| Actions . . . | Goals . . . |
- Bring together the agencies engaged in regulatory and pharmacovigilance-related activities to develop a collaborative and cohesive approach to ensure New Zealanders have access to safe, quality and effective medicines.
| Quality, safety, efficiency: New Zealand has a sustainable, efficient and effective regulatory system that is consistent with international best practice. It ensures that safe, quality and effective medicines are available to New Zealanders in a timely way. |
- Evaluate and review the effectiveness of Medicines New Zealand.This will be undertaken and reported on by the Ministry of Health in December 2008.
- The Ministry of Health will hold a stakeholder forum every two years. This will give stakeholders, including consumers, a formal opportunity to contribute to the implementation of Medicines New Zealand and to respond to new issues that arise during the monitoring and evaluation of the medicines strategy.
| Access: The systems within the medicines sector work well and contain appropriate checks and balances and clear accountabilities. |
- Pharmac will hold a regular forum for interested stakeholders to comment on Pharmac’s operation, including Pharmac’s stakeholder engagement activity.
- Funding applicants will be formally invited to meet with Pharmac at the beginning of the funding application process.
- Other stakeholders, including consumers, will be encouraged to provide their views on medicines-funding applications, which will then be considered in the application process.
- Opportunities for stakeholder input will be publicised and consumers will be provided with guidance on how to contribute to Pharmac’s decisions.
| Access: Stakeholders, including consumers, will have the opportunity to provide information or perspectives that will contribute to Pharmac’s decision-making processes and will be provided with guidance on how to do so. |
- The Ministry of Health will bring together agencies engaged in access-related activities to ensure a collaborative and cohesive approach to ensuring New Zealanders have access to the medicines they need.
| Access: Medicines are affordable for individuals, the community and the health and disability system and meet the needs of New Zealanders. |
| Actions . . . | Goals . . . |
- Extend the audit function provisions in the Health Act 1956 (section122G) to support robust accountability and monitoring across the medicines system.
| Quality, safety, efficacy: New Zealand has a sustainable, efficient and effective regulatory system that is consistent with international best practice. It ensures that safe, quality and effective medicines are available to New Zealanders in a timely way. |
- District Health Boards (DHBs) and Pharmac will move to a principles-based approach for setting the community pharmaceuticals budget, which aims to maximise health outcomes across pharmaceuticals and other health services.
- Pharmac will publish public summaries of decisions on medicines funding applications.
| Access: New Zealanders understand and can access information about the medicines system including, where appropriate, information about medicines funding decisions and related health and disability system prioritisation criteria. |
- Look to extend the Primary Health Care Strategy’s initiative that introduces reduced prescription charges to people moving from secondary health care services back into the community.
- Update the DHB/Pharmac Memoranda of Understanding so there is a clear structure and processes for how the organisations work together.
| Access: The roles and functions of agencies within the medicines system are aligned to enable them to deliver Medicines New Zealand outcomes effectively and efficiently and to minimise duplication. |
- The Ministry of Health and Pharmac will review the Pharmacology and Therapeutics Advisory Committee (PTAC) appointment protocol to ensure that it supports the independent appointment process required by the New Zealand Public Health and Disability Act 2000.
- Consult broadly on changes to PTAC’s Operational Guidelines to ensure optimal arrangements are in place for PTAC to provide free and frank advice to the Pharmac Board.
- Review the Consumer Advisory Committee’s (CAC) Terms of Reference to ensure optimal arrangements for CAC to undertake its legislative role.
| Access: The systems within the medicines sector work well and contain appropriate checks and balances and clear accountabilities. |
- Changing medicines brands can be an issue for some people. Pharmac will seek to develop a mechanism that will, when decisions give rise to brand changes, enable people to access funding for their existing brand of medicine in defined circumstances.
- Review the Exceptional Circumstances funding and criteria to ensure that they continue to fulfil the purpose of the Exceptional Circumstances Scheme.
