A change to a medicine where an item or product listing may no longer be prescribed, but may be dispensed and supplied. That is, the item is still "active" and may be claimed in the same manner as an effective item.

This situation is handled using the supply-only effectivity element. An item or a product listing may be changed to supply-only effectivity. If an item (prescribing-rule) is in supply-only mode, then all of its product listings will also be in supply-only mode.

If the product listings to be made supply-only are substitutable with product listings under other item codes then the brand substitution group remains effective.

Figure 1. Supply-only Items

The example below shows a PBS Item, 1001Q, in supply-only mode. The item started being in supply-only mode in July 2020 and will become delisted in July 2021 (one year later). NB. the item's product listing is also in supply-only mode.

<prescribing-rule>
  <ready-prepared>
    ...
    <product-listing>
      <tpp-reference xlink:href="#a3487424">
      </tpp-reference>
      ...
      <supply-only>
        <date>2020-07-01</date>
        <non-effective>
          <date>2021-07-01</date>
        </non-effective>
      </supply-only>
    </product-listing>
  </ready-prepared>

  <preferred-term>Examplovir 500mg tablet, 24</preferred-term>
  <code rdf:resource="http://pbs.gov.au/code/item">1001Q</code>

  <supply-only>
    <date>2020-07-01</date>
    <non-effective>
      <date>2021-07-01</date>
    </non-effective>
  </supply-only>
</prescribing-rule>

The example below shows a PBS Item, 1002R. The item is effective. The item has two product listings, one of which is in supply-only mode.

<prescribing-rule>
  <ready-prepared>
    ...
    <product-listing>
      <tpp-reference xlink:href="#a3487424">
      </tpp-reference>
      ...
      <effective>
        <date>2005-01-01</date>
      </effective>
    </product-listing>
    <product-listing>
      <tpp-reference xlink:href="#a3487424">
      </tpp-reference>
      ...
      <supply-only>
        <date>2020-07-01</date>
        <non-effective>
          <date>2021-07-01</date>
        </non-effective>
      </supply-only>
    </product-listing>
  </ready-prepared>

  <preferred-term>Examplovir 250mg tablet, 24</preferred-term>
  <code rdf:resource="http://pbs.gov.au/code/item">1002R</code>

  <effective>
    <date>2000-07-01</date>
  </supply-only>
</prescribing-rule>

Certain PBS Items (prescribing rules) are classified as "Complex Authority Required" (CAR). These are known as 'CAR Items'. There are two different meanings to the phrase "CAR":

PBS Items in the Public Hospital HSD program (HB) that are marked as 'Administrative CAR' may be dispensed by a Community Pharmacy. Such items may have either a Streamlined or Authority Required restriction level (benefit type).

<prescribing-rule>
  ...
  <member-of-list>
    ...
    <member-of rdf:resource='http://pbs.gov.au/complex-authority-required/is-complex'>
      <code rdf:resource="http://pbs.gov.au/code/group">is-complex</code>
      <effective>
        <date>2019-02-01</date>
      </effective>
    </member-of>
  </member-of-list>
</prescribing-rule>

<prescribing-rule>
  ...
  <member-of-list>
    ...
    <member-of rdf:resource='http://pbs.gov.au/complex-authority-required/not-complex'>
      <code rdf:resource="http://pbs.gov.au/code/group">not-complex</code>
      <effective>
        <date>2017-08-01</date>
      </effective>
    </member-of>
  </member-of-list>
</prescribing-rule>

<administrative-advice xml:id="a25639" rdf:resource="http://pbs.gov.au/DHS/authority/complex">
  <code rdf:resource="http://pbs.gov.au/code/prescribing-text">11165</code>
  <dbk:note>
    <dbk:para>For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Department of Human Services website at www.humanservices.gov.au</dbk:para>
  </dbk:note>
  <effective>
    <date>2017-09-01</date>
   </effective>
</administrative-advice>

<prescribing-rule>
  <prescribing-text-references-list>
    <administrative-advice-reference xlink:href="#a25639">
      <code rdf:resource="http://pbs.gov.au/code/prescribing-text">11165</code>
      <effective>
        <date>2017-09-01</date>
      </effective>
    </administrative-advice-reference>
  </prescribing-text-references-list>
  ...
</prescribing-rule>

