In this section of the newsletter we will help you apply the poisons legislation in your practice. Each newsletter will include explanations, guidance, tips and resources relating to one or more of the common areas where the Council sees that practitioners have difficulties or experience confusion.
This month’s newsletter covers computer-generated Schedule 8 prescriptions and what constitutes appropriate “quantity and purpose”.
Computer generated Schedule 8 prescriptions
Clause 80 of the NSW Poisons and Therapeutic Goods Regulation 2008 sets out the details which must be included in a valid Schedule 8 prescription: date of issue; name and address of patient; name and strength of the drug to be supplied; quantity to be supplied in words and figures; adequate directions for use; maximum number of supplies (repeats); repeat interval; details of the prescriber; any authority number required by the legislation.
This clause states that the bolded details must be written in the prescriber’s handwriting, or in such other manner as may be approved for the time being by the Director-General. The Regulation does not stipulate what this other manner is, but the details are found in the NSW Health publication Criteria for issuing non-handwritten (computer generated) prescriptions. This document is also known as the TG184. The current version of this document is the TG184/10 which replaced the TG184/9 in November 2020.
Some key requirements for computer-generated Schedule 8 prescriptions are that:
- prescriptions must not be altered by hand after they are printed – if the prescriber wishes to change and of the prescription details, a new one MUST be generated
- if the prescription is covered by the Pharmaceutical Benefits Scheme (ie an original and duplicate are printed), the bolded details MUST be rewritten by the prescriber in their own handwriting on ONE copy of the prescription only*, which is retained by the pharmacy
- if the prescription is a private prescription (non-PBS), a duplicate MUST NOT be printed, and the bolded details MUST be rewritten by the prescriber in their own handwriting on the single side which is printed
In practice, if you receive a PBS computer-generated Schedule 8 prescription with the handwritten details on BOTH copies (original and duplicate copy), it is not valid. If you receive a computer-generated Schedule 8 prescription with NO handwritten details, it is also not valid. If you receive a private computer-generated Schedule 8 prescription which has an original and duplicate, it is not valid.
* The TG184/10 removed the word “only” from this requirement, and it has been clarified that the wording now does not preclude the prescriber from handwriting the required particulars on both copies of a computer-generated PBS Schedule 8 prescription. Therefore, from November 2020, a PBS computer-generated Schedule 8 prescription with the handwritten details on BOTH copies (original and duplicate copy) is no longer invalid.
When you receive a Schedule 8 prescription which is not written correctly, it is not valid and you MUST NOT dispense it. You will need to contact the prescriber to obtain a new prescription which has been written validly, in order to supply medication to the patient.
It is worth noting that any computer-generated prescription which has been altered by hand after printing is not valid – in other words, this requirement extends to prescriptions for Schedule 2, 3 and 4 medications as well as to Schedule 8.
There are other requirements outlined in the TG184, and it is strongly recommended that you access and familiarise yourself with this publication.
Quantity and purpose
Six clauses in the NSW Poisons and Therapeutic Goods Regulation 2008 prohibit the prescribing and supply of scheduled medicines “in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances”. Three clauses relate to prescribing, and the remaining three relate to supply, usually by pharmacists.
These clauses specifically impose an obligation on pharmacists to use their clinical judgement when receiving prescriptions for unusually large quantities of scheduled medicines, or if they become suspicious/aware that medications are likely to be used for non-therapeutic purposes (for example, diverted for illegal use). This obligation must be exercised independently of the prescriber – it is not sufficient for a pharmacist to accept what a prescriber has written if it contravenes these quantity and purpose clauses.
In practice, the question is frequently asked, “How do I determine what is an appropriate quantity or purpose?” There is no clear-cut answer to this, and you as the pharmacist must use your own clinical knowledge and judgement to ascertain what is likely to be appropriate – or inappropriate – in any given situation. For example, using your professional expertise to consider the use of the medicine in this patient - the indication for use, the dose, the intended or appropriate duration and quantity prescribed, and so on. If there is any doubt, you should contact the prescriber to discuss your concerns; if the prescriber continues to insist that the medication is supplied according to the prescription, you are NOT OBLIGED TO SUPPLY IF YOUR CONCERNS ABOUT QUANTITY AND PURPOSE REMAIN. A significant number of pharmacists have been subject to disciplinary action because they have failed to recognise their obligations in this regard.
Your first concern should be for the patient, and for the duty of care you have towards them. You may find yourself in an ethical dilemma, since your duty to provide continuity of care may be in conflict with your legal obligations under the quantity and purpose clauses. Again, there is no clear-cut answer, and you will need to continue to exercise judgement when deciding upon the most appropriate course of action.
If you find yourself in a situation such as described here, you should document in detail the actions you have taken and the references you have used to determine why you believe the prescribed quantity and/or purpose are inappropriate. You should contact your professional indemnity insurer for advice as soon as practicable, and you may need to consider if a complaint about the prescriber is warranted.