The total cost of medical negligence payouts by the NHS in 2024–25 is estimated at £60 billion, including cases related to consent. This figure has quadrupled since 2006–07, reflecting a significant and ongoing rise in clinical negligence claims.
So, why is consent often so confusing for both patients and pharmacists? What must pharmacy professionals do to ensure the consent they obtain is valid and can be upheld in court?
Consent can take many forms: it may be given explicitly by the person, such as in writing or implied through a person’s actions or circumstances. Pharmacy professionals must use their professional judgment to determine when implied consent is appropriate and when it is not. In making this decision, they should consider legal requirements, NHS service specifications, and their workplace policies. If there is any uncertainty about whether consent has been given, explicit consent should be obtained. Ultimately, obtaining valid consent is both a legal and a professional duty of care owed to the patient.
Informed consent has certain key elements which must be present when obtaining consent in practice:
- The patient must have the capacity to understand the information the pharmacy professional provides about the treatment.
- The patient must be free from undue influence and coercion and must be acting voluntarily.
- The patient must have received ‘sufficient information’ from the pharmacy professional to make an informed decision (including information about the material risks associated with that treatment and advice on reasonable alternative treatments).
Which risks should be disclosed to the patient during the consent process? Is it realistic, or even necessary, for pharmacy professionals to go through every possible risk associated with a treatment?
These questions are best answered by reference to the Montgomery v Lanarkshire Health Board case. Nadine Montgomery was not informed about the 9-10% risk of shoulder dystocia, which could occur during vaginal delivery in her case as a diabetic mother. She was told that she would be having a larger-than-normal baby but was not offered the option of a caesarean section. The consultant considered the risk of shoulder dystocia to be low and stated that it was not her usual practice to spend much time discussing this risk with patients. However, if shoulder dystocia does occur, the consequences can be life-changing, potentially resulting in severe disabilities for the baby, as tragically happened in Nadine Montgomery’s case.
Such risks are not minor or insignificant; instead, they are of considerable importance and life-changing. If such a risk were to materialise, the impact on the patient’s life could be profound. It is the responsibility of the pharmacy professional to ensure that, through effective communication, they clearly explain the pros and cons of the treatment, outline the associated risks and benefits, and present any reasonable alternatives, enabling the patient to make a truly informed decision. Patient autonomy must be respected, and individuals’ right to make decisions about their own bodies should remain central to all healthcare provision.
Although this case involved a medical doctor, its ruling applies equally to other pharmacy professionals involved in patient care, providing treatment and advice, either individually or as part of a multidisciplinary team.
As pharmacists and independent prescribers, whose roles in patient care are continually evolving, the key takeaway is to ensure that every consultation includes all the essential elements of valid consent. Simply obtaining a signature is not enough. Professionals must:
- Explain the treatment clearly
- Discuss risks, benefits and alternatives
- Check for understanding
- Document the conversation appropriately.
My recommendation
I strongly encourage all pharmacists to read the latest General Pharmaceutical Council (GPhC) publication, titled ‘In practice: Guidance on Consent’, updated in 2025, to ensure they fully understand what constitutes valid informed consent in pharmacy practice.
If there’s just one case you read to deepen your understanding of your responsibilities in obtaining valid informed consent, let it be Montgomery v Lanarkshire Health Board.
By Sima Hassan, Senior Lecturer at Aston University
Learn more
- NHS medical negligence costs reach £60bn as maternity payouts soar
- Costs of clinical negligence
- GPhC In practice: Guidance on consent
- Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland)
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