Anthony Menezes, PharmD. March 20, 2016 Central Florida Academy of Veterinary Medicine

Anthony Menezes, PharmD. March 20, 2016 Central Florida Academy of Veterinary Medicine

Definitions Dispensing is the direct distribution of products by veterinarians to clients for use on their animals Prescribing is the transmitting of an order authorizing a licensed pharmacist or equivalent to prepare and dispense specified pharmaceuticals to be used in or on animals in the dosage and in the manner directed by a veterinarian http://www.avma.org/issues/policy/ethics.asp

First step in providing care for a patient. Basis for any and all interaction among veterinarians, their clients, their patients, and any other health professional with regard to that patient. Required for the dispensing or prescribing of a prescription

The following conditions must be met for a valid VCPR: 1. The veterinarian has assumed responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarians instructions.

2. The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s), or by medically appropriate and timely visits to the premises where the animal(s) are kept. http://www.avma.org/issues/policy/ethics.asp

3. The veterinarian is readily available, or has arranged for emergency coverage, for follow-up evaluation in the event of adverse reactions or the failure of the treatment regimen. http://www.avma.org/issues/policy/ethics.asp

Veterinary Prescription Orders Orders issued by licensed veterinarians authorize drug distributors to deliver veterinary prescription drugs to a specific client, or authorize pharmacists to dispense such drugs to a specific client. Veterinarians should assure compliance with relevant regulations of their State Board of Pharmacy and State Board of Veterinary Medicine.

Veterinary Prescription Drugs Veterinary prescription drugs are those drugs restricted by federal law to use by or on the order of a licensed veterinarian [Section 503(f) Food, Drug, and Cosmetic Act]. The law requires that the drug sponsor label such drugs with the statement: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. http://www.avma.org/issues/policy/prescription_drugs.asp

Prescriptions Veterinarians should honor client s requests for a prescription in lieu of dispensing a medication. Without a VCPR, veterinarians merchandising or use of veterinary prescription drugs or their extra-label use of any pharmaceutical is unethical and is illegal under federal law. http://www.avma.org/issues/policy/ethics.asp

Prescriptions Cont Veterinary prescription drugs must be properly labeled before being dispensed. Appropriate dispensing and treatment records must be maintained. Veterinary prescription drugs should be dispensed only in quantities required for the treatment of the animal(s) for which the drugs are dispensed. Avoid unlimited refills of prescriptions or any other activity that might result in misuse of drugs.

Basic Information for Records (R) Prescriptions (P), and Labels (L) Name, address, and telephone number of veterinarians (RPL) Name (L), address, and telephone number of clients (RP) Identification of animal(s) treated, species and numbers of animals treated, when possible (RPL) Date of treatment, prescribing, or dispensing of drug (RPL) Name, active ingredient, and quantity of the drug (or drug preparation) to be prescribed or dispensed (RPL) Drug strength (if more than one strength available) (RPL) Dosage and duration Route of administration (RPL) Number of refills (RPL) Cautionary statements, as needed (RPL) Expiration date if applicable Slaughter withdrawal and/or milk withholding times, if applicable (RPL) Signature or equivalent (P) http://www.avma.org/issues/policy/prescription_drugs.asp

Animal Medicinal Drug Use Clarification Act (AMDUCA) Compliance in Drug Use The therapeutic administration of any approved dosage form drug in a manner that is not in accordance with the drug's labeling requires additional management. AMDUCA regulations are in force for all approved therapeutic dosage form drugs if administered in a manner not in accordance with the drug's labeling.

AMDUCA Make a careful diagnosis and evaluation of the conditions for which the drug is to be used. There is no approved animal drug that is labeled for such use, or that contains the same active ingredient in the required dosage form and concentration. Alternatively, an approved animal drug exists, but a veterinarian finds, within the context of a veterinarian/client/ patient relationship, that the approved drug is clinically ineffective for its intended use. Assure that the identity of the treated animal(s) is carefully maintained. Establish a substantially extended withdrawal period supported by appropriate scientific information prior to marketing milk, meat, eggs, or other edible products from the treated animal(s). http://www.avma.org/issues/policy/prescription_drugs.asp

Drug Container The actual container must bear the veterinarian's name, address, name of the drug (active ingredient), identification of the animal(s) to be treated, adequate directions for proper use, and cautions/precautions including milk and meat withdrawal times. This information may be on the label applied by the manufacturer, or on a label attached to the product by the veterinarian. If there is inadequate space on the label for any of the other required information, the veterinarian must provide the additional information on a separate sheet that accompanies the drug dispensed or prescribed. http://www.avma.org/issues/policy/prescription_drugs.asp

