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The NHS first published their Patient Safety Strategy in 2019. The aim of the strategy was to outline ways in which the NHS planned to support patient safety and optimise care in line with their logistical challenges.
One key part of protecting patients from harm is to ensure that they can make informed decisions around the care and treatment that they receive. This includes deciding whether to take a specific medication.
In order to make decisions and give informed consent, patients must first have all of the information they need to decide whether or not to proceed with treatment.
Patient-Centred Care
Patient-centred care takes a collaborative approach to treating and healing patients. It means healthcare workers and patients themselves are working towards a common goal. Patient-centred care treats patients as individuals and takes into account their healthcare needs, opinions and feelings.
Patient-centred care aims to make people feel listened to and valued and ensures that they have a voice and can make choices.
In some circumstances, it isn’t always possible for a person to make choices about their care (such as if they have limited capacity due to dementia). In these cases, an appointed person may act on their behalf. Sometimes, clinicians may act on behalf of a person who lacks capacity due to a severe mental health condition, a cognitive disability or incapacity due to alcohol or drugs. However, even in such instances, best practice dictates that family or next of kin should be involved in decisions as far as practicable.
Patients in the UK have rights when it comes to deciding what treatments they will accept and this includes patient rights in medication administration. This includes the right to request information about different medications and the right to refuse treatment.
A patient-centred approach should ensure that everyone is treated appropriately with dignity and respect and in line with their cultural or religious beliefs.
Informed Consent
Prior to administering medication, it is important that the process of informed consent is followed for both ethical and legal reasons.
According to NHS guidelines, consent is only valid if it is:
- Informed
- Voluntary
- Given by someone who has capacity
This means that a person can only give consent if they are informed and have been given all of the information available such as:
- Benefits of the medication or treatment
- Possible side effects or interactions
- Alternative treatments
- Implications of refusing the medicine or treatment
Consent also needs to be voluntary, meaning that the decision is made from the free will of the patient and not due to pressure from medical staff or their family members.
Patients can also only give valid consent if they have capacity and are able to. This means that they can understand, retain and process all of the information given to them. Sometimes this is not possible, due to a patient’s age or mental capacity.
The three caveats must be satisfied and all necessary information should be communicated clearly so that a patient can make an informed decision.
In some extreme circumstances, medication or treatment may be administered without prior consent, for example if a person requires emergency intervention and is unconscious. Parents or carers are usually able to give informed consent on behalf of their children.
Consent may be given:
- Verbally – such as when a person agrees to collect their prescription and take their medication as prescribed
- In writing – such as when they sign a consent form before a procedure indicating that they understand any risks and are willing to proceed
Sometimes, a person’s behaviour indicates that they are consenting to a procedure, such as rolling their sleeve up and presenting their arm for an injection. This is referred to as implied consent which should not be confused with informed consent.
Sometimes, after receiving the information that they need, a person may decide not to go ahead with a procedure or they may refuse to take the recommended medication for their condition. Anyone involved in healthcare should know how to proceed in this situation.
Right to Refuse Medication
Under most circumstances people have the right to refuse medication or treatment even if doing so could result in them (or their unborn child) dying.
There are a number of reasons a person may refuse medication, including:
- Anxiety
- Concerns about side effects
- Mistrust of medical professionals
- Lack of proper understanding
- Belief that the medication won’t work
- Worries about pain (especially with injections) or fear of swallowing pills
- They believe the negatives outweigh the positives or that the medicine won’t significantly improve their quality of life
- Moral, cultural or religious reasons (for example, the patient is vegan and the medicine contains gelatine)
- Combative personality
- They want to use ‘alternative’ or ‘natural’ therapies and treatments instead
- They dislike the way the medicine looks, smells or tastes
- Allergy to some of the ingredients
- They don’t agree with their diagnosis
It is important that staff are trained in what to do if a patient refuses medication and know how to take steps to support them. The action needed will depend on the individual scenario, but may include:
- Showing empathy and understanding
- Investigating the reasons behind their refusal
- Providing education and reassurance to the patient
- Offering an alternative
- Documenting the refusal
- Trying again later
Patients cannot usually be coerced, tricked or forced into taking medication except in extreme circumstances, such as if they are being detained under the Mental Health Act, when informed consent would not apply.
Privacy and Confidentiality
Patient records usually contain highly sensitive and personal information. It is vital that all professionals in the health and social care sector uphold patient privacy and confidentiality when it comes to medication administration and treatment. This includes during routine examinations, discussions about treatment and the actual administering of medication. All patients are entitled to be respected and cared for with dignity.
Personal, confidential information about a patient’s history, treatment and medication is usually only held by their GP or other clinical staff who are directly caring for them and should not be widely accessible to others. All hospital and medical settings should have adequate protections in place to limit the likelihood of a data breach or cyber-attack. Paper records should also be stored securely.
