Counterfeit Medications | Global Statistics | Australia Risks

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Counterfeit Medications | Global Statistics | Australia Risks

Counterfeit medicines — fake drugs and falsified medicines — are endangering lives.

How large is the problem of substandard medications and falsified pharmaceuticals? What are the global statistics of counterfeit medications entering countries across the globe?

And how many fake medicines are entering Australia’s pharmaceutical supply chains?

Once primarily seen in low-income regions, the phenomenon of falsified and substandard medicines has hit the mainstream.  Just last month, the World Health Organisation (WHO) announced an initiative to improve regulatory functions (June 2019), in the wake of recalls of high blood pressure treatment medications that were distributed across the globe. The medicines were found to contain carcinogenic impurities. It wasn’t a single manufacturer, either — it was several.

Another contaminated product issue related to malaria treatment drugs containing haloperidol (an antipsychotic substance).  That pharmaceutical product failure led to nearly 1,000 SAE’s (Serious Adverse Events). Over 930 people were hospitalised and 11 deaths were reported from that one drug alone (e.g., 11 fatalities related to contaminated medications). 

Consumers are unlikely to report issues stemming from fake medications due to privacy concerns (e.g., embarrassment at purchasing Viagra), fears of legal repercussions when they’ve purchased controlled medications without prescriptions, or being unable to complain when a seller has no system to accept medication complaints

This means complications and fatalities from counterfeit and substandard medications are unlikely to be reported and tracked by any authority.

Result: Significant risks and Public Health costs. 

  • A staggering 96% of online pharmacies are not compliant (meaning they could arguably be selling medications of unknown quality and/or contamination). 

One pharmaceutical manufacturer reportedly discovered over 78 different counterfeit medications had infiltrated over 109 countries. That’s just one manufacturer, and the fake medications they discovered.  The problem is growing, with the World Health Organisation concerned that over 50% of online medications could be fake


This blog covers the increasing global problem of counterfeit medications and falsified pharmaceutical products (substandard medications) and public health harms.

Discussed are global statistics, counterfeit medication fatality risks, medication purchase trends, GMP requirements, and related public health and safety concerns. Reading time: 3 minutes.

 

How do fake medications enter the supply chain? Substandard Pharmaceuticals and Counterfeit Medications


Counterfeit Medicines | Fatality Risks and Supply Chains

Public Health and Safety and Substandard Medications

Pharmaceutical manufacturing is increasingly complex.  Due to cost pressures and long-held patent changes, pharmaceutical manufacturers have relocated many of their processing plants to lower-income countries.

  • Numerous countries are now involved in the production of many common medications
  • Yet no two countries are alike in their compliance GMP and GDP

These pharmaceutical manufacturing changes have created record-keeping challenges and medication quality concerns. The contaminated blood pressure medication recall was reported as stemming from changes in manufacturing processes; and there are many medications on the market that have far too little of the active ingredient in them. This leads to sub-therapeutic dosing; which could be deadly not only to the patient (but hard to detect) but also lead to strains of antimicrobial-resistant bugs (the so-called ‘super bugs’).

GMP (and EU GMP) standards are designed to protect patients from poorly-produced medications.  There are notable inconsistencies in quality-monitoring measures around the world, however.  Irregularity in GMP Audits is common; and at times, a total lack of distribution system monitoring. This means fake medicines can enter markets more easily than ever before, at various stages of production or distribution.

  • The result is increasing uncertainty about the sterility, safety, efficacy, and potency of medications being sold worldwide.
  • It could mean that the medicines or supplements you’re taking today are fake, contaminated and/or lacking in the appropriate active ingredients.  

How big is the global problem of substandard or falsified medications?

There are two key concerns in terms of pharmaceutical quality assurance:

  • fake medicines: falsified medications/counterfeit drugs
  • substandard medications: the production process was compromised in terms of GMP / EU GMP standards; the medications are below standards and/or potentially contaminated with poisons or other medications

Large numbers of medications are now produced in low-income countries.  People are also shopping for medications online, and not paying attention to supply chains. This has led to substandard pharmaceuticals reaching patient markets around the world.

