menace of poor quality children's medicines was encountered irrespective of the country of manufacture of the product (Table 6).

4. Discussion

Children require safe, effective, and quality paediatric pharmaceutical formulations for the management and treatment of diseases to cater for the differences between children and adults regarding drug metabolism and treatment responses [22]. Furthermore, the use of converted adult dosages of medicines for children is discouraged due to the potential for over- and underdosages leading to harmful adverse clinical effects.

The quality of the children's medicines was assessed using the three quality parameters of content of active pharmaceutical ingredient (API), pH, and microbial load. Inadequate amounts of API will result in underdosed medication, leading to poor treatment outcomes while excessive amounts of API cause overdosage of medication, leading to increased adverse drug reactions and treatment failure. The pH of liquid children's medicines is important in assuring the quality, stability, and efficacy of medicines. Medicines with high microbial load due to product contamination and poor quality assurance during manufacturing pose formidable health risks, particularly to children. The presence of pathogenic bacteria such as Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa can cause serious microbial infections such as pneumonia and eye infections in children. While all the three quality parameters assessed in the current study are important to the overall quality of children's medicines, the content of API is the most significant quality parameter which ultimately determines the attainment of positive treatment outcomes or treatment failure.

In the current study, less than one-third of the products sampled passed all the three quality evaluation tests and were considered to be of good quality. The rest of the children's medicines were deemed to be poor quality medicines. Poor quality medicines may be classified into substandard (manufacturing errors), falsified (including counterfeit), or degraded (loss of activity due to poor storage of product in supply chain). Most of the paediatric formulations sampled were substandard and therefore of poor quality. Significantly, none of the products sampled was found to be counterfeit or fake. Substandard medicines are genuine medicines which fail to meet either their quality standards or their specifications, or both. On the other hand, counterfeit medicines are medicines deliberately and fraudulently mislabeled with respect to identity and/or source and may contain the correct ingredients, wrong ingredients, no ingredients, or insufficient ingredients or have fake packaging [23].

The prevalence of poor quality children's medicines was comparable between locally manufactured and foreign produced (imported) medicines. This observation runs counter to the general perception that imported medicines are of better quality than those manufactured locally in developing and other resource-poor countries. There also appeared to be no correlation between the registration status/licensing of children's medicines and product quality.

The use of poor quality paediatric medicines can lead to increased child mortality and morbidity, increased adverse reactions, and the development of drug resistance [4]. Even though the reasons for the high substandard nature of the medicines were not determined, the high failure rates could be attributed to poor manufacturing and possibly poor storage of the essential medicines in the supply chain. The rate of decomposition of the API in medicines is accelerated in high temperature and humidity conditions [6]. There is therefore the need for manufacturers of these paediatric pharmaceutical formulations to adhere strictly to current good manufacturing practices (cGMP). Also, manufacturers, wholesalers, and retailers of children's medicines should adhere to the recommended storage conditions to reduce the incidence of physical and chemical degradation of the products.

The microbial quality of the paediatric formulations studied was generally good. There is however the need for continuous evaluation of the microbial quality of paediatric syrups and suspensions since microbial and fungal growth in such dosage forms increases with time and can threaten the life of immunocompromised children [24]. The stability of pH of a liquid formulation over time provides an indication of the microbial quality and chemical stability of the product. Poor storage conditions and the formulation of unstable products can have adverse effects on pH as well as on the physical and chemical stability of children's medicines.

In Ghana, the Food and Drugs Authority (FDA), formerly the Food and Drugs Board, was established in 1997 under the Food and Drugs Law, 1992 (PNDCL 305B). The FDA is the medicines regulatory authority (MRA) of Ghana with the objective of providing and enforcing standards for the sale of food, herbal medicinal products, cosmetics, drugs, medical devices, and household chemical substances. The presence of so many unregistered children's medicines in the study area denotes inadequate regulatory and surveillance activities of the FDA, Ghana. The absence of PML numbers on some products could be due to neglect associated with poor product labelling by the manufacturers involved as none of such products was found to be counterfeit. To mitigate the menace of unlicensed/unregistered medicines in Ghana, the many entry points of the country's borders should be properly manned with adequate trained FDA, Ghana personnel to stem the infiltration of unregistered and counterfeit medicines from neighboring countries into Ghana.

