Pharmacology and prescribing: Module 1 — Legal Frameworks & Medicines Management

Why is medicines legislation important?

It provides the legal framework to ensure medicines are prescribed, supplied, administered and monitored safely, protecting wāhine, pēpi, whānau, practitioners and public safety.

What legislation regulates controlled drugs in New Zealand?

The Misuse of Drugs Act 1975 and its amendments.

What does the Misuse of Drugs Act 1975 regulate?

The classification, prescribing, administration, storage and supply of controlled drugs.

Which controlled drugs can an appropriately educated midwife prescribe?

Pethidine, morphine and fentanyl, with tramadol added following a 2022 amendment.

What is the midwifery scope for prescribing opiate analgesia?

Intrapartum use only.

When can fentanyl be used by a midwife?

In a hospital setting with medical back-up available.

Who can a midwife prescribe medicines for?

A client in their care, within their scope of practice.

Can midwives prescribe benzodiazepines?

No. Benzodiazepines such as diazepam, lorazepam, midazolam, nitrazepam, temazepam and triazolam are controlled drugs that midwives cannot prescribe.

What are possible consequences of breaching controlled drug legislation?

Disciplinary action, fines and/or imprisonment.

What are the main responsibilities relating to controlled drug registers?

Recording stock received, medicines administered or supplied, monitoring stock levels, supporting auditing and accountability, and detecting discrepancies or medication errors.

How long must controlled drug records be kept?

4 years.

How must controlled drugs be stored? In a locked cupboard secured to the building.

Some healthcare organisations may have an additional double-locking system under local policy.

What must a midwife's controlled drug prescription state?

It must state "for midwifery use only."

What is required when writing a controlled drug prescription?

The prescription must be on the appropriate prescription form and meet the legal requirements.

How should the dose and frequency be written on a controlled drug prescription?

In both words and figures.

What should a midwife do if the Medical Officer of Health requests information about a controlled drug?

The midwife must provide information about the prescribing, administration or supply of the controlled drug.

What is the Medicines Act 1981?

It provides the legal framework for medicines and was amended to enable midwives to have limited prescribing rights.

What did the 1990 amendment to the Medicines Act allow midwives to do?

Prescribe, administer and give directions on the administration of prescription medicines.

What did the 1990 amendment allow pharmacists to do?

Provide prescription medicines on the prescription of a midwife.

What does the 1999 amendment relate to?

Benzodiazepines were removed from midwifery prescribing and are regulated under the Misuse of Drugs Act 1975.

What is an unapproved medicine?

A medicine that has not been approved by Medsafe for a particular use, meaning its safety, quality or efficacy for that use has not been assessed by Medsafe in New Zealand.

What is an example of an unapproved/off-label medicine?

Nifedipine may be used off-label for premature labour, and misoprostol may be used for induction of labour with appropriate forms completed.

Can midwives prescribe unapproved medicines?

Medicines prescribed in an unapproved manner may be prescribed by the medical team but are outside the midwife's prescribing scope.

What is an example of a medicine outside the midwife's scope?

Domperidone when used as a galactagogue, because it is not registered in New Zealand for increasing lactation.

What does the Medicines Regulations 1984 set out?

The conditions under which a midwife may prescribe.

What are the prescribing timeframes for midwives?

Midwives can prescribe for the antenatal, intrapartum and postnatal period up to six weeks.

Are midwives expected to prescribe for underlying or pre-existing conditions?

No. Examples include asthma, pre-existing hypertension and thyroid conditions.

What should a midwife understand before prescribing a medicine?

The medicine's mechanism of action, possible interactions, adverse reactions, contraindications and relevant safety considerations.

What does the Medicines Amendment Regulations 2011 allow?

As authorised prescribers, midwives can prescribe for women and their newborn infants under their care, within their scope of practice.

What conditions should midwives commonly prescribe for?

Conditions commonly associated with the normal experience of pregnancy, childbirth and the postnatal period.

What should a midwife do if a medicine is outside their knowledge or expertise?

They should not prescribe it and should seek appropriate advice or referral.

What is the role of the Midwifery Council in prescribing?

The Midwifery Council determines the scope of practice and authorises midwives to prescribe within that scope.

What is the role of the Minister of Health regarding midwife prescribing?

The Minister of Health can prohibit an individual midwife from prescribing on the recommendation of the Midwifery Council.

When can a Medical Officer of Health prohibit a midwife from prescribing?

If satisfied that the midwife is addicted to medicines.

What is one key responsibility of an authorised midwife prescriber?

To prescribe safely, competently and within their scope of practice, education and expertise.

What is dispensing?

When a midwife supplies a medicine from a stock supply, such as stock held in a facility or within the midwife's practitioner supply.

What legislation governs dispensing by midwives?

The Medicines Regulations 1984 and subsequent amendments.

What should a medicine NOT be dispensed in?

In a paper container, envelope or laboratory specimen container.

What should a prescription indicate if part of the medicine has already been supplied?

The quantity already supplied should be deducted, and a comment should alert the pharmacist that part of the prescription has already been dispensed.

What are the legal requirements for a prescription under Regulation 41?

It must be legibly and indelibly printed, personally signed and dated by the prescriber, and contain the required prescriber, patient and medicine information.

What information must be included about the prescriber?

Full name, full street or postal address, and telephone number.

What information must be included about the person receiving the prescription?

Surname, each given name and address. For a child under 13, the date of birth must also be included.

What medicine information must be included on a prescription?

Medicine name, strength where appropriate, total amount or total period of supply, and dose/frequency where required.

What must be included when a medicine is administered by injection?

The dose and frequency of the dose.

What must be included when a medicine is applied externally?

The method and frequency of use.

