~ icon. cancer care. TGA Submission: Options for reform of the regulatory framework for pharmacy compounding

Transcription

1 ~ icon cancer care TGA Submission: Options for reform of the regulatory framework for pharmacy compounding

2 Introduction Icon Cancer Care is pleased to have the opportunity to make this submission regarding reform options for Australia s regulatory framework for pharmacy compounding. Put simply, our mission is to provide exceptional, personalised care to cancer patients and their families. We currently manage more than 73,000 patient separations (visits) each year under three brands Haematology & Oncology Clinics of Australia (HOCA), Queensland Haematology & Oncology Group (QHOG) and Tennyson Infusion Centre (Adelaide) with the support of more than 70 visiting medical officers (VMOs). In addition to supporting the VMOs who refer to our day hospitals and other smaller private hospitals in regional Queensland, Icon Cancer Care directly employs more than 370 staff, including 24 pharmacists. Our HOCA operating brand has been leading the way in cancer care for 25 years and became the foundation for Integrated Clinical Oncology Network Pty Ltd (now trading as Icon Cancer Care), a privately owned company established in February It should be noted all of our operations will be transitioning to the Icon Cancer Care brand throughout August and September Table 1 provides a snapshot of our day hospital operation and chair capacity, including for our new day hospital in Townsville, north Queensland, which is currently under development to help meet the growing demands of that region. The table also details our pharmacy model of service per site. Table 1 Icon facilities and pharmacy services Icon site Chair numbers Pharmacy services Nature of compounding service Wesley 29 Clinical support on-site and at River City Pharmacy (QCPP licensed). Mater 27 Clinical support on-site and at River City Pharmacy (QCPP licensed). HOCA Chermside 25 Clinical support and compounding. Compounding of complex cytotoxic items as well as monoclonal anti-bodies. Pressurised class C ante- and clean room with class A isolators. Compounding of complex cytotoxic items as well as monoclonal anti-bodies. Pressurised class C ante- and clean room with class A isolators. Compounding of monoclonal antibodies only using a closed system and aseptic technique. HOCA Gold Coast 28 Clinical support. No compounding on-site. Third party TGA supplier only. Tennyson Infusion Centre Adelaide 27 Clinical support. No compounding on-site. Third party TGA supplier only. Icon Cancer Care Townsville 15 Clinical support and compounding. Compounding of monoclonal antibodies only using a closed system and a septic technique. 2

3 Icon aims to maintain an integrated operating model where doctors, treatment, pharmacy and research are co-located, creating greater efficiencies for patients and those who treat them. Our Icon Pharmacy Services model uses a third party TGA supplier for of our reconstituted chemotherapy and monoclonal antibody preparation. The other is compounded by our pharmacies and is purely extemporaneous compounding with no bulk preparation. Items that we compound have a short expiry, are for newly diagnosed patients needing to start their chemotherapy the same day and for dosage changes for patients waiting in the chair. Icon Pharmacy Services follows good manufacturing practice and the guidelines set by the Pharmaceutical Society of Australia s (PSA) Professional Practice Standards, Society of Hospital Pharmacists of Australia s (SHPA) Safe Handling of Chemotherapy and the International Society of Oncology Pharmacy Practitioners (ISOPP). We also conduct annual oncology and oncology manufacturing audits that are benchmarked externally with the APHS Group. We acknowledge that the scope of this consultation does not extend to the traditional role of the pharmacist in preparing medicine for a particular patient (page 6). However, we would like to submit our comments in line with our support for a form of professional regulation for pharmacies dispensing extemporaneous complex medication (this is cytotoxics for Icon Cancer Care s Pharmacies), put in place with the aim of guaranteeing patient safety. Icon Cancer Care is happy to share its view on reform options in the hope of avoiding significant risk to the continuity and cost of patient care. Icon Cancer Care thanks the Therapeutics Good Administration for its consideration of the following information. Responses to questions in consultation paper Option A status quo Are there other risks and benefits of the continuation of existing regulatory arrangements that have not been identified in this consult paper? While there are currently extensive guidelines and practice standards that apply to compounding, there is no enforced regulation to accompany it and to guarantee that regular and sufficient environmental monitoring is applied, or that good manufacturing practices are followed in the case of complex compounding of medicine with option A. This poses a potential risk to not only the safety of patients for whom the medication is compounded, but also for operators in the case of manufacturing cytotoxics. Icon Cancer Care does not support option A. 3

4 Option B enhance co-regulation and update legislation Do you have any views on how option B could be approved? Icon Cancer Care supports the view that a National Pharmacy Compounding audit should be implemented by an appropriate regulatory body other than the TGA. This could be done in collaboration with the TGA, but it should be clearly distinguished from the TGA approval process. What wording should be used on medicine labels to highlight that the medicine is compounded? Icon Cancer Care suggests that the words This is a compounded medicine should be used on medicine labels to highlight that medicine is compounded. Icon Cancer Care supports option B. Option C manufacturing licence for specified manufacture in pharmacies What are the risks and benefits of option C? Icon Cancer Care believes option C will pose significant risk to the continuity and cost of patient care. Good manufacturing processes are currently followed at our compounding pharmacy River City Pharmacy which already results in an average turnaround time of an hour and a half from when a medicine order is received to delivery of it to one of our day hospitals. The convoluted process of working within a TGA registered facility would significantly slow down provision of chemotherapy to patients (extemporaneously compounded products), leading to increased wait times and poor patient service. The process of having pharmacies TGA approved, together with any required refurbishments to bring premises up to the specified standard, would add significant costs to patient care and would not be affordable to Icon Cancer Care and most other pharmacy operators. This poses a risk of additional costs being passed on to patients. If your business would be affected by this proposal, what would be the financial impact on your business and flow-on impact on consumers, if any? We recently looked at refurbishing two new pharmacies in each of our smaller Icon Cancer Care day hospitals to meet the current PICs. The estimated costs for each of these would have been almost $500,000. This amount does not consider any costs involved in having them TGA approved and any associated annual licensing fees. Additionally, staffing costs to maintain TGA processes would also dramatically increase due to the introduction of extra processes. Current TGA approved pharmacies and third party providers operate a business model independent of PBS funding. They structure the pricing of the compounded molecules in such a way that makes them commercially viable. On the other hand, private pharmacy providers are dependent upon reimbursement through the PBS. Pharmacy operators are currently negotiating with the Australian 4

5 Government to overcome the PBS funding shortfall for chemotherapy. The negotiations are based on the current costs of supply of services by chemotherapy compounding pharmacies. A move to make TGA accreditation compulsory for compounding pharmacies will mean yet another gap in the PBS funding for the supply of chemotherapy an unsustainable move for Icon Cancer Care. For consumers, the flow-on impact would be on the cost of their patient care. Icon Cancer Care does not support options C1, C2 or C3. In sub-option C3, which means of controlling quantity do you support? Icon Cancer Care does not support any controlling quantity where a pharmacy has to become TGA approved if it surpasses certain volumes of products compounded per month. We do not support the suggested controlling quantity of 500 compounded products per month. At the commencement of any new requirement for requiring a manufacturing licence, would a two year transition time to be sufficient? Icon Cancer Care suggests a transition time of up to three years would be sufficient. Option C3 will be too costly and is not supported. Conclusion In conclusion, Icon Cancer Care supports option B manufacturing licence for specified manufacture in pharmacies. Icon Cancer Care recommends that a similar process as to what is recommended in option B be regulated under the control of the Pharmacy Board as a central body with possible input from the TGA. Icon submits this submission provisionally, pending the Pharmacy Board of Australia discussion paper that is due to be released. 5