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Research, Testing and Teaching Organisations: Summary of Audit Report Research, Testing and Teaching Organisations: Summary of Audit Report Introduction To find out how research, testing and teaching organisations (RTTOs) are now working within the agricultural compounds and veterinary medicines (ACVM) legislation after an initial ‘slice of life’ review in 2006, the Approvals and ACVM Group Director commissioned NZFSA’s Compliance and Investigation Group to carry out an audit in 2007. Aims of the audit were to: • provide relevant information on how RTTOs are now working within the ACVM legislation • ascertain current levels of awareness and compliance to approved codes of practice and standards • assess the usefulness of the approved codes of practice and standards in developing operational procedures that ensure the conditions of veterinary medicine registration or exemption are met. Legislation/Standards The ACVM legislation, standards, and approved codes of practice formed the terms of reference for this audit, with particular emphasis on: • Agricultural Compounds and Veterinary Medicines Act 1997 • ACVM Operational Procedures Standard 1: The Use of Veterinary and Human Medicines by Non-veterinarians for Research, Testing and Teaching Purposes • Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing and Teaching Organisations (Sponsor: The Royal Society) • ACVM Standard for Prescription Animal Remedy Veterinary Medicines • ACVM Standard for Unregistered Veterinary Medicines Requiring Veterinary Overview. Summary of audit report: Research, testing and teaching organisations 0608 1 of 6 Research, Testing and Teaching Organisations: Summary of Audit Report Background In 2006, the NZFSA Compliance and Investigation Group carried out a ‘slice of life’ review of six research, testing and teaching organisations (RTTOs) in New Zealand to check compliance with ACVM legislation. (The 2006 review findings are available on the website.) Two of the locations visited were deemed to be compliant with the ACVM legislation. Four locations visited were not fully compliant with the legislation. These locations were audited in 2007, at the request of the Approvals and ACVM Group Director, to determine the effectiveness of any corrective actions taken after the 2006 visit. Emphasis of Audit Subsequent to findings in recent ACVM audits special emphasis was placed on: • purchasing and storing • prescribing, dispensing and using • disposing of surplus agricultural compounds, veterinary medicines and unregistered veterinary and human medicines requiring veterinary overview, within the RTTOs’ spheres of activity. Other areas, that included all of the above, were record keeping, training and auditing. Areas of concern in 2006 and general responses observed in 2007 are summarised below. Areas and Responses Purchasing In 2006 it was recommended that appropriate steps be taken to manage the use of human and veterinary medicines as stipulated and required by the Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing and Teaching Organisations (sponsor: Royal Society of New Zealand). Purchasing is the first link in the chain of controlled drug use. Response At one location, all veterinary PAR suppliers have been provided with a letter and attached sample order form which explains that only approved and compliant orders with traceable order numbers are to be dispatched to the organisation. The list of authorised veterinary validators approved to order PARs is included in this form. All of the authorised veterinarians on this list were registered as practicing veterinarians with the Veterinary Council of New Zealand at the time of the 2007 audit. Summary of audit report: Research, testing and teaching organisations 0608 2 of 6 Research, Testing and Teaching Organisations: Summary of Audit Report The organisations now perform six-monthly internal audits of drug purchases and use. One organisation has provided its veterinary drug wholesaler with a mandate to supply PARs to the organisation only on the order of the Study Director. Secure storage To comply with the legislation and best practice procedures, storage of drugs must be secure. Some deficiencies were noted in 2006. Response In response to the lack of security noted in 2006, one organisation had installed a drug safe that was concealed in a floor mounted cabinet. Entry to the cabinet is via key and final access to the internal steel safe that contains the PARs and any necessary controlled drugs is via a combination lock. Prescribing, dispensing and using It is ultimately the prescribing veterinarian who is held responsible for onsite prescriptions and for training in drug security, administration, plus anesthesia and analgesia performed by nonveterinarians. Therefore, it is critical for RTTOs to have veterinarian(s) in this role. Keeping accurate records (see section below) is also an important part of the process. In 2006 it was recommended that operational procedures be developed for situations wherever there is irreconcilable or suspicious drug use, and that staff are made aware of these procedures. Response One organisation now has a standard operating procedure that clearly defines the steps to be taken wherever there is irreconcilable or suspicious drug use. At one location, computer records showing veterinarians authorised to validate orders for prescription and controlled drugs, drug storage locations and the staff hierarchy (veterinarian, drug controller and deputy) with authorised access to each location are kept. Another auditee now keeps a list of commercial practice veterinarians who provide preventative or remedial animal treatment services to production animals at all the organisation’s locations in New Zealand. One organisation audited in 2007 has had difficulty replacing a veterinarian who has resigned but was reaching an agreement with someone at the time of audit. Disposal In 2006 some expired or surplus drugs were not being disposed of correctly. Response Summary of audit report: Research, testing and teaching organisations 0608 3 of 6 Research, Testing and Teaching Organisations: Summary of Audit Report At one location, correct disposal of all expired and surplus drugs and their residues is now undertaken via a specialist contractor. Another organisation now holds expired drugs in a central location where disposal records are kept. A standard operating procedure for disposal is in place. The physical disposal of expired drugs in a sealed yellow bag is witnessed and counter-signed in the controlled drug register by two recognised responsible staff members. Once this witnessed signing and sealing occurs, the sealed bag is sent for destruction via a contractor. Recordkeeping Recordkeeping issues in 2006 ranged from keeping accurate drug registers to identifying versions of documents to recording the details of any treatments and/or manipulations that have taken place on specific animals. It was noted that reconciliation of all