Safety and compliance are fundamental to responsible antimicrobial use. Withdrawal periods protect food safety by eliminating antimicrobial residues before products enter the food chain. Treatment completion prevents resistance development by eliminating all susceptible bacteria. Adverse reaction tracking protects animal welfare. Supports product safety monitoring. Off-label use documentation demonstrates responsible practice when approved alternatives are unavailable.

This chapter explains these essential safety and compliance elements. Shows how Kora supports proper management of each.

Withdrawal Periods

What Withdrawal Periods Are

Withdrawal periods are the required waiting time between the last dose of antimicrobial and when animal products (meat, milk, eggs, honey, other edible products) can safely be consumed or sold. During this time, the animal's body eliminates antimicrobial residues to levels below established safety thresholds.

Withdrawal periods vary based on specific antimicrobial product, species treated, route of administration, product type (meat, milk, eggs), regulatory requirements in your jurisdiction. Product labels specify withdrawal periods. These are established through scientific studies that measure residue elimination rates. Some antimicrobials have short withdrawal periods (1-2 days). Others require extended periods (several weeks).

Why Withdrawal Periods Matter

Food Safety: Antimicrobial residues in food can cause allergic reactions in sensitive individuals. Disrupt human gut bacteria. Contribute to antimicrobial resistance through environmental exposure. Proper withdrawal periods protect consumer health.

Regulatory Compliance: Violating withdrawal periods is illegal in most jurisdictions. Products with residues exceeding safety thresholds will be condemned, destroyed. May result in fines, prosecution, or loss of operating licences. Repeat violations can end your ability to sell products.

Market Access: Buyers, processors, and retailers require assurance that products meet safety standards. Withdrawal period violations damage reputation. Terminate contracts. Restrict market access even beyond regulatory penalties.

Animal Welfare: Proper withdrawal periods are part of responsible animal care. Demonstrate commitment to producing safe food while maintaining animal health through appropriate antimicrobial use.

Recording Withdrawal Periods

Withdrawal Period Days: Enter the number of days required between last treatment dose and when products can safely be used. Information comes from product labels, veterinary guidance, or regulatory references.

Treatment End Date: Record when antimicrobial treatment was completed (last dose administered). Establishes starting point for withdrawal period calculations.

Withdrawal End Date: Kora automatically calculates when withdrawal period ends by adding required withdrawal days to treatment end date. This is the first date when products can be safely consumed or sold.

If withdrawal periods differ for different products (e.g., 7 days for milk, 21 days for meat), use the longest period or create separate records for tracking multiple product types from the same animal.

Managing Withdrawal Periods

Animal Identification: Clearly mark animals under withdrawal to prevent accidental product collection or slaughter (paint marks, leg bands, distinctive ear tags, separate housing areas, visual charts or boards, digital tracking systems with automatic alerts).

Withdrawal Calendars: Maintain calendars showing withdrawal end dates (calendar alerts on smartphones or management systems, visual calendars posted near animal housing, milk withdrawal charts in dairy parlours, integration with slaughter or product collection schedules).

Product Segregation: For food-producing animals: discard milk from cows in withdrawal (cannot be used for human consumption or fed to calves in many jurisdictions), do not send animals for slaughter until withdrawal completes, mark eggs from treated birds and do not sell for consumption, separate honey from treated bee colonies.

Verification Before Use: Before using products from previously treated animals: verify withdrawal end date has passed, check that no additional treatments were given that reset the withdrawal period, if uncertain extend withdrawal period or seek veterinary guidance, consider residue testing for high-value animals or critical situations.

Extended or Multiple Treatments

Treatment Extensions: If antimicrobial treatment is extended beyond initially planned duration, withdrawal period restarts from the new last dose. A 7-day treatment with 5-day withdrawal requires 12 days total (7 treatment + 5 withdrawal). If treatment extends to 10 days, it becomes 15 days total (10 treatment + 5 withdrawal).

Multiple Antimicrobials: When animals receive multiple antimicrobials simultaneously or sequentially, use the longest withdrawal period among all products administered. If one product requires 5 days and another requires 14 days, observe the 14-day withdrawal.

Off-Label Use: When using antimicrobials off-label (different species, different route, different dosing than labelled), withdrawal periods may need to be extended. Veterinary guidance should specify appropriate withdrawal periods for off-label use. Often using extended periods as safety margin.

