Medicines Act 1968
- Introduction
- Defences
- Dispensing errors by pharmacists
- The decision-making process - The Code for Crown Prosecutors: applying the Full Code Test
Introduction
The Medicines Act 1968 protects patients from unscrupulous suppliers of medicines. Safeguarding public safety from the illegal sale or supply of medicines or any inaccurate and misleading labelling is very important. The offences in the Act are wide-ranging but there are two offences which are of particular relevance to prosecutors which are detailed below.
The Medicines Act allows a pharmaceutical mistake to be treated as a criminal offence. Parliament has decided that it should be so to protect the public.
Prosecutors should be aware there is an ongoing review of the Medicines Act, principally to consolidate the large body of secondary legislation created over the years to govern medicines regulation; however, unless and until the law is changed, this guidance should be followed by prosecutors.
The General Pharmaceutical Council (GPhC) is the current regulatory body for the pharmaceutical profession. The GPhC has wide ranging powers to set regulatory standards for pharmacists, pharmacy technicians and pharmacy premises. The GPhC also has policies in place to govern enforcement action; for example, when a dispensing error should be investigated or where regulatory sanction is more appropriate). The GPhC website is: http://www.pharmacyregulation.org/.
Investigations into suspected breaches of the Medicines Act are generally the responsibility of the Medicines and Healthcare products Regulatory Agency (the MHRA) and, in general, prosecutions under the Medicines Act (where investigated by the MHRA) are brought by the Department of Health Legal Services (Prosecutions) which has experience and expertise in prosecuting such cases. Prosecutions by MHRA are rare - in the 10 years between 1999 and 2009, three prosecutions were brought by the Department of Health. The MHRA website is: http://www.mhra.gov.uk/index.htm.
The CPS rarely prosecutes cases under the Medicines Act. Cases tend only to be investigated by the police and referred to the CPS if there has been a death following a dispensing error and gross negligence manslaughter is being considered. Medicines Act offences are occasionally used where manslaughter cannot be proved (usually where causation cannot be established or where the dispensing error was insufficiently gross).
Section 64 - protection of purchasers of medicinal products
A person commits an offence under section 64 if he or she, to the prejudice of the purchaser, sells any medicinal product, and that product is not of the nature or quality demanded by the purchaser or specified in the prescription.
Section 85(5) - labelling and marking of containers and packages
A person commits an offence under section 85(5) if he or she, in the course of a business, sells or supplies a medicinal product, or has in his or her possession for the purpose of sale or supply a medicinal product, and the medicinal product is in a container or package which is labelled or marked in a way which:
a) falsely describes the product; or
b) is likely to mislead the purchaser or another as to the nature or quality of the product or as to the uses or effects of medicinal products of that description.
The offences are either way, punishable by up to 2 years' imprisonment when tried in the Crown Court, or a fine if tried in the Magistrates' Courts.
The offences are unusual in that no mens rea is required for either offence to be committed; the offences do not distinguish between negligent, reckless or intentional commission (though the sentencing range is broad enough to allow the court to take differing levels of culpability into account when sentencing). The majority of offenders who contravene sections 64 and 85(5) are likely to do so as a result of a mistake.
Defences
There are statutory defences to both offences of 'due diligence' and 'warranty'.
Due diligence
The defence of due diligence is set out in section 121 of the Act. This section deals with contraventions that were committed by a second person. It provides that where a contravention of the Act by one person (A) is as a result of an act or default of another person (B), B may be prosecuted for the offence, irrespective of whether proceedings are brought against A. This covers the situation where a pharmacy technician prepares a prescription for the pharmacist to authorise, or where any other person has been involved in the sale and dispensing of a medicinal product.
The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 which came into force on 1 October 2009 regulate the duties of responsible pharmacists who are required under section 72A Medicines Act 1968 to establish, maintain and keep under review procedures to ensure that a pharmacy is operating in a safe and effective manner. They regulate how the responsible pharmacist should identify staff competent to undertake pharmacy tasks and how to respond to any incident suggesting that the pharmacy may not be operating in a safe and effective manner. Section 72A and the Regulations will therefore be of assistance to prosecutors when considering the extent to which a defence of due diligence might apply in an individual case.
