Changes to the Medicines and Poisons Act
There are some important changes to the regulations for the Medicines and Poisons Act 2019 (Medicines and Poisons Act) which we want to bring to the attention of our members.
All ‘relevant practitioners’ required to check the monitored medicines database (Section 41)
Queensland Health has removed the terms ‘prescriber’ and ‘dispenser’ in this section, and replaced it with ‘relevant practitioner’, which makes it clear that all relevant health practitioners need to check the monitored medicines before prescribing or dispensing a regulated medicine.
AMA Queensland agrees that this technical amendment clarifies which practitioners are required to check the monitored medicines database before prescribing a monitored medicine, however, we still have concerns about how practical this requirement will be for medical practitioners working in residential aged care facilities (RACF), medical practitioners working in accident and emergency or medical practitioners doing ward rounds in public and private hospitals.
This is despite QScript being accessible via mobile and tablet devices (as stated in the Report No.8, 57th Parliament Economics and Governance Committee May 2021) as AMA Queensland believes this requirement is administratively burdensome.
Extended practicing authority (Sections 232 and 233)
This section of the regulations enables the chief executive to make extended practice authorities (EPA) for certain classes of persons. The EPA states the places or contexts an approved person may deal with a regulated substance, imposing conditions on dealings with the substance, or requiring a person to hold particular qualifications or training.
The classes of persons include dentists, specialist medical practitioners, nurses, Aboriginal and Torres Strait Islander Health Practitioners and Indigenous health workers, other allied health practitioners (i.e. anaesthetic technicians), Queensland Ambulance Service, first aid providers, veterinary surgeons, ship’s master, pharmacists and physiotherapists.
AMA Queensland agrees with EPA being provided to nurses and notes the expansion of scope for enrolled nurses working in an anaesthetic environment, equivalent to those proposed for anaesthetic technicians, as long as this is limited to retrieval of medication for doctors and anaesthetists.
AMA Queensland opposes EPAs specifically being provided to pharmacists and physiotherapists as this will allow Queensland Health to expand the current Pharmacy UTI trial and the Physiotherapy prescribing trial in emergency departments in public hospitals including authority for a regulated substance to be carried out under direction or supervision.
AMA Queensland has asked Queensland Health to publish the scope of clinical practice for each ‘class of person’ in an easily accessible format including the formulary for prescribing.
That regulated substance must be dealt with in the ‘authorised way’
The new regulations state that regulated substances must be dealt with in the ‘authorised way’. A person carries out a regulated activity in the ‘authorised way’ if they are authorised to deal with regulated substances, if they undertake dealing with those substances, they are authorised to deal with, and if they comply with the requirements imposed under the legislation on how these dealings must be undertaken. The requirements for how the dealings are undertaken include compliance with Departmental Standards and the Substance Management Plan, if at a regulated place.
The new regulations include new ‘categories of medicines’ that were previously identified in the HDPR as controlled drugs, ‘regulated controlled drugs’ or restricted drugs of dependence. The new categories are:
The new regulations include new ‘categories of medicines’ that were previously identified in the HDPR as controlled drugs, ‘regulated controlled drugs’ or restricted drugs of dependence.
The new categories are:
Restricted medicines - Schedule 4 and Schedule 8 medicines identified as having specific health risks that may be mitigated by restricting availability through specialist medical practitioners.
‘Restricted medicines’ includes medicines specified in Appendix D of the Poisons Standard 6 (Cwlth) requiring prescribing by a certain class of specialist medical practitioner or an individual who holds a prescribing approval.
High-risk medicines - Refers to Schedule 8 medicines and particular Schedule 4 medicines (specified in Schedule 2, Part 2 of the Medicines Regulation that have a recognised therapeutic purpose but have a higher potential for impairment, misuse, abuse and dependence.
Specific offences apply for self-prescribing and self-administration of these medicines.
Diversion-risk medicines - Medicines (specified in Schedule 2, Part 3 of the Medicines Regulation that may have value as an illicit substance, such as medicines classified as drugs of dependence under the HDPR; anabolic steroids, peptides or pseudoephedrine products.
There are significant penalties for improperly purchasing or supplying these medicines.
Monitored medicines - Medicines identified by Queensland Health as potentially presenting a high risk of harm to patients as a result of misuse, abuse, diversion, substance use disorder and/or overdose.
The list of ‘monitored medicines’ is prescribed in Schedule 2, Part 4 of the Medicines Regulation.
AMA Queensland understands why the terms restricted medicines and diversion-risk medicines have been developed but recommend the regulations use one term for the categories; high-risk medicine and monitored medicines given that the medicines listed in Schedule 2, Part 2 of the Medicines Regulation and the medicines listed in Schedule 2, Part 4 of the Medicines Regulation are the same and the explanation provided in the regulations for both “high-risk medicine” and “monitored medicines” is also the same.
Disposal of waste from a diversion-risk medicine (Section 42)
AMA Queensland agrees with the new amendments related to the disposal of waste from diversion-risk medicine and the expansion of the regulations to include all S8 medicines and some S4 medicines (for example, anabolic steroidal agents, growth hormones, codeine and barbiturates) but does question the need for everyone in the state to send the unused controlled medications to Coopers Plains, at an incredible cost to the state.
AMA Queensland believes monitored medicines are regularly diverted for illicit use in Queensland, and with 2.9 million prescriptions being written in Queensland for S8 medicines in 2019-2020 (MODDS), the chances of these medicines being diverted for illegal use is high. As this possibility represents a serious risk to public health and safety, we also support the penalty provisions associated with these amendments.
AMA Queensland supports the Return Unwanted Medicines’ or RUM scheme which allows unwanted or expired medicines to be returned to any community pharmacy free of charge.