- Undertake ongoing review of and, where appropriate, removal of specialist restrictions on prescribing specified Pharmaceutical Schedule medicines.
| Access: Taking account of and balanced against other health priorities, the medicines system is responsive to individual variation, within a population focus. |
- Implement a nationally co-ordinated decision-making, funding and procurement programme for vaccines that builds on the strengths of the national immunisation programme and the sector.
| Access: New Zealand will implement a nationally co-ordinated decision-making, funding and procurement programme for vaccines that builds on the strengths of the national immunisation programme and the health and disability sector. |
- Consider and implement a mechanism to support a cohesive and co-ordinated approach to Optimal Use of medicines practices(including those that address inequalities). This would aim to build on the existing structures and agencies across all parts of the medicines sector (including the Best Practice Advocacy Centre, the Centre for Adverse Reactions Monitoring, the Safe and Quality Use of Medicines Group and the Quality Improvement Committee).
| Optimal Use: The roles and functions of agencies within the medicines system are aligned to enable them to deliver Medicines New Zealand outcomes effectively and efficiently and to minimise duplication. |
| Actions . . . | Goals . . . |
- Address the outdated regulatory framework in the Medicines Act 1981 to:
- provide a modern regulatory framework
- regulate all medicines in a way appropriate to their risk profile
- address sustain ability and capacity issues
- capture opportunities to improve child safety provisions in medicines packaging and labelling
- improve timeliness.
- Review the use of medicines prescription practices through section 29, the exemption for medicines required by a medical practitioner, of the Medicines Act 1981.
| Quality, safety, efficacy: New Zealand has a sustainable, efficient and effective regulatory system that is consistent with international best practice. It ensures that safe, quality and effective medicines are available to New Zealanders in a timely way. |
- Continue to progress plans to build enhanced pharmacovigilance practices, in particular:
- maintain pharmacovigilance capacity in New Zealand
- facilitate growth in research capacity with a focus on projects that benefit public health. In particular by using electronic data,for example, to integrate pharmacovigilance information into wider national utilisation and epidemiological data and to detect signals of adverse reactions to medicines and other therapeutic products
- facilitate data collection, specifically adverse patient reactions, through the integration of an online reporting tool into general practitioner (GP) practice software.
| Quality, safety, efficacy: Pharmacovigilance activities are supported by input from all stakeholders, including consumers, health practitioners and the medicines industry, to achieve post-market monitoring, in line with international best practice. |
- Develop user friendly and linked websites across the medicines system so stakeholders can easily navigate the medicines system and find the information they require.
| Access: New Zealanders understand and can access information about the medicines system including, where appropriate, information about medicines funding decisions and related health and disability system prioritisation criteria. |
- The Ministry of Health will work with regulatory authorities and education providers to ensure cultural competence and knowledge about the drivers of health inequalities is incorporated in training for health practitioners. This will include addressing known issues about the over- and under-use of medicines by particular population groups.
| Access: Health practitioners will be aware of, and responsive to, the particular needs of Maori, Pacific people, disabled and low incomepeople and children, including defined processes and mechanisms to achieve improved outcomes for these groups. |
- Explore amending the Medicines Act 1981 and the Medicines Regulations 1984 to give nurse practitioners and optometrists the same prescribing rights (within their scope of practice) as currently available to medical practitioners, dentists and midwives.
- Amend the Medicines Act 1981 to create a new class of prescriber called a ‘collaborative prescriber’. Collaborative prescribing is a mechanism to allow non-prescribing practitioners, such as registered nurses, to prescribe medicines under the direct authorisation of a medical practitioner, dentist or midwife.
- Review the Medicines (Standing Orders) Regulations 2002 to ensure patient safety in the current practice environment in which they are being used.
- Explore and support initiatives to realise the potential of the pharmacist workforce (for example, delivering medicines management services) and identify and aim to address barriers to the delivery of innovative pharmacist and pharmacy services.
| Optimal Use: The medicines system has the capability it needs to deliver Medicines New Zealand outcomes effectively: financial resources; workforce availability and skill sets; infrastructure; and knowledge and information. |
- Explore the development and implementation of a national formulary (including an electronic prescription ordering system and New Zealand-specific guidelines) to support best practice prescribing. This would include examining links to a comprehensive medicines reference source and to the Pharmaceutical Schedule.
- Develop a national programme to reduce the rate of errors in medication management including:
- developing systems to effectively and continually reconcile a patient’s medication list, particularly when a patient is transferring from one part of the health system to another
- introducing standardised inpatient medication charting in all public hospitals
- introducing an electronic prescribing system
- verifying medication at the bedside through the use of barcoded point-of-care systems
- identifying high-risk medicines and introducing safety mechanisms to support safe administration practices.
- Address regulatory barriers that impede the use of electronic technology to support safe prescribing.
| Optimal Use: Robust and integrated systems support and monitor best practice prescribing and the optimal use of medicines, including safe medicines use practices. |