Reports suggest from 10% to 70% of medications distributed internally in low-income countries are either counterfeit, contaminated or substandard.

With counterfeit drugs, and substandard medications, infiltrating their local health systems, how can manufacturers and exporters ensure that medicines produced in these countries are CGMP / EU GMP compliant, fully tested, properly stored, sterile, properly potent and safe?

What do production channel changes mean for pharmaceutical risk management?

Yet more and more, pharmaceutical companies are seeking the economic benefits of foreign manufacturing facilities 

  • The trouble is that overseas regulation is spotty
  • GDP and GMP training, auditing and CGMP adherence, including laboratory testing of source materials and batch samples at various points of production, can vary tremendously between regions
  • Foreign GMP regulatory processes are not necessarily as rigorous, or as consistently applied, as they are in countries like Australia or the USA
  • Quality checks have less reliability; production processes themselves are also prone to compromises

These factors create numerous risk implications for pharmaceutical companies and the patients they sell to; which we cover below.

Yet overseas differences in GMP and GDP adherence are only one part of the problem of substandard medications and counterfeit brands. The other contributing factor to counterfeit drugs is consumer behaviour changes, which we’ll cover further below.


First, let’s investigate risks related to the global nature of most pharmaceutical and vitamin production processes.


Pharmaceutical manufacturing today, more than ever before, is being taken offshore…and variability in CGMP audits, other quality assessments, cleanroom processes and validation are a growing concern.

The first patient safety concern (and supplier risk) relates to GMP/GDP compliance, employee training, regulatory audits and corrective measures being so variable in different countries.

This is a notable public safety concern. 

Numerous journal publications have highlighted problems related to non-compliant pharmaceutical production facilities in several regions around the world. 

Concerns include falsified laboratory reports, unregulated storage facilities and corruptable distribution channels.

An alarming number of overseas production facilities have been exposed as having inadequately trained employees, compromised cleanrooms, a lack of sterility and hygiene monitoring, safety testing variances, testing report falsification, and outdated validation processes (amidst other concerns).

 


Production reliability, product sterility, and active ingredient potency become questionable when compliance auditing is spotty or potentially falsified. 

Substandard drugs either don’t work, leaving patients untreated (or under-treated), or contain dangerous levels of contaminants or other medications that could cause serious adverse effects or drug reactions.  


Pharmaceutical Production | GMP and Regulatory Measures

Certainly, there are reasons for seeking offshore production and distribution facilities, especially relating to labour costs. But what are the risks?

Cleanroom Designs, GMP Audits, Validation Processes and GDP (record-keeping) are not equal around the world.

  • The biggest risks in relation to overseas production, storage and distribution facilities are inconsistencies in regulatory monitoring and reporting (e.g., CGMP and GDP Audits, validation processes, testing compliance)
  • These contribute to the risks of releasing ineffective and/or contaminated products into worldwide healthcare systems

Pharmaceutical products that fall short of GMP safety and efficacy standards can go unnoticed, or under-reported, when production is scattered across the globe. 

fatalities from counterfeit medications and fake pharmaceuticals

Sample testing and source report falsification (non-compliance with GDP) is also a problem. 

Pharmaceuticals production in low-income countries or disadvantaged regions

Some Government agencies overseeing the quality of pharmaceutical production processes are simply more diligent in monitoring GMP in drug production. Not all Governments have the resources, budgets or incentives to closely monitor the industry; especially in low-income countries.

In low-income countries, there’s also a chance that financial incentives could sway an Auditor to approve samples from contaminated batches or substandard supplies. Considerations include:

  • It is feasible that bribery could corrupt the GMP Audit findings in overseas production lines
  • GMP and validation audit outcomes might rely too much on who’s been chosen to handle GMP Audits, rather than rigorous monitoring processes and integrated record-keeping systems
  • There may also be a risk of laxity in employee GMP training (including cleanroom/validation and laboratory testing training), especially in employees who have lacked educational opportunities and may have inadequate reading and writing skills for proper GMP adherence 
  • Source-to-final-supply chains are increasingly subjected to being compromised along the way

Afraid yet? You should be.

