Following a consultation by the Government last year new measures have been proposed to provide a defence for pharmacists in respect of inadvertent dispensing errors. Under the Medicines Act 1968 dispensing errors are criminal offences regardless of whether the incident is intentional or inadvertent and regardless of the severity of harm resulting in the incident. Any person found guilty of such an offence faces a fine or imprisonment for up to two years. This was seen as a significant barrier to encourage error reporting thereby increasing patient safety.
The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 amends the Medicines Act 1968 by inserting a new defence. The new defence places the burden on the defendant to prove that;
a) the adulteration took place at a registered pharmacy;
b) the defendant—
i. was a registrant acting in the course of his or her profession, or
ii. was acting under the supervision of a person who was a registrant acting in the course of his or her profession; and
c) at the time of the alleged contravention, the defendant did not know that the product was being or had been adulterated.
A similar provision is included in respect of products sold or supplied where the product was sold or supplied in pursuance of a prescription or directions given by a relevant prescriber or a patient group direction, or was a prescription only medicine that was sold or supplied in circumstances where there was an immediate need for it to be sold or supplied and a prescription could not have been obtained without undue delay.
The new legislation was approved by the Privy Council on 8 February 2018 meaning it can come into force anytime from 8 March 2018.
Whilst this may provide some comfort to pharmacists and pharmacist technicians it should be noted that other legislation may still be used in prosecutions such as gross negligence manslaughter. The legislation does not apply to those working in hospital settings.
For more information on this or any other Health and Safety issues, please contact Mark Stouph, Health and Safety Consultant.
To read more information on The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 please click here.
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