Snapshot Current Vet Drugs AMR Initiatives

Transcription

1 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) new regulatory amendment 2) Facilitating access to low risk veterinary health products, as additional tools for the maintenance of animal health and welfare new regulatory amendment and existing policy tools 3) Increasing oversight on importation and quality of veterinary active pharmaceutical ingredients new regulatory amendment 4) Reporting veterinary antimicrobial sales volume from manufacturers, importers and compounders to support surveillance new regulatory amendment 5) Removing growth promotion claims from medically-important antimicrobials (MIAs) policy under existing regulatory tools 6) Switch from Over-the-Counter to Prescription status for all MIAs used in agriculture policy under existing regulatory tools 25

2 1) Oversight on Importation of vet drugs (1 of 2) Regulation Came into Force Nov 13, 2017 Health Canada has restricted personal importation (also known as own use importation) of veterinary drugs for food-producing animals or animals intended to be consumed as food (including horses). Under the new rules, no person can import a drug for use in food-producing animals unless it is approved in Canada or it appears on Health Canada s list incorporated by reference (List B). List B is a list of veterinary drugs not authorised for sale in Canada that are eligible to be imported for personal use in food producing animals. It can be found be found on Health Canada s website. Currently List B contains 23 veterinary drugs (approved in US, UK). 26

3 2) New Pathway for Veterinary Health Products (VHPs) (1 of 3) Regulation Came into Force November 13, 2017 Risk-based regulatory pathway to allow importation and sale of low risk Veterinary Health Products for use in animals, including food animals Veterinary Health Products are drugs in dosage form used to maintain or promote the health and welfare of animals (e.g. products that contain vitamins and minerals, botanicals, traditional medicines and homeopathics), but are not used to treat, prevent or cure disease Active, homeopathic and traditional medicine substances permitted in Veterinary Health Products are on Incorporated by Reference list List C: Veterinary Health Products. Important conditions are also on List C (e.g. route of administration, species, mandatory label statements and qualifiers) 27

4 2) New Pathway for Veterinary Health Products (VHPs) (3 of 3) Notification Program The Program is being administered by the Veterinary Drugs Directorate, and is similar in functionality to the pilot program ( including: Notification of VHPs (Notification Number issued once met all the conditions), Permitted Substances, Reporting of serious adverse events The Notification Program can be accessed through Health Canada s website: For In-Feed Products - Working with Canadian Food Inspection Agency in their efforts to modernize Canada s Feed Regulations. At this time, the Feed Regulations do not allow for the addition of non-din products to feeds The Program also permits users to submit a new Substance Application and permits the public and manufacturers (notifiers) to submit adverse reaction reports If you have any questions, contact HC by VHP-PSA@hc-sc.gc.ca 28

5 3) Oversight on Importation & Quality of Vet Active Pharmaceutical Ingredients (APIs) Regulation Coming into force May 17, 2018 (additional 14-month transition period ending July 17, 2019 to submit a Drug Establishment License (DEL) application) New regulatory requirements to manufacture all veterinary active pharmaceutical ingredients (APIs) according to Good Manufacturing Practices (GMPs) (formulated veterinary drugs already under GMPs) Persons who fabricate, import, package, label and test APIs for veterinary use to hold a Drug Establishment License (DEL) Pharmacists, veterinarians or those compounding a drug under the supervision of a licensed veterinarian to hold a DEL when importing medically important antimicrobials (MIAs) that are on Incorporated by Reference list List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients List A names certain antimicrobial APIs that are important in human medicine. List A includes antimicrobials that meet the categorization criteria (I, II, III) for MIAs or are fist in-class antimicrobial entities not yet categorized. These restrictions mean that importation of MIA APIs by food animal producers for their direct use in food animals is no longer allowed (effective Nov 13, 2017). 29

