Medicines & Poisons Act 2014 and Regulation 2016

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The below is a guide to some of the changes affecting pharmacy. You should satisfy yourself of the requirements of the Act and Regulations and not rely solely upon this information.

You may need to seek legal advice for further clarification.

Much of the Act is already well-known and discussed, with many of the changes being expected. However the Regulations have not been so widely discussed.

There is provision for paperless prescriptions at some time in the future. There are very strict security provisions on the prescriber and as yet there is probably no-one authorised to provide paperless prescriptions. However, it will come in over the life of this Act. In preparation the requirement for doctors to also hand-write computer generated S8 scripts has been removed.

It is no longer necessary to apply for a Poisons Licence

The Department considers that the poisons licence is held by the pharmacist with overall responsibility for any pharmacy business, without any further need to apply for a licence.

Penalties

Penalties for offences have now increased significantly. The previous Act came into being in 1964 and penalties have now been increased in line with inflation.

The penalty is written as a dollar amount. It is noted that penalties are not written as "up to a dollar amount".

Supply of S2 and S3 scheduled medicines

A person may supply a schedule 2 or 3 medicine under conditions to a patient or the patients’ agent if:

- there is an appropriate therapeutic purpose; AND
- the amount supplied is reasonable in the circumstances; AND
- the supplier has the belief the patient will use it correctly, or the agent will supply or administer it to the patient for therapeutic purposes.

Section 13 (4) A person authorised under an appropriate licence to supply S2 or S3 poisons, who supplies the poison where the person reasonably suspects or ought to suspect the recipient intends to use it in a way which might pose a serious threat to the health, safety and welfare of a person or of the public commits an offence. The penalty is $15,000.

Similarly, unless S4 and S8 supply is made where the person has a script and believes the patient will use it in accordance with the instructions the person making the supply commits an offence. Penalty $30,000.

Record Keeping and Reporting

Records must be kept as per regulations and may not be false or misleading. This includes all S8 recordings. S8 Prescriptions dispensed from 31st January now only need to be kept for 5 years. There are changes to allow electronic record keeping, providing privacy and confidentiality are maintained and records are able to be accessed in the future. The penalty for an offence of this rule is $15,000.

Drugs of AddictionAs well as a definition of a drug-dependent person there is a new category: an oversupplied person.

An oversupplied person means a person who has, over a period of time, obtained or obtained prescriptions for quantities of drugs of addiction that are greater than is reasonably necessary for therapeutic use. The regulations may also prescribe S4 poisons that have a high propensity for drugs where misuse, abuse or illicit use.

This rule covers the “doctor shopper”. It allows the Health Department to treat the person similarly to a drug-dependent person, but without the stigma of being called drug-dependent or being on the Drug Register.

An authorised Health Professional who reasonably believes that a client of the professional is an over-supplied person commits an offence if the practitioner does not make a report within 48 hours of forming that belief commits an offence. Penalty $45,000

Partnerships and employees

If one member of a partnership commits an offence all partners may be charged with the offence. It is a defence to prove the offence was committed without the member’s knowledge, authority or consent AND the member took all measures to prevent the commission of the offence.

Similarly, if an employee commits an offence the pharmacist with overall responsibility commits the offence unless the employee acted contrary to the employer’s orders or instructions AND the employer took all the measures reasonably expected to prevent the commission of the offence

Ensuring your QCPP protocols and processes are in place and followed will reduce your risk of offending this rule.

Prescription Regulations

Regulations set out the requirements for prescriptions (Dr details, date, Patient details, medicine details (date of birth for an S8) directions of use for each item, maximum number of repeats and S8 interval of repeats.

A pharmacist who dispenses a medicine that is an S4 or S8 poisons must be satisfied that the class of health professional of which the person is issuing the prescription is a member of a class that is authorised to prescribe prescription.

It should be noted that an endorsed podiatrist, endorsed midwife or endorsed optometrist can prescribe, but optometrists, podiatrists and midwives who are not endorsed cannot prescribe.

You can check this on the AHPRA website.

Medication chart requirements.

Meds charts can also be used for patients being discharged from hospitals. The chart requires all the same information, in ink written by prescriber and signed and dated by the prescriber (note: it may not be a PBS script unless it is notated NHS).

