Canterbury DHB

Context

Use of Unapproved Medicines in Palliative Care

Background and definitions

Before a medicine can be marketed in New Zealand it must be registered by Medsafe. The registration process is costly and results in the production of a drug datasheet outlining several things including indications, contraindications, cautions, doses, routes of administration and formulation. These are considered to be the parameters for which the drug is ‘approved’ to be used in New Zealand. Medicines which have not gone through this registration process, or which have become unregistered, are considered to be drugs which are ‘unapproved’ in New Zealand. Unapproved medicines may still be prescribed under Section 29 of the Medicines Act. The prescribing of registered or approved medicines outside of the agreed parameters (e.g for a different indication) is also possible under Section 25 of the Medicines Act. Use of medicines under each of these sections requires additional discussion with, and consenting of patients.

The "unapproved" use of medicines has become a legitimate part of clinical practice, particularly in the palliative care population. Asking the question "Would this be considered appropriate by a body of my peers?" may be useful in deciding whether to prescribe a drug in this way.

This guide applies to situations where approved medicines are being used for unapproved indications, doses or routes (i.e. Section 25 drugs).

Patient information rules in regard to the unapproved use of medicines:

The Code of Health and Disability Services Consumers’ Rights 1996 specifies:

The following points must be considered:

  1. Consumers should be advised of the unapproved status and of any safety concerns, or warnings or contraindications regarding use of a medicine in their particular condition. The Code requires frank disclosure of information including information that may dissuade the consumer from agreeing to use of the medicine. Issues such as whether the medicine is widely used for this indication, whether its use is supported by well conducted clinical trials, whether the medicine is approved for use in adults but not in children or whether it is in fact contraindicated for use in this situation should be discussed.
  2. Informed consent to the use of a medicine is required at all times. When using an unapproved medicine, however, the requirement to obtain written consent may apply particularly where there is minimal evidence to support this use, where the evidence of the efficacy or safety of the medicine used in this manner is equivocal or if there is significant risk of adverse effects. If none of these concerns exist, a record of consent being given for ‘unapproved use’ should be still be made in the clinical record in all situations.
  3. When use of a drug is experimental or within the context of a clinical trial informed consent must be in writing. Prescribers must take responsibility for thinking through all the issues, deciding in each situation whether the use is experimental or not, and taking the necessary action.
  4. The obtaining of written consent does not mean that the requirements of the Code have been complied with. The obtaining of informed consent is a process which involves effective communication, frank information disclosure and freely given consent. It also involves careful investigation of the clinical condition of the patient and maintaining a current knowledge of treatment options.

Medicines used commonly in Palliative Care under Section 25 (approved medicines for unapproved uses)

When considering the use of a medicine for an unapproved indication, or via an unapproved route or for an unapproved age group or at an unapproved dose, it may be helpful to approach the situation as below:

Is there published evidence to support its use?

In This Section

Table of Unapproved Medicines

Table of Unapproved Medicines

Drug

Approved indication

Unapproved indication

Unapproved dose

Unapproved route

nortriptyline

depression, aid in smoking cessation

neuropathic pain

-

-

citalopram

depressive illness

anxiety (chronic)

-

-

fluoxetine

depression and associated anxiety, bulimia nervosa, obsessive-compulsive disorder, premenstrual dysphoric disorder

anxiety (chronic)

-

-

clonazepam

epilepsy, injection – status epilepticus

sedation, anxiety, agitation, restless leg syndrome, neuropathic pain, dyspnoea, hiccoughs, myoclonic jerks

> 20 mg per day

subcutaneous injection /infusion

cyclizine

-

-

-

subcutaneous infusion (but not subcutaneous injection)

dexamethasone

-

-

-

subcutaneous injection/infusion

diclofenac

pain and inflammation

itch, sweating

-

Caution: must not be given subcutaneously - irritant

fentanyl

-

patches should not be used in opioid naïve patients

-

subcutaneous injection/infusion

frusemide

 

 

 

subcutaneous injection/infusion

glycopyrrolate

during anaesthesia to dry up secretion, in peptic ulcer disease

retained secretions, i.e., "death rattle"

-

subcutaneous injection/infusion

haloperidol

psychoses, alcoholism, manic phase of bipolar disease, Tourette syndrome, intractable nausea and vomiting, neuroleptanalgesia

hiccoughs

-

subcutaneous injection/infusion

hyoscine butylbromide

muscle spasm of GI tract

retained secretions, i.e., "death rattle"

> 100 mg/ day

subcutaneous infusion

hyoscine hydrobromide

perioperative sedation and amnesia, nausea and vomiting

retained secretions, i.e., "death rattle"

-

subcutaneous infusion

ketamine

anaesthesia

severe pain, opioid tolerance reversal, neuropathic pain (in subanaesthetic doses)

-

subcutaneous injection/infusion

lorazepam

anxiety, insomnia, pre-med

skeletal muscle spasm, nausea/ vomiting

-

-

methotrimeprazine (levomepromazine)

terminal or severe pain, anxiety, restlessness, schizophrenia

nausea/ vomiting (at low doses)

-

-

methylphenidate

ADHD, narcolepsy

depression, fatigue

-

-

metoclopramide

digestive disorders, nausea and vomiting, migraine, post-op gastric hypotonia, post vagotomy syndrome, diagnostic procedures

hiccoughs

> 30 mg/day

subcutaneous injection/infusion

midazolam

pre-med, conscious sedation, sedation in ICU, anaesthesia induction, neuroleptanalgesia

hiccoughs, seizures, muscle spasm, dyspnoea

-

subcutaneous injection/infusion, buccal administration

morphine

analgesic

dyspnoea, cough, diarrhoea

-

-

naloxone

opioid overdose antidote

low dose enhancement of opioid analgesia and decrease in opioid adverse effects

-

subcutaneous infusion

naproxen

pain, inflammation

itch, sweating

-

-

octreotide

relief of symptoms related to carcinoid syndrome and vasoactive intestinal peptide secreting tumours (VIPomas), emergency treatment of gastroesophageal varices, acromegaly

nausea and vomiting due to malignant bowel obstruction, secretory diarrhoea, high fistula output

-

subcutaneous infusion

ondansetron

nausea and vomiting associated with chemo or radiotherapy, post-op nausea and vomiting

other nausea and vomiting

-

subcutaneous injection/infusion

phenobarbitone

seizures, pre-med

terminal restlessness

-

subcutaneous injection/infusion

quetiapine

psychoses, bipolar disorder

nausea and vomiting, sedation

-

-

ranitidine

duodenal/gastric ulcers, GI reflux, dyspepsia, pre-med

itch, sweating

-

subcutaneous injection/infusion

valproate

epilepsy, bipolar disorder

neuropathic pain

-

-

venlafaxine

major depression, generalised anxiety disorder, social anxiety disorder, panic disorder

neuropathic pain

-

-

Kate Grundy, Palliative Care Service, Oncology, Christchurch Hospital
Jane Vella-Brincat, Clinical Pharmacology, Christchurch Hospital

About this Canterbury DHB document (58016):

Document Owner:

Kate Grundy (see Who's Who)

Issue Date:

January 2016

Next Review:

January 2018

Keywords:

hiccups

Note: Only the electronic version is controlled. Once printed, this is no longer a controlled document. Disclaimer

Topic Code: 58016