Counterfeit Drugs and Recalled Drugs: All you need to know to keep your patients safe

Background

In 2022, the Nigerian market – known as one the largest producing country of counterfeit medicines – was reported to have a prevalence rate of counterfeit drugs in circulation, higher than the global average of 10% and this contributes to a significant number of deaths recorded in the country annually. According to NAFDAC (National Agency for Food and Drug Administration and Control), some of the drugs most counterfeited are antibiotics, analgesics and antimalarials.

What are Counterfeit Drugs and Recalled Drugs

Drugs – also known as medicines or medications – are ideally produced as chemical and physiological substances to treat illnesses or relieve symptoms. However, Counterfeit Drugs – interchangeably referred to as Fake, Falsified or Substandard drugs – are medicines with low or wrong concentration of active ingredients, in some cases with no active ingredients at all; deliberately packaged, fraudulently mislabelled, and marketed in a deceptive manner with respect to its identity or source.

According to the World Health Organisation (WHO), these drugs usually do not meet regulatory standards and approvals, as they are unregistered and unlicensed products that have not undergone or failed the evaluation process and/or approval by the National or Regional Regulatory Authority for the market in which they are marketed, distributed or used.

On the other hand, Recalled Drugs are the original products from the original manufacturer of the drug. However, the medicine was found to have one issue or the other that makes it unfit or unsafe for consumption. These drugs are usually voluntarily announced and recalled by the producers. Some of the recorded reasons for recall are labelling mix-up, unsafe substance or ingredient in the drug, contamination of content from production to packaging and so on.

Several Counterfeit and Recalled Drugs have been withdrawn from the market and circulation to the public, largely to ensure the safety of the consumers. In 2022, well over 50 drugs – inclusive of oral liquids, capsules, supplements, tablets, gels, sprays and various parenteral products – were announced for recall by the Food and Drug Administration (FDA). In Nigeria, some of the recent alerts by NAFDAC on counterfeit and substandard drugs in circulation include

Meronem brand of Meropenem 1g IV injection & 625mg Augmentin Tablets (both antibiotics);
Different brands of 0.5mg oral Dexamethasone & topical Neo Medrol (both glucocorticosteroidal drugs);
5 mg tablet Daonil & 100 I.U Lantus Solostar Solution for Injection in Prefilled Pens (both anti-diabetics);
Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup & Magrip N Cold Syrup (all four are substandard and contaminated cough syrups).

An analgesic product exposed via social media was the P-500 brand of paracetamol and efforts were made by the regulatory agency to ensure these drugs were moped up from circulation.

Effects of Counterfeit or Substandard drugs

Circulation of fake medicines is a life-threatening issue of global health concern as it accounts for the death of over 100,000 people yearly in Africa alone. Also, these counterfeit drugs easily reach 3 in every 10 medicines users, and the market worth of these fake drugs is well over 200 billion USD.

Consumption of these substandard or fake medicines can cause adverse reactions, as well as continued or worsening symptoms and progression of illness, leading to complication and sometimes, death.

Also, this significantly harms our health care system, as people lose trust in the system and its healthcare workers, because the medication prescribed or dispensed to them are not having the expected or required effects. Furthermore, the cheaper cost and wide spread of falsified medicines, as opposed to its authentic counterparts, causes a remarkable loss of the capital invested in manufacturing and distributing the genuine drugs by impeding its sales and profit. Hence, leading to a cumulative loss and discouragement for the companies producing the original health and life-saving products.

How to easily spot or identify falsified drugs

Some of the features to look out for on drugs before purchasing and consuming them are

Wrong spellings and/or mimicry of original drug names; this could be in form of misarrangement of alphabets, wrong colour codes, logos and text appearance.
Identification and registration parameters such as NAFDAC registration number, batch number, the manufacturer address, expiry and manufacture dates; every original drug should have these set of information.
Unique authentication codes or scratch pins not returning authenticity or confirmation messages; this could also be a giveaway that the drug is fake.

Battle against drug falsification: recommended action for all

Everyone – including Patients, Pharmacists, Patent drug sellers, Doctors, Nurses, Health facility management, Regulatory bodies, Policy makers and other stakeholders – have a role to play in eradicating counterfeit and substandard drugs. Some of our recommendations include

purchase and distribution of drugs via secured and qualified sources of original medicines only,
embracing the innovation of technology and mobile services to curb this menace,
improving the quality assurance operations among drug manufacturers nationwide,
effective pharmacovigilance by experts and involved stakeholders,
enforcing the National Drug Control Bill,
continuous enlightenment of the general public to avoid cheaply peddled medicines, and
education about counterfeit drugs and its devastating effects.