<prescribing-rule>
  <benefit-types-list>
    <benefit-type rdf:resource="http://pbs.gov.au/benefit-type/authority-required">
      <restriction-references-list>
        <restriction-reference xlink:href="#a13912">
          <code rdf:resource="http://pbs.gov.au/code/restriction">5965</code>
          <effective>
            <date>2017-09-01</date>
          </effective>
        </restriction-reference>
      </restriction-references-list>
      <effective>
        <date>2017-09-01</date>
      </effective>
    </benefit-type>
  </benefit-types-list>
  ...
</prescribing-rule>

<restriction xml:id="a13912">
  <code rdf:resource="http://pbs.gov.au/code/restriction">5965</code>
  <code rdf:resource="http://pbs.gov.au/code/treatment-of">6189</code>
  <assessment rdf:resource="http://pbs.gov.au/assessment/full">
    <code rdf:resource="http://pbs.gov.au/assessment">full</code>
    <effective>
      <date>2017-09-01</date>
    </effective>
  </assessment>
  <indication-reference xlink:href="#a35361">
    <code rdf:resource="http://pbs.gov.au/code/prescribing-text">10646</code>
    <effective>
      <date>2017-09-01</date>
    </effective>
  </indication-reference>
  <administrative-advice-reference xlink:href="#a25639">
    <code rdf:resource="http://pbs.gov.au/code/prescribing-text">11165</code>
    <effective>
      <date>2017-09-01</date>
    </effective>
  </administrative-advice-reference>
  <effective>
    <date>2017-09-01</date>
  </effective>
</restriction>

Increases to Maximum Quantity and/or Number of Repeats.

Every prescribing rule specifies the amount by which the Maximum Quantity (Maximum Amount for infusibles) and/or Number of Repeats may be increased. The increase amount is represented by the increase element. Each increase element describes whether the increase is permitted for Maximum Quantity or Number of Repeats, the Prescriber Types that the increase may be prescribed by, whether authority approval is required to prescribe the increase and the manner in which the approval may be sought, and finally any restrictions that may apply to the prescribing of the increase.

Figure 2. Restriction/Increase Data Model

<increase rdf:resource="http://pbs.gov.au/increase/maximum-prescribable">
  <value>2</value>
  <benefit-type rdf:resource="http://pbs.gov.au/benefit-type/authority-required">
  ...
  </benefit-type>
</increase>

<increase rdf:resource="http://pbs.gov.au/increase/maximum-prescribable">
  <value>2</value>
  <benefit-type rdf:resource="http://pbs.gov.au/benefit-type/authority-required">
    <member-of-list>
      <member-of rdf:resource="http://pbs.gov.au/prescriber/medical">
        <code>medical</code>
      </member-of>
      <member-of rdf:resource="http://pbs.gov.au/prescriber/nurse">
        <code>nurse</code>
      </member-of>
    </member-of-list>
  </benefit-type>
</increase>

<increase rdf:resource="http://pbs.gov.au/increase/maximum-prescribable">
  <value>2</value>
  <benefit-type rdf:resource="http://pbs.gov.au/benefit-type/authority-required">
    <member-of-list>
      <member-of rdf:resource="http://pbs.gov.au/prescriber/medical">
        <code>medical</code>
      </member-of>
      <member-of rdf:resource="http://pbs.gov.au/prescriber/nurse">
        <code>nurse</code>
      </member-of>
    </member-of-list>
    <restriction-references-list>
      <restriction-reference xlink:href="#d4639247">
        <effective>
        <date>2015-11-01</date>
        </effective>
      </restriction-reference>
    </restriction-references-list>
  </benefit-type>
</increase>

A stock shortage of an essential medicine where a new item code is listed and scripts written for the existing listing, that is out of stock, are valid for supply using the new item code. The unavailable item code remains listed.

In this situation the existing item code remains effective and a brand substitution group is created (if one does not already exist) that includes the new TPP (brand).

All drug concepts have a SNOMED code. However, the code will be issued by either ADHA, as part of the AMT, or by the Department of Health. The AMT code for a drug concept is used where it is available, but sometimes this is not possible and a Health-issued code is used instead.

