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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.
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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.
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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
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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-
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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.
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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.
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