scholarly journals Quality of selected anti-retroviral medicines: Tanzania Mainland market as a case study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sophia Mziray ◽  
Betty A. Maganda ◽  
Kissa Mwamwitwa ◽  
Adam M. Fimbo ◽  
Seth Kisenge ◽  
...  

Abstract Background Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure and development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. To ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market. Methods This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All sampled ARVs were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and 10 % (10 %) of all that complied with the screening test requirements were selected for full quality control testing. Quality control testing was conducted at the Tanzania Medicines and Medical Devices Authority (TMDA) laboratory a World Health Organisation prequalified. Samples collected from the medicine distribution outlets were also, subjected to product information review. Results A total of 2,630 samples were collected, of which 83.7 % (2200/2630) were from port of entry (POEs). All sampled ARVs were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27 % (7/2630) and lamivudine/zidovudine/nevirapine 0.27 % (7/2630) that failed the disintegration test. Out of the 100 samples selected for full quality control testing, 3 % of them failed to comply with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2 % (2/100) and 1 % (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6 %) versus specification limits (90 -110 %). Out of the 430 samples which were subjected to product information review, 25.6 % (110/430) failed to comply with the TMDA packaging and labelling requirements. Conclusions The quality of majority of ARVs circulating on the Tanzania Mainland market was good, even so, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania Mainland market.

2020 ◽  
Author(s):  
Sophia Mziray ◽  
BETTY MAGANDA ◽  
Kissa Mwamwitwa ◽  
Adam M. Fimbo ◽  
Seth Kisenge ◽  
...  

Abstract Background: Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure, and prolonged illness, development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. Thus, to ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market.Methods: This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All collected samples were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and ten percent (10%) of all that complied with the screening test requirements were selected for full quality control testing in the World Health Organisation prequalified laboratory at Tanzania Medicines and Medical Devices Authority (TMDA). Samples collected from the medicine distribution outlets were also subjected to product information review. Results: A total of 2,630 samples were collected, of which 83.7% (2200/2630) were from port of entry (POEs). Of the 2200 samples screened, all conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27% (7/2630) and lamivudine/zidovudine/nevirapine 0.27% (7/2630) that failed the disintegration test. Also, of the 100 samples selected for full quality control testing, 3% of them failed to compile with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2% (2/100) and 1% (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6%) versus specification limits (90% -110%). Out of the 430 samples which were subjected to product information review, 25.6% (110/430) failed to comply with the packaging and labelling requirements. Conclusion: The quality of majority of ARVs circulating on the Tanzania Mainland market was good but, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania market.


2020 ◽  
Author(s):  
Sophia Mziray ◽  
BETTY MAGANDA ◽  
Kissa Mwamwitwa ◽  
Adam M. Fimbo ◽  
Seth Kisenge ◽  
...  

Abstract Background Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (HIV/AIDS) is still health problem worldwide, particularly in sub-Saharan African countries, such as Tanzania. Anti-retroviral medicines (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Thus, good quality ARVs is amongst the key factors which guarantee successful therapeutic outcomes and prevention of development of drug resistant strains. This study was aimed at monitoring the quality of ARVs circulating on the Tanzania Mainland market.Methodology This was a prospective cross sectional study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All samples were subjected to screening testing using the Global Pharma Health Fund ® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and ten percent (10%) of all that complied with the screening test requirements were subjected to confirmatory testing using full pharmacopoeia monographs at the Tanzania Medicines and Medical Devices Authority (TMDA), quality control laboratory prequalified by the World Health Organisation. Samples collected from the medicine distribution outlets were also subjected to product information review.Results A total of 2,630 samples were collected, of which 83.7% (2200/2630) were from port of entry (POEs). Out of the 430 samples which were subjected to product information review, 25.6% (110/430) failed to comply with the packaging and labelling requirements. All sampled ARV’s that were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27% (7/2630) and lamivudine/zidovudine/nevirapine 0.27% (7/2630) that failed the disintegration test. In confirmatory testing using full pharmacopoeia monographs, all samples conformed to the requirements, except of FDC stavudine/lamivudine/nevirapine which failed disintegration 2% (2/100) and assay tests 1% (1/100) respectively. Samples failing the assay test had low content of stavudine (86.6%) versus specification limits (90% -110%).Conclusion The quality of majority of ARVs circulating on the Tanzania Mainland market was good. The existence of number of ARVs circulating on Tanzania Mainland market which do not comply with product information requirements was significant. These results call for continuous monitoring of quality of medicines circulating on the Tanzania market.


