scholarly journals Institutional barriers and enablers to implementing and complying with internationally accepted quality standards in the local pharmaceutical industry of Pakistan: a qualitative study

2019 ◽  
Vol 34 (6) ◽  
pp. 440-449 ◽  
Author(s):  
Fatima Tauqeer ◽  
Kirsten Myhr ◽  
Unni Gopinathan

Abstract Complying with good manufacturing practices (GMP) and ensuring a quality system is integral to production and supply of quality medicines and achieving universal health coverage. This study focus on the local production of medicines in Pakistan, a lower middle-income country that has observed considerable growth in the number of pharmaceutical companies over the past two decades. Against this background, we investigated: (1) How is quality assurance (QA) and GMP compliance understood and acted upon by local pharmaceutical manufacturers?; (2) What are the institutional barriers and enablers for QA and GMP compliance in the local pharmaceutical sector from the perspective of key stakeholders?; and (3) What are the institutional barriers and enablers for strengthening local regulatory capacity to improve QA in the industry in the long term? We used a qualitative study design involving 22 interviews of the drug regulatory bodies (n = 9), academia (n = 3) and local manufacturers (n = 10), identifying key themes in data by thematic analysis. Document analysis was used to collect additional information and supplement the interview data. We identified that manufacturing facilities operated under different GMP standards and interpretations, pointing towards an absence of harmonization in quality standards across the industry. Views diverged about the status of GMP compliance, with interviewees from academia presenting a more critical view compared with regulators who promoted a more positive story. Among the barriers explaining why companies struggled with quality standards, the lack of a mindset promoting quality and safety among profit-oriented manufacturers was prominent. At the federal level, DRAP’s establishment represented an institutional improvement aiming to promote QA through inspections and guidance. While some positive measures to promote quality have been observed, the need for DRAP to strengthen its technical and regulatory capacity, enhance its engagement in international collaboration and learning, and improve transparency and accountability were highlighted. Overall, since the challenges in Pakistan are shared with other low- and middle-income countries with local production, there is a need to commit to international collaborative mechanisms, such as those lead by WHO, on this issue.

2021 ◽  
Author(s):  
Fanuel Bickton ◽  
Harriet Shannon

Abstract Low- and middle-income countries bear a disproportionately high burden of global morbidity and mortality caused by chronic respiratory diseases. Pulmonary rehabilitation is recommended as a core intervention in the management of people with chronic respiratory diseases. However, the intervention remains poorly accessed/utilised globally, especially in low- and middle-income countries. This qualitative study explored barriers and enablers to pulmonary rehabilitation in low- and middle-income countries from the perspective of healthcare professionals with pulmonary rehabilitation experience in these settings. Online-based semi-structured in-depth interviews with healthcare professionals were undertaken to data saturation, exploring lived barriers and enablers to pulmonary rehabilitation in their low- or middle-income country. Anonymised Interviews were audio-recorded, transcribed verbatim, and analysed using thematic analysis. A total of seven healthcare professionals from seven low- and middle-income countries representing Africa, Asia, and South America, were interviewed. They included five physiotherapists (four females), one family physician (male), and one pulmonologist (female). Themes for barriers to pulmonary rehabilitation included limited resources, low awareness, Coronavirus Disease 2019, and patient access-related costs. Themes for enablers included local adaptation, motivated patients, Coronavirus Disease 2019 (which spanned both enablers and barriers), better awareness/recognition, provision of PR training, and resource support. Successful implementation of these enablers will require engagement with multiple stakeholders. The findings of this study are a necessary step towards developing strategies that can overcome the existing pulmonary rehabilitation evidence-practice gap in low- and middle-income countries and alleviating the burden of chronic respiratory diseases in these countries.