6 4) Reporting Veterinary Antimicrobial Sales Volume New Regulation Sales reports for medically important antimicrobials are required to be submitted every year to reflect data collected over the period of January 1 to December 31. The annual deadline to submit sales reports of the previous calendar year to Health Canada is March 31 of each year. The first reporting year is 2018 and sales reports will need to be submitted by March 31, Requires annual reports on the sale of veterinary antimicrobials considered important in human medicine that are on Incorporated by Reference list List A: List of Certain Antimicrobial Active Pharmaceuticals Manufacturers, importers and compounders to submit sales reports of drugs (final dosage form and API) on List A, including total quantity sold or compounded for veterinary use approximate quantity sold or compounded for each intended animal species Data gathered will support the surveillance pillar of the Federal Action Plan on AMR 30

7 5) Prudent use & Removal of Growth Promotion Claims Initiative Revised Labels to be on the market by December 1, 2018 To enhance responsible use of medically important antimicrobials (MIAs) in animals, Health Canada is working to phase out non-prudent uses i.e. for long-term non-therapeutic purposes (i.e. growth promotion and weight gain) No growth promotion claims approved for new MIAs post-2004 About 64 products are implicated Minimal impact on availability of treatment options Labels of all in-feed and in-water MIAs to include responsible use statements Labels of MIAs to also include responsible use logo. 31

8 Responsible Use Logo Canadian Animal Health Institute led initiative

9 6) Increasing Veterinary Oversight of all MIAs (1 of 5) Initiative Revised Labels to be on the market by December 1, 2018 To promote prudent use, Health Canada is moving all remaining medically important antimicrobials (MIAs) to prescription status (via the Prescription Drug List (PDL)), since supervision by a licensed veterinarian in treatment decisions is an important part of antimicrobial stewardship Since 2004, new MIAs approved by Health Canada have been included on the PDL and must be sold pursuant to a prescription; so with this proposal, there will be the same level of oversight for those remaining MIAs approved prior to 2004 All in-feed MIAs to be included in the Canadian Food Inspection Agency s Compendium of Medicating Ingredient Brochure, and require a Prescription (Pr) prior to sale for on-label products ~340+ products implicated in all dosage forms (with about 75 in-feed MIAs) Significant engagement with producer associations, CAHI, ANAC, provincial/territorial governments and the CVMA while these changes roll out. 33

10 6) Increasing Veterinary Oversight of all Medically Important Antimicrobials (MIAs) (2 of 5) Path Forward for In-feed Medications containing MIAs All approved in-feed drugs (including over-the-counter and prescription) to be included in the Canadian Food Inspection Agency s Canadian Medicating Ingredients Brochure (CMIB). A veterinary prescription will be required prior to sale when an MIA drug is mixed in livestock feed. There will be no restriction on manufacturing (floor stocking) of such MIA-medicated feeds if manufactured pursuant to Health Canada approvals (i.e. as per CMIB). Restrictions remain if manufacturing a medicated feed in a manner deviating from Health Canada s approvals and veterinary prescriptions will continue to be required prior to manufacturing (i.e. no floor stocking). 34

11 6) Increasing Veterinary Oversight of all Medically Important Antimicrobials (MIAs) (3 of 5) Who Can Sell Prescription Drugs? Federal Rules: The Food and Drug Regulations contain certain rules about the sale of prescription drugs (1) No person shall sell a prescription drug unless (a) they are entitled under the laws of a province to dispense a prescription drug and they sell it in that province under a verbal or written prescription that they received; or (b) they sell it under section C (2) Requirement to follow record keeping for at least 2 years Under Section C A person may sell a prescription drug to (a) a drug manufacturer; (b) a practitioner; (c) a wholesale druggist; (d) a pharmacist; 35

12 6) Increasing Veterinary Oversight of all Medically Important Antimicrobials (MIAs) (4 of 5) Who Can Sell Prescription Drugs? Federal Rules Commercial Feed mills can continue to dispense mixed feed containing MIAs pursuant to a prescription; typically, medications containing MIAs (with a Drug Identification Number (DIN)) can be mixed into feed and dispensed by Commercial Feed mills as: Medicated Complete feed Medicated Supplement Medicated Macro Pre-mix Medicated Micro Pre-mix Prescription required before sale and record keeping rules apply (Federal oversight) On-Farm Feed Mills Access to medications would be limited to any of the above four forms from a commercial feed mill pursuant to a prescription (Federal Rules) or Via accessing the drug-premix (DIN) product pursuant to a Prescription from individuals entitled under the Provincial rules (e.g. veterinarians, pharmacists) 36

