Diversion of Pharmaceutical Products: Prevention Measures

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Diversion of Pharmaceutical Products: Prevention Measures

Diversion of prescription drugs

This is Blog 5 of 10 blogs in the overdose awareness and prevention series.

Diversion of pharmaceutical products is an ongoing concern in terms of overdose deaths, as diversions can lead to potent medical substances (such as synthetic opioids), being moved into illicit supply chains, where they are mixed with a variety of contaminated, deadly chemicals – increasing toxicity risks and overdose harms.

This article provides a brief overview of:

  • diversion of pharmaceutical products for non-medical use (NMU)
  • unintentional overdose deaths resulting from purchasing unregulated products and/or polysubstance use
  • product security risks and importance of Good Distribution Practice (GDP)
  • the need for effective pharmaceutical materials inventory controls, supply chain auditing, and other product security measures

 

Diversion of pharmaceutical products for NMU

Diversion of pharmaceutical products – a growing concern for overdose prevention

  • Diversion of pharmaceutical products is an ongoing concern in the pharmaceutical sector and patient care settings.
  • Diversion of pharmaceuticals and APIs can lead to potent medical substances (synthetic opioids) being moved into illicit supply chains, where they are mixed with a variety of contaminated, deadly chemicals.
  • Diversion of pharmaceuticals can also lead to individuals taking un-prescribed medications (prescription thefts) without physician supervision; which is notoriously dangerous (particularly for opioids).

Medicines most likely to be diverted are opioid prescription medicines and Benzodiazepines.

Diversion attempts can involve the diversion of raw materials (APIs), shipments to distribution channels, finished products, prescription theft, and prescription fraud.


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Review the latest overdose statistics in the Penington Institute’s 2021 Australian Overdose Report.*

*Report publication date: 31st of August 2021.


Dangers of diversion of opioid medications, APIs, and other active ingredients

Pharmaceutical products are key ‘diversion’ targets for illicit drug distributors.

These distributors include illicit online pharmacies that fool consumers into purchasing substandard medicines and/or counterfeit pharmaceutical products by advertising ‘low-cost prescriptions’.

Products purchased from illicit online pharmacies are dangerous because they are either misused (mixed with or taken with other substances) or, more commonly, not at all what the consumer was expecting.


Illicit pharmacies spend a lot of money on advertisements — and consumers are lured into making purchases due to the low cost of products.

But low-cost medicines come at a much higher price – the price of people’s lives, from unintentional overdoses — and the use of toxic, substandard, counterfeit medications.


Consumers risks in relation to product diversions of APIs, finished pharmaceutical products, and prescriptions

  • The consumer typically only finds out their pharmaceutical supplies were fake, and highly contaminated, when they wake up in the Emergency Room — if they wake up in the emergency room.
  • They may be too embarrassed to admit to buying medicines from illicit supply chains or they may have genuinely thought their medicine was ‘real’.
  • Or if they experience an overdose related to taking someone else’s medication – they may wait too long to get treatment – and waiting before calling for an Ambulance can prove fatal in a matter of minutes

Sometimes, tragically, they bypass the ER and head straight for the morgue.

In an overdose toxicity scenario — every second counts.

A suspected overdose must be treated as an urgent medical emergency (dial 000 or our relevant emergency services number).

We should all learn what to do, and what not to do, in the event we become a first responder to an overdose scenario.


And the illicit distributors, including those illegal online pharmacies?

They remain unaccountable, unpunished, and at large.

Very often, these illicit online pharmacy products are fake. They leave patients and consumers exposed not only to inadequate levels of their prescribed medications, but to other chemical contaminations and toxicity levels that can, and often do, lead to death.

  • These criminal organisations and illicit pharmaceutical supply chains are driven by profits.
  • They show no regard for the safety of the patient or [non-medical use] consumer.
  • Because they are underground and/or offshore distribution channels, deaths related to their drug supply chains are rarely punished.

It may not even be recognised by medical providers that such deaths related directly to illicit pharmaceutical supply chains (products never subjected to quality testing, regulatory audits, or manufacturing facility inspections).


