POSTPONED: Changes to dispensing frequency rules and ‘stat’ medicines list

Source: Pharmac

What we’re proposing

We are proposing to amend the dispensing frequency rules and expand the list of pharmaceuticals that can be dispensed in a single lot. The purpose of the proposed changes is to enable greater flexibility in tailoring medicine supply to the needs of patients.

Consultation closes 5 pm Friday 17 April 2020 and feedback can be emailed to schedule.rules@pharmac.govt.nz.

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What would the effect be?

The proposal would result in:

• Expansion of the list of pharmaceuticals which are able to be dispensed as a single lot
• A broader range of circumstances under which modifications to default dispensing periods can be made
• A reduced administrative burden to prescribers and pharmacists arising from less detailed and prescriptive documentation requirements

We expect the effect of these combined changes would be more flexible dispensing arrangements that better meet the needs of patients.

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Who we think will be interested

We think people who are involved in the provision, prescribing, dispensing and reimbursement for funded pharmaceuticals could be interested. We expect that this proposal will be of particular interest to community pharmacists, District Health Boards, prescribers, patients and pharmaceutical suppliers.

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About dispensing frequency

Community pharmacies are contracted by District Health Boards to dispense medicines that are listed in the Pharmaceutical Schedule.

Products in Section B of the Pharmaceutical Schedule are designated as monthly lot dispensing or single lot (‘stat’) dispensing (which generally means three months dispensed at once, except for oral contraceptives).

Over time, the proportion of pharmaceuticals listed in the Schedule designated as single lot (‘stat’) dispensing has increased. However, permitted changes during the dispensing process mean that it is common for patients to receive ‘stat’ medicines monthly or even more frequently and, similarly, there are monthly medicines that are regularly dispensed all-at-once.

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Why we’re proposing this

PHARMAC wants to enable patients to receive medicines for adequate periods, suited to their needs. This is in line with the ‘people-powered’ theme of the 2016 New Zealand Health Strategy and is consistent with The World Health Organisation definition of the rational use of medicines:

“patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community”

In 2018 the Schedule General Rules were rewritten to make them simpler and clearer. The scope of the rewrite excluded changes to the meaning or intent of the rules, therefore no significant changes were made to dispensing frequency rules.

Currently, the composition of the list of pharmaceuticals designated as single lot (‘stat’) or monthly dispensing, combined with the rules permitting changes to those dispensing periods, is complicated, lacks flexibility and can create confusion and difficulty for patients in managing their medicines.

There is good evidence that a proportion of patients do not collect repeats or are unaware that they have further repeats for medicines that they are still taking. Obtaining new prescriptions and having them dispensed can lead to patients paying extra fees and co-payments. The proposed changes aim to improve access and convenience for patients.

We want prescribers and pharmacists to be able to achieve the right balance in partnership with patients. We think that building more flexibility into the rules and making some additions to the list of medicines that are able to be dispensed all at once will more explicitly support the dispensing adjustments that pharmacists currently make to meet the needs of patients.

The proposal aims to balance greater flexibility with avoidance of unintentional oversupply and retains mechanisms for shorter periods of supply where needed. Meanwhile, maintaining this balance may generate a useful side effect – dispensing larger quantities in a single lot across a broader range of medicines increases the resilience of the supply chain to unexpected increases in demand, emergencies or issues that impact manufacturing and supply processes.

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Details about our proposal

There would be more pharmaceuticals on the ‘stat’ list (medicines which may be dispensed in a single lot).

Most prescriptions are currently written without the prescriber specifying dispensing frequency. The proposed rules would allow, in most cases, patients and pharmacists to agree to dispensing arrangements that best meet the needs of the patient.