The menace of poor quality children's medicines in Ghana and other developing and resource-poor countries can be reduced through the strengthening of the national medicines regulatory authorities (MRAs) and enhancement in the quality of medicines manufacturing. The MRAs could be strengthened through the provision of adequate financial and logistical resources; enforcement of existing legislation; provision of medicines analytical equipment/laboratories; recruitment of adequate qualified staff; and enhancement of conditions of service to attract and retain qualified staff. Also, the quality of medicines produced by medicines manufacturers in resource-poor countries could be enhanced through the recruitment and retention of qualified manufacturing staff, for example, pharmaceutical technologists, analysts, quality control personnel; adherence to quality assurance protocols, and adequate regulatory control.

In Ghana, licensed chemical shops, unlike pharmacies, are medicine outlets which are authorized to engage in the retail supply of only over-the-counter medicines or class C medicines. The availability of some prescription-only children's medicines in some licensed chemical shops is therefore a gross abuse of the relevant regulations by proprietors of such outlets and an indication of regulatory failure by the Pharmacy Council, Ghana, the statutory regulatory body established by the Pharmacy Act, 1994 (Act 489). The major function of the Pharmacy Council is to "secure in the public interest the highest standards in the practice of pharmacy" in Ghana and its mission is to "secure the highest level of pharmaceutical care by ensuring competent pharmaceutical care providers who practice within agreed standards and are accessible to the whole population." The Pharmacy Council should enhance its monitoring activities of all medicine outlets in the country to ensure compliance with existing rules, regulations, and standards. It is also pertinent for the Food and Drugs Authority and the Pharmacy Council to collaborate and work together to enhance their medicines surveillance and regulatory activities to ensure that only licensed, good quality medicines are made available to the Ghanaian people and that pharmaceutical care providers are in compliance with existing standards and rules and regulations.

5. Conclusions

The results from the study clearly show that a significant proportion of the children's medicines available in the Ashanti Region, Ghana, are of poor quality. This has serious consequences on the health and general well-being of children in the region. Even though most of the medicines sampled passed the pH and microbial load tests, they also failed the content of API test and were thus of poor quality. Both locally manufactured and imported children's medicines studied demonstrated similar defective quality properties. Also, medicines sourced from the United Kingdom and India were similarly found to be of poor quality. There was no correlation between unlicensed children's medicines and product quality. The administration of poor quality medicines to children will cause treatment failures and increase drug resistance, leading to increased morbidity and mortality. The poor quality of the children's medicines could be attributed generally to inadequate quality assurance processes employed during manufacturing of the products. It is therefore recommended that manufacturers of children's medicines adhere strictly to good manufacturing practices to ensure the production of quality medicines.

https://doi.org/10.1155/2018/1494957

Conflicts of Interest

The authors declare that there are no conflicts of interest regarding the publication of this paper.

Acknowledgments

The authors are grateful to the Association of African Universities (AAU) for the award of a Small Grants for Dissertations and Theses to Grace Frimpong. They also gratefully acknowledge the management and staff of Aspee Pharmaceuticals Ltd., Ejisu, Ghana, for providing the analytical equipment for the study.

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[21] United States Pharmacopoeia and National Formulary. United States Pharmacopoeia XXIII: Rockville USP Convention Inc., 2013.

[22] L. Hartling, K. D. M. Wittmeier, P. Caldwell et al., "StaR child health: developing evidence-based guidance for the design, conduct, and reporting of pediatric trials," Pediatrics, vol. 129, no. 3, pp. S112-S117, 2012.

[23] World Health Organization, Counterfeit Drugs. Guidelines for the development of measures to combat counterfeit drugs, 2018, WHO/EDM.QSM/99.1. Geneva, WHO, 1999, http://apps.who .int/medicinedocs/pdf/h1456e/h1456e.pdf.

[24] G. F. M. Gad, R. A. I. Aly, and M. S. E.-D. Ashour, "Microbial evaluation of some non-sterile pharmaceutical preparations commonly used in the Egyptian market," Tropical Journal of Pharmaceutical Research, vol. 10, no. 4, pp. 437-445, 2011.

