9.2 Standing orders

This guidance provides a summary of the key points from The Ministry of Health’s Standing Order Guidelines (2016) as relevant to General Practice.

To support practices further, we’ve included a standing order template and other information to help understand standing orders, all available in the resources section.

Fundamentals of standing orders

What is the intention of standing orders?

The intention of a standing order is to improve a patients’ timely access to medicines; for example, by authorising a regulated health practitioner, such as an extended paramedic or a registered nurse to administer medicine/s in a primary health care setting.

What does a standing order not allow?

A standing order does NOT allow a person to create a prescription for a patient to take to a pharmacy for dispensing, even if the issuer plans to sign it later; pharmacies are not legally allowed to dispense unsigned prescriptions.

Nor does a standing order allow a person to provide a patient with a prescription that has been pre-signed by the general practitioner or nurse practitioner who issued the standing order.

What governs the use of standing orders?

The use of standing orders is governed by Medicines (Standing Order) Regulations 2002 , which sit within a broader regulatory framework, including:

1. Medicines Act 1981 and Medicines Regulations 1984
2. Misuse of Drugs Act 1975 and Misuse of Drugs Regulations 1977
3. Health Practitioners Competence Assurance Act 2003
4. Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996.

What is the consequence of not complying with the legislation?

Failing to meet the requirements of the Medicines (Standing Order) Regulations 2002

is an offence and the Ministry of Health can audit standing orders at any time to check the correct process is being followed. . The Ministry of Health’s Standing Order Guidelines (2016) simplify the legislation into practical steps for implementing standing orders.

For practices that choose to use standing orders, it is essential to follow these guidelines and have a clear policy and procedure in place.

Who can issue a standing order in General Practice?

A standing order can be issued by a general practitioner or a nurse practitioner; the issuer must have the necessary skills and expertise regarding the medicine and conditions covered by the standing order.

The issuer is responsible for:

• Ensuring the standing order meets all legislative requirements.
• Verifying that anyone working under the standing order has the required training and competency.
• Countersigning, auditing, and regularly reviewing the standing order. (An audit can be prepared for the issuer by another team member).

Ultimately, the issuer, as the prescriber of a medicine under a standing order, is legally accountable for its safe administration and appropriate use and/supply.

Who can work under a standing order in General Practice?

The Ministry of Health’s Standing Order Guidelines (2016) describes those who can administer and/or supply medicines under a standing order as being ‘engaged in the delivery of a health service’.

The New Zealand Nurses Organisation NZNO supports midwives, registered and enrolled nurses using standing orders. Extended care paramedics (EPC) In New Zealand, are regulated by Te Kaunihera Manapou Paramedic Council, and together with Te Whatu Ora, acknowledge ECPs use of standing orders as regulated workers.

The person/groups of people authorised to be working under standing orders must have the competency and training to be able to:

• Make an assessment that the standing order applies to the presenting patient
• competently administer the medicine
• knowledgeably assess the contraindications and/or exclusions.

In general practice, team members authorised to work under a standing order are usually regulated health practitioners. NZNO supports midwives, registered and enrolled nurses using standing orders in situations where timely access to medicines can be facilitated more effectively with their use, the nurse or midwife has the requisite education and training, and the issuer of the Standing Order complies with the relevant legislation.

It is recommended that the standing order be developed in consultation with the team members expected to work under that standing order.

Unregulated (unregistered) healthcare team members working under a standing order

Unregulated healthcare workers are those who are not registered or regulated by a professional and/or a regulatory body such as those required by the Health Practitioners Competence Assurance Act 2003. Examples of unregulated team members working in general practice may include healthcare assistants and/or community health workers.

Although an issuer can legally authorise an unregulated healthcare worker engaged in the delivery of health services to administer and/or supply medicines under a standing order, it is not common practice. This is because it introduces additional risks to patient safety, and places increased responsibilities on the issuer. We have outlined below the risks and mitigation strategies for issuers when considering utilising unregulated healthcare workers to work under a standing order.

Risks of unregulated healthcare worker administering and /or supplying a medicine under a standing order.

Unregulated healthcare workers differ from regulated/registered healthcare workers, they:

• are unlikely to have in place robust professional competence and ethics oversight that is governed by a regulatory/registering body or a professional body; and
• are unlikely to have the level of clinical knowledge and assessment skills, and clinical experience as regulated healthcare workers who would usually work under a standing order i.e. nurses and paramedics.

Mitigation strategies for an issuer considering unregulated healthcare workers to administer and/or supply a medicine under a standing order.

If a health practitioner is considering authorisation of an unregulated healthcare worker to administer and/or supply medicines under a standing order, they need to involve the clinical governance group and:

1. Conduct a risk assessment to identify potential risks and their severity.
2. Evaluate risk mitigation options to determine whether and how the risks can be managed.
3. Assess overall safety to ensure that any remaining risks to patient safety are reasonable and acceptable.

To minimise risks and maintain patient safety, the practice and issuer must ensure that unregulated healthcare worker(s):

• Have a clearly defined and documented scope of practice, which is explicitly outlined in the standing order policy
• Have separate standing orders that reflect their level of competency and scope of practice
• Receive comprehensive training covering all key aspects of the standing order, the medicine being administered, and relevant health conditions.
• Work under appropriate supervision from a regulated healthcare professional by:
  • Undergoing regular competency assessments and performance monitoring
  • Following a strict countersigning process, ensuring that administration is reviewed within a limited timeframe, ideally within 24–48 hours
  • Having a separate process for unregulated health workers to address performance concerns and ensure safety and continuous improvement.

Summary of the 2016 Standing order guidelines

NB: For more detail please refer to the  Ministry of Health: Standing order guidelines August 2016 .