Drug Handling & Storage The veterinarian should inform clients to whom prescription drugs are delivered or dispensed about appropriate drug handling and storage. In the clinic, veterinary prescription drugs should be stored separately from over-the-counter drugs, and be easily distinguishable by the professional and paraprofessional staff. Drugs should be stored under conditions recommended by the manufacturer. All drugs should be examined periodically to ensure cleanliness and current dating. Food animal clients should be advised that veterinary prescription drugs should be securely stored, with access limited to key personnel. http://www.avma.org/issues/policy/prescription_drugs.asp

Handling & Storage Cont Proper care should be taken to avoid exposure to other animals/family members. If Possible, drugs dispensed to clients should be dispensed in child-resistant containers. When medications are stored in the client s home, they should be stored in a cool, dry place (room temp) Refrigerated medications should be kept in the refrigerator at all times. Poison Control Centers (US) 1 (800) 222-1222

Handling & Storage Cont Hazardous Substances NIOSH list available at CDC website: http://www.cdc.gov/niosh/docs/2014-138/ Print and post in pharmacy if hazardous drugs are stocked. Personnel training should include safe handling of hazarous substances

Pharmaceutical Disposal Minimize unused pharmaceuticals: Maintain close inventory control to decrease expired/unused drugs. Write prescriptions for infrequently used drugs to prevent expirations. Consider assigning responsibility for inventory control and disposal to one or a limited number of staff members. Whenever possible, return drugs nearing expiration to the distributor. http://www.avma.org/issues/policy/pharmaceutical_disposal.asp#tips

Pharmaceutical Disposal Cont Garbage landfill is second best For partially used liquids in syringes : Squirt the remaining liquid into a container of kitty litter or other absorbent substance. Dispose of the syringe and needle as appropriate medical waste. Seal it and dispose of it in a leak-proof bag. Blacken all personal information and place a large X over the product label but maintain product identification. Segregate from other types of waste and keep sealed in a leakproof container. Use three layers of packaging to ensure the container does not leak. Fill tablet containers with water and seal to prevent others from using contents. http://www.avma.org/issues/policy/pharmaceutical_disposal.asp#tips

Pharmaceutical Disposal Cont Incineration is best management: Commercial disposal company Use containers provided by or recommended by the disposal company Place needles in sharps containers disperse liquids in leak-proof container with kitty litter or other absorbable material For drugs in a labeled package, black out all personal info, place an X over label (preserve drug info), and place in tamper-resistant, leak-proof container.

Pharmaceutical Disposal Cont Controlled substances and hazardous wastes (including chemotherapeutic agents and epinephrine) are handled differently from non-hazardous waste, and must be disposed of in accordance with federal and state laws. The services of a commercial company may be needed to comply with those laws. Never flush pharmaceuticals into the toilet or squirt down the sink. Never burn pharmaceutical waste unless authorized by federal and state regulations in an approved incinerator. Train all clinic employees on proper disposal of hazardous and non-hazardous waste. http://www.avma.org/issues/policy/pharmaceutical_disposal.asp#tips

Pharmaceutical Disposal Cont Educate clients on proper disposal Inform clients that flushing unused pharmaceuticals is never appropriate. Be aware of return-for-disposal (take-back) programs in your area and encourage clients to participate. Dispense only the necessary quantity for appropriate treatment. Use refills rather than dispensing large quantities of a medication. http://www.avma.org/issues/policy/pharmaceutical_disposal.asp#tips

Dispensing Controlled Substances FS 893.05: A veterinarian may so prescribe, administer, dispense, mix, or prepare a controlled substance for use on animals only, and may cause it to be administered by an assistant or orderly under the veterinarian's direction and supervision only. A prescription may not be issued in order for an individual practitioner to obtaincontrolled substances for supplying the individual practitioner for the purpose ofgeneral dispensing to patients. http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual01 2508.pdf Container label should display: - Date of delivery - Directions - Name and address of doctor - Patient name (species if applicable) - Warning that it is a crime for med to be given to anyone other than whom intended

Controlled Substance Prescription Should have the following info: - Full name and address of patient or owner of animal. - Name, address, DEA # of practitioner - If for animal, the species - Name, strength, quantity, directions of controlled substance. - Rx number - Initials of filling pharmacist and date filled. -MUST BE WRITTEN ON COUNTERFEIT-RESISTANT PRESCRIPTION PAPER Veterinarians exempt Pharmacy to keep Rx on file for 2 years