Grace Frimpong, (1,2) Kwabena Ofori-Kwakye (iD), (1) Noble Kuntworbe, (1) Kwame Ohene Buabeng, (3) Yaa Asantewaa Osei, (1) Mariam El Boakye-Gyasi, (1) and Ofosua Adi-Dako (iD)

(1) Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana

(2) Department of Pharmaceutical Sciences, Faculty of Medicine and Health Sciences, Kumasi Technical University, Kumasi, Ghana

(3) Department of Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana

(4) Department of Pharmaceutics and Microbiology, University of Ghana School of Pharmacy, Legon, Accra, Ghana

Correspondence should be addressed to Kwabena Ofori-Kwakye; koforikwakye@yahoo.com

Received 23 December 2017; Revised 2 April 2018; Accepted 11 April 2018; Published 21 May 2018

Academic Editor: Marcel Tanner
Table 1: Product characteristics of the essential children's
medicines investigated.

Product                 Labeled            Country of       Batch
and code                strength           manufacture      number

Ciprofloxacin
CPF1                  250 mg/5 ml              UK          0710069
CPF2                   250mg/5ml              India           --

Cotrimoxazole

CTX1                  125 mg/5 ml              UK          EXMT 002
CTX2                  125 mg/5 ml             India         XT 029
CTX3                  125 mg/5 ml             Ghana         0302R
CTX4                  125 mg/5 ml             Ghana         15012
CTX5                  125 mg/5 ml             Ghana        0250495

Metronidazole

MTZ1                  200 mgt/5 ml        South Africa      46159A
MTZ2                  200 mg/5 ml             Ghana         X-214
MTZ3                  200 mg/5 ml              UK          MTXT-002
MTZ4                  200 mg/5 ml             Ghana         0403R
MTZ5                  200 mg/5 ml             Ghana         15002
MTZ6                  200 mg/5 ml             Ghana        0260385

Amoxicillin

AMX1                  125 mg/5 ml              UK           676164
AMX2                  125 mg/5 ml              UK          13305001
AMX3                  125 mg/5 ml             Ghana         AS159
AMX4                  125 mg/5 ml             Ghana        0270435
AMX5                  125 mg/5 ml             Ghana         15009
AMX6                  125 mg/5 ml             Ghana         2305P

Flucloxacillin

F CXI                 125 mg/5 ml             India         150079
FCX2                  125 mg/5 ml             Ghana         2307R
FCX3                  125 mg/5 ml             Ghana        0390315
FCX4                  125 mg/5 ml             Ghana         15021

Cefuroxime

CFX1                  125 mg/5 ml             Ghana         4808R
CFX2                  125 mg/5 ml             India        BS-59001
CFX3                  125 mg/5 ml              UK          C703319
CFX4                  125 mg/5 ml             India           83
CFX5                  125 mg/5 ml              UK          STR44A00
CFX6                   125 mg/5 m             India        CFL-073

Artemether-
lumefantrine

ATL1               20 mg/120 mg/5 ml          India          0633
ATL2               20 mg/120 mg/5 ml          Ghana         LG-414
ATL3               20 mg/120 mg/5 ml          Ghana         2804R
ATL4               20 mg/120 mg/5 ml          India        3A09150

Mebendazole

MBZ1                  100 mg/5 ml            Belgium       DLB 3600
MBZ2                  100 mg/5 ml             Ghana         15001
MBZ3                  100 mg/5 ml             Ghana        0780165
MBZ4                  100 mg/5 ml             Ghana           12
MBZ5                  100 mg/5 ml             Ghana         M2002

Albendazole

ABZ1                  100 mg/5 ml             India         340960
ABZ2                  200 mg/5 ml             India         G4016
ABZ3                  100 mg/5 ml             India        W150828
ABZ4                  100 mg/5 ml             India         14328
ABZ5                  100 mg/5 ml             India         340953
ABZ6                  100 mg/5 ml             India        T140023
ABZ7                  100 mg/5 ml             India        L-564001
ABZ8                  200 mg/5 ml             India         331134

Griseofulvin

G F VI                125 mg/5 ml             India        GS 1401
GFV2                  125 mg/5 ml             India        5E 01045
GFV3                  125 mg/5 ml             Ghana          001

Ferrous
sulphate

FES1                   10 mg/5 ml             Ghana         VL 785
FES2                   75 mg/5 ml             India        2F140KE
FES3                  200 mg/5 ml             India        T140011

