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Prescription Animal Remedy Traders (Veterinarians)

Summary of Review Report

Prescription Animal Remedy Traders (Veterinarians)

Background

To ascertain the level of understanding and compliance by traders of prescription animal remedies (PARs) with the ACVM Standard for Prescription Animal Remedy Veterinary Medicines and ACVM Expectations for Approved Traders of PAR Products, the Approvals and ACVM Group Director commissioned the New Zealand Food Safety Authority’s (NZFSA) Compliance and Investigation Group (CIG) to carry out a review. This review is an important part of giving assurance to international trading partners that we are managing risks associated with PAR trading.

The Approvals and ACVM Group consulted with the New Zealand Veterinary Association and the Veterinary Council of New Zealand about the review. It was decided to focus on veterinary practices because non-veterinary traders are audited on entry to the approved trader list, and registrants and manufacturers wishing to sell PARs to end users are audited as part of their good manufacturing practice (GMP) audits.

Twelve randomly selected veterinary practices were examined in June 2006. The sample covered a range of practice types in New Zealand but was weighted to emphasise areas of particular interest, ie where greatest volume of PAR trading occurs and/or where issues relating to food safety and risk to trade might occur. Five dairy practices, three sheep and beef practices, two equine and two companion animal practices were selected. In the case of mixed practices, only the area of the selection category was inspected.

The review examined the following areas:

Quality system:

• Was there a person responsible for the operation of the quality system?

• Was the system documented?

• Was there training for staff operating under the system?

• Were internal reviews of the quality system carried out at regular intervals?

Transportation:

An assessment was made on transportation arrangements for all PAR products.

• Were they transported in an appropriate manner for their PAR classification?

• Were they protected from the weather with appropriate temperature maintained?

• Were PAR II and III products transported securely locked?

• Was the procedure documented?

Receipt and storage:

An assessment was made on the documented receipt and storage of PAR products and the arrangements in place for their storage.

Dispensing:

• If dispensing was carried out, was there an appropriate designated area set aside?

• Was documentation and record keeping adequate?

• Were all dispensed PARs adequately labelled and traceable?

Training:

Where the person trading the PAR was neither a registered veterinarian nor a pharmacist, the trader must have been able to demonstrate, through training records, competence to operate within the quality system and carry out specific dispensing activities.

Documentation:

Documentation checks included electronic and hard copy versions of current regulatory standards and guidelines, standard operating procedures (SOPs), and records of activities, eg transactions.

Legislative regime

The review considered requirements laid down in relevant legislation, codes of practice, and standards or expectations including:

• Agricultural Compounds and Veterinary Medicines Act 1997

• Agricultural Compounds and Veterinary Medicines Regulations 2001

• Agricultural Compounds and Veterinary Medicines (Transitional Provisions) Regulations 2002

• Agricultural Compounds and Veterinary Medicines Amendment Regulations 2004

• Agricultural Compounds and Veterinary Medicines Amendment Regulations (No2) 2004

• Agricultural Compounds and Veterinary Medicines Amendment Regulations 2005

• Code of Practice for Registered Veterinarians Writing Prescriptions For Prescription Medicines and Prescription Animal Remedies

• ACVM Expectations for Approved Traders of PAR Products

• ACVM Standard for Prescription Animal Remedy Veterinary Medicines.

ACVM Act

The ACVM Standard for Prescription Animal Remedy Veterinary Medicines and ACVM Expectations for Approved Traders of PAR Products are empowered by the following clauses of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997, which state:

23. (1) “The Director-General may register a trade name product in accordance with section 21, subject to all or any of the following conditions:

(a) A condition on the use of the trade name product:

(d) A condition specifying the labelling, advertising, or other information requirements for the trade name product:

(e) A condition specifying standards of competence for manufacturers, sellers, purchasers, or users of the trade name product:

(f) A condition requiring codes of practice approved by the Director-General under section 28 to be followed when importing, manufacturing, selling, or using the trade name product:”

Section 23. (2) of the same Act furthers this empowerment by stating: “A condition imposed in accordance with this section may apply to any specified class of person or to every person who imports, manufactures, sells, or uses a trade name product; and every person to whom a condition applies must comply with that condition”.

REVIEW

Approach

The review approach was to visit each allocated clinic and assess the staff’s level of understanding and compliance with the relevant requirements. Interviews were held with the person responsible for the operation of the documented quality system.