Author(s):  
Bernard Hope Taderera

The study of healthcare personnel migration in Ireland reports that most medical graduates plan to leave the country’s health system. It may be possible to address this challenge by understanding and addressing the reasons why young doctors plan to leave. Future studies should contribute to the retention of early career doctors in highincome countries such as Ireland. This will help reduce the migration of doctors from low- and middle-income countries in order to address the global health workforce crisis and its impact on the attainment of universal health coverage in all health systems.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Alexandre Medeiros Figueiredo ◽  
Danette Waller McKinley ◽  
Adriano Massuda ◽  
George Dantas Azevedo

Abstract Background Shortages and inequitable distribution of physicians is an obstacle to move towards Universal Health Coverage, especially in low-income and middle-income countries. In Brazil, expansion of medical school enrollment, curricula changes and recruitment programs were established to increase the number of physicians in underserved areas. This study seeks to analyze the impact of these measures in reduce inequities in access to medical education and physicians’ distribution. Methods This is an observational study that analyzes changes in the number of undergraduate medical places and number of physicians per inhabitants in different areas in Brazil between the years 2010 and 2018. Data regarding the number of undergraduate medical places, number and the practice location of physicians were obtained in public databases. Municipalities with less than 20,000 inhabitants were considered underserved areas. Data regarding access to antenatal visits were analyzed as a proxy for impact in access to healthcare. Results From 2010 to 2018, 19,519 new medical undergraduate places were created which represents an increase of 120.2%. The increase in the number of physicians engaged in the workforce throughout the period was 113,702 physicians, 74,771 of these physicians in the Unified Health System. The greatest increase in the physicians per 1000 inhabitants ratio in the municipalities with the smallest population, the lowest Gross Domestic Product per capita and in those located in the states with the lowest concentration of physicians occurred in the 2013–2015 period. Increase in physician supply improved access to antenatal care. Conclusions There was an expansion in the number of undergraduate medical places and medical workforce in all groups of municipalities assessed in Brazil. Medical undergraduate places expansion in the federal public schools was more efficient to reduce regional inequities in access to medical education than private sector expansion. The recruitment component of More Doctors for Brazil Program demonstrated effectiveness to increase the number of physicians in underserved areas. Our results indicate the importance of public policies to face inequities in access to medical education and physician shortages and the necessity of continuous assessment during the period of implementation, especially in the context of political and economic changes.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Embleton Lonnie ◽  
Shah Pooja ◽  
Gayapersad Allison ◽  
Kiptui Reuben ◽  
Ayuku David ◽  
...  

Abstract Background In Kenya, street-connected children and youth (SCY) have poor health outcomes and die prematurely due to preventable causes. This suggests they are not accessing or receiving adequately responsive healthcare to prevent morbidity and mortality. We sought to gain insight into the health systems responsiveness to SCY in Kenya through an in-depth exploration of SCY’s and healthcare provider’s reflections on their interactions with each other. Methods This qualitative study was conducted across 5 counties in western Kenya between May 2017 and September 2018 using multiple methods to explore and describe the public perceptions of, and proposed and existing responses to, the phenomenon of SCY in Kenya. The present analysis focuses on a subset of data from focus group discussions and in-depth interviews concerning the delivery of healthcare to SCY, interactions between SCY and providers, and SCY’s experiences in the health system. We conducted a thematic analysis situated in a conceptual framework for health systems responsiveness. Results Through three themes, context, negative patient-provider interactions, and positive patient-provider interactions, we identified factors that shape health systems responsiveness to SCY in Kenya. Economic factors influenced and limited SCY’s interactions with the health system and shaped their experiences of dignity, quality of basic amenities, choice of provider, and prompt attention. The stigmatization and discrimination of SCY, a sociological process shaped by the social-cultural context in Kenya, resulted in experiences of indignity and a lack of prompt attention when interacting with the health system. Patient-provider interactions were highly influenced by healthcare providers’ adverse personal emotions and attitudes towards SCY, resulting in negative interactions and a lack of health systems responsiveness. Conclusions This study suggests that the health system in Kenya is inadequately responsive to SCY. Increasing public health expenditures and expanding universal health coverage may begin to address economic factors, such as the inability to pay for care, which influence SCY’s experiences of choice of provider, prompt attention, and dignity. The deeply embedded adverse emotional responses expressed by providers about SCY, associated with the socially constructed stigmatization of this population, need to be addressed to improve patient-provider interactions.


