Explain the difference between the definitions of substandard and falsified medicines and how important is it to make clear this distinction?
There remains debate about both terms and definitions. There is a growing trend in using the term ‘falsified’ rather than counterfeit in case the latter is used to invoke intellectual property considerations. The term used is relatively unimportant but the underlying definition is crucial. We have used the definitions that WHO has utilised as the basis for defining counterfeit (=falsified) and substandard medicines. Falsified medicines are produced fraudulently and often, but not always, lack any of the stated active pharmaceutical ingredients. In contrast, substandard medicines are produced by authorised manufacturers that do not meet national pharmacopeial standards because of errors in the quality or quantity of raw materials or in manufacturing.
The distinction is important as the origins and solutions for the two types of poor quality medicines differ considerably. Falsified medicines are deliberate criminal attempts to deceive health workers and patients, requiring primarily police/Medicines Regulatory Authority (MRA) legal action. In contrast, substandard medicines result from poor quality control and manufacturing processes, potentially remedied by MRA intervention and support for improvement of factory processes.
A legal debate on the correct definitions and terminology has thwarted progress in combating counterfeit and substandard medicine. What will standardised terminology resolve? And how damaging has this drawn-out wrangling been?
The lack of consensus and the extraordinarily long delays have impeded progress in improving medicine quality. Consensus on appropriate standardised terminology will help reporting and understanding of medicine quality epidemiology and discussion of appropriate interventions. Those deciding this issue should remember the human cost of poor quality medicines and come to a rapid conclusion. If a new pathogen, such as a new ‘flu variant with ‘visible’ mortality had arisen, it would not have taken the international community nearly two years to debate definitions. WHO and member states should be strongly encouraged to invest more resources in the regulation and protection of the global medicine supply. Whether the new WHO Member State mechanism will be able to improve the current situation remains to be seen. It will need to take rapid action if the public health of vulnerable patients is to be protected.
What is the size of the problem now and what are the consequences in term of death and induction of drug resistance in a series of microbial agents?
There are no data that allow anything more than (badly) informed guesses as to the global extent of the problem. However, attempts to collect such statistically valid data have only started recently. Notably, there is still much debate, despite over a hundred years of collecting data, as to how many people contract and die of malaria each year. However, that has not and should not deter public health attempts to control the disease. Similarly, although we do not have good estimates of the proportion of the medicine supply that is poor quality, this should not deter attempts to improve medicine quality. Although there are many examples of poor quality medicines, the paucity of reliable data means that it is difficult to know whether the problem is getting better or worse, how the epidemiology of substandard and falsified medicines differ and whether interventions are effective.
Medicines that contain zero or insufficient active ingredient will not give patients the benefit they and their health workers rightly expect. Hence, such ‘medicines’ must logically increase mortality and morbidity, increase patient and health system health expenditure and result in loss of confidence in health systems and pharmaceuticals. Medicines with more than the stated amount of active ingredient or wrong active ingredients can result in confusing adverse events. The severe consequences of poor quality medicines are often invisible, hidden within health statistics by the difficulty of investigating morbidity, deaths and medicine content in the rural tropics.
Anti-infective medicines containing inadequate amounts of the stated active ingredient, usually substandards, will engender drug resistance. Pathogens will be exposed to subtherapeutic amounts of active ingredient, allowing the more resistant pathogens to multiply whilst the susceptible pathogens are eliminated. Hence, subsequent patients are more likely to be infected with pathogens selected to be resistant to the active ingredient in the poor quality medicine. For infections treated with combination therapy of multiple drugs, such as HIV, TB and malaria, if one active ingredient is at low concentrations the pathogens also risk becoming co-resistant to the partner drugs.
Paul Newton is the Head of the Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, and highly-cited author on issues related to counterfeit and substandard medicines.
The full interview can be found here
Did you like this? Share it: