#FightTheFakes: How the Ghanaian Food and Drugs Authority is fighting fake medicines

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The Fight the Fakes 2020 campaign aims to draw attention to the problem of substandard and falsified medicines around the world. Fake drugs are dangerous, increase patient mortality and morbidity and can increase drug resistance. Jennifer Bonnah, Fleming Fund Fellow and Pharmacist at the Food and Drugs Authority of Ghana highlights why these drugs are a problem and how the public can combat fake drugs.

Jennifer, can you tell us about yourself?

I’m a Pharmacist and I work with the Food and Drugs Authority of Ghana as a Principal Regulatory Officer. I’m also the AMR committee Chairperson (within the FDA) and I’m a member of the National AMR Platform. I evaluate medicinal products for human and animal use and have done a lot of AMR-related work because of my committee affiliations. Pharmacists play a key role in responding to the problem of drug resistance and encouraging the proper use of antibiotics – that’s what motivated me to apply to the Fleming Fund Fellowship.

Why are substandard and falsified medicines a problem and how do they relate to drug resistance?

Substandard and falsified medicines are a big problem, especially when you look at medicines that treat underlying conditions. Substandard and falsified antibiotics can contain sub-therapeutic levels of active antibiotic agents. This means the treatment is usually ineffective and because the dosage of the antibiotic agent is lower, bacteria often become resistant.

As a result, patients need to be treated with more intense and expensive antibiotics, which overall costs the national health system and the patient more. Patients can also lose confidence in the health system if their treatment is ineffective, and they may not return for follow up care. Obviously this increases patient morbidity and mortality and ultimately has a crippling effect on the whole health system.

Who are the perpetrators making these fake drugs?

I wish I knew so I could go and arrest them! What we do know is that fictitious companies use other valid drug manufacturers’ names to mimic authentic products. In some cases, fake drug manufacturers can also have links to other criminal activities.

It sounds tough to root out this issue, how do you test the medicines to make sure they are effective?

We have a rigorous medicines registration procedure at the FDA. We take samples of drugs to the laboratory for analysis, inspect manufacturing facilities and ensure products are coming from manufacturing companies with valid licences. We also do post-market surveillance to ensure compliance by importers and manufacturers.

Nonetheless, counterfeiters and domestic falsifiers are always finding ways to bypass the system. Some of these fake products are imported and are often hidden within other cargo. Also, some medicines are trafficked over our land borders. To manage this, we’ve restricted the importation of medicines into Ghana through two ports so they can be better regulated.

What is your message to the public and what do people need to know about fake drugs?

We advise people to get to know their medicines, especially for patients who will take medicines throughout their lives (for cancer, hypertension, diabetes, etc.). If patients are getting side effects that are not normal, they should report this either to a hospital, pharmacy, or through our Pharmacovigilance app, the Medsafety app.

Patients should also know how to examine their medicines’ packaging. Normally fakes have a lot of typos and the manufacturing & expiry dates and batch numbers are in a different format or different place on the box compared to the authentic medicines. Also – people need to get their medicines from the right sources; we advise the public to go to a pharmacy to buy their medicines so that any issues can be reported , traced and investigated.

In collaboration with the WHO, you are conducting research about fake drugs in Ghana, can you tell us more about this?

According to the WHO, 1 in 10 medical products in low-and middle-income countries are substandard or falsified. To combat this issue, several years ago we ran a programme with support from the US Pharmacopoeia and WHO of rigorous drug sampling and testing, regularly publishing our findings. We also took regulatory action against importers or manufacturers who didn’t abide by the rules and in some cases issued fines and recalls. With strengthened and sustainable programmes for post market surveillance, we were able to better prevent, detect and respond to fake/substandard antimalarials on the Ghanaian market.

The FDA’s current research with the WHO builds on the success of the previous antimalarial and antibiotic project and aims to rigorously sample and test medicines, publish results and take regulatory actions against manufacturers and importers who are not abiding by FDA rules and regulations. Results from the project will be summarised and disseminated and we hope to get more funding to do similar projects.