© 2012 Wisconsin Veterinary Medical Association, Inc.
Reproduction prohibited without license from WVMA
HACCP FOR
PROPER DRUG USE
Proactive Approach to Drug Residue Prevention
© 2012 Wisconsin Veterinary Medical Association, Inc.
Reproduction prohibited without license from WVMA
Wisconsin Veterinary Medical Association
• 1994 - AMDUCA Taskforce
• AMDUCA: Animal Medicinal Drug Use Clarification Act
• Law regarding extra label drug use
• 2000 - Best Practices Taskforce
• Addressed drug use on dairy
• Developed computer software
• 2009 - Wisconsin topped the list for tissue residues
• Meat processors wanted more regulation
• Beef producers wanted to eliminate dairy meat harvest
• Milk processors were concerned with speed of commerce and
expanded pharmaceutical testing of samples
• Dairy producers were angered by media attention,
lack of current food safety credit
© 2012 Wisconsin Veterinary Medical Association, Inc.
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WVMA Residue Taskforce
• WVMA Taskforce created (2010)
• WVMA advocated for a non-regulatory approach (Each herd is unique)
• Education for all stakeholders
• Proposed Mindset Shift changes that needed to occur
• Identified and collected facts about residues
• Identified possible partners, supporters, spectators and detractors
• Professional Dairy Producers of Wisconsin (PDPW)
• WVMA and PDPW forms partnership (WHAT MATTERS: Safe Meat and Milk)
• Milk testing/FDA sampling
• Attention turned to milk
• FDA milk sampling
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Producing Two Safe Products
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Mindset Shifts for Dairy Industry
• BOTH meat and milk are food products and should be treated as such
• Assume all calves sent to market will be harvested and consumed
• Drug residue is a symptom, the disease is lack of DRUG VCPR
• Drug residues are a people problem, not a drug problem
• Drug VCPR includes usage oversight and treatment records
• Protocols: How you want treatment given in your name, in your absence
• Identify “problem cow”- (stop treating the incurable)
• Oversight involves both Rx and OTC drugs through
treatment records
© 2012 Wisconsin Veterinary Medical Association, Inc.
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HACCP: Hazard Analysis & Critical Control Points
Traditional HACCP
• Identify hazards
WVMA HACCP For Proper Drug Use
VCPR
• Establish critical control points
• Monitors
• Breakpoints
• Action at breakpoint
• Mandatory records
Proper
Drug Use
• Verify the system
SOPs
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Meeting HACCP Requirements
• Identify Hazards
• VCPR and drug list
• Establish Critical Control Points
VCPR
• VCPR responsibilities, protocols, SOPs
• Monitors
• Oversight
• Breakpoints
• Regulatory tolerances
• Non-regulatory appropriate drug use
Proper
Drug Use
• Action at breakpoint
• On-the-job training (teachable moment)
SOPs
• Mandatory Records
• Drug list, protocols, prescriptions, cow side oversight
• Verification
• Milk processor oversight
• Veterinarian and producer
• oversight and records usage
© 2012 Wisconsin Veterinary Medical Association, Inc.
Reproduction prohibited without license from WVMA
Three Areas of Focus
1. Food Safety
Meat and milk residues
2. Appropriate Drug Use
Label and Extra label drug use
Accountability to treatability
3. Messaging
Truth and half-truths
Dairy Beef Regulatory Authority System
Farm
Veterinary/Client/Patient
Relationship (VCPR)
90% of violations originate from dairy
• 70% cull cows Truckers, Dealers &
Markets
FDA
FDA
• Authority
20% bob veal (few days old to 150 pounds)
Authority
USDA Authority
Slaughter
Plant
FSIS Authority
Dairy Beef Regulatory Authority System
Farm
Veterinary/Client/Patient
Relationship (VCPR)
Sampling
1) Directed Random
2) Unscheduled Targeted
• Mastitis
Truckers, Dealers &
FDA
Authority
• Metritis
Markets
USDA Authority
• Pneumonia
• Injection lesions
• Surgeries
Slaughter
• And much
more…
Plant
FSIS Authority
FDA
Authority
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Dairy Beef Regulatory Authority System
Farm
Processor
Letter
Veterinary/Client/Patient
Relationship (VCPR)
How will you ensure that “good milk” does not get dumped as a result of this
additional testing?
Top Tissue
Violator Drugs
Milk Residues
Answer: The only milk that we will reject under this program is milk that tests
positive for the presence of drugs, using commercially accepted testing
Cull
Cows
Failed
EUany
milk
audit
results
in Veal
increased
technology. The• presence
of
drug
at any
level Bob
in
Truckers,
Dealers
& milk is considered adulterated
testing
to maintain
export
market
access
under the FDA
FD&C and
therefore
prohibited.
