All professionals who are involved in medicines management are governed by a legal and professional accountability to follow best practice when prescribing and administering medication. This is essential in the provision of safe and effective patient care.
A strict legal framework regulates the supply, prescription and administration of medicines to protect patient safety. By inappropriately crushing tablets or opening capsules, healthcare professionals could be legally held to account for any harm caused by this action.
In summary, the law requires that the:
- Right medicine is given to the:
- Right patient, at the
- Right time, using the
- Right dose, in the
- Right formulation
The following is a summary of the laws and professional codes of conduct which govern the prescription and administration of medicines in the UK.
The 1968 Medicines Act regulates the licensing, supply and administration of medicines. Prescription only medicines can only be given in accordance with the directions of an appropriate practitioner. Unless instructed, there is no scope to alter the dose or change the form of a prescription only medicine, for example, by crushing or opening a capsule. To do so would be a breach of the 1968 Act.
The crushing of a tablet before administration in most cases renders its use unlicensed. Consequently the manufacturer will not be liable for any ensuing harm that may come to the patient or the person administering it under the Consumer Protection Act 1987. Where harm is caused as a result of the tablet being altered by crushing, it will not be the producer who is liable but the person who crushed or advised the crushing of the tablet.
The 1995 Disability Discrimination Act means that it is unlawful to discriminate against a person because of their disability. This includes the right of access to and benefit from medicinal products.
Providing disabled patients with the support to manage and take a medicine safely is an essential duty under the Act. If a person, due to their disability, had difficulty taking medicines, the doctor, practice nurse and pharmacist would have a duty to ameliorate that impairment. A person with swallowing difficulties may require their medication in a suitable format like a liquid rather than a tablet or capsule.
In October 2000, The Human Rights Act came into effect in the UK meaning that people in the UK can take cases about their human rights into a UK court. The "right to life" is fundamental and now enshrined in UK law. The Act states that: "Care must be given with respect and be proportionate to the needs of the person." Therefore, medication should be given in its safest form to protect patients from any adverse clinical outcome.
Royal Pharmaceutical Society of Great Britain (RPSGB), 2003
The RPSGB states that ‘If a formulation is tampered with then the product will be unlicensed. Pharmacists must consider and advise on the potential for distortion of bioavailability profile of the medicine.’ Pharmacists ‘must also consider whether alternative licensed products are available, such as the same drug with a different formulation or a different drug for the same indication.’
The Nursing & Midwifery Council (2007 and 2008)
The NMC has issued advice for registered nurses and standards for medicines management on the issue of tablet crushing. It advises nurses not to crush any medication or open capsules that are not specifically designed for that purpose, as by doing so the chemical properties of the medication could be altered.
The NMC states that "The mechanics of crushing medicines may alter their therapeutic properties rendering them ineffective and are not covered by their product licence. Medicinal products should not routinely be crushed unless a pharmacist advises that the medication is not compromised by crushing, and crushing has been determined to be within the patient’s best interest."
Nurses are reminded by the NMC that under the Medicines Act 1968, only medical practitioners can authorise the administration of unlicensed medicines to humans. It is therefore unlawful to crush a tablet before administration without the authorisation of the independent prescriber (Nursing & Midwifery Council 2007b).
A nurse who advises that a tablet is crushed or a capsule opened to assist with swallowing difficulties must proceed with caution. Even when an independent prescriber authorises a medicine to be administered by crushing a tablet a percentage of liability for any harm that is caused will still lie with the administering nurse. The balance of this liability would be assessed in court.