When a Health-issued code is used for a drug concept, at such time as an AMT code becomes available then Health will switch to using that code. It is also possible for a drug concept to switch from an AMT code to a Health-issued code.

This situation is handled using the history mechanism of the PBS XML Schema. In the case of a drug concept changing from a Health-issued code to an AMT code, the concept's code element will change it's rdf:resource attribute value from http://snomed.info/sct/911000144106 to http://snomed.info/sct/900062011000036108 and its content will change to the new value. The code element will also have a previous attribute added and it's value will correspond to the xml:id attribute of a previous element in the previous-list. The corresponding previous element will contain the image of the code element as it appeared in the previous month's Schedule.

For examples in test data see drug concepts indicated by XML comments.

In some circumstances there can be different preferred terms (names or descriptions) for an object. For example, a drug concept may have be described using one term for clinical purposes and another term for legal purposes.

This situation is handled by the object having two (or more) preferred-term elements. Each preferred-term may have a rdf:resource attribute to specify its meaning or use.

For an example in test data see the drug concept Bevacizumab.

A restriction may be added to a prescribing rule.

In this situation the restriction is added as a restriction-reference element to a benefit-type within the prescribing-rule. The effective date of the newly added restriction-reference element is the date of the publication.

There are two sub-scenarios: either the restriction is pre-existing or the restriction is new.

Pre-Existing Restriction

In this case, there is no change to the pre-existing restriction.

In the following example, the publication date is July 2020 (2020-07-01).

Example 11. Adding a Restriction Reference

<prescribing-rule>
  <ready-prepared>
    ...
  </ready-prepared>

  <preferred-term>Examplovir 500mg tablet, 24</preferred-term>
  <code rdf:resource="http://pbs.gov.au/code/item">1001Q</code>

  <benefit-types-list>
    <benefit-type rdf:resource="http://pbs.gov.au/benefit-type/restricted">
      <restriction-references-list>
        <restriction-reference xlink:href="#a34972345">
	  <effective>
	    <date>2020-07-01</date>
	  </effective>
	</restriction-reference>
      </restriction-references-list>
    </benefit-type>
  </benefit-types-list>
  <effective>
    <date>2010-08-01</date>
  </effective>
</prescribing-rule>

Figure 3. Add Restriction Reference

New Restriction

In this case, the new restriction is also added to the prescribing-texts-list and the effective date of the restriction is the date of the publication.

In the following example, the publication date is July 2020 (2020-07-01).

Example 12. Adding a New Restriction

<root>
  <schedule>
    <program>
      <prescribing-rule>
        <ready-prepared>
	  ...
	</ready-prepared>

	<preferred-term>Examplovir 500mg tablet, 24</preferred-term>
	<code rdf:resource="http://pbs.gov.au/code/item">1001Q</code>

	<benefit-types-list>
	  <benefit-type rdf:resource="http://pbs.gov.au/benefit-type/restricted">
	    <restriction-references-list>
              <restriction-reference xlink:href="#a3487426">
	        <effective>
	          <date>2020-07-01</date>
	        </effective>
	      </restriction-reference>
            </restriction-references-list>
          </benefit-type>
        </benefit-types-list>
	<effective>
	  <date>2010-08-01</date>
	</effective>
      </prescribing-rule>
    </program>
  </schedule>
  ...
  <prescribing-texts-list>
    ...
    <restriction xml:id="a3487426">
      ...
      <effective>
        <date>2020-07-01</date>
      </effective>
    </restriction>
  </prescribing-texts-list>
</root>

Figure 4. Add Restriction

A restriction may be removed from a prescribing rule.

In this situation the restriction-reference element is removed from the restriction-references-list element within the benefit-type element within the prescribing-rule. The restriction-reference element is replaced by a moved element. The effective date of the moved element is the date of the publication. The restriction-reference element now appears in a previous element in the previous-list section of the PBS XML document. The effective date of the old restriction-reference element is its original effective date and it will now have a non-effective date that is the date of the publication. The moved element and the previous element containing the old restriction reference both have a xlink:href attribute that link to each other.

NB. The history of restrictions for prescribing rules is retained over a twelve month period, so moved elements with older effective dates may also be included in the same restriction-references-list element.

Figure 5. Remove Restriction Reference

There are two sub-scenarios: either only the reference to the restriction is removed, because it is still referred to by another active prescribing rule, or the restriction itself is also removed.