Controlled Substances Authorized Agents 21 U.S.C. 822(c)(1). An agent is defined as "an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser." An authorized agent may: 1) Prepare a written prescription for signature by the prescribing practitioner. 2) Telephone a pharmacy and convey prescription information. 3) Transmit a signed prescription to a pharmacy via fax. The prescriber is ultimately responsible for the accuracy of the prescription. The authorized agent does NOT have the authority to make medical determinations. http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr1006.htm

Controlled Substances Schedule I Schedule II Schedule III Schedule IV Schedule V May vary between states 26

Schedule I Abuse Potential: High No medically accepted use in the U.S. Examples: Heroin LSD mescaline GHB Cannabis

Schedule II Currently accepted but Laws severely restricted medical use Abuse Potential: High May cause severe psychological and physical dependence Written Rx only No phone-ins May be faxed But original must be handed in to pick up (outpts) Hospice/LTCF pts Emergency Phone-in but Rx to pharmacy in 7 days No Refills Partial fills 72H supply (due to stock only)

Schedule II Drugs Opiates & derivatives - Oxycodone - Hydrocodone - Morphine - Oxymorphone - Hydromorphone - Codeine - Tincture of Opium Cocaine Fentanyl Methadone Amphetamine Methamphetamine Methylphenidate

CII Prescription Requirements Date Patient Name Patient Address Drug Name Strength Dosage Form Capsules, tablets Quantity Directions Prescriber Name Prescriber Address Prescriber DEA# Prescriber Signature

Schedule III Abuse Potential: May cause limited dependence Examples: Marinol Tussionex Tylenol with codeine Laws Written, faxed or verbal by prescriber Refill 5 times in 6 months Partial-fill counts as a refill

Schedule IV Abuse Potential: Lower abuse potential Examples: Valium Ativan Xanax Ambien Darvocet Restoril Tramadol Laws Rx can be written, verbal, faxed by health care professional Must be signed by physician Refill 5 times in 6 months Partial-fill counts as a refill

Schedule V Abuse Potential: Low abuse compared Cough suppressants + codeine Anti-diarrheals Examples: Phenergan with codeine Robitussin AC Lomotil Laws Non-prescription (some) Sales can only be made by pharmacist Medically Necessary 18 years old Limits on Sale Log book

Prescription Drug Monitoring Program Statewide electronic database which collects data on substances dispensed in the state. Data is housed by a statewide agency which distributes this information from the database to individuals authorized to receive this information for purposes of their professions. NOT affiliated with the DEA. Prescription info must be transmitted at least every week. http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm

PDMP Patient advisory report must be requested. Info to be reported: - Doctor name and info - Rx written date - Date filled and method of payment - Name and info of patient - *physical address (C-II) - Drug info - Pharmacy info - Other info as determined by monitoring agency

Responsible Drug Administration Must be up to date SE s Contraindications Use, Administration Interactions Disease states Know the patients medical need Evaluate the situation Plan interventions Based upon Evidence Skilled and safe drug delivery Provide Patient Education Moral, ethical, and legal responsibility

Principles of Administration Cleanliness wash hands, instruments, etc Clean & neat prep area Organization avoid errors and to delivery medicine adequately Reorder stock drugs that are used Prep Area well lit and free from distractions

6 Rights of Medication Administration 1. Right Medication Check bottle (NDC) vs. order 2. Right amount Check dose (writing, references, body wt, etc) 3. Right time dosing regimen (amount, frequency, total daily doses) 4. Right route Affects ADME 5. Right patient check DOB, address, etc 6. Right documentation prescription, order, medication administration record (MAR)

Dosage Calculation No margin of error Life & Death 3 Basic Steps 1. Make sure all units are in same system of measurement Use ratio method 2. Write problem in equation form Label all parts 3. Check answer Make sure answer is reasonable Have someone else check your answer

Prevention of Medication Errors Always place 0 before decimal point Never place a.0 after a whole number Avoid decimals when you can use whole numbers Ex: 500mg instead of 0.5g Avoid unclear abbreviations Always Question suspicions

Commonly Misinterpreted Abbreviations Abbreviation used Intended as Misread as U Units 0 (zero) IU International Units IV (intravenously) mcg or µg Microgram mg (milligram) SID Once daily BID (twice daily) and QID (four times daily) TIW Three times a week Three times daily Qhs At bedtime Every hour http://www.fda.gov/animalveterinary/resourcesforyou/ucm214772.htm

