Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)

Background The aim of the study was to investigate the common deficiencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011–2017) for products that were finalised by the Pharmaceutical and Analytical pre-registration Unit. Methods There were 3148 finalised products in 2011–2017, 667 of which were sterile while 2089 were non-sterile. In order to attain a representative sample for the study, statistical sampling was conducted. Sample size was obtained using the statistical tables found in literature and confirmed by a sample size calculation with a 95% confidence level. The selection of the products was according to the therapeutic category using the multi-stage sampling method called stratified-systematic sampling. This resulted in the selection of 325 applications for non-sterile products and 244 applications for sterile products. Subsequently, all the deficiencies were collected and categorised according to Common Technical Document (CTD) subsections of the FPP section (3.2.P). Results A total of 3253 deficiencies were collected from 325 non-sterile applications while 2742 deficiencies were collected from 244 sterile applications. The most common deficiencies in the FPP section for non-sterile products were on the following sections: Specifications (15%), Description and Composition (14%), Description of the Manufacturing Process (13%), Stability Data (7.6%) and the Container Closure System (7.3%). The deficiencies applicable to the sterile products were quantified and the subsection, Validation and/or Evaluation (18%) has the most deficiencies. Comparison of the deficiencies with those reported by other agencies such as the USFDA, EMA, TFDA and WHOPQTm are discussed with similarities outlined. Conclusions The overall top five most common deficiencies observed by SAHPRA were extensively discussed for the generic products. The findings provide an overview on the submissions and regulatory considerations for generic applications in South Africa, which is useful for FPP manufacturers in the compilation of their dossiers and will assist in accelerating the registration process.

Assessment of COVID-19 vaccines acceptance in the Lebanese population: a national cross-sectional study

Background Vaccines have become the best weapon for epidemic prevention and control in the absence of standard approved effective therapies. However, skepticism about the vaccine efficacy and safety is constantly reported. To our knowledge, there has been no study assessing COVID-19 vaccine acceptance in Lebanon. The primary objective of this survey is to assess the COVID-19 vaccines’ acceptance and its related determinants in the Lebanese population. Methods A cross-sectional study was conducted in Lebanon from February 16 through February 25, 2021. Data was collected using an online questionnaire via social media platforms using the snowball technique. The questionnaire consisted of 47 questions related to sociodemographic and medical history, COVID-19 experience, knowledge, practice, and beliefs towards COVID-19 vaccines, including vaccines acceptance. Binary logistic regression was performed to identify factors associated with vaccine acceptance. Results A total of 1209 questionnaires were completed; around 63.4% have reported their acceptance for receiving the COVID-19 vaccine, while only 57% of participants registered themselves on the national platform. The multivariable analysis showed that a higher knowledge scale, living in an urban residential area, having hypertension, not having a food allergy, reporting a higher fear to experience COVID-19 infection, and receiving or wanting to receive influenza vaccine, were positive predictors of COVID-19 vaccines acceptance. Conclusions Our findings support the need to improve knowledge about COVID-19 infection and vaccination through education and awareness programs. Specifically residents of rural areas should be targeted to optimize COVID-19 vaccine acceptance among the Lebanese population.

The landscape of antibiotic usage among COVID-19 patients in the early phase of pandemic: a Malaysian national perspective

Background During the early phase of the COVID-19 pandemic, antibiotic usage among COVID-19 patients was noted to be high in many countries. The objective of this study was to determine the prevalence of antibiotic usage and factors affecting antibiotic usage among COVID-19 patients during the early phase of the COVID-19 pandemic in Malaysia. Methods This was a cross-sectional study that involved reviewing medical records of COVID-19 Malaysian patients aged 12 and above who were diagnosed with COVID-19 and received treatment in 18 COVID-19 hospitals from February to April 2020. A minimum sample of 375 patients was required. A binary logistic regression analysis was performed to determine factors associated with antibiotic usage. Variables with p < 0.05 were considered statistically significant. Results A total of 4043 cases were included for analysis. The majority of the patients (87.6%) were non-smokers, male (65.0%), and had at least one comorbidity (37.0%). The median age was 35 years (IQR: 38). The prevalence of antibiotic usage was 17.1%, with 5.5% of them being prescribed with two or more types of antibiotics. The most frequent antibiotics prescribed were amoxicillin/clavulanic acid (37.8%), ceftriaxone (12.3%), piperacillin/tazobactam (13.3%), azithromycin (8.3%), and meropenem (7.0%). Male patients (adjusted OR 1.53), who had a comorbidity (adjusted OR 1.36), associated with more severe stage of COVID-19 (adjusted OR 6.50–37.06), out-of-normal range inflammatory blood parameters for neutrophils, lymphocytes, and C-reactive protein (adjusted OR 2.04–3.93), corticosteroid use (adjusted OR 3.05), and ICU/HDU admission (adjusted OR 2.73) had higher odds of antibiotic use. Conclusions The prevalence of antibiotic usage in the early phase of the COVID-19 pandemic was low, with amoxicillin/clavulanic acid as the most common antibiotic of choice. The study showed that clinicians rationalized antibiotic usage based on clinical assessment, supported by relevant laboratory parameters.

