VETERINARY COMPOUNDING: A REGULATORY OVERVIEW AND SAFETY ASSESSMENT
|
|
- Christian Evans
- 5 years ago
- Views:
Transcription
1 1
2 VETERINARY COMPOUNDING: A REGULATORY OVERVIEW AND SAFETY ASSESSMENT Lauren Eichstadt Forsythe, PharmD, DICVP, FSVHP 2
3 HOUSEKEEPING Cell Phones Download the Slides Questions No photography, audio, or video recordings 3
4 COPYRIGHT/DISCLAIMER DISCLAIMER: The information contained in this program, which may include treatment modalities, diagnostic and therapeutic information, and instructions related to regulatory guidelines and current standards of practice for pharmacy compounding, is FOR EDUCATIONAL PURPOSES ONLY and should not be taken as a treatment regimen, product indication, suggested treatment modality, or suggested standard of practice. NOTE TO MEDICAL OR ALLIED HEALTH PROFESSIONAL: Any treatments, therapies, or standards of practice must be fully investigated and prescribed by a duly licensed medical practitioner in accordance with accepted professional standards and compendia. Any regulatory or practice standard must be fully investigated by a licensed pharmacist in accordance with accepted professional practice standards and compendia. 4
5 ACCREDITATION PHARMACIST & PHARMACY TECHNICIAN CREDITS CPE Consultants, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education and complies with the Accreditation Standards for continuing education activities. Activity Type Pharmacist Pharmacy Technician Pharmacist UAN L07-P L07-T Credits 1 CPE Hours = 0.1 CEUs 1 CPE Hours = 0.1 CEUs Release Date October 27 th 2018 October 27 th 2018 Expiration Date October 27 th 2019 October 27 th
6 ACCREDITATION HOW TO OBTAIN CREDITS Create your LP3 Account Register for WCC 2018 Workshops Note the Tacking Code at the END OF THE PRESENTATION Submit a completed Evaluation (within 14 days) online for each Workshop. 5 Statement of credits will be provided within 30 days. 6
7 LAUREN FORSYTHE, PharmD, DICVP, FSVHP Clinical Veterinary pharmacist at the University of California Davis Veterinary Medical Teaching Hospital Completed Doctor of Pharmacy degree at the University of Findlay, College of Pharmacy Completed a residency in Veterinary Pharmacy at the Purdue Veterinary Teaching Hospital Associate editor of Plumb s Veterinary Drug Handbook Research interests include behavioral therapy in cats and safety and efficacy of compounded products for veterinary patients. Disclosure: Associate Editor, Plumb s Veterinary Drug Handbook. 7
8 LEARNING OBJECTIVES PHARMACISTS 1. Explain when compounding is appropriate for animal patients. 2. Identify appropriate ingredients for use in veterinary compounds. 3. Review potential pitfalls with medications commonly compounded for veterinary patients. 4. Consider ways to improve veterinarian-pharmacist relationships. 8
9 LEARNING OBJECTIVES PHARMACY TECHNICIANS 1. Explain when compounding is appropriate for animal patients. 2. Identify appropriate ingredients for use in veterinary compounds. 3. Review potential pitfalls with medications commonly compounded for veterinary patients. 4. Consider ways to improve veterinarian-pharmacist relationships. 9
10 OUTLINE Compounding regulations What do the studies say? How do we respond to studies? Safety concerns and toxicities Transdermal medications Working with veterinarians 10
11 COMPOUNDING REGULATIONS: Strict legal framework or wild west? 11
12 REGULATORY TIMELINE AMDUCA Legalized ELDU in certain situations FD&C Act Amended to include veterinary medications 2013 DQSA Addressed office use for humans Separate pharmacy categories 12
13 FOOD, DRUG, AND COSMETIC ACT (FD&C) Established requirement of safety for human medications in 1938 Amended in 1968 to include veterinary medications Drugs were unsafe unless FDA approved All ELDU became illegal 1968 FD&C Act Amended to include veterinary medications 13
14 FOOD, DRUG, AND COSMETIC ACT (FD&C) Note to Self: Only Use Drugs Per Label Species Indication Route Dose Frequency Duration 1968 FD&C Act Amended to include veterinary medications 13
15 ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT (AMDUCA) Legalized Extra-label drug use (ELDU) in certain situations Legalized compounding but not from bulk chemicals Food animal and non-food animal algorithms AMDUCA Legalized ELDU in certain situations
16 FOOD ANIMALS Drug used as labeled ELDU prohibited for certain medications! Food animal drug used extra Extended withdrawal time Non-food animal or human drug used extra-label Compound AMDUCA Legalized ELDU in certain situations
17 NON-FOOD ANIMALS Cost is NOT a valid reason Compound Drug used as labeled or identical human drug Cost is a valid reason Human or animal drug used extralabel AMDUCA Legalized ELDU in certain situations
18 PERFORMANCE ANIMALS Legal to compound for performance animals Caution when compounding because of drug testing If compound contains more than stated on the label, a positive drug test may occur 18
19 DRUG QUALITY AND SECURITY ACT (DQSA) Created in response to Meningitis outbreak Created 503B/outsourcing facilities Office use compounds can only come from 503B pharmacies Excludes animal patients! 2013 DQSA Addressed office use for humans Separate pharmacy categories 19
