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Tablet crushing: calls for caution

Richard Griffith
LLM BN DipN PgDL CPE RMN RNT CertEd
Lecturer in Healthcare Law
Centre for Philosophy Law and Healthcare
School of Health Science
University of Wales, Swansea

Every year approximately 10,000 serious adverse drug reactions are reported in the NHS,(1) despite a strict legal framework that regulates the supply and administration of medicines to protect public safety. The Department of Health suggests that half of these are avoidable errors in medication administration.(2) Disquiet over administration errors by the DH and audit commission has focused on the widespread practice of crushing tablets. In a recent survey 84% of staff working in nursing and residential care admitted crushing tablets.(3)
 
Accountability
By inappropriately crushing tablets, a nurse could be held to account in four areas of law. Through this mechanism a nurse is legally answerable with regard to their right to administer medicine and the standard of giving the medicine. The regulations can mutually or collectively demand that actions are justified and apply sanctions if those demands are not satisfied. That is, you could be fined or imprisoned under public law provisions, dismissed by your employer, removed from the professional register by the Nursing and Midwifery Council and sued by the patient.

Reasons for crushing tablets
A nurse's decision to crush tablets is generally based on one of the following:

  • To disguise the administration of the medicine.
  • To assist a patient with swallowing difficulties to take the medication.

Covert administration of medicines
As a general principle of law, every human being, of adult years and sound mind, has a right to determine what shall be done with his body.(4) It is well established that the principle of self-determination requires that respect is given to the wishes of the patient. If an adult patient of sound mind refuses, however unreasonably, to consent to treatment or care, those responsible for his care must respect his wishes, even if they do not consider it to be in his best interests to do so.(5)
Therefore, even though a nurse has the right to administer medicine, it can only be given to the person with their consent. Crushing a tablet to disguise its administration from a capable adult would be a trespass to the person in the same way that nonconsensual touching would be unlawful.
Where a person is unable to consent due to incapacity through being unconscious, or some other impairment of mental functioning such as dementia, then the law allows medication to be given, in their best interests, in the absence of a valid consent.
Inability to make a decision may occur in one of two situations: either the patient is unable to understand and retain the information that is material to the decision, especially as to the likely consequences of having or not having the treatment in question; or the patient is unable to use the information and reason as part of the process of arriving at the decision.
In England and Wales currently, relatives have no legal right to consent on behalf of incapable adults, so the decision to act in the best interests of the patient rests with the person in charge of their care.
Here, covert administration by crushing a tablet may occur if shown to be safe and in the person's best interests. If not, then the nurse will be held to account. For example, a nurse was removed from the register when found guilty of forcing a patient to swallow a tablet hidden in a marshmallow.(6)
In the case of covert administration to an incapable adult, a nurse would need to demonstrate that:

  • The patient is incapable of consenting to the treatment.
  • The medication is convincingly shown to be therapeutically necessary in the patient's best interests.
  • The decision to administer covertly accords with a practice accepted by a responsible body of professional opinion in that it can be shown that:

- All other methods of administration have been unsuccessfully tried.
- The pharmacist and those administering the medication agree on the method to be used.
- The form of the drug is safe to use covertly.

    Medication, especially in tablet form, will usually need to be crushed if administered covertly and disguised in food or drink. Nurses must ensure that no harm will result from food-drug interactions. For example, the therapeutic effect of ampicillin is likely to fail if taken with food, as it is destroyed by stomach acid. Mixing frusemide with food can result in altered diuresis as absorption is impaired by food.(7)

    The patient with swallowing difficulties
    Crushing a tablet to assist a person with swallowing difficulties appears at first glance to be a less contentious issue. Patients regularly report they are unable to take their tablets because of difficulties beyond their control - for example, the tablets are too big to swallow or too hard to break. Difficulty swallowing tablets is one of the most common problems affecting medication compliance among patients. A survey of a general practice population of some 7,000 patients reported difficulty swallowing tablets by a quarter of patients, with younger people experiencing greater problems than older persons.(8) Nurses commonly encounter patients with swallowing difficulties who need to be managed if medication adherence is to be achieved.