For an example in test data see the prescribing rule 1759N in the 1st January 2016 Schedule. This example removes three restrictions from the prescribing rule.

Remove Restriction Reference

In this scenario, the reference to a restriction is removed from a prescribing rule, but there are other active references to the restriction so the restriction itself is not removed.

The restriction reference is removed, as described above.

Figure 6. Remove Restriction Reference

A restriction may be changed in a manner that is not significant, i.e. the intent or meaning of the restriction is unchanged. This is referred to as an editorial change. Examples of this type of change include correction of typographical or spelling errors. Changes of this nature do not cause the restriction's code to be changed.

In this situation a restriction component element, such as a condition, treatment-phase or parameter element, is modified. When this happens the effective date of the element is the same as the publication date and a previous attribute is added to the element and the old version of the element appears in the previous-list section of the XML document.

Figure 7. Restriction Editorial Change

If a restriction changes its restriction code then it is considered to be a new restriction. In this case the old restriction is deleted and the new restriction is added. See above for

If a restriction changes its treatment-of code, then its restriction code will also change; see above.

When a prescription for a streamlined authority item is to be dispensed then the script must have a valid Streamlined Authority Code (SAC). Values for SACs are taken from the treatment-of code for restrictions attached to the PBS Item. The SAC appearing on the script must have been valid at the time that the prescription was written, which may be up to 12 months prior to it being dispensed. However, the item's restrictions may have changed between the time that the prescription was written and the item dispensed.

This situation is handled by using the moved elements in the restriction-references-list element of the benefit-type for the prescribing rule. A Streamlined Authority Code is the treatment-of code given to a restriction for a prescribing rule that has a streamlined benefit type. These restrictions appear in the benefit type as a restriction-reference element. Whenever a restriction-reference element is removed, it is replaced by a moved element and the restriction-reference element then appears in the previous-list section of the PBS XML. The effective date of the moved element is the date that the restriction was removed. The PBS XML populates non-effective restriction-reference elements for a 12 month period prior to the effective date of the Schedule.

NB. the code included in the restriction-reference element is the restriction code, not the treatment-of code.

In the example below, PBS Item 1003T is streamlined. It currently has one restriction, with treatment-of code 9332 (Streamlined Authority Code 9332). In the recent past it has had two restrictions: codes 9330 and 9331. Restriction 9330 was replaced by code 9331 in the October 2019 PBS Schedule. Restriction 9331 was replaced by code 9332 in the March 2020 PBS Schedule. Since this is the July 2020 PBS Schedule, the history of restrictions includes all restrictions that were effective from the July 2019 PBS Schedule to the current Schedule.

<root>
  <info>
    ...
    <dct:valid>2020-07-01</dct:valid>
    ...
  </info>
  <previous-list>
    <previous xlink:href="#a33800">
      <restriction-reference xml:id="a33787" xlink:href="#a33786">
        <code rdf:resource="http://pbs.gov.au/code/restriction">7622</code>
        <non-effective>
          <date>2020-03-01</date>
        </non-effective>
        <effective>
          <date>2019-10-01</date>
        </effective>
      </restriction-reference>
    </previous>
    <previous xlink:href="#a33801">
      <restriction-reference xml:id="a33788" xlink:href="#a33786">
        <code rdf:resource="http://pbs.gov.au/code/restriction">7621</code>
        <non-effective>
          <date>2019-10-01</date>
        </non-effective>
        <effective>
          <date>2018-08-01</date>
        </effective>
      </restriction-reference>
    </previous>
    <previous xlink:href="#a33791">
      <restriction xml:id="a33789">
        <code rdf:resource="http://pbs.gov.au/code/restriction">7622</code>
        <code rdf:resource="http://pbs.gov.au/code/treatment-of">9331</code>
        <non-effective>
          <date>2020-03-01</date>
        </non-effective>
        <effective>
          <date>2019-10-01</date>
        </effective>
        ...
      </restriction>
    </previous>
    <previous xlink:href="#a33792">
      <restriction xml:id="a33790">
        <code rdf:resource="http://pbs.gov.au/code/restriction">7621</code>
        <code rdf:resource="http://pbs.gov.au/code/treatment-of">9330</code>
        <non-effective>
          <date>2019-10-01</date>
        </non-effective>
        <effective>
          <date>2018-08-01</date>
        </effective>
        ...
      </restriction>
    </previous>
  </previous-list>
  <schedule>
    <program>
    ...
    <prescribing-rule>
      ...
     <preferred-term>aciclovir 200mg tablet, 25</preferred-term>
     <code rdf:resource="http://pbs.gov.au/code/item">1003T</code>