Similarly, in an aged care facility, all the details about the person and medicine must be on the chart, and each entry must be in ink written by the prescriber and dated and signed by the prescriber.

Emergency Supply

A doctor may give direction to a pharmacist for S4 or S8 prescriptions orally, by telephone or electronic means ONLY in an emergency. The doctor must prepare the document, mark it confirmation of a direction and send within 24 hours.

A pharmacist who supplies a medicine that is an S8 on a direction given under this sub-regulation must notify the CEO if the pharmacist does not receive the document for the supply of the medicine within 5 working days of the supply of the medicine. Penalty $1000

A pharmacist who is presented with a prescription for the supply of an S8 must take reasonable steps to confirm the authenticity of the script, the identity of the prescriber and the bona fides of the person wishing to have the medication. Despite reasonable steps, if unable to confirm the details, the pharmacist may supply enough for 2 days in accordance with the directions.

Cancelling of scripts.

The pharmacist must cancel an S4 or S8 under the following circumstances:

  • The script has been dispensed once and the maximum number of times it may be dispensed has not been clearly indicated;
  • (S8) when the script does not provide the interval at which it may be dispensed;
  • it has already been dispensed the maximum number of times;
  • not completed;
  • not issued by an authorised person; or
  • false in a material particular

Emergency S4 supply is allowed where the person under regular treatment with the medicine, where it is not practical to obtain a script in sufficient time, and interruption of treatment is likely to do harm. Max 3 days supply. Penalty $1000

Structured Administration and Supply Arrangement (SASA)

This is a new section where authorisations of health professionals are all brought together. Authorisations issued by the CEO or Health Organisations (acute care or public health programs) cover only one medication.

Doctors can issue authorisations to an employee for medications and in circumstances for acute care or a public health program.

Health Professional Authorisations:

There are some specific authorisations for each health professional and health workers. Generally health professionals can supply some S2 and S3 medications (as per the SASA). Restrictions apply to S4 and S8 medications.

  • Authorised ATSI health practitioners may be authorised to supply S3 medications, administer, possess or supply S4 only on circumstances outlined in the SASA
  • ATSI health workers are similar, with more restrictions on S4 medicines.
  • A dentist, in the lawful practice of their profession may supply S2, S3 and S4 or S8 poisons and administer, possess, supply or prescribe scheduled medicines.
  • Dental workers (hygienist, dental therapist or oral health therapist) may supply an S2 or S3 in their lawful practice or administer and possess S4 &  S8 (Note NOT prescribe).
  • First Aid Persons (Vessels) in the lawful practice may administer, possess and supply scheduled poisons, depending upon the vessel size, and purpose (livestock vessels allow veterinary products). If you supply to shipping companies check the chart.
  • Nurse Practitioners are able to prescribe in the lawful practice of their profession, administer, or possess and supply scheduled medicines.
  • Registered nurses can administer, supply and possess S4 medicines. They can administer and possess S8 medicines. Supply of S2, S3 and S4 medicines are limited to the SAS authorisation.
  • An enrolled nurse can administer, possess or supply an S4, administer or possess an S8, and supply S2, S3 and S4 as per SASA. Limited administration of S4 or S8 are permitted only under circumstances in SASA.
  • Pharmacists can administer, supply, possess AND dispense. Interns and technicians (people who assist pharmacists in the dispensing process) may supply S2 & S3 under supervision of the pharmacist.
  • Podiatrists can administer, possess or supply from a prescribed” Medicines List”. Endorsed podiatrists can also prescribe.
  • Optometrists can follow the “Optometry Guidelines for Optometrists” to supply S2 and S3 medicines and administer and possess. Endorsed optometrists can also prescribe.

Storage of S2 and S3 medications

When not for retail sale S2 and S3's must not be visible to the general public; this includes ensuring bulk stock is not visible.

Pharmacies will require a large safe. Specifications are included in the regulations.

There is a new section on Cannabis-based products and the rules and regulations concerning all aspects of supply.

CPOP

Medical practitioners may be authorised CPOP prescribers and Nurse practitioners may be authorised pharmacotherapy practitioners.

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Page last updated 16 July 2019