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

Author(s):  
R. J. Moshoeshoe ◽  
G. M. Enslin ◽  
D. R. Katerere

Abstract 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.

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Megan Quinn ◽  
Colleen Cummings ◽  
Jill Stinson

Abstract Focus of Presentation Adverse Childhood Experiences (ACEs) have been shown to increase health risk behaviors and negative health outcomes. ACE surveys have been well documented in high income countries, but have been less widely used in low and middle-income countries. The current project included three phases and used a mixed methods study design to understand ACEs in Munsieville, South Africa. The first phase included focus groups to modify the World Health Organization’s ACE International Questionnaire (ACE-IQ) for cultural competence and relevance. The second phase included a community wide survey using the adapted ACE-IQ. The third phase closed the feedback loop and disseminated the findings to the community to identify steps to build a trauma-informed community. Findings Focus groups identified 23 questions and four response options for modification and two questions for deletion. Survey results (N = 917) showed ACEs are common in Munsieville: 53.7% had a guardian die, 30.1% lived with someone who abused substances or alcohol, 54.7% experienced emotional abuse, 41.4% physical abuse, 11.5% reported sexual abuse. Most people did not report their abuse (74.6%). Community violence was common with 75.3% witnessing someone being beaten up and 58.7% witnessing someone being stabbed or shot. Conclusions/Implications The community recommended providing training on trauma, creating a center that would serve as a safe, centralized location for services, and identifying key stakeholders and partners in the community to build a trauma-informed system of care. Key messages The mixed methods approach proved valuable to understand and describe the prevalence of ACEs, provide feedback to the community, and determine community driven next steps.


Author(s):  
Lesja Kosmii

Goal. The purpose of this work is to analyze the norms of the current labor legislation regarding the regulation of the relations between the employee and the employer in the introduction of any restrictions and anti-epidemic measures in the conditions of national quarantine and prevention in such conditions of violations of labor rights of employees. It is important that during the course of the COVID-19 coronary pandemic measures, they were not only effective but also violated human rights, including work. Method. The methodology includes a comprehensive analysis and generalization of available scientific and theoretical material, experience of foreign countries and formulation of relevant conclusions and recommendations. During the research the following methods of scientific knowledge were used: terminological, comparative, functional, system-structural, logical-normative. Results. During the research it was found that the Ukrainian legislature, including foreign experience, was able to respond promptly to the quarantine situation by adopting anti-crisis laws, which did not neglect labor legislation. This is understandable, because in connection with the announcement of quarantine in the whole territory of Ukraine, employers had to make personnel decisions, and the current legislative framework did not clearly regulate the issues that arose. Scientific novelty. The study found that the updating of labor legislation in the area of labor relations regulation during the national quarantine period allows the employer to use certain forms of labor organization, in which the basic labor rights and guarantees of employees can be preserved. Practical importance. The results of the study can be used in law-making and law enforcement activities, as well as by employers in regulating labor relations with employees during the quarantine period.


Mousaion ◽  
2019 ◽  
Vol 36 (2) ◽  
Author(s):  
Nkholedzeni Sidney Netshakhuma

This study was conceptualised in order to assess the appraisal, disposal and transfer of archival records from the Mpumalanga Provincial Government (MPG) to the Mpumalanga Provincial Archives (MPA) for the period from 1994 to 2013. The study’s specific objective was to investigate the transfer process of archival records in terms of the Mpumalanga Archives Act, No. 14 of 1998. The study used a qualitative method through document analysis, interviews and observation. The sample for the study comprised the MPG and municipality records managers. The Mpumalanga provincial archivists were also interviewed as the custodians of the MPA. The key findings revealed that the MPG and the municipality did not comply with the Mpumalanga Archives Act, No. 14 of 1998 in terms of transferring records with archival value to the MPA as stipulated by the act. This has adverse implications for efficient administration of records in the country.  


Children ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. 133
Author(s):  
Perpetua Modjadji ◽  
Mpinane Pitso