At all locations visited the quality system invariably consisted of a combination of hard copy and electronic applications. The day-to-day use of the quality system was observed in operation where possible. A ‘reality check’ was performed using the procedures for PAR transportation, receipt, storage and dispensing. Evidence of staff training documents and records were sought.

At each location only the trade of PARs in the allocated category was reviewed. However, if the reviewer found what were considered to be critical non-compliances in an area outside the allocated category, discussion of the findings was provided in the final report.

Dairy PAR trading

Five practices involved in the trade of dairy PARs were visited (two in the South Island and three in the North Island). All of the dairy practices visited belonged to organisations that operated at more than one trading site, so they employed multiple veterinarians and lay staff. Each location had a substantial dairy clientele and also provided PARs for other animal species.

Quality system

In the ACVM Expectations for Approved Traders of PAR Products, the section on ‘Quality system’ defines the elements and requirements that need to be incorporated into a quality system to be used by those engaged in trading PARs. Each dairy practice had a senior principal veterinarian designated as the person responsible for the operation of the quality system. All practices had generally well developed quality systems that included customised computer software programmes, which aided in the control of the authorisation of PAR supply for the ensuing period of twelve months. The quantities and product types of PARs that individual clients were prescribed were also controlled by the computer applications.

There are four main software programmes in use by dairy veterinarians to control the trade of PARs in New Zealand, so it is difficult to draw a conclusion as to the security each system might provide under all circumstances. Although different systems have different capabilities, each principal interviewed seemed frank and openly aware of any installation shortcomings. Generally principals appeared to be proactive in seeking programme updates for enhancements to PAR trade security from their respective software companies.

In conjunction with the computer, all practices had developed hard copy documents to aid in controlling the day-to-day trade of PAR products. The reliance on hard copy documentation within the clinic setting varied. Where there was a high level of computerisation, the reliance on documentation lessened. However, because PARs are often traded from a veterinarian’s vehicle at the time of a farm visit, documentation had to be transferred to computer upon return to the clinic.

Training for staff operating under the quality system was provided at all locations.

Internal reviews of the quality systems appeared to take place at regular intervals to maintain relevance to the legislation.

Transportation

The ACVM Expectations for Approved Traders of PAR Products states that: “The quality system will contain procedures and records for the safe and secure transportation of all PAR products. The trader will be specifically responsible for the conveyance of goods from the trader’s own premises to the next location in the distribution chain” (clause 1).

In general the written quality systems viewed did not contain procedures per se for the safe and secure transportation of all PAR products. However, there were invariably good records kept at veterinary dispensaries of all PARs transported to the next location in the distribution chain. PAR transportation to end users is usually by one of three methods:

• in clinic sale and personal transport from the clinic by the client

• on farm sale to the client directly from the veterinarian’s vehicle

• delivery from the clinic by a third party to the end user on farm.

This third method of transport is not uncommon, particularly in isolated areas, and occurs via a client’s designated agent, courier, or rural post. PAR transport between branch clinics was generally by way of traceable courier delivery or via clinic vehicle and was deemed compliant at all locations viewed. Delivery of PARs via rural mail to letter boxes or to any unauthorised locations, such as local general stores or garages, is not optimally safe and secure. Where PAR transport procedures were identified as being potentially not safe and secure, recommendations were made to develop procedures and records that ensured requirements were met.

Receipt and storage

Most quality systems viewed did not contain specific written procedures for the safe and secure receipt and storage of PAR products. However, all clinics provided verbal instructions and staff appeared generally experienced and well informed of the needs regarding receipt and storage of PARs. It was noted at two locations that delivery couriers deposited parcels either onto reception area floors or outside external entrance ways. At one location there were large roller doors open to the external environs through which PARs plus bulk animal remedies were received into an inwards goods store. A recommendation was made at this site to maintain minimal access from the external environs to this PAR receipt area.

It should be emphasised that the lack of written procedures does not in general reflect on the reasonably compliant nature of receipt of PARs as viewed during location visits.

At two locations recommendations were made to alter storage. One recommendation related to the observed storage of PAR I products on shelving and in a refrigerator, both of which were located within a clinic’s public retail and display area. This practice allowed public view and direct access to these PAR products, which is not compliant with the ACVM Standard for Prescription Animal Remedy Veterinary Medicines. At another location the principals rectified the storage of PAR II products to ensure compliance with the security requirements for this class of drug.