13 Health Canada is strengthening Canada s regulatory framework for veterinary antimicrobials May 2017 Regulation changes published Canada Gazette Part II November 13, 2017 Regulations Coming Into Force: OUI, VHPs OUI: MIAs used in food-producing animals may no longer be imported into Canada under the OUI Policy. Going forward, only drugs that Health Canada has determined do not pose a risk to human health or food safety may be imported and only in limited quantities. Refer to the exempted product list established by Health Canada: List B: List of Certain Veterinary Drugs Which May Be Imported But Not Sold VHP: A flexible, risk based regulatory framework allowing companies to import and sell products for food and companion animals. These products are intended to promote the health and welfare in animals. May 17, 2018 Coming into force APIs, GMPs, DELs* Expansion of Health Canada s GMP regulatory requirements for human APIs to veterinary APIs. Expands existing Health Canada regulatory requirements to manufacture according to GMPs for APIs for human drugs to all veterinary APIs. Pharmacists, veterinarians or those compounding a drug under the supervision of a licensed veterinarian must hold a DEL when importing MIAs that are on Incorporated by Reference list List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients. The importation of MIA APIs by food animal producers for their direct use in food animals will not be allowed. * Additional 14-month transition period ending July 17, 2019 to submit a DEL application. January 1, 2019 Mandatory reporting of sales volume As of January 1, 2018, reporting of sales information will no longer be voluntary for manufacturers, importers and compounders. The 2018 data must be submitted to Health Canada between January 1, 2019 and March 31, December 2017 Notice of Intent to amend PDL Health Canada advises stakeholders of plans to include all MIAs on the PDL which will require their sale to be done pursuant to a prescription (this includes in-feed). This change was consulted on during the summer of 2017 and will be enforced as of Dec. 1, 2018 February 2018 HC approval of labels Revised labels approved by Health Canada: - Pr status - Removal of growth promotion claims April 2018 Update of CFIA s CMIB New CMIB look and feel All approved in-feed drugs (including OTC and Pr) to be included in CFIA s CMIB Marketplace adjustment and transition Inventory management at retail level December 1, 2018 Outreach to all stakeholders Updated PDL published All MIAs for Veterinary Use approved by Health Canada will be Sold by Prescription Only. Regulatory Changes Policy Changes Acronyms: API Active Pharmaceutical Ingredients CFIA = Canadian Food Inspection Agency CMIB = Compendium of Medicating Ingredient Brochures DEL = Drug Establishment License GMP = Good Manufacturing Practice HC Health Canada MIAs = Medically Important Antimicrobials OUI Own-Use-Importation PDL= Prescription Drug List VHP = Veterinary Health Product Pr = Prescription OTC = Over the Counter 37

14 Refer to the Canada.ca AMR and Animals pages and infographic for additional information about the actions we are taking to address this problem 38

15 WHAT IS VETERINARY OVERSIGHT? Canadian Veterinary Medical Association (CVMA) Veterinary Pharmaceutical Stewardship Advisory Group (VPSAG) Canadian Council of Veterinary Registrars (CCVR) Increased Veterinary Oversight of Antimicrobial Use A Pan-Canadian Framework of Professional Standards for Veterinarians (December 2016)

16 INCREASED VET OVERSIGHT Government of Canada website Antimicrobial Resistance and Animals Actions : we are proposing to move all medically important antimicrobials to prescription status. Supervision by a licensed veterinarian in treatment decisions is an important part of antimicrobial oversight. Veterinarians who prescribe for animals under their care have the training to assess animal health and diagnose disease. They can also determine the need for antimicrobial drug treatment and choose the treatment.

