Pharmaceutical Services

The Pharmaceutical Services section of the Health Protection Service (HPS) ensures the safe supply of medicines, poisons and therapeutic goods to the ACT community.

We are responsible for conducting various regulatory activities that help ensure medicines or poisons are prescribed, stored and supplied in line with local legislation. This includes responsibly regulating community pharmacy ownership and premises in the ACT.

We also distribute information about medicines and therapeutic goods recalls across the ACT community to ensure their protection from any harm associated with the use of sub-standard or unsafe products.

Find out more about each of our services

For more information, please contact us on 02 5124 9208 or hps@act.gov.au

Our postal address is: Pharmaceutical Services, Health Protection Service Locked Bag 5005, Weston Creek ACT 2611. Fax 02 5124 9309.

Find us at Howard Florey Centenary House, 25 Mulley Street, Holder ACT 2611

News

Medicines management during COVID-19

Information for health professionals about prescribing and supplying medicines in the ACT during the COVID-19 outbreak is now available on the ACT Government COVID-19 website.

In the ACT, a suitably trained pharmacist is authorised to administer vaccines in accordance with the ACT Pharmacist Vaccination Standards (Vaccination Standards). The Vaccination Standards require pharmacists administering vaccines to hold current First Aid and Cardiopulmonary Resuscitation (CPR) qualifications.

Due to the COVID-19 emergency restrictions, some training providers are unable to deliver first aid or CPR training. This is creating challenges for pharmacists who are already qualified immunisation providers to meet the requirements for renewing mandatory first aid and CPR refresher training.

The current pandemic together with the onset of influenza season has created increased demand on pharmacist immunisation providers and a need to ensure pharmacists may continue to provide this valuable service to the community. Therefore, the ACT Chief Health Officer has temporarily modified the Vaccination Standards to enable already qualified pharmacists to continue providing immunisations until six months after the COVID-19 declared emergency is over, without the required first aid or CPR refresher training.

The modified Vaccination Standards do not permit pharmacists to administer immunisations if they have not previously met all the training requirements.

ACT Health Directorate is aware some first aid and CPR training organisations are still conducting limited training and encourages pharmacists to consider these options where it is possible for them to attend.

If you have further queries, please do not hesitate to contact the Pharmaceutical Services Section at the Health Protection Service on 02 5124 9208 or hps@act.gov.au.

The Therapeutic Goods Administration (TGA), in consultation with state and territory health departments and national stakeholders, has developed a national protocol for enabling pharmacists to substitute medicines during serious medicines shortages.

In the event of a serious medicines shortage, the TGA will coordinate stakeholder advice on whether a pharmacy-level substitution is warranted. The decision to confirm a serious medicines shortage and allow substitution would be made by the TGA and will be published as a Serious Shortage Medicine Substitution notice (Notice) on the TGA website.

There is a range of situations where substitution by a pharmacist could be undertaken by a Notice, such as dispensing tablets of:

  • a lower or higher strength of a product, 
  • another dose form of the same medicine, 
  • a combination of individual medicines when a fixed dose combination is not available, or 
  • an immediate release form in lieu of a sustained/ extended release version or vice versa. 

Under the TGA protocol, substitution will not be permitted for another product containing a different active ingredient or for Schedule 8 (controlled) medicines, such as strong opioids. 

A pharmacist is not required to check with the patient’s prescriber before substitution in accordance with a TGA Notice, however they should advise the prescriber as soon as practicable.

To enable pharmacist substitution under a TGA Notice in the ACT, on 1 May 2020, Dr Kerryn Coleman, ACT Chief Health Officer issued a temporary Standing Order for the supply of medicines during a public health emergency under the Medicines, Poisons and Therapeutic Goods Regulation 2008. 

This decision has been made to reduce the impact of a serious medicines shortage in the ACT and prevent or mitigate any resulting public health harms. 

The Standing Order automatically enables pharmacist substitution of any medicine in accordance with a TGA Notice in the ACT. The Standing Order is in force for the duration of the ACT declared public health emergency, unless revoked earlier. ACT Health Directorate will consider options to adopt the TGA scheme in the longer term. 

