Legal and Ethical Issues

Written by Richard Griffith, Lecturer in Healthcare Law, University of Wales, Swansea. There are several important legal and ethical implications that become relevant when the form of a medicine is changed by crushing a tablet or emptying a capsule.  These can render the person administering the medicine liable for any harm that is caused to the patient's health.

"If the nurse changes the physical form of a drug - either by crushing or opening a capsule or through adding it to something like a PEG feed - that can have some implications.  It could very well be that by changing a drug you could cause harm or injury to the patient.  If that happens, then the nurse would be accountable and could be sued for negligence."

Cassam Tengnah, Lecturer in Healthcare Law, University of Wales, Swansea.

If a person cannot swallow their medication there may be no choice but to crush up tablets or open capsules. However, unless specifically designed to do so, if tablets are crushed or capsules are emptied out this can influence the way the chemicals work and, therefore alter the clinical outcomes for the patient. Some medicines are designed to release the active ingredients into the body over a long period of time, others have a special coating to protect the stomach or to protect the medicine from breakdown in the stomach acid. In these circumstances the safety and effectiveness of the treatment cannot be guaranteed by the manufacturer if the form of the medicine is changed. You should always check with an Information Pharmacist or the company who manufactured the medicine if it is safe to alter the medication in any way.

"Pharmacists.... must consider whether alternative licensed products are available, such as the same drug with a different formulation" 

Royal Pharmaceutical Society, Professional Standards Directorate

"Pharmacists should be aware that if a formulation is crushed, dissolved or otherwise tampered with then the product will be rendered unlicensed." 

Royal Pharmaceutical Society, Professional Standards Directorate

The legal implications of dysphagia

The Consumer Protection Act

Statutory protection against harmful products is provided by the Consumer Protection Act 1987 that implements the Product Liability Directive (Directive 85/374/EEC ) from the European Union. Strict liability (liability without fault) makes a producer accountable for damage caused by a defective product and this includes medicines. For example, in Les Laboratoires Leo SA v Scovazzo [1999] a manufacturer was found liable when a tablet coated with a digestible sponge caused serious inflammation of the intestine in patients who took it.

Unless it is designed to do so, changing the form of medication by crushing a tablet or emptying a capsule removes the protection afforded by the Consumer Protection Act 1987 and renders the person administering the altered the medication liable for any harm caused.

The main statutory framework for the regulation of medicines is the Medicines Act 1968. The Act requires that all medicinal products for human use are manufactured and used in accordance with a product license or manufacturing authorisation. The actual licence is not published but its provisions are summarised in the Summary of Product Characteristics produced by the drug company. It is an essential component of this licence that the medicine would be used in an unlicensed manner if the dose, route or form are outside the licensed terms. The Act states:

"a medicine with a product licence would be used in an unlicensed manner if the dose, route or form were outside the licensed terms".

A healthcare professional who directs that a medicine can be administered by crushing a tablet or opening a capsule would be directing the use of the medicine in an unlicensed form. This would remove the protection afforded by the Consumer Protection Act 1987 that holds a manufacturer liable for a defective medicinal product and render the healthcare professional liable in negligence for any harm caused.

Unless instructed by a doctor, there is no legal scope for nurses or carers to alter the dose or change the form of a medicine by crushing a tablet or opening a capsule and to do so would be directing the use of the medicine in an unlicensed form. This would remove the protection afforded by the Consumer Protection Act 1987 that holds a manufacturer liable for a defective medicinal product.

It would also render the healthcare professionals liable for any harm caused and they would be required to justify their actions in the event of an adverse reaction. If a patient is harmed as a result then liability in negligence might arise and the person may seek damages for the harm caused.

"You are personally accountable for your practice.  This means that you are answerable for your actions and omissions, regardless of advice or directions from another professional." 

Nursing & Midwifery Council - Code of Professional Conduct 2001

The law places a duty of care on health professionals (Kent v Griffiths [2001]). They are required to prescribe and administer medication to others to a standard consistent with a responsible body of professional opinion (Bolam v Friern HMC [1957]). If harm is caused as a result of failing to discharge that duty then liability in negligence will occur (Rehman v University College London Hospitals NHS Trust [2004]).