20 DQSA PHARMACY 503A PHARMACY Traditional compounding pharmacy Patient-specific prescriptions Follows USP Non-sterile and sterile compounding Overseen by State Board of Pharmacy 503B PHARMACY Outsourcing facility Non-patient specific Follows cgmp Sterile compounding Overseen by FDA 2013 DQSA Addressed office use for humans Separate pharmacy categories 20
21 COMPOUNDING FROM BULK CHEMICALS FDA maintains that this is illegal Certain compounds require the use of bulk chemicals Dosage forms adversely affected by excipients Drugs non-commercially available Drug shortages 21
22 COMPOUNDING FROM BULK CHEMICALS FDA maintains that this is illegal Certain compounds require the use of bulk chemicals Dosage forms adversely affected by excipients Drugs non-commercially available Drug shortages 22
23 CPG Developed shortly after AMDUCA Modified in early 2000s Obsolete in May 2015 Draft GFI #230 Released May 2015 Comment period Removed November 2017??? 23
24 OFFICE USE Compounding regulated by the states Office-use compounding questions arise AVMA website summarizes state requirements AVMA supports dispensing a 120 hours supply meningitis outbreak Drug Quality and Security Act (DQSA) gave FDA more oversight 24
25 Does USP <800> Apply to Veterinary Compounding? Yes! All USP <800> requirements for handling hazardous drugs apply regardless of whether compounding for humans or animals Veterinary drugs are not considered for NIOSH inclusion must consider whether they are similar to NIOSH drugs and therefore, warrant inclusion. 25
26 CANADIAN SPECIFICS Approved veterinary drug (DIN): Label instructions Approved veterinary drug (DIN): Extra-label drug use (ELDU) Approved human drug (DIN): ELDU Compounding product: From approved drug: ELDU Compounded product: From API: ELDU 26
27 CANADIAN SPECIFICS Compounders must report annual sales data for all medically important antimicrobials (List A) sold for veterinary use. Data collected throughout 2018 Reported between January 1 and March 31, 2019 List A: Additional information: 27
28 AUSTRALIAN SPECIFICS 28
29 AUSTRALIAN SPECIFICS Excerpt from the AVA Guidelines to the preparation and use of compounded pharmaceuticals choosing a compounded medication over an available registered product on the basis of price along should only occur where: 1. The veterinarian has recommended the registered product in the first instance, making no mention of the cheaper compounded alternative. Versus 2. The patient s animal owner has then refused treatment with the registered product on the basis of price; and 3. The veterinarian has then clearly confirmed that the sole or dominant reason for the owner s refusal is that the registered product is not affordable for that owner on that occasion Australian Journal of Pharmacy Online Version published 1 st of March
30 WHAT DO THE STUDIES SAY? 30
31 EXPERIMENTAL FINDINGS CONCENTRATION Burton, et al. 2016: Potency of lomustine capsules from 5 pharmacies found to range from % with only one being within +/- 10% Burton, et al. 2017: Chemotherapy agents from five pharmacies % variation for chlorambucil % variation for melphalan % variation for cyclophosphamide 31
32 EXPERIMENTAL FINDINGS STABILITY Papich, et al. 2013: Doxycycline suspension lacked stability after 7 days 32
33 EXPERIMENTAL FINDINGS EFFICACY Cook, et al. 2012: Trilostane dissolution in compounded products was lower than with commercial Mawby, et al and 2018: Compounded itraconazole is not as effective as commercially available itraconazole for dogs and cats Merritt, et al and Nieto, et al. 2002: Compounded omeprazole paste is not as effective as the commercial product for horses Pimobendan?? 33
34 HOW DO WE RESPOND TO STUDIES? 34
35 SUPPORTING EVIDENCE Base compounds on studies showing efficacy Have references on hand specific to veterinary safety and efficacy Use conservative beyond-use dates 35
36 STABILITY STUDIES Can be used to extend the BUD beyond USP guidelines Must be performed using a validated method with forced degradation Allows the analyte and degradant(s) to be fully resolved on HPLC Much more expensive than strength over time studies Published stability studies and USP monographs can be used Putting medications into oil can extend the BUD legally, but may not be a good idea clinically 36
37 POTENCY OF A SINGLE ANALYTE 6 37
38 FULLY RESOLVED PEAKS STABILITY INDICATING 6 38
39 SAFETY CONCERNS and TOXICITIES 39
40 CANINE COMPANIONS Limited acetylation ABCB1 (MDR1) Mutation Ivermectin Acepromazine Butorphanol Loperamide Erythromycin NSAIDs Isoniazid Sulfonamides Hydralazine Efficient Bile Excretors Estrogen (estriol) Opportunistic Gorgers 40
41 FICKLE FELINES Lack/poorly express UDP-glucouronyl transferase isoforms No glucuronide conjugation/ poor conjugation -OH -COOH -NH 2 -NH -SH Limited demethylation Primidone Chloramphenicol Acetaminophen Phenozypyridine NSAIDs Plant-derived medications Limited hydroxylation Phenytoin Barbiturates Warfarin Finicky picnickers Grooming 41
42 XYLITOL Toxic threshold: 100 mg/kg for dogs Symptoms: Vomiting, hypoglycemia, loss of appetite Concerns: hyperinsulinemia and hepatic necrosis Products to watch for: Oral suspensions, ODT tablets, gum, low carb products, toothpaste, dental rinses Amount in product not required to be listed 42