     <benefit-types-list>
       <benefit-type rdf:resource="http://pbs.gov.au/benefit-type/streamlined">
         <restriction-references-list>
	   <restriction-reference xlink:href="#a33786">
             <code rdf:resource="http://pbs.gov.au/code/restriction">7623</code>
             <effective>
               <date>2020-03-01</date>
             </effective>
	   </restriction-reference>
	   <moved xml:id="a33800" xlink:href="#a33787"
	     rdf:resource="http://pbs.gov.au/change/removed">
             <effective>
               <date>2020-03-01</date>
             </effective>
	   </moved>
	   <moved xml:id="a33801" xlink:href="#a33788"
	     rdf:resource="http://pbs.gov.au/change/removed">
             <effective>
               <date>2019-10-01</date>
             </effective>
	   </moved>
         </restriction-references-list>
       </benefit-type>
     </benefit-types-list>
    </prescribing-rule>
      ...
  </schedule>
  <prescribing-texts-list>
    <restriction xml:id="a33786">
      <code rdf:resource="http://pbs.gov.au/code/restriction">7623</code>
      <code rdf:resource="http://pbs.gov.au/code/treatment-of">9332</code>
      ...
    </restriction>
    <moved xlink:href="#a33789" xml:id="a33791"
      rdf:resource="http://pbs.gov.au/change/removed">
      <effective>
        <date>2020-03-01</date>
      </effective>
    </moved>
    <moved xlink:href="#a33790" xml:id="a33792"
      rdf:resource="http://pbs.gov.au/change/removed">
      <effective>
        <date>2019-10-01</date>
      </effective>
    </moved>
  </prescribing-texts-list>
</root>

Figure 8. Streamlined Authority Code History

Every product-listing element is a member of a brand substitution group. Brand substitution groups belong to the concept type http://pbs.gov.au/brand-substitution/. The group contains those product listings that may be substituted for each other. The substitutable product listing gives the TPP and prescribing rule that may be substituted.

If a product listing is the only member of a brand substitution group then there are no other products that may be substituted.

An item must only be approved for an approved prescriber with a certain speciality code.

This scenario makes use of PBS terminology concepts in the rdf:RDF section of the PBS XML. In the PBS terminology, types of prescribers are represented at two levels: a broad categorisation of prescriber types and a more detailed list of specialists. The appropriate specialist concept is then linked to a prescriber-type restriction parameter.

Figure 9. Specialist Restriction Parameter

Prescriber types are identified as being types of the http://pbs.gov.au/prescriber concept. These are the broad categories of prescriber types, such as Medical Practitioner (http://pbs.gov.au/prescriber/medical), Nurse Practitioner (http://pbs.gov.au/prescriber/nurse), Dental Practitioner (http://pbs.gov.au/prescriber/dental), and so on.

Specialist concepts are also identified as being types of the http://pbs.gov.au/prescriber concept. However, they are related to the broader concept using the skos:narrower and skos:broader relationships. These relationships may be used to represent a hierarchy of specialists.

<p:prescriber rdf:about="http://pbs.gov.au/prescriber/medical">
    <db:title>Medical Practitioner</db:title>
    <p:code>M</p:code>
    <skos:narrower rdf:resource="http://pbs.gov.au/prescriber/medical/rheumatologist"/>
  </p:prescriber>
  <p:prescriber rdf:about="http://pbs.gov.au/prescriber/medical/rheumatologist">
    <db:title>Rheumatologist</db:title>
    <db:para>A Rheumatologist is a medical specialist.</db:para>
    <skos:broader rdf:resource="http://pbs.gov.au/prescriber/medical"/>
    <skos:narrower rdf:resource="http://pbs.gov.au/prescriber/medical/rheumatologist/paediatric"/>
  </p:prescriber>
  <p:prescriber rdf:about="http://pbs.gov.au/prescriber/medical/rheumatologist/paediatric">
    <db:title>Paediatric Rheumatologist</db:title>
    <db:para>A specialist Rheumatologist.</db:para>
    <skos:broader rdf:resource="http://pbs.gov.au/prescriber/medical/rheumatologist"/>
  </p:prescriber>

For examples in test data see items 10001J, 3430M, 3431N and 6367D.