Dispensing

The major volumes of dairy PAR dispensing seen to occur at the five locations appeared to occur under “sale subject to veterinary authorisation” (ACVM Standard for Prescription Animal Remedy Veterinary Medicines, section 2, clause 2.5.5). Under this clause there is recognition that in some cases parties may have a need to hold PAR veterinary medicines in anticipation of a veterinary prescription. (A veterinary authorisation is a variation on a prescription.) Provision is made for PARs to be used in animal health programmes at the discretion of a person specified by the prescribing veterinarian, according to the instruction and training provided by that veterinarian. PAR use is tied to generalised circumstances, so the authorisation does not contain the same detail in regard to animal identity and use instructions, which are arranged directly between the veterinarian and the client.

At all locations visited the veterinary authorisations for clients to buy and hold dairy PARs were written as being valid for 12 months by the prescribing veterinarian. These 12 month time frames appear practically workable and logical given the seasonal nature and the yearly rotation of ‘share milkers’. However, this time frame does not conform to the relevant approved code of practice. This code, Registered Veterinarians Writing Prescriptions for Prescription Medicines and Prescription Animal Remedies, section D 1. (b) states, “A veterinarian shall not prescribe for any animal(s) under his/her care a quantity of a prescription that exceeds 6 months supply”.

The 12 month duration of authorisations to supply PAR products appears to be common practice as it was found at almost all of the practices visited.

Training: staff

The ACVM Expectations for Approved Traders of PAR Products requires that:

• the quality system provide training in specified tasks for staff operating within the system

• training be documented

• training records be kept.

At the locations visited the training of staff involved in the trade of PAR products consisted of work place practical experience, verbal communications and delivery of written SOPs or procedures manual documentation. Some senior lay staff were very experienced and conversant with the PAR trade legislative requirements by workplace immersion over many years. Most locations had training documents by way of SOPs and procedures manuals.

Only two locations had training programmes formally recognised as such. There was also a lack of evidence at every location that all staff trained to trade PARs were formally identified, documented, and recognised by practice principals as being competent in specific tasks within the PAR trading system.

Recommendations in this area related to the need to develop formal training programmes and registers of competent individuals. It was also emphasised by the reviewer that training needed to be ongoing to maintain relevance to changes in legislation.

Training: clients

Substantial amounts of traded dairy PARs are sold under veterinary authorisation (see ‘dispensing’ above) and are administered to animals at some later stage by the client. To ensure safe and correct PAR administration, those entrusted with this task must have adequate documented training and this training must be recorded at the time of authorisation for future supply. At the five dairy review locations, documentary evidence concerning training of clients using PARs was variable. At two locations considerable effort and thought appeared to have been applied to ensuring comprehensive training of clients. However, dairy farms were not visited to assess the effectiveness of this training.

Sheep and beef PAR trading

Three practices involved in the trade of sheep and beef PAR products were visited (two in the North Island and one in the South Island). All of the sheep and beef traders visited traded at more than one location. As such they all employed multiple veterinarians and lay staff. Each practice had a substantial sheep and beef farming clientele.

Quality system

Each sheep and beef practice had a senior principal veterinarian designated as the person responsible for the operation of the quality system. All practices had generally well developed quality systems that included customised computer software programmes. Each location utilised a different software programme. As previously explained, the idiosyncrasies of each of these applications makes it hard to draw a single conclusion as to the PAR trade security each system might provide under all circumstances. However, these programmes aided in the control of the authorisation of supply of sheep and beef PARs for the ensuing twelve months. Quantities and PAR product types prescribed for individual clients were also controlled by the computer applications.

In conjunction with the computer, all practices had developed hard copy documents to aid in the control of day-to-day trade. The hard copy documents were used extensively where PARs were prescribed and traded from veterinarians’ vehicles while performing farm visits; this information was transferred to computer applications when the veterinarian returned to the clinic.

Training for staff operating under the quality system was provided at all locations. Internal reviews of quality systems appeared to be undertaken at regular intervals to maintain relevance to the legislation.