List changes:

The following pharmaceuticals would be added to the single lot dispensing list (identified by ❋):

Alimentary Tract & Metabolism

• Alginic acid
• Calcium carbonate oral liquid
• Macrogol 3350 with potassium chloride, sodium bicarbonate and sodium chloride
• Pancreatic enzyme

Cardiovascular System

• Bosentan
• Ezetimibe with simvastatin
• Sildenafil
• Pentoxifylline

Dermatologicals

• Acitretin
• Isotretinoin

Genito-Urinary System

• Solifenacin

Hormone Preparations – Systemic

• Cyproterone acetate
• Testosterone
• Testosterone cipionate
• Testosterone esters
• Testosterone undecanoate

Musculoskeletal System

• Celecoxib
• Leflunomide
• Penicillamine
• Risedronate

Nervous System

• Bupropion
• Levetiracetam
• Rizatriptan
• Sodium valproate
• Sumatriptan

Respiratory System & Allergies

• Beclomethasone dipropionate inhalers
• Budesonide inhalers and nasal spray
• Fluticasone inhalers and nasal spray
• Ipratropium bromide inhalers, nebuliser solution and nasal spray
• Salbutamol inhalers and nebuliser solution
• Salbutamol with ipratropium bromide inhalers and nebuliser solution

Key rules changes:

The General Rules of the Pharmaceutical Schedule would be amended, as summarised in the table below. Full details of the rule changes can be found after the table.

These changes cover the scope of the current Part 4 Rules (Community Pharmaceutical Dispensing Quantities for Subsidy) and Part 5 Rules (Community Pharmaceutical Modified Dispensing Quantities) and replace these with a single new section. There would also be consequential amendments to Part 10 Definitions.

The current Pharmaceutical Schedule General Rules can be found on the PHARMAC website.