2021 ◽  
Vol 6 (2) ◽  
pp. 86
Author(s):  
Mark Tefero Kivumbi ◽  
Claire J. Standley

The global burden of antimicrobial resistance is on the rise, resulting in higher morbidity and mortality in our communities. The spread of antimicrobial resistance in the environment and development of resistant microbes is a challenge to the control of antimicrobial resistance. Approaches, such as antimicrobial stewardship programmes and enhanced surveillance, have been devised to curb its spread. However, particularly in lower- and middle-income countries, the overall extent of antimicrobial resistance and knowledge on ongoing surveillance, stewardship or investigation efforts, are often poorly understood. This study aimed to look at the efforts that have been undertaken to detect and combat antimicrobial resistance in Uganda as a means of establishing an overview of the situation, to help inform future decisions. We conducted a systematic literature review of the PubMed database to assess these efforts. A search combining keywords associated with antimicrobial resistance were used to find relevant studies between 1995 and 2020 on surveillance of antimicrobial resistance in Uganda, and susceptibility of microbes to different drugs. The search yielded 430 records, 163 of which met the inclusion criteria for analysis. The studies were categorized according to country and region, the type of antimicrobial resistance, context of the study, study design and outcome of the study. We observed that antibacterial resistance and antimalarial resistance had the most published studies while antiviral and antifungal resistance were represented by very few studies each. Most studies were conducted in humans and hospital settings, with few in veterinary and One Health contexts, and only one that included environmental sampling. The majority of studies have focused on surveillance, susceptibility testing or resistance genes; none of our included papers had a policy or stewardship focus. The results from our work can inform public health policy on antimicrobial stewardship as it contributes to understanding the status of antimicrobial resistance surveillance in Uganda, and can also help to guide future research efforts. Notably, a One Health approach needs to be followed with respect to surveillance of antimicrobial resistance to better understand the mechanisms of resistance transfer across the human-animal–environment interface, including additional investigation in antiviral and antifungal resistance.


2018 ◽  
Vol 2018 ◽  
pp. 1-5
Author(s):  
Paibul Suriyawongpaisal ◽  
Pongsakorn Atiksawedparit ◽  
Samrit Srithamrongsawad ◽  
Thanita Thongtan

Background. Previous policy implementation in 2012 to incentivize private hospitals in Thailand, a country with universal health coverage, to provide free-of-charge emergency care using DRG-based payment resulted in an equity gap of access and copayment. To bridge the gap, strategic policies involving financial and legal interventions were implemented in 2017. This study aims to assess whether this new approach would be able to fill the gap. Methods. We analyzed an administrative dataset of over 20,206 patients visiting private hospital EDs from April 2017 to October 2017 requested for the preauthorization of access to emergency care in the first 72 hours free of charge. The association between types of insurance and the approval status was explored using logistic regression equation adjusting for age, modes of access, systolic blood pressure, respiratory rate, and Glasgow coma scores. Results and Discussion. The strategic policies implementation resulted in reversing ED payer mix from the most privileged scheme, having the major share of ED visit, to the least privileged scheme. The data showed an increasing trend of ED visits to private hospitals indicates the acceptance of the financial incentive. Obvious differences in degrees of urgency between authorized and unauthorized patients suggested the role of preauthorization as a barrier to the noncritical patient visiting the ED. Furthermore, our study depicted the gender disparity between authorized and unauthorized patients which might indicate a delay in care seeking among critical female patients. Lessons learned for policymakers in low-and-middle income countries attempting to close the equity gap of access to private hospital EDs are discussed.


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