2017 ◽  
Vol 3 (1) ◽  
Author(s):  
Tri Nurhudi Sasono

Abstract : Indicator of the health welfare through Sustanable Development Goals (SDGs) is to reduce the incidence of HIV-AIDS, decrease the rate of the epidemic and maintain the quality of life of people living with HIV-AIDS (PLWHA). Trend cases of HIV-AIDS is the most recent spread among people, especially housewives. In Malang until 2015 found 278 Housewife of 409 cases of AIDS. The prevalence of HIV-AIDS in Malang Regency is ranked second after Surabaya city in East Java. For the importance of public participation and citizen care AIDS Cahaya Care Turen take responsibility for the condition. Determination Rule Goverment number 2 2015 year on the Participation of the community response to HIV-AIDS in Malang as a legal rule. Concerned Citizens activities AIDS (WPA). WPA Cahaya Care Turen is increases HIV risk and quality of life PLWHA. The purpose of this study was to determine the role of Citizens AIDS Cahaya Care Quality of Care Turen against people living with HIV in Puskesmas Turen Malang. The study design using a quasi-experimental, with purposive sampling using a sampling technique. Total number of research subjects 23. Based on test results obtained with the Wilcoxon p value <0.005, which means that there is a significant difference before and after PLWHA joining participated in the WPA Cahaya Care Turen. The conclusion of this study is WPA activities involving people living with HIV and at risk groups can optimize compliance with antiretroviral drugs that have an impact on improving the quality of life of PLHIV. Suggestions in this research is done WPA Program activities are structured and ongoing cross-sector in order to improve the quality of life and empower PLWHA.Keywords : WPA Cahaya Care Turen, Quality of life, PLWHA Abstrak : Salah satu indikator kesejahteraan kesehatan melalui Sustanable Development Goals (SDGs) adalah menekan angka kejadian HIV-AIDS, menurunkan laju epidemik dan mempertahankan kualitas hidup Orang dengan HIV-AIDS (ODHA). Trend kasus HIV-AIDS terkini terbanyak adalah menjangkit dikalangan masyarakat khususnya pada ibu rumah tangga. Kabupaten Malang sampai dengan tahun 2015 ditemukan 278 Ibu Rumah Tangga dari 409 kasus AIDS. Prevalensi HIV-AIDS di Kabupaten Malang ini merupakan peringkat kedua di Jawa Timur setelah Kota Surabaya. Untuk itu pentingnya peran serta masyarakat dan warga peduli AIDS Cahaya Care Turen ikut bertanggung jawab terhadap kondisi tersebut. Penetapan Peraturan Bupati Malang no.2 th.2015 tentang Peran serta masyarakat penanggulangan HIV-AIDS di Kabupaten Malang diharapkan dapat mengurangi risiko penularan HIV dan meningkatkan kualitas hidup ODHA. Tujuan dari penelitian ini adalah untuk mengetahui Peran Warga Peduli AIDS Cahaya Care Turen terhadap Kualitas ODHA Di Wilayah Kerja Puskesmas Turen Kabupaten Malang. Desain penelitian menggunakan quasi eksperimen, dengan teknik sampling menggunakan purposive sampling. Jumlah subyek penelitian sejumlah 23. Berdasarkan hasil uji dengan Wilcoxon didapatkan nilai p value < 0.005 yang berarti bahwa terdapat perbedaan bermakna sebelum dan sesudah ODHA bergabung mengikuti kegiatan WPA Cahaya Care Turen. Kesimpulan dalam penelitian ini adalah kegiatan WPA dengan melibatkan ODHA dan kelompok beresiko dapat mengoptimalkan kepatuhan obat ART sehingga berdampak terhadap peningkatan kualitas hidup ODHA. Saran dalam penelitian ini adalah dilakukannya Program kegiatan WPA yang terstruktur dan berkesinambungan lintas sektor guna meningkatkan kualitas hidup dan memberdayakan ODHA.     Kata kunci : WPA Cahaya Care Turen, kualitas hidup, ODHA