The gap in patient safety due to substandard medications is primarily related to a lack of regulatory oversight. In many cases, it’s proven fatal.


However, the problem of contaminated medicines and substandard batches of pharmaceutical products is multi-faceted.


Consumers also have a role to play in protecting themselves from ‘bad medicines’ and counterfeit medications (brand fraud).

  • Concerns about high rates of substandard pharmaceuticals and counterfeits medications are not limited to overseas production lines
  • That noted, producing drugs offshore makes quality testing and reporting reliability more difficult to manage 
  • But changes in consumer behaviours in recent decades have also played a key role in the growing problem of counterfeit medications and substandard medical products entering distribution markets around the globe

Consumption of fake medications, long seen in low-income countries, has reached the mainstream….thanks, in no small part, to our growing reliance on the internet for purchasing decisions.

The outcome of counterfeit medications and substandard pharmaceutical products entering distribution channels around the world are these:  public health harms, consumer deception and — in worst case scenarios — SAE’s that have led to a number of fatalities.

Yet consumers remain ill aware, or gullible…and even legitimate pharmaceutical supply chains have been impacted.


Fatality Statistics from Counterfeit Medicines or Contaminated Pharmaceuticals

counterfeit medications SAEs and deaths from counterfeit medications fake medications

Multiple fatalities from contaminated medicines (substandard products)  

Failure to meet GMP or PIC/S standards due to inconsistent monitoring or a lack of compliant validation processes has led to significant epidemics and other health harms.

Perhaps the most memorable incident of fatalities linked to contaminated medicines was the number of deaths resulting from contaminated steroid medication injections compounded in the USA in 2012.

The meningitis outbreak in the USA resulted in a large number of illnesses and fatalities.

This example highlights the importance of  PIC/S, GMP, GDP, cleanroom validation audits; and the public health risks of substandard medications.

Contaminated or substandard medications can result in a large number of serious illnesses and fatalities.

  • While reporting adverse effects (or SAEs) is a mandatory WHO requirement for pharmaceutical manufacturers, this wasn’t mandated for compounding chemists in the USA 
  • The contamination, and subsequent meningitis epidemic went insufficiently detected for at least four (4) months
  • Over 13,000 people were exposed to contaminated injectable medications, with an estimated 7% fatality rate

Given the epidemic outbreak of fungal meningitis from compounding chemist medications was so severe — and so deadly — the CDC moved into rapid action to ensure higher quality production and testing. Over 67 deaths were attributed to the contaminated steroid injections produced from an unregulated compounding pharmacy.

This example may not demonstrate the specific risks of multiple country production processes. But it remains a prime example of why current GMP is so critical in the manufacturing of standardised medications and quality injectable pharmaceutical solutions; and why Governments are needing increased resources to monitor online pharmaceutical suppliers.

Details of the contaminated medication crisis are as follows:


Global Pharmaceutical Manufacturing – Current Status of Affairs

Could something like the meningitis outbreak happen again? You bet.

Fatality risks from taking contaminated medications, substandard pharmaceuticals or falsified, counterfeit drugs, is on the rise.

Increased risks to patient safety stem from the dual impact of differences in GMP regulatory measures (internationally), as outlined above, and consumers’ online buying behaviours.

  • Producing sterile, standardised medications in GMP compliant settings and well-regulated countries — including frequent validation, sample testing and GMP / GDP auditing — can be costly
  • Overseas production might help producers cut costs, but the risks need to be considered

GMP, GDP and PIC/S compliance needs to be closely monitored in overseas pharmaceutical facilities and distribution channels to minimise liability risks. Frequent GMP audits, validation reporting, employee training and product testing can reduce organisational exposure to a potential catastrophe in relation to substandard or contaminated medicines. 

PIC/S and GMP protects public health and safety. 

When it comes to pharmaceutical manufacturing, frequent audits by internal Q&A teams and validation engineers, as well as from the TGA (Australia), FDA (USA) and EU PIC/S regulatory authorities, are crucial to risk reduction and public safety. Audits help identify substandard medication batches before they hit the market

Certainly, PIC/S and GMP compliance for quality production has a price.