drug purchases, uses and disposals should occur at least every six months. The need for training in record keeping, particularly in regard to controlled drug registers, was highlighted in 2006. In one case it was recommended that staff be retrained in the requirements for recording, reconciling, disposing and auditing the use of all veterinary and human medicines that are used on animals and that more comprehensive drug use log books, which facilitate easier drug use recording and reconciliations at the stated frequencies, should be provided. Response Where drug registers were deficient, excellent systems are now in place. For example, one organisation now has two types of registers: A ‘Controlled Drug Register’, for use in laboratories by Principal Investigators and their staff/students, also records training competencies of drug use signatories. A ‘Central Drug Register’ affords the Departmental Drug Control Officer overall control and reconciliation of all drugs used in the facility. Version control of documents is important, particularly in areas where change is frequent. Because the ACVM legislation was amended in 2007, requirements in this area are changing (and are likely to continue changing for some time). The 2007 audit showed that version control had been initiated where needed. At one location, a new spreadsheet system has been initiated to record the currently 280 approved Animal Ethics Committee experimental protocols under the organisation’s direct care. This spreadsheet system is also used to record dispensing, storage, training, location and drug types approved for specific locations. In one organisation, a regularly updated Controlled Drugs and Prescription Animal Remedies Policy document now establishes compliant procedures for controlled drugs and PARs. This is an over arching document which provides an outline of the legislation, definitions, responsibilities and general policy of drugs being used in research experiments plus their use in the treatment of non- Summary of audit report: Research, testing and teaching organisations 0608 4 of 6 Research, Testing and Teaching Organisations: Summary of Audit Report research (production) farm animals. This document ties in with another document that explains the legislative requirements and practical applications, including purchase, storage, allocation, distribution, use and stocktake of relevant drugs. Training (and documentation) The ACVM Operational Procedures Standard 1: The Use of Veterinary and Human Medicines by Non-Veterinarians for Research, Testing and Teaching Purposes requires training documents records and competency registers of all staff involved in the use of veterinary and human medicines to be centrally collated and available for audit. Staff training (and/or documentation of that training) was found to be inadequate in 2006. In some organisations documentation and procedures appeared to have been adequately developed but resources allocated for ongoing training of staff and students who use veterinary and human medicines for the purposes of management of animals were inadequate. Because some organisations have a high turnover of staff and students, there is a need to resource the training programme to ensure it is more readily accessible to all users. Those personnel who have received training need to be recorded as competent and their records should be available to designated dispensing officers prior to the provision of medicines. At one location, it was recommended that formal training be provided for the drug control officers. These individuals are critical controllers of ACVM compliance in any situation, and if a full-time veterinarian is not on staff, their role of ensuring compliance becomes more important. Response All four organisations have improved their training systems and/or documentation. This has been achieved through various combinations of more resources, staff qualification/competency/training registers, lectures, and computer training programs covering areas such as: • legislation, compliance and the relevant standards, codes of practice etc • animal welfare • the legislative, ethical and prescribing requirements for drugs used in the RTTO domain • the organisation’s operating plan • online assessment test modules. One location now uses a spreadsheet system for keeping track of approximately 2000 individual personnel (140 of whom are Principal Investigators) who are potentially working in this area. (Although many of these people may have left the organisation, they are maintained within the system for up to five years on the understanding that they may reactivate their involvement in the domain.) All of these people must be adequately trained and compliant with the legislation. Summary of audit report: Research, testing and teaching organisations 0608 5 of 6 Research, Testing and Teaching Organisations: Summary of Audit Report Comments from the 2007 audit indicate that the organisations have training systems plus well developed records and procedures in place to be in compliance with the ACVM legislation. Auditing The Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing and Teaching Organisations requires annual audits conducted by an independent party. In 2006 all four organisations were deficient in this matter. Response At the time of the 2007 audits, the four organisations had either completed independent audits as required or had allocated resources for this task. In one case, the independent audit, which appears to have been well commissioned and executed, did not focus on the training of all personnel involved in ACVM (and other drug) use. Therefore, the 2007 NZFSA audit recommended that training be the focus of the next annual audit performed by an independent party. Conclusion Four RTTO locations, which were deemed to be non compliant in the 2006 initial review, were audited in 2007. The 2007 ACVM audits found a positive and proactive approach by the organisations to comply with the requirements. All four locations have made considerable effort to respond adequately to the recommendations made in the 2006 review. They are well underway to becoming self-regulating in the area of the use of prescription medicines for the direct management of animals used in research, testing or teaching. There were no serious non compliances or non compliances raised in the 2007 audit. Recommendation for NZFSA For the Director ACVM: Ongoing audits in the ACVM RTTO Domain The fact that four out of six locations visited in the 2006 ACVM RTTO Review were deemed to be non compliant and warranted a re-audit in 2007 may indicate the trend of compliance at RTTOs not as yet visited by the Authority. Ongoing ACVM audits in the RTTO domain appear to be warranted. NZFSA response An ongoing programme of audits of RTTOs will be arranged, especially to confirm compliance with recent changes to the ACVM Act which will require them to have approved operating plans. Summary of audit report: Research, testing and teaching organisations 0608 6 of 6