Medicine Quality Monitoring Globe data categories

Lay press articles - data categories

Drugs: ATC

Describes types of medicine products reported in the articles, using the Anatomical Therapeutic Chemical (ATC) classification developed by the World Health Organization (WHO).

Quality

Although important consensus has been achieved with the adoption of substandard and falsified definitions by the WHO at the Seventieth World Health Assembly in 2017, confusion over the terms used to describe medicine quality remains in lay literature.

Information on the quality of medicines in the MQM Globe is extrapolated from the terms used in the articles. There is often confusion in the lay literature between the terms falsified, substandard, spurious, fraudulent, degraded and counterfeit and these terms need to be interpreted with great caution. See the WHO recommended terms. 

Definitions 

Five types and definitions of quality are used in the MQM Globe: 

Falsified – samples with falsified packaging and the correct stated 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. Without packaging analysis, samples that had wrong API or no API we assume to be falsified but acknowledge that this is imperfect with potential confusion with substandard medicines.

Substandard – samples with genuine packaging but incorrect API quantity or type or defects in dissolution/disintegration or not sterile.

Substandard or falsified – samples, without reference packaging available for comparison, containing incorrect quantities 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, substandard or falsified or of unknown quality.

Not directly relevant (NDR) - When medical product quality in general is discussed but it is not specified if the products described are substandard, falsified, degraded etc. (e.g. General discussion often discuss poor quality products in general and thus the Medicine quality field would be “not directly relevant”).

The type of outlet where medicines/medical products were collected/bought/seized:

• Airport
• Clandestine laboratory – unauthorised laboratory producing medical products
• Distributor/Wholesaler – authorised distributor or wholesaler of medicines whose prime objective is the high level stocking of medicines and their distribution to smaller outlets
• Hospital pharmacy – licensed pharmacy within a public or private health facility that includes inpatient beds
• Land point of entry
• Manufacturer – licensed/authorised manufacturer Not applicable – E.g. when the report is a general discussion on quality but the source of the product is not discussed Non-governmental organisation – non-governmental-national or international organisation, including faith based, distributing/selling/donating medical products
• Other – other type of source
• Private pharmacy – licensed pharmacy outside of government or NGO or international organisation distribution system. Includes public-private mix
• Public and private outlets – undifferentiated mixture of licensed public and private outlets
• Seaport Street vendors Unknown – unknown/not reported
• Unlicensed outlets – unlicensed/unauthorized outlet, including shops and markets selling medical products
• Unspecified outlet – outlets selling medical products - but without other details given
• Website(s) – medicines available through purchase on the web and delivery by post

Medicine classes

In addition to ATC classification, the following medicines classes are used: 

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