Supply chain

The dark consequences of supply shortages

For patients who are struggling to get hold of medicines because of supply chain issues or left without legally approved medications due to political rulings, illegal online pharmacies can be a tempting – if risky – solution. Chloe Kent talks to industry experts about the impact of these illicit outlets on legitimate businesses and asks what can be done to fix the problem.

Since the start of the Covid-19 pandemic, there has been a notable increase in the purchase of medicines through online outlets. Acquiring medication online can have a number of significant benefits for many patients, such as lower cost, increased convenience and improved access. However, many digital outlets selling medication are operating outside the bounds of the law, leaving purchasers vulnerable to substandard or even counterfeit products.

A 2017 study by the US National Association of Boards of Pharmacy (NABP) found that nearly 96% of websites selling prescription medicines were acting illegally. The World Health Organization (WHO) estimates that, in over half of cases, medicines purchased online from illegal sites which conceal their address have been found to be counterfeit.

Despite these statistics, a team of researchers at Butler University and Michigan State University have found that almost 18% of US consumers buy medications online, often from sources recommended by people they know in the hopes of getting a genuine product at a lower price point. These sites include legitimate online pharmacies, but also include illegitimate retailers, as well as e-commerce sites like Amazon, social media platforms and instant messaging services.

In an increasingly online world where consumers can get more or less anything they need delivered to their door, it’s hardly surprising that they turn to the web for medicine. But when more people feel comfortable going online for these kinds of purchases, more opportunities are created for illegal actors to step in and take advantage.

Alliance for Safe Online Pharmacies (ASOP) advisor Libby Baney says: “Healthcare is not like buying shoes and purses on the internet. Your life is at stake, and it’s regulated for a reason. There are some really great, reputable online pharmacies and telemedicine companies that will provide you with legitimate, approved drugs. The challenge is knowing which is which.”

What constitutes a counterfeit?

“There’s anywhere between 35,000 and 40,000 online pharmacies that operate worldwide and of that number 95% do operate illegally in some way,” says Butler University associate professor of pharmacy practice John Hertig, who also works with ASOP.

“Either they’re not licensed properly, they’re selling substandard or falsified medicines or they’re selling products that aren’t approved either within the jurisdiction they operate in or the jurisdiction they’re selling to – you need to have both to be considered legitimate.”

A number of different products can be classified as counterfeit, substandard or falsified, some of which are far more harmful than others. Medication that has been legitimately and safely manufactured but has been stolen and resold by a third party still counts as a counterfeit product. This, Hertig says, is the best-case scenario in the world of illegal online pharmacies.

There currently is no medication that’s on shortage that isn’t available from an illegal online website.

Far riskier for patients are products that have been entirely falsified. Some of these may simply be sugar pills, meaning patients could miss doses of medication they need but are unlikely to be directly injured by what they’re ingesting. Others may contain ingredients that are dangerous to put into the human body.

These ingredients include, but are not limited to, arsenic, uranium, brick dust, chalk and even ethylene glycol, a substance used in anti-freeze. These dangerous ingredients aren’t typically used to make up the entirety of the falsified medicine, but as a binding or filling agent. They’re used by fraudulent manufacturers when they do not have access to the compounds a legitimate producer would have.

The situation has been exacerbated in multiple ways by the Covid-19 pandemic. Many drugs have fallen into short supply due to increased demand and supply chain disruptions, leaving patients with few other places to turn to when seeking the care they need.

Hertig says: “There currently is no medication that’s on shortage that isn’t available from an illegal online website. There is not a single medication that you wouldn’t be able to get access to just by going online. There’s a direct correlation between something that’s hard to get and a criminal taking advantage of that opportunity.”

False flags

Alongside this, many people are now seeking access to false cures and treatments for Covid-19 – things no doctor will prescribe to them, but which they can easily find online. Ivermectin, a drug most commonly used to deworm horses, has dominated headlines after false claims about its ability to treat Covid-19. Action has been taken against companies claiming their saline nasal sprays can cure the disease or flogging false vaccines.

Hertig and his colleagues found that, while the 1,000 consumers they surveyed considered online pharmacies, Amazon and Google to be the safest digital outlets to purchase medication from, even places perceived as the least trustworthy, such as Kik and TikTok, were still generally seen as safe.

Even more alarmingly, 54.6% of the participants had reportedly purchased narcotics from these channels while 52% had purchased stimulant drugs. Stigma is likely to contribute significantly to these numbers, with many of these patients in legitimate need of these medications but too ashamed to visit a doctor.

When we restrict access to medicine… it’s going to be human tendency and nature to try to get access to that product via another route.

Some may also find themselves cut off from the traditional route for these medications by their healthcare provider after showing signs of addiction or dependency.

“When we restrict access to medicine, no matter what the reason, it’s going to be human tendency and nature to try to get access to that product via another route,” says Hertig. “When you restrict safe sources of medicine through a proper supply chain that’s been vetted by a regulatory agency, what you’re going to end up doing as an unintended consequence is point people towards more risky sources of medicine.

“It’s going to take all of us, in terms of the broader healthcare community, to engage in proper discussion and education and develop tools and regulatory frameworks that are going to make sure that we keep our patients safe.”

