Department of Health and Human Services SYSTEM PURCHASING AND PERFORMANCE - MEDICATION STRATEGY AND REFORM Policy for the Compounding of Medicines in Tasmanian Public Hospital Pharmacy Departments SDMS Id Number: Effective From: June 2014 Replaces Doc. No: Custodian and Review Responsibility: Contact: Applies to: Policy Type: Policy ID (as assigned by Corporate Document and Information Services) New SPP - Medication Strategy and Reform Director of Medication Strategy and Reform THO-North, THO-South, THO-North West DHHS wide Policy Review Date: May 2017 Keywords: Routine Disclosure: Manufacture, Extemporaneous, Medicine, Aseptic, Sterile, Cytotoxic, Safety Yes Approval Prepared by Sulfi Newbold Medicines Policy Officer 61661029 16 May 2014 Through Through Cleared by Anita Thomas Senior Specialist Pharmacist Quality Use of Medicine THO-N Medication Management and Safety Committee THO-NW Medication Safety & Improvement Committee THO-S Quality Use of Medicine Committee John Kirwan Karen Linegar Matthew Daly THO-N Chief Executive Officer THO-NW Acting Chief Executive Officer THO-S Acting Chief Executive Officer 61661086 16 May 2014 16 May 2014 6 June 2014 2 June 2014 3 June 2014 Revision History Version Approved by name Approved by title Amendment notes Name Name Name Position Title Position Title Position Title Page 1 of 6
Purpose The purpose of this policy is to ensure a quality compounding system for pharmaceutical preparations, by Pharmacy staff, within the Pharmacy Department of each major Tasmanian public hospital (sites). Medicinal products compounded at each site may include sterile and non-sterile product preparations, as required. This policy underpins any locally developed procedure that further details necessary safety measures specific to each site and specific to the medicines compounded or re-packaged in that site. The objective of all Pharmacy Departments should be to produce a consistently safe and effective product for every patient, while maintaining a safe work place for Pharmacy and support staff. Compliance with this policy will assist sites to meet legislative requirements and the National Safety and Quality Health Service Standard 4 in Medication Safety. This policy should be read in conjunction with the SPP-MSR: Preparation and Handling of Cytotoxic, Hazardous and Potentially Hazardous Medicines Policy and the SPP-MSR: Management and Disposal of Unwanted Medicines Policy. Risk controls appropriate to the compounding of medicines that are classified as hazardous or potentially hazardous, and the disposal of related waste, must be implemented accordingly. Mandatory Requirements Definitions Compounded medicines: in the context of this policy, this term refers to any medicinal product that has been prepared by Pharmacy staff in the manufacturing area of the Pharmacy department. Products may be prepared in batches for general Pharmacy stock, or as a single preparation for patient-specific supply. This includes sterile, non-sterile, or re-packaged medicines, as described below: Sterile preparation (injectable and ophthalmic): This refers to compounded medicines that have been prepared using aseptic technique and sterile equipment for maximum exclusion of microbiological and particulate contamination of the final product. Non-sterile preparation (oral, rectal and topical): This refers to compounded medicines that are prepared using clean techniques and equipment only. Whilst measures should be taken to reduce microbiological and particulate contamination, the absolute sterility of the final product is not essential due to a less invasive route of administration. Re-packaged medicines: This refers to batch labelling (non-patient specific) and packing of medicines into specific quantities, in advance, to suit the needs of hospital clinics or wards. Manufacturing area: The designated area within the Pharmacy department in which medicines are compounded. Pharmacy Manufacturing Manager: The direct supervisor of the manufacturing area. Page 2 of 6
Quality Assurance Sites must not compound medicines unless the Pharmacy Manufacturing Manager and the Pharmacy Site Manager are satisfied that there are in place the correct standards of skills, training, preparative and quality assurance procedures, and resources available to produce a consistently high standard of effective, quality medicine. Sites must have work-flow procedures in place to manage compounding tasks safely and cleanly. Sites must not compound a medicinal product if a suitable alternative is available as a TGA registered commercial product. Wherever practicable, sites must outsource medicine compounding to a specialist manufacturing company, as per the Pharmaceutical Compounding Services contract. Personal Hygiene Pharmacy operators involved with compounding medicines must maintain a high level of personal hygiene and cleanliness. They must report any health condition, such as a cough or cold, or a relevant skin infection, to the Pharmacy Manufacturing Manager or Senior Pharmacy Technician of the manufacturing area. Personal Protective Equipment (PPE) Pharmacy operators must be issued with PPE appropriate to the compounded medicine, the risk of exposure to the medicine for the operator, and the method of preparation. All sites must document procedures relating to the PPE requirements of compounded medicine production, with consideration given to operator safety and product integrity. Premises and Equipment The area/s used for the compounding of medicinal products should be light, clean, and dry, with sufficient space for the separation of products and activities, and free from noise or other distractions. Cleaning procedures of equipment and preparation areas must be documented, monitored and recorded, and available at the point-of-use. Specialised facilities, such as cleanrooms or cytotoxic isolators, must strive to meet relevant Australian standards. The cleanroom environment must be regularly monitored and documented including, but not limited to, data regarding air-pressure differentials, air supply, and air and surface particulates or microbial growth. Equipment used for the compounding of medicines must be kept clean, dry and protected from contamination when not in use, and in accordance with locally developed procedures. Such Page 3 of 6