43 POLYSORBATE 80 (TWEEN 80) Solubilizing agent Non-immune anaphylactic reaction due to histamine release and complement cascade activation Well documented post IV administration; unclear post PO 43
44 AZO DYES Metabolized to 2 toxic products rhabdomyolysis, kidney damage, methemoglobinemia, hepatotoxicity, and death Use vitamins (i.e. cyanocobalamin) instead 44
45 BENZENE RINGS Toxic Threshold: 200 mg/kg/day Symptoms: ataxia, blindness, aggression, coma, convulsions, respiratory failure Products to watch for: Benzyl alcohol and benzoic acid Metronidazole benzoate??? Glucuronide Conjugate Benzyl Alcohol Benzoic Acid Glycine Conjugate 45
46 THE METRONIDAZOLE QUESTION Metronidazole approved in US as HCl salt BAD taste! Metronidazole benzoate: mg/kg q12 to 24 hours Toxic dose: 200 mg/kg/day toxicity unlikely Normal hepatic and renal function 46
47 TRANSDERMAL MEDICATIONS 47
48 ADVANTAGES Reduction of first pass metabolism Non-invasive Avoid gastric route Decreased degradation Decreased gastric irritation Improved owner compliance 48
49 DISADVANTAGES Unknown bioavailability Potential variability between dose and response between individuals Potential for adverse reactions from vehicle Unknown long-term stability of formulation 49
50 EVIDENCE OF DRUG ABSORPTION Measurable blood levels of the drug Detectable excretion of the drug and/or its metabolites in the urine Clinical response of the patient to the therapy 50
51 AVAILABLE RESEARCH Amitriptyline Amlodipine Atenolol Buspirone Cyclosporine Dexamethasone Enrofloxacin Fluoxetine Glipizide Methimazole Mirtazapine commercially available Ondansetron Phenobarbital Theophylline 51
52 DRUGS TO AVOID Drug Class Reason to Avoid Antibiotics Cytotoxic medications Photosensitizing agents Diagnostic agents Medications exerting their effect in the GI tract Medications toxic to humans Prodrugs metabolized by gut enzymes Medications requiring dosages > 25mg Likely to lead to resistance and lack of efficacy due to low blood levels Unnecessary risk to caregiver and likely to cause damage to the ear Exposure to sunlight (outside or through a window) may cause irritation Unpredictable absorption will affect test results Medication will not reach site of action Unnecessary risk to caregiver Medication will not be metabolized to active form Maximal absorption based on surface area of the ear is 25mg 52
53 DRUGS TO USE CAUTIOUSLY Drug Class Reason to Avoid Corticosteroids Irritating medications Narrow therapeutic index Likely to cause cartilage atrophy if used long term May cause irritation to the ear Unpredictable absorption may lead to ineffective or toxic drug levels 53
54 WORKING WITH VETERINARIANS 54
55 LAUREN S TOP 10 LIST 1. Call with questions/ Don t assume 2. Provide studies to support formulations 3. Stand firm on formulations that are not a good idea clinically (i.e. transdermal antibiotics) 4. Have a veterinary reference handy 5. Take time to explain why you can t do something (i.e. legal, safety, efficacy, etc.) 55
56 LAUREN S TOP 10 LIST 6. Develop relationships with local vet clinics 7. Provide options/suggest dosage forms for difficult patients 8. If requested formulation doesn t work, suggest other options 9. Think outside the box, but stay within the law and efficacy evidence 10.Develop a network of resources that you can call upon with questions. 56
57 REFERENCES 1. Burton, J.H., Stanley, S.D., Knych, H.K., et al. J Vet Intern Med 2016;30(1): Burton, J.H., Kynch, H.K., Stanley, S.D., et al. Vet Comp Oncol 2017: Papich, M.G., Davidson, G.S., Fortier, L.A. JAVMA 2013;242(12): Merritt, A.M., et al. Equine Vet J 2003;35(7): Nieto, J.E., et al. JAVMA 2002;221(8): USP Compounding Expert Committee, et al. Strength and Stability Testing for Compounded Preparations. Published 13 Jan Davidson, G. To benzoate or not to benzoate: cats are the question. IJPC; 5(2): Court MH. Feline drug metabolism and disposition: pharmacokinetic evidence for species differences and molecular mechanisms. Vet Clin North Am Small Anim Pract. 2013;43(5): Rost, E. What lies beneath: potentially harmful excipients to avoid when compounding for small animals a note of caution. IJPC; 20(6): Peterson, M.E. Topical Review: Xylitol. Topics in Compan An Med; 28:
58 Lauren Eichstadt Forsythe, PharmD, DICVP, FSVHP UC Davis Veterinary Medical Teaching Hospital 58
59 TRACKING CODE WCC2018VET 59
60 THANK YOU FOR LISTENING ANY QUESTIONS? 60
Proceedings of the 56th Annual Convention of the American Association of Equine Practitioners - AAEP -
http://www.ivis.org Proceedings of the 56th Annual Convention of the American Association of Equine Practitioners - AAEP - December 4-8, 2010 Baltimore, Maryland, USA Next Meeting : Nov. 18-22, 2011 -
More informationVeterinary Pharmacy Issues
KPhA s 133 rd Annual Meeting and Trade Show KPhA s 133 rd Annual Meeting and Trade Show Be the Critical Link DoubleTree by Hilton Hotel Overland Park, Kansas Veterinary Pharmacy Issues September 21, 2013
More informationVeterinary Pharmacy An Introduction Jennifer A. Kelleher, PharmD, BCPS, FSVHP Compounding Pharmacist
Veterinary Pharmacy An Introduction Jennifer A. Kelleher, PharmD, BCPS, FSVHP Compounding Pharmacist IVG Veterinary Compounding Pharmacy Massachusetts Veterinary Referral Hospital - Woburn, MA Disclosure
More informationGUIDE TO THE PROFESSIONAL PRACTICE STANDARD
