PROSPERO International prospective register of systematic reviews
A systematic review of the quality of antiretrovirals
Chanvilay Sichanh, Celine Caillet, Paul Newton
Citation
Chanvilay Sichanh, Celine Caillet, Paul Newton. A systematic review of the quality of antiretrovirals. PROSPERO
2016:CRD42016039531 Available from
http://www.crd.york.ac.uk/PROSPERO_REBRANDING/display_record.asp?ID=CRD42016039531
Review question(s)
What is the available evidence on the quality of antiretrovirals?
What is the likely impact of poor quality antiretrovirals?
Searches
Scientific and lay reports using PubMed, EMBASE, MEDLINE, Google, Google Scholar, World Health Organization
(WHO), United States Pharmacopeia (USP), and Medicines Regulatory Agencies (MRA), AIDS, AIDSinfo,
Mescape, The Body, AIDSmap.
The Search was performed in English and French.
Types of study to be included
Inclusion: any study describing in vivo or in vitro tests to determine antiretroviral medicine quality, assays to
determine quality, discussions over sampling methodology and pharmaceutical legislation. Any published report in
English and/or French. Articles about seizures, recalls and confiscations of antiretrovirals; case reports or articles
describing side effects or patients not responding to antiretroviral treatments where quality was questioned, studies
with results from several countries or locations are included under each specific country/location.
Condition or domain being studied
Medicines and medical devices will be classified as of 'good quality', 'falsified', 'substandard' or 'degraded'. Only
essential medicinal products used for antiretrovirals will be included.
Participants/ population
Not applicable.
Intervention(s), exposure(s)
Inclusion: any types of report related to the quality of antiretrovirals.
Exclusion: reports in which the quality of the antiretrovirals is not clearly detailed.
Comparator(s)/ control
Not applicable.
Outcome(s)
Primary outcomes
Prevalence and distribution of poor quality medicines. Poor quality medicines are classified into four categories:
‘Falsified’ is used as a synonym for counterfeit or spurious, and refers to a medical product produced with criminal
intent to mislead, but without reference to intellectual property concerns.
'Substandard' medicines are pharmaceutical products that do not meet their quality standards and specifications, most
of the time because of negligence or error during the manufacture process.
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'Degraded' medicines are those which leave the factory as good quality but that degrade because of external factors
such as heat, light and humidity.
Samples that fail chemical assays, but in which there is no identification of incorrect active ingredients, and for which
there has been no packaging analysis, are classified as 'poor quality' and not as falsified or substandard as this
distinction cannot be reliably made without reference to the packaging. Samples that contain incorrect API or none of
the stated API but for which there has been no packaging analysis are assumed to be falsified.
Not applicable.
Secondary outcomes
None.
Data extraction, (selection and coding)
Titles and abstracts will be screened first and full articles will be read if necessary. A pre-set Microsoft Access
database (adapted from a previous review on medicine quality by our group) will be used to manage the data
extracted from the eligible studies. Extracted data will include year of publication, publication type, definition used
for medicine quality, starting and ending dates of the survey, location, sampling strategy, sample size, outlet type,
name-dosage and manufacturer country of medicines or medical devices collected, types of tests conducted for
quality assessment and failure rates (with additional descriptions of the type of failure where appropriate). One
researcher will be involved in data extraction.
Risk of bias (quality) assessment
The quality assessment of the methodology is an outcome of our systematic review and will be performed by
analyzing the surveys informed by the Medicine Quality Assessment Reporting Guidelines (MEDQUARG) (See
Newton et al, PlosMed 2009).
Strategy for data synthesis
A narrative approach will be used.
Analysis of subgroups or subsets
Exploration will be performed by type of medicine/medical devices; by location (regions, country income, etc.); by
sampling type of medicine (convenience, randomized, etc.) and by medicine preparation (tablets, injection, etc.).
Dissemination plans
Peer-review article in a scientific journal. Publication on IDDO website.
Contact details for further information
Chanvilay Sichanh
Microbiology Laboratory, Mahosot Hospital 01000 Vientiane
[email protected]
Organisational affiliation of the review
WorldWide Antimalarial Resistance Network, University of Oxford
http://www.wwarn.org/
Review team
Dr Chanvilay Sichanh, WWARN
Dr Celine Caillet, WWARN
Dr Paul Newton, WWARN; LOMWRU
Anticipated or actual start date
01 December 2015
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Anticipated completion date
31 October 2016
Funding sources/sponsors
None
Conflicts of interest
None known
Language
English
Country
Laos
Subject index terms status
Subject indexing assigned by CRD
Subject index terms
Anti-Retroviral Agents; Counterfeit Drugs; Drug Contamination; Drug Industry; Drug-Related Side Effects and
Adverse Reactions; Drug Utilization; HIV Infections; Humans; Patient Safety
Stage of review
Ongoing
Date of registration in PROSPERO
27 June 2016
Date of publication of this revision
27 June 2016
Stage of review at time of this submission
Preliminary searches
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Data extraction
Risk of bias (quality) assessment
Data analysis
Started
Completed
No
No
Yes
Yes
No
No
Yes
Yes
No
No
No
No
PROSPERO
International prospective register of systematic reviews
The information in this record has been provided by the named contact for this review. CRD has accepted this information in good
faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record,
any associated files or external websites.
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