The trading and the use of falsified medicinal products potentially toxic or simply ineffective are some of the major threat to the global health safety and involve both the developing countries and the industrialized ones.
In order to clarify this issue, it is useful to specify that, on the base of the recent European Union regulations, the words “falsified medicinal product” refer to all the products that are manufactured, sold or distributed outside the authorized channels. For this reason, the falsified medicinal products lack the necessary guarantees of quality, safety and effectiveness that only the uninterrupted chain of legal pharmaceutical professionals can ensure.
This criminal traffic involves a wide variety of products ranging from the sub-standard or fake versions of regularly authorized medicinal products to the miracle drugs sold to the public to improve sexual performances or to increase the sense of well being (so-called lifestyle drugs). This is a phenomenon spread worldwide and includes also western countries, where the increasing use of the internet has led to an enormous growth of illegal trade.
In the last years, the number of people buying online medicinal products with unknown origins and composition, has had a huge boost. These people, without any concern, are exposed to the risk resulting from the assumption of dangerous substances, in some case potentially lethal. This unreasonable and misplaced faith-attitude for pseudo-medicinal products sold online often comes with a suspicious mistrust in the “official medicinal products”, and this increases the negative effects of the extremely dangerous self-help approach, the way these people deal with health problems, potentially really tough.
Understanding the risks for health
No match between declared and actual substances
In a few medicinal products, found during customs control activities or controls on the territory, there was no match between the composition declared on the label and the actual content.
When this divergence regards the active ingredient and its replacement with a different or inactive ingredient, there is inevitably a loss in the expected and wanted therapeutic effect. This might cause extremely serious consequences on the patient’s health and, in case of lifesaving medicinal products, might undermine the patient’s survival.
Furthermore, undeclared pharmaceutical active ingredients might cause serious or lethal reactions if unconsciously taken. This might occur when the assumption of these active ingredients needs special precautionary measures or is contra-indicated. The risk is particularly high for old people because of the concurrence of several diseases and the interactions between the various medicinal products used to treat them.
Also the presence of a simple undeclared excipient may be extremely dangerous for allergic or intolerant people.
The inadequate storage of a medicinal product can determine its inactivation and/or the build up of degradation products that could be harmful, especially when the pharmaceutical active ingredient is particularly sensitive to thermal variations or is photodegradable.
Furthermore, the possibility, indeed found, to illicitly handling of products open an infinite range of scenarios on the possible consequences: from contamination with pathogens to adulteration due to various foreign substances, also toxic ones.
No possibility to reproduce the conditions that guarantee the effective and safe use of a medicinal product
A medicinal product can be placed on the market only when the competent health authorities (for example, AIFA, EMA) have assessed that the risk/benefit balance is clearly favourable, on the base of the results of the studies to which the medicinal product has been subjected. This positive judgment guarantees the effectiveness and the safety of a medicinal product and is strictly limited to the conditions established by the experimental procedures: treatment of a well-defined disease, accurate dosages and dose intervals, exclusion of pathologies, status or co-treatments that contraindicates the medicinal product’s dosage, use of special requirements to reduce the risk of adverse reactions, etc. These conditions are specified in the medicinal product’s Marketing Authorization (MA) and are included in the medicinal product’s characteristics summary and in the package leaflet. When the medicinal product is assumed in accordance to these conditions we talk about a “label” use of a medicinal product and, in this case, it’s highly possible that a patient could receive a favourable result in using it, with a probability level near to the one observed during the experimental studies. Any other and different use of the medicinal product leads to an unknown area where the patient has not the guarantee to receive an effective and safe treatment (“off-label” use, that is the use of a medicinal product beyond the conditions experimented and authorized). It is essential that, moving from the experimental phase to the clinical practice, all these conditions are accurately reproduced, starting first of all from the use of a standard quality medicinal product (precise qualitative and quantitative active pharmaceutical ingredient, sterility, impurities within the limits, etc.) and from the respect of the authorized treatment regimen (single-dose use, total dose, dose interval, treatment length, etc.).
The unaware dosage, even of a single falsified medicinal product, prevents from the correct reply of this delicate process and dramatically reduces the therapy success.
Risks factors associated with the patient’s conditions
The risk of potential harms for health due to the use of falsified medicinal products must be valued considering that the medicinal products subjected to criminal aims are often those used to treat illness that are serious or undermine the patients’ life. In these patients, the lack of therapeutic effect or the adverse effects may cause a dramatic worsening of their clinical conditions, already precarious.
The damages to health
Acute toxic effects
Cases reporting the consequences of the illegal trade of medicinal products on human health show that the risk in taking falsified medicinal products exposed to toxic substances is not so hypothetical. For example, in the last ten years medical literature reports many extremely serious mass poisoning episodes caused by ethylene glycol. Among these cases, in 2008/2009, 84 Nigerian children died, while in the same period, in Panama, 219 people died. In this last case, the local authorities and the WHO stated that these 219 people were only a minimum part of a considerably more tragic total frame. And no less alarming is the recent case in which the competent authorities have found toxic levels of chromium in the capsules produced by the 13% of the Chinese production sites manufacturing this particular pharmaceutical form.
The risk for poisoning is not relegated to remote areas throughout the world or to particular categories of medicinal products, but is associated to the use of any medicinal product produced without the guarantees of quality, safety and effectiveness granted by the competent health authorities that have to control the manufacturing, the trade and the distribution of the regularly authorized medicinal products. The chance of being victim of poisoning is proportional to the quantity of the medicinal product sold.
For example, in the Western world, the most popular illegal and/or falsified medicinal products are those used to improve male sexual performances. These medicinal products are part of a motley group of preparations ranging from the falsified versions of PDE5-i (that is the active pharmaceutical ingredient of the medicinal product for the erectile dysfunction treatment) to the “natural” compounds of alleged vegetal origin, but constantly containing one or more of these pharmaceutical active ingredients.
For all these medicinal products, the risk is due to their common characteristics to contain a variable quantity, over/under, of pharmaceutical active ingredients able to provide erection. This absolute uncertainty increases the risks of an adverse reaction, because the below-dose medicinal products lead the patient to take multiple or repeated doses, facing the inevitable harms that occur when there is a substitution of the standard quantity of the pharmaceutical active ingredient; in general, falsified medicinal products can be harmful even if the patient takes the recommended dose.
Progression of the untreated diseases
Even if poisoning is a real risk in the illicit trade of medicinal products, the most pervasive problem of falsified medicinal products is that they simply do not work. These products, indeed, may contain inert and harmless substances or a pharmaceutical active ingredient that do not treat the disease, but can hide the symptoms: this is the case, for example, of the presence of paracetamol in the anti-malarial falsified medicinal products that lower fever, but are entirely ineffective on the malaria plasmodium. In both cases, the result is that the non-treated disease moves forward and the patients’ conditions get worse, culminating, in some cases, in their death.
Another dramatic example of treatment failure due to the use of falsified or sub-standard medicinal products is about the medicinal products used to reduce the bleeding that may complicate the birth. A recent investigation in Ghana has shown that the 89% of the antihaemorrhagics, placed on the market in a large part of the territory, have a dose of pharmaceutical active ingredient lower than the international standards. In this Country the maternal mortality rate is estimated in 350 deaths every 100.000 live births and the majority of deaths is due to the post-partum haemorrhage, that is treatable with a good quality antihaemorrhagic.
If you don’t know whether you have used a falsified medicinal product, you would think that the disease progress is due to natural causes and you won’t be able to recognize the real causes of worsening of the health conditions of the patient. On the contrary, a growing awareness and a constant attention from house doctors are essential to restrain and prevent the phenomenon.