GUIDE TO THE PROFESSIONAL PRACTICE STANDARD Use of Compounded Products in Veterinary Practice Published: December 2014 Introduction The College s Professional Practice Standard: Use of Compounded Products
More informationOctober 10, 2014 MEMORANDUM
L A W O F F I C E S 7 0 0 T H I R T E E N T H S T R E E T, N. W. S U I T E 1 2 0 0 W A S H I N G T O N, D. C. 2 0 0 0 5-5929 ( 2 0 2 ) 7 3 7-5600 F A C S I M I L E ( 2 0 2 ) 7 3 7-9329 w w w. h p m. c
More informationThe Top 10 Things You Should Know Before Filling Veterinary Prescriptions
The Top 10 Things You Should Know Before Filling Veterinary Prescriptions Gigi Davidson, BSPharm, Dipl.ICVP NC State University College of Veterinary Medicine Disclosure Gigi Davidson declare(s) no conflicts
More informationAmerican Veterinary Medical Association
AVMA American Veterinary Medical Association Governmental Relations Division 1910 Sunderland Place, NW Washington, DC 20036-1642 phone 202.789.0007 800.321.1473 fax 202.842.4360 AVMA Headquarters 1931
More informationPROFESSIONAL PRACTICE STANDARD
PROFESSIONAL PRACTICE STANDARD Dispensing Drugs TBD Introduction Under the Veterinarians Act and Regulations, veterinarians licensed by the College of Veterinarians of Ontario are authorized to engage
More informationRegulatory Framework for the Availability and Use of Animal Drugs in the United States
Regulatory Framework for the Availability and Use of Animal Drugs in the United States Sanja Modric, DVM, PhD KEYWORDS Drug approval process Approved versus unapproved drugs Regulatory Safety KEY POINTS
More informationThe College of Veterinarians of Ontario. Guidelines. for the Compounding of Veterinary Drugs
The College of Veterinarians of Ontario Guidelines for the Compounding of Veterinary Drugs GUIDELINES Compounding of Veterinary Drugs Approved by Council: September 26, 2007 Publication Date: Website September
More informationVeterinary. Kevin Oberlander, RPh Deborah Clark, RPh Chris Simmons, RPh International Seminar Houston, TX November 10 12, 2016
Veterinary Kevin Oberlander, RPh Deborah Clark, RPh Chris Simmons, RPh International Seminar Houston, TX November 10 12, 2016 2016. All Rights Reserved. 1 Building Relationships with Veterinarians Kevin
More informationAmerican Association of Feline Practitioners American Animal Hospital Association
American Association of Feline Practitioners American Animal Hospital Association Basic Guidelines of Judicious Therapeutic Use of Antimicrobials August 1, 2006 Introduction The Basic Guidelines to Judicious
More information2/21/2017. Doctor of Veterinary Medicine (DVM) Veterinary Medical Doctorate (VMD) Board Specialties. Technicians
We agree that we have no conflicts of interest in this presentation. We also agree that there is no commercial bias related to this continuing education course. Discuss the role of veterinarians, their
More informationARCI Controlled Therapeutic Medication Schedule for Horses - Version 4.1 Revised January, 2019
ARCI Schedule for Horses - Version 4.1 Revised January, 2019 Acepromazine 10 nanograms per milliliter as 2-(1- hydroxyethyl) promazine sulfoxide (HEPS) in urine Single intravenous dose of acepromazine
More informationCOMPOUNDING REGULATORY PERSPECTIVE
COMPOUNDING REGULATORY PERSPECTIVE Janice Steinschneider Supervisory Regulatory Counsel Office of Surveillance & Compliance FDA/Center for Veterinary Medicine USP Veterinary Drugs Stakeholder Forum November
More informationTHE IMPORTANCE OF QUALITY IN COMPOUNDED VETERINARY MEDICINES
THE IMPORTANCE OF QUALITY IN COMPOUNDED VETERINARY MEDICINES GOOD MANUFACTURING PRACTICES On the 12th of June 2015 Bova was the first pharmacy in Australia to be granted a licence to manufacture veterinary
More informationUPDATE ON THE ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 REGULATIONS FOR WILDLIFE VETERINARIANS
UPDATE ON THE ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 REGULATIONS FOR WILDLIFE VETERINARIANS Mark L. Drew, D VM Department of Large Animal Medicine and Surgery, College of Veterinary Medicine,
More informationTHE ADVANTAGES OF cgmp Manufactured Veterinary Drugs
THE ADVANTAGES OF cgmp Manufactured Veterinary Drugs VS Compounded Drugs - WHY IT MATTERS Educational content provided by: 8809 Ely Rd, Pensacola, FL 32514 (850) 476-9462 www.prnpharmacal.com Veterinary
More informationPrescription Label. Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long):
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided
More informationGuidelines for the preparation and use of compounded pharmaceuticals
Australian Veterinary Association Ltd Guidelines for the preparation and use of compounded pharmaceuticals Introduction These guidelines have been produced to assist members in making informed decisions
More informationPrescription Label. Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long):
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided
More informationUNAPPROVED VETERINARY DRUGS
UNAPPROVED VETERINARY DRUGS Janice Steinschneider Supervisory Regulatory Counsel Office of Surveillance & Compliance FDA/Center for Veterinary Medicine USP Veterinary Drugs Stakeholder Forum February 20,
More informationARCI Controlled Therapeutic Medication Schedule for Horses - Version 3.2 Revised December 9, 2016.
