Investing in safety …
Research and development into bringing a new chemical entity to market is a very costly process - $2.6billion, according to the Tufts Center for the Study of Drug Development.
Proof of safety is one of the cornerstones of marketing authorisation, and maintaining safety through all aspects of preparation and administration of hazardous drugs, for example, chemotherapies, is of no less importance.
Safety in this context encompasses three core areas: (i) safety from contamination of the drug; (2) safety from contamination with the drug, and (3) safety of the patient from medication errors.
Safety from contamination of the drug
Ingress of microbial contaminants into the chemotherapy infusion product can have catastrophic consequences for the patient. Closed drug transfer devices mechanically prohibit the transfer of environmental contaminants into a system, and are heavily promoted to ensure product integrity.
Safety from contamination with the drug
The word ‘pharmacy’ derives from the Greek ‘pharmakon’, whose ambiguous meaning is ‘medicine’ or ‘poison’. Environmental contamination with the ‘poison’ can occur at any point of the product journey. Pre-hospital contamination points begin on the surfaces of vials as they leave the manufacturer, through the packaging process to delivery at the hospital. Once in the hospital, contamination can occur in the compounding units (in isolators and biosafety cabinets), on the ward (spillages) and at all points in between. Post-hospital, contamination is a major consideration in waste and linen management.
It follows that everyone who is exposed to these environments will be exposed to contamination. In the hospital alone, this will include porters, pharmacists, pharmacy technicians, ward nurses,patients and their families, and the general public – the fact that one of the main contamination points is ward toilet seats speaks volumes.
The same closed drug transfer devices that prohibit the transfer of environmental contaminants into a system also prevents the escape of hazardous drug or vapour outside the system, ie. in the pharmacy and on the ward.
Safety of the patient from medication error
The European Medicines Agency defines medication errors as unintended failures in the treatment process that lead to, or have the potential to lead to, harm to the patient. Types of medication error committed during drug reconstitution or administration fall into one of four categories: wrong medication, wrong dose, wrong route of administration or wrong product. More than half of all the most serious and most costly medication errors are associated with intravenous drugs: of the 38% of all errors that occur at the point of administration, only 2% are intercepted.
Innovative technologies report significant success in ensuring safety, and include (in addition to closed system drug transfer devices) software-controlled dispensing and infusion systems that integrate patient data and hospital drug libraries with working practices in the pharmacy and on the ward.
… while yielding cost-saving dividends
The annual cost of chemotherapy drugs to the NHS exceeds £1billion, and is set to rise in line with increasing demand and rising manufacturers’ costs.
In 2016, the Carter Review identified hospital pharmacy as being one of six areas requiring improved efficiencies to achieve savings for the NHS. He challenged Trusts to develop plans for ensuring improved efficiencies, and reducing waste of expensive drugs is suggested as being an achievable step toward significant savings for the NHS.
Not only have innovative devices been shown to minimise risk of contamination of product, place and people, they have also proven themselves to be instrumental in managing left-over product, reducing litigation expense and minimising medication preparation time – all contributing to cost-savings for the NHS.
It is often argued that any intervention in the process of cytotoxic preparation and administration that is shown to improve patient and healthcare worker safety justifies its existence. That it also yields cost savings is the icing on the cake.