Adulteration in the context of herbal medicines is the intentional introduction of extraneous ingredients into a product. The objects of such adulteration include drugs for clinical effectiveness, industrial dyes to modify appearance and substitution to enhance quantities. Historical reviews demonstrate that adulteration is an old vice as recorded by Dioscorides in Materia Medica, Pliny the Elder in Naturalis Historica and Pomet’s, A Complete History of Drugs. In the 17th century, King James granted a separate charter to the Apothecaries Guild to distinguish them from general merchants of the Grocers Guild. He remarked that ‘the business of the apothecary is a mystery’, hence less likely to be influenced by adulteration. The desire to guard against adulteration and sophistication led to the development of specific legislation and pharmacopoeias in various jurisdictions.
The emergence of the COVID-19 pandemic has propelled the use of alcohol-based hand sanitizers to the fore as a SARS-CoV-2 control measure. To be effective these products must comply with relevant quality parameters such as alcohol concentration, methanol limits and purity. The current study was designed to determine the quality of alcohol-based hand sanitizer products in the Nairobi metropolitan area. For this purpose, 74 commercially marketed samples were collected and subjected to analysis by gas chromatography. Only three samples (4.1%) complied with the regulatory specifications for alcohol content, methanol limits and pH. Five samples (6.8%) complied with the specification for alcohol content but did not meet methanol or pH limits. A total of 44 (59.5%) samples had methanol levels that exceeded threshold limits. Eleven samples (14.9%) were found with methanol substitution (i.e., methanol, instead of ethanol or isopropanol, was the main alcohol component). The results show that users of alcohol-based hand sanitizers are being exposed to substandard and falsified products which in addition to being non-efficacious pose harm due to unacceptable levels of toxic impurities. Regular, routine post-market surveillance is needed to prevent such products from reaching the market.
High performance thin layer chromatography (HPTLC), high performance liquid chromatography (HPLC), column chromatography and Fourier transform infrared spectrophotometer (FTIR) analytical methods were used for the identification and analysis of phosphodiesterase type-5 (PDE-5) inhibitors in 50 randomly selected aphrodisiac herbal samples. Results showed that 27 samples were found to contain one or two or all three synthetic PDE-5 inhibitors representing 54% of the analyzed samples. The FTIR spectral characteristics obtained from the isolated compounds were found to be in conformity with the FTIR spectral characteristics obtained from sildenafil, tadalafil and vardenafil reference standards respectively. The results indicate that patients who use these herbal sexual enhancers with the notion that they are safe and natural, are likely to be exposed to serious health risks related to safety and quality of the herbal products. There is therefore need for additional effort to effectively regulate the herbal medicines in order to protect the consumers from emerging threat of adulteration.
During the period 2011-2015, the Drug Analysis and Research Unit (DARU) analyzed 1972 drug samples. The samples consisted of 21.5% locally manufactured and 78.2% imported products while the origin of 0.3% of products was indeterminate. Samples were subjected to compendial and/or in-house analytical specifications. The overall non-compliance rate was 4.5% comprising 2.5% local products and 2.0% imports. High failure rates were recorded for uterotonics (37.5%), hemostatics (33%), anthelmintics (17%) and anticancers (10.5%) while ophthalmic, immunomodulatory, musculoskeletal and endocrine drugs all complied with the quality acceptance criteria. Erectile dysfunction drugs, received by the laboratory for the first time, all complied with specifications. The results obtained demonstrate an improvement in the quality of samples submitted to DARU when compared to previous performance.