ARCI Schedule for Horses - Version 3.2 Revised December 9, 2016. Acepromazine 10 nanograms per milliliter as 2-(1- hydroxyethyl) promazine sulfoxide (HEPS) in urine Single intravenous dose of acepromazine
More informationVeterinary Drugs Stakeholder Forum Meeting 1 - Summary
Veterinary Drugs Stakeholder Forum Meeting 1 - Summary Sanja Modric, D.V.M., Ph.D., Chair j,,, FDA Center for Veterinary Medicine Wrap Up Session Friday, November 9, 2012 Organization Overviews FDA Center
More informationMitigating Pain in Livestock: What Options are Available
Mitigating Pain in Livestock: What Options are Available NIAA 2014 Annual Conference Omaha, Nebraska April 2, 2014 Craig A. Lewis, DVM, MPH, DACVPM Center for Veterinary Medicine U.S. Food and Drug Administration,
More informationBeekeeping for the Future Duane Landals B.Sc.Ag. DVM Senior Advisor Alberta Veterinary Medical Association
Beekeeping for the Future 2017 Duane Landals B.Sc.Ag. DVM Senior Advisor Alberta Veterinary Medical Association Antibiotic Use In Beekeeping Part 3 Antimicrobial Use Culture Shift: the Impact on Beekeepers
More informationEducational materials development supported by a grant from the Community Pharmacy Foundation.
U.S. vs Franck s Lab 2012 and 2013 surveys conducted by 5 state Veterinary Medical Associations 5 : - 1/3 DVMs knew of a dispensing error that occurred at a community pharmacy - 1/10 reported the error
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 500 mg tablets for dogs and cats (AT, BE, BG, CY, CZ, DE, EL, ES, FR, HR, HU, IE, IT, LU, NL, PL, PT, RO, SI,
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 250 mg tablets for dogs and cats (AT, BE, BG, CY, CZ, DE, EL, ES, FR, HR, HU, IE, IT, LU, NL, PT, RO,
More informationARCI Controlled Therapeutic Medication Schedule for Horses - Version 2.2 Revised April 2015
ARCI Schedule for Horses - Version 2.2 Revised April 2015 Acepromazine 10 nanograms per milliliter as 2-(1- hydroxyethyl) promazine sulfoxide (HEPS) in urine Single intravenous dose of acepromazine at
More informationEquine Pharmaceuticals: Manufacturing/ Compounding Issues. Legal and Ethical Veterinary Compounding. Horse Industry Integrity
Equine Chemistry Research Legal and Ethical Veterinary Compounding Scott D. Stanley, Ph.D., Professor University of California, Davis School of Veterinary Medicine Drug Detection Determination, Identification,
More informationPrescription Label. Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long):
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided
More informationSUMMARY OF PRODUCT CHARACTERISTICS
[Version 8, 10/2012] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS (Based on the current SPC of the reference product Baytril RSI 100 mg/ml Injektionslösung für Rinder und Schweine) 1 1. NAME OF THE VETERINARY
More informationIntroduction to Canine and Feline Dispensing
SCSHP 2014 Annual Meeting Introduction to Canine and Feline Dispensing Clay Sprouse, BA, CPhT Piedmont Technical College A house is not a home without a pet. Unknown Animals are such agreeable friends
More informationMetacam 1.5 mg/ml oral suspension for dogs
Metacam 1.5 mg/ml oral suspension for dogs Species:Dogs Therapeutic indication:pharmaceuticals: Neurological preparations: Analgesics, Other NSAIDs, Locomotor (including navicular and osteoarthritis) Active
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RONAXAN 20mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance : Doxycycline (as doxycycline
More informationSnapshot Current Vet Drugs AMR Initiatives
Snapshot Current Vet Drugs AMR Initiatives These regulatory and policy initiatives are interconnected and mutually supportive: 1) Increasing oversight on importation of veterinary drugs (Personal Use Importation)
More informationHuman Food Safety of Veterinary Drugs. Bettye K. Walters, DVM
Human Food Safety of Veterinary Drugs Bettye K. Walters, DVM Bettye.walters@fda.hhs.gov Pertinent International Resources Organization for Economic Co-Operation and Development (OECD) Understanding the
More information1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Summary of Prodcuct Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrox Max 100 mg/ml Solution for Injection for Cattle and Pigs Enroxal Max 100 mg/ml Solution for Injection for Cattle and
More informationBASICS OF VETERINARY COMPOUNDING Presented By: Stephanie Montoya, MBA, BS, CPhT.