Medicines

The medicines which are administered under standing orders must be available onsite and be administered by authorised individuals in accordance with the legislation.

The type and category of medicines which may be administered under standing orders is specified in the standing orders guidelines. Refer to page 5 of the Standing Order Guidelines for details.

Requirements for the labelling, packing, storage and handling of medicines are specified in the Medicines Regulations 1984 . These requirements are outlined below and must be complied with for all medications administered under standing orders.

Labelling

Medicines must be labelled in English with clear and legible information and include:
• The name of the medicine.
• Active ingredients and their amounts.
• Dosage instructions.
• Warnings or precautions.
• Batch number and expiry date.
• Storage conditions.

Packaging

Medicines must be packaged in containers that protect them from contamination and degradation. Prescription, restricted, or pharmacy only medicines should not be packaged in paper containers.

Storage and handling

Medicines must be stored and handled in a manner which prevents contamination and ensure product integrity. This includes maintaining appropriate environmental conditions and following hygiene practices.

Specified contents of a standing order

Medicines (Standing Order) Regulations 2002 require that the standing order includes specific content. This information is detailed on page 6 of the Standing Order Guidelines 2016.

To support practices wishing to utilise standing orders, a standing order template, which includes the required content, is available in the resources.

How long is a standing order valid for?

The standing order must specify the period for which it applies. If it is not appropriate to state a specific period, then the standing order must state that it is to apply until it is either:

Whatever the specified period for the standing order, it must be reviewed by the issuer at least annually. The standing order must specify the required review date. Following review, the standing order should be re-signed and dated.

NB: If the issuer is on extended leave or leaves the practice, the standing order is no longer valid.

Record keeping

The authorised person administering a medicine under a standing order must document in the patient’s clinical record:

• Their assessment findings
• medicines administered
• The date and time of administering the medicine
• any adverse reactions to the medicines administered
• any monitoring or follow-up of the patient’s treatment
• the name of the person administering the medicines under the standing order.

Competency and training

All standing orders must clearly outline the required level of competence and any specific training needs and those working under standing orders must receive:

1. In-house training on the policy, procedure and documentation requirements for standing orders.
2. Training to ensure competency to safely administer the medicine under the standing order.

The issuer must review the competency of each person permitted to work under the standing order at least once a year. Clearly defining competency and training requirements in standing orders is especially important for medicines with a higher risk of serious adverse events and for unregulated healthcare workers authorised to administer medicines under standing orders.

Additional safeguards, such as assessed competency through peer or case reviews, may be required before a health professional is allowed to independently administer a high risk medicine or an unregulated health care worker administers a medicine under a standing order. This would be in addition to completing in-house training on the practice’s standing order policies and procedures.

Countersigning and audit of standing orders

The issuer of a standing order can decide whether to countersign every administration of a medicine or specify that countersigning is not required, in preference of auditing. This allows the issuer to tailor the countersigning requirements to the skill level and expertise of the individuals working under the standing order.

Key points on countersigning and auditing

Countersigning requirements

The standing order must clearly state if countersigning is required, under what circumstances and must specify the time frame for countersigning. This method is recommended for unregulated workers.

Auditing in place of countersigning

If countersigning is not required, or is required less often than once a month, the issuer must audit a sample of the medicines administrated at least monthly. If the issuer has issued multiple standing orders for different medicines or conditions, a sample must be audited for each standing order.

Audit sample sizes:
• Review 50% of records if there are 20 or fewer in total.
• Review 20–30% of records if there are 21–100 in total.
• Review 15–20% of records if there are more than 100.

Non-compliance: If non-compliance is found during the audit, double the sample size for further review.

Follow-up actions: Record audit results, document changes to the standing order, processes, or training and address any issues without delay.

Reviewing Standing Orders

Annual review

The issuer must review the standing order at least once a year to decide if it is still necessary and appropriate. If any terms need to be changed or removed, the issuer must date and sign the updated standing order. Team members affected by any changes should be identified and consulted.

Monitoring and adverse Incidents

The issuer must have a process to monitor how the standing order is being used and review any adverse incidents that occur.

Document control

A system must be in place to ensure that outdated copies of the standing order are replaced with updated versions after a review.

Availability of standing orders

The regulations require that standing order/s are available to every person working under them, any person affected by the standing order, and, on request to the issuer, any other person.

Practices can enable access to the individuals who require it through a shared electronic file, or hard copies stored in an accessible location.

Why a standing orders policy/procedure is needed

A standing order gives authorised individuals the ability to administer medicines but does not require them to do so. The decision to act under a standing order must always rely on the person’s professional judgment.

The Ministry of Health’s standing order guidelines do not go into detail on this matter and state that general practices need to develop a written standing orders policy to address this aspect. (page 4)

The standing orders policy needs to clearly outline what the agreement is between management, the issuers of the standing order, and those authorised to administer medicines under it; in relation to the decision to proceed with the standing order. To support this, the College has provided a detailed outline of the essential content practices need to include for their standing orders policy and procedure.

Standing orders policy and procedures must include:

• Demonstrate a commitment to the Ministry of Health: Standing Order Guidelines (August 2016) and include information on:
  • Record keeping (clinical documentation)
  • annual review of those working under the standing order
  • agreed methods/process for auditing and /or countersigning
  • how team member can access the standing order documentation
  • the process for initialising and managing a standing order (clinical governance involvement)
  • how the practice intends to undertake competency training for those working under standing orders and the annual review process
  • any additional competency training for administering high risk medicines
  • issuers, their expectations and responsibilities.
• Include what the agreement is between management, the standing order issuers, and those authorised to administer medicines under the standing order.
• Include the team roles who may be allowed to work under standing orders in the practice (unregulated and regulated)
• Include risk mitigation for unregulated healthcare workers