Multivitamin

                   2 mg/5 ml (Vit Bl,
MVM1               B2),2mcg/5ml (Vit          Ghana         AY 231
                   B3), 0.225 mg/5 ml
                        (Vit B6)

                  2 mg/5 ml (Vit Bl),
MVM2             1.2 mg/5 ml (Vit B3),        Ghana        0290158
                  0.2 mg/5 ml (Vit B6)

Folic acid

F LAI                 500 meg/5 ml            Ghana        0430025
FLA2                  500 meg/5 ml            Ghana         FO-035

Paracetamol

PCM1                  125 mg/5 ml              UK          AS 17120
PCM2                  125 mg/5 ml             Ghana        RNA2P018
PCM3                  125 mg/5 ml             Ghana         3609R
PCM4                  125 mg/5 ml             Ghana         10L319
PCM5                  125 mg/5 ml             Ghana         E 005
PCM6                  125 mg/5 ml             Ghana        0361865
PCM7                  125 mg/5 ml             Ghana         1008F

Ibuprofen

IBF1                  100 mg/5 ml              UK          IBXT-002
IBF2                  100 mg/5 ml             Ghana         1506P
IBF3                  100 mg/5 ml             Ghana          E001
IBF4                  100 mg/5 ml             India        IB4 001
IBF5                  100 mg/5 ml             Ghana        1030025

Product          Manufacturing    Expiry     FDA/PML
and code              date          date      number

Ciprofloxacin
CPF1                06/2015       05/2017      Yes
CPF2                06/2014       05/2017       No

Cotrimoxazole

CTX1                09/2014       08/2017       No
CTX2                02/2015       01/2018      Yes
CTX3                02/2015       02/2018       No
CTX4                08/2015       08/2018      Yes
CTX5                05/2015       04/2017      Yes

Metronidazole

MTZ1                12/2014       11/2016      Yes
MTZ2                03/2015       03/2017      Yes
MTZ3                10/2014       09/2017       No
MTZ4                03/2015       03/2017       No
MTZ5                04/2015       04/2018      Yes
MTZ6                07/2015       06/2017      Yes

Amoxicillin

AMX1                11/2013       11/2018       No
AMX2                08/2013       07/2016       No
AMX3                06/2015       04/2018      Yes
AMX4                05/2015       04/2017      Yes
AMX5                05/2015       05/2018      Yes
AMX6                05/2014       05/2016       No

Flucloxacillin

F CXI               01/2015       12/2017       No
FCX2                07/2015       07/2017      Yes
FCX3                09/2015       08/2017      Yes
FCX4                08/2015       08/2018       No

Cefuroxime

CFX1                08/2015       08/2017       No
CFX2                07/2015       06/2017      Yes
CFX3                10/2014       10/2016       No
CFX4                08/2015       07/2017       No
CFX5                08/2014       08/2016      Yes
CFX6                10/2015       10/2017      Yes

Artemether-
lumefantrine

ATL1                02/2014       02/2016      Yes
ATL2                02/2015       01/2017      Yes
ATL3                03/2016       03/2018       No
ATL4                01/2015       12/2017      Yes

Mebendazole

MBZ1                01/2014       12/2018       No
MBZ2                05/2015       05/2018       No
MBZ3                07/2015       06/2017       No
MBZ4                03/2015       03/2018      Yes
MBZ5                09/2014       08/2017       No

Albendazole

ABZ1                08/2014       07/2017       No
ABZ2                06/2014       05/2017      Yes
ABZ3                08/2015       07/2018      Yes
ABZ4                05/2014       04/2017      Yes
ABZ5                08/2014       07/2017      Yes
ABZ6                03/2014       02/2017       No
ABZ7                02/2014       01/2017      Yes
ABZ8                11/2013       10/2016       No

Griseofulvin

G F VI              01/2014       02/2016      Yes
GFV2                02/2015       01/2018      Yes
GFV3                05/2015       05/2018       No

Ferrous
sulphate

FES1                10/2015       09/2017      Yes
FES2                12/2014       11/2016       No
FES3                07/2014       07/2016       No