More information about the TGA Serious Medicine Shortage Substitution protocol, including Questions and Answers, is available on the TGA website.

The Australian Government is fast-tracking implementation of electronic prescribing (ePrescribing) as part of its COVID-19 National Health Plan.

ACT legislation supports electronic prescribing. Practitioners who are ready and using conformant software may commence use of electronic prescriptions for their patients.

Further information about electronic prescriptions is available here.

The Australian Government has enabled the dispensing and claiming of pharmaceutical benefits using a digital image (photo, scanned copy or pdf) of the prescription as an interim measure to support telehealth services.

Under the Australian Government interim arrangements[2], the dispensing and claiming of pharmaceutical benefits using a digital image are allowed, including:

  • A digital image (photo, scanned copy or pdf) of the entire prescription sent to the patient’s pharmacy of choice directly from the prescriber via email or text message (Digital Image Prescriptions), or
  • A copy of the entire prescription sent to the patient’s pharmacy of choice directly from the prescriber via fax (Faxed Prescriptions).

Digital image and faxed prescriptions are enabled by ACT legislation [1]. Further information about these types of prescriptions is listed below.

Telephone (verbal) prescriptions are also enabled by ACT legislation[1]. An original written prescription must be sent to the pharmacy within 24 hours of being given verbally. Written includes in electronic form. Telephone prescriptions are not claimable under the Australian Government interim arrangements.

The supply of schedule 4 (prescription only) Appendix D and schedule 8 (controlled) medicines using electronic, digital image, fax or telephone prescriptions is enabled under ACT legislation[1].

It is critical that prescribers send prescriptions directly to the patient’s pharmacy and have the necessary ACT standing or Chief Health Officer approval in place in order to mitigate risk of diversion or duplicate dispensing of Appendix D or schedule 8 medicines that may be subject to abuse or misuse.

Prescribers and pharmacists are also reminded to use the DORA real time prescription monitoring website to support patient care for those requiring treatment with a controlled medicine. Further information about ACT DORA is available here.

Digital Image Prescriptions

Digital image prescriptions transmitted electronically are enabled by ACT legislation[1].

A digital image prescription must be sent from the prescriber directly to the patient’s pharmacy of choice. Digital image prescriptions should never be given directly to the patient.

You can search for your patient’s preferred pharmacy and their contact details using the Healthdirect Find a health service website.

Under ACT and Australian Government interim arrangements, prescribers are not required to send a printed paper prescription to the pharmacy. The Australian Government interim arrangements require a prescriber to retain the prescription for at least 2 years.

Prescribers should also obtain and record patient’s consent to send the prescriptions electronically.

Please note that the PBS and RPBS interim arrangements are only for prescriptions written as a result of telehealth attendance or phone attendance provided on or after 20 March 2020. The PBS and RPBS interim arrangements are temporary and will cease in accordance with the COVID-19 National Health Plan which is currently scheduled to cease on 30 September 2020.

Faxed Prescriptions

The PBS and RPBS interim arrangements and ordinary arrangements[3] allow pharmacists to supply pharmaceutical benefits from a copy of prescription sent via fax.

Faxed prescriptions are also enabled by ACT legislation[1]. ACT pharmacists may claim for pharmaceutical benefits supplied on a faxed prescription according to the PBS and RPBS interim arrangements.

Under the Australian Government interim arrangements, a prescriber is required to retain the original of a faxed prescription for at least 2 years, which is permitted by ACT legislation.

Pharmacists are required to confirm that the faxed prescription was written as part of a telehealth consultation in order to meet the ACT record keeping requirements and should make a record of this.

Verbal advice from the prescriber or patient is considered sufficient for this purpose. Prescribers can also confirm this in writing on the faxed prescription.

If a faxed prescription was not written as part of a telehealth consultation, ACT legislation requires:

  • the prescribers to send the original prescription to the pharmacy within 7 days of sending it via fax[4].
  • the pharmacists to notify the Pharmaceutical Services Section of the Health Protection Service (on behalf of the Chief Health Officer), in writing, if they fail to receive the original prescription of a faxed prescription within 14 days of dispensing [5]. Notifications may be sent to pss@act.gov.au or via fax 02 5124 9309.

