With the multi-billion dollar fake drugs industry now having set its sights deliberately on making further inroads into the churning out of brands associated with children’s illnesses, medical experts and reputable international organizations are becoming increasingly concerned that poor countries where environmental conditions render children more vulnerable to diseases may have little if any real defence against ‘cures’ that could exacerbate rather than ease their child welfare headaches.
A study of the phenomenon of fake drugs that became public in March revealed, for example, that fake anti-malarial drugs may be responsible for the deaths of more than 150,000 children across the world and notably in poor countries every year. It is a microcosm of a wider and worsening problem of falsified and substandard medical products according to the co-authors of a report published last month in the American Journal of Tropical Medicine and Hygiene. Whereas just over ten years ago an investigation by a subsidiary of the internationally known drugmakers named Pfizer Global Security working to counteract counterfeit drugs, identified 29 of its products in 75 countries as being falsified, just ten years the same investigators found 95 fakes in 113 countries.
Contextually, a senior official of the American Society of Tropical Drugs and Medicine disclosed that the focus regarding the monitoring of counterfeit drugs including those associated with the treatment of illnesses in children is on poor countries since not only do they suffer from a high burden of disease but have only the flimsiest of controls over the proliferation of fake drugs.
Current global estimates of the impact of fake and substandard drugs is estimated to be as high as 10% of all medicines, costing up to $200 billion, in low- and middle-income countries.
Director of the local Government Analyst Food & Drugs Department (GAFDD) Marlan Cole told Stabroek Business earlier this week that when account is taken of the amount of resources that are pumped into the fake drugs industry, fending off the menace will always be a challenge to poor countries like Guyana. “The issue of medications associated with children’s diseases is particularly troubling,” he says.
In a further printed response Cole said that his Department works in close collaboration with the Guyana Revenue Authority (GRA) “issuing a licence and permit before any prescription drug is registered. We also have Inspectors processing licences before imports.”
“All of these procedures are in compliance with the Food and Drug Act Chapter 34:03 which also affords GAFDD officials the power to enter premises to inspect drugs and to seize and confiscate fake or any substandard drugs,” Cole says. Moreover, the statement afforded the Stabroek Business by the GAFDD Head states that before prescription drugs can be imported they must be registered according to the Food and Drug regulations.
Beyond this, the GAFDD, almost two years ago, teamed up with the Caribbean Public Health Agency’s (CARPHA) Caribbean Regulatory System (CRS) to develop electronic drug registration procedures in collaboration with manufacturers and distributors. Additionally, Guyana also enjoys a collaborative arrangement with the PAHO/WHO Global Drug Monitoring System that provides access to information that could help detect and eliminate sub-standard and falsified drugs.
Still, Cole says, the GAFDD is not so naïve as to assume that its defences against fake and substandard drugs, including those linked to the treatment of children’s diseases are impregnable. “We never forget that we are up against an organization that is rich and powerful and has tools at its disposal to respond to the defences that we erect. It really is a question of seeking to adjust where information is received and acted on regarding Substandard and Falsified (SF) drugs.
“In the recent past the Department has initiated and responded to several litigious actions involving defaulters with measured success in the Courts though we have not caused this to allow us to get ahead of ourselves,” Cole says.
“We are still involved in a battle out there”, he added. Among the primary areas of concern insofar as the proliferation of fake and sub-standard drugs in developing countries is concerned is anti-malarials, given the high level of child deaths associated with malaria (a disease that is common in Guyana) each year.
Antimalarials and artemisinin combination therapy (often called ACT) are the best solution for treating malaria.
A second key concern in low- and middle-income countries is antibiotics for treating childhood pneumonia with reports suggesting that each year, antibiotics that are either fake or substandard may well be responsible for as many childhood fatalities as fake anti-malarials.
