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					The law and prescribing practice
In the second of his two part series on law and prescribing Richard Griffith
discusses the widespread practice of crushing tablets and opening capsules. He
addresses the three main areas of negligence, covert administration and
accountability to the profession and offers advice on how to avoid liability and
ensure patients continue to benefit from the therapeutics effects of their
medication.

General practitioners need to exercise great care in their prescribing practice in
order to avoid liability.

The exercise of such care extends to giving advice to patients’ carers and nurses
about the risks inherent in treatment and safe methods of administration.
Those caring for patients in primary care are in a duty situation1. This means that
as well as obtaining consent from a capable adult or acting in the best interests
of an incapable adult the law of negligence places a duty of care on those
considered to be in duty situations2. They are required to prescribe and
administer medication to others to a standard consistent with a responsible body
of professional opinion3. If harm is caused as a result of breaching a duty of care
then there will be liability in negligence4.

The Court of Appeal in Gold v Haringey5 held that duty of care extended to all
aspects of the medical relationship. This includes advice giving, diagnosis,
treatment and prescribing practice.

In Prendergast v Sam Dee Ltd6 a GP appealed against a finding of 25 per cent
liability when a community pharmacist dispensed daonil instead of amoxil due to
an illegible prescription. The Court of Appeal held, dismissing the appeal, that a
GP’s duty extended to writing prescriptions legibly.

In Hucks v Cole7 a GP was held liable in negligence when a patient developed
septicaemia after he refused to alter a prescription for an antibiotic that a swab
result had shown to be ineffective against the organism causing the infection.
Where advice has been sought regarding the treatment of a specific patient, then
as the GP is putting himself out as an expert, a higher standard is expected of
them than of the carer. Liability for harm would generally fall on them 8.

For example, if a GP advises that medication is crushed or a capsule opened to
assist an elderly person with swallowing difficulties and harm results then liability
in negligence might arise and the person could seek damages for the harm
caused.

The classic defence in such cases is to argue that the advice was in accordance
with practice accepted by a responsible body of professional opinion3. However,
in their opinions in Bolitho v City & Hackney Health Authority9 the House of Lords
held that judges have the right to reject the professional standard as not standing
up to logical analysis. That is, unless it can be shown that the action taken was
safe or the only option in the circumstances, the court could reject the defence
and find for the applicant.

In Marriot v West Midlands RHA10 the Court of Appeal rejected expert testimony
supporting a GP’s examination and diagnosis of a patient with a head injury as
not standing up to logical analysis and found for the patient.

In considering their ruling the court adopted an officious bystander test (Re F
1990)11 to consider the logical options available. Here the law requires that
alternatives are contemplated as though an officious busy body is at your side
demanding to know what alternatives have been considered and why they have
been discounted.

Were this to be applied to a case of tablet crushing the court would consider
whether:
   There were alternative products available such as liquid preparations
   The appropriate practitioner gave approval for the crushing
   The community pharmacist was consulted about the safety of crushing the
      tablet
   The person was told about the risks involved and gave consent or a
      determination of best interests was made
   A respected body of professional opinion would have crushed the
      medication in the same circumstances
   The evidence stands up to logical analysis.

Covert administration

Administering medication covertly is a contentious issue12. To covertly administer
medication to a capable adult would be a trespass, as the person would not have
consented to the administration. If the covert administration were malicious then
a crime under the Offences Against the Person Act 1861 would be committed.
Covert administration can only occur where the recipient lacks capacity. Under
provisions of the Human Rights Act 1998 care must be given with respect and be
proportionate to the needs of the person. The European Court of Human Rights
has acknowledged that incapable adults are vulnerable and are subject to the
protection of the Court. However the Court accepts that in general the principles
of medical practice apply as long as the therapeutic necessity of the intervention
can be convincingly shown to exist13.

The Court of Appeal recently held this to mean that the decision to proceed was
in accordance with practice accepted by a responsible body of medical opinion
and that it was in the best interests of the patient.