ACT Health Directorate has worked with key medical and pharmacy stakeholder and developed the following FAQs to assist with Telehealth Prescribing.

Further information about the Australian Government interim prescribing arrangements for prescribers and pharmacists are available via these links.

Further information on requirements for Digital image prescriptions and Faxed prescriptions in the ACT is available here.

Further information about prescribing via telehealth for your patients is available on the telehealth prescriptions FAQ page.

Contact details of  community pharmacies are available at the Healthdirect Find a health service website.


[1 Medicines, Poisons and Therapeutic Goods Act 2008]

[2 National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020]

[3 National Health (Pharmaceutical Benefits) Regulations 2017]

[4 Section 31 of Medicines, Poisons and Therapeutic Goods Regulation 2008]

[5 Section 120(g) of Medicines, Poisons and Therapeutic Goods Regulation 2008]

The Australian Government’s Continued Dispensing – Emergency Measures have been extended until 30 June 2020 for the COVID-19 emergency. 

The Continued Dispensing arrangements enable a pharmacist to supply a Pharmaceutical Benefits Scheme (PBS) or Repatriation Pharmaceutical Benefits Scheme (RPBS) medicine to a patient when there is an immediate need and they cannot obtain a prescription. 

Continued Dispensing is fully enabled under the ACT Medicines, Poisons and Therapeutic Goods Act 2008 and has immediate effect in the ACT. More information about Continued Dispensing is available on the PBS website.

In addition, on 1 April 2020, Dr Kerryn Coleman, ACT Chief Health Officer issued the Medicines, Poisons and Therapeutic Goods (Temporary Authority – Supply by pharmacists of designated Schedule 4 medicines without prescription) CHO Standing Order 2020 (No 2) to enable the emergency supply of a standard pack size of private designated (non-PBS) prescription only medicines by pharmacists without a prescription during the COVID 19 emergency. 

Prescribers and pharmacists are encouraged to read this Information sheet.

Further information about novel coronavirus is also available on our website.

Information about Coronavirus

The ACT Chief Health Officer has provided information to community pharmacists on 28 January 2020 for people presenting with flu-like symptoms or suspected cases of coronavirus. Further information about novel coronavirus is also available on our website.

Electronic Prescribing

The Australian Government is fast-tracking implementation of electronic prescribing (ePrescribing) as part of its COVID-19 National Health Plan.

ACT legislation supports electronic prescribing. Practitioners who are ready and using conformant software may commence use of electronic prescriptions for their patients.

Further information about electronic prescriptions is available here.

Amendment to faxed prescription requirements

Changes have been made to the Medicines, Poisons and Therapeutic Goods Regulation 2008 (MPTG Regulation) to support pharmacists and prescribers with record keeping for faxed prescriptions.

On 20 June 2020, sections 31A and 120A were added to the MPTG Regulation to exempt the requirement to send or receive the original of a faxed prescription where the supply is made for a medicine in accordance with a Commonwealth special arrangement that requires prescribers to retain the original.

An example is the recent Commonwealth Pharmaceutical Benefits Scheme (PBS) interim arrangements for telehealth consultations during COVID-19.

This regulatory change aligns the ACT record keeping requirements for faxed prescriptions with the Commonwealth PBS interim arrangement for telehealth consultations.

This means that prescribers do not need to send the original of a faxed prescription to a pharmacist where it is prescribed during a telehealth consultation while the PBS special arrangements are in place. Pharmacists are also not obligated to receive the original in these circumstances.

Pharmacists are required to confirm whether the faxed prescription was written as part of a telehealth consultation in order to meet the ACT record keeping requirements and should make a record of this.

Verbal advice from the prescriber or patient is considered sufficient for this purpose. Prescribers can also confirm this in writing on the faxed prescription.

