My patient has run out of their medication and doesn’t have a script but needs the medication today. I don’t want them to go without - what are my obligations and what can I do?
The issue of the request for or the supply of a medication without a physical prescription is one which continues to cause much confusion. There is no provision in the legislation permitting a prescription to be “owed”, and the understanding of obligations for various forms of prescriptions may not be consistent across the profession of pharmacy.
Most commonly a patient will ask for a supply of a prescription medicine without presenting a prescription when they have run out of their supply of a particular medication, and need more of it with some urgency. There are some important questions to ask and the way that you are able to deal with the request from a legal perspective is dependent on the answers you receive. You may well need to make a judgement about what you can do to remain compliant with the legislation, so it is important that you are aware of the constraints on your ability to supply.
The relevant legislation is found in the NSW Poisons and Therapeutic Goods Regulation 2008 (PTGR). For Schedule 4 medications (restricted substances), the applicable clauses are 36, 44 and 45; for Schedule 8 they are 81 and 96. Helpful additional information is also found on the NSW Health Pharmaceutical Services webpages. It is easiest to outline the possible actions by means of a series of scenarios.
A regular patient comes in late on a Saturday afternoon, and tells you she has completely run out of her blood pressure medication. Your records confirm that this is likely to be correct since she collected her last repeat one month ago. What must you do in order to act legally as well as assisting your patient as best as you can?
In order to act legally in response to this scenario, you will need to ask a number of questions. These should include:
- Does the patient have any tablets left or is she completely out of them?
- Does she hold a token for an electronic prescription?
- Is it possible for her to get a new prescription from a prescriber today?
- If not, is it possible for you to contact a prescriber for a verbal prescription?
If the answer to question c or d is YES, then those are the most appropriate approaches to take. If the patient brings back a valid, prescription form or presents a token for a conformant electronic prescription for her medicine, then obviously you can dispense it as normal. If you are able to contact her usual or an alternate prescriber for confirmation, the prescriber can provide the instruction either verbally, by phone, fax or email.
Clause 36 of the PTGR indicates that “In an emergency, an authorised practitioner may direct the supply of a restricted substance orally, by telephone, by electronic mail or by facsimile.” The prescriber is then obliged to generate the hard-copy prescription and send it to the pharmacy within 24 hours and must ensure that the prescription is endorsed with words that indicate the prescription has been issued in confirmation of a direction under this clause. In this case, clause 44 allows you to supply the whole prescribed quantity to the patient. Clause 44 also outlines how to record the details of the prescription, and states that if the prescription (which may be either hard copy or an electronic prescription token) is NOT received within 7 days, this must be reported to NSW Health. Many dispensing software systems include an “owing” function which can be used to indicate when an emergency prescription provision has been used and the pharmacist is awaiting the physical prescription. This situation is the only legitimate use of this function.
If the answer to question c is NO, then you will need to consider the provisions of clause 45. This covers the emergency supply of a restricted substances otherwise than on the direction of an authorizer practitioner. It is critical to note that the term emergency supply only relates to the situation where it has not been possible to contact a prescriber for a prescription. In addition, Clause 45 indicates that you will need to decide if ALL of the following four conditions are satisfied:
- that the person is undergoing treatment essential to the person’s well-being, and
- that the substance has previously been prescribed for the treatment, and
- that the person is in immediate need of the substance for continuation of the treatment, and
- that, in the circumstances, it is not practicable for the person to obtain a prescription for the substance from an authorised practitioner.
Notice in particular condition d – that it is not practicable to obtain a prescription – which indicates that this should have been considered first. In other words, the law expects that an emergency prescription is the preferable first step, and that emergency supply is only considered if an emergency prescription is not obtainable.
When considering condition a, you will need to make a judgement about the importance of maintaining continuous therapy for a patient’s medical condition. In the case of antihypertensive medication, there is a strong argument that the medication is part of treatment essential to the patient’s well-being and that continuous therapy is desirable. Condition b can be satisfied for a regular patient by reference to the medication history, and condition c can be checked by asking the patient how many tablets remain.
If all conditions are satisfied, you are able to supply sufficient medication for no more than 3 days of treatment. If the formulation is not amenable to the supply of a broken pack (this includes liquids, aerosols, creams, ointments etc), or if the supply is for the oral contraceptive (anovulants), then the smallest standard pack can be supplied. Remember, that Continued Dispensing may be appropriate in specific circumstances for supply of certain oral contraceptives and lipid modifying agents without a prescription (Clause 45A).
If a medicine is supplied in an emergency by a pharmacist under the circumstances referred to in clause 45, the words “EMERGENCY SUPPLY” must also be included on the dispensing label.
While you are working out what to do in relation to the antihypertensive medication, the same patient asks if you can give her a supply of her tramadol tablets in advance of her obtaining a prescription. What must you do in order to act legally as well as assisting your patient as best you can in this situation?
In this case, you would ask the same three questions as in scenario 1, and if it is possible to obtain a hard-copy, a conformant electronic prescription or emergency prescription, then you can proceed in the same manner. However, if it is not possible to contact the prescriber for an emergency prescription, you MUST NOT supply the tramadol as an emergency supply. Clause 45 specifically excludes “prescribed restricted substances” from its provisions, and as tramadol is a prescribed restricted substance (ie it is listed in Appendix D of the PTGR), then it is not able to be supplied as an emergency supply without a prescription.
If you are asked for supply of a Schedule 8 medication in advance of obtaining a prescription, you should treat it in the same way as scenario 2. In other words, if you obtain a hard-copy, conformant electronic prescription or emergency prescription, then you are able to supply the medication to the patient. If you cannot obtain a prescription, you cannot supply.
There are some exceptions to the use of clauses 81 and 96 (emergency prescription for Schedule 8 medicines). There is a class of Schedule 8 medicines which are unregistered drugs of addiction. Clause 81(1) specifically excludes unregistered drugs of addiction from the emergency prescription provisions, meaning that a physical hard-copy must be presented before you can dispense it. The definition of an unregistered drug of addiction is:
“any therapeutic good that consists of a Schedule 8 substance and that is not—
- a registered good, or
- a substance or good that has been excluded from this definition by an order made by the Secretary and published in the Gazette”.
The most likely circumstance in which an unregistered drug of addiction would be prescribed is where an extemporaneously compounded preparation is Schedule 8 because of one or more of its ingredients. You MUST NOT dispense a product of this nature on the basis of an emergency prescription. Under the NSW Poisons and Therapeutic Goods Act 1966 (PTGA), an authority (NSW Health authority) is required to prescribe and supply an unregistered Schedule 8 medicine that is compounded. https://www.health.nsw.gov.au/pharmaceutical/Pages/unregistered-s8s.aspx
From a practical point of view, do not use the term “owing” and instead use the more precise terms “emergency prescription” and “emergency supply” where these apply, and always explain that one of these forms of arrangements must exist for the pharmacist to make a supply. While a patient will still ask you for supply in advance of obtaining a prescription, and your dispensing software may also use the term “owing”, greater precision in your own language should help to reduce confusion and increase compliance.