Sian C. Owen, medical journalist, Cardio Debate

In September 2016, the World Health Organisation (WHO) launched the ‘Global Hearts’ initiative in order to tackle the global threat of cardiovascular disease, especially in developing countries. This is no mean feat. According to the WHO, in 2012 an estimated 17.5 million people died from CVD – that is around 31% of all deaths worldwide. [1]

One of the big issues facing patients and healthcare providers in developing countries is access to quality medicines. The United Nations Millennium Development Gap Task Force Report 2012 [2] states that just over half (51.8%) of public health facilities in developing countries are able to provide ‘essential medicines’.

There are initiatives in place to improve access to medicines, with particular regard to the production of generic drugs. However, the quality of these medicines is of great concern.

The SEVEN Study assessed the quality of seven cardiovascular drugs in 10 Sub-Saharan countries: 3468 samples were collected, 1530 were tested at random. Of these, 249 (16.3%) were of ‘poor quality’ (defined as a ratio of 85% – <95% to >105%-115% of the expected dose of the active ingredient.). [3]

An editorial published in JAMA Cardiology – ‘Evaluating and Improving the Cardiovascular Drug Supply for Better Global Health’ – [4] highlighted the results of this study. Author Mark D. Huffman, Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, US, asserts that the availability gap of quality drugs must be addressed, saying that: “Improving and maintaining the safety of the global medicine supply is a shared priority for many stakeholders including patients, physicians, governments, and payers as well as legitimate pharmaceutical manufacturers, who all benefit from a safe and effective medicine chain.” [4]

Cardio Debate recently published a series of interviews discussing the challenges of using generic drugs in cardiology. Here, Professor David Holt, Professor of Bio-Analytics at St George’s University of London says: “I am often asked if generic formulations are all the same in terms of efficacy and safety with respect to the originator formulation. The thing you have to understand for the generic regulations, the procedure you go through when you produce a generic medication, they do not look at safety and efficacy. We have a process whereby they show bioequivalence for solid dose formulations – liquid formations don’t have to show that, only that they are the same drug in the same drug.”[5, 6] This is in the context of producing generic drugs in Europe, one can only imagine the challenges in areas of the world with less stringent manufacturing regulations in place.

References

  1. http://www.who.int/cardiovascular_diseases/global-hearts/en/
  2. MDG Gap Task Force Report 2012. ‘The global partnership for development: Making rhetoric a reality.’
  3. Quality assessment of seven cardiovascular drugs in 10 Sub-Saharan countries. The SEVEN Study. JAMA Cardiol 2017; 2(2): 223-5.
  4. http://jamanetwork.com/journals/jamacardiology/fullarticle/2569799
  5. http://www.cardio-debate.com/2017/03/06/critical-challenges-when-using-generic-agents/
  6. http://www.cardio-debate.com/2017/02/27/challenges-of-using-generic-drugs/