Multivitamin

MVM1                06/2015       05/2017      Yes

MVM2                02/2016       02/2017      Yes

Folic acid

F LAI               09/2015       11/2016       No
FLA2                11/2014       10/2016      Yes

Paracetamol

PCM1                02/2015       02/2018       No
PCM2                08/2015       08/2018      Yes
PCM3                09/2015       09/2018       No
PCM4                10/2013       09/2016      Yes
PCM5                10/2015       09/2018       No
PCM6                10/2015       09/2017      Yes
PCM7                08/2015       08/2018      Yes

Ibuprofen

IBF1                09/2014       08/2017       No
IBF2                06/2014       06/2017       No
IBF3                04/2015       04/2017       No
IBF4                09/2014       08/2017       No
IBF5                09/2014       08/2017      Yes

(a) CPF = ciprofloxacin suspension, CTX = cotrimoxazole suspension,
MTZ = metronidazole suspension, AMX = amoxicillin suspension, FCX =
flucloxacillin suspension, CFX = cefuroxime suspension, ATL =
Artemether-lumefantrine suspension, MBZ = mebendazole suspension,
ABZ = albendazole suspension, GFV = griseofulvin suspension, FES =
ferrous sulphate syrup, MVM = multivitamin syrup, FLA = folic acid
suspension, PCM = paracetamol syrup, and IBF = ibuprofen
suspension; (b) FDA = Food and Drugs Authority, Ghana; PML =p
manufacturing license; (c) the numbers indicated against a
particular product are different brands of the same drug.

Table 2: Results of content of API, pH, and microbial load of the
essential children's medicines investigated.

Product           Retention    * Content of     Remarks on      ** pH
and Code          time (min)      API (%)       content of
                                                  API (%)

+Ciprofloxacin

CFX1                 8.73          72.14           Failed       10.24
CFX2                 8.73          67.45           Failed       4.52

Cotrimoxazole

CTX1                 n/a       110.94/102.69       Failed       5.46
CTX2                 n/a       112.50/100.00       Failed       5.30
CTX3                 n/a       134.00/123.00       Failed       5.16
CTX4                 n/a        122.00/93.75       Failed       5.66
CTX5                 n/a       118.13/124.75       Failed       5.57
                                 (TMP/SMZ)

Metronidazole

MTZ1                 n/a           113.60          Failed       6.56
MTZ2                 n/a           91.50           Failed       5.42
MTZ3                 n/a           90.00           Failed       4.95
MTZ4                 n/a           95.60           Passed       6.28
MTZ5                 n/a           69.70           Failed       5.15
MTZ6                 n/a           106.70          Failed       6.06

+Amoxicillin

AMX1                 4.04          85.74           Passed       4.84
AMX2                 3.65          95.46           Passed       5.14
AMX3                 3.68          95.70           Passed       5.57
AMX4                 4.04          88.12           Passed       4.75
AMX5                 4.05          103.58          Passed       5.73
AMX6                 3.67          94.07           Passed       4.65

+Flucl
oxacillin

F CXI                2.37          53.84           Failed       4.75
FCX2                 2.36          35.10           Failed       4.47
FCX3                 2.36          60.01           Failed       4.78
FCX4                 2.36          46.12           Failed       5.13

Cefuroxime

CFX1                 n/a           45.43           Failed       3.18
CFX2                 n/a           74.90           Failed        4.1
CFX3                 n/a           58.60           Failed       4.06
CFX4                 n/a           96.70           Passed        3.7
CFX5                 n/a           135.00          Failed       4.75
CFX6                 n/a           90.10           Failed       4.98

+Artemether-
lumefantrine

ATL1              4.07/5.80     141.99/97.13       Failed       4.88
ATL2              3.30/14.21    84.82/125.85       Failed       3.84
ATL3              3.23/3.91     153.43/45.32       Failed       3.70
ATL4              3.35/14.18   209.67/127.68       Failed       2.88

Mebendazole

MBZ1                 n/a           111.97          Failed       5.02
MBZ2                 n/a           85.91           Failed       7.30
MBZ3                 n/a           93.60           Passed       5.07
MBZ4                 n/a           72.80           Failed       5.37
MBZ5                 n/a           89.00           Failed       5.46