The availability of priority medicines for children under 5 years in eThekwini, South Africa

Background Globally, an estimated 8.1 million children under 5 years die annually in developing countries. Ensuring essential medicines are accessible and affordable to the population is key to saving lives. This study investigated accessibility, availability and affordability of a basket of priority medicines for children under 5 years in public and private healthcare sector pharmacies in the eThekwini Metropolitan area in Durban, South Africa. Methods The WHO/HAI survey tool for assessing medicine prices, availability and affordability was adapted and employed for a basket of WHO Priority life-saving medicines for children under 5 years. Six district hospitals in the north, south and central eThekwini Metropolitan were selected as major facility reference points and for data collection and pharmacies within a 5 km radius from each major facility were also invited to participate in the study, as outlined in the WHO/HAI tool methodology. Of the 58 pharmacies selected, a total of 27 pharmacies from both private and public healthcare sectors agreed to participate and were surveyed, representing a 47% response rate. Data was analysed using Microsoft excel. Results All participating pharmacies (and hence the selected basket of priority medicines at these facilities) were deemed accessible. Overall the public sector had more medicines available on the shelf (averaging 64%) than the private sector (48%) which had more medicines available on order (84%). At least one medicine for each of the eight (8) conditions was available at both sectors which meant patients could be treated for these conditions. Medicines for priority conditions (except HIV, which was a 28-day course) were deemed affordable as these regimens were obtainable within a day’s wage for the lowest paid unskilled worker. Priority medicines for children under 5 years were more available and more affordable in the public sector. Conclusion The basket of WHO essential medicines for priority conditions for children under 5 years were accessible, available and affordable in the eThekwini Metropolitan areas. This was the first study in eThekwini to determine access to the WHO basket of priority medicines for children and can be scaled-up to a national study to provide a holistic comparison of these medicines in the country, and also for global comparison.

An exploratory assessment of the legislative framework for combating counterfeit medicines in South Africa

Background Substandard and Falsified (SF) medical products are a growing global concern. They harm the individual patient, the healthcare system and the economy. The World Health Organisation (WHO) has highlighted contributing factors globally: insufficient national medicine regulation, poor enforcement of existing legislation, weak stakeholder collaboration and the rise of novel viruses, such as the COVID-19. The study aimed to assess the legislative and policy framework and institutional relationships governing pharmaceuticals and anti-counterfeiting strategies. Methods The study was explorative and consisted of two phases. The first phase was between 2016 and 2017. It looked at document analysis (annual reports and press releases from 2011 to 2016) from government institutions involved in medicines regulation and law enforcement for SF seizure reports between 2004 and 2017. The second phase was between 2016 and 2018 through in-depth semi-structured interviews (seven in total) with selected stakeholders. Results First Phase—the data collected and reported by various departments was sporadic and did not always correlate for the same periods indicating, a lack of a central reporting system and stakeholder collaboration. In South Africa, counterfeiting of medicines mainly involves the smuggling of non-registered goods. The most common counterfeit items were painkillers, herbal teas, herbal ointments, while some were medical devices. Furthermore, Customs identified South Africa as a transhipment point for SF infiltration to neighbouring countries with less robust regulatory systems. Second phase—interview transcripts were analysed by thematic coding. These were identified as the adequacy of legislation, institutional capacity, enforcement and post-market surveillance, stakeholder collaboration and information sharing, and public education and awareness. Conclusion Document analysis and interviews indicate that South Africa already has a national drug policy and legislative framework consistent with international law. However, there is no specific pharmaceutical legislation addressing the counterfeiting of medicines. Law enforcement has also been complicated by poor stakeholder engagement and information sharing.