A simple, sensitive, accurate and precise high-performance liquid chromatography (HPLC) method for determination of artemisinin in crude plant material was developed and validated. Optimal separation of artemisinin from matrix components in the plant extracts was achieved using a Waters XTerra® RP18, 5 μm, 250 × 4.6 mm column, maintained at 40 °C, a mobile phase consisting of 0.05 M potassium phosphate buffer, pH 6.0 - acetonitrile (60:40) containing 5 mM hexane sulfonate in isocratic flow. The mobile phase flow rate was 1.0 ml/min while elution was monitored at 216 nm. The method satisfied the International Conference on Harmonization (ICH) validation criteria for linearity, accuracy, precision and sensitivity. The developed method is applicable in routine quality control of Artemisia annua crude extracts. Key words: Artemisia annua, artemisinin content, crude extract
Older adults’ level of expectations about pharmaceutical care was assessed. A cross-sectional survey was conducted among 196 patients attending the outpatient pharmacy of Olabisi Onabanjo University Teaching Hospital, Ogun State, Nigeria. An 18-item pretested questionnaire was self-administered for four weeks. Analysis was done with GraphPad Instat. P <0.05 was considered significant. Expectation score ranged from 12 to 60. The response rate was 65.8% (129/196). Nearly a half of the respondents (63, 48.8%) were 60-69 years old; seventy-three (56.6%) were females; 50 (38.8%) were businessmen/women; 104 (80.6%) were married; 61 (47.3%) had tertiary education; and 51 (39.5%) had an income of ˃N49, 999. Overall mean (SD) of expectations was 3.91 (0.96) with a score of 46.92 (78.2%). ‘Expectation to dispense prescriptions accurately’ had the highest (53.7), score. Respondents between 50-59 years of age, females, the unemployed, single, secondary educated and those with incomes of ₦40, 000- ₦49, 999 had higher expectations with no significant association. Keywords: Older adults, expectations, operational research.
In recent times, pharmacists’ roles have expanded beyond just dispensing activities to include other patient-oriented services. We aimed to evaluate the level of pharmacist involvement in patient care optimization and their relationship with other caregivers in the management of hypertensive patients. A non-randomized study was carried out among pharmacists. Data was collected using a modified questionnaire, measuring pharmacist role, extent of involvement in patient care and the relationship with other caregivers. Data obtained were entered into Microsoft excel, SPSS software version 23 and GraphPad in stat for descriptive and inferential statistics. Out of 155 Pharmacists, 80 (51.9%) were females, 76 (49.4%) had practiced for 1-5 years and 81 (52.6%) practiced in a community setting. Eight five (55.2%) were most of the time involved in identifying, resolving and preventing drug therapy problems, 79 (51.3%) were always providing adequate information on hypertensive therapy, 64 (41.6%) were most of the time involved in developing therapeutic care plans. Inferential statistics showed that gender, qualifications, years of experience, practice setting, affected pharmacists’ involvement in therapeutic care planning. Community pharmacists were more involved in hypertensive patients counseling and therapeutic care planning (p<0.05). More than half of the respondents were involved in newer roles of pharmaceutical services. In addition, Pharmacists with additional qualifications and those with more years of service had a better relationship with other healthcare professionals. Key words: Hypertensive therapy, therapeutic care planning, patients counseling.
A Taguchi-based design of experiments was employed to optimize fast-dissolving tablet formulations of domperidone using three starches from banana (Musa acuminata), cassava (Manihot esculenta) and Chinese yam (Dioscorea rotundata). The starches were modified by carboxymethylation (degree of substitution 0.32±0.02) and used as superdisintegrants (2–8%w/w), in comparison to sodium starch glycolate (SSG). Effects of two variables (superdisintegrant type and superdisintegrant concentration) at four levels on crushing strength-friability ratio (CSFR), disintegration time (DT) and dissolution time to 80% drug release (t80) were analyzed. Domperidone tablets containing carboxymethylated starches had higher CSFR values (p<0.05) than SSG while DT and t80 decreased with concentration. Taguchi’s delta values and analysis of variance showed that superdisintegrant type had greater influence on CSFR and t80 while superdisintegrant concentration had greater influence on DT. Optimum fastdissolving domperidone tablets were obtained using 2% w/w Chinese yam starch (CSFR= 251.25±16.32) and 8% w/w SSG (DT = 0.42±0.03 min; t80 = 0.50±0.02 min).
Inadequate counseling by pharmacists on medication–related issues could cause therapeutic failure. This study examined extent of counseling by community pharmacists; appraised their actual counseling activities; and identified barriers to counseling. The study utilized two approaches: (i) an observational cross-sectional survey of 198 randomly selected community pharmacists and (ii) stimulated-patient (SPs) method to appraise counseling practices in 106 pharmacies. Data were summarized with appropriate statistics at p<0.05. Extent of counseling was moderate (60%) and gaps exist between SPs and community pharmacists’ assessments of counseling practices. Significant associations exist between years in practice as community pharmacists (χ2=31.81, p=0.021), their ages, (χ2=55.48, p=0.043, academic qualifications (χ2=26.79, p=0.001) with extent of counseling. Barriers to counseling include absence of patient medication history (84.6%), insufficient space in pharmacies (79.6%), and training of pharmacists (78.2%). Level of counseling was suboptimal but could be improved if community pharmacists embark on continuous training to acquire more counseling skills.