At two locations trading significant quantities of sheep and beef PAR products the quality system had been developed to a high level of compliance. At these locations there were well developed protocols, guides, and instruction sheets (for both staff and client use) to ensure that training and the correct trade plus use of PARs, as defined in the legislation, was accomplished. At the third location, where the amount of PARs traded was significantly less, the quality system was still under development.

Transportation

In general the quality systems at each location did not contain specific written instructions for procedures for the safe and secure transportation of PAR products, but there were instructions where temperature sensitive products were to be transported. Sheep and beef farms are often located in quite isolated areas, and traders are frequently required to rely on third parties to transport PARs to end user clients.

As a general recommendation procedures should be developed by all sheep and beef PAR traders instructing staff how best to ensure safe transport. In the reviewer’s opinion a non-traceable rural delivery PAR parcel dropped off to a local garage or store may well be less than safe and secure, and more so in the absence of any written protocols.

Receipt and storage

At one location there was a comprehensive instruction protocol instructing staff on the receipt and storage of PARs. At this same location there had also been installed a coded keyless security facility to ensure that out of hours couriers supplied with the code could deliver PARs in a manner that afforded secure receipt. This situation is highly compliant with the receipt and storage requirements in the ACVM Expectations for Approved Traders of PAR Products. In contrast, at another location there was reliance on experienced senior staff to train personnel on the receipt and storage of PARs by workplace practical experience and verbal instructions.

None of the three sheep and beef PAR trade locations stored PARs in the public view or access, and all class II and III PARs were stored in locked facilities. This finding was deemed to be compliant with the requirements of the Standard.

Dispensing

As seen in the dairy PAR trading reviews (see above), the major volumes of sheep and beef PAR dispensing seen to occur appeared to be under sale subject to veterinary authorisation. At the three sheep and beef PAR trader locations visited, these veterinary authorisations were written by the prescribing veterinarian as being valid for 12 months. Refer to the dairy section of this report for explanation as to how this 12 month validity practice contravenes the code of practice. The reviewer submits that the trade of sheep and beef PARs differs little from that of dairy PARs and makes the same recommendation to extend the valid time period from 6 to 12 months.

Training: staff

At the three locations visited the training of staff involved in the trade of PARs consisted of work place practical experience and verbal instructions. This was backed up with computer training and the use of instruction manuals. At one location an ACVM 1997 Policy Manual had been developed and there was a newly instigated register of staff who had been employed, trained and deemed competent since early 2006. This record of training where individuals are recognised as being competent is compliant with the ACVM Expectations for Approved Traders of PAR Products. It is, however, quite important to consider the training and documentation records of staff who were employed prior to the ACVM Act. While these staff may be experienced, competent and, in some cases, employed for considerable time they should be included into the formal training process and recorded as such. Training also needs to be ongoing to maintain relevance to changes in requirements.

Training: clients

As with dairy PARs, substantial amounts of traded sheep and beef PARs are sold under veterinary authorisation, and the same comments about training requirements apply. At the three review locations, documentary evidence concerning training of clients using PARs was variable. At two locations considerable effort and thought appeared to have been applied to ensuring comprehensive training of clients. However, sheep and beef farms were not visited to assess the effectiveness of this training.

Equine PAR trading

Two practices involved in the trade of equine PAR products were visited (one on each island). One practice was a multi-veterinarian and lay staff employer and, as such, traded in significant quantities of equine PARs. This practice had well developed equine hospitalisation facilities that were also used by outside veterinarians on a contractual basis. Some companion animal veterinary services and PAR trade for these species also occurred at the site. At the other location visited a sole veterinarian without any support staff was involved in trading small quantities of equine PARs.

Quality system

Each equine practice had the senior veterinarian designated as the person responsible for the operation of the quality system. Both practices had generic accounting software computer programmes. These were used in conjunction with various documents to coordinate the quality systems to monitor and control compliance of equine PAR trade. These generic software applications, such as MYOB or QuickBooks, designed primarily as accounting packages, are less secure PAR trading applications than the customised software systems as seen in use during the review of the dairy and sheep/beef PAR traders.

The documented recording of PAR trade at both locations relied on patient treatment records or day-sheets, stud treatment forms, and monthly tax invoices or statements. Where training for the operation of the quality system was provided it consisted of verbal instructions, workplace experience, and practical exposure. Training was not documented. It was not evident that there were predetermined intervals for internal review of the quality systems to maintain relevance to legislation. One location employed a significant number of foreign locum veterinarians on a rotating and temporary basis each year to provide veterinary services during the seasonal equine reproductive months of September to February.