Furthermore, sections 31 and 120 of the MPTG Regulation were also updated to change the ordinary faxed prescription record keeping requirements as follows:

  • the timeframe within which a prescriber must send the original of a faxed prescription to a pharmacist has been changed from 24 hours to 7 days.
  • the timeframe within which a pharmacist must receive the original of a faxed or verbal prescription before notifying the Chief Health Officer about non-receipt of the original prescription has been changed from 7 days to 14 days.

This means the ordinary record keeping requirements for faxed prescriptions have been extended for pharmacists and prescribers. These changes will allow greater flexibility for pharmacists and prescribers when issuing or dispensing faxed prescriptions during and after COVID-19.

Further information on telehealth prescribing including updated FAQs can be accessed here.

The MPTG Regulation can be found on the ACT Legislation Register.

Updates to the ACT Controlled Medicines Prescribing Standards - June 2020

Changes have been made to the ACT Controlled Medicines Prescribing Standards (the Prescribing Standards) which came into effect on 12 June 2020.

The Prescribing Standards establish conditions and criteria under which a prescriber may be approved to prescribe a controlled medicine in the ACT under the Medicines, Poisons and Therapeutic Goods Regulation 2008.

The changes primarily relate to Category 3 for Opioid Maintenance Treatment (OMT) arising due to COVID-19 as well as routine improvements, and include:

  • Insertion of new special case provisions for supply of unsupervised (take away) doses of OMT during a declared public health emergency.

    This authorises up to three additional take away doses of methadone or buprenorphine under a Category 3A or 3B approval or an Approval by Drug during a declared public health emergency (such as COVID-19) to enable rapid commencement or continuation of take away doses for a person unable to attend their usual pharmacy for supervised dosing for reasons outside their control (such as compulsory isolation). Where this provision is used, the prescriber is still required to seek Approval by Drug (or an amendment to their existing Approval by Drug) for the additional take away doses.
     
  • Updates to ordinary take away limits under Category 3A and 3B approvals.

    This enables earlier commencement and increases in take away doses for buprenorphine/naloxone. Clients may commence take aways after minimum 1 month in treatment (previously 3 months) and may reach the maximum allowance from 9 months (previously 12 months).

    The proposed changes provide for a less rigid framework that aligns with equivalent NSW guidelines.
     
  • Update to the opioid dose conversion ratios and Morphine Equivalence calculator.

    The new ratios reflect those recommended by the Faculty of Pain Medicine, Australian and New Zealand College of Anesthetists (ANZCA). This change impacts the conversion factors for tapentadol and fentanyl which will result in a higher dose being authorised under a Category approval.

The changes follow valued input and consultation with the ACT Opioid Treatment Advisory Committee and Medicines Advisory Committee.

Updates to the ACT Controlled Medicines Prescribing Standards - October 2019

Changes have been made to the ACT Controlled Medicines Prescribing Standards (the Standards). The Standards are made under the Medicines, Poisons and Therapeutic Goods Regulation 2008 for the purposes of establishing the conditions and criteria under which a prescriber may be approved to prescribe a controlled medicine in the ACT.

The changes relate to Category 5- Psychostimulants to address the use of stimulants for the treatment of narcolepsy, treatment resistant depression and binge eating disorder. The changes also include more flexible arrangements for prescribers to apply for approval by drug for codeine for intestinal conditions (under Chapter 1).

The amended Standards can be found on the ACT Legislation Register.

New depot buprenorphine products

Two new depot buprenorphine products are now available in Australia for treatment of opioid dependence. There are important safety and funding restrictions that prescribers and pharmacists need to be aware of before supplying this product.

Prescribers and pharmacists are encouraged to read this Information sheet before applying to prescribe or dispensing these products. Further information about Opioid Maintenance Treatment in the ACT may also be found here.

Emergency supply of prescription only medicines by pharmacists during bushfires

A temporary Standing Order has been issued by the ACT Chief Health Officer, Dr Kerryn Coleman to enable supply of designated prescription only medicines by pharmacists without a prescription, to support people directly or indirectly affected by the bushfire crisis in NSW and other states. Prescribers and pharmacists are encouraged to read this Information sheet as well as the Medicines, Poisons and Therapeutic Goods (Temporary Authority – Supply by pharmacists of designated Schedule 4 medicines without prescription) CHO Standing Order 2020 (No 1).