Tobacco and alcohol use among mothers is associated with numerous adverse consequences for affected offspring, including poor growth and development. This study determined the association between maternal tobacco and alcohol use, and malnutrition, among infants aged ≤ 12 months (n = 300), in selected health facilities situated in Gauteng, South Africa. Data on alcohol and tobacco use were collected using a validated questionnaire, in addition to mothers’ socio-demographic characteristics and obstetric history. Stunting (low height/length-for-age), underweight (low weight-for-age) and thinness (low body mass index-for-age) were calculated using z-scores based on the World Health Organization child growth standards. The association of tobacco and alcohol use with stunting, underweight and thinness was analysed using logistic regression analysis. The results showed a mean age of 29 years (24.0; 35.0) for mothers and 7.6 ± 3 months for infants, and over half of the mothers were unemployed (63%). Approximately 18.7% of mothers had used tobacco and 3% had used alcohol during pregnancy. The prevalence of current tobacco and alcohol use among mothers were estimated at 14.3% and 49.7%, respectively, and almost three-quarters (67.3%) of them were still breastfeeding during the study period. Stunting (55%) was the most prevalent malnutrition indicator among infants, while underweight was 41.7%, and thinness was 22%. Current tobacco use was associated with increased odds of being thin [OR = 2.40, 95% CI: 1.09–5.45), and after adjusting for confounders, current alcohol use was associated with the likelihood of being underweight [AOR = 1.96, 95% CI: 1.06–3.63] among infants. Future prospective cohort studies that examine growth patterns among infants who are exposed to maternal tobacco and alcohol use from the intrauterine life to infancy are necessary to inform, partly, the public health programmes, to reduce malnutrition among children.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Saiendhra Vasudevan Moodley ◽  
Muzimkhulu Zungu ◽  
Molebogeng Malotle ◽  
Kuku Voyi ◽  
Nico Claassen ◽  
...  

Abstract Background Health workers are crucial to the successful implementation of infection prevention and control strategies to limit the transmission of SARS-CoV-2 at healthcare facilities. The aim of our study was to determine SARS-CoV-2 infection prevention and control knowledge and attitudes of frontline health workers in four provinces of South Africa as well as explore some elements of health worker and health facility infection prevention and control practices. Methods A cross-sectional study design was utilised. The study population comprised both clinical and non-clinical staff working in casualty departments, outpatient departments, and entrance points of health facilities. A structured self-administered questionnaire was developed using the World Health Organization guidance as the basis for the knowledge questions. COVID-19 protocols were observed during data collection. Results A total of 286 health workers from 47 health facilities at different levels of care participated in the survey. The mean score on the 10 knowledge items was 6.3 (SD = 1.6). Approximately two-thirds of participants (67.4%) answered six or more questions correctly while less than a quarter of all participants (24.1%) managed to score eight or more. A knowledge score of 8 or more was significantly associated with occupational category (being either a medical doctor or nurse), age (< 40 years) and level of hospital (tertiary level). Only half of participants (50.7%) felt adequately prepared to deal with patients with COVD-19 at the time of the survey. The health workers displaying attitudes that would put themselves or others at risk were in the minority. Only 55.6% of participants had received infection prevention and control training. Some participants indicated they did not have access to medical masks (11.8%) and gloves (9.9%) in their departments. Conclusions The attitudes of participants reflected a willingness to engage in appropriate SARS-CoV-2 infection prevention and control practices as well as a commitment to be involved in COVID-19 patient care. Ensuring adequate infection prevention and control training for all staff and universal access to appropriate PPE were identified as key areas that needed to be addressed. Interim and final reports which identified key shortcomings that needed to be addressed were provided to the relevant provincial departments of health.


Author(s):  
Cody Minks ◽  
Anke Richter

AbstractObjectiveResponding to large-scale public health emergencies relies heavily on planning and collaboration between law enforcement and public health officials. This study examines the current level of information sharing and integration between these domains by measuring the inclusion of public health in the law enforcement functions of fusion centers.MethodsSurvey of all fusion centers, with a 29.9% response rate.ResultsOnly one of the 23 responding fusion centers had true public health inclusion, a decrease from research conducted in 2007. Information sharing is primarily limited to information flowing out of the fusion center, with little public health information coming in. Most of the collaboration is done on a personal, informal, ad-hoc basis. There remains a large misunderstanding of roles, capabilities, and regulations by all parties (fusion centers and public health). The majority of the parties appear to be willing to work together, but there but there is no forward momentum to make these desires a reality. Funding and staffing issues seem to be the limiting factor for integration.ConclusionThese problems need to be urgently addressed to increase public health preparedness and enable a decisive and beneficial response to public health emergencies involving a homeland security response.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mohammad Hassan Emamian ◽  
Hossein Ebrahimi ◽  
Hassan Hashemi ◽  
Akbar Fotouhi