Polypharmacy and the occurrence of potential drug–drug interactions among geriatric patients at the outpatient pharmacy department of a regional hospital in Durban, South Africa

Background Polypharmacy is the administration of an excessive number of medicines and a significant irrational medicine use practice. Little is known about this practice in South Africa. This study aimed to determine the level of polypharmacy and potential drug–drug interactions amongst the geriatric patient population in a facility in South Africa. Method A cross-sectional retrospective prescription chart review for 250 geriatric patients was conducted at the outpatient pharmacy department of a regional hospital. Variables extracted included demographic information, diagnosis, type of prescriber contact, and polypharmacy. Potential drug–drug interactions were determined with web-based multi-drug interaction checkers. Results The average (SD) number of diagnosed clinical problems was 3.54 ± 1.26, with hypertension, diabetes mellitus, and heart disease occurring most frequently. The level of polypharmacy was high with patients receiving an average (SD) of 12.13 ± 4.25 prescribed medicines from 3032 prescribed medicines. The level of polypharmacy was highest within the age categories, 60–64, and 70–74 years of age, respectively. The level of potential drug–drug interactions was also high with an average (SD) of 10.30 ± 7.48 from 2570 potential drug interactions. The majority of these interactions were moderate (72.5%) and pharmacodynamic (73.2%) by nature of the clinical severity of action and mechanism of action, respectively. Polypharmacy and type of prescriber contact were statistically significant contributors to the occurrence of potential drug–drug interactions, (F (2, 249) = 68.057, p < 0.05). However, in a multivariate analysis of variables to determine the strength of the association, polypharmacy was determined to be the strongest contributor to the occurrence of potential drug–drug interactions (p < 0.05) when compared with the type of prescriber contact (p value = 0.467). Therefore, irrespective of the type of prescriber contact, polypharmacy increases the potential for drug interactions among the sampled patient population. Conclusion A comprehensive consideration of disease management guidelines, patient factors, and rational medicine review could be measurable strategies towards improving medicine use. This would also limit the occurrence of significant drug interactions among the geriatric patient population. A national study is required to determine if differences occur across hospitals and regions.

Pharmacists’ perceptions and attitudes toward drug importation into the State of Florida

Background The Department of Health and Human Services and the Food and Drug Administration released the Safe Importation Action Plan in July 2020 detailing methods to import medicines from Canada to combat increasing drug costs. In November 2020, Florida became the first state in the United States to create and propose an importation plan from Canada. This study examines the proposal submitted by Florida, Florida pharmacists’ perceptions of the program on patient safety, and Florida pharmacists’ thoughts on the pharmacy operational impact. Methods This was a cross-sectional study utilizing an electronic questionnaire sent to pharmacist members of the Florida Pharmacy Association. The survey incorporated closed-ended and open-ended questions. The results from the study were reported and analyzed through descriptive statistics, qualitative and quantitative data. Results Two-hundred and forty-four pharmacists responded to the survey. Of those respondents, 25% stated they had no knowledge about Florida’s drug importation plan. Less than 12% of respondents stated they would trust the safety and quality of imported medicines. Seventy percent of pharmacists expressed concerns regarding the changes required in pharmacy operations to increase medicine safety. About half of the respondents questioned whether this plan would promote cost-savings as intended. Conclusion Florida pharmacists believe the drug importation plan does not address all aspects of patient and medicine safety and expressed concerns regarding logistical operations of a pharmacy. This article highlights those concerns and acts as a summons to action.

Prevalence and predictors of self-medication among university students in Ethiopia: a systematic review and meta-analysis