What is a Special Authority number?

A number allocated to a patient where required for a prescribed medicine.

What is the purpose of a persons category code?

It designates the patient's co-payment and records whether they are eligible for funded services.

What are examples of persons category codes?

Y, J, A, Z, & O

1 = Community Services Card holder

3 = Not eligible/no CSC

4 = eligible prescriber/PHO or DHB

NS = not subsidised.

Category code Y = Youth

0- 13

Category code J = Junior

14- 17

Category code A = Adult

18-64

Category code Z =

High User Health Card holder

Category code O =

Oral Contraceptive

What is the maximum period of supply mentioned following the Medicines Amendment Act 2025?

The period of supply for a prescriber cannot exceed 12 months.

What can a midwife do if urgent prescription pads are unavailable or electronic prescribing has crashed?

The midwife can phone or fax the pharmacy to request the prescription be filled, but the written or electronic prescription must be presented within 7 days.

What are the three key pharmacological considerations before prescribing?

Mechanism of action, interactions and adverse reactions.

What is the role of Medsafe?

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and regulates therapeutic products in New Zealand.

Which legislation does Medsafe administer?

The Medicines Act 1981 and Medicines Regulations 1984.

What is the New Zealand Pharmacovigilance Centre?

An independent body funded by Medsafe that monitors adverse drug reactions in New Zealand.

What is CARM?

The Centre for Adverse Reactions Monitoring, which receives reports of adverse drug reactions.

What should a midwife do if they identify an adverse drug reaction?

Seek any required medical help as a priority, then report the adverse reaction to CARM.

What is PHARMAC?

The Pharmaceutical Management Agency, which decides which medicines and related products are subsidised for use in the community and public hospitals.

What is the Pharmaceutical Schedule?

A list of medicines and related products subsidised in New Zealand.

Why is it important for midwives to know whether a medicine is subsidised?

Cost can affect a woman's informed choice and access to treatment.

What should a midwife do if a suitable medicine is not fully subsidised?

Explain that a subsidised alternative is available and discuss the differences so the woman can make an informed choice.

What medicines are considered outside midwives' prescribing scope?

Drugs identified in the Pharmaceutical Schedule as unapproved for pregnancy or lactation, and drugs prescribed for the neonate.

What is a Practitioner Supply Order (PSO)?

A written order made by an authorised practitioner for the supply of community pharmaceuticals for specified purposes.

Who is included in the definition of practitioner for a PSO?

Doctors, dentists, dietitians, midwives, nurse prescribers and optometrists as defined in the Pharmaceutical Schedule.

What is NZULM?

The New Zealand Universal List of Medicines.

What is the purpose of NZULM?

It brings together medicine information from Medsafe, PHARMAC and the Pharmacy Guild into a standardised resource using common medicines language.

What is the New Zealand Formulary (NZF)?

A resource containing information about most medicines available in New Zealand.

What is BPAC?

Best Practice Advocacy Centre, which provides information supporting best-practice healthcare treatments.

What is LacMed?

The Drugs and Lactation Database, used to access information about medicines and lactation.

Why should midwives use current medicines information resources?

To support evidence-informed prescribing and ensure medicine information is current.

What is one important medication calculation safety issue?

Poorly placed decimal points and spaces can result in underdosing or overdosing.

What is Rongoā Māori?

The traditional Māori system of healing.

What does holistic health encompass in the context of Rongoā Māori and Pacific remedies?

Physical, spiritual, emotional, social and cultural wellbeing.

Why are Pacific traditional remedies culturally significant?

They are connected to cultural identity, spirituality, family relationships and community values.

Why should midwives know and ask about traditional remedies?

To understand their use, respect cultural practices and consider possible interactions with prescribed medicines.

How should midwives discuss traditional remedies?

Respectfully, openly and without judgement.

What should be documented regarding traditional remedies?

Their use should be documented as part of a comprehensive health assessment.

What should a midwife consider when a woman uses traditional remedies alongside medicines?

Potential safety concerns and interactions between traditional remedies and prescribed medicines.

Should midwives provide Rongoā Māori or Pacific remedies?

No. Midwives are not trained to provide these remedies; their role is to understand and respect their importance and support culturally safe care.

Who may provide traditional healing practices?

Traditional practitioners with the appropriate knowledge, training and role.

How can midwives support culturally safe use of traditional remedies?

Ask about their use, listen respectfully, document use, discuss potential interactions, collaborate with appropriate Māori and Pacific health practitioners, provide balanced information and support informed decision-making.

What is the role of whānau in culturally safe medicines care?

Whānau-centred care should acknowledge cultural and spiritual beliefs and support partnership and informed decision-making.

What is the overall role of the midwife in relation to Rongoā Māori and Pacific remedies?

To have awareness, recognise and value traditional practices, communicate openly, consider medicine interactions and support culturally safe, coordinated care.

What are the three frameworks mentioned for holistic and culturally responsive medicines management?

BRAIN(s)/BRAN, Te Whare Tapa Whā and the Hui Process.

What is the purpose of BRAIN(s)/BRAN?

To support informed decision-making by considering Benefits, Risks, Alternatives and Intuition/Nothing.

How does Te Whare Tapa Whā support medicines management?

It provides a holistic framework for considering different dimensions of wellbeing when supporting wāhine and whānau.

How does the Hui Process support medicines management?

It supports partnership, communication, shared understanding and culturally safe care.

What does culturally safe practice require from the midwife?

Critical reflection on personal values, beliefs, history and experiences and how these may influence practice.

Why is interprofessional collaboration important in medicines management?

It supports safe prescribing, administration and management of medicines and ensures appropriate referral or consultation when care is outside the midwife's scope.