BASICS OF VETERINARY COMPOUNDING Presented By: Stephanie Montoya, MBA, BS, CPhT. Review veterinary pharmacology List compounding Guidelines (USP 795) OBJECTIVES Choose appropriate equipment and supplies
More informationResidues. Mike Apley, DVM, PhD
Residues Mike Apley, DVM, PhD Residues: It s Black and White Residues occur when detected concentrations of the marker residue are above the approved tolerance for that drug in that tissue. Residues are
More informationYOUR COMPLETE SOURCE FOR MEDICAL MISSIONS SUPPLIES.
YOUR COMPLETE SOURCE FOR MEDICAL MISSIONS SUPPLIES. When disasters strike, Blessings International provides pharmaceuticals and medical supplies quickly, so you can bring healing to the hurting. Where
More informationDosing Your Cat with Azithromycin Pediatric Suspension. By Lorraine Shelton
Dosing Your Cat with Azithromycin Pediatric Suspension By Lorraine Shelton To join a community of cat fanciers and health professionals interested in cattery related health issues, visit http://groups.yahoo.com/group/fanciershealth
More informationPrescription Label. Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long):
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided
More informationScientific Discussion post-authorisation update for Rheumocam extension X/007
5 May 2011 EMA/170257/2011 Veterinary Medicines and Product Data Management Scientific Discussion post-authorisation update for Rheumocam extension X/007 Scope of extension: addition of 20 mg/ml solution
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Rycarfa 100 mg tablets for dogs (BE, DE, ES, FR, IE, IT, NL, PT, UK) Rycarfa vet 100 mg tablets for dogs (DK, FI) Carprox
More informationUSA Product Label CLINTABS TABLETS. Virbac. brand of clindamycin hydrochloride tablets. ANADA # , Approved by FDA DESCRIPTION
VIRBAC CORPORATION USA Product Label http://www.vetdepot.com P.O. BOX 162059, FORT WORTH, TX, 76161 Telephone: 817-831-5030 Order Desk: 800-338-3659 Fax: 817-831-8327 Website: www.virbacvet.com CLINTABS
More informationappropriate healthcare professionals employed at my pharmacy. I understand that I am
Patient Group Direction: For the supply of Silver Sulfadiazine 1% Cream by Community Pharmacists in Somerset to patients for the topical treatment of minor localised impetigo under the Somerset Minor Ailments
More informationALPHABETICAL REFERENCE GUIDE
ACEPROMAZINE ACETAZOLAMIDE ALBUTEROL SULFATE ALENDRONATE ALLOPURINOL ALUMINUM HYDROXIDE AMANTADINE AMINOCAPROIC ACID AMINOPHYLLINE AMITRIPTYLINE AMITRIPTYLINE/PREDNISOLONE COMBINATION AMLODIPINE AMLODIPINE/BENAZEPRIL
More informationMedically Important Antimicrobials in Animal Agriculture. Sheep
Medically Important Antimicrobials in Animal Agriculture Sheep Mike Murphy DVM, JD, Ph.D., DABVT, DABT Veterinary Medical Officer Office of the Director Center for Veterinary Medicine FDA Outline Take
More informationTHIS ARTICLE IS SPONSORED BY THE MINNESOTA DAIRY HEALTH CONFERENCE.
THIS ARTICLE IS SPONSORED BY THE MINNESOTA DAIRY HEALTH CONFERENCE. ST. PAUL, MINNESOTA UNITED STATES OF MINNESOTA Responsible Drug Use: Has the Regulatory Cloud Been Lifted? M. Gatz Riddell, Jr. Auburn
More informationYOUR COMPLETE SOURCE FOR MEDICAL MISSIONS SUPPLIES.
YOUR COMPLETE SOURCE FOR MEDICAL MISSIONS SUPPLIES. When disasters strike, Blessings International provides pharmaceuticals and medical supplies quickly, so you can bring healing to the hurting. Where
More informationAntibiotics use and Considerations: Calves and Heifers CLASSIFICATION OF CALVES. Danielle A. Mzyk TITLE 24 PT. ARIAL BOLD ALL CAPS
CALF AND HEIFER CONGRESS - 2016 Antibiotics use and Considerations: Calves and Heifers Danielle A. Mzyk TITLE 24 PT. ARIAL BOLD ALL CAPS Today s Presentation Classification of Calves Define Preruminant
More informationWITHDRAWAL TIME RECOMMENDATIONS ARIZONA RACE TRACKS MEET
WITHDRAWAL TIME RECOMMENDATIONS ARIZONA RACE TRACKS 2018-19 MEET IMPORTANT WARNING: The information on drug withdrawal times does not constitute and is not a warranty, guarantee, assurance, undertaking,
More informationSession 1: An introduction to the new requirements under the Food and Drug Regulations affecting industry and health care practitioners who compound
Session 1: An introduction to the new requirements under the Food and Drug Regulations affecting industry and health care practitioners who compound veterinary drugs February 13, 2018 Webinar Presentation
More informationAMR in Codex Alimentarius Commission and country responsibilities
FMM/RAS/298: Strengthening capacities, policies and national action plans on prudent and responsible use of antimicrobials in fisheries Final Workshop in cooperation with AVA Singapore and INFOFISH 12-14
More information1 January 2017, It is Coming Preparation for VFD Changes Beginning 1 January 2017
1 January 2017, It is Coming Preparation for VFD Changes Beginning 1 January 2017 ASM-00007 1 CHAPTERS Background: Food and Drug Administration (FDA) guidance documents Introduction: Veterinary Feed Directive
More informationPrescription Label. Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long):
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided
More informationCenter for Veterinary
Center for Veterinary Medicine: Overview Sanja Modric, DVM, PhD Office of New Animal Drug Evaluation Center for Veterinary Medicine i Food and Drug Administration USP Veterinary Stakeholder Forum, 11-09-2012
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amfipen LA 100 mg/ml suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each ml contains:
More informationISMP Canada HYDROmorphone Knowledge Assessment Survey
ISMP Canada HYDROmorphone Knowledge Assessment Survey Knowledge Assessment Questions 1. In an equipotent dose, HYDROmorphone is more potent than morphine. True False Unsure 2. HYDROmorphone can be given
More informationMetacam. The Only NSAID Approved for Cats in the US. John G. Pantalo, VMD Professional Services Veterinarian. Think easy. Think cat. Think METACAM.