Background Self-medication of medicines is a global issue particularly among those with good access and familiarity with medications such as university students. It has a significant impact on drug resistance and medication-related complications. There are limited and inconsistent studies on self-medication practices in Ethiopia. The aim of this systematic review and meta-analysis was to estimate the pooled prevalence of self-medication and its predictors among university students in Ethiopia. Methods A systematic review and meta-analysis was conducted to assess the prevalence and predictors of self-medication among university students in Ethiopia. Published articles from various electronic databases such as Medline, Hinari, Pub Med, Cochrane library, and the Web of Science were accessed. In addition, a manual search was performed including Google Scholar. Searching of articles were searched from January 1st to February 1, 2021. All observational studies conducted among university students in English language were included in the review. Two reviewers independently assessed articles before inclusion in the final review using the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) instrument for critical appraisal. The I2 test was used to assess heterogeneity. Since the included studies exhibited high heterogeneity, a random-effects model was used to estimate the pooled prevalence of self-medication. Results We found of 812 published and unpublished studies in our search. Finally, 31 full-text studies were reviewed, and 13 studies fulfilled the inclusion criteria and were included in the final meta-analysis. A total of 5377 study respondents from 13 studies were included in the study. The results of our study revealed that the pooled prevalence of self-medication among university students was 49.41% (95% CI 38.67%, 60.13%). The included studies had a sample size ranging from 250 to 792 with the lowest prevalence (19.87%) of self-medication from the University of Gondar, whereas the highest prevalence (77.01%) was recorded in a study conducted at Arsi University. From the pooled estimation, there was a significant association between self-medication and income (OR = 0.67: 95% CI 0.55–0.80). However, the association between self-medication and year of study and sex of participants was insignificant. Conclusion The pooled prevalence of self-medication among Ethiopian university students was relatively high compared to the current global health problem with an increase in anti-microbial resistance. Health professionals and concerned bodies should pay attention to raising awareness regarding the consequences of using medications without prescription.

Pharmaceutical policies and regulations of oral antiviral drugs for treatment of hepatitis C in Egypt—case study

Background There are limited studies on the role of efficient regulatory mechanisms in facilitating greater access to Hepatitis C virus (HCV) treatment. Evidence to support the importance of effective pharmaceutical policies and regulations in improving access to oral viral drugs towards the elimination of HCV is needed. This study aims to explore the adequacy of the implemented pharmaceutical policies and regulations in Egypt and their role to improve the availability and affordability of direct-acting antivirals (DAAs) to achieve universal access to the treatment of HCV. Methods The study adopts a qualitative methodology using desk review of regulatory and legislative information, literature review, and semi-structured interviews with key experts from the concerned governmental regulatory agencies, pharmaceutical industries, academic organizations, professional associations, civil society organizations, and clinicians who are working in researching treatments for hepatitis C. Findings The common DAAs available in the market are Daclatasvir, Sofosbuvir, and Sofosbuvir-based direct-acting antiviral combinations. Fast-track medicines registration pathway for marketing authorization of DAAs is used to reduce market access time frames. The pricing policies are supplemented using price negotiation to set up affordable prices that led to a reasonable price for DAAs. Using Trade-Related Aspects of Intellectual Property Rights (TRIPs) flexibility and local production of quality generics DAAs at lower prices. In addition, political will and collaboration between the government, civil society, and pharmaceutical companies improved patients' access to affordable DAAs and succeeding hepatitis C treatment in Egypt. Conclusions The study findings indicated that the implemented pharmaceutical policies and regulations have an immense role in enhancing access to medicines towards the elimination of hepatitis C in Egypt.

Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study

Background Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients’ quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital. Methods A before-and-after study was conducted from January 2016 to December 2018. All patients with a diagnosis of epilepsy and being treated at the investigated hospital were recruited and screened for eligibility and exclusion criteria. The primary outcome was the proportion of patients in good control of their epilepsy (with two seizures or less in a year). The secondary outcome was the number of patients maintaining optimized concentrations within the therapeutic range of carbamazepine (4–12 mg/L), phenytoin (10–20 mg/L), or valproic acid (50–100 mg/L). Collected data were analyzed using two proportions Z-test or Chi-square test. Results A total of 141 participants were enrolled in the study. While most patients were given lower prescribed daily doses than the recommendations from the World Health Organization, over 56% of the participants still experienced adverse drug effects. More than half of the patients received at least one pharmacists’ intervention, which increased by 25.0% the effectiveness of the therapy (p < 0.001) and by 14.6% the number of patients with optimized drug concentrations (p = 0.018). Conclusion Epilepsy management requires a multiple-stepped and comprehensive approach, with a focus on the health and safety of the patients. As part of the healthcare team, pharmacists need to engage at every stage to monitor the patient’s response and determine the most effective treatment with the fewest adverse drug reactions. Trial registration ClinicalTrials.gov, NCT04967326. Registered July 19, 2021—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04967326