Our
protocol
for testing
remains
Markets
FDAthe
1)We
Penicillin
1) Neomycin
same asAuthority
it is today.
are simply expanding the universe
of drugs for
which we
Authority
USDA
Authority
will test. As with• current
testing
for Beta
two
tests will be run on
2)
Flunixin
2) additional
Sulfas began
January
2012
FDAlactams,
blind sampling
any positive sample,
“good
milk” being rejected due
3) thereby
Sulfas minimizing the risk of3)
Gentamicin
to a false positive 4)
test.
Desfuroylceftiofur
Flunixin
• Milk processors increase 4)
testing
5) Gentamicin
Additionally, the cooperative that is responsible for the load will have the full
Slaughter
opportunity to conduct follow-up testing
on any milk that tests positive for the
Plant
presence of drug residue.
FSIS Authority
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Tissue Testing
Consumer Reality
Consumers do not want to hear
you are within tolerance levels.
They want to hear there are no
residues in the products they buy.
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Dairy Beef Regulatory Authority System
Farm
Veterinary/Client/Patient
Relationship (VCPR)
TopTop
Tissue
Violator
Drugs
Common
ELDU
Conditions
FDA
3
Reasons
for
Violations
Top MilkSolution
Violator Drugs
No Veterinary-Client-Patient-Relationship
Cull Cows
Bob Veal (VCPR)
Mastitis
Records + Oversight
?
Truckers,
Dealers &
1) No on-farm treatment
records
Markets
1) Neomycin FDA
FDA 1) Penicillin
Authority
Metritis
2) Flunixin
2) Sulfas
2) Authority
Increased
dosage without
adjusting
withdrawal
USDA Authority
3) Gentamicin
times 3) Sulfas
4) Desfuroylceftiofur
4) Flunixin
Pneumonia
3) No individual animal
ID
5) Gentamicin
Slaughter
Plant
+ VCPR
FSIS Authority
13
© 2012 Wisconsin Veterinary Medical Association, Inc.
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VCPR
VETERINARIAN-CLIENT-PATIENT RELATIONSHIP
© 2012 Wisconsin Veterinary Medical Association, Inc.
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VCPR
• Regulatory accountability
• Take non-regulatory approach but accomplish intent of
law within the diversity of individual dairies and people
involved
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Statutory VCPR
• Veterinarians have a regulatory
accountability
• Federal law
• State law
• WVMA HACCP For Proper
Drug Use
• Non-Regulatory
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VCPR (Personalized)
• Non-regulatory team of people
• Patient - people working cow side
• Client - people representing management
• Veterinarians
• Attending, referral, consulting
• Who is responsible?
• What are their roles?
Identify high risk people
Roles and responsibilities
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Mindset Shift
Focus attention on drug usage accountability
and treated animal oversight
© 2012 Wisconsin Veterinary Medical Association, Inc.
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DRUG LIST
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Drug List
• Regulatory consideration is dealing with prescriptions
• All drugs (oral/injectable; prescription/over-the-counter)
• Identify Extra Label Drug Use (ELDU)
• Target high risk drugs
© 2012 Wisconsin Veterinary Medical Association, Inc.
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VCPR Accountability to the Drug List
• Work from list of ALL purchased
drugs
• Prescription accountability for the
drug on the list
• Extra Label Drug Use (ELDU)
identification by protocol writer
• AMDUCA algorithm accountability
• Who secured withdrawal information
for any Extra Label Drug Use?
Drug Usage and Categories
• Approved use
• Over the Counter (OTC)
• Purchased without a Veterinary Prescription,
use on label only (LDU)
• Prescription
• Purchase with prescription, use by label
(LDU)
• Extra-label Drug Use (ELDU)
• OTC or Prescription Drugs not used in
accordance to label directions
• No tolerance level for drug not approved for
animal type
• Veal calves
• Not for animals>20 months of age
• Illegal use
• Prohibited drug list
• Approved drug list, but not for ELDU
• Leaving residue above tolerance
• Residue above sensitivity of test for drugs
with no tolerance
© 2012 Wisconsin Veterinary Medical Association, Inc.
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High Risk Drugs – No Tolerance Level
• Label restrictions if used on veal calves
• Label restrictions if dairy is less than 20 months of age
• For example, but not limited to: Draxxin (Tulathomycin), Micotil
(Tilmicosin), Tylan (Tylosin), Nuflor, Nuflor Gold, Resflor Gold
(Florfenicol)
• Identifies risk and establishes critical control points
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Defining Extra Label Drug Use (ELDU)
• Giving an animal a drug (Over The Counter or
prescription) in a manner different in any way
from the manufacturer’s label
• When Over The Counter drugs are NOT used
according to the manufacturer’s label
directions they require a prescription
• A valid VCPR (Veterinarian-Client-Patient
Relationship)
• Has requirements for use (records)
AMDUCA: Animal Medicinal Drug Use Clarification Act of 1994
© 2012 Wisconsin Veterinary Medical Association, Inc.
