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CPS publishes guidance on prosecuting Medicines Act offences where a dispensing error has occurred

21/06/2010

The Crown Prosecution Service has today published Legal Guidance to Crown Prosecutors on the prosecution of offences in the Medicines Act 1968, including where there has been a dispensing error by a pharmacist. This Legal Guidance has been agreed in consultation with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health (DH).

Keir Starmer QC, Director of Public Prosecutions said: "We were made aware of rising concerns among pharmacists' professional bodies in relation to prosecuting offences under the Medicines Act 1968 where a dispensing error has occurred. The MHRA subsequently approached us with a view to creating guidance for prosecutors and we have worked together to reach agreement.

"We welcome this cooperation between our departments and believe that this Legal Guidance will ensure high quality decision making and consistency of approach when prosecutors come to consider such cases."

The Medicines Act exists to protect patients from unscrupulous suppliers of medicines and to safeguard public safety from the illegal sale or supply of medicines or any inaccurate and misleading labelling. The Act also provides for a pharmaceutical mistake to be treated as a criminal offence.

Although the Act is due to undergo a review and, therefore, some aspects of the law may change in the future, unless and until the law is changed, prosecutors should follow this Legal Guidance when reviewing such cases.

Prosecutors have to apply the Full Code Test in the Code for Crown Prosecutors when making their decisions; this includes the evidential and the public interest stages. When the evidential stage of the Full Code Test is met, prosecutors must go on to consider the public interest stage and should weigh up the following points included in the Legal Guidance:

  • The culpability of those involved in the dispensing error; for example, was it simply an error or is there evidence of recklessness or intent?
  • The seriousness of the dispensing error; for example, were the drugs particularly dangerous or poisonous in themselves, requiring very careful handling and additional checks to be in place; or was the dosage dispensed substantially greater than that prescribed or substantially beyond the usual treatment range?
  • The consequences of the dispensing error; for example, did it lead to death or moderate or severe harm, or did it have the potential to do so (without, for example, the intervention of another person)?
  • The actions of the pharmacist, pharmacy technician or any other person following the incident; did he or she report the incident and co-operate with the investigation or was there a failure to record or report the error, or evidence that it was concealed?
  • Is there evidence that the pharmacist, pharmacy technician or any other person has made other dispensing errors?
  • Has regulatory or remedial action been taken in respect of the pharmacist, pharmacy technician or any other person, or is it likely to be taken?

Ends

Notes to Editors

  1. For further information contact CPS press office on 020 3357 0906.
  2. In general, prosecutions under the Medicines Act are brought by the Department of Health Prosecution Service following investigation by the MHRA, or by the Royal Pharmaceutical Society (RPS) as part of its regulation of the pharmaceutical profession. The latter has policies in place to govern when to investigate dispensing errors, when to advise upon improvements and when to prosecute.
  3. The DPP has published his long term vision for the prosecution service and its role within the wider criminal justice system. It includes modernising the service and increasing the efficiency and effectiveness of criminal justice - read "The Public Prosecution Service: Setting the Standard" at www.cps.gov.uk/pps
  4. The CPS consists of 42 Areas in total, each headed by a Chief Crown Prosecutor (CCP). These are organised into 13 Groups, plus CPS London, each overseen by Group Chair, a senior CCP.
    In addition there are four specialised national divisions: the Central Fraud Group, Counter-Terrorism, Organised Crime and Special Crime. A telephone service, CPS Direct, provides out-of-hours advice and decisions to police officers across England and Wales. The CPS employs around 8,250 people and prosecuted 1,032,598 cases with an overall conviction rate of 86.6% in 2008-2009. Further information can be found on our website.
  5. The CPS, together with ACPO and media representatives, has developed a Protocol for the release of prosecution material to the media. This sets out the type of prosecution material that will normally be released, or considered for release, together with the factors we will take into account when considering requests. Publicity and the Criminal Justice System protocol