These findings resulted in the reviewer recommending to the principal at the larger equine PAR trading location that the documented quality system needed to be further developed to attain full compliance. At the smaller sole operator equine PAR trader the quality system was deemed to meet the perceived lesser risks to PAR trade compliance and was thus deemed acceptable.

Transportation

It was not apparent at either site that there was a documented system for the transport of PARs, but most equine clients are within close proximity to the traders and there is little need to utilise third parties in transportation. Usually clients purchasing PARs receive the product personally from dispensing staff either on farm or at the clinic. Transportation was deemed compliant with the ACVM Expectations for Approved Traders of PAR Products.

Receipt and storage

There were no documented PAR receipt and storage procedures available at either location. A reality check at both sites revealed that receipt and storage for PAR I products were compliant with the ACVM Expectations for Approved Traders of PAR Products. At the larger equine PAR trading location, PAR II and III products were stored in locked facilities, but this stock was not subject to regular reconciliation as required in the ACVM Standard for Prescription Animal Remedy Veterinary Medicines. A recommendation was made to the principal at this site that regular reconciliation of PAR II and III products should be undertaken in order to comply with the legislation.

Dispensing

PAR products are all subject to labelling requirements, which are set down in the appendix to the ACVM Standard for Prescription Animal Remedy Veterinary Medicines. The minimum requirements are: “No matter what the labelling instructions are from the prescribing veterinarian, no PAR product may be supplied without at least the prescribing veterinarian’s name and contact information”. This information is crucial for traceability, which may be needed for a variety of reasons.*

“The prescribing veterinarian must also provide written instruction on use and disposal of surplus product and management of used syringes and needles” (ACVM Standard for Prescription Animal Remedy Veterinary Medicines, clause 2.4.4).

At one location four major equine breeding farms were sold PARs under sale subject to a veterinary authorisation. One of these four major equine breeding farms was visited at the interview and the veterinary medicine dispensary at this site was viewed. Several PAR products were held in a locked room but there was no evidence of the products being labelled with the authorising veterinarian’s name and contact information. There were reconstituted and expired PARs stored in the farm dispensary. A significant number of old used needles and syringes containing drug residues were sitting on a bench.

The lack of any labels with veterinarian’s name and contact information, plus the farm dispensary manager’s failure to dispose of surplus product, and inadequate management of used needles and syringes was deemed not compliant with the above requirements.

At the sole veterinarian PAR trader location, evidence was provided that compliant labels containing prescribing veterinarian identification and contact details were available. However, a visit to a farm where PAR product was sold subject to veterinary authorisation was not performed from this location.

* As a general comment regarding veterinary practices, the reviewer noted that the majority of practices selling large animal PARs do not appear to affix prescription labels as part of their dispensing routine. Some practices affix labels for drugs that are dispensed from the clinic. Almost invariably when PARs are dispensed from the veterinarian’s car on farm, no labels are attached. In this situation the vet may or may not write out a duplicate slip of paper that is loose and not affixed to the PAR but is given to the farmer. This practice makes traceability difficult, if not impossible.

Training: staff

There were no procedures developed for training documentation of staff at the sole veterinary PAR equine trader location. However, this sole operator was a registered veterinarian and had copies of the Terms of Reference (TOR) documents (see Background above). This individual was conversant with the legislative requirements. Because no other person was involved in PAR trade at this site, the risks were ameliorated and activities in this area were deemed compliant with legislative requirements.

At the larger trader of equine PARs, where several lay staff, contracting veterinarians and temporary foreign locum veterinarians work on a seasonal basis, documentation or records of staff training was not apparent. The principal veterinarian, however, was very experienced and had developed his own systems and methods for controlling veterinary medicines.

The absence of any training documents and records at this location is non-compliant with the requirements. The reviewer believes that there are heightened risks to safe and secure PAR trade in this instance, particularly because there is a yearly employment rotation of up to five locums from countries where the PAR requirements may be different from New Zealand’s.

