The Three-Level Approach: A Framework for Ensuring Medicines Quality in Limited-Resource Countries

Pribluda, Victor S.; Barojas, Adrian; Coignez, Veerle; Bradby, Sanford; Dijiba, Yanga; El-Hadri, Latifa; Hajjou, Mustapha; Krech, Laura; Phanouvong, Souly; Smine, Karim; Chibwe, Kennedy M.; Lukulay, Patrick; Evans, Lawrence

doi:10.4172/2167-7689.1000117

Cited by 6 publications

(4 citation statements)

References 19 publications

(25 reference statements)

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“…This checklist which would be based on visual analysis by package inspection could include product licensing status and expiry date. Similar checklists have been proposed and studied (51,52). They could also help create community awareness on SF medicines.…”

Section: Developments Knowledge and Implementation Gaps And Suggestions For Regulatory Strengtheningmentioning

confidence: 87%

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

Orubu

Samad

Rahman

et al. 2021

Preprint

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Poor-quality medicines lead to large individual, health systems and national economic losses. Most low- and middle-income countries (LMICs) lack the robust regulatory quality assurance system necessary to contain the spread of poor-quality medicines. Innovations in regulatory systems strengthening are needed to protect public health. In this study, we assessed the integrity of the antimicrobial supply chain in Bangladesh and suggest innovations. We employed a qualitative methodology comprising a policy content analysis, and literature and database reviews. Bangladesh was chosen as a model LMIC because of its pharmaceuticals production capacity. Using a framework modified from the World Health Organization’s and the United States Pharmacopoeia’s, the Bangladesh National Drug Policy (BNDP) was evaluated for provisions on quality assurance mechanisms that match regulatory functions. Newspaper, peer-reviewed and post-marketing surveillance reports were used to assess the extent of poor-quality antimicrobials in circulation. There are provisions for quality assurance in the BNDP. Newspaper reports identified the circulation of substandard antimicrobials and reported on actions by the government to seize fraudulent/falsified and expired products. Only six peer-review studies testing antimicrobial product quality were identified; the three studies with the larger sample size (over 10 samples tested) reported results of out-of-specifications products. This assessment found evidence of regulatory actions against poor-quality antimicrobials as well as news reports and studies suggesting quality concerns, but no current rigorous assessment of the extent in Bangladesh. We suggest a multi-pronged approach to regulatory system strengthening comprising three strategies: community-based surveillance, task-shifting, and technology-enabled consumer participation.

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Section: Developments Knowledge and Implementation Gaps And Suggestions For Regulatory Strengtheningmentioning

confidence: 87%

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

Orubu

Samad

Rahman

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…Such a checklist could rely on visual analysis by package inspection for product licensing status and expiry date. The effectiveness of similar visual analysis checklists have been demonstrated in the Democratic Republic of Congo [52,53]. The DGDA could use data from the quality checklists collated by these NGOs to further help create community awareness on SF medicines.…”

Section: Developments Knowledge and Implementation Gaps And Suggestio...mentioning

confidence: 99%

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

Orubu

Samad

Rahman

et al. 2022

J Public Health Pol

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Most low-and middle-income countries lack the regulatory capacity to contain substandard and falsified (SF) medicines. Innovations for strengthening regulatory systems are needed to protect public health. We assessed the integrity of the antimicrobial supply chain in Bangladesh. We employed qualitative methods comprising policy content analysis, and literature and database reviews. Using a framework modified from the World Health Organization's and the United States Pharmacopoeia's, the Bangladesh National Drug Policy (BNDP), was evaluated for provisions on medicines quality assurance mechanisms. We used newspaper, peer-reviewed, and post-marketing surveillance reports to assess prevalence of SF antimicrobials. The BNDP contains provisions for quality assurance. Newspaper reports identified circulation of substandard antimicrobials. We identified only six peer-review studies testing antimicrobial product quality with three studies reporting out-of-specifications products. We suggest three strategies for strengthening the regulatory system: community-based surveillance, task shifting, and technology-enabled consumer participation.

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“…A preliminary screening to limit generics to a maximum of about three for each individual medicine, identified by its International Non-proprietary Name (INN), included in the country's essential medicines list can help reduce the number of samples that need to be tested. This screening can be conducted using the protocol suggested in the WHO Medicine Quality Assurance System for Procurement Agencies [92,93]. The contracted service provider should be requested to perform potency and dissolution tests to ensure both active ingredient content and a dissolution profile necessary to ensure bioavailability.…”

Section: Improving Access: Licensing Of Medicines Outlets Under mentioning

confidence: 99%

“…Within formal health systems, pharmacists take the lead in this, and in order to be fully equipped to respond to suspected issues of poor-quality medicines, should be able to evaluate such medicines using lowcost technologies. Physical/visual inspection checks can also be employedas part of a three-level approach [92]. Mandating a Quality Control/Quality Assurance officer pharmacist who employs this checklist as a first step to detecting possible poor-quality medicines may be necessary.…”

Section: Improving Access: Licensing Of Medicines Outlets Under mentioning

confidence: 99%

Tackling the blind spot of poor-quality medicines in Universal Health Coverage

Orubu¹,

Ching²,

Zaman³

et al. 2020

J of Pharm Policy and Pract

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Background: Universal Health Coverage (UHC) is challenged by the prevalence of poor-quality medicines, those that either do not meet required specifications (substandard) or are outrightly fraudulent (falsified), especially in Low-and Middle-Income Countries, LMICs. Whereas poor-quality medicines are a significant burden in these countries, medicine quality still remains a neglected component of UHC programs. This article describes key barriers to quality medicines and presents five select approaches leveraging the scale-up of UHC for medicine quality assurance. Main body: Barriers to medicine quality assurance, while numerous, are described in five key interrelated domains as: low political priority, weak regulatory systems capacity, poor access to accredited facilities and licensed outlets, medicine manufacturing and other supply-chain challenges, and lack of public awareness. Five select approaches for leveraging the scale-up of UHC for medicine quality assurance in LMICs are (1): political commitment (2) strengthening the capacity of regulatory authorities and investment in detection technologies as part of national security (3); licensing of medicines outlets and expanding pharmacovigilance (4); strengthening the supply-chain; and (5) public awareness and participation. Conclusions: Unchecked, poor-quality medicines can jeopardize UHC. National governments in LMICs need to prioritize medicine quality assurance through enforcing policies, regulatory strengthening and investments in technologies. Healthcare facilities and insurance schemes under UHC also play critical roles through incorporating medicine quality assurance into procurement practices and by promoting awareness among beneficiaries. Tackling medicine quality with a committed systems approach will enhance progress towards UHC implementation.

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The Three-Level Approach: A Framework for Ensuring Medicines Quality in Limited-Resource Countries

Cited by 6 publications

References 19 publications

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

Tackling the blind spot of poor-quality medicines in Universal Health Coverage

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