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AQ Surveyor Methodology

  • A systematic review of  Pubmed, Google Scholar, World Health Organization, United States Pharmacopeia and Medical Regulatory Agencies (MRA) websites – using the terms ‘antimalarials’,’artemisinin derivatives’, ‘counterfeit drugs’ or ‘substandard’, ‘fake’, ‘falsified’ or ‘quality’ – identified over 300 English, French and Spanish language, scientific and lay reports since 1976
  • Any study describing assays to determine quality, discussion of sampling methodology, drug legislation, and in vivo or in vitro tests for antimalarial quality was included
  • Studies with results from several countries or locations are included under each specific country/location. Studies with results for a whole region or a whole class of drugs, without specific country or location data, are excluded from the database  
  • News reports were collected from online agencies including Daily Monitor, Nigerian Tribune, Modern Ghana, Ghana web and AllAfrica. Many were retrieved from Google searches
  • Study locations and years are based on information presented in publications or provided by authors as personal communications. Geolocations were generated from place names using utilities at http://www.distancesfrom.com/id/
  • Selected details about the publication, survey data and their interpretation were entered in a Microsoft Access 2007 database

Data categories

Medicine 

Three categories based on International Nonproprietary Names (INN) or medicine category: 

  • Artemisinin derivatives (including all the artemisinin derivative monotherapies)
  • Artemisinin-based combination therapies (ACTs)
  • Non-artemisinins. Categories are mutually exclusive and individual drugs or combinations are listed. 

Report type  

  • Peer-reviewed article: Articles published in a peer-reviewed journal
  • Non peer-reviewed article: Articles not peer-reviewed before publication
  • Public alert: Health warnings and articles issued by National Medicines Regulatory Agencies (MRA)
  • Lay press: Articles about seizures or recalls published in newspapers or magazines, both printed and online
  • Report: National and international organisation surveys not published in scientific journals   
  • PhD thesis: A thesis submitted to fulfill the requirements of a Doctor of Philosophy degree examination, or equivalent
  • Technique: Article describing an analytical technique for quality testing or sampling
  • Review: Compilation of articles on antimalarial quality using published reports
  • Medicine regulation and definitions: Article regarding antimalarial medicine regulation and/or definitions
  • Other: Article related to antimalarial quality but without sample collection 
  • Short communication/note: Posters, notes or short communications about antimalarial quality

Collection type 

Describes sample collection methodology used in the published studies:

  • Convenience survey: Uses non-randomised sample collection methods
  • Case reports: Patients not responding to antimalarials or showing toxic side effects are recorded as 100% failure rate. The category also includes samples analysed for quality not included in a survey and antimalarial recalls published by sources other than MRAs 
  • Random survey: Describes the conduct of randomised outlet and/or sample selection. Only studies with details of randomisation methods are included
  • MRA seizure: Antimalarial confiscations, or warnings by police or MRAs
  • Bioavailability studies: In vivo comparative bioavailability testing for adequate antimalarial treatment levels including the rate and extent to which drug reaches the systemic circulation
  • Laboratory assembled collections: Samples assembled in a laboratory to answer a chemical, rather than an epidemiological, question

Quality classification

Controversy and confusion over the terms used to describe medicine quality remains. Whilst the international community seeks consensus, and unless otherwise specified in the report, WWARN uses the term 'falsified' as a synonym for ‘counterfeit’ or ‘spurious’ to refer to a medical product, produced with criminal intent to mislead, without reference to intellectual property concerns. 

If authors did not examine packaging we class any samples that failed chemical assays but had detectable stated Active Pharmaceutical Ingredient (API), but without detected wrong active ingredients, as poor quality and not as falsified/counterfeit. Without packaging analysis, samples that had wrong API or no API we assume to be falsified/counterfeit. There is a small risk of misclassification of substandard samples(due to gross manufacturing errors)  as falsified/counterfeit but thankfully, such catastrophic errors appear to be relatively rare.

There is often insufficient information to distinguish substandard (errors in factory production) from degraded (due to post-production inappropriate storage) medicines. Therefore, substandard medicines may be erroneously categorized as degraded. 

Quoted from each report without additional analysis, ‘failure rate’ is a coarse measure of antimalarial quality. It considers pharmaceutical quality attributes, such as the amount of API, dissolution, disintegration, packaging and other tests such as microbiological testing.

  • Falsified: Samples with fake packaging and the right amount of Active Pharmaceutical Ingredient (API); or those containing a wrong API, or incorrect API quantity, or no API; or samples without genuine packaging available to compare with and the wrong or no stated API
  • Good quality: Sets of samples that did not fail chemical assays and/or packaging tests 
  • Substandard: Samples with genuine packaging but incorrect API quantity or type or defects in dissolution/disintegration or not sterile
  • Poor-quality: Samples, without reference packaging available for comparison, containing incorrect quantities (>zero %) of the correct API or failure to comply with other quality specifications (e.g. dissolution tests, contents of impurity, sterility etc)
  • Degraded: Samples with genuine packaging, containing the correct or incorrect quantity of API with chemical evidence of degradation
  • Diverted-Unregistered: Diverted or Unregistered medicines. These medicines could be good quality, sub-standard or falsified

Medicine source 

The type of outlet where samples were collected or the sample source:

  • Hospital pharmacy: Public or private sector hospital or hospital pharmacy
  • Private pharmacy
  • Clinic: private sector
  • Government & Private Outlets: Public and private sector outlets not otherwise categorised. Includes reports of antimalarials collected in multiple outlets, but lacking results for one or more separate outlet type 
  • Manufacturing company: Provided by the company manufacturing the medicine brand reported
  • Distributor/agent/trader/wholesale pharmacies
  • Unknown: Sample source unknown

The web-based mapping application was built used Google’s Web toolkit and Google Maps.

SQL query generated input files for mapping application.

There are important limitations on the use of these data and we have added warning statements to alert the users to these issues.