The content and stability of phenols, flavonoids, saponins and alkaloids in Ocimumgratissimum upon exposure to sunlight, red and ultra-violet (UV) radiation over aperiod of 168 h was investigated as well as the effect of irradiation on its antiradicaland antimicrobial activities. Total phenolic, flavonoids, saponins and alkaloid contentswere determined using standard methods while antiradical and antimicrobial analyseswere determined using 1,1-diphenyl-2-picrylhydrazyl and agar diffusion methods,respectively. Exposure to sunlight significantly increased (p<0.05) the total phenolicand alkaloid contents. Ultra-violet and sun light significantly decreased the totalflavonoid and saponin content, while all the three forms of radiation significantlyincreased antiradical activity as well as antimicrobial activity against Staphylococcusaureus. Red and UV light significantly increased the activity against S. aureus whileUV light increased activity against Escherichia coli. These findings suggestphotochemical instability with increased antiradical and antimicrobial activities of themethanol extracts of O. gratissimum after irradiation.
During the period 2011-2015, the Drug Analysis and Research Unit (DARU) analyzed 1972 drug samples. The samples consisted of 21.5% locally manufactured and 78.2% imported products while the origin of 0.3% of products was indeterminate. Samples were subjected to compendial and/or in-house analytical specifications. The overall non-compliance rate was 4.5% comprising 2.5% local products and 2.0% imports. High failure rates were recorded for uterotonics (37.5%), hemostatics (33%), anthelmintics (17%) and anticancers (10.5%) while ophthalmic, immunomodulatory, musculoskeletal and endocrine drugs all complied with the quality acceptance criteria. Erectile dysfunction drugs, received by the laboratory for the first time, all complied with specifications. The results obtained demonstrate an improvement in the quality of samples submitted to DARU when compared to previous performance.
Tuberculosis (TB) is a leading global cause of death and Kenya is among the top 20 countries with a high burden of the disease. Adherence to drugs used to treat the disease remains a crucial challenge towards the elimination of TB in Kenya. This study evaluated the rate and determinants of adherence to TB chemotherapy among adult patients attending health clinics in Nairobi between April and May 2017. A cross-sectional study was carried out in five randomly selected health centres in the Eastlands area of Nairobi involving 113 respondents who voluntarily consented and met the inclusion criteria. Data was collected using a researcher-administered questionnaire and the level of adherence assessed using participants self-reporting. From the results obtained, the participants exhibited low (11, 9.7%), medium (46, 40.7%), and high (56, 49.6%) adherence to TB therapy. Upon stepwise multivariate regression, the absence of a DOT supporter (p=0.039) and being on other medications (p=0.021) were significantly associated with non-adherence. It is inferred that DOT support enhanced adherence while co-morbidities decreased it.
The pharmacy profession has largely been quiescent with respect to vaccinations since time immemorial despite the critical role pharmacists play in other facets of healthcare. It is a well-established fact that pharmacists are more accessible to patients and health seekers in the community. Therefore, utilizing these versatile professionals in vaccination campaigns is likely to pay dividends both to the patients and government departments concerned with preventive health. Several countries have found it imperative to engage pharmacists in adult vaccination programs to achieve sufficient outreach and uptake among underserved populations.
