Community Pharmacy Roadmap Program Development Template Program/Service: Quadrant: Pharmacist Only Medicine Notifiable (POMN) B- Pharmacy medicines and health products services and programs 1. Program/Service Description a) Background Medicines and poisons are classified into schedules to allow restrictions to be placed on their supply to the public, in the interests of public health and safety. The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) 1, or Poisons Standard, is the legislative instrument that lists medicines and poisons according to their schedule classification. The implementation of the SUSMP, as it affects access to and supply of medicines and poisons, is given legal effect through the relevant State and Territory drugs, poisons and controlled substances legislation. Poisons for therapeutic use (medicines) are mostly included in Schedules 2, 3, 4 & 8, with progression through these schedules signifying increasingly restrictive regulatory controls, whilst medicines that are exempt from scheduling are available through the grocery sector. Schedule 2 (Pharmacy Medicine) Pharmaceuticals that can only be supplied through a pharmacy. This category is for substances for which the safe use may require advice from a pharmacist, and should therefore only be available from a pharmacy. Schedule 3 (Pharmacist Only Medicine) Pharmaceuticals which must be supplied by a pharmacist in a pharmacy. This category is for substances for which the safe use requires professional advice, but which should be available to the public without a prescription. Schedule 4 (Prescription Only Medicine) Medicines that can only be obtained with a prescription. This category is for substances for which the use or supply should be by or on the order of persons permitted by State or Territory legislation to prescribe (i.e. a doctor) and should only be available from a pharmacist on prescription. Schedule 8 (Controlled Drug) Drugs of addiction. This category is for substances that should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence. Discussions regarding the introduction of a sub-schedule to the current Schedule 3 category, namely a Pharmacist Only Medicine Notifiable (POMN) have been held with government in recent years. The rationale for such an approach is set out below. The proposal would otherwise retain the current scheduling arrangements for non-prescription medicines. The sale of medicines in the POMN category would be recorded by the pharmacist in order to monitor usage. POMN medicines may include those with a potential for misuse and/or abuse, as well as other medicines where it is considered clinically appropriate. This would also provide a platform for the potential down-scheduling of medicines from the Prescription Only (S4) category. Variations of POMN currently in practice include: Project STOP, which involves the real-time recording and monitoring of the sales of 1 http://www.tga.gov.au/industry/scheduling-poisons-standard.htm 1
pseudoephedrine products, to minimise criminal diversion. Asthma Card 2, which is a hard-copy record in WA and NSW/ACT for the over-thecounter sales of asthma relievers, which provides pharmacists a tool to assist patients selfmanage their condition Further to the above, various health bodies have called for a POMN-type status or a similar real-time monitoring/notification scheme to apply to combination analgesics containing codeine (CACC), such as codeine-ibuprofen and codeine-paracetamol products. It is wellestablished that, while most people use these medicines appropriately, a small minority abuse them due to an addiction to codeine, which is often initiated by excessive use of these medicines to address chronic pain. Such misuse has resulted in serious health consequences. 3 Concerns over this matter led the then National Drugs and Poisons Schedule Committee (NDPSC) to change the scheduling restrictions for CACC, limiting the strength and quantity that can be supplied over the counter (OTC) and stipulating pharmacist intervention through scheduling as a Pharmacist Only Medicine (POM) (S3). These changes were applied from May 1 st, 2010. However, it is noteworthy that prominent health bodies continue to call for real-time monitoring of these medicines, contending that the recent scheduling changes do not adequately address the issue of misuse. It is interesting to note developments outlined above against the back-drop of the recommendations from the Galbally Review of Drugs, Poisons and Controlled Substances Legislation 4, which identified that mandatory recording of the retail supply of S3 medicines has limited use because there is no real time monitoring (pg 119 of part B). The Galbally Review advised that the mandatory recording of supply of S3 medicines should be considered on a case by case basis rather than as a broad application. b) Brief Description A POMN medicine would be recorded in a database, with national integrated access by the community pharmacy network on a real-time basis where this is considered appropriate. This would provide a platform for pharmacists to observe and monitor medicine usage to assist them in providing advice to their patients. It would also allow for data to be gathered by relevant health authorities. This technology would be applied to non-prescription medicines in cases: where there is a risk of misuse/abuse, such as codeine-containing analgesics or pseudoephedrine; and where such arrangements may improve the safe and appropriate use of the identified medicines, such as asthma relievers. A POMN schedule will include the following key features: real-time monitoring, where this is considered appropriate, of those medicines by community pharmacists across all pharmacies; mandatory recording requirements; consistency across all jurisdictions; and the gathering of de-identified data for provision to relevant health and other authorities where appropriate. This then provides the opportunity for interventions such as: pharmacist advice, support or referral where the requested use of the medicine is contrary to specific drug protocols or not consistent with Quality Use of Medicine (QUM) principles; and identification of patterns or trends by health agencies to inform, develop and improve health policy. 2 http://www.asthmansw.org.au/content.cfm?id=2303 3 See, for example, MY Frei, S Nielsen, M Dobbin & CL Tobin; Serious morbidity associated with misuse of over-the-counter codeine-ibuprofen analgesics: a series of 27 cases; MJA 2010; 193 (5): 294-296 4 Review of Drugs, Poisons & Controlled Substances Legislation, A Council of Australian Governments Review, January 2001 2