Training: clients

As with dairy and sheep/beef practices, substantial amounts of traded equine PARs are sold under veterinary authorisation. The same comments apply. There was variable documentary evidence available at the two equine review locations about this training of clients. At one location considerable effort and thought appeared to have been applied to ensuring training of clients using PARs. However, only one equine stud was visited to assess the effectiveness of this training. No equine training farms were visited.

Companion animal PAR trading

Two practices involved in the trade of companion animal PAR products were visited. Both were located in the North Island and were not involved in the sale of PARs for any other animal species. Both locations were single clinics operated by one veterinarian with lay staff assistants employed. Neither clinic employed a second full-time veterinarian but both relied on temporary veterinary locum employees as backup.

Quality system

At both companion animal practices the principal veterinarian was the person responsible for the PAR trading quality system. At one location the responsible person did not have access to the TOR documents; these were furnished by the reviewer at a later stage. At both locations the quality systems were documented. Neither of these two clinics used computer applications. Clinical records were written onto client and patient cards. This hard copy card format was used to record PAR prescription information relating to individual patients.

At both locations instruction sheets had been developed to aid staff in the protocols of transportation, receipt and storage, plus dispensing of PARs. These instruction sheets also served as training documents to be used by all staff involved in the trade of PARs. The size of each trading location meant that the principal veterinarian was invariably on site during all trading hours and was intimately involved in any initial PAR dispensing and subsequent prescription repeats. Because of the small number of people working and the constant presence of a veterinarian onsite, the documented quality systems were not as detailed as one would expect to see in a multi vet and support staff facility.

Receipt and storage

Both locations had procedures and records for the safe and secure receipt and storage of PAR products. Such products were not stored in a manner that was accessible or able to be viewed by the public. At one location PAR II and III drugs were stored in locked faculties but were not subject to regular reconciliation. Failure to perform this reconciliation as required in the Standard was deemed to be a non compliance.

Dispensing

The majority of PARs dispensed at both locations occurred immediately subsequent to a veterinary consultation. At one location there was a system that allowed repeat prescriptions as authorisation for future PAR supply to bona fide patients for a six-month period. This time complies with the approved code of practice. There was adequate traceability and labelling of PAR products sold at both locations and dispensing activities complied with the TOR documents.

Training: staff

At both locations there was no formal training documentation although the instruction sheets coupled with verbal instructions and practical workplace experience appeared adequate in these smaller working environments. Both principals were advised that they needed to comply with training requirements in the ACVM Expectations for Approved Traders of PAR Products. To achieve compliance, formal training and an individual’s assessment of competence to trade PAR should be recorded in a training register.

Finding outside the Terms of Reference: Veterinary authorisations

At one location visited to review the trade of dairy PARs, documents relating to the trade of PARs to other species were sighted. Because prior assurances had been given by the reviewer that only dairy PAR trade was to be examined at this site, the findings relating to PAR trade for these other species is reported here as being outside the Terms of Reference.

The reviewer identified instructions in an operational procedures manual used by both veterinarians and staff that allowed veterinary authorisations to be given for a period of two years. This clearly does not comply with the approved code of practice, which limits the time to six months.

Summary of Recommendations for NZFSA and VCNZ

Authorisation time limit

That consideration be given to extending the current 6 month limitation on prescription supply as defined in the Code Registered Veterinarians Writing Prescriptions for Prescription Medicines and Prescription Animal Remedies section D 1. (b). This clause states, “A veterinarian shall not prescribe for any animal(s) under his/her care a quantity of a prescription that exceeds 6 months supply”.

This time limit could be altered and extended to 12 months duration under dairy and sheep/beef PAR trade circumstances.

Response from VCNZ

The report was discussed and the suggestions regarding the amendment of the current 'Prescription Writing' code to extend the current six month limitation on prescription supply for 12 months were noted. The task was given to the Professional Standards Committee to develop a strategy to improve the level of compliance with the Standard.

Client training

That further assessment be made of the effectiveness of the instruction and training provided by veterinarians to authorised clients who buy, hold and use PARs. Further, that this include:

• documents and records held by persons specified as authorised to buy, hold and use PARs be reviewed;

• PAR labelling compliance, traceability, and security at the site of use of PAR on farms;

• on farm verification of the above.

Response from NZFSA

The effectiveness of the instructions and training provided by veterinarians to authorised clients will be included in the next planned review of PAR traders.