Medicine at the margins unapproved unregistered and off label
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Medicine at the Margins Unapproved, unregistered and off-label. Katie Elkin , Chief Legal Advisor Lydia Wadsworth , Legal Advisor HDC Medico-legal Conference 2012.

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Medicine at the Margins Unapproved, unregistered and off-label

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Medicine at the margins unapproved unregistered and off label

Medicine at the MarginsUnapproved, unregistered and off-label

Katie Elkin, Chief Legal Advisor

Lydia Wadsworth, Legal Advisor

HDC Medico-legal Conference 2012


Medicine at the margins unapproved unregistered and off label

“Regulation touches the point between the public and the personal … When harm happens we blame ineffective regulation but when we are stopped from doing something risky we say regulation is excessive … We want to be free and we want to be safe. Nothing is wrong with either.”

Council for Healthcare Regulatory Excellence, 2010


Medicine at the margins unapproved unregistered and off label

  • Information that a reasonable consumer, in that consumer’s circumstances, would expect to receive – Right 6(1)

  • Services can only be provided if the consumer makes an informed choice and gives informed consent – Right 7(1)


Unregistered providers

Unregistered providers


Medicine at the margins unapproved unregistered and off label

  • Minimal risk of harm

  • Work under supervision

  • Other forms of regulation

    • Employer

    • Self-accreditation

  • Licensure

  • Certification


Medicine at the margins unapproved unregistered and off label

  • “Any other person who provides, or holds himself or herself or itself out as providing, health services to the public or to any section of the public, whether or not any charge is made for those services”

    Health and Disability Commissioner Act, section 3(k)


Complaints about unregistered providers

Complaints about unregistered providers


Medicine at the margins unapproved unregistered and off label

  • Honest and accurate answers to questions relating to services, including questions about the identity and qualifications of the provider – Right 6(3)(a)

  • Information that a reasonable consumer, in that consumer’s circumstances, would expect to receive – Right 6(1)


Medicine at the margins unapproved unregistered and off label

  • Services that comply with legal, professional, ethical, and other relevant standards – Right 4(2)


Treatment of woman with cancer by iridologist natural therapist 10hdc00970

Treatment of woman with cancer by iridologist / natural therapist10HDC00970


Medicine at the margins unapproved unregistered and off label

Treatment of woman with cancer by iridologist / natural therapist10HDC00970

  • Services that comply with legal, professional, ethical, and other relevant standards – Right 4(2)

  • Services that minimise the potential harm to, and optimise the quality of life of, the consumer – Right 4(4)

  • Co-operation among providers to ensure quality and continuity of services – Right 4(5)

  • Information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including an explanation of their condition– Right 6(1)(a)

  • Services can only be provided if the consumer makes an informed choice and gives informed consent – Right 7(1)


Medicine at the margins unapproved unregistered and off label

Treatment of woman with cancer by iridologist / natural therapist10HDC00970

  • Inform

  • Consult

  • Cry halt

  • Record

  • Maintain professional boundaries


Unapproved medicines

Unapproved medicines


Medicine at the margins unapproved unregistered and off label

  • Medicine

  • Set of indications

  • Dosages

  • Instructions

  • Route of administration


Unapproved medicines1

Unapproved medicines


Medicine at the margins unapproved unregistered and off label

  • An authorised prescriber / medical practitioner may sell, supply or administer(or procure for sale, supply or administration) anymedicine

    Medicines Act 1981, ss 25 and 29


Medicine at the margins unapproved unregistered and off label

  • Be satisfied that the medicine is safe and efficacious

  • Seek rigorous evidence

  • Inform the consumer

  • Follow up


Dermal filling procedure 10hdc00986

Dermal filling procedure10HDC00986


Dermal filling procedure 10hdc009861

Dermal filling procedure10HDC00986

  • Services provided with reasonable care and skill – Right 4(1)

  • Information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including an explanation of their condition– Right 6(1)(a)

  • Services can only be provided if the consumer makes an informed choice and gives informed consent – Right 7(1)


Off label

Off-label


Off label use of an approved medicine for purposes other than those approved for use in new zealand

Off-labeluse of an approved medicine for purposes other than those approved for use in New Zealand


Common off label use substantial evidence of accepted efficacy and safety

Common off-label useSubstantial evidence of accepted efficacy and safety


Medicine at the margins unapproved unregistered and off label

  • Information that a reasonable consumer, in that consumer’s circumstances, would expect to receive – Right 6(1)


Treatment of sexual dysfunction 09hdc00905 09hdc01077 09hdc01082 09hdc01540

Treatment of sexual dysfunction09HDC00905, 09HDC01077, 09HDC01082, 09HDC01540

“Mr B should have been aware that prescribing the APM nasal spray for erectile dysfunction was an ‘off-label’ use of the medication not currently included in relevant erectile dysfunction management guidelines, and not generally recognised as the first step in treatment for erectile dysfunction.”


Novel off label use where the evidence base is not extensive or the use of the medicine is uncommon

Novel off-label useWhere the evidence base is not extensive or the use of the medicine is uncommon


Experimental use

Experimental use

  • Medsafe:

  • “the unapproved use of a medicine would be considered to be experimental if there is little or equivocal documented support for the use”.


Experimental use1

Experimental use

  • Where informed consent to a health care procedure is required, it must be in writing if the procedure is experimental – Right 7(6)(b)


Research

Research

  • Randomised controlled clinical trial

  • Observational studies

  • Innovative practice?


Medicine at the margins unapproved unregistered and off label

  • “I consider the aim, hypothesis, or intent of the Proposal is the best means of distinguishing whether or not it was intended only as a means of treating patients or whether it had a research component”

    Judge Cartwright


Medicine at the margins unapproved unregistered and off label

  • Information that reasonable consumer, in that consumer’s circumstances, would expect to receive, including notification of any proposed participation in research, including whether the research requires and has received ethical approval – Right 6(1)(d)

  • Services that comply with legal, professional, ethical and other relevant standards – Right 4(2)

  • Honest and accurate answers to questions relating to services, including the results of research – Right 6(3)(d)

  • Where informed consent to a health care procedure is required, it must be in writing if the consumer is to participate in any research – Right 7(6)(a)

  • The Code extends to those occasions when a consumer is participating in, or it is proposed that a consumer participate in, research – Right 9


Medicine at the margins unapproved unregistered and off label

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