PROSPERO International prospective register of systematic reviews
A systematic review of the quality of medicinal products for maternal and
reproductive health
Celine Caillet, Chanvilay Sichanh, Paul Newton
Citation
Celine Caillet, Chanvilay Sichanh, Paul Newton. A systematic review of the quality of medicinal products for
maternal and reproductive health. PROSPERO 2016:CRD42016037826 Available from
http://www.crd.york.ac.uk/PROSPERO_REBRANDING/display_record.asp?ID=CRD42016037826
Review question(s)
What is the available evidence on the quality of essential medicines and other medicinal products for maternal and
reproductive health?What is the likely impact of poor quality essential medicines for maternal and reproductive health
?
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) and other key organisation
websites such as FHI360, UNFPA, Reproductive Health Supplies Coalition, the Partnership for Safe Medicines and
the Institute for Reproductive health.
Search performed in English and French.
Types of study to be included
Inclusion:Any study describing in vivo or in vitro tests to determine medicine quality, assays to determine quality,
discussion over sampling methodology and pharmaceutical legislation; Any published report in English, French and
Spanish; Articles about seizures, recalls and confiscations of medicines and medical devices for maternal and
reproductive health; Case reports or articles describing adverse drug reactions or patients not responding to 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
The medicines and medical devices will be classified as of 'good quality', 'falsified', 'substandard' or 'degraded'. Only
essential medicinal products used for maternal and reproductive health will be included.
Participants/ population
Not applicable
Intervention(s), exposure(s)
Inclusion:any types of report related to the quality of medicines and medical devices for maternal and reproductive
health
Exclusion: reports in which the quality of medicines and medical devices 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, refers to a medical product produced with criminal intent
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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. 'Degraded' medicines are those who leave the factory as good quality but that
degrade because of external factors such as heat, light and humidity. Samples that failed chemical assays but without
detection of wrong active ingredients and without 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 wrong API or none of the stated API but without packaging analysis are assumed to be falsified.
Not applicable
Secondary outcomes
The quality of the methodology used to assess the quality of medicines (definitions used, type of sampling,techniques
used...) in the surveys.
Data extraction, (selection and coding)
Titles and abstract will be screened first and full article will be read if needed. A pre-set Microsoft Access database
(adapted from a previous review on medicine quality by our group) is used to manage the data extracted from the
eligible studies. Extracted data 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, type of tests conducted for quality assessment,
failure rate (with additional description of the type of failure when 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. However, the global failure rate will be calculated. The readers will be reminded to
remain vigilant regarding aggregated results because of the methodological bias.
Analysis of subgroups or subsets
Exploration will be performed by type of medicine/medical devices; by location (regions, country income...); by
sampling type of medicine (convenience, randomized...); by medicine preparation (tablets, injection...).
Dissemination plans
Peer-review article in a scientific journal. Publication on IDDO website.
Contact details for further information
Dr Caillet
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
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Dr Celine Caillet, WWARN
Miss Chanvilay Sichanh, WWARN
Dr Paul Newton, WWARN; LOMWRU
Anticipated or actual start date
01 October 2015
Anticipated completion date
31 July 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
Humans; Legislation, Drug; Plant Preparations; Reproductive Health
Stage of review
Ongoing
Date of registration in PROSPERO
20 May 2016
Date of publication of this revision
20 May 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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