In fact, cost-saving GMP engineering is one of the benefits of using some of the world’s best international GMP consultants (PharmOut) to design your facility and manufacturing processes. PharmOut can also train your employees in GMP, GDP, CAPA, validation across the life cycle, laboratory testing and more.

But then there’s the problem of consumers buying medications (and just about everything else) online.

While relocating production facilities overseas reduces production costs, it puts patient safety at risk.  Yet patients are actually contributing, perhaps even driving, these manufacturing decisions, by demanding lower cost medications.

  • Patients are now comparison shopping — they’re buying pharmaceuticals from unauthorised online chemists and other dodgy suppliers
  • Self-sourcing medications, even without a prescription, means patients aren’t seeing their Doctors for checkups, blood tests or medication monitoring

The net results of using online chemists include:

  • an exponentially increased risk of medications of unknown quality and potency being consumed by discount-minded patients
  • a loss of public safety controls

Pharmaceutical safety thus comes at a cost…the higher cost of producing safer medications.  Then there are the public health costs of consumers buying cheaper medications from online Chemists, of which less than 5% are legitimate. This can lead to fatalities through untreated illnesses and/or contaminated medicines.

Illegitimate online pharmacies are part of the problem. 

Excerpt: “Globally, there are about 36 000 active internet pharmacies, of which less than 5% are estimated to be legitimate.”

Source: The Medical Journal of Australia (MJA)


Global Pharmaceutical Production Practices | GMP and GDP Risks | SAEs and Safety

In essence, key contributors to substandard medications and counterfeits produced through offshore Pharmaceutical Manufacturing include:

  • varying regulation or too little regulation
  • too much room for substandard, contaminated and counterfeit medications to enter the supply chain at any given point in time
  • more difficult for decision-makers to ensure employees are fully trained, and compliant, in GMP
  • language barriers and a lack of adequate GMP training, especially if there is high turnover in production facilities
  • audit compromises and documentation falsification risks
  • contaminated water supplies
  • workers with illnesses being in the production facility
    • because they are disadvantaged and need the income
    • they might fear being fired in low-wage, employee-abundant regions
  • medications containing contaminants, toxins, unapproved formulations or inadequate supply of active ingredients
  • emerging technologies, new software systems and data integration problems present new validation concerns that need to be addressed

fatalities from counterfeit medications and fake pharmaceuticals

Summary: The public health ramifications for cheaper production are that global pricing pressures, combined with increasing demand for lower medication prices, is placing safety — and lives — at risk.

Continue reading for more on case studies of fatalities from contaminated and/or substandard medications, including counterfeit pharmaceuticals.


Statistics of Deaths from Counterfeit Medications or Substandard Pharmaceuticals

More alarming statistics — and stories — about deaths resulting from substandard or counterfeit medications are easy to find. A sampling follows.

Drug Deaths from Counterfeit or Contaminated Pharmaceutical Products or Frauds

Another mass fatality related to substandard pharmaceuticals occurred in Pakinstan, where up to 60 people died from drinking contaminated cough syrup, and over 44 children were hospitalised.

Details of the cough-syrup fatalities in Pakinstan.

Fake Heart Disease Medications and Substandard Cancer Medications

Excerpt: “Peter Gillespie, who was jailed for introducing 72,000 packets of falsified medicines into the UK’s distribution system from 2006 to 2007. 25,000 packets reached pharmacies and were given to patients. These knock-off tablets were used to treat heart disease, pancreatic cancer and mental illnesses, and had none or only part of the active ingredient they were supposed to contain. This meant that those people’s illnesses were left to take their course.” Source: https://mosaicscience.com/story/fake-drugs-global-antibiotics-amr-counterfeit-meds/

More on the fake drugs from jailed supplier Peter Gillespie

Fake Antibiotics leading to drug-resistant microbial strains

Another concern is the development of deadly antibiotic and antiviral drug-resistant microbial strains due to counterfeit products.  Anti-microbial resistant strains are suggested as being at least partially related to widespread use of substandard antibiotic medications and other counterfeit products entering the supply chain.

Some of the areas where counterfeit drugs are impacting public health in Australia include cosmetic injectables (fraudulent or contaminated injectable products causing facial disfigurement, blindness or death), pain medications, blood pressure medications, cancer medications and many others.