Current	Proposed	Meaning in Practice
Prescribers and Dispensing Frequency
Current rules limit prescriber discretion on dispensing frequency to managing trial periods for new medicines and dose changes and to a list of ‘safety medicines’	More frequent dispensing could be prescribed for any product, for any reason. The current list of ‘safety medicines’ would be disestablished. A patient request for larger lots could not override frequent dispensing instructions from a prescriber	There would be no trial period or safety and co-prescribed medicines rule. If a prescriber wished to limit the quantity dispensed for any reason, they would need to endorse the prescription with the maximum quantity or period to be dispensed. The requirements of the new rule would be met if a prescriber continued to use the text ‘trial period’ on prescriptions. Similarly, prescriptions specifying a dispensing period for a medicine previously on the safety medicines list would be acceptable
		If a prescriber specified frequent dispensing and the patient wished to have larger lots (less frequent dispensing), this would not be allowed without prescriber agreement under the proposed rules
Dispensing to Meet Patient Needs
Medicines identified with the ▲ symbol may be dispensed in a single lot if the patient wishes to have a greater quantity than a monthly lot, has been stabilised on the medicine for a reasonable period and the prescriber or pharmacist thinks the patient will continue to take the medicine as prescribed. The prescription must be endorsed or annotated with “Certified Exemption”	Medicines identified with the ▲ symbol would have more flexible criteria allowing access to dispensing in larger lots than the monthly default. Limited access due to travel, relocation, limited mobility or distance from a pharmacy would also be valid reasons for dispensing these medicines in larger lots	If a patient wanted a ▲ medicine in a quantity greater than a monthly lot, is stable on the medicine and expects to continue to take it, or the patient has limited access to a pharmacy or will be unable to collect repeats when due, the pharmacist could dispense according to the patient’s wishes and would annotate the prescription with the words “patient circumstances” and the period of supply dispensed
Current rules require patients to meet specific criteria and sign a declaration, (commonly known as Access Exemption) for single lot dispensing of medicines without the ❋ or ▲ symbols	Patients would not need to meet such specific criteria or sign a declaration for larger lot dispensing of medicines that are not on the single lot dispensing (❋) list	If a patient has limited access to a pharmacy or will be unable to collect their repeats when due, the pharmacist could dispense the medicine in larger lots and would annotate the prescription with the words “patient circumstances” and the period of supply dispensed
Current rules specifically provide for dispensing as often as the pharmacist deems appropriate to meet the compliance and adherence needs of a patient registered in the Long Term Conditions service. For other (“Core”) patients dispensing more frequently than monthly requires prescriber approval or must comply with other rules such as trial periods or safety and co-prescribed medicines	Specific and differential dispensing frequency rules for Long Term Conditions and Core patients would be removed from the Schedule Rules. Medicines could be dispensed no more frequently than every 10 days without prescriber endorsement, where this best meets the needs of a patient. More frequent dispensing than 10 day lots, without prescriber endorsement, could be enabled by service contract provisions (such as Long Term Conditions and Clozapine Services Schedules in the Integrated Community Pharmacy Services Agreement	A patient presenting a prescription for a medicine from any symbol category (with the exception of Class B controlled drugs) could, on request, have their medicine(s) dispensed every 10 days (or at other intervals greater than this) without reference to the prescriber
		If dispensing at shorter intervals than every 10 days better met the needs of the patient, this would require prescriber endorsement. However, dispensing more frequently than every 10 days would be allowed for a patient registered on the Long Term Conditions service as the new rules permit more frequent dispensing under a service contract with provision for smaller lots. Frequent dispensing of clozapine would also be provided for under this rule. No annotation would be needed in these circumstances
Residential Care Facilities and Prisons
More frequent dispensing for patients in Residential Disability Care Institutions and Aged Residential Care Facilities is limited to not less than 28 days supply at one time for medicines other than Class B controlled drugs or clozapine and the prescriber or pharmacist must include additional patient details on the prescription as per the Schedule rules	Residents of these institutions or facilities could have medicines dispensed more frequently than their default designation. The threshold for the minimum dispensing period without prescriber endorsement for residents in these facilities would change from 28 days to 10 days	Rules applying only to Residential Disability Care Institutions and Aged Residential Care Facilities would be removed and these patients would fall under the new rules. No extra patient information would be needed on the prescription
	Prescribers could specify dispensing frequency for people in residential disability care institutions and aged residential care facilities as for other patient groups.  We think that this would reduce confusion and conflict between Schedule Rules and prescriber instructions in these circumstances, which were noted as issues in a 2016 audit by the Ministry of Health	This means that where weekly dispensing is appropriate for patients in these facilities, this would be allowed, provided the prescriber specifies this frequency on the prescription. Frequent dispensing at greater intervals than this would be permitted on request of the patient or their agent with annotation of the prescription by the pharmacist
Prisons are currently excluded from frequent dispensing arrangements such as trial periods and safety and co-prescribed medicines	Prisons would be included in the new modified dispensing arrangements that apply to residential disability care institutions and aged residential care facilities and all other patients	As for Residential Disability Care Institutions and Aged Residential Care Facilities above
Pharmaceutical Supply Management Rule
The Pharmaceutical Supply Management Rule for management of stock supply or emergency situations does not include an override for patients with access issues	Patients with limited access to a pharmacy or who will be unable to collect their repeats when due could have larger quantities than specified under notified Pharmaceutical Supply management arrangements	If a patient presented a prescription for a medicine with current mandatory frequent dispensing arrangements and had limited access to a pharmacy or would be unable to collect repeats when due, the pharmacist could dispense a larger lot than specified under the arrangement and would annotate the prescription with the words “patient circumstances” and the period of supply dispensed
Specific Products
Nicotine and varenicline tartrate are not funded in amounts of less than four weeks of treatment	The rule “will not be funded in amounts of less than 4 weeks of treatment” would be removed from nicotine and varenicline tartrate as this would be incompatible with the broader rules changes	Nicotine and varenicline tartrate could be dispensed more frequently than every 28 days. This would be allowed without prescriber endorsement for dispensing no more frequently than every 10 days and with prescriber endorsement for more frequent dispensing (for example, weekly dispensing)
Class B controlled drugs  are generally prescribed for up to 30 days but Schedule subsidy rules require dispensing in 10 day lots	Dispensing of Class B controlled drugs would be as prescribed, unless otherwise specified by the prescriber. This aligns with the Misuse of Drugs Regulations 1977 which require the prescriber to direct the total amount to be supplied in a single occasion or on each of multiple occasions (refer to Misuse of Drugs Regulations 1977 for complete requirements)	There would be no rule requiring dispensing in 10 day lots for Class B controlled drugs. Dispensing would be as prescribed. For multiple dispensings the prescriber would need to endorse the prescription with the maximum quantity or period of supply to be dispensed at any one time, according the Misuse of Drugs Regulations 1977