Read the article on Good Distribution Practice and prevention of dangerous medicines – “GDP – can we do more?


The war on crime, going on for 50 years, has failed. Overdoses and other drug-related harms have steadily increased. Read more about the need for drug-use safety measures in the Penington Institute’s 2020 Overdose Statistics Report.


The 2021 Overdose Report is now available.

Download the 2021 Overdose Report from the Penington Institute.

This is the 5th of 10 blogs in a series of articles bringing awareness to overdose risks, non-medical use of prescription medications, and overdose prevention research being conducted by the Penington Institute.  For additional information, read this entire series of blogs being published from 22 August 2021 through 31 August 2021 in support of overdose awareness and overdose prevention day.


What’s being sold in the illicit supply chains?

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These distribution channels sell fake (counterfeit), substandard, and unregulated products (meaning they are not quality tested). These illicit products contain varying amounts of active ingredients — as well as toxic chemicals — that would never pass a batch-testing quality procedure in a pharmaceutical manufacturing facility.

APIs are diluted by criminal supply chains. They are mixed with various toxic chemicals and fillers.

Even glass shards and paint thinners have been found in medicines sold illicitly via the web (unauthorised pharmacy chains).


Consumer/patient education is needed

The fact that most online pharmacies are unauthorised (and selling illegally-branded, contaminated counterfeits) is not widely known by consumers.

Consumers remain underinformed about the risks of purchasing medicines through unregulated supply chains.

They often believe they’re buying ‘the real thing’ – or a ‘close enough’ substitute.

But what they end up taking is anything but ‘close’ to what they think they’re buying.

So it’s not simply street-purchased pharmaceuticals and ‘party drugs’ that lead to fatality risks. It’s ANY substance that, originally intended for a quality-managed supply chain, has been criminally diverted into the hands of individuals with no regard for public safety.


How does diversion of opioid medications actually occur?

Opioid-based prescription drugs and active/psychoactive ingredients, and other types of pain-relieving medications, are key targets for criminal diversions by sophisticated crime gangs.

There are many ways that sophisticated crime rings access — and divert — supplies.

For example, diversions may result from bribing low-paid delivery drivers (or warehousing personnel), to swap deliveries with substitute products and/or falsely branded products.

Some crime rings use very sophisticated methods to substitute real products with look-alike counterfeits — even highly trained pharmacists may have a difficult time telling a counterfeit package from a real one!


  • Entire batch shipments of products or APIs (active pharmaceutical ingredients) might be stolen, for example, and substituted for fake/counterfeit versions of those products.
  • This diversion may remain undetected, especially if GMP/GDP procedures aren’t being followed.
  • This diversion risk is why several Regulatory Authorities are demanding packaging serialisation technologies as well as other batch-tracing GMP compliance measures such as GDP.

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Pharmaceutical Industry and Government reading (recommended):

Importance of Good Distribution Practice (GDP) and prevention of product diversions

How pharmaceutical product serialisation technology helps prevent product diversions


Other pharmaceutical product diversion risks

Pain management medication (opioids) prescription diversions and “prescription fraud”

Potent pharmaceutical products are key diversion targets for illegal distribution channels — but they also attract diversion efforts for non-medical use (NMU).

  • Doctors are typically closely monitored in relation to their prescribing habits for opioid-based medicines.
  • The factors leading to the opioid pandemic in the US have been covered extensively in the news.
  • Fines are into the billions of dollars (so far) for the over 800,000 opioid-related deaths since 2000.

Not all of these opioid-related overdose deaths were linked with legal prescriptions.

Additionally, some healthcare workers – under increasing amounts of stress – may find themselves in a position to ‘divert’ potent opioid medications; or substitute these medications for something similar-looking but far less effective.


Again, once products leave a quality-managed supply chain, they are often mixed with alcohol and other substances for non-medical purposes (otherwise known as ‘recreational use’).