c) Alignment with Government Policy d) Expected Outcomes for Government and Community Pharmacy The objectives of a POMN category are closely aligned with the key objectives of Australia s continuing health reform agenda. Reports from the Preventative Health Taskforce, National Primary Healthcare Strategy and National Health and Hospitals Reform Commission emphasise the themes of improved self-care and health literacy, prevention, and strengthening primary care through better use of primary health care providers, including pharmacists. From a government perspective, the establishment of a POMN system would: facilitate the collection and analysis of critical health care and supply data through an IT system, thus providing evidence to inform future policy; facilitate earlier health professional engagement with those misusing medicines, meaning earlier counselling and referral to support services- this can potentially avert the serious societal consequences of chronic medicine misuse (ie- health, economic, social and legal costs) facilitate harmonisation of the supply of S3 medicines across all jurisdictions; and enable provision of information and data, where appropriate, to police and/or law enforcement agencies. From a community pharmacy perspective, the establishment of a POMN system would: provide a powerful, data-driven decision-support tool for pharmacists, electronically linking them, helping them determine if the supply of a medicine is appropriate and generally assisting in applying Quality Use of Medicines principles; broaden the scope of health care intervention provided by pharmacists, to include the monitoring and management of more serious and chronic conditions after diagnosis by an appropriate medical practitioner; facilitate the down-scheduling from the S4 category for medicines requiring initial medical diagnosis but not requiring close medical management; and create a greater level of accountability for pharmacists, consistent with the vision of an expanded primary health care role for the profession, and ensure that a risk-based approach is employed. e) Consumer Benefits The establishment of a POMN system would benefit consumers by: retaining access to effective medicines under the supervision and support of a highly trained health professional, without the need for a prescription; potentially facilitating the down-scheduling of some medicines from the S4 category, because pharmacists would be able to monitor their appropriate use; leading to earlier health professional recognition and assistance for those consumers misusing/abusing medicines assisting to de-stigmatise the purchase of certain medicines by legitimate users, as pharmacists will have a decision support tool which removes any default assumption that they involve misuse/abuse f) Who Performs the Service? g) Collaboration with Other Health Care Professionals Pharmacists Pharmacy assistants The pharmacist is involved in the sale of all S3 medicines to determine the appropriateness of the medicine for the condition being treated, and ensure its safe and proper use. Pharmacy assistants may be trained in order to complete the administrative recording element of the POMN system. Will service delivery require any formal collaboration with other health care professionals? There may be opportunity for the pharmacist to collaborate with health professionals providing the original diagnosis for conditions requiring POMN products. Generally, relevant medicine protocols would also detail referral processes to other health professionals for situations where the pharmacist identifies QUM issues requiring further review or intervention. 3
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 - TGA GP organisations Law enforcement agencies Commonwealth and State Pharmacy organisations Pharmacy software vendors Industry Professional insurers b) IT Requirements Is pharmacy software required to deliver this program? Pharmacy software should have a recording and real-time monitoring system that is integrated with existing pharmacy IT to maximise workflow. With the development of e-health records, there is the opportunity for consumers use of S3 medicines to be recorded so details are available to other health professionals as required. c) Infrastructure and Staffing Is a private consultation area required to deliver this program? An appropriate consultation area within the pharmacy will be required to conduct private consultations with patients. Is the program within the pharmacist s/pharmacy assistant s normal scope of practice? Is an additional pharmacist likely to be needed? To be determined - Pharmacies will need to give consideration to the need for another pharmacist to be available to ensure that all professional activities within the pharmacy are adequately managed by a pharmacist. d) Training What additional formal training is likely? No additional training. Apart from introductory instruction for pharmacists and pharmacy assistants in relation to system operation, there should be no special training needs. Does any suitable training exist? To be determined. The availability of training will depend on the format of the system developed. Training for the existing Project STOP system may be able to be reviewed and refined for this purpose. e) Supporting Standards, Procedures and Templates / Checklists Will an amendment to the QCPP requirements be necessary? Strict adherence by pharmacists to professional protocols set out in an auditable standard should ensure the public receives a standardised, quality-assured professional support service. Generic requirements for delivery of health programs and services are set out in Element 3 of the QCPP Standard. As services are developed, the need for supporting templates and procedures can be assessed, and, where not available, the development of new ones should be part of the program structure. Will professional guidelines and/or standards for pharmacists be required? Are there any other national guidelines which need to be taken into account in developing the program to ensure consistency with best practice? 4
To be determined. Depending on the interventions included in the service, it will be necessary to confirm if any national guidelines relate to the intervention and, if so, ensure that the service is aligned. f) Legislation/ Regulation Implications There will need to be an amendment to relevant Commonwealth and State/Territory Legislation. POMN should be recognised by the National Pharmacy Board as a professional pharmacy service so it is anticipated that there would be no additional requirements for pharmacist indemnity with insurance companies. 3. Funding Funding Options Possible funding options include: Commonwealth program State/Territory Government User-pays (Would require a review of GST implications ) Has any funding for this program been secured? No. Funding arrangements would also need to be considered for bodies/organisations responsible for monitoring the data; this may be either at Commonwealth or State level. 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 ) 5