Reproduction prohibited without license from WVMA
© 2012 Wisconsin Veterinary Medical Association, Inc.
Reproduction prohibited without license from WVMA
Illegal For Use
• Baytril
• Extra label use of florquinalones (Baytril) are expressly prohibited
• Sulfa
• Extra label use of sulfas are expressly prohibited
• There are a few ON LABEL uses of Sulfadimethoxine (Albon) in
lactating cows (foot rot and pneumonia)
• Using any other sulfa is prohibited as well as using Albon for other
conditions or giving oral solution IV
• Ceftiofur
• Limited extra label applications
© 2012 Wisconsin Veterinary Medical Association, Inc.
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On Farm Testing?
• What is the role of on farm testing for residues?
• We cannot test our way out of proper drug use!
© 2012 Wisconsin Veterinary Medical Association, Inc.
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PROTOCOLS
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Protocols
• Treatments given in our name; in our absence
• Define condition, drug protocol, records, withdrawal times
• Identify label drug use opportunities first
• Plan food safety if ELDU is appropriate
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Protocols v. SOPs
• Protocol - What to do
• Defined condition (situation)
• Drug treatment - dose, route,
duration
• Records to keep for verification of
food safety and accountability for
proper drug use
• Withdrawal for meat and milk
• SOP – How to do it
• Steps to a process and procedure
• People responsibilities
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Protocol Development
• Have sufficient knowledge about the farm’s clinical case
definitions
• Perceived v. Actual
• First, identify and write protocols where on-label
treatments will be effective
• Meat and milk withdrawals as labeled
• Challenge will be satisfying expectations of outcomes that
satisfy VCPR team
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Protocol Development
• Second, identify where ELDU is needed
• If no treatment records, no ELDU
• Meat and milk withdrawals are calculated based on treatment
duration, dose, route and frequency (Check with FARAD)
• Veterinarians have accountability to AMDUCA Algorithms
• Review and update annually, or as needed
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Justifying ELDU
• What evidence do we go
through to justify ELDU?
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True jeopardy…
Having protocols and not following them
Worker consistency, compliance, and competency
© 2012 Wisconsin Veterinary Medical Association, Inc.
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SOPs
© 2012 Wisconsin Veterinary Medical Association, Inc.
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SOPs
• Consistency, compliance, competency
• Identifying people skills through the records
• Allows on-going, on-the-job training at oversight
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SOPs Are the Steps of the Process
• Daily routines
• How we milk (pre-strip)
• Daily fresh cow exam (metritis)
• Daily cow observations (pneumonia)
• Health
• How does a mastitis case get processed?
• How does a metritis case get processed?
• Pneumonia case examination and
treatment decision
SOP for withdrawal accountability after treatment
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Mindset Shift
Residues are not a drug problem.
They are a people problem.
© 2012 Wisconsin Veterinary Medical Association, Inc.
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RECORDS
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Records
• Required records situations
• Three types of records on dairies
• Train record usage by VCPR team members
• Management usage (epidemiology,
consistency, etc.)
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Records
• Statutory
• AMDUCA requirements for ELDU
• State law requirement (VE7)
• Wisconsin Examining Board
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Value = Records Usage by VCPR Team
• Patient – cow side personnel
• Client – management team
• Veterinarian – oversight
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Three Herd Categories
• No records
• herd or a management group
• Fundamental records (logs)
• Manage the case, food safety,
• Permanent level records (medical history)
• Manage case, food safety, herd epidemiology, oversight,
outcomes
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No Records, High Risk
• Label Drug Use Only
• Protocols for label usage and we best monitor compliance
• Note in veterinary records that we checked for records and repeatedly
gave oral recommendations to follow label
• We have the right to refuse service (there is a process for this)
• If we are attending veterinarian do we have the right to refuse VCPR
responsibilities? (Do we need to have assurance someone else holds
VCPR if we attend this dairy?)
• Milk processors must oversee these dairies, we can’t verify drug use
without records
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Fundamental Records
• Records that will manage food safety
• Daily drug treatment usage records
• Includes: Animal ID, condition, date treated, drug used, dosage,
route, duration, meat and milk withdrawal
• Huge step up from no records, but can we
verify a HACCP plan (proper drug use)?