Class B Controlled Drugs

We are aware that removal of the rule requiring dispensing in 10 day lots for Class B controlled drugs could result in a shift in the quantity dispensed at a time and also affect the stockholding requirements of pharmacies. We are interested in understanding how best to implement this change, which could include extending the current arrangements to allow time for the sector to adjust. We welcome any information and feedback on current Class B controlled drug prescribing practice and dispensing considerations.

All of these proposed changes, if accepted, would be implemented no earlier than 1 June 2020.

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Part 4 – Community Pharmaceutical Dispensing Periods for Subsidy

4.1   Pharmaceuticals marked with a ❋ (❋ Pharmaceuticals) 

4.1.1    Default dispensing for ❋ Pharmaceuticals is a single Lot, generally up to 90 days (or up to 180 days for an oral contraceptive).

4.1.2     A ❋ Pharmaceutical must be dispensed more frequently (in smaller Lots than the default) if a Prescriber has prescribed more frequent dispensing and has Endorsed the Prescription with the maximum quantity or period of supply to be dispensed at any one time.

4.1.3   A ❋ Pharmaceutical may be dispensed more frequently (in smaller Lots than the default), in the following circumstances:

1. If a patient (including a patient residing in a Residential Disability Care Institution, Age Related Residential Care Facility or Prison), their agent or caregiver has requested that the ❋ Pharmaceutical is dispensed at a frequency which meets the patient’s needs and the Pharmacist has Annotated the Prescription with:
   1. the words “patient request”; and
   2. the maximum period of supply to be dispensed at any one time. 
2. A ❋ Pharmaceutical must not be dispensed more frequently than every 10 days unless:
   1. the Prescription is being dispensed in accordance with 4.1.2  above; or
   2. the Prescription is being dispensed under a service contract with provisions for smaller lots.

4.2   Pharmaceuticals marked with a ▲ (▲ Pharmaceuticals)

4.2.1    Default dispensing for▲ Pharmaceuticals is in Monthly Lots.

4.2.2    A ▲ Pharmaceutical may be dispensed in larger Lots (less frequently than the default) provided all of the following circumstances are met:

1. A patient, their agent or caregiver has requested  that the ▲ Pharmaceutical is dispensed in a quantity greater than a Monthly Lot; and
2. either the patient
   1. has been stabilised on the applicable ▲ Pharmaceutical and expects to continue to take the ▲ Pharmaceutical as prescribed; or
   2. has limited access to a pharmacy; or
   3. will be unable to collect the repeat dispensings when they are due; and

3. the Pharmacist has Annotated the Prescription with:
   1. the words “patient circumstances”; and
   2. the period of supply to be dispensed at any one time. 

4.2.3    A ▲ Pharmaceutical must be dispensed more frequently (in smaller Lots than the default) if a Prescriber has prescribed more frequent dispensing and has Endorsed the Prescription with the maximum quantity or period of supply to be dispensed at any one time.

