This article covers the practicalities surrounding the supply of Schedule 3 medications.
Where to find critical information
There are a few different sources of information which pharmacists need to be aware of in order to ensure they are fulfilling their responsibilities in relation to the supply of Schedule 3 medications.
“Substances which are for therapeutic use and:
- about which personal advice may be required by the user in respect of their dosage, frequency of administration and general toxicity,
- with which excessive unsupervised medication is unlikely, or
- which may be required for use urgently so that their supply only on the prescription of a medical practitioner or veterinary practitioner would be likely to cause hardship.”
This description indicates that pharmacists must take particular care with the supply of these medications, and pharmacists should be diligent in ensuring appropriate supply and advice. The details of supply and advice are elaborated upon in the NSW Poisons and Therapeutic Goods Regulation (2008) and the Pharmacy Board of Australia Codes and Guidelines.
Decision to supply or refuse supply
The first consideration is whether it is appropriate to supply the medication in the first place. Pharmacists are entitled to refuse a request for any medication if they are not satisfied that it is appropriate, based on sound clinical and professional judgement. In addition, some medications are only included in Schedule 3 when they are supplied for specific indications. Examples of this include:
- chloramphenicol – for ophthalmic use only
- fluconazole – in single-dose oral preparations containing 150 mg or less of fluconazole for the treatment of vaginal candidiasis
- metoclopramide – when combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs containing not more than 10 dosage units
This indicates that the pharmacist must take an appropriate history prior to supplying these medications in order to confirm that the intended use matches the specified indications. If a request is made for a different indication, the patient should seek a prescription.
This list is not comprehensive, and pharmacists should ensure they are familiar with permitted indications by checking the current version of the Poisons Standard.
In general, Schedule 3 medications should not be supplied in anticipation of need.
i. Quantity and purpose
There are two main sources of information on how to make the decision regarding Schedule 3 medications. The first is the NSW Poisons and Therapeutic Goods Regulation (2008) clause 23. Often known as one of the quantity and purpose clauses, this places responsibility on the pharmacist to ensure that there are justifiable reasons for supplying Schedule 3 medications. There are parallel clauses for Schedule 4 (clause 54) and Schedule 8 (clause 109). It is also worth noting that similar obligations are placed on prescribers through clauses 16, 34 and 79.
The summary of a “quantity and purpose” clause is that a pharmacist must NOT supply a therapeutic substance “in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances”. The wording indicates that judgement needs to be exercised in deciding what is appropriate in the circumstances, and therefore you as the pharmacist will need to make that decision before you supply.
Obviously, you will need to understand the reasons for any request through discussion with the customer. You will also need to be very familiar with the therapeutic use of the medication, and in particular, the risks of inappropriate use. Part of the discussion will include any previous use, but it is not considered sufficient only to ask this one question, and in fact should prompt additional discussion to determine if further or ongoing supply is warranted where medical supervision or monitoring is lacking. You need to ask sufficient questions so that you can be satisfied that supply would meet clause 23. The Australian Pharmaceutical Formulary and Handbook (APF) contains a number of non-prescription medicine guides to support your practice.
ii. Multiple packs
A particular complication arises when a customer asks for more than one box/unit. In this case, together with clause 23, you must also consider the Pharmacy Board of Australia Guidelines on practice-specific issues which can be found on the Codes and Guidelines page. This states clearly that
“Only one proprietary pack of Pharmacy Medicines and Pharmacist Only Medicines is to be supplied at a time, unless there are exceptional circumstances clearly demonstrable by the customer, additional documentation of which should be kept.”
Again, your own judgement needs to be exercised here in relation to what would constitute exceptional circumstances. While it is impossible to list all possible circumstances here, as a general rule you need to consider alternatives to multiple supply that you can offer the customer, and how practical and feasible they are. In many circumstances, it is mostly for convenience that a customer may request multiple boxes, and this is difficult to justify as an exceptional circumstance. If you do judge that exceptional circumstances apply, you should clearly document the reasons behind your decision. These details should be sufficient to back up your decision if it is later questioned. Again, you should consider what monitoring the patient may require, or if referral is warranted.
The Guideline singles out pseudoephedrine for special mention. The Board states:
“The sale of multiple packs of pseudoephedrine-containing products (other than in exceptional circumstances and when appropriately prescribed by an authorised prescriber) and failure to comply with the local regulations applying to Schedule 3 poisons (Pharmacist Only Medicines) and these guidelines may be considered as unprofessional conduct.”