Unsafe substance use and opioid products are often made from diverted pharmaceutical products and/or stolen medications.

Diverted products, and their derivatives, can result in dangerously increased blood toxicity levels. This toxicity can lead to a potentially fatal overdose; and if urgent medical care is not sought (or is otherwise unavailable), a person can die.

And according to CDC overdose statistics and other studies by the Penington Institute, many overdose victims DO die – and these are typically unintended overdose reactions and preventable deaths.

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Snapshot: Why diverted pharmaceutical substances and APIs are harmful in illicit distribution channels

  • Diversion of pharmaceutical medicines leads to unsafe, contaminated products entering illegal/unregulated supply chains.
  • These products vary greatly in potency (dosing) and purity levels.
  • Substance purity from a quality-tested, Quality Department approved pharmaceutical product can decrease by 90% or more once it reaches an illicit supply chain.
  • Products get diluted with various deadly toxins and fillers to ‘extend the production line’ (volume).

Stolen pharmaceutical products are often mixed, or heated up, in dirty tubs in garage-style drug labs. They have been found to contain glass particles, metals, paint thinners, and various other organ-damaging, deadly toxins.


Stopping deadly illicit products from entering the consumer supply chain has proven an impossible task, despite billions of dollars spent — and 5 full decades of effort! More needs to be done on the consumer end to ensure drug-use safety and overdose prevention.


Please get involved in the International Drug Overdose Awareness Day and ongoing research efforts.

Please click here to donate to the Penington Institute and click here to organise an overdose awareness campaign or fundraising event.


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FAQs about the diversion of pharmaceutical products – with a focus on opioid medications

Read the article on 2021 overdose statistics, annual emergency room visits (US/CDC data), and the impact of the pandemic on substance use rates and unintentional overdose deaths.

1) How does diversion of opioids occur?

Diversion of pain medications can range:

  • from a family member (or healthcare worker/carer) stealing medications from medicine storage cabinets (for ‘partying purposes’)
  • to criminal drug rings diverting APIs and finished products into their ‘street drug’ supply chains
  • to sophisticated interceptions of legitimate supply chains

These materials become contaminated with dangerous bacteria, health-damaging moulds, and deadly poisons.

 


2) When is the diversion of pharmaceuticals most likely to occur?

Product diversion can occur at ANY TIME.

This includes diversion efforts:

  • during the raw source material purchasing/shipping stages
  • during manufacturing/production
  • during warehousing and/or delivery
  • during final distribution or patient administration process.

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3) Diversion of pharmaceutical products – high-risk activities and time frames.

These medicinal products are very valuable to illicit distribution chains. This includes illicit online pharmacies as well as street-level drug distributers (‘dealers’).

So regarding opioids and other products:


Diversion risks of pharmaceutical products (opioids/synthetic opioids) may occur in relation to GMP breaches such as:

  • Manufacturing personnel not being adequately trained in GMP and GxP
  • Inadequate or poor recordkeeping practices during manufacturing, warehousing and/or delivery
  • Data governance breaches (lack of inventory controls) at various points of production or product movement
  • Intentional fraud during recordkeeping to avert API diversion/product theft detection (e.g. diverting a portion of the original active ingredient quantity and then entering incorrect weights, or entering the incorrect number of finished product boxes off a production line)
  • Warehouse and transportation personnel not having GDP training
  • Theft of medications from patients by friends or caring teams

Please donate to support Penington Institute’s important drug overdose prevention research and life-saving overdose awareness education resources. 

 

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The 2021 Overdose Report is now available.

Download the 2021 Overdose Report from the Penington Institute.

 


For additional information, read this entire series of blogs being published from 22 August 2021 through 31 August 2021 in support of polydrug-use overdose awareness and overdose prevention day.


Overdose research/drug diversion articles (suggested reading):


Read the article on Good Distribution Practice and prevention of dangerous medicines – “GDP – can we do more?” 

Review last year’s Australian and International Overdose Research Report (2020)

Download the 2021 Overdose Report from the Penington Institute (latest overdose statistics).