Legal and NZSCM Requirements of Standing Orders.
Standing Orders are written documents that allow non-doctor health professionals (e.g. nurses) to dispense medications without a prior doctor's consultation, as long as certain standards are met.
In the field of Cosmetic Medicine, this allows nurses, who have been assessed by the issuing doctor as suitably competent, to administer injectable treatments such as botulinum toxin (Botox) or hyaluronidase (Hyalase) without the presence of that doctor.
A nurse of lesser competency or experience requires closer supervision by the doctor.
The doctor who writes the Standing Order ("the issuer") has responsibility to:
· ensure the legislative requirements for the Standing Order are met
· ensure that anyone operating under the Standing Order has the appropriate training and competency to fulfill the role
· countersign, audit and review the Standing Order
· review the nurse's competency annually
· document the results of audit and review
Only the doctor who originally issued the Standing Order can perform countersigning, audit and annual review.
Legal responsibilities for the issuing doctor are set out in the Medicines (Standing Order) Regulations 2002. To assist doctors to comply with these regulations, the Ministry of Health released the "Standing Order Guidelines" in 2012, a plain English interpretation of the legislation.
RESPONSIBILILTIES OF "THE ISSUER" (the doctor)
The doctor must:
1. WRITE THE STANDING ORDER
The doctor is responsible for describing the conditions under which the Standing Order operates. This includes the level of supervision and a description of the procedure including indications, contraindications, dose, administration and documentation.
NZSCM advises that its members they should require a nurse working under their Standing Order to adhere to the same standards of assessment, treatment and documentation that NZSCM requires of its doctor members.
The law requires that staff potentially affected by the Standing Order should be identified in the development of the Standing Order. The Standing Order should be developed in consultation with such staff.
2. DEFINE THE COMPETENCY REQUIRED OF THE NURSE
A nurse 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 (e.g. the ability to identify vascular occlusion after dermal filler requiring treatment with hyaluronidase) , the competency to administer botulinum toxin or hyaluronidase, and the knowledge to assess the contraindications.
The issuing doctor must define the required competency of the nurse administering, for example, botulinum toxin or hyaluronidase.
As there is potential for a significant adverse event to occur with botulinum toxin and hyaluronidase additional requirements to in-house training, such as peer and case review, may be required before a nurse may work independently under the standing order. Adverse effects of botulinum toxin include ptosis, diplopia, neck weakness and difficulty swallowing; hyaluronidase is used for emergency treatment of vascular occlusion caused by dermal filler, which can cause disfiguring scarring, tissue loss, blindness and stroke.
3. ASSURE THEMSELF OF THE NURSES' COMPETENCY
The law requires that the doctor must assure himself or herself of the nurse's competency. In the absence of a recognized qualification for cosmetic nurses in New Zealand, NZSCM considers the onus falls on the issuing doctor to personally assess the nurse's competency.
NZSCM considers that the doctor must be appropriately trained and experienced in performing botulinum toxin and dermal filler treatments, as per New Zealand Medical Council guidelines, and proficient in the subtleties of management of the cosmetic patient, to be able to properly assess the nurse's competence.
NZSCM advises a suitable period of direct observation by the issuing doctor of the nurse performing assessment and treatment is necessary to properly assess their competence.
4. PERFORM ANNUAL COMPETENCY REVIEW
Competency is a skill that must be maintained. The law requires that the issuing doctor must formally review the administering nurse's competency annually, commencing from the original date the order was signed.
NZSCM considers direct observation of the nurse performing assessments and treatments, review of patient notes (e.g. during countersigning or audit), and review of adverse events are necessary to ensure levels of competency are being maintained.
The process and results of this annual review must be documented.
5 PERFORM AUDIT
If countersigned less frequently than monthly, the clinical records must be audited to ensure they comply with the instructions contained within the Standing Order. NZSCM members must also comply with NZSCM standards of clinical records such as consent, photographs and documentation of treatment, which are based on international best practice.
Results of the audit should be recorded along with any required changes to the Standing Order documentation, processes or training. Prompt action should be taken to address any issues identified.
Audit sample sizes should be at least:
· 50 % of records if there are 20 or fewer per month
· 20–30 % of records if there are 21–100 per month
· 15–20 % of records if there are over 100 per month
If any records are found to be non-compliant with the standing order, the sample size should be doubled.
6. COUNTERSIGN THE CLINICAL RECORDS
"Countersigning" means the doctor "signing the charted treatment of a patient to whom medicine has been administered or supplied under a standing order".
"Charted treatment" means "a written clinical record of a patient's illness or condition, including the medicine administered or supplied to the patient."
Note the law requires that the issuing doctor must sign the written clinical record of the patient's illness or condition, in order to familiarize himself or herself with the patient.
The doctor must define how often the Standing Order must be countersigned.
There may be different countersigning requirements for people administering under standing orders appropriate to the level of competency and expertise of each individual.
If the nurse is suitably experienced for the Standing Order to require countersigning less frequently than monthly, audit is required as described above.
7. ENSURE MONITORING AND DETECTION OF ADVERSE INCIDENTS
The issuing doctor must ensure there is a process in place for monitoring and reviewing the correct operation of the Standing Order and any adverse incidents that occur.
REQUIREMENT FOR AVAILABILITY OF THE STANDING ORDER
The regulations require that the issued Standing Order is made available to:
1. Every person permitted to administer and/or supply a medicine under the standing order
2. An employer of any practitioner, whether or not he or she is the issuer
3. Any affected practitioner who is not the issuer
4. Any person affected by the standing order
5. The Director-General of Health, on request.