Non-medical use (NMU) of Pharmaceuticals (Diversions)
Non-medical use (NMU) of prescription medications, polysubstance use, and criminal product diversions are contributing to overdose incidents and drug-induced deaths.
We’d like to bring your attention to International Overdose Awareness Day, held annually on the 31st of August, and to the risks of non-medical use of prescription medications.
- Concurrent drug use is common, and it is also far too common a cause of overdose harms and fatalities.
- Non-medical use of pharmaceutical products (taking someone else’s prescription, or more than the recommended dose) are also known to lead to overdose toxicity reactions including overdose fatalities.
- Many overdoses (approximately 2 of every 3) are accidental (unintentional).
- Drug-induced deaths often involve polysubstance use (concurrent use of more than one substance).
Sadly, of the hundreds of thousands of people presenting to an Emergency Room for an overdose reaction – approximately 1 in 7 people will die from a subsequent overdose, within a year’s time (but often within weeks or days), according to the Penington Institute.
Many of these overdose deaths are considered preventable, according to research by the Penington Institute.
But not everyone is aware of how to reduce our community risks of overdose deaths, such as how to recognise a suspected overdose reaction and seek emergency medical attention — in time to make a difference. This is why we all need to get involved with International Overdose Awareness Day, and increase our support of research funding for this important intiative.
- Read more about non-medical use (NMU) of prescribed medications in the blog series on the PharmOut website.
- Read the 2020 Overdose Report (Australia statistics).
- Download the Penington Institutes prevention of overdose resources including their COPE overdose prevention guidelines.
Newly released! 2021 Australian Overdose Statistics Report
- Watch the latest video from Penington Institute on their 2021 Australian Overdose Report.
Why is mixing various drug substances and/or prescriptions and alcohol unsafe? How can polydrug use lead to grievous harm, including an overdose or organ damage?
- The short answer is that drugs interact with each other in the bloodstream. This can lead to unpredictable outcomes including higher-than-normal levels of intoxication than anticipated.
- Concurrent substance use generally equates to higher levels of intoxication (blood toxicity), sometimes fatal toxicity levels.
- Concurrent use (e.g. drugs used in a single drug-taking session or an overlapping time period) is a common occurrence in a large number of overdose cases presenting to hospital Emergency Rooms.
In most cases, it is an accidental overdose; and the majority of these involve more than one substance (legal drugs like alcohol and/or illicit drugs and/or prescription medications used for non-medical-purposes).
Drug overdose awareness is an important initiative.
The 2021 Overdose Awareness Day was held on Tuesday, 31 August 2021.
The theme for the 2021 International Drug Overdose Awareness Day:
“Time to remember…Time to act”.
These awareness-building projects are led by the Penington Institute, with its team and CEO (John Ryan) key drivers of overdose awareness programs, drug-induced death prevention efforts, and drug-use safety campaigns.
Donate to drug overdose prevention research projects.
How our industry can help with prevention efforts.
Effective pharmacovigilance is a crucial factor for preventing drug-related harms
- Pharmacovigilance systems may be one of our greatest resources in preventing non-medical use (NMU) and overdose risks.
- These systems are ‘adverse-drug reaction tracking systems’.
- They ensure dose-related reactions and drug-to-drug interactions are properly recorded, categorised/attributed, reported, monitored (e.g. trends analysis), communicated, and publicised (prevented).
Training options for GMP compliance
Please also ensure your personnel, contractors, suppliers and logistics/delivery teams are compliant with:
- Pharmacovigilance system requirements and adverse event reporting responsibilities (cGMP)
- Data Integrity requirements in GMP environments
- GMP/GXP including good warehousing and good distribution practice
Resources and further reading
The Penington Institute reports and AIHW reports of drug overdose statistics in Australia
Comparison of road toll/motor-vehicle fatalities and deaths from drug overdoses (annual statistics)
- Number of fatalities/deaths from drug overdoses in Australia = ~2,000 (Source: Penington Institute)
- Number of fatalities/deaths from motor vehicle accidents in Australia ~ 1,100 to 1,200 (Source: National Road Safety Strategy)
Resources for drug safety and overdose prevention initiatives?
Research from FARE
Review the chart below from F.A.R.E’s report on online alcohol sales during Covid-19 (Source: the Foundation for Alcohol Research and Education’s report titled ‘Online and Delivered Alcohol During Covid-19‘, dated July 2021).
