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Legal Information On Medicine Manipulation

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 action1.

In summary, the law requires that1:

  • 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.

Smiling women holding cup Doctor talking with male patient


Human Medicines Regulation 2012

The Human Medicines Regulations 2012, regulation 46,2 broadly requires that medicinal products for human use are to be supplied and administered in accordance with a marketing authorisation. The summary of product characteristics defines the terms of use, outlining the indications, recommended doses, contraindications and route of the medicine. When a product is altered or crushed, it is being administered outside of the marketing authorisation and therefore deemed to be unlicensed usage.3

Consumer Protection Act 1987

The Consumer Protection Act 1987 assigns liability of any harm caused by a product with the producer, generally the manufacturer.4 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, the person who crushed or advised the crushing of the tablet has the liability.1

The Equality Act 2010

The Equality Act 2010 legally protects people from discrimination. It brings together previous anti-discrimination laws (such as The Disability Act 1995) with a single act.5 You are classified as disabled under the Equality Act 2010 if you have a physical or mental impairment that has a ‘substantial’ and ‘long-term’ negative effect on your ability to do normal daily activities. 6 A swallowing difficulty is likely to be long term and has a significant impact on a person’s ability to undertake normal activities such as eating and drinking.

People with a disability have the same rights of access to a service. 7 This includes patients with a long-term swallowing difficulty. Failure to make provision to support these patients is a breach of the law.

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The Human Rights Act 1998

In October 2000, The Human Rights Act came into effect, this regulates the relationship between the individuals and public authorities such as the NHS.8 This has placed a positive obligation on government to ensure that there are laws, policies and procedures in place that prevent a person, from violating the human rights of another, particularly where that person is vulnerable. This has resulted in the introduction of a range of obligations on nurses and other health professionals that now underpins their duty of care to patients.9

The Care Quality Commission now apply a human rights approach to regulation. Respecting diversity, promoting equality and ensuring human rights helps to ensure that everyone using health and social care services receives safe and good quality care.10 This may mean that medication should be given in its safest form to protect patients from any adverse clinical outcome.

View References

1. Wright et al. 2011. Prescribing Medicines for Patients with Dysphagia. A handbook for healthcare professionals. | 2. Human Medicines Regulations 2012. Available online: http://www.legislation.gov.uk/uksi/2012/1916/contents/made (accessed on 28th April 2020). | 3. Wright D, Smithard D, Griffith R (2020) Optimising Medicines Administration for Patients with Dysphagia in Hospital: Medical or Nursing Responsibility? Geriatrics 2020, 5, 9. | 4. The Consumer Protection Act 1987. Available online: https://www.legislation.gov.uk/ukpga/1987/43 (accessed on 28th April 2020) | 5. Equality Act 2010: guidance. https://www.gov.uk/guidance/equality-act-2010-guidance (accessed 28th April 2020) | 6. Definition of disability under the Equality Act 2010 https://www.gov.uk/definition-of-disability-under-equality-act-2010 (accessed 28th April 2020) | 7. Equality Act 2010. Available online: http://www.legislation.gov.uk/ukpga/2010/15/data.pdf (accessed 28th April 2020) | 8. Human Rights Act 1998. Available online: http://www.legislation.gov.uk/ukpga/1998/42/data.pdf (accessed 28th April 2020) | 9. Griffith. R. Duty of care is underpinned by a range of obligations. British Journal of Nursing, 2014, Vol 23, No 4. | 10. Care Quality Commission. Our human rights approach for how we regulate health and social care services: February 2019. Available at: https://www.cqc.org.uk/sites/default/files/20200922_Our_human_rights_approach_post_consultation_document_FINAL_WEB_accessible.pdf (accessed 28th April 2020)

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