Can we achieve safe and effective medicines for all?

Roy T. Bennett in The Light in the Heart argues “Do not let the memories of your past limit the potential of your future. There are no limits to what you can achieve on your journey through life, except in your mind.” The 25th of September 2019 was World Pharmacists Day, celebrated this year with the theme “Safe and effective medicines for all.”

Since this day was designated by the International Pharmaceutical Federation (FIP) Council in Istanbul, Turkey in 2009. I have always used it as a day to reflect on the profession that has been the underpinning of my career since 1998. This year, I have felt rather conflicted in my reflection just because of the theme. I have because practising in a country that has been my home for most of my adult life and having a passion for the land in which my umbilical cord is buried, I see a serious disconnect.

The pharmaceutical definition of medicine is a drug used to diagnose, cure, treat, or prevent disease. Thus, for most humans’ medicines are part of their activities of daily living either by choice or as a result of a sudden or existing medical condition. In the country where I practice my profession, data indicates that less than 1% of medicines in the pharmaceutical supply chain are substandard, compared to 10%-30% in developing countries. Reliable data on the prevalence of substandard medicines in Ghana is hard to come by. However, the World Health Organisation estimates that 30% of all drugs on the Ghanaian market could be fake.

This situation is one that must be of grave concern to all especially those of us who profess to be “friends of the human race.” Apart from the risk of treatment failure with infectious diseases like malaria, it also impacts on chronic disease management like the control of blood pressure for hypertensives and glycaemic control in diabetes just to name a few. All of which could have serious consequences on the health of the patient or could even lead to mortality. On the part of prescribers, it can often mar their decision making in situations of treatment failure as they could be unsure whether the chosen treatment option is inappropriate.

The reality is, even with the trained eye, a pharmacist has no way to save gut feelings and reliance on the security of their pharmaceutical supply chain to identify substandard drugs. Many practitioners, as a result, rely on the recommendation of branded products where patients can afford as a means of circumventing the risks counterfeit medicines pose. This route, unfortunately, has also been rendered porous by unscrupulous individuals with a majority of these fake brands ending up in pharmaceutical markets of sub-Saharan Africa. According to Pfizer Global Security 2017, between 2004 and June 2016, counterfeit versions of 26 Pfizer medicines were detected in the legitimate supply chain of at least 60 countries, including the US, Canada and the UK. They further assert that about 38% of all branded Viagra on African markets are fake.

As a result of these breaches, many countries and trading blocks like the European Union have put protocols like the Falsified Medicines Directive (FMD) in place relying on digital technology to help in the fight against spurious medicines. On the contrary, many developing countries Ghana included have struggled to have a coordinated approach in this fight. Being the new frontier for organised crime and knowing that the loopholes are closing in the more lucrative Western pharmaceutical markets, the kingpins have turned their focus towards Africa. Leading to the European Union ranking Ghana as the sixth largest producer of fake drugs in the world in 2013. Since then a lot has taken place from a regulatory standpoint in Ghana at least to bring the situation under control. However, most of these efforts have been akin to a firefight as regulators like the Food and Drugs Authority and Pharmacy Council lack the resources to adequately police Ghana’s medicines supply chain.

To put real numbers to this problem, worldwide, it is estimated that the counterfeit drug market is worth up to US$200 billion. With WHO statistics indicating that 42% (US$84 billion) of detected substandard or falsified pharmaceuticals occurring in Africa. Using the law of averages, it can be inferred that each of the 54 African countries potential can be exposed to US$1.6 billion worth of substandard drugs annually. In 2018 Ghana’s total health spend as a percentage of GDP (US$65.19 billion) was 6.5%. Indicating that US$4.24 billion was spent on health in that year. Meaning, approximately 38% of our total health expenditure could potentially have been going towards this trade and the funding of criminal elements unknowingly. This is the true size of the problem and the source of my moral conflict.

We cannot sit and ignore this huge loss of limited state funds and hope that the situation would wish itself away. If the dumping of tramadol in West Africa and the warnings of the United Nations Office on Drugs and Crime (UNODC) are to be taken seriously, the situation is even going to get worse. The point is the penalties for engaging in the illicit trade of pharmaceuticals worldwide are not stiff enough. Apart from China where it is on record that some unscrupulous elements who engaged in this trade received hefty jail sentences with some even being executed, many culprits walk away with a fine or a nominal custodial sentence. In Ghana, though many drug peddlers are routinely arrested, few end up being jailed. More importantly, I am unaware of any major player locally who has been arrested, tried and jailed for offences in this area under the Public Health Act (Act 851). This situation has led to many criminals abandoning other forms of illicit activity and channelling their attention to this underworld niche.

Our society can never achieve “safe and effective medicines for all” if we are not prepared to confront this albatross. There is no likelihood of effective medicines if the safety of the pharmaceutical supply chain cannot be guaranteed. I believe many in my profession are aware of this but hapless as to what they can do individually or as a collective to lead the fight. Our laws in this area are robust enough but not enforced. The situation is made even more complicated by the peddling of medicines of all forms in almost every corner of the country. Education of the citizenry and public lectures have done little to empower the population. On the surface, it may look like a dead rubber but it needn’t be.

We must refuse to let the memories of our past or current predicament in this area prevent us from a vision of a future where this issue does not plague us all. Countries that have fashioned solutions to this problem have done so not just because of their wealth but because they have taken the problem seriously. We must begin to take it seriously too. Technology that democratises this area of health through the empowerment of the citizens exist and has been deployed in many countries.  In 2018, the National Institution for Transforming India (NITI) announced that they would be partnering with US-based computer technology company Oracle13 to deploy blockchain technology to advance the traceability of pharmaceutical products. I count myself fortunate to have the originators of similar technology Sproxil and mPedigree as indigenes of the land of my birth but wonder why they have become unwelcome messiahs in their land.

I would conclude by asking if spending potentially 38% of our total health expenditure or 2.4% of our GDP on otherwise useless medicines does bot push as to rethink our national approach in this area, what would? The limits to solving this problem lie only in our minds and must be confronted.

By Kwame Sarpong Asiedu

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