Opioids - prescriptions and approvals 012-20101406

Item

Description

1

Phone approvals

Service Officers must:

• check if the prescriber is requesting a General (S85) schedule opioid or a Palliative Care Schedule opioid. The item selected will determine the restriction criteria that the prescriber will need to address through the Q&As
• read out the question(s) exactly as they appear in the OPA system
• select the relevant option based on response provided by prescriber
• pause before continuing when prescribers:
• do not let staff finish with the Q&As, or
• provide information inconsistent with the answers required

2

Written approvals

Prescribers must provide enough information to meet the restriction criteria in the Q&As in OPA system to produce an authority approval.

If the prescriber has not stated initial or continuing on the submitted form or copy of the prescription, staff may approve under initial if all other information is available.

Summarised information is acceptable as prescribers have limited space for the PBS criteria.

If the prescriber has not stated that the patient has previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020, check the patient history to confirm.

Two application forms are available for prescribers when submitting a written application for an opioid item. The form selected will determine which item code Service Officers needs to use.

Service Officers must select an item code from the

• General PBS Schedule when the prescriber submits the General (S85) Schedule - opioid treatment authority application form (PB294)
• Palliative Care Schedule when the prescriber submits the Palliative Care Schedule - opioid treatment authority application form (PB306)

If the prescriber does not provide enough information to meet the criteria on the submitted form or prescription, Service Officers must reject and return it to the prescriber with the relevant rejection letter.

Item

Description

1

Question: Is there a limit on the maximum quantity of palliative care opioids that Services Australia (the agency) can approve for an authority prescription?

Answer: Yes, if the restriction criteria are met, the prescriber can apply for an approval of the following quantities:

• a quantity of up to one month over the phone or prescriber self-serve (OPA)
• a quantity of up to one month and 2 repeats for a 3 month supply via prescriber self-serve (OPA) or in writing either by post or HPOS form upload

Note: OPA system may reject valid requests due to the multipliers. See Multipliers (rejection reason codes 075 and 076).

2

Question: Can the prescriber apply for an authority prescription for up to 3 months' supply on the phone?

Answer: No, phone approvals are restricted to a one month supply.

A prescriber can apply via prescriber self-serve (OPA) or in writing either by post or HPOS form upload for up to a 3 month supply. Some requests may reject on OPA due to quantity and/or repeat (multiplier) limitations.

If a prescriber asks about a rejection and the request meets all other restriction requirements, override the approval rejection in OPA with an authority comment Q/R within guidelines.

3

Question: Can Service Officers approve more than 2 repeats depending on the daily dose?

Answer: Yes, if the restriction criteria allows an increase in repeats, Service Officers can approve more than 2 repeats depending on the daily dose.

As long as the total approved quantity and repeats are no more than a one month supply (via phone) or a 3 month supply (in OPA or in writing either by post or HPOS form upload only).

4

Question: Can Service officers approve a palliative care opioid when the prescriber submits the other form(PB294)

Answer: Service Officers must approve items based on which form the prescriber submits. It is up to the prescriber to make the decision about which criteria their patient meets, and to use the corresponding application form.

5

Question: Can Service Officers approve a request if a doctor wants a quantity that would require a pack to be broken?

Answer: Yes, as long as the quantity does not exceed a maximum of one month's supply via phone, or 3 months’ supply (in OPA or in writing, either by post or HPOS form upload only).

Item

Description

1

Question: What do Service Officers do if a prescriber calls asking about opioid authority rejections in OPA due to multipliers?

Answer: Advise the prescriber the system will assess within regular dosage requirements, and may reject due to quantity and/or repeat (multiplier) limitations.

If the request meets all other requirements, Service Officers can approve the authority by overriding the rejection.

Item

Description

1

Question: If a prescriber applies for an authority for increased quantities and/or repeats (written or phone) but does not provide a reason that is in line with the restriction criteria, will a Service Officer be able to make a decision to approve the authority?

Answer: No. The prescriber must provide enough information to answer all the restriction criteria questions.

Note: when the request becomes Authority required, the prescriber must confirm that the patient has chronic severe disabling pain.

2

Question: If a prescriber has not stated Continuing PBS treatment for this drug and form after 1 June 2020, can the agency approve if all other information is available?

Answer: Yes. This can be approved if the Service Officer can see in the OPA patient history that the patient has received this drug and form after 1 June 2020.

3

Question: If the prescriber has stated Initial, will OPA reject if there has been a previous approval for initial therapy?

Answer: No, OPA will not reject the application. Service Officers must accept and approve according to the information the prescriber provides.

4

Question: If a prescriber asks What is opioid-naïve? is a Service Officer able to provide a definition?

Answer: Yes, Service Officers may provide some guidance.

Opioid naive refers to a patient’s previous use of opioids. For the purposes of a PBS approval, a patient is opioid naive if they have not recently used opioids.

5

Question: Does the prescriber have to state Daily, Continuous, Long term in full?

Answer: Yes - Daily, Continuous, Long term must be stated for the Initial treatment restriction criteria.