Cells ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. 909
Author(s):  
Laura Cheney ◽  
John M. Barbaro ◽  
Joan W. Berman

Antiretroviral drugs have dramatically improved the morbidity and mortality of people living with HIV (PLWH). While current antiretroviral therapy (ART) regimens are generally well-tolerated, risks for side effects and toxicity remain as PLWH must take life-long medications. Antiretroviral drugs impact autophagy, an intracellular proteolytic process that eliminates debris and foreign material, provides nutrients for metabolism, and performs quality control to maintain cell homeostasis. Toxicity and adverse events associated with antiretrovirals may be due, in part, to their impacts on autophagy. A more complete understanding of the effects on autophagy is essential for developing antiretroviral drugs with decreased off target effects, meaning those unrelated to viral suppression, to minimize toxicity for PLWH. This review summarizes the findings and highlights the gaps in our knowledge of the impacts of antiretroviral drugs on autophagy.


PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251944
Author(s):  
Kate Alford ◽  
Stephanie Daley ◽  
Sube Banerjee ◽  
Jaime H. Vera

Quality of life (QoL) is recognized as an essential end point in the disease management of chronic conditions such as HIV with calls to include good QoL as a ‘fourth 90’ in the 90-90-90 testing and treatment targets introduced by World Health Organization in 2016. Cognitive impairments impact a broad spectrum of experiences and are a common issue effecting people living with HIV (PLWH). Despite this, few studies have examined QoL in PLWH who also have a cognitive disorder. This study aimed to synthesize and describe what is known about QoL in those living with HIV-associated neurocognitive disorders (HAND). A scoping review of peer-reviewed literature was conducted to identify how QoL has been investigated and measured in PLWH with HAND, and how PLWH with HAND report and describe their QoL. We searched PsychInfo, Medline, Scopus, and Web of Science along with hand-searching reference lists from relevant studies found. Included studies were those published in English after 1st January 2003 which included PLWH with cognitive impairment not due to other pre-existing conditions. Fifteen articles met criteria for inclusion. Two studies measured QoL as a primary aim, with others including QoL assessment as part of a broader battery of outcomes. The MOS-HIV and SF-36 were the most commonly used measures of overall QoL, with findings generally suggestive of poorer overall QoL in PLWH with HAND, compared to PLWH without cognitive impairment. Studies which examined dimensions of QoL focused exclusively on functionality, level of independence, and psychological QoL domains. There is a considerable dearth of research examining QoL in PLWH with HAND. The initiatives which advocate for healthy aging and improved QoL in PLWH must be extended to include and understand the experiences those also living with cognitive impairment. Research is needed to understand the broad experiential impacts of living with these two complex, chronic conditions, to ensure interventions are meaningful to patients and potential benefits are not missed.


2014 ◽  
Vol 22 (6) ◽  
pp. 994-1000 ◽  
Author(s):  
Ana Cristina de Oliveira e Silva ◽  
Renata Karina Reis ◽  
Jordana Almeida Nogueira ◽  
Elucir Gir

OBJECTIVES: to assess the quality of life of people living with HIV/AIDS and verify its association with clinical characteristics and treatment adherence.METHOD: cross-sectional study conducted in a hospital in the state of Paraíba, Brazil. A questionnaire was used to collect socio-demographic and clinical data. The quality of life scale proposed by the World Health Organization and a questionnaire to measure treatment adherence were used.RESULTS: of the 314 interviewees, 190 (60.5%) were male, aged 43 years on average, 121 (38.5%) had attended up to five years of schooling, 108 (34.4%) received up to two times the minimum wage, and 112 (35.7%) were on sick leave. In regard to clinical variables, individuals with an undetectable viral load scored higher in all the domains concerning quality of life, with statistically significant differences in three domains. Regarding treatment adherence, 235 (73.8%) presented poor adherence and those who strictly adhered to treatment obtained better scores in quality of life. The results show that quality of life is better among individuals adherent to ART. Supporting people to adhere to the antiretroviral treatment should be a persistent task of healthcare workers and other people participating in the treatment, such as family members and friends.