Withdrawal Period Compliance Tracking

Kora tracks your withdrawal period compliance rate: the percentage of treatments where withdrawal periods were properly observed. Perfect compliance (100%) is the only acceptable target. Any violation is food safety failure requiring immediate corrective action.

If compliance falls below 100%: review all current animals in withdrawal and verify no violations are occurring, investigate why violations occurred (miscommunication, lost records, inadequate marking), implement corrective measures (improved marking systems, better calendars, staff training), consider whether products from violated withdrawals entered food chain and whether notification is required.

Treatment Completion

Why Completion Matters

Antimicrobial treatment courses are prescribed for specific durations based on time needed to eliminate bacterial infections. Stopping treatment early (even when animals appear recovered) allows most resistant bacteria to survive, multiply, and spread. These survivors are harder to treat in future. Contribute to broader resistance problems.

Tracking Completion

Kora compares planned treatment duration to actual treatment duration:

Completed Treatment: Actual duration equals or exceeds planned duration. Full prescribed course was administered. Maximises effectiveness. Prevents resistance.

Incomplete Treatment: Actual duration is less than planned duration. Treatment was stopped early. Increases resistance risk and likelihood of relapse.

Extended Treatment: Actual duration exceeds planned duration. Treatment was extended beyond initial prescription. Possibly due to poor response or veterinarian recommendation.

Your treatment completion rate is the percentage of treatments completed as prescribed.

Reasons for Incomplete Treatment

Incomplete treatments sometimes occur for valid reasons: animal death (animal died during treatment course), ineffective treatment (veterinarian advised switching to different antimicrobial), adverse reactions (serious adverse reaction required discontinuation), product unavailable (ran out of product and could not obtain more).

However, many incomplete treatments result from preventable causes: perceived recovery (animal looked better, assumed treatment was complete), inconvenience (lost track of treatment schedule or found dosing difficult), cost concerns (attempted to save money by using less than prescribed), misunderstanding (did not understand importance of completion), poor planning (did not ensure sufficient product supply before starting).

Improving Completion Rates

Set Reminders: Use calendar alerts, smartphone reminders, or treatment schedule charts to ensure all doses are administered on time.

Buy Sufficient Product: Before starting treatment, ensure you have enough product to complete full course. Don't start treatment if you can only afford partial course.

Communicate with Staff: Ensure everyone involved in animal care knows which animals are receiving treatment, dosing schedule, importance of completion.

Record Immediately: Document each dose when administered. Creates accountability. Helps track progress through multi-day courses.

Plan for Absence: If you'll be unavailable during treatment course, arrange for someone else to administer doses. Written instructions and pre-measured doses help ensure consistency.

Isolate Treated Animals: Keeping treated animals in easily accessible areas makes dosing more convenient. Improves compliance with treatment schedules.

When to Modify Treatment

Consult with veterinarian before stopping or modifying antimicrobial treatment. Legitimate reasons to modify treatment include: no response after 48-72 hours (may indicate antimicrobial resistance or misdiagnosis), worsening condition (animal deteriorating despite treatment), adverse reactions (serious side effects outweigh benefits), diagnostic findings (culture results indicate different antimicrobial would be more effective).

Document modification reasons, veterinary consultation, and new treatment plan. Modified treatments should still be completed according to new plan.

Adverse Reaction Tracking

What Constitutes Adverse Reactions

Adverse reactions are unwanted effects from antimicrobial administration:

Allergic Reactions: Hives, swelling, itching, respiratory difficulty, anaphylactic shock (rare but life-threatening), facial swelling or tongue swelling.

Injection Site Reactions: Excessive swelling, heat, or pain at injection site, abscess formation, tissue damage or necrosis, lameness or movement restriction.

Gastrointestinal Effects: Severe diarrhoea or constipation, reduced appetite or complete anorexia, colic or abdominal pain, dehydration.

Neurological Effects: Seizures or tremors, incoordination or weakness, behaviour changes or depression, blindness or other sensory changes.

Systemic Effects: Fever or hypothermia, organ dysfunction (kidney, liver), blood abnormalities, general deterioration.

Recording Adverse Reactions

Document adverse reactions when they occur:

Adverse Reaction Occurred: Mark whether any adverse reaction was observed during or after antimicrobial administration.