The law regarding data protection was overhauled in 2018 when the EU General Data Protection Regulation (GDPR) 2016 came in. This legislation set out seven key principles as follows:
- Lawfulness, fairness and transparency
- Purpose limitation
- Data minimisation
- Accuracy
- Storage limitation
- Integrity and confidentiality (security)
- Accountability
Managers, administrators and anyone responsible for collecting and recording data about patients, including their medication regimes, should have an understanding of GDPR rules.
Patients have a right to expect that the information they share with primary carers is confidential. Under some circumstances, such as when there is a safeguarding issue, a decision may be made to disclose information to a third party but only if it is in the best interests of the patient.
Patients may expect a certain degree of privacy when collecting prescriptions and may want to take medication at home or in a private area. There are some instances where this is not the case, such as when heroin addicts come to the pharmacy to collect their methadone. As part of ensuring correct and effective treatment, it is necessary for addicts to take their methadone in front of the pharmacists. This ensures correct dosage and limits opportunities for medication misuse.
If medication is being administered whilst a person is an in-patient on a hospital ward, privacy curtains may be pulled closed to maintain a degree of dignity for the patient.
Medication Information
Patients have the right to request comprehensive information about medication prior to receiving treatment, such as:
- The name of the medicine and its use
- The appearance of the medication (syrup, tablets, topical cream etc)
- Potential common side effects
- Potential uncommon side effects
- How the medication might interact with other drugs or treatments
- What the correct dosage is
- How it should be kept and stored
It is extremely important that patients are given the correct information so that they can give informed consent. This reduces the chances of medicine being used wrongly which can lead to serious side effects or the treatment not working.
Clear and compassionate communication of accurate information builds trust and reduces the probability that medication nonadherence will occur. Medication adherence means how far a patient’s behaviour aligns with instructions from their healthcare professional, or how closely they are following their healthcare plan.
If a patient does not fully understand information about their treatment or medication, they have the right to ask further questions.
Right to Ask Questions
You have the right to ask questions about your medical treatment. As medications form such an important part of treatment, it is important to have a good understanding of them. This includes understanding:
- What medicine can be bought without a prescription, over the counter (OTC)
- The difference between licensed and unlicensed medication
- Brand names versus generic names (for example diazepam is sold under the brand name Valium)
- Safety of medicines
- Interactions
- Whether you can drink alcohol while taking the medicine or not
You also need a good understanding of how to take your medicine including frequency, dosage and storage to reduce the chance of medication nonadherence or a medication error.
It is also important to decide if any additional safeguards or tools need to be put in place to make sure that information is clear, for example if a patient has language or educational barriers or hearing problems.
Reporting Medication Errors
Medication errors are defined as errors that either lead to or could have led to patient harm. It applies to all of the steps in medication administration, including:
- Prescribing
- Preparing
- Dispensing
- Administering
- Monitoring
- Providing advice
Medication errors can be costly for the NHS. In the five years leading up to 1st April 2020, the total amount in damages in closed legal cases relating to medication error exceeded £10 million. Of the 321 claims that concerned only one element of the prescribing process, an error in administering occurred most frequently (in 45% of cases). 146 claims regarding errors in administration were analysed further. Errors found included:
- Wrong dosage
- Wrong patient
- Wrong drug
- Poor technical skills
Instances of wrong dose and wrong drug added together accounted for almost half of all of the cases analysed.
To minimise the chance of a medication error occurring, healthcare workers are advised to:
- Utilise technology to minimise the risk of medication errors
- Use an NHS Smartcard
- Check patient records carefully
- Report and learn from incidents to ensure they do not happen again
- Understand any relevant legislation and prescribing guidance
- Only perform tasks that they are trained to
- Ensure good record-keeping and organisation of patient notes and records
Errors are more likely to occur when services are overstretched and when staff are stressed, tired or lack the appropriate training. To reduce medication errors and improve levels of care, managers are advised to ensure adequate staffing levels and promote a culture of continuous learning within their organisation. It is also crucial to have an organised, structured and clear framework in place for medication management and storage.
Legal Framework
Patients who feel they have been given medication or treatment that they did not consent to may be able to make a complaint to the Medicines and Healthcare Regulatory Authority (MRHA).
Key pieces of legislation that relate to patient rights in medication administration include:
- The Mental Capacity Act 2005
- The Human Right Act 1998
- Medicines Act 1968
- Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001
- Human Medicines Regulations 2012
Additional information and legislation include:
- Best prescribing guidance, which is published by professional bodies including the General Medical Council (GMC) or Royal College of Nursing (RCN)
- A competency framework for prescribers which is available to prescribers from all backgrounds from the Royal Pharmaceutical Society (RPS)
All healthcare professionals must act within the law and should uphold best practice at all times as this reduces the risk of harm to patients, lessens instances of medication error and promotes a culture of transparency and trust.
Details about incidents and adverse reactions should be reported via the Yellow Card Scheme. The scheme collects data about the side effects of different drugs which helps to increase patient safety.
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