• No. Fundamental Records ≠ WVMA HACCP
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Permanent Records
The next level of record keeping is individual cow
permanent records
• Permanent record information is collected from the cow side
recording form
• Includes cow’s medical, fertility, production and other history
• The permanent record sets the stage for science-based appropriate
drug usage with consideration of medical history
• Organizing individual permanent records is the basis for identifying
epidemiology (disease patterns) and therefore prevention
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Permanent Records
• To meet WVMA HACCP For Proper Drug Use
• Permanent records must be kept
• Veterinarian oversight of those records is essential
• Allows us to identify opportunities to improve management
• Appropriate drug use
• Management of prevention
• Oversight of welfare
• Food safety
• Identify opportunities for increased profitability for dairies
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Value of Records
Usage by VCPR Team
• Patient – (cow side personnel)
• Client - (management team)
• Veterinarian (oversight)
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Plan What to Record So You Can…
• Recognize SOP compliance and
competency
• That was the reason for defining severity
• Recognize protocol drift
• Definitions match protocols
• Manage epidemiology
• By age, stage of lactation, severity, cause,
history
• Ensure Food safety
© 2012 Wisconsin Veterinary Medical Association, Inc.
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OVERSIGHT
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Oversight – The “Key” to Making it All Work!
What is Oversight?
• The regular, timely review of the
dairy producers’ medical records
• Monitor treatment, outcome and
compliance
• No Records = No Oversight
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Oversight – Is the “Key” Because…
• It validates VCPR (“sufficient knowledge”)
• It allows you to monitor, validate, refine protocols and SOP’s
• Are people doing what we agreed? (drift)
• Are patients responding? (effectiveness)
• Did the pattern change? (epidemiology shift)
• It allows you to watch the drug list
• Where did that Miraclemycin come from?
• It reinforces the value of keeping records to the producer
• It reinforces the value of veterinary involvement in treatment decisions
and drug use to the producer
• It allows identifying “teachable moments”
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Oversight – Target Herd Needs
• Identify drug usage hazards and resolve
them with a control plan
• Improve welfare by finding opportunities
to treat cows in need
• Improve appropriate drug use by finding
cows that don’t need to be treated
• Find opportunities to improve profitability
within treatment plan
• Teachable moment is when the treatment
decision is fresh
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Oversight – Which Records Need to be
Reviewed?
Permanent & Fundamental Records
• Different clients will have varying
records, competencies and needs
Remember why we’re here today:
• To stop residue violations in dairy beef
and milk products
• Proper drug use
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Oversight – Moving to the Next Level
The Permanent Record - Bringing Information to Management
• Measure outcomes of protocols and SOPs
• Becoming sub clinical status after treatment
• Measuring relapses, reoccurrences, retention in the herd, etc.
• Noting changes in productive potential post treatment
• Begin to understand disease processes occurring
on the farm (epidemiology)
• Define incidence, prevalence, management groups
• Look for patterns across parity, days fresh, seasons
• Severity, pathogens, treatment
• Do records suggest an intervention, or management decision
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Oversight – Moving to the Next Level
The Permanent Record - Bringing Information to Management
• Determine quantity of drugs being used - reconciliation
• Per cow, per case, per condition, per management group
• Cowside by totaling cc’s, pills, bottles from “daily treatments records”
• In the office by reviewing drug purchases (BPW)
• (starting inventory + purchases-ending inventory=drug use)
• Is there any glaring over usage? Under usage?
• Use records to characterize the economic impact
of disease on the farm
• Quantify drug costs per case, per cow, per condition, per management
group
• Days out of tank (DOOT) - value of discarded milk
• Costs due to death and premature culling
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Oversight – Where Do I Start?
First Things First - Stop Drug Residues in Milk and Dairy Beef
• Review fundamental records
• Answers who, what, when, how, and why drugs are being used
• Validate that meat and milk withdrawal times are correctly established and
observed
• Review animals that were sold or died
• Validate that meat withdrawal times are correctly established and observed
• Doing sold/dead cows can suggest a need to refine any protocols/SOPs
• Don’t forget about bull calves – free of residues?
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Mindset Shift
Identification of “problem cow”Stop treating the incurable
© 2012 Wisconsin Veterinary Medical Association, Inc.
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Conclusion
TopTop
Tissue
Violator
Drugs
Common
ELDU
Conditions
FDA
3
Reasons
for
Violations
Top Milk
Violator Drugs
Solution
Clarify
Extra Label Drug
Use (VCPR)
No Veterinary-Client-Patient-Relationship
Cull Cows
Bob Veal
Mastitis
1) No on-farm treatment
records
Veterinarians
1) Penicillin
1) Neomycin
Metritis
Producers
2) Flunixin
2) Sulfas
2) Increased
dosage
without
adjusting
withdrawal
Records +
Oversight
+
VCPR
3)
Sulfas
3)
Gentamicin
times
?
4) Desfuroylceftiofur
4) Flunixin
Pneumonia
3) No individual animal
ID
5) Gentamicin
59