When good drugs turn bad and how Good Distribution Practice can help
I’m currently involved in the implementation of the regulatory controls around medicinal cannabis in Australia and eventually, we will need to work out the good distribution practice for medicinal cannabis. The Australian Government’s drug regulator, the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC), along with all the other stakeholders, have done a great job regulating the production, distribution and use of medicinal cannabis. But I am concerned that an equal amount of effort is not going into preventing deaths from other drugs. Drugs that have proven far more harmful than cannabis.
The stats might surprise you!
The Australian Bureau of Statistics reports on drug-induced deaths. In their latest report they say: “In 2016, an individual dying from a drug-induced death in Australia was most likely to be a middle-aged male, living outside of a capital city who is misusing prescription drugs such as benzodiazepines or oxycodone in polypharmacy (the use of multiple drugs) setting. The death was most likely to be an accident. This profile is quite different from that in 1999, where a person who died from a drug-induced death was most likely to be younger (the early 30s) with morphine, heroin or benzodiazepines detected on toxicology at death.”
While the public perception is that illicit drugs such as methamphetamines (including the drug Ice) are the biggest problem in Australia, prescription drugs actually cause the most drug-induced deaths. Those drug-induced deaths are typically in older Australians (45 years and over) and result from the use of benzodiazepines and prescription opiates.
The Government response
One of the ways the Australian Government has responded to this problem is by moving codeine-based products from over-the-counter distribution to requiring a prescription. This law change came into effect on Feb 1st 2018 and is in response to the Australian Bureau of Statistics finding that “prescription painkillers such as oxycodone, morphine and codeine were present in over 30% of deaths in 2016. Similar to benzodiazepines, they are associated with addiction, polypharmacy misuse, and are common in both accidental and intentional drug-induced deaths. Between 2010 and 2015 there was an increase of over 100% in prescriptions of oxycodone, a slow-releasing opioid (PBS, 2015).”
Organised crime own pharmacies in some countries
It’s concerning that organised crime groups are now operating legitimate pharmacies in some countries, not just pushing illegal drugs.
“With the increase in the use of illicit online pharmacies, one can expect a future rise in the level of corruption of pharmacists and medical professionals at clinics and practices, notably through fictitious prescriptions and other medical documentation.”
“Medicines also illegally enter the pharmaceutical market through theft or diversion, with small criminal groups specializing in the robbery of medicines which are then resold to secondary distributors and wholesalers, or, as is often the case, directly to pharmacists. “
Medicines also illegally enter the pharmaceutical market through theft or diversion, with small criminal groups specializing in the robbery of medicines which are then resold to secondary distributors and wholesalers, or, as is often the case, directly to pharmacists.
“Likewise, criminals have been found to also be qualified pharmacists or doctors, holding positions within genuine pharmacies and diverting medicines or buying known counterfeit medicines in order to make private gains. Criminals are also known to operate the pharmacies themselves, as well as wholesalers,42 distribution companies and other facilities, leading to the development of criminal rings in which counterfeit and illicit medicines are moved through the legal supply chain. One example from 2012 highlights this issue, with two New York pharmacists found to be involved in purchasing almost USD 274 million worth of illegally obtained HIV and AIDS medication since 2008 through a distribution network run by another suspect”.
The responsibility of pharmaceutical companies
The latest version of the PIC/S Good Manufacturing Practice guidelines, known as version 13, includes a requirement for manufacturers to consider the full lifecycle of their drugs. This arguably includes knowing where your drugs are going and who is consuming them and for time and temperature-sensitive drugs making sure they are controlled within their time and temperature bounds.
Good Distribution Practice (GDP)
Pharmaceutical manufacturers should be introducing technology and process solutions to allow the tracking of their products from the factory to the end consumer as required by good distribution practice.
Emerging Industry 4.0 technologies like blockchain and the IoT could be used for serialisation solutions include could include concepts such as RFID chips built into the packaging of high value or critical drugs. The product can then be tracked across the whole supply chain to the customer, similar to many police cars and the inventory therein is automatically scanned in and out of the yard saving countless hours for checking.
How PharmOut can help
As GMP Consultants and Engineers, we can help pharmaceutical manufacturers and distributors select and implement systems and processes to improve distribution practice. Contact us for an obligation free chat.
Other articles which may be of interest, the impact of PIC/S on Australian Wholesalers and training on Australian Wholesalers and Good Distribution Practice.