Albendazole

ABZ1                 7.25          106.80          Passed       4.42
ABZ2                 7.26          102.60          Passed       4.08
ABZ3                 7.25          93.11           Passed       4.52
ABZ4                 7.25          95.59           Passed       4.50
ABZ5                 7.23          97.64           Passed       4.38
ABZ6                 7.23          103.37          Passed       4.29
ABZ7                 7.24          130.54          Failed       4.61
ABZ8                 7.28          188.45          Failed       4.60

Griseofulvin

GSV1                 n/a           105.10          Passed       4.96
GSV2                 n/a           70.85           Failed       4.96
GSV3                 n/a           94.31           Failed       5.67

Ferrous
sulphate

FES1                 n/a           97.50           Passed       6.07
FES2                 n/a           104.60          Passed       3.81
FES3                 n/a           106.70          Passed       5.44

+Multivitamin
MVM1                                                            2.50

(i) Vit B1           2.06          120.00          Failed
(ii) Vit B2          6.84          25.33           Failed
(iii) Vit B3         2.74          113.68          Failed
(iv) Vit B6          1.97          88.16           Failed

MVM2                                                            2.69

(i) Vit BI           2.75          99.41           Passed
(ii) Vit B2           -              --              -
(iii) Vit B3         3.17          129.7           Failed
(iv) Vit B6          1.97          12.58           Failed

+Folic acid

F LAI                3.83          71.40           Failed       3.59
FLA2                 3.83          68.38           Failed       4.93

Paracetamol

PCM1                 n/a           89.00           Failed       4.92
PCM2                 n/a           97.40           Passed       4.17
PCM3                 n/a           108.00          Failed       4.10
PCM4                 n/a           106.80          Failed       4.34
PCM5                 n/a           101.70          Passed       4.71
PCM6                 n/a           102.80          Passed       5.18
PCM7                 n/a           105.40          Failed       7.20

+Ibuprofen

IBF1                19.73          98.48           Passed       4.27
IBF2                19.56          100.97          Passed       4.78
IBF3                20.34          99.28           Passed       5.88
IBF4                19.59          119.87          Failed       5.62
IBF5                20.43          99.24           Passed       4.40

Product           Remarks    Microbial
and Code           on pH        load

+Ciprofloxacin

CFX1               Failed      Passed
CFX2               Passed      Passed

Cotrimoxazole

CTX1               Passed      Passed
CTX2               Passed      Passed
CTX3               Passed      Passed
CTX4               Passed      Passed
CTX5               Passed      Passed

Metronidazole

MTZ1               Passed      Passed
MTZ2               Passed      Passed
MTZ3               Passed      Passed
MTZ4               Passed      Passed
MTZ5               Passed      Passed
MTZ6               Passed      Passed

+Amoxicillin

AMX1               Passed      Passed
AMX2               Passed      Passed
AMX3               Passed      Passed
AMX4               Passed      Passed
AMX5               Passed      Passed
AMX6               Passed      Passed

+Flucl
oxacillin

F CXI              Passed      Passed
FCX2               Passed      Passed
FCX3               Passed      Passed
FCX4               Passed      Passed

Cefuroxime

CFX1               Failed     AFailed
CFX2               Passed      Passed
CFX3               Passed      Passed
CFX4               Passed      Passed
CFX5               Passed      Passed
CFX6               Passed      Passed

+Artemether-
lumefantrine

ATL1               Passed      Passed
ATL2               Failed      Passed
ATL3               Failed      Passed
ATL4               Failed      Passed

Mebendazole

MBZ1               Passed      Passed
MBZ2               Failed      Passed
MBZ3               Passed      Passed
MBZ4               Passed      Passed
MBZ5               Passed     AAFailed

Albendazole

ABZ1               Failed      Passed
ABZ2               Failed      Passed
ABZ3               Passed      Passed
ABZ4               Passed      Passed
ABZ5               Failed      Passed
ABZ6               Failed      Passed
ABZ7               Passed      Passed
ABZ8               Passed      Passed

Griseofulvin

GSV1               Failed      Passed
GSV2               Failed      Passed
GSV3               Passed      Passed

Ferrous
sulphate

FES1               Passed      Passed
FES2               Failed      Passed
FES3               Passed      Passed