PBS Items that may only be approved providing other PBS Items are not approved in the patient's history.

[Need further explanation of scenario]

[Need further explanation of scenario]

Age limitations for certain PBS Items and/or restrictions.

This scenario makes use of PBS terminology concepts in the rdf:RDF section of the PBS XML. In the PBS terminology, the age of a patient is represented by the http://pbs.gov.au/parameter/age concept. Specialisations of this concept represent variations and constraints on the age of the patient. The appropriate age related concept is then linked to an age-type restriction parameter.

  <p:parameter rdf:about="http://pbs.gov.au/parameter/age">
    <db:title>Age</db:title>
    <db:para>Patient's age.</db:para>
    <skos:broader rdf:resource="http://pbs.gov.au/criteria/population"/>
  </p:parameter>
  <p:parameter rdf:about="http://pbs.gov.au/parameter/age/min70">
    <db:title>Age 70 or older</db:title>
    <db:para>Patient must be aged 70 years or older</db:para>
    <skos:broader rdf:resource="http://pbs.gov.au/parameter/age"/>
    <xs:minInclusive>70</xs:minInclusive>
  </p:parameter>

For examples in test data see items 8481J, 9288W.

Gender limitations for certain PBS Items and/or restrictions.

This scenario makes use of PBS terminology concepts in the rdf:RDF section of the PBS XML. In the PBS terminology, the gender of a patient is represented by the http://pbs.gov.au/parameter/sex concept. Specialisations of this concept represent variations and constraints on the gender of the patient. The appropriate gender related concept is then linked to a sex-type restriction parameter.

  <p:parameter rdf:about="http://pbs.gov.au/parameter/sex">
    <db:title>Sex</db:title>
    <db:para>Patient gender.</db:para>
    <skos:broader rdf:resource="http://pbs.gov.au/criteria/population"/>
  </p:parameter>
  <p:parameter rdf:about="http://pbs.gov.au/parameter/sex/male">
    <db:title>Male</db:title>
    <db:para>Patient must be male</db:para>
    <skos:broader rdf:resource="http://pbs.gov.au/parameter/sex"/>
    <owl:sameAs rdf:resource="http://snomed.info/sct/248153007"/>
  </p:parameter>

For examples in test data see items 10205D, 2114G.

Initial vs continuing therapy.

[Check that this is being handled by authority-required/streamlined listings]

[Need further explanation of scenario]

Short-term limitations.

Once in a lifetime drugs.

This scenario makes use of PBS terminology concepts in the rdf:RDF section of the PBS XML. In the PBS terminology, the treatment of a patient is represented by the http://pbs.gov.au/parameter/treatment/lifetime concept. Specialisations of this concept represent variations on the treatment the patient may receive in their lifetime. The appropriate specialist concept is then linked to a treatment-parameter-type restriction parameter.

  <p:parameter rdf:about="http://pbs.gov.au/parameter/treatment/lifetime">
    <db:title>Treatment in a Lifetime</db:title>
    <db:para>Limitation on PBS-subsidised treatment of a patient in their lifetime</db:para>
    <skos:broader rdf:resource="http://pbs.gov.au/parameter/treatment"/>
    <skos:narrower rdf:resource="http://pbs.gov.au/parameter/treatment/lifetime1"/>
  </p:parameter>
  <p:parameter rdf:about="http://pbs.gov.au/parameter/treatment/lifetime1">
    <db:title>Once in a Lifetime Therapy</db:title>
    <db:para>A patient may only qualify for PBS-subsidised treatment under this restriction once in a lifetime.</db:para>
    <skos:broader rdf:resource="http://pbs.gov.au/parameter/treatment/lifetime"/>
    <xs:maxInclusive>1</xs:maxInclusive>
  </p:parameter>

For examples in test data see items 9411H, 10193L.