    Crushing tablets
    Tablet crushing carries significant risks, and nurses must carefully discuss these with their patients before advising them to crush tablets. For example, the crushing of verapamil tablets on the advice of a nurse resulted in the death of the patient.(9)

    Protecting the patient
    Statutory protection against harmful products is provided by the Consumer Protection Act 1987, which makes a producer accountable for damage caused by a defective product, and this includes medicines. For example, a manufacturer was found liable when a tablet coated with a digestible sponge caused serious inflammation of the intestine in patients who took it.(10)
    Liability for harm caused by an inherent defect in the medicinal product, however, would fall to the producer, not the nurse administering it.
    Patients are further protected by the provisions of the Medicines Act 1968 that require medicinal products for humans to be used in accordance with a product licence or manufacturing authorisation. It is essential that to safely prescribe, advise on or administer medicines to others nurses are aware of the licensed uses of the product.
    Medicines would be used in an unlicensed manner if the dose, route or form were outside the licensed terms. A nurse who advises a patient to crush a tablet or open a capsule to overcome a swallowing difficulty would be sanctioning the use of the medicine in an unlicensed form. This would remove the protection afforded by the Consumer Protection Act 1987 and render them liable to negligence for any harm caused.
    It is therefore vital that before advising a patient with swallowing difficulties to crush a tablet the nurse must conduct a full assessment of the problem. If a swallowing difficulty is present then consideration must be given to any alternative products that might be available, such as liquid or effervescent preparation, or rectal and parenteral formulation.
    Most commonly prescribed medicines are now available in liquid form, and many more can be obtained as unlicensed special formulations. The law allows the manufacture and supply of unlicensed medicinal products, commonly known as specials, by pharmaceutical companies that hold a specials licence. The medicines are formulated in accordance with the requirements of a doctor, and the product must be for use by the individual patient on the prescriber's direct personal responsibility. Specials cannot, by law, be advertised and cannot be supplied if an equivalent licensed product is available that could meet the patient's needs. Nurses can obtain information on the availability of a medicine as a special from their local pharmacist.
    Some forms of tablet medication should never be crushed (see Table 1). However, where no alternative formulation is available, then crushing may be the only option for a patient with swallowing difficulties. Before proceeding it is essential that the nurse in consultation with the prescriber and the pharmacist should consider whether:

    • There were alternative products available, such as liquid preparations.
    • The pharmacist was consulted about the method of administration and gave approval for crushing the tablet.
    • The pharmacist was consulted about the safety of crushing the tablet.
    • The patient was informed about the possible risks involved and gave consent.
    • A respected body of professional opinion would have condoned crushing the medication under the same circumstances.

    By ensuring that there are no suitable alternative preparations, confirming with a pharmacist that the tablet is safe to crush and verifying that the patient has given an informed consent and is aware of any risks, nurses will discharge their duty of care and justify their decision to advise that a tablet may be crushed.

    [[NIP27_table1_52]]

    Conclusion
    It is essential that those who administer medication to others abide by legal and professional standards at all times. The practice of crushing tablets is one that has the potential to endanger public safety and breach legal and professional requirements. It must not be done where there is a safer alternative such as a liquid preparation. Where there is no alternative, the practitioner must demonstrate that they have fully considered the safety issues by consulting the prescriber, the pharmacist and the patient, and administer the medication in accordance with a practice accepted by a responsible body of professional opinion and the drug's product licence. By following this advice the practitioner will avoid liability and the patient will safely continue to benefit from the therapeutic effects of the medication.

    References

    1. Audit Commission. A spoonful of sugar - medicines management in NHS hospitals. London: Audit Commission for Local Government & NHS in England & Wales; 2002.
    2. Department of Health. An organisation with a memory: report of an expert group on learning from adverse events in the NHS. London: Stationery Office; 2000.
    3. Wright D. Tablet crushing is a widespread practice but it is not safe and may not be legal. Pharm J 2002;269:132.
    4. Schloendorff v Society of New York Hospitals (1914) 211 NY 125.
    5. Airedale NHS Trust v Bland (1993) AC 789.
    6. Nursing and Midwifery Council. Cardiff nurse struck off over patient abuse. NMC Press Statement 184/02. London: NMC; 2002.
    7. Jordan S, Griffiths H, Griffith RA. Administration of medicines part 2: pharmacology. Nurs Standard 2003;18(3):45-54.
    8. Andersen O, Zweidorff O, Hjelde T, Rodland E. Problems when swallowing tablets. A questionnaire study from general practice. Tidsskr Nor Laegeforen 1995;115(8):947-9.
    9. Freeman H. Crushing blow. Daily Mirror 2003 Apr 17.
    10. Les Laboratoires Leo SA v Scovazzo (1999) ECC 365.