Overdose related terms, definitions and statistics
Definition of the term ‘overdose’ or ‘drug overdose’
The term ‘overdose’ (‘drug overdose‘) is used to describe the contributory cause, and/or direct cause, of death of an individual due to acute toxic effects of a drug (or drugs), including prescription pharmaceuticals – where an expert death investigator such as a coroner, forensic pathologist, forensic toxicologist or other qualified forensic medical investigator – determines the death was caused by acute toxic effects of the drug or drugs (e.g., the toxic effects of the drugs directly caused the death and/or played a contributory role to the individuals death).
The term ‘drug overdose death’ is synonymous with ‘drug-induced death’. Both terms exclude deaths from drug-related accidents or intoxication-related behaviours (e.g., a death from a drug overdose relates specifically to the toxic effects of the drug and/or drug quantity, including deadly contamination that occurs during illegal/unregulated manufacturing or sales).
The above definition of a drug overdose is consistent with the SAMHSA definition of overdose as a ‘drug poisoning death’.
Exclusions: Deaths associated with the behavioural effects of drug-taking (for example, fatal motor vehicle accidents or drug-influenced dangerous/self-harm behaviours) and long-term chronic effects of drug-taking (for example, alcoholic liver disease) are excluded from the definition of ‘drug overdose’. Deaths from allergic reactions to pharmaceuticals and other drugs and injuries relating to drug administration are also excluded (in other words, overdose deaths are directly related to drug product toxicity levels, such as may occur when a larger than recommended dose is ingested, consumed, or injected, or otherwise enters the bloodstream).
Source of these definitions: Coroner’s Court of Victoria, Australia (paraphrased).
Definition of “NMU” – non-medical use of pharmaceutical products.
What does the acronym “NMU” mean? It means “non-medical use” of drugs. NMU is a term primarily used to describe the diversion, use, and public health effects (such as overdoses) from non-medical use of potent drugs, such as opioids. NMU of medicines, including interceptions of supply chains by criminal groups and individuals with drug dependencies and addictions to prescription drugs and/or illicit drugs, is a key contributor to accidental and intentional self-harms (accidental overdoses as well as intentional overdoses/suicides related to NMU of prescription opioids, other types of pain control medications (‘painkillers’), and related medicines.
Drugs change hands many times between the manufacturer and patient; every transaction is an opportunity for falsified or substandard products to infiltrate the market. (Shann Hulme, David Bright, Suzanne Nielsen).
Industry support for overdose prevention
Seven (7) key pharmaceutical manufacturing responsibilities that can help reduce pharmaceutical drug abuse risks and overdose risks.
Manufacturers can take 7 key steps to play a larger role in preventing drug-related deaths from overdoses.
These 7 steps (at a minimum) include:
- Accurate product descriptions and warning labels (GMP compliant packaging and labelling) – which includes full disclosures in communications to patients and doctors, accurate promotional and marketing materials, accurate website content
- Dedicated pharmacovigilance systems (adverse event reporting to all relevant individuals, entities, and Regulatory Agencies)
- Appropriate data governance measures (data integrity checks and controls)
- Ensuring training and organisation-wide compliance with good recordkeeping practice/good documentation practice (GRK/GDocP)
– from source material acceptance
– through final delivery to patients
– including suppliers/vendors, equipment maintenance professionals, cleaners, and warehouse/distribution/logistics personnel
- Complying with Good Warehousing Practice (GWP) guidelines
- Complying with Good Distribution Practices (GDP) guidelines
- ‘Serialisation packaging technologies to improve product traceability and reduce product diversion risks (as well as prevent counterfeit products from entering medical product supply chains)
Recommended Research Articles, Peer-reviewed Journals and Government Resources
The pharmacology and toxicology of “ecstasy” (MDMA) and related drugs – Harold Kalant (Journal: CMAJ/JAMC)
Excerpt: The source and diversion of pharmaceutical drugs for non-medical use: A systematic review and meta-analysis
- The prevalence of pharmaceutical NMU now rivals the use of illicit drugs in many developed countries around the world.
- General population surveys conducted in the United States (US), Canada and Australia have found that the NMU of pharmaceutical opioids is second only to the illicit use of cannabis (Australian Institute of Health and Welfare (AIHW), 2017; Center for Behavioral Health Statistics and Quality, 2015; Health Canada, 2012; Office of National Drug Control Policy, 2011)
Article / Source: The source and diversion of pharmaceutical drugs for non-medical use: A systematic review and meta-analysis
Authors: Shann Hulme (NDARC),⁎ David Bright (UNSW), Suzanne Nielsen (UNSW)
NDARC – National Drug and Alcohol Research Centre, 22-32 King St, Randwick, NSW, 2031, Australia
UNSW – School of Social Sciences, UNSW Australia, High Street, Kensington, NSW, 2052, Australia