17 VETERINARY OVERSIGHT Veterinary oversight is a key element of antimicrobial stewardship. Professional involvement of licensed veterinarians in providing direction for appropriate use of antimicrobials in animals Objective of ensuring prudent use and minimizing resistence Veterinarians, through their education, experience and accountability, provide guidance or direction for appropriate use and distribution of antimicrobials.

18 PRESCRIBING and DISPENSING Prescribing and Dispensing are INDIVIDUAL Veterinary Activities Prescribing has its own set of regulations and requirements Dispensing has its own set of regulations and requirements

19 PRESCRIBING Professional obligations to be met by the licensed veterinarian in order to appropriately prescribe a drug include: 1. Establish and meet conditions of a valid Veterinary Client Patient Relationship (VCPR) in regards to a specific animal or group of animals 2. Make an evidence-based determination of medical need 3. Complete appropriate documentation in the medical record 4. Provide oversight of use and follow up

20 VETERINARY-CLIENT-PATIENT RELATIONSHIP A VCPR exists when all of the following conditions have been met: 1. the veterinarian has assumed responsibility for making clinical judgments regarding the health of the animal or group of animals and the need for medical or other treatment and the Client has agreed to follow the veterinarian s instructions regarding the medical or other treatment of the animal or group of animals; and

21 VETERINARY-CLIENT-PATIENT RELATIONSHIP A xis2. the veterinarian must have sufficient current and relevant knowledge of the client s animal or group of animals, by medically appropriate and timely examinations, interventions or visits to the premises, or through a history and knowledge of prevalence or frequency of occurrence of the pathologic conditions in the herd, so that the veterinarian may make at least a preliminary diagnosis of the medical condition and treatment plan of the client s animal or group of animals.

22 VETERINARY-CLIENT-PATIENT RELATIONSHIP A VCPR exists when all of the following conditions have been met: the veterinarian is of the opinion that the prescription drugs or other treatment or procedure, if prescribed, is prophylactically or therapeutically indicated for the animal or group of animals; and 4.the veterinarian has made the provision for readily available follow-up evaluation in the event of adverse reactions by the animal or group of animals to the prescription drug or other treatment or procedure prescribed or the failure of the treatment regime.

23 DETERMINATION OF MEDICAL NEED Requirement for prescribing Licensed veterinarian makes an informed decision that a particular drug will be prescribed Establishes the medical needs of the patient - individual animal or group of animals Pertinent medical history &/or conducting a physical examination Not necessary that an individual animal is examined in every instance Veterinarian MUST have relevant medical knowledge to support the establishment of medical need.

24 ANIMAL HEALTH PROTOCOL (SOP) An animal health protocol or SOP is a series of steps to be undertaken following an indication. Veterinarians may establish animal health protocol(s) in advance or anticipation of the animal health event Establishes the medical need for issuing a prescription. An animal health protocol is not a prescription When an animal health protocol includes a step that a drug be administered to an animal or group of animals, a prescription must be authorized before pharmaceuticals are dispensed.

25 Animal Health Protocols Protocols will facilitate issuing prescriptions for predictable animal health events It is helpful to think of the animal health protocol as a set of directions for dealing with a common animal indication. The veterinarian establishes a protocol unique for that farm, incl. a prescription A prescription is an order that a specified animal or group of animals be treated with a particular drug, at a specified dose for a period of time. So the protocol is not the prescription. When the veterinarian sets up the protocol, the prescription exists in that the veterinarian is giving the order to treat those animals in that manner. The prescription must be documented in the medical record. The prescription is documented and there must be a record of dispensing. (later) Only once the prescription exists, can the drug be left on the farm (dispensed). The act of dispensing requires a record of dispensing and labelling.

26 DOCUMENTATION Requirement for prescribing Clearly document the intention to prescribe the product All medication dispensed or sold for the animal or group of animals must have evidence that a valid prescription is on file. Medical records shall document the diagnosis or purpose of use, Communication regarding progress of care, patient response to treatment including treatment failures and any adverse reactions.