2019 ◽  
Vol 30 (13) ◽  
pp. 1318-1328
Author(s):  
Bakhytkul T Zhakipbayeva ◽  
Zhamilya S Nugmanova ◽  
Melissa Tracy ◽  
Guthrie S Birkhead ◽  
Gulzhakhan M Akhmetova ◽  
...  

The study purpose was to determine the factors associated with health-related quality of life (HRQoL) among people living with HIV (PLHIV) in Kazakhstan. A convenience sample of 531 adult PLHIV registered at the Almaty City AIDS Center was used for this cross-sectional study. HRQoL data were collected with the World Health Organization’s Quality of Life HIV brief questionnaire, depression – with Patient Health Questionnaire-9, and clinical data were retrieved from medical records. Multivariate logistic and Tobit censored regressions were used to examine the relationship of socio-demographic, behavioral, and clinical factors with HRQoL and the six specific HRQoL domains: 35.8% of participants did not report good HRQoL. The following variables were identified as independent predictors of poor HRQoL: probable depression (adjusted odds ratio [AOR] 13.42, 95% confidence interval [CI]: 4.56–39.52); history of injecting drug use (AOR 2.10, 95% CI: 1.40–3.14); CD4+ T-cell count <200 cells/mm3 (AOR 2.17, 95% CI: 1.30–3.62); previously married status (AOR 2.23, 95% CI: 1.16–4.28); and co-infection with tuberculosis, syphilis, toxoplasmosis, Chlamydia, herpes simplex, or cytomegalovirus (AOR 1.59, 95% CI: 1.06–2.39). HRQoL of PLHIV in Almaty was independently influenced by several factors. An interdisciplinary approach is needed in planning healthcare and social services addressing improvement of HRQoL among PLHIV.


2018 ◽  
Vol 49 (3) ◽  
pp. 20-29
Author(s):  
George Mamboleo ◽  
George T. Mugoya ◽  
Jonathan Nauser ◽  
Adrionia Molder ◽  
Fais Connor ◽  
...  

The development of highly active antiretroviral therapy (HAART) has shifted human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) from an acute to a chronic condition. Due to reduced fatality, approximately 1.1 million people living with HIV/AIDS (PLWHA) are faced with increased longevity in conjunction with functional consequences associated with chronic disability. Employment has been associated with increased treatment adherence, quality of life (QoL), and mental and physical health for people living with HIV/AIDS. The purpose of this study was to determine the relationship between employment status and QoL for PLWHA. Participants included 115 patients receiving services from two Ryan White HIV/AIDS Program (RWHAP) clinics in a rural Mid Atlantic Appalachian region of the U.S. Findings revealed statistically significant differences in employment status on six domains of the World Health Organization’s Quality of Life scale for PLWHA (WHOQOL-HIV-Bref), except for spirituality/religion/personal beliefs. Implications for practice and research are discussed.


Author(s):  
Bibilola Damilola Oladeji ◽  
Babafemi Taiwo ◽  
Olushola Mosuro ◽  
Samuel A. Fayemiwo ◽  
Taiwo Abiona ◽  
...  

Background: Suicidality has rarely been studied in HIV-infected patients in sub-Saharan Africa. This study explored suicidal behavior in a clinic sample of people living with HIV, in Nigeria. Methods: Consecutive patients were interviewed using the Composite International Diagnostic Interview (CIDI-10.0) and the World Health Organization Quality of Life (WHO-QOL-HIV-BREF). Associations of suicidal behavior were explored using logistic regression models. Results: In this sample of 828 patients (71% female, mean age 41.3 ± 10 years), prevalence of suicidal behaviors were 15.1%, 5.8%, and 3.9% for suicidal ideation, plans, and attempts, respectively. Women were more likely than men to report suicidal ideation (odds ratio 1.7; 95% confidence interval 1.05-2.64). Depression and/or anxiety disorder was associated with increased odds of all suicidal behaviors. Suicidal behavior was associated with significantly lower overall and domain scores on the WHO-QOL. Conclusion: Suicidal behaviors were common and significantly associated with the presence of mental disorders and lower quality of life.