Abstract Background Previous studies have reported a high prevalence of hypertension in Iranian students, especially in rural areas. The aim of this study was to investigate the daily intake of salt in students and its association with high blood pressure. Methods A random sub-sample was selected from the participants of the second phase of Shahroud schoolchildren eye cohort study and then a random urine sample was tested for sodium, potassium and creatinine. Urine electrolyte esexcretion and daily salt intake were calculated by Tanaka et al.’s formula. Results Among 1455 participants (including 230 participants from rural area and 472 girls), the mean age was 12.9 ± 1.7 year and the mean daily salt intake was 9.7 ± 2.6 g (95% CI 9.5–9.8). The mean salt consumption in rural areas [10.8 (95% CI 10.4–11.2)] was higher than urban areas [9.4 (95% CI 9.3–9.6)], in people with hypertension [10.8 (95% CI 10.3–11.3)] was more than people with normal blood pressure [9.4 (95% CI 9.3–9.6)], and in boys [9.8 (95% CI 9.7–10.0)] was more than girls [9.3 (95% CI 9.1–9.6)]. Higher age, BMI z-score, male sex and rural life, were associated with increased daily salt intake. Increased salt intake was associated with increased systolic and diastolic blood pressure. Conclusion Daily salt intake in Iranian adolescents was about 2 times the recommended amount of the World Health Organization, was higher in rural areas and was associated with blood pressure. Reducing salt intake should be considered as an important intervention, especially in rural areas.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elizabeth Katana ◽  
Bob Omoda Amodan ◽  
Lilian Bulage ◽  
Alex R. Ario ◽  
Joseph Nelson Siewe Fodjo ◽  
...  

Abstract Background In March 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Many countries in Sub-Saharan Africa, Uganda inclusive, implemented lockdowns, curfew, banning of both private and public transport systems, and mass gatherings to minimize spread. Social control measures for COVID-19 are reported to increase violence and discrimination globally, including in Uganda as some may be difficult to implement resulting in the heavy deployment of law enforcement. Media reports indicated that cases of violence and discrimination had increased in Uganda’s communities following the lockdown. We estimated the incidence and factors associated with experiencing violence and discrimination among Ugandans during the COVID-19 lockdown to inform control and prevention measures. Methods In April 2020, we conducted a secondary analysis of cross-sectional data under the International Citizen Project (ICP) to assess adherence to public health measures and their impact on the COVID-19 outbreak in Uganda. We analyzed data on violence and discrimination from the ICP study. We performed descriptive statistics for all the participants’ characteristics and created a binary outcome variable called experiencing violence and/or discrimination. We performed logistic regression analysis to identify the factors associated with experiencing violence and discrimination. Results Of the 1726 ICP study participants, 1051 (58.8%) were males, 841 (48.7%) were currently living with a spouse or partner, and 376 (21.8%) had physically attended work for more than 3 days in the past week. Overall, 145 (8.4%) experienced any form of violence and/or discrimination by any perpetrator, and 46 (31.7%) of the 145 reported that it was perpetrated by a law enforcement officer. Factors associated with experiencing violence or discrimination were: being male (AOR = 1.60 CI:1.10–2.33), having attended work physically for more than 3 days in the past week (AOR = 1.52 CI:1.03–2.23), and inability to access social or essential health services since the epidemic started (AOR = 3.10 CI:2.14–4.50). Conclusion A substantial proportion of Ugandan residents experienced violence and/or discrimination during the COVID-19 lockdown, mostly perpetrated by law enforcement officers. We recommend mitigation of the collateral impact of lockdowns with interventions that focus on improving policing quality, ensuring continuity of essential services, and strengthening support systems for vulnerable groups including males.


2020 ◽  
Vol 13 (1) ◽  
pp. 291
Author(s):  
Masike Malatji ◽  
Annlizé L. Marnewick ◽  
Suné von Solms

The water and wastewater sector is an important lifeline upon which other economic sectors depend. Securing the sector’s critical infrastructure is therefore important for any country’s economy. Like many other nations, South Africa has an overarching national cybersecurity strategy aimed at addressing cyber terrorism, cybercriminal activities, cyber vandalism, and cyber sabotage. The aim of this study is to contextualise the water and wastewater sector’s cybersecurity responsibilities within the national cybersecurity legislative and policy environment. This is achieved by conducting a detailed analysis of the international, national and sector cybersecurity stakeholders; legislation and policies; and challenges pertaining to the protection of the water and wastewater sector. The study found some concerning challenges and improvement gaps regarding the complex manner in which the national government is implementing the cybersecurity strategy. The study also found that, along with the National Cybersecurity Policy Framework (the national cybersecurity strategy of South Africa), the Electronic Communications and Transactions Act, Critical Infrastructure Protection Act, and other supporting legislation and policies make provision for the water and wastewater sector’s computer security incidents response team to be established without the need to propose any new laws or amend existing ones. This is conducive for the immediate development of the sector-specific cybersecurity governance framework and resilience strategy to protect the water and wastewater assets.


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