In the case of covert administration to an incapable adult there would be a need
to demonstrate that the patient is incapable of consenting to the treatment. Also
they would need to demonstrate that 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 that have to administer 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 by disguising
       in food or drink
     The medication is necessary in the patients best interests.

A patient group that requires further consideration where covert administration is
used are those with a mental disorder. Where an incapable adult with a mental
disorder requires treatment then the doctrine of necessity applies. Treatment can
be given in the patients best interests. However, where the patient actively
resists treatment for a mental disorder the House of Lords requires that
consideration be given to detention under the Mental Health Act 1983 14.

Failing to consider these issues might render GPs liable in negligence if harm is
caused or in trespass to the person for unlawful touching if it cannot be
objectively demonstrated to be in the person’s best interests.

In extreme cases where that failure results in death then a jury may consider that
the carelessness is so careless as to amount to a crime. Here the charge would
be gross negligence manslaughter and has applied to health situations 15,16.

GPs protect themselves from civil claims by taking indemnity insurance. Doctors
who are employed by a practice are also protected by the vicarious liability that
holds the employer liable for the torts or civil wrongs of their employee
committed during the course of their employment. In return for this protection the
employee warrants through an implied contract term that they will carry out their
duties with due care and skill17. Such duties include safe prescribing practice.

To minimize their liability, employers are able to hold employees to account
through reasonable disciplinary policies. In addition the law of subrogation allows
their public liability insurers to sue the employee for the damages paid under the
Romford Ice Principle18. In this case, the House of Lords held that an employee
owes a duty to his employer to take reasonable care. Breach of this duty allows
an action in contract to be brought and damages awarded against the employer
(by reason of the employee’s negligence and breach of his duty) could be
recovered.
Accountability to the profession

The professional regulatory body, the General Medical Council (GMC), imposes
its own standards on the prescribing and administration of medication. The
emphasis is on protection of the public through these professional standards.

The standards generally follow the principles laid down by law. The key
difference is that a practitioner may be guilty of serious professional misconduct
even though they have not caused harm necessary to find them liable in
negligence. The GMC publishes guidance on the prescribing and administration
of medicines and GPs must inform their practice by reference to this guidance.

Conclusion

The practice of crushing tablets and opening capsules is one that has the
potential to endanger public safety and thereby breach the 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 pharmacist and the patient
and direct that the medicine is administered in accordance with a practice
accepted by a responsible body of professional opinion. In that way the
practitioner will avoid liability and the patient will safely continue to benefit from
the therapeutic effects of the medication.

Richard Griffith is a Lecturer in Healthcare Law, Centre for Philosophy Law and
Healthcare, School of Health Science, University of Wales, Swansea

Links

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References

   1. Kent v Griffiths & Ors 2001; Q.B. 36

   2. Caparo v Dickman 1990; 2 A.C. 605

   3. Bolam v Friern HMC 1957; 1 W.L.R. 582

   4. Barnett v Chelsea HMC 1969; 1 QB 428

   5. Gold v Haringey HA 1988; Q.B. 481

   6. Prendergast v Sam Dee Ltd 1989; Times 14th March
7. Hucks v Cole 1964; 118 NLJ 469

8. Wilsher v Essex AHA 1988]; A.C. 1074

9. Bolitho v City of Hackney Health Authority 1998; A.C. 232

10. Marriott v West Midlands RHA 1999; Lloyd's Rep. Med. 23

11. F v West Berkshire HA (1990) 2 AC 1

12. Treloar A, Beats, Philpot M. A pill in the sandwich: covert medication in food and drink J
    R Soc Med 2000; 93: 408–1

13. Herczegfalvy v Austria 1993; 15 E.H.R.R. 437

14. R. v Bournewood Community and Mental Health NHS Trust Ex p. L 1999];1 A.C. 458


15. R v Adamoko 1991; 2 Med. L.R. 277
                                     th
16. R v Misra 2003; Times April 12

17. Harmer v Cornelius 1858; 5 CB 236


18. Romford Ice & Cold Storage Co v Lister 1957; A.C. 555

				
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