The Court of Appeal have held that the duty of care includes giving advice to patients, carers and nurses about the risks inherent in treatment, safe methods of administration and even the standard of handwriting used to convey instructions (Prendergast v Sam and Dee [1989]). If a healthcare professional advises that medication is crushed or a capsule opened to assist with swallowing difficulties and harm results then liability in negligence might arise and the person could seek damages for the harm caused.

The standard of care generally required by law is that treatment and advice is in accordance with a practice accepted by a responsible body of professional opinion (Bolam v Friern HMC [1957]). However, unless it can be shown that the practice is a safe, evidence based, well reasoned intervention then the court has the right to reject the professional standard (Bolitho v City & Hackney Health Authority [1998]). A healthcare professional will not to be exonerated because others too are negligent or common professional practice is slack (Reynolds v North Tyneside Health Authority [2002]).

Healthcare professionals have a clear duty to administer medicines in their safest and most effective form to protect patients from any adverse clinical outcome.

The ethical implications of dysphagia

The Human Rights Act 1998

The Human Rights Act 1998 incorporates into UK law the main rights and freedoms set out in the European Convention on Human Rights by regulating the relationship between individuals and public authorities. It is now unlawful for public authorities to act in a way which is incompatible with a Convention right (Human Rights Act 1998, s.6). The Human Rights Act 1998 states:

"care must be given with respect and be proportionate to the needs of the person"

Individuals working within the NHS or for local authorities are required by law to observe Convention rights in reaching decisions and must be able to demonstrate that they have done so.

When deciding on appropriate methods of medication management and administration, it is now necessary to focus on the patient's wishes and interests as these closely echo the requirements of the Human Rights Act.
 
"Elderly patients must be treated with dignity and respect. They should not be forced to take medication against their will. If they have swallowing difficulties the most suitable preparation of the drug should be used usually in the liquid form if available. If a person has difficulties, they, a carer, or a nurse, should contact the prescribing doctor, usually the GP."
 
Royal College of General Practitioners, 2001

Best practice requirements such as careful assessment of best interests, evaluation of the therapeutic necessity of treatment and consulting with patients and when appropriate their relatives, take on added importance as a result of the Human Rights Act, which makes them an essential part of the decision-making process. (R v Dr M & Ors, Ex Parte N [2002] ).

The Disability Discrimination Act

The Disability Discrimination Act 1995 (as amended) gives people with disability the same right to access services as an able bodied person and it is unlawful to discriminate against a person because of their disability. This includes the right of access to and to benefit from medicinal products.

The Disability Discrimination Act of 1995 states that:

"A person has a disability if they have a physical or mental impairment that has a substantial and long-term adverse effect on their ability to carry out normal day-to-day activities."

"Providing disabled patients with support to manage and take a medicine safely is an essential duty under the 1995 Act."

Disability is widely defined and includes any physical or mental impairment which has a substantial and long-term adverse effect on a person's ability to carry out normal day-to-day activities. Providing disabled patients with support to manage and take a medicine safely is an essential duty under the 1995 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. For example, it may be necessary to change a bottle top to a non safety version or remove tablets from blister packs into a bottle for a person with arthritis. A person with dysphagia may require a liquid medicine, rather than a solid dose tablet or capsule. Patients with visual impairment can now expect large print labels on their medicines and those with complex regimes or who are forgetful may be given medication administration records to help them manage their medicines. Where further assistance is required then pharmacists may provide monitored dosing systems for the patient's use.

Patients with a disability no longer need to register as disabled they only have to meet the definition under the 1995 Act. The duty to meet the requirements of the 1995 Act is engaged when the patient makes their disability known to the practice nurse, doctor or pharmacist.

Tablet crushing case study

A common solution for those with swallowing difficulties is to advise them to crush the tablet (Wright 2002b). However, tablet crushing and opening a capsule to ease swallowing can pose significant risks to the health of patients.  Nurses should not give advice on this method of administration without discussing these risks with the prescriber or pharmacist. The resulting impact of such an action is well documented. At an inquest, a coroner heard how such an action resulted in the death of an elderly person suffering with angina.  Her granddaughter had crushed her slow release verapamil tablet following advice from a nurse (Freeman 2003). In another incident a nurse did not wish to disturb a patient's sleep. She crushed her oral antibiotic, mixed it with sterile water and injected it into her intravenous line. The patient recovered after receiving intensive therapy (Department of Health 2003).

More information can be found on www.swallowingdifficulties.com

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