Section 121(2) Medicines Act 1968 provides that, where a person can prove that he or she exercised all due diligence to secure that the Act would not be contravened and that the contravention was due to the act or default of another person, he or she has a defence to a criminal charge. Notice of intention to rely upon the defence must be served on the prosecutor seven days before the date of the hearing (section 121(3)).
Typically in such cases, an infringement is alleged to be due to a medicine being improperly dispensed. In order to establish the first limb of the due diligence defence, a pharmacist will need to prove, on a balance of probabilities, that he or she could not reasonably have done anything more to prevent the error occurring. In practice, this is likely to mean proving that he or she fulfilled a number of stringent, professional obligations.
The second limb of the defence requires proof by the defendant that the contravention was committed by someone else. It is often the case that medicines are dispensed, not by a pharmacist, but by a pharmacy technician or other person who may also be liable under the Act. Depending on the circumstances of the case, more than one pharmacist may be guilty of an offence, for example, where they are fulfilling the different roles of dispensing or supplying the medicines, supervising the transactions, acting as the responsible pharmacist or acting as the superintendent pharmacist.
There may also be more than one pharmacist on duty at any one time, which can complicate the evidence of liability under the Act; however, good standard operating procedures should set out clear lines of responsibility for individuals carrying out specified roles, such as a final check or patient counselling. In the absence of these, and, again, depending on the circumstances of the case, both pharmacists may be guilty of an offence.
Warranty
Section 122 provides for a defence of warranty. If the person dispensing the drugs can show that he or she purchased the product as something that could lawfully be sold in the UK, that he or she was in possession of a warranty to that effect and that the substance was in the state as when purchased, he or she will have a defence.
Dispensing errors by pharmacists
Pharmacists are required to put into place and operate written standard operating procedures defining individual responsibilities and accountability for the overall quality of care, setting out clear policies aimed at managing risks, establishing procedures for identifying and remedying poor performance and ensuring that members of the dispensing team are suitably trained, up to date and competent to undertake the tasks for which they are responsible.
They are also expected to practise the use of proper accuracy checking procedures and other risk management strategies, including patient counselling (this is, the conversation with a patient, at the time the medicine is handed over, to ensure that the right patient gets the right medicine and that he or she understands how the medicine should be taken). Pharmacists should be able to demonstrate that they have taken all reasonable steps to minimise the risks in the dispensing process and to deal with any error of which they are made aware and its consequences.
Most errors cause minimal damage or are discovered before any damage is done, but some result in injury or even death.
Pharmacists are required to record and notify incidents and the accurate and prompt recording and reporting of dispensing errors is something that the Department of Health encourages, notwithstanding that this may render the pharmacist liable to prosecution under the Medicines Act. Accurate recording and reporting allows for improvements to be made to systems and, in individual cases, action can be taken to deal with any adverse consequences the error may have had for the patient. Prompt and accurate incident reporting is essential for enhancing medicines regulation and increasing public confidence in it.
To protect the public, a balance needs to be struck between prosecution and incident reporting; the routine prosecution of pharmacists for simple dispensing mistakes would have the effect of discouraging the recording and reporting of dispensing errors, with adverse consequences for patient safety and public health. For this reason, investigations by the MHRA and prosecutions by the Department of Health are rare.
The decision-making process - The Code for Crown Prosecutors: applying the Full Code Test
CPS prosecutors are only likely to encounter the Medicines Act offences when considering other offences, most commonly gross negligence manslaughter. Note that medical manslaughter cases must be referred to Special Crime Unit within the Special Crime and Counter Terrorism Division (see Referral of Cases within the CPS Headquarters, elsewhere in the Legal Guidance).
Prosecutors will apply the Full Code Test within the Code for Crown Prosecutors when making their decisions. When the evidential stage of the Full Code Test is met, prosecutors must go on to consider the public interest stage.
When applying the public interest factors in the Code, prosecutors should consider the following points:
- 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?
Where it is not clear which prosecuting authority should have conduct of the prosecution, refer to Relations with Other Prosecuting Agencies, elsewhere in the Legal Guidance.