27 PRESCRIPTION Medical record of prescribing must document: Prescribing veterinarian and certified veterinary facility, and contact information Patient owner/agent (client) Date of prescription Identification of individual animal or group of animals Name of drug prescribed, concentration Quantity of drug Directions for use, including dose, frequency, and duration Route of administration Substitution (yes or no) of same drug (different brand name) Number of refills (implies zero if not indicated) Withdrawal time Signature of the veterinarian

28 PRESCRIPTION FOR IN-FEED ADMINISTRATION In addition, prescriptions for pharmaceuticals to be administered via feed must be consistent with federal legislation and minimally include the following: Animal production type Weight or age Type of feed Total amount of feed or feeding period Amount of drug used per tonne Manufacturing instructions Cautions CgFARAD # if applicable

29 Professional activity within scope of practice of veterinary medicine Veterinary Medical Act Definitions DISPENSING 1h. Veterinary medicine means any service usually performed by a veterinarian including (ii) the diagnosis or treatment of, and the prescribing, treating, pertaining to animals.

30 DISPENSING Expected professional standards Establish the identity of client and create medical record Establish the identity of prescriber Maintain prescriptions on file and manage available refills Appropriate delegation of dispensing Label according to PEIVMA Bylaws Substitute medications only if appropriate Store and display pharmaceuticals in accordance with the PEIVMA Bylaws.

31 LABELLING Dispensing Label Information A dispensing label that includes prescription specific information must be confirmed by a licensed member working at the dispensing Veterinary Facility. The dispensing label must include: Name of client or owner, Name, address and phone number of prescribing veterinarian and Veterinary Facility, Identification of specified animal or group of animals Name of drug dispensed and concentration Total quantity of drug dispensed, DIN, Expiry Date and Directions for use in the animals for which drug is prescribed, including dose, frequency, and duration of treatment.

32 SHIPPING PHARMACEUTICALS Veterinary practice entities may ship appropriately prescribed and dispensed pharmaceuticals. Appropriately prescribed and dispensed pharmaceuticals may only be shipped by a veterinary practice. Drop shipping, or shipping of pharmaceuticals from the distributor or manufacturer directly to a client s place of residence or business, does not constitute appropriate dispensing.

33 VERIFICATION OF COMPLIANCE Ensure that veterinarians and veterinary practices undertake prescribing and dispensing activities in accordance with the expected professional standards Accountability Oversight of veterinarians Expectation of the public and other stakeholders

34 QUESTIONS If veterinarians are providing oversight of antimicrobial use, who is providing oversight of the veterinarians? If I comply with the guidelines and refuse a request for an antimicrobial, what is stopping my client from going down the street to the next veterinary practice and buying it there?

35 COMPLIANCE APPROACH PEIVMA steps to insure compliance Profession establishes the professional standards Bylaw 19.4 PEIVMA informs members Advise members of the expected professional standards / answer question Undertake verification activities - Facility Inspections, dispensing audit and medical record audit Enforcement in cases of non-compliance, complaints / discipline process

36 DISPENSING AUDIT Veterinary Oversight of Antimicrobial Use a Pan-Canadian Framework of Professional Standards for Veterinarians All pharmaceuticals that are sold from an accredited veterinary practice must have a recorded audit trail. The sale of any prescription pharmaceutical that is recorded by an invoice will require as part of the audit trail: A dispensing record of the appropriate dispensing, including the labeling, A record of the prescription: medical record entries if prescribed by a veterinarian in the same practice where the pharmaceutical was sold, A medical record of the investigation that was undertaken to determine the medical need if the prescribing veterinarian is working in the practice that dispensed the pharmaceutical.

37 FACILITY INSPECTION Process for Dispensing Audit 1. Select date 2. Review transaction history / invoices of prescription drugs sold 3. Review medical record(s) of dispensing for each transaction 4. Review record of the prescription, either a) Documented VCPR, determination of medical need, and follow up, or b) Prescription from another veterinarian / VPE of record

38 NON-COMPLIANCE Practices that fail to comply with Bylaws / Guidelines Practices that are non-compliant may be referred to the Complaints Committee Complaints

39 Questions?