2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Ervan Meidan Ariatama ◽  
Titik Respati ◽  
Eka Nurhayati

Penyakit HIV/AIDS selain mengakibatkan dampak kesehatan dapat juga mengakibatkan dampak negatif terhadap psikologi, sosial, dan spiritual pada kualitas hidup orang dengan HIV/AIDS (ODHA). Antiretroviral (ARV) merupakan obat penghambat proses replikasi HIV yang merupakan solusi untuk meningkatkan kualitas hidup dan harapan hidup penderita. Tujuan penelitian ini adalah menggambarkan kondisi psikologi, sosial, dan spiritual ODHA selama menjalani pengobatan ARV di Komisi Penanggulangan AIDS (KPA) Kota Bogor periode bulan Agustus–September 2019. Penelitian ini dilakukan menggunakan metode observasi analitik dengan pendekatan cross sectional. Data diambil menggunakan kuesioner World Health Organization Quality of Life-HIV Instrument (WHOQOL-HIV Instrument) yang terdiri atas 120 pertanyaan dan terbagi menjadi 6 domain (psikologi, sosial, spiritual, fisik, lingkungan hidup, dan tingkat kebebasan). Pada penelitian ini hanya diambil 3 domain, yaitu psikologi, sosial, dan spiritual dengan jumlah pertanyaan 52 butir yang dibagikan kepada 80 responden dan dilaksanakan selama bulan Agustus sampai bulan September 2019. Teknik pengambilan sampel menggunakan non-probability sampling jenis consecutive sampling berdasar atas rumus besar estimasi proporsi dengan presisi absolut. Hasil menunjukkan mayoritas kondisi psikologi, sosial, dan spiritual ODHA selama pengobatan antiretroviral di KPA Kota Bogor tahun 2019 dalam kondisi baik dengan persentase kondisi psikologi 96%, sosial 99%, dan spiritual 70%. Simpulan penelitian ini adalah kondisi psikologi, sosial, dan spiritual pada ODHA di Komisi Penanggulangan AIDS Kota Bogor tahun 2019 mayoritas dalam kondisi baik, walaupun kondisi spiritual ODHA masih terdapat hasil kurang baik. PSYCHOLOGICAL, SOCIAL, AND SPIRITUAL CONDITIONS IN PEOPLE LIVING WITH HIV/AIDS DURING ANTIRETROVIRAL TREATMENT AT THE AIDS PREVENTION COMMISSION AT BOGOR CITY IN 2019Apart from having an impact on health, HIV/AIDS can also have a negative psychological, social, and spiritual impact on people living with HIV/AIDS (PLWHA). Antiretroviral (ARV) as drugs that inhibits the process of replication of HIV, which is a solution to improve the quality of life and life expectancy of patients. The purpose of this study was to describe the psychological, social, and spiritual conditions of PLWHA during ARV treatment at the AIDS Prevention Commission in Bogor City in August to September 2019. The study was a cross-sectional study. The research material consisted of primary data taken using the World Health Organization-Quality Instrument HIV questionnaire (WHOQOL-HIV Instrument) consisting of 120 questions and divided into six domains (psychological, social, spiritual, physical, environment, degree of freedom). However, in this study, only three domains studied, which are psychological, social, and spiritual, with 52 questions and then distributed to 80 respondents and carried out from August to September. The sampling technique uses non-probability sampling type consecutive sampling based on large formula of proportion estimation with absolute precision. Results showed the psychological, social, and spiritual condition of PLWHA during antiretroviral treatment at the Bogor City AIDS Commission in 2019 shows a good condition. The majority of good psychological, social, and spiritual domain experienced by 96%, 99%, and 70% of respondents, respectively. The conclusion of this research is the psychological, social, and spiritual conditions of PLWHA in the Bogor AIDS prevention commission in 2019 in the good conditions, even though there was a spiritual condition of ODHA that was still not good.


Sign in / Sign up

Export Citation Format

Share Document