This Standing Order remains in place now until 31 March 2020. The Federal Department of Health arrangements commence from Monday 13 January 2020 until 31 March 2020 and have immediate effect in the ACT.

Controlled medicines storage consultation

ACT Health is undertaking targeted consultation with key stakeholders on proposed amendments to the ACT controlled medicines storage requirements.

Under the Medicines, Poisons and Therapeutic Goods Act 2008 (MPTG Act), controlled medicines must be stored in a compliant medicine cabinet or safe. These requirements exist to reduce the risk that controlled medicines are unlawfully removed from the possession of prescribers or pharmacists and diverted for misuse in the community.

Controlled medicines are Schedule 8 medicines as defined by the Commonwealth Poisons Standard. Examples include morphine, oxycodone, dexamfetamine and alprazolam.

ACT Health has identified several opportunities for improvement to the requirements for controlled medicines storage in the ACT.

An Issues and Options paper has been developed. Stakeholders are invited to provide feedback from their organisation by email to hps@act.gov.au or by completing the online survey that can be accessed at: https://arcg.is/jeTKS.
Submissions are requested by 15 November 2019.

Real time prescription monitoring

From March 2019, a new secure real time prescription monitoring website called DAPIS Online Remote Access (DORA) is available for health professionals. DORA allows prescribers and pharmacists to look up information about their patient relating to their use of controlled medicines.

DORA is intended to support clinical decision making by enabling health professionals to better identify and manage patients who may be exhibiting signs of drug dependency, such as ‘doctor shopping’.

DORA has been introduced to improve the safety of ACT patients by giving prescribers and pharmacists valuable information before they write or dispense a prescription for a controlled medicine.

For more information about DORA for patients, prescribers and pharmacists, please visit ACT Health’s Real Time Prescription Monitoring webpage.

Updated ACT Pharmacist Vaccination Standards

In the ACT, eligible pharmacists can provide certain vaccinations to patients. Pharmacist vaccinations are aimed at complementing existing immunisation services and improving public access to immunisations in the ACT.

From 7 April 2020, changes have been made to the ACT Pharmacist Vaccination Standards to enable trained pharmacists to:

  • administer eligible vaccines to pregnant women,
  • administer the influenza vaccine to patients aged 10 years or over, and
  • administer the Measles, Mumps and Rubella (MMR) vaccine.

The changes have been made to improve access to vaccinations in the community and recognise the important role that pharmacists play in the health system.

Improving access to the influenza vaccine for families will assist to prepare for the 2020 influenza season. This is especially important during the COVID-19 outbreak to reduce public health risks and pressures on the health system.

More information on these updates can be found on the Pharmacist Vaccinations webpage.

Pilot Program – NIP funded influenza vaccines for people aged 65 and older

During the 2019 influenza season, ACT Health will be operating a pilot program with participating pharmacies to provide NIP funded influenza vaccinations for patients aged 65 years and over.

For more information for pharmacies about this program, please see the Pharmacist Vaccinations webpage.

More information about influenza and staying healthy in winter is available on the  ACT Health Winter Wellbeing webpage.

Banned sports substances

It has come to the attention of the Health Protection Service (HPS) that sports supplements labelled as containing banned substances are being sold in the ACT primarily through retail supplement stores.

Banned substances include selective androgen receptor modulators (SARMs), cardarine, tadalafil, oxedrine, melatonin, clomifene, l-dopa, DHEA and phenibut. These substances are associated with important health and safety concerns.

It is illegal for supplement stores to supply these banned substances. It is also illegal for consumers to possess some of these substances without a prescription.

If you are taking a supplement which is labelled as containing a banned substance, you should stop taking it immediately. If you are concerned about your health, please contact your general practitioner.

The HPS is currently investigating this issue further and will be testing a number of products. If you have information to support this investigation, please contact the Pharmaceutical Services Section of the HPS on (02) 5124 9208.

Banned substances in sports supplements

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Page last updated on: 23 Jun 2020