haccp for proper drug use proactive approach to drug residue prevention © 2012 wisconsin veterinary...

© 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

HACCP FOR PROPER DRUG USEProactive Approach to Drug Residue Prevention


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


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


Producing Two Safe Products


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

HACCP: Hazard Analysis & Critical Control Points

Traditional HACCP

• Identify hazards• Establish critical control points• Monitors • Breakpoints• Action at breakpoint• Mandatory records• Verify the system


VCPR

Drug List

Protocols

SOPs

Records

Oversight

Proper Drug Use

WVMA HACCP For Proper Drug Use

Meeting HACCP Requirements• Identify Hazards

• VCPR and drug list

• Establish Critical Control Points• VCPR responsibilities, protocols, SOPs

• Monitors• Oversight

• Breakpoints• Regulatory tolerances• Non-regulatory appropriate drug use

• Action at breakpoint• On-the-job training (teachable moment)

• Mandatory Records• Drug list, protocols, prescriptions, cow side oversight

• Verification• Milk processor oversight• Veterinarian and producer

• oversight and records usage

VCPR

Drug List

Protocols

SOPs

Records

Oversight

Proper Drug Use


Three Areas of Focus

1. Food SafetyMeat and milk residues

2. Appropriate Drug Use

Label and Extra label drug use

Accountability to treatability

3. Messaging

Truth and half-truths


FarmVeterinary/Client/Patient

Relationship (VCPR)

Slaughter Plant

Truckers, Dealers & Markets

FSIS Authority

FDA

Authority

FDA

AuthorityUSDA Authority

Dairy Beef Regulatory Authority System

90% of violations originate from dairy• 70% cull cows• 20% bob veal (few days old to 150 pounds)


Relationship (VCPR)

Slaughter Plant


FSIS Authority

FDA

Authority

FDA



Sampling1) Directed Random

2) Unscheduled Targeted

• Mastitis

• Metritis

• Pneumonia

• Injection lesions

• Surgeries

• And much more…


Relationship (VCPR)

Slaughter Plant


FSIS Authority

FDA

Authority

FDA




Cull Cows

1) Penicillin2) Flunixin3) Sulfas4) Desfuroylceftiofur5) Gentamicin

Bob Veal

1) Neomycin2) Sulfas3) Gentamicin4) Flunixin

Top Tissue Violator DrugsMilk Residues

• Failed EU milk audit results in increased testing to maintain export market access

• January 2012 FDA blind sampling began

• Milk processors increase testing

Processor LetterHow will you ensure that “good milk” does not get dumped as a result of this additional testing?

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 technology. The presence of any drug at any level in milk is considered adulterated under the FD&C and therefore prohibited. Our protocol for testing remains the same as it is today. We are simply expanding the universe of drugs for which we will test. As with current testing for Beta lactams, two additional tests will be run on any positive sample, thereby minimizing the risk of “good milk” being rejected due to a false positive test.

Additionally, the cooperative that is responsible for the load will have the full opportunity to conduct follow-up testing on any milk that tests positive for the presence of drug residue.


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.

13


Relationship (VCPR)

Slaughter Plant


FSIS Authority

FDA

Authority

FDA



FDA Top 3 Reasons for Violations

No Veterinary-Client-Patient-Relationship (VCPR)

1) No on-farm treatment records

2) Increased dosage without adjusting withdrawal times

3) No individual animal ID

Cull Cows


Top Tissue Violator Drugs

Bob Veal


?Top Milk Violator Drugs

Mastitis

Metritis

Pneumonia

Common ELDU ConditionsSolution

Records + Oversight + VCPR



VCPR VETERINARIAN-CLIENT-PATIENT RELATIONSHIP

VCPR• Regulatory accountability

• Take non-regulatory approach but accomplish intent of law within the diversity of individual dairies and people involved



Statutory VCPR

• Veterinarians have a regulatory accountability• Federal law• State law

• WVMA HACCP For Proper Drug Use• Non-Regulatory

• 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


VCPR (Personalized)


Mindset Shift

Focus attention on drug usage accountability and treated animal oversight

DRUG LIST


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



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

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



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


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


On Farm Testing?

• What is the role of on farm testing for residues?

• We cannot test our way out of proper drug use!

PROTOCOLS



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

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



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


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


Justifying ELDU• What evidence do we go

through to justify ELDU?


True jeopardy…

Having protocols and not following them

Worker consistency, compliance, and competency

SOPs



SOPs• Consistency, compliance, competency

• Identifying people skills through the records

• Allows on-going, on-the-job training at oversight

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

Mindset Shift

Residues are not a drug problem.

They are a people problem.


RECORDS



Records

• Required records situations

• Three types of records on dairies

• Train record usage by VCPR team members

• Management usage (epidemiology, consistency, etc.)


Records

• Statutory

• AMDUCA requirements for ELDU

• State law requirement (VE7)

• Wisconsin Examining Board

Value = Records Usage by VCPR Team

• Patient – cow side personnel

• Client – management team

• Veterinarian – oversight



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


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


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


Permanent RecordsThe 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


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


Value of Records

Usage by VCPR Team

• Patient – (cow side personnel)

• Client - (management team)

• Veterinarian (oversight)


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

OVERSIGHT



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


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”

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



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

Oversight – Moving to the Next LevelThe 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



Oversight – Moving to the Next LevelThe 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


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?


Mindset Shift

Identification of “problem cow”- Stop treating the incurable

59

Conclusion

Clarify Extra Label Drug Use

Veterinarians

Producers


FDA Top 3 Reasons for Violations

No Veterinary-Client-Patient-Relationship (VCPR)

1) No on-farm treatment records

2) Increased dosage without adjusting withdrawal times

3) No individual animal ID

Cull Cows


Top Tissue Violator Drugs

Bob Veal


?Top Milk Violator Drugs

Mastitis

Metritis

Pneumonia

Common ELDU ConditionsSolution

Records + Oversight + VCPR

haccp for proper drug use proactive approach to drug residue prevention © 2012 wisconsin veterinary...

Documents

wvma slide

wvma wvma haccp

drug vcpr drug residues

drug problem drug vcpr

proper drug use slide

drug residue prevention

consumed drug residue

milk residues