The road ahead

For companies that are not acting illegally, these counterfeit retailers can cause serious problems. The market for counterfeit pharmaceuticals is worth $200bn a year and growing at 20% annually – twice the growth rate of the legitimate pharmaceutical market.

This forces legitimate outlets to compete with illegal actors, which may be offering a lower price point for what appears to be the same product to consumers.

The presence of illegitimate online pharmacies can also damage consumer trust in digital pharmacies in general.

“It creates an unlevel playing field when you allow unregulated, unlicensed, illegal online drug sellers to be peddling cures and treatments that aren’t regulated,” Baney says.

“It muddies the market. As a patient myself I want to be sure that I’m getting legitimate healthcare from a reputable organisation, but the fact that there’s a muddy, messy, illegal market creates risks and sows the seeds of distrust in what are otherwise legitimate businesses.”

ASOP has called on US policymakers to reform drug importation policies, particularly when it comes to ‘Canadian pharmacies’, outlets that appear to be supplied by licensed pharmacies in Canada and sell to US residents. These sites have no real connection to Canada at all, and do not work with a pharmacy or pharmacist licensed by a Canadian province, nor do they have a physical presence in Canada.

The fact that there’s a muddy, messy, illegal market creates risks and sows the seeds of distrust.

It has also been critical of the introduction of the General Data Protection Regulation (GDPR) in the EU. GDPR, ASOP says, has drastically restricted access to the international WHOIS database, a public directory with ownership records and contact information for every domain name registered on the web.

The law has prompted registrars and registry operators to block access to WHOIS, allowing criminals to bulk buy domain names through which to run illegal online pharmacy scams and leaving law enforcement unable to trace their origin.

ASOP has also called for registries and registrars to lock and suspend suspicious domain names, for the reform of Section 230, and for the endorsement of bipartisan legislation, such as the PACT Act, SHOP SAFE Act, and INFORM Consumers Act, which could help reduce the powers of illegitimate medical retailers online.

Online pharmacies and the Texas abortion crisis

As well as supply shortages and falsified claims about products, political interference in access to legal medications can force consumers online. Even though a pregnant person’s right to an abortion without excessive government restriction is supposed to be constitutionally protected in the US, several states have taken steps to restrict access to abortion care.

Abortions are now banned after six weeks of pregnancy in Texas, essentially putting an end to Roe v Wade in the state. The Texas law bans abortion as soon as foetal heart activity is detected, something which happens long before many people are even aware they’re pregnant.

Even those who do realise before this point may find themselves unable to receive an appointment to undergo an abortion before the deadline set by the new law. The law has no exceptions in the case of rape or incest.

Many pregnant people in the state of Texas who wish to end their pregnancies are now turning to online pharmacies to do so. Early pregnancies can be terminated through a medical abortion, where patients take a combination of mifepristone and misoprostol to induce a miscarriage.

Aid Access, an organisation based in the Netherlands, is the only physician-run service that provides people seeking self-managed abortions in the US with this medication. Despite attempts from the US Food and Drug Administration (FDA) to put a stop to its work during the Trump administration, the organisation continues to supply the drugs.

Patients simply fill in an online form to assess their suitability for the medication. For pregnant people in Texas, the prescription is then filled by a pharmacy in India and the drugs are shipped directly to the patient’s home address. While Aid Access is one of the most legitimate actors in this space, many online vendors are readily selling mifepristone and misoprostol to patients without a prescription.

Every indication we have is that these medications are very safe and effective and so simple to use that they are appropriate for OTC sale.

University of California, San Francisco professor of obstetrics, gynaecology and reproductive science Daniel Grossman says that medical abortion should be available over-the-counter (OTC) across the US, following a brief consultation with a licensed pharmacist.

While the cramping and heavy bleeding experienced by the patient as they pass the pregnancy can sound rather gruelling, medical abortion has a safer track record than other common drugs like paracetamol and Viagra and is 14 times safer than carrying a pregnancy to term. It also has a 97% success rate.

“Every indication we have is that these medications are very safe and effective and so simple to use that they are appropriate for OTC sale,” Grossman says. “People can accurately figure out on their own how far along in pregnancy they are and can screen themselves for eligibility for the medications using a simple checklist.”

A 2017 study published in the journal Contraception saw researchers order 22 products from 16 different sites, 20 of which were mifepristone-misoprostol combination products and two that contained only misoprostol. They found that the 18 tablets labelled 200mg mifepristone contained between 184.3mg and 204.1mg mifepristone, while the 20 tablets labelled 200mcg misoprostol contained between 34.1mcg and 201.4mcg of the active ingredient.

Despite the short fallings in misoprostol quality, the researchers concluded that people for whom clinic-based abortion is not easily available or acceptable may well consider sourcing pills from the internet to be a rational option.

Given that this practice is already being carried out, making medical abortion readily available OTC could go a long way toward ensuring patients are accessing safe and legitimate medicines and are less likely to turn to illegitimate sources.

Grossman says: “We’re hoping to build up the evidence base to help move this forward. I think the process of showing how safe and effective medical abortion is will help us move further away from this overly medicalised and restricted service to something that may not be quite OTC but is something that could at least be prescribed by a pharmacist who could then dispense the medication.”