Metacam The Only NSAID Approved for Cats in the US John G. Pantalo, VMD Professional Services Veterinarian Think easy. Think cat. Think METACAM. Today s Agenda New pain management guidelines for cats Only
More informationSUMMARY OF PRODUCT CHARACTERISTICS. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Emdocam 20 mg/ml solution for injection for cattle, pigs and horses
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Emdocam 20 mg/ml solution for injection for cattle, pigs and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
More informationOptimizing Antimicrobial Stewardship Activities Based on Institutional Resources
Optimizing Antimicrobial Stewardship Activities Based on Institutional Resources Andrew Hunter, PharmD, BCPS Infectious Diseases Clinical Pharmacy Specialist Michael E. DeBakey VA Medical Center Andrew.hunter@va.gov
More informationCHAPTER:1 THE RATIONAL USE OF ANTIBIOTICS. BY Mrs. K.SHAILAJA., M. PHARM., LECTURER DEPT OF PHARMACY PRACTICE, SRM COLLEGE OF PHARMACY
CHAPTER:1 THE RATIONAL USE OF ANTIBIOTICS BY Mrs. K.SHAILAJA., M. PHARM., LECTURER DEPT OF PHARMACY PRACTICE, SRM COLLEGE OF PHARMACY Antibiotics One of the most commonly used group of drugs In USA 23
More informationBeef Producers. The Judicious Use of Antimicrobials for
The Judicious Use of Antimicrobials for Beef Producers Introduction The production of safe and wholesome animal products for human consumption is a primary goal of beef producers. To achieve that goal,
More informationNew Maryland Racing Medication Guidelines
New Maryland Racing Medication Guidelines January 1, 2014 NEW MEDICATION REFORMS EFFECTIVE JANUARY 1, 2014 The Mid Atlantic racing states have joined together to implement a uniform medication and drug
More informationMeloxicam withdrawal time veterinarian bovine
Meloxicam withdrawal time veterinarian bovine The Borg System is 100 % Meloxicam withdrawal time veterinarian bovine Meloxicam Pain Relief in Cows and Calves. Meloxicam meat and milk withdrawal the standard
More informationANNEX III LABELLING AND PACKAGE LEAFLET
ANNEX III LABELLING AND PACKAGE LEAFLET 1 A. LABELLING 2 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE Card box and package leaflet for brown glass bottle (Type 1) 1. NAME OF THE
More informationNon-steroidal anti-inflammatory drugs (NSAIDs) are used widely to relieve pain, with or without
May 2013 Contents About NSAIDs What about COXselectivity? How effective are NSAIDs? Adverse effects of NSAIDs How frequent are the adverse effects of NSAIDs? General prescribing guidelines for NSAIDs What
More informationThe Changing Veterinary Pharmaceutical Landscape
The Changing Veterinary Pharmaceutical Landscape Dan Grooms DVM, PhD Michigan State University College of Veterinary Medicine The use of pharmaceutical products in food animals is under close scrutiny
More informationFor Alberta broiler producers, the biggest impacts will be:
Changes to Health Canada s Prescription Drug List: Getting Ready for Changes in Veterinary Oversight Requirements On December 1, 2018 prescription requirements for medically important antimicrobials come
More informationمادة االدوية المرحلة الثالثة م. غدير حاتم محمد
م. مادة االدوية المرحلة الثالثة م. غدير حاتم محمد 2017-2016 ANTIMICROBIAL DRUGS Antimicrobial drugs Lecture 1 Antimicrobial Drugs Chemotherapy: The use of drugs to treat a disease. Antimicrobial drugs:
More informationPHARMACIST CLINICIAN:
16.19.4.17 PHARMACIST CLINICIAN: D. Prescriptive authority, guidelines or protocol: (1) Only a registered pharmacist clinician with current protocols, registered with the New Mexico medical board or the
More informationTEACHERS TOPICS A Lecture About Pharmaceuticals Used in Animal Patients
TEACHERS TOPICS A Lecture About Pharmaceuticals Used in Animal Patients Elaine Blythe Lust, PharmD School of Pharmacy and Health Professions, Creighton University Submitted October 30, 2008; accepted January
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HALOCUR 0.5 mg/ml oral solution for calves 2. Qualitative and quantitative composition Active substance Halofuginone
More informationUSA Product Label LINCOCIN. brand of lincomycin hydrochloride tablets. brand of lincomycin hydrochloride injection, USP. For Use in Animals Only
USA Product Label http://www.vetdepot.com PHARMACIA & UPJOHN COMPANY Division of Pfizer Inc. Distributed by PFIZER INC. 235 E. 42ND ST., NEW YORK, NY, 10017 Telephone: 269-833-4000 Fax: 616-833-4077 Customer
More informationAgvet Chemicals Task Group Veterinary Prescribing and Compounding Rights Working Group
Agvet Chemicals Task Group Veterinary Prescribing and Compounding Rights Working Group Submission from the Australian Veterinary Association Ltd www.ava.com.au The Australian Veterinary Association Limited
More informationHost, Syndrome, Bug, Drug: Introducing 2 Frameworks to Approach Infectious Diseases Cases with an Antimicrobial Stewardship Focus
Host, Syndrome, Bug, Drug: Introducing 2 Frameworks to Approach Infectious Diseases Cases with an Antimicrobial Stewardship Focus Montana ACP Meeting 2018 September 8, 2018 Staci Lee, MD, MEHP Billings
