Community Pharmacy Roadmap Program Development Template
Program/Service
Quadrant
Medicine Recalls
A – Prescribed Medicines – Services and Programs
1. Program/Service Description
a) Background
A medicine is recalled from supply from the Australian market when there is an 'established
deficiency in quality, efficacy or safety'. A recall might be initiated as a result of reports
referred from a variety of sources, including:





manufacturers
wholesalers
retail and hospital pharmacists
research facilities
medical practitioners and dentists.
The Therapeutic Goods Administration (TGA) may also request a recall as a result of:



analysis and testing of samples of therapeutic goods
advice from an expert advisory committee
information received from international regulatory authorities. 1
The current process followed is largely defined by the Uniform Recall Procedure for
Therapeutic Goods (URPTG), established by the TGA. This procedure describes the stages of
recall, including notification, crisis management, information requirements, an assessment of
strategy, class and level of recall, communications, responsibilities of sponsors and recall
coordinators and follow-up actions.
A review of the role of community pharmacy in drug recalls was undertaken as part of the 4th
Community Pharmacy Agreement. (4CPA) This review’s report, released in February 2010,
found the URPTG made little mention of community pharmacy and that there was a lack of
any standardised national recall procedures for the sector. This means that, beyond the
initiation of the recall, performance of medicine recall tasks at the pharmacy level is reliant
upon pharmacist’ professional responsibilities, rather than explicitly defined procedures.2
b) Brief Description
Pharmacies play a key role in the quarantine and return of recalled medicines to the
manufacturer, as well as the counselling of patients. A real-time internet based alert system for
medicine recalls would assist pharmacies in this important role.
This is consistent with the findings of the 4CPA report which suggests: “..the development of
a system that sends an immediate electronic multi-modal message to all pharmacies”
The report notes such a system “…could be included in dispensing systems, added to other
existing data base systems such as Project STOP or be an entirely new product.” 3
c) Alignment with
An effective and efficient medicine recall process aligns with the National Medicine Policy4,
Government Policy with medicines needing to meet appropriate standards of quality, safety and efficacy.
TGA Product Recalls: http://www.tga.gov.au/recalls/index.htm
Nova Public Policy Pty Ltd: Review of the role of community pharmacy in drug recalls- Final report, 2 February 2010
http://www.health.gov.au/internet/main/publishing.nsf/content/3AFDB28CDC5C43A5CA25751400032D03/$File/Drug%20Recalls%20Revi
ew%20Final%20Report%2020100202.pdf
1
2
3
Ibid. p7
4
http://www.health.gov.au/internet/main/publishing.nsf/Content/National+Medicines+Policy-1
1
d) Expected
Outcomes for
Government and
Community
Pharmacy
From the government perspective, a real-time, standardised electronic alert system for recalls
would mean the timely removal of recalled medicines across all pharmacies, meaning superior
outcomes for public health.
From the community pharmacy perspective, a uniform process to be followed for medicine
recalls would maximise efficiency/simplicity, and ensure recall-related tasks were
commensurate with any remuneration provided.
e) Consumer Benefits An effective and efficient medicine recall process, supported by an internet-based real time
monitoring and alert system, would minimise the risk to consumers.
f)
Who Performs the
Service


Pharmacists
Pharmacy assistants
The pharmacist will be involved with any professional aspects associated with the service,
while pharmacy assistants will be involved with administrative functions.
g) Collaboration with
Other Health Care
Professionals
Will service delivery require any formal collaboration with other health care professionals?
The pharmacist may need to collaborate with the prescriber after a medicine has been recalled
to discuss alternative therapies for patients.
2. Implementation and Enablers
a) Stakeholder
Consultation
Representative bodies from the following areas will need to be consulted in order to fully develop and implement
a program:
 Consumer organisations
 Funders
 Government and regulatory bodies
 GP organisations and other prescriber groups
 Pharmacy organisations
 Pharmacy software vendors
 Product sponsor groups
 Professional insurers
b) IT Requirements
Is pharmacy software required to deliver this program?
Yes.
The current medicine recall processes rely substantially on facsimile as the mode of
communication between pharmacies and others in the medicine recall chain.
A real time monitoring and alert system that sends an immediate electronic message to all
pharmacies would reduce the delays reportedly experienced with the current system. It could
be included in dispensing systems or added to other existing data base systems such as for
Project STOP5.
c) Infrastructure
and Staffing
Is a private consultation area required to deliver this program?
No.
Is the program within the pharmacist’s/pharmacy assistant’s normal scope of practice?
Yes.
Is an additional pharmacist likely to be needed?
No.
5
d) Training
What additional formal training is likely?
Initial instruction on any systems that are developed will be required.
e) Supporting
Will a QCPP standard be required?
http://www.projectstop.com.au/
2
Standards,
Procedures and
Templates /
Checklists
Yes.
An update to existing Quality Care Pharmacy Program (QCPP) standards may be required to
accommodate aspects of this service.
Will professional guidelines and/or standards for pharmacists be required?
Yes.
Are there any national guidelines which need to be taken into account in developing the program to ensure
consistency with best practice?
Yes.
The URPTG should be expanded to include the role of community pharmacy.
f)
Legislation /
Regulation
Implications
The management of safety and quality in the medicine supply (and recall) system in Australia
is largely provided via agreements, protocols and procedures between sponsors and the TGA
including the URPTG. It is unlikely that either Commonwealth or State/Territory legislation
should need to be changed.
3. Funding
Funding options
Possible funding options include:
 Commonwealth funding – through an incentive scheme (e.g. via QCPP)
 User-pays – sponsors remain responsible for costs associated with recalls, and pharmacies
are reimbursed for direct and indirect costs incurred, such as customer counselling
Has any funding for this program been secured?
No.
4. Timelines
Timelines
□ Established community pharmacy practice
√ Immediate to short-term implementation (< 30 June 2015)
□ Medium-term implementation (1 July 2015 to 30 June 2020)
□ Longer-term implementation (> 1 July 2020 )
3