Response by Wirtz et al to Letter Regarding Article, “Access to Medications for Cardiovascular Diseases in Low- and Middle-Income Countries”
We greatly appreciate the positive comments regarding our article1 in the letter from Antignac et al. We agree that there is a dearth of published information about the quality of noncommunicable disease medicines including cardiovascular.
In 2011, contamination of a cardiovascular medicine in Lahore, Pakistan, caused nearly 200 deaths among up to 40 000 exposed patients.2,3 This major incident led to the establishment of the Judicial Inquiry Tribunal to determine the causes of patient deaths in Lahore in 2011 and 2012.4
Investigating and implementing corrective actions is 1 way of preventing other similar incidents. Agreeing on a standard terminology and understanding the extent of the problem are 2 other areas where urgent global and national action is required. The Institute of Medicine published a comprehensive report on this topic titled “Countering the Problem of Falsified and Substandard Drugs.”5 The report standardizes the terms describing the different mechanisms resulting in poor-quality medicines:
Counterfeit: the unauthorized use of a trademark to identify a medicine.
Falsified: a medicine in which there is an intention to deceive.
Substandard: a product that fails to meet pharmacopeial standards.
Unregistered: product that lacks market authorization from the national regulatory authorities.
The standard definitions are important because the national and international response will vary according to which problem is faced.
A short section in the Institute of Medicine report indicates that problems of medicine quality exist for different types of noncommunicable diseases. However, assessing the prevalence of poor-quality noncommunicable disease medicines and the resulting health and economic implications is not possible because of the lack of data.
Last, apart from regulatory authorities, wholesalers and procurement agencies play an important role in promoting quality-assured medicine by testing the quality of medicines they sell or procure.6
In summary, effective regulation and active quality surveillance mitigate the risk of harm to patients. In countries where regulatory bodies are unable to ensure the quality of circulating products, procurement organizations must ensure that they are of adequate quality and that they test the products before they sell them.
Veronika J. Wirtz, MSc, PhD
Warren A. Kaplan, PhD, JD, MPH
Gene F. Kwan, MD, MPH
Richard O. Laing, MB ChB, MSc, MD
Circulation is available at http://circ.ahajournals.org.
- © 2016 American Heart Association, Inc.
- Wirtz VJ,
- Kaplan WA,
- Kwan GF,
- Laing RO
- 2.↵World Health Organization. Drug Alert 125 Contaminated Isotab® (isosorbide mononitrate) incident in Lahore Pakistan February 3rd 2012. http://www.who.int/medicines/publications/drugalerts/DrugSafetyAlert125.pdf?ua=1 Accessed July 20, 2016.
- 4.↵Report of WHO Mission to Pakistan: Lahore Medicine Contamination 6th–19th February 2012. In: Batch J093. The Pathology of Negligence. Report of the Judicial Inquiry Tribunal: pp 171–206. http://apps.who.int/medicinedocs/documents/s22131en/s22131en.pdf Accessed August 3, 2016.
- Gostin LO,
- Buckley G J