More informationPrescription Label. Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long):
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided
More information[Version 8.1, 01/2017]
[Version 8.1, 01/2017] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERADIA 125 mg/ml oral suspension for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each
More informationCHAPTER 1 Introduction
Table of Contents Dispensing Manual for Veterinarians CHAPTER 1 Introduction LEGISLATION... 1-2 Federal... 1-2 Provincial... 1-2 HAZARDOUS MATERIALS (WHMIS) LABELING REQUIREMENTS... 1-4 EXTRA-LABEL DRUG
More informationApproved by the Food Safety Commission on September 30, 2004
Approved by the Food Safety Commission on September 30, 2004 Assessment guideline for the Effect of Food on Human Health Regarding Antimicrobial- Resistant Bacteria Selected by Antimicrobial Use in Food
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Animeloxan 1.5 mg/ml oral suspension for dogs. Active substance: Meloxicam 1.5 mg (equivalent to 0.
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Animeloxan 1.5 mg/ml oral suspension for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of suspension contains:
More informationDiscover the. Discover the. innovative science. Veraflox (pradofloxacin) Veraflox. Efficacy. Safety. Ease-of-use.
Discover the Discover the innovative science. science of Veraflox Oral Veraflox. Suspension for Cats Efficacy. Safety. Ease-of-use. An unprecedented combination of efficacy, safety and ease-of-use. Designed
More informationPrescription Label. Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long):
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided
More informationPrecision Compounding - Nationwide. The Stokes Difference
TM Precision Compounding - Nationwide. p: 800-754-5222 f: 800-440-5899 w: stokespharmacy.com REDEFINING QUALITY The Stokes Difference Specialties Dosage Forms Injectables Medi-Turn Transdermal Pens Petibles
More informationLivestock Quality Assurance Education for Youth Producers 2017
Livestock Quality Assurance Education for Youth Producers 2017 As a Livestock Producer: You have an important and responsible role in food production and food safety. You are visible; you are the face
More informationPrescription Label. Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long):
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided
More informationPART 530 EXTRALABEL DRUG USE IN ANIMALS
529.2503 (c) Conditions of use (1) Amount. 6 grams per day, intrauterine, for 3 consecutive days during estrus. (2) Indications for use. Horses. Intrauterine treatment of endometritis caused by beta-hemolytic
More informationPrescription Label. Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long):
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided
More informationBaytril 100 (enrofloxacin) Injectable is FDA-approved for BRD control (metaphylaxis) in high-risk cattle.
Baytril 100 (enrofloxacin) Injectable is FDA-approved for BRD control (metaphylaxis) in high-risk cattle. Whether controlling or treating BRD, it s important to kill bacteria to let the calf s immune system
More informationGuidance for Industry
Guidance for Industry #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors
More informationWhat Veterinarians Should Tell Clients About Pain Control and Their Pets
What Veterinarians Should Tell Clients About Pain Control and Their Pets by Michele Sharkey, DVM, MS, Office of New Animal Drug Evaluation; Margarita Brown, DVM MS, Office of Surveillance and Compliance;
More informationChanges in Antibiotic Labeling Veterinary Feed Directive. Changes in Antibiotic Regulations. Concerns with Antibiotic Use 2/29/2016
Changes in Antibiotic Labeling Veterinary Feed Directive Craig A. Payne, DVM, MS Extension Veterinarian Commercial Agriculture Program University of Missouri Changes in Antibiotic Regulations How did we
More informationCME/CE QUIZ CME/CE QUESTIONS. a) 20% b) 22% c) 34% d) 35% b) Susceptible and resistant strains of typical respiratory
CME/CE QUIZ CME/CE QUESTIONS Continuing Medical Education Accreditation This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for
More informationLABELLING AND PACKAGE LEAFLET
LABELLING AND PACKAGE LEAFLET 1 A. LABELLING 2 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MILTEFORAN 20 mg/ml oral solution for dogs miltefosine 2.
More informationIndicated for the treatment of pruritus associated with allergic dermatitis and the clinical manifestations of atopic dermatitis in dogs.
Zoetis UK Limited Telephone: 0845 300 8034 Website: www.zoetis.co.uk Email: customersupportuk@zoetis.com Apoquel film-coated for dogs Species: Therapeutic indication: Active ingredient: Product: Product
More informationCommunity Acquired Pneumonia: An Update on Guidelines
Community Acquired Pneumonia: An Update on Guidelines Claudia Summa, BScPhm Pharmacy Resident September 12, 2006 Objectives To give a brief description of the pathophysiology of community acquired pneumonia
More information