“Unsuspecting patients have no idea what potentially toxic or dangerous ingredients lie in counterfeit medicines. Counterfeits have been found to contain everything from arsenic, brick dust, ink and paint. Counterfeiting medicines is first and foremost a crime against patients.”  Source: Australian Department of Health | Therapeutic Goods Association (TGA)

The TGA and Australian Border Control, who participate in global efforts to curb counterfeit medications, are warning consumers not to take the risks.


When medications are produced in countries where PIC/S and GMP monitoring is lax, patients are being harmed along the way.


How big is the problem of counterfeit drugs in Australia?

  • The full extent of the problem of counterfeit drugs, in Australia, is in question. It was once estimated as being as low as under 2%.
  • What we do know now, however, is that counterfeit drugs and substandard medications are gaining entry into more countries, at higher levels, including Australia.

The current ratio of counterfeit or substandard medications vs legitimate medications (in Australia) is likely to be far greater than the percentages being published a mere 4 to 6 years ago.

Global statistics show the following fatalities from substandard pharmaceuticals and counterfeit medications:

Read more about fake medications in global markets.

Without regular laboratory testing and frequent auditing of medications arriving through various supply channels, it’s difficult to assess the full extent of damage these fake drugs — or rather, substandard and falsified pharmaceuticals — are actually causing to public health.

But counterfeit medications are certainly managing to find their way into pharmaceutical supply chains,  (including brick-and-mortar chemists, online stores and discount drug supply chains buying vitamins and medicines in bulk)

The World Health Organisation (WHO Intl) is worried. 

So, too, are public health researchers like myself, and others who remain dedicated to protecting consumers from fake medication harms.

Let’s talk about consumers!

Consumers, sadly, have developed a discount online shopping mentality that has impacted their buying behaviours.  Medications are no exception.  They’ve also learned to ‘self-diagnose’ by consulting ‘Dr. Google’. Combined, these behavioural changes mean consumers are inadvertently putting themselves in harm’s way. Firstly, by not seeking qualified medical advice when warranted; and relying on invalid claims about products, potions and creams. Secondly, from buying unproven herbal products (unapproved, untested and/or substandard) and impure or counterfeit medications, from unknown sources and supply chains.

Gullible consumers are also buying other dangerous so-called ‘health’ products online. A good example is the high rate of consumers burning toxic scented soy candles, based on supplier claims that burning scented candles can soothe respiratory concerns, such as asthma. These products are also primarily untested, and those that have been, have been found to contain numerous carcinogens. 

Further harms also occur from patients trying to save on their medication costs, or self-diagnosing and self-treating conditions based on information they find on the web.

  • They remain unaware of the fatal dangers of fraudulent medications (counterfeit copies of pharmaceuticals, only containing impurities and rarely having the correct formulations)
  • The problem is growing rapidly across the world as more suppliers enter the counterfeit drug market and more consumers across the world gain access to the internet and online purchasing options

Global Statistics of Fake Medicines | Counterfeit Drugs

  • What’s currently known about the size of the global counterfeit medication trade, likely only reflects a percentage of the actual problem.
  • Counterfeit medication statistics indicate fake medications are entering countries at alarming rates.
  • What was once mostly seen in high numbers in low-income countries, has now spread across the globe

Statistics and harms:  The issue of fake medication harms is more widespread than initially suspected.

  • Even where production sites are frequently audited, such as in heavily regulated countries (including Australia), counterfeit medications and substandard products are getting into medication supply chains — and endangering lives.
  • Growth in the online sales of counterfeit medications is reaching broader markets, via online chemist suppliers and online buying habits — meaning nearly anyone’s at risk.

These substandard medications are entering primary pharmaceutical distribution channels, despite failing to meet stringent FDA, EU and TGA quality standards.

