The Scourge of Substandard, Falsified Products Only Gets Worse with Pandemic

May 31 , 2020
By Fisseha Shiferie

The United Nations has declared access to “safe, effective, quality, and affordable essential medicines” to be one of the Sustainable Development Goals (SDGs) of their 2030 Agenda. Still, substandard and falsified (SF) medical products represent a serious problem for public health, especially in Africa, Southeast Asia and Latin America.

Substandard medical products can be defined as “authorised medical products that fail to meet either their quality standards or specification, or both,” according to the World Health Organisation (WHO) and may result through poor manufacturing, shipping or storage conditions, or when the drug is sold beyond the expiration date. Falsified medicines, on the other hand, are medical products that deliberately misrepresent their identity, composition or source.

Risks posed by SF medical products can be broadly categorised as health and economic consequences. Health-related consequences of SF medicines include, but are not limited to, risks of morbidity and mortality (resulting from either treatment failure or adverse drug reactions), drug resistance and erosion of patients’ trust in the healthcare system, health care providers and genuine drug manufacturers. By the same token, its economic consequences include increased costs for patients and governments, reduced economic productivity and poverty.

The Novel Coronavirus (COVID-19) is the third coronavirus infection in two decades that was originally described in Asia, after Severe Acute Respiratory Syndrome (SARS) and the Middle East Respiratory syndrome (MERS). There are currently over five million confirmed cases and over 345,000 have died from the virus worldwide. In Ethiopia, the total number of confirmed cases is in the hundreds, while the number of those that have died from the virus, fortunately, stands in the single digits.

COVID-19 and substandard and falsified medicines share one thing in common: both are global public health threats. However, COVID-19 and SF products are different in many fundamental ways. Obviously, COVID-19 is a disease, but the latter is not. While COVID-19 is spreading across both developed and developing nations, the profound impact of SF medical products is more pronounced in low- and middle-income countries, including Ethiopia. It is estimated that 10pc of medical products in developing countries are SF, according to the WHO. Due to the current increased demand for medicines, vaccines and reagents following the pandemic, this prevalence will increase.

COVID-19 might increase the demand and consumption of SF medical products in three major ways.

The first way is due to the inability of a vulnerable segment of the population - pregnant women, individuals working in the informal sector, and patients with comorbidities - to access healthcare services.

As a way of curbing the transmission of the virus and preventing its devastating consequences, the Ethiopian government declared a five-month state of emergency (SOE). As part of the SOE, stay-at-home or work-from-home orders were issued. Businesses, schools and universities are closed. Transportation fares have doubled as compensation for the 50pc reduction of passenger loads.

With the stay-at-home orders and increased tariffs, millions of individuals might face unprecedented difficulties to access healthcare services. Essential medicines are one of them. It is during this time that these people get exposed to SF medical products.

The inevitable consequences of SF medical products are not only limited to people working in the informal sector. It also affects the other vulnerable segments of the population such as people living with HIV/AIDS, patients with comorbidities, communities living in malaria-endemic settings, pregnant women and people under treatment for tuberculosis.

It is inevitable that the pandemic would take attention away from routine health care services. Pregnant women, for example, are expected to visit health facilities as frequently as possible. With the pandemic taking the air out of the attention from other health services, women and their babies’ health will definitely be at high risk. This will open the door for ill-intended SF dealers to easily distribute their products. The risk posed to the remaining vulnerable segment of the population is no different.

The other way for people to get exposed to SF medical products is due to fear of being quarantined, isolated and traced. Quarantine of suspected cases and isolation of COVID-19 patients and contact tracing are the strategies being implemented to contain the spread of the virus. The acceptability of these measures by the community has not been encouraging though. Fear of being quarantined and isolated might force people to use whatever is available in the market as a substitute for visiting healthcare facilities. In this regard, the chances of accessing SF medical products is very high.

Yet another way is related to import permits for medical products. Since the first case was reported in Ethiopia back in March 2020, an overwhelming number of applications from medicine and medical supplies importers are being filed.

The government has given priority and incentives to importers that have submitted applications to import COVID-19 related medical supplies such as face masks, hand sanitiser and gloves. This is a good and timely decision in terms of filling the PPE shortage we are facing.

In a country like Ethiopia, where there is an already existing shortage of essential medicines, the tight window through which these products are allowed to come in is tantamount to adding fuel to the fire. It complicates the problem and will be a good recipe for dealers of SF medical products to easily penetrate the market.

The threat from SF medical products will continue even after the COVID-19 era unless strict steps are taken by the government. Genuine importers, healthcare providers and end-users should be vigilant in the war against SF medical product dealers.

One way of overcoming such threats, especially for consumers, is by following certain general guidelines that can go a long way in combatting the flood of SF medicines.

People need to look at the packaging and search for spelling mistakes and grammatical errors. Checking who the manufacturer is and whether or not the expiry date matches the inner package would also go a long way. Discussing the products with healthcare providers by any available means is critical, as is reporting suspicious medicines to the authorities.

Although the measures that are being taken to halt the transmission of COVID-19 are timely and appropriate, it is also highly important to consider the underemployed and the vulnerable segments of society. They need to be protected both from the pandemic and the consequences of these control measures, consumption of SF medical products in this case. Concerned regulatory bodies should intervene aggressively to ensure the safety, quality and effectiveness of medical products before we face a parallel pandemic of substandard or falsified alternatives.

PUBLISHED ON May 31,2020 [ VOL 21 , NO 1049]

Fisseha Shiferie is a public health expert and pharmacist. He can be reached at

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