Evaluation of the dissolution characteristics of drugs and their bioavailability can be conducted using an in vitro-in vivo correlation model. This can help in assessing the products available in the market for quality. Random testing in post-marketing surveillance would gauge the quality of the drug products. This study involved evaluation of three batches of controlled-release carbamazepine, Tegretol 200mg CR® tablets through dissolution tests from which a dissolution profile and blood concentration-time profile were derived. The in vitro-in vivo correlation simulation model was used to determine the Area Under Curve and Maximum Plasma Concentration and demonstrate bioequivalence of the product batches. The three batches exhibited similarity upon statistical analysis. The results also correspond to the values obtained in literature from bioequivalence studies. In vitro-in vivo correlation can thus be a useful instrument in pharmacovigilance for marketed drug products. Keywords: IVIVC, carbamazepine, bioavailability, pharmacokinetic parameters, dissolution
Alcohol based hand sanitizers are currently recommended for routine use in curbing the spread of the COVID-19 global pandemic. The present survey examined hand sanitizers marketed in Nairobi County with regards to product appearance, packaging, labelling and declared composition. Seventy-six samples were collected from five sites within the Nairobi metropolis - Central Business District, Kibera, Kilimani/Karen, Ngong and Thika. A wide range of non-conformities were observed for the criteria applied. Many samples had incomplete or missing label information, ingredient lists, cautionary warnings, Kenya Bureau of Standards (KEBS) standardization marks and permit numbers. Glycerin, fragrances and carbomers were the most common added ingredients. Poor formulation indicators such as haziness and phase separation were encountered in some products. The median price of the products was KES 250 (USD 2.36) per 100 ml although there was considerable variation in pricing of samples. None of the samples evaluated fully met all the standards for the parameters evaluated. Strict adherence to regulatory standards by producers of hand sanitizers is required to ensure that only compliant products are available on the market. Keywords: Hand sanitizer, alcohol, labelling, coronavirus, product quality
A simple, precise and accurate high-performance thin layer chromatographic (HPTLC) method was developed for the assay of mebendazole tablets. The separation was carried out by using HPTLC Silica gel 60 F254, (20 × 10 cm) with 250 μm thickness using ethyl acetate - ammonia 25% solution (25:0.5) as a mobile phase. HPTLC separation of the drug was followed by densitometry measurement at 310 nm. Mebendazole was satisfactorily resolved with retention factor (Rf) values of 0.51 ± 0.02. The method complied with International Conference on Harmonization acceptancecriteria for linearity (250 - 600 ng), precision, accuracy and specificity. Key words: HPTLC, method validation, assay, mebendazole
Neonatal sepsis is one of the most common causes of morbidity and mortality among infants in developing countries. The etiology and antimicrobial sensitivity patterns of bacteria responsible vary in different hospitals. This study identified bacteria in blood cultures of neonates with clinically suspected septicemia and demonstrated their susceptibility patterns. A longitudinal design targeting all neonates at Pumwani maternity hospital with suspected sepsis was used. One hundred and fifty neonates were selected using consecutive sampling. Data was collected using a questionnaire. Out of 150 blood specimens cultured, the cases of confirmed bacterial sepsis were 48(32%). Gram-positive pathogens predominated with Staphylococcus aureus and Streptococcus viridans accounting for 70%. The only Gram-negative isolates were E. coli and Klebsiella spp. Gram-positive isolates showed high sensitivity (above 80%) to meropenem, gentamicin, ceftriaxone, ofloxacin, and amikacin. Gram- negative organisms were generally resistant to penicillins and absolutely sensitive to meropenem, ceftazidime and ciprofloxacin. Keywords: Prevalence, Antimicrobial susceptibility, Neonatal sepsis
This study sought to determine the prescribing patterns and designed a treatment guideline for primary open-angle glaucoma (POAG) that is more cost-effective from a third-party payer’s perspective than the current practice based on real-world evidence. A retrospective descriptive study on eighty patients on POAG therapy for at least 3 months was carried out. A Stochastic Monte Carlo simulation model based on the outcome and cost was constructed with the aid of Vanguard studio 5.0. The input data were the prices of drugs and the proportion of the patient’s intraocular pressure outcome per month. Drug prices were entered as a uniform distribution while the outcome values were fixed. Sensitivity analysis was conducted by varying the input data by ±50%. The frequency of monitoring of patients with intraocular pressure was low (26.76%). The commonly prescribed drugs were the beta-blockers and carbonic anhydrase inhibitors. The cost per patient per annum was estimated at ($490.90) whereas the proposed guideline that results in the improved outcome will cost $50.19. Therefore, cost savings will be obtained by the proposed guideline for POAG per patient per annum. Key words: Cost-effectiveness, antiglaucoma, treatment guideline