This applies to opioid patches e.g. Norspan® and fentanyl. These patches are not applied daily, however, the drug is released daily and continuously. If the prescriber did not state this or answered No to the question, Services Officers should reject the application.

6

Question: If the prescriber states that 2 of the indications apply to their patient, how does a Service Officer record that answer into OPA?

Answer: For phone approvals, ask the prescriber which of the 2 indications best suits their patient for this approval and record it in OPA. For authority requests by post or HPOS upload, chose one option and leave a comment.

Advise that the agency can only approve under one indication.

Item

Description

1

Question: When processing a phone request for opioids, the prescriber has stated it is less than 12 months. However, if it is obvious that it is greater than 12 months, what do Services Officers do?

Answer: Service Officers should not check patient history and must accept the information the prescriber has provided.

2

Question: If a prescriber does not know the length of opioid treatment for their patient, can a Service Officer check and provide the information?

Answer: No, the prescriber must state the length of opioid treatment.

PBS restriction criteria refers to the use of both PBS and non-PBS opioids and the agency cannot see non-PBS opioid treatment. The prescriber needs to get this information from the patient or from the patient's previous prescriber.

3

Question: If a patient has never had an authority prescription for opioid treatment, is their treatment duration defined as less than 12 months?

Answer: No, the agency needs to consider the total length of opioid treatment.

This may include non-PBS treatment, PBS treatment with listed amounts and PBS treatment supplied under an authority for increased quantities and repeats. Medicines such as tramadol and paracetamol+codeine combinations are considered opioid treatment and must be reviewed by the prescriber.

4

Question: If a prescriber states a patient is on long term methadone, is their opioid treatment duration defined as more than 12 months?

Answer: If a patient is being prescribed methadone to treat long-term pain, only the length of treatment for pain management should be considered.

When opioid treatment is more than 12 months, it is up to the prescriber to:

• provide the length of the opioid treatment
• make sure another medical practitioner consults with the patient about the continuing need for opioid treatment

Note: Methadone is not always prescribed to treat pain. It is sometimes prescribed for opioid dependence, which has no bearing on the treatment length for pain management approvals.

Item

Description

1

Question: Is an opioid or narcotic review the same as a pain management review or a clinical review?

Answer: Yes, if it is a review of the patient’s opioid treatment for their pain management.

2

Question: Do patients have to attend a face-to-face appointment for their opioid treatment review?

Answer: No, a telehealth consult is acceptable.

3

Question: Which health professionals can conduct the opioid review?

Answer: An Ahpra-registered medical practitioner (doctor) must conduct the review. For palliative care patients only, a palliative care nurse practitioner can conduct the review.

4

Question: If a patient has not had an opioid review in the last 12 months, can the agency approve an application for increased quantities and/or repeats for opioids?

Answer: If a patient has been on opioid treatment for less than 12 months, a review is not required.

A review is only required if the patient has been receiving PBS and non-PBS opioid pain treatment for longer than 12 months.

In certain circumstances an authority for increased quantity and repeats can be approved:

• If a patient has proven malignant neoplasia (note: not all opioids have this option)
• If the patient is in palliative care and they cannot attend a review due to their condition

The authority application must not be approved if:

• the length of the patient’s opioid treatment is more than 12 months
• they have not had a review in the last 12 months, and
• a review is not planned in the next 3 months

The prescriber may write a PBS prescription for the listed quantity.

5

Question: Where a review is required, does the prescriber need to provide the review details for every authority request?

Answer: From 1 October 2020:

• review details are no longer required to be sent to the agency
• the prescriber must keep the details of the review on the patient’s medical file, and
• reviews must still be conducted once every 12 months

6

Question: Are aged-care patients (e.g. nursing home patients) exempt from an opioid (narcotic) review?

Answer: No.

7

Question: If a prescriber writes a streamlined authority for listed quantity of 28, is a review of opioid pain management required within the next 3 months if a review has not been done in the last 12 months?

Answer: No, streamlined authority items for listed quantities do not require an opioid (narcotic) review.

Streamline authority items are assessed by prescribers and the prescriber must answer the criteria for the streamline indication.

8

Question: Can the prescriber calling for the authority request be the reviewing prescriber?

Answer: Yes, as long as they are not the patient's regular prescriber.

9

Question: If a prescriber has taken over care of a patient and will be their regular doctor in the future, can they be the reviewing prescriber?

Answer: Yes, but after 12 months a different prescriber will need to do a new opioid (narcotic) review.

10

Question: What are the options for GP working by themselves in a solo practice who is not able to refer their patient to any other GP for an opioid (narcotic) review?

Answer: The agency cannot approve an authority application for increased quantity if the patient is due for a review. The prescriber may write a PBS prescription for the listed quantity, noting that reviews can be conducted via telehealth and this may be an option for the patient.

11

Question: How should prescribers conduct opioid pain management reviews?

Answer: The prescriber must tell the agency at the time of the authority application if an opioid (narcotic) review has been conducted for their patient. The agency does not question or record how the prescriber did it.