+Multivitamin
MVM1               Passed      Passed

(i) Vit B1
(ii) Vit B2
(iii) Vit B3
(iv) Vit B6

MVM2               Passed      Passed

(i) Vit BI
(ii) Vit B2
(iii) Vit B3
(iv) Vit B6

+Folic acid

F LAI              Failed      Passed
FLA2               Failed      Passed

Paracetamol

PCM1               Passed      Passed
PCM2               Passed      Passed
PCM3               Passed      Passed
PCM4               Passed      Passed
PCM5               Passed      Passed
PCM6               Passed      Passed
PCM7               Failed      Passed

+Ibuprofen

IBF1               Passed      Passed
IBF2               Failed      Passed
IBF3               Failed      Passed
IBF4               Failed      Passed
IBF5               Passed      Passed

(a) + denotes samples analysed by high performance liquid
chromatography, otherwise samples were analysed by ultraviolet
spectrophotometry; (b) TMP = trimethoprim; SMZ = sulphamethoxazole;
(c) * Acceptance criteria: ciprofloxacin suspension (98-102%),
co-trimoxazole suspension (TMP & SMZ: 92.5-107.5%), metronidazole
suspension (95-105%), amoxicillin suspension (80-120%),
flucloxacillin suspension (80-120%), cefuroxime suspension
(95-105%), artemether-lumefantrine (90-110%), mebendazole
suspension (90-110%), albendazole suspension (90-110%),
griseofulvin suspension (95-105%), ferrous sulphate syrup
(95-110%), Vitamins Bl, B2, B3 and B6 (90-106%, 90-110%, 95-105%
and 90-110%, respectively), folic acid syrup (90-110%), paracetamol
syrup (95-105%), ibuprofen syrup (95-105%); (d) "Acceptance
criteria: ciprofloxacin suspension (3.0-4.5), co-trimoxazole
suspension (5.0-6.5), metronidazole suspension (5.0-6.5),
amoxicillin suspension (4.0-7.0), flucloxacillin suspension
(4.0-7.0), cefuroxime suspension (3.5-7.0), artemether-lumefantrine
(4.5-6.8), mebendazole suspension (4.5-5.5), albendazole suspension
(4.5-5.5), griseofulvin suspension (5.5-7.5),: ferrous sulphate
syrup (5.2-6.5), multivitamin syrup (2.5-4.0), folic acid
suspension (5.2-6.50), paracetamol syrup (4.0-6.9), ibuprofen
suspension (3.6-4.6); (e) ^ Staphylococcus attretts was isolated;
(f) ^^ Total aerobic microbial count of 1012 cfu/ml, exceeding the
BP (2013) limit of <1000 cfu/ml.

Table 3: Summary results of the quality of essential children's
medicines investigated based on content of API, pH, and microbial
load.

Type of essential         Number of    Content
children's medicine       samples      of API       Fail
                          analysed     Pass

Ciprofloxacin             2            0 (0.0)      2 (100.0)
Cotrimoxazole             5            0 (0.0)      5 (100.0)
Metronidazole             6            1 (16.7)     5(83.3)
Amoxicillin               6            6 (100.0)    0 (0.0)
Flucloxacillin            4            0 (0.0)      4 (100.0)
Cefuroxime                6            1 (16.7)     5 (83.3)
Artemether-lumefantrine   4            0 (0.0)      4 (100.0)
Mebendazole               5            1 (20.0)     4 (80.0)
Albendazole               8            6 (75.0)     2 (25.0)
Griseofulvin              3            1 (33.3)     2 (66.7)
Ferrous sulphate          3            3 (100.0)    0(0.0)
Multivitamin              2            0 (0.0)      2 (100.0)
Folic acid                2            0 (0.0)      2 (100.0)
Paracetamol               7            3 (42.9)     4 (57.1)
Ibuprofen                 5            4(80.0)      1 (20.0)

Total                     68           26 (38.2)    42 (61.8)

Type of essential         pH                      Microbial load
children's medicine       Pass        Fail        Pass        Fail