  • Sadly, consumers remain ill aware of the dangers of fake drugs
  • Alternatively, some believe what they’re buying is real, and that safety messages are part of an industry-protective conspiracy theory
  • But until another large fatality catastrophe occurs, everyone will remain at risk (and many, even after)

Counterfeit pharmaceuticals | Necessity of GMP and Frequent Regulatory Audits of all Supplies

The counterfeit pharmaceuticals issue highlights the importance of:

  • the necessity of GMP and the value of GMP Audits including validation
  • the need for more frequent and rigorous monitoring of offshore pharmaceutical production processes and supply chains
  • stringent monitoring of pharmaceutical supply channels, especially online distribution channels where more patients are purchasing their medicinal products

Fake medicines and substandard pharmaceutical products have infiltrated health systems due to changes in purchasing behaviors (online pharmacies) and growing counterfeit manufacturers. 

Until another large fatality catastrophe related to a counterfeit or contaminated drug, it’ll be difficult to educate consumers about the importance of caution when their buying medications.


Counterfeit Medications vs Substandard Pharmaceutical Products: Is there a difference? 

To summarise, the two types of medication concerns impacting countries across the globe are:

  • Counterfeit Medications – branded as if they were the original, but found to contain contaminants and/or non-standardised active ingredients (some have no relevant active ingredients)
  • Substandard Medications that failed to meet FDA, EU and TGA standards (may be contaminated with poisons or microbes, may contain varying levels of an active ingredient)

The cost of counterfeit and substandard medications, in terms of social harms and mortality rates, is estimated to be $200,000 BILLION.

FAQS:

How fast are counterfeit medicines growing as a trend?

  • It’s also growing at an alarming rate, in part due to consumers seeking to purchase their medications either at a discount — or without a valid prescription — via online sources.
  • But even public health systems and legitimate suppliers have been impacted by falsified medications, counterfeit drugs and substandard formulations.  

There’s been a growing influx of counterfeit medications and substandard products, including fake cannabis medications; and growing awareness of the problem. But finding a solution remains to be seen.

How big is the fake medication market?

  • Reports suggest that the fake-drug epidemic is reaching $30 billion to $80 billion dollars per year.
  • The influx of counterfeit medications into health systems was once far more prevalent in low and middle-income countries, such as Africa and India.
  • But today, even high-income countries like Australia, the UK and the United States, are not immune to the problem of counterfeit pharmaceutical medications.

Counterfeit Drugs: How many fake medicines are entering the country?

  • Up to 10% of medicines in several surveyed countries were found to be counterfeit or substandard
  • In Africa, one study revealed that 70% of medications used to treat infections were fake
  • Fatalities are hard to measure in many cases, as untreated or under-treated conditions would not have been reported as being related to the counterfeit drug, which may have escaped detection as a subpar or contaminated medication

Which medications or drug brands have been found to have been counterfeit products?

Some of the drugs found to be counterfeit at large wholesale levels included:

  • Avastin (falsified cancer drug)
  • Cancer Medicines
  • HIV Medications
  • Iclusig

Fake or substandard drugs can contain unknown contents.

  • Some contents may be toxic, when manufactured under less than sterile conditions
  • Other content might be contraindicated by a patient’s health status, allergies or other health considerations

 

Concerned about your overseas GMP? Contact PharmOut’s international GMP and compliance experts, architects, engineers and validation process designers.


References and Journal Publications


. 2019 Mar; 41(1): e95–e102.

Published online 2019 Apr 11. DOI: 10.1093/pubmed/fdy092
PMCID: PMC6459355   PMID: 29860331

Substandard and falsified medical products are a global public health threat. A pilot survey of awareness among physicians in Sweden

Authors: H FunestrandMD,1 R LiuPhD,2 S LundinProfessor,3 and M TroeinProfessor1

. 2013 Sep; 183(3): 661–664.

doi: 10.1016/j.ajpath.2013.06.010   PMCID: PMC3763769   PMID: 23876717

Fungal Disease Following Contaminated Steroid Injections

Author: Marta Feldmesser
Accessed online: July 3, 2019.

Author: Connie May MHST

Connie May, B.Sci, MHST is a health researcher and writer. Qualifications: Masters Degree in Health (University of Queensland) and Bachelor of Science at the University of Texas (UTD). Her background includes post-graduate studies in cannabis, addictions, substance use trends and health-related outcomes.

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