Adverse Reaction Details: Describe the reaction including specific symptoms observed, timing (immediate, hours later, days later), severity (mild, moderate, severe, life-threatening), duration of reaction, any interventions required (treatment, veterinary care), outcome (resolved, ongoing, animal died).

Managing Adverse Reactions

Immediate Response: Stop antimicrobial administration if severe reaction occurs. Contact veterinarian immediately for serious reactions. Provide supportive care as directed. Monitor animal closely for progression or resolution.

Documentation: Record reaction in treatment record. Note product name, batch number, and expiration date. Include animal details (species, age, weight, previous exposures). Document all interventions and outcomes.

Reporting: Report serious adverse reactions to veterinarian. Some jurisdictions require reporting to regulatory authorities. Manufacturers may request adverse reaction reports for product monitoring. Contribute to pharmacovigilance systems when available.

Future Prevention: Mark animal as sensitive to this antimicrobial. Avoid using this product family for this animal in future. Share information with other caregivers and veterinarians. Consider alternatives for future infections.

Adverse reaction tracking supports product safety monitoring. Informs future treatment decisions. Protects animal welfare.

Off-Label Use

What Off-Label Use Means

Off-label use (also called extra-label use) occurs when antimicrobials are used in ways not specified on approved product label:

Species Differences: Using products labelled for cattle on goats, or products labelled for dogs on wildlife species.

Indication Differences: Treating conditions not listed on label as approved uses for that product.

Dosage Differences: Using higher or lower doses than specified on label.

Route Differences: Administering products by different routes (e.g., oral product given by injection).

Duration Differences: Using products for shorter or longer duration than labelled recommendations.

When Off-Label Use Occurs

Off-label use sometimes becomes necessary: minor species (many animal species lack approved antimicrobial products, requiring use of products labelled for other species), resistance issues (labelled products prove ineffective, requiring alternatives), clinical judgement (veterinary assessment determines different dosing or duration is appropriate), product availability (preferred products unavailable, requiring substitution), cost constraints (approved products unaffordable, requiring economical alternatives).

Legal and Ethical Requirements

Off-label antimicrobial use is generally legal but requires:

Veterinary Oversight: In most jurisdictions, off-label antimicrobial use requires veterinary authorisation and supervision. Self-directed off-label use without professional guidance is often illegal.

Valid Veterinarian-Client-Patient Relationship (VCPR): Prescribing veterinarian must have established relationship with you and knowledge of animals being treated.

Medical Rationale: Clear clinical justification for why off-label use is necessary and preferable to labelled alternatives.

No Approved Alternative: Off-label use should occur only when no approved product exists for the indication, species, or clinical situation.

Extended Withdrawal Periods: Off-label use in food-producing animals requires extended withdrawal periods to ensure safety despite unlabelled use.

Documenting Off-Label Use

When using antimicrobials off-label:

Mark Off-Label Use: Indicate that this treatment represents off-label use in the antimicrobial record.

Document Justification: Record detailed explanation of why off-label use was necessary (no labelled product available for this species/indication, labelled products proven ineffective, culture sensitivity results indicate this unlabelled product is effective, veterinary recommendation based on clinical judgement, cost constraints preventing use of labelled alternatives).

Record Veterinary Involvement: Document veterinarian who authorised off-label use, their clinical reasoning, and any special instructions provided.

Note Extended Withdrawal: Record extended withdrawal period recommended by veterinarian for off-label use. This is typically longer than labelled withdrawal to provide safety margin.

Track Outcomes: Carefully monitor and document treatment outcomes for off-label use. Success supports future use in similar situations. Failure indicates need for alternatives.

Responsible Off-Label Use

Seek Professional Guidance: Never use antimicrobials off-label without veterinary consultation and authorisation.

Document Thoroughly: Comprehensive documentation of off-label use protects against regulatory challenges. Demonstrates responsible practice.

Prioritise Labelled Products: Use labelled products whenever possible. Off-label use should be the exception, not the routine.

Monitor Carefully: Off-label use carries higher uncertainty. Monitor treated animals closely for both effectiveness and adverse reactions.

Extended Safety Margins: Use conservative extended withdrawal periods for food-producing animals. Compensates for uncertainty about residue elimination in off-label scenarios.