Ciprofloxacin             1 (50.0)    1 (50.0)    2 (100.0)   0 (0.0)
Cotrimoxazole             5 (100.0)   0 (0.0)     5 (100.0)   0 (0.0)
Metronidazole             6 (100.0)   0 (0.0)     6 (100.0)   0 (0.0)
Amoxicillin               6 (100.0)   0 (0.0)     6 (100.0)   0 (0.0)
Flucloxacillin            4 (100.0)   0(0.0)      4 (100.0)   0 (0.0)
Cefuroxime                5(83.3)     1 (16.7)    5 (83.3)    1 (16.7)
Artemether-lumefantrine   1 (25.0)    3 (75.0)    4 (100.0)   0 (0.0)
Mebendazole               4 (80.0)    1 (20.0)    4 (80.0)    1 (20.0)
Albendazole               4 (50.0)    4 (50.0)    8 (100.0)   0 (0.0)
Griseofulvin              1 (33.3)    2 (66.7)    3 (100.0)   0 (0.0)
Ferrous sulphate          2 (66.7)    1 (33.3)    3 (100.0)   0 (0.0)
Multivitamin              2 (100.0)   0(0.0)      2 (100.0)   0 (0.0)
Folic acid                0 (0.0)     2 (100.0)   2 (100.0)   0 (0.0)
Paracetamol               6 (85.7)    1 (14.3)    7 (100.0)   0 (0.0)
Ibuprofen                 2 (40.0)    3 (60.0)    5 (100.0)   0 (0.0)

Total                     49 (72.1)   19 (27.9)   66 (97.1)   2 (2.9)

Values for pass and fail provide the nugory and the number in
parenthesis is the percentage of pass or fail.

Table 4: Summary results of the quality of locally manufactured and
foreign (imported) essential children's medicines investigated.

Source of essential      Number of samples   Content of API (%)
children's medicines     analyzed            Pass        Fail

Locally manufactured     36                  13 (36.1)   23 (63.9)
Foreign-produced         32                  13 (40.6)   19 (59.4)

Source of essential      pH                      Microbial load
children's medicines     Pass        Fail        Pass         Fail

Locally manufactured     27 (75.0)   9 (25.0)    34 (94.4)    2 (5.6)
Foreign-produced         22 (68.8)   10 (31.2)   32 (100.0)   0 (0.0)

Values for pass and fail provide the number of samples in each
category and the number in parenthesis is the percentage pass or fail.

Table 5: Summary results of the quality of sampled essential children's
medicines with and without Food and Drugs Authority, Ghana, and/or
Product Manufacturing License (PML) numbers.

Registration status of   Number of    Content of API (%)      pH
essential children's     samples
medicines                 analyzed      Pass        Fail        Pass

FDA/PML number               36       12 (33.3)   24 (66.7)   27 (75.0)
No registration number       32       14 (43.7)   18 (56.3)   22 (68.8)

Registration status of               Microbial load
essential children's
medicines                  Fail         Pass        Fail

FDA/PML number           9 (25.0)    36 (100.0)    0 (0.0)
No registration number   10 (31.2)   30 (93.7)     0 (6.3)

Table 6: Summary results of the quality of sampled essential
children's medicines based on country of manufacture.

Country of manufacture   Number of    Content of API (%)      pH
of essential             samples      Pass        Fail        Pass
children's medicines     analyzed

Ghana                        36       13 (36.1)   23 (63.9)   27 (75.0)
India                        21       10 (47.6)   11 (52.4)   12 (57.1)
United Kingdom               9         3(33.3)    6 (66.7)    8 (88.9)
Belgium                      1         0 (0.0)    1 (100.0)   1 (100.0)
South Africa                 1         0 (0.0)    1 (100.0)   1 (100.0)

Country of manufacture               Microbial load
of essential             Fail        Pass         Fail
children's medicines

Ghana                     9(25.0)    34 (94.4)    2 (5.6)
India                    9 (42.9)    21 (100.0)   0 (0.0)
United Kingdom           1 (11.1)    9 (100.0)    0 (0.0)
Belgium                   0(0.0)     1 (100.0)    0 (0.0)
South Africa              0(0.0)     1 (100.0)    0 (0.0)
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Title Annotation:Research Article
Author:Frimpong, Grace; Ofori-Kwakye, Kwabena; Kuntworbe, Noble; Buabeng, Kwame Ohene; Osei, Yaa Asantewaa;
Publication:Journal of Tropical Medicine
Geographic Code:9INDI
Date:Jan 1, 2018
Words:8740
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