4.2.4   A ▲ Pharmaceutical may be dispensed more frequently (in smaller Lots than the default), in the following circumstances:

3. If a patient (including a patient residing in a Residential Disability Care Institution, Age Related Residential Care Facility or Prison), their agent or caregiver has requested that the ▲ Pharmaceutical is dispensed at a frequency which meets the patient’s needs and the Pharmacist has Annotated the Prescription with:
   1. the words “patient request”; and
   2. the maximum period of supply to be dispensed at any one time.
4. A ▲ Pharmaceutical must not be dispensed more frequently than every 10 days unless:
   1. the Prescription is being dispensed in accordance with 4.2.3 above; or
   2. the Prescription is being dispensed under a service contract with provisions for smaller lots.

4.3   Any other Community Pharmaceuticals (Neither ❋ nor ▲ Pharmaceuticals)

4.3.1    Default dispensing of Neither ❋ nor ▲ Pharmaceuticals is Monthly Lots.

4.3.2    A Neither ❋ nor ▲ Pharmaceutical may be dispensed in larger Lots (less frequently than the default), to the extent permitted by the Misuse of Drugs Regulations 1977, provided both of the following circumstances are met:

3. the patient: 
   1. has limited access to a pharmacy; or
   2. will be unable to collect the repeat dispensings when they are due; and 
4. the Pharmacist has Annotated the Prescription with: 
   1. the words “patient circumstances”; and
   2. the period of supply to be dispensed at any one time. 

4.3.3    A Neither ❋ nor ▲ Pharmaceutical must be dispensed more frequently (in smaller Lots than the default) if a Prescriber has prescribed more frequent dispensing and has Endorsed the Prescription with the maximum quantity or period of supply to be dispensed at any one time.

4.3.4   A Neither ❋ nor ▲ Pharmaceutical may be dispensed more frequently (in smaller Lots than the default), to the extent permitted by the Misuse of Drugs Regulations 1977 in the following circumstances:

3. If a patient (including a patient residing in a Residential Disability Care Institution, Aged Related Residential Care Facility or Prison), their agent or caregiver has requested that the Neither ❋ nor ▲  Pharmaceutical is dispensed at a frequency which meets the patient’s needs and the Prescriber has Endorsed or Pharmacist has Annotated the Prescription with:
   1. the words “patient request”; and
   2. the maximum period of supply to be dispensed at any one time.
4. A Neither ❋ nor ▲ Pharmaceutical must not be dispensed more frequently than every 10 days unless:
   1. the Prescription is being dispensed in accordance with 4.3.3 above; or
   2. the Prescription is being dispensed under a service contract with provisions for smaller lots.

4.4   Unstable Medicines

4.4.1    A Community Pharmaceutical that is stable for only a limited period may be dispensed more frequently if the Pharmacist has Annotated the Prescription with:

1. the words “unstable medicine”, and
2. the maximum period of supply to be dispensed at any one time.

4.5  Pharmaceutical Supply Management

4.5.1    PHARMAC may enable more frequent dispensing (or smaller Lots) than is otherwise provided for in these rules of any Community Pharmaceutical to manage stock supply issues or emergency situations.  If this Pharmaceutical Supply Management rule applies, then:

1. PHARMAC will notify arrangements for frequency of dispensing and Lot sizes for the relevant Community Pharmaceutical and specify whether those arrangements are optional or mandatory; and
2. Prescriber Endorsement is not required in respect of the relevant Community Pharmaceutical for the time specified by PHARMAC.

4. 5. 2  If PHARMAC has specified under clause 4.5.1 a. above that the notified arrangements are mandatory, Pharmaceuticals dispensed under the Pharmaceutical Supply Management rule may be dispensed less frequently than specified (or in larger Lots) in the following circumstances:

1. the patient:
   1. has limited access to a pharmacy; or
   2. will be unable to collect the repeat dispensings when they are due; and 
2. the Pharmacist has Annotated the Prescription with:
   1. the words “patient circumstances”; and
   2. the period of supply to be dispensed at any one time. 

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To provide feedback

Send us an email: schedule.rules@pharmac.govt.nz by 5 pm Friday 17 April 2020.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

MIL OSI