It further advises pharmacists that “requests for pseudoephedrine are to be treated cautiously to limit the risk of the product being diverted for illicit use/manufacture. A genuine therapeutic need is to be established by careful questioning, including when requested on prescription.”
The intent is not, however, that all customers who request a pseudoephedrine-containing product are treated as suspicious, or as potential criminals. Most requests can readily be confirmed as appropriate, and your duty of care is to facilitate appropriate supply when it is justified.
How to supply
Once you have decided that supply of a schedule 3 medication is appropriate, you need to consider the legalities of the supply process itself.
i. Who supplies
Clause 18 outlines the basics of supply to the customer. Most importantly, the pharmacist must personally hand the item to the person requesting it, and must give that person the opportunity to “seek advice as to the use of the substance, including advice that the person may require in respect of the dosage, frequency of administration and general toxicity of the substance.”
This clause requires the pharmacist to be physically part of the interaction. In other words, the pharmacist must be the person who hands the item to the customer and speaks directly to them. It is not sufficient for a non-pharmacist such as a technician or assistant to supply the medication, even if they have relayed information to and/or from the pharmacist; the pharmacist must come out of the dispensary if necessary, to meet the requirements of the legislation. It is important to note that interns are pharmacists and can carry out this activity under an appropriate level of supervision.
The second part of clause 18 requires the pharmacist to give the customer an opportunity to seek advice about the item. Note that it does not direct counselling must be provided for the medication, however it is considered good practice to offer counselling as appropriate and in accordance with the PSA Professional Practice Standards for the provision of Non-prescription Medicines and Therapeutic Devices (Standard 4). How you give the customer the opportunity to seek advice is up to you, however it does require some form of conversation between the two of you.
There are a number of situations when the pharmacist is not required to hand over the medication personally, and these are outlined in sub-clauses 2 to 5. These situations are:
- the Schedule 3 item is being supplied on a valid prescription
- the Schedule 3 item is being supplied to another authorised health practitioner (eg a doctor, nurse, dentist etc)
- salbutamol or terbutaline MDIs are supplied for first aid purposes to certain qualified individuals
- single use adrenaline autoinjectors are supplied for first aid management of anaphylaxis to certain qualified individuals
- Schedule 3 items are supplied to the responsible person of a residential care facility in specified circumstances
You are encouraged to read the full clause at https://www.legislation.nsw.gov.au/view/html/inforce/current/sl-2008-0392#sec.18
Before the item is handed over to the customer, clause 9 of the PTGR requires that the product is labelled with the name and address of the pharmacy. This is usually achieved by attaching an adhesive label with these details. It is not necessary for the phone number to be on the label, although it is obviously fine for that detail to be there as well.
Records do not need to be kept of the supply of most Schedule 3 items. The exception is pseudoephedrine, the supply of which must be recorded each time. Clause 24 details the requirements, which can be summarised as follows:
- at the time of supply (ie this is a real-time record), an electronic record must be made in an approved system, and include
- date of supply
- a unique reference number
- name and address of the purchaser (not necessarily the patient)
- details of the supplier
- details of the item supplied (name, strength, quantity)
- a reference number from an approved photographic identification document if the pharmacist does not know the customer
- acceptable photographic identification documents are
- Australian driver’s licence with photograph
- NSW Photo Card
- proof-of-age card with photograph
While clause 24 does not specify the system to be used, NSW Health has published the following statement on its website: The only electronic record that is an approved system is Project STOP.
In summary, pharmacists are entrusted with what is effectively the prescribing of Schedule 3 substances. This is a trust which all pharmacists should strive to justify through compliance with the requirements whilst at the same time fulfilling their duty of care.
Changes mandated during the COVID-19 pandemic
During the early stages of the pandemic in March 2020, the TGA declared that sales of a number of non-prescription medicines must be limited to one unit per purchase. At the time of writing, the medicines subject to this requirement are *:
- Adrenaline auto-injector
- Chloramphenicol eye drops/ointment
- Glyceryl trinitrate
In addition, all supplies of salbutamol-containing products were required to be recorded and the inhaler labelled with the name of the patient.
Pharmacists should be alert to any further updates from the TGA.