How can you fight a problem you cannot see? Such is the insidious nature of substandard and falsified medicines which are difficult to detect with the naked eye and can easily slip into the fractured pharmaceutical supply chain in low-and middle-income countries (LMIC).
Weak detection methods coupled with lenient legislation and vast profits of up to US $200 billion make fake medicines the perfect crime.
In 2018, the Rwanda Food and Drugs Authority (RFDA) issued an alert that fake medicines used to prevent postpartum haemorrhage had infiltrated the pharmaceutical supply chain causing a public outcry.
Rwanda has made significant strides in halving maternal deaths in just under a decade, but as poor quality and fake medicines make their way into Rwanda, this threatens to put more mothers at risk.
With 1 in 10 medicines in LMICs estimated to be of poor-quality or fake, it is alarmingly more common than suspected. Every year, 250,000 children are thought to die ‘just’ from falsified malaria and pneumonia medications, however the real number will almost certainly be much higher.
One way to stay ahead of the criminals is to ensure regulatory systems are fit for purpose. This is just one part of a complex issue.
A systematic approach is required to address the ubiquity of falsified medical products, from amending laws to allow for the arrest of criminal gangs accompanied with serious jail time, to increasing the current low levels of general public awareness.
Key to the fight against falsified medicines are pharmacists. As medication experts, pharmacists are well-positioned to educate patients on safe ways to purchase medicines and to report treatment failure or suspicious side effects.
Sub-Saharan Africa faces the greatest burden of fake medicines with 42% of reports originating from the continent. Just last month, authorities in Tanzania seized fake drugs worth thousands of dollars.
Despite the tenuous situation along the border, Rwanda is emerging as a leader in Africa around medicines quality assurance. There are three main reasons for this.
First, the Rwandan government purchases high-risk drugs, such as those for tuberculosis, solely from manufacturers approved by the World Health Organisation (WHO).
Secondly, it has also prohibited their sale through private pharmacies and instead distributes them exclusively through the public sector supply chain to hospitals.
In July 2018, the country also set up the Rwanda Food and Drugs Authority to regulate pharmaceutical products and vaccines and to ensure high quality through an array of new regulatory measures.
These measures have helped to ensure greater medicines quality yet fakes still find their way onto the market. Since November 2018, the Rwanda FDA has recalled 21 batches of medicines due to poor quality, and 8 batches were quarantined and are still under investigation.
Porous borders and a lack of co-operation between neighbouring countries make it difficult to track all medicines that circulate in the country. The ratification of the treaty to set up the African Medicines Regulatory Agency by the Rwandan government in July, marks a crucial first step in improving regional cooperation.
Strengthening and investing in regulatory systems is vital but further training of health care professionals is required for earlier detection. The WHO data shows that healthcare professionals have the lowest rate of reporting falsified medicines.
Yet pharmacists are often the first port of call for patients seeking medical advice. Here is a missed opportunity for pharmacists to educate patients about the dangers of purchasing medicines from unregulated markets, such as street bazaars, online or other unlicensed vendors.
In both high-income and LMIC settings, pharmacy curricula often do not include the issue of fake medicines in compulsory modules. An analysis of national pharmacy curricula in six developing countries found that none specifically mentioned training in falsified medicines.
The WHO has responded by partnering with the International Pharmaceutical Federation and the Commonwealth Pharmacists Association to develop and pilot falsified pharmacy curricula across five African universities. This is an important step, but we need to do much more.
Optimising pharmacists’ skillset and knowledge of falsified medicines has shown to have a profound positive impact on patient’ safety. Governments, together with regulatory bodies, pharmacists and universities, need to work together to identify pharmacy training needs and opportunities to upskill the pharmaceutical workforce.
Ultimately, while pharmacists are the medicines experts, we all have a role to play in fighting fake medicines.
Here’s how you can bring the issue of fake medicines to your community:
Ask your local pharmacist questions about where your purchased medicines come from and how to differentiate between a fake and an authentic medicine.
As a reader join thousands of pharmacists, doctors, nurses, patient advocates and business leaders around the world for Fight the Fakes Week (2-8 December) and spread the word about the dangers of fake and substandard medicines on your personal social media accounts.
Oksana Pyzik, Senior Teaching Fellow and Global Engagement Lead, University College London (UCL) and founder of UCL Fight the Fakes and Flandrie Habyarimana, R.Ph President of the Rwanda Community Pharmacists Union (RCPU) and Eastern & Southern Africa Regional Representative at the Commonwealth Pharmacists Association (CPA)
The views expressed in this article are of the authors.