equipment must be inspected for cleanliness, and decontaminated or replaced if necessary, before product preparation begins. Equipment used for weighing and measuring must be maintained in accordance with a locally developed procedure, and records must be kept of any testing or calibration of such equipment. Records must be kept wherever equipment maintenance, or lack of it, may affect product quality. Production Wherever possible, a double check should occur for all compounded medicines for the following processes: o Primary materials, batch numbers, labels and orders, o All weighing (tare, final weight) and volumes, and o Final product accounting for all primary materials, including remaining materials and labelling of products. Expiry Dates All compounded medicines must include an expiry date. Product stability information for compounded medicines must be well documented and include referenced publications and validated data from trusted sources. In cases where validated stability data of a compounded medicine is not available, an expiry should be applied that is consistent with the recommendations of the Australian Pharmaceutical Formulary (APF) or Society of Hospital Pharmacists Association (SHPA) Guidelines (*Refer to Attachments). The expiry date of re-packaged medicines should be the original manufacturers expiry date, or one year from re-packaging, whichever is sooner. Re-packaged tablets or capsules may use the original manufacturers expiry date if they are intact in original blister-packs. Patient-specific medicines should be prepared as close to the appointed collection time as is practicable for the manufacturing area work-flow to ensure the longest shelf-life of the product for patient use. Pharmacy staff should communicate with patients about the required storage conditions of compounded medicines to ensure the integrity of the product for maximum efficacy. This is a statewide policy and must not be re-interpreted so that subordinate policies exist. Should discreet operational differences exist, these should be expressed in the form of an operating procedure or protocol. Failure to comply with this policy, without providing a good reason for doing so, may lead to disciplinary action. Page 4 of 6
Roles and Responsibilities/Delegations It is the responsibility of the Pharmacy Manufacturing Manager to oversee the operations of the manufacturing area and ensure that all processes are conducive to staff safety, and the production of a consistently safe and effective medicine. The Pharmacy Manufacturing Manager at each site must ensure staff members who work in the manufacturing area, including cleaning and maintenance staffs, are aware of procedures that are necessary to uphold the integrity of the medicines being prepared, and also staff safety. It is the responsibility of the Pharmacy Manufacturing Manager to report directly to the Pharmacy Site Manager, and via the approved hospital reporting system, if the space, equipment, or other resources used to manufacture medicines are inadequate in servicing the requirements of the area, or if product quality or staff safety is compromised for any other reason. It is the responsibility of all staff involved with the preparation of compounded medicines to be familiar with this policy, and to comply with the mandatory requirements at all times to ensure all products are prepared to an optimal standard. Risk Implications Failure to comply with this policy may affect patient care, as non-compliance may compromise the integrity of the compounded product, and result in the administration of a sub-standard medicine. Unsafe work practices place staff and the environment at risk. Adherence to this policy will assist sites to meet occupational and environmental legislative requirements relevant to medicines management within a health care facility. Training All staff involved in the compounding of medicines within the Pharmacy Department must be trained in techniques to ensure the efficacy and cleanliness of medicines, and optimal operator safety. All staff involved in the preparation of medicines classified as being hazardous must be trained in accordance with SPP-MSR: Management of Cytotoxic, Hazardous and Potentially Hazardous Medicines Policy. All Pharmacy department staff, including reception, dispensary and stores staff, whether directly involved in the manufacturing area s operations or not, must complete annual Hazardous Spill Kit training and Hand Hygiene training. This training is particularly relevant to Pharmacy manufacturing staff where personnel are most likely to handle and prepare hazardous medicines, and where hygiene is paramount. All staff training related to safe and effective medicine compounding must be updated, documented and recorded at each site. This Policy may be varied, withdrawn or replaced at any time. Compliance with this directive is mandatory for the Agency (Department of Health and Human Services and Tasmanian Health Organisations). PLEASE DESTROY PRINTED COPIES. The electronic version of this Policy is the approved and current version and is located on the Department of Health and Human Services Strategic Document Management System. Any printed Page 5 of 6
Audit All records of staff training, cleaning, and equipment maintenance must be kept for a minimum period of two years and made available for audit as required. Attachments 1 The Poisons Act 1971 2 The Poisons Regulations 2008 3 APF: The Australian Pharmaceutical Formulary: The everyday guide to pharmacy practice 4 SHPA: Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments 5 SPP-MSR: Management and Disposal of Unwanted Medicines Policy. 6 SPP-MSR: Preparation and Handling of Cytotoxic, Hazardous and Potentially Hazardous Medicines Policy 7 DHHS: Incident and Reporting and Management Policy 8 Hazardous Spill Kit training module [link] 9 Hand Hygiene training module [link] 10 Manual Handling training module [link] This Policy may be varied, withdrawn or replaced at any time. Compliance with this directive is mandatory for the Agency (Department of Health and Human Services and Tasmanian Health Organisations). PLEASE DESTROY PRINTED COPIES. The electronic version of this Policy is the approved and current version and is located on the Department of Health and Human Services Strategic Document Management System. Any printed Page 6 of 6