Ways to Avoid Medication Errors Completely write out the prescription, including the drug name and dosage regimen. The full dosage regimen includes the dose, frequency, duration, and route of administration of the drug to be administered. When writing out a dose, do not use a trailing zero and do use a leading zero. When calling in or writing out a human drug prescription for animals, verbally state or write out the entire prescription because some pharmacists may be unfamiliar with veterinary abbreviations. Consider using a computerized prescription system to minimize misinterpretation of handwriting. Educational programs should be considered at the veterinary school level to teach students about the dangers of using abbreviations. http://www.fda.gov/animalveterinary/resourcesforyou/ucm214772.htm

Veterinary Premises 61G18-15.002 Minimum Standards for Premises Where Veterinary Medicine Is Practiced. (5) Pharmacy: a. Clean and orderly. b. Blood storage or blood donor available. c. Existence of accurate controlled substance log and individual patient records. d. If controlled substances are on premises, a locking, secure cabinet for storage.

Veterinary Premises Cont e. DEA certificate on premises. f. Segregated area for the storage of expired drugs. g. Disposable needles and syringes. h. All drugs stored in the pharmacy must be properly labeled with drug name, strength, and expiration date.

Veterinary Premises Cont 61G18-15.005 Periodic Inspections (1) The Department shall make inspections of veterinary premises every two (2) years. Such inspection shall include but not be limited to verification of compliance with Rule 61G18-15.002, F.A.C., governing minimum standards for veterinary premises. (2) Additionally, the Department shall conduct unannounced routine inspections of one percent (1%) of the veterinary premises each year. The selection of premises to be inspected shall be made by the Department on a random basis

Medical Records 61G18-18.002 Maintained for 3 years from last entry Must contain the following: 1. Name of owner or agent 2. Patient identification 3. Record of any vaccinations administered 4. Complaint or reason for provision of services 5. History 6. Physical examination 7. Any present illness or injury noted 8. Provisional diagnosis or health status determination

Records Cont Must contain the following if such services are provided: Clinical laboratory reports Radiographs and their interpretation Consultation Treatment medical, surgical Hospitalization Drugs prescribed, administered, or dispensed Tissue examination report Necropsy findings

Hydrocodone-Containing Products Effective October 6, 2014 All products containing Hydrocodone must be C-II Same rules as other C-II drugs RX s written b/f 10/6/14 with refills can be honored before 4/8/14 (same rules as C-III) Some pharmacy filling systems may not allow this rule.

Tramadol Effective August 18, 2014 Tramadol is a C-IV controlled substance Pertains to all products containing tramadol.

Counterfeit-Proof Paper Controlled substances Supplied by FLDOH-approved vendor Law applies to human physicians, podiatrists, & dentists Does NOT apply to Veterinarians

Compounded Drugs Pharmacies may NOT dispense compounded preparations to practitioners for sale or dispensing. (FL Statutes not changed yet) Pharmacies may dispense compounded preparations to practitioners for use in the office. Qty must be such that it should not expire before being used Qty must be reasonable given the intended use Qty must be an amount which can be compounded and still be compliant with pharmaceutical standards. The pharmacy & practitioner must enter into a written agreement which states the following: (next slide)

Compounded Drugs Cont Written Agreement: 1. The compound may only be administered and not dispensed to pt. (Still in force for Florida pharmacies.) 2. Lot # & BUD must be recorded on pt s chart, MAR, or medication order. 3. The practitioner must provide a way for the patient/client to report adverse events to facilitate a recall. The agreement must be signed by the practitioner and kept on file by the pharmacy.

Compounded Drugs Cont The pharmacy must maintain readily retrievable records for 4 years. The compounded drugs must be adequately labeled. Vet compounds must read Compound Drug Sterile compounds for office use for human patients must be compounded by FDA-registered outsourcing facilities only. 64B16-27.700 FAC. Definition of Compounding. accessed:http://floridaspharmacy.gov/resources/

References 1. American Veterinary Medical Association. Guidelines for Veterinary Prescription Drugs: http://www.avma.org/issues/policy/prescription_drugs.asp 2. American Veterinary Medical Association. Principles of Veterinary Medical Ethics: http://www.avma.org/issues/policy/ethics.asp 3. American Veterinary Medical Assoc. What veterinarians should know about prescribing and dispensing: http://www.avma.org/issues/prescribing/prescribing_faq.asp 4. American Veterinary Medical Assoc. Best Management Practices for Pharmaceutical Disposal: www.avma.org/drugdisposal 5. Journal of the American Veterinary Medical Association. Is it Time to Inventory Your Controlled Substances? Vol 220, no 6. pg 736. Mar 15, 2002. 6. Kemp, Douglas T. PharmD. Controlled Substances Regulation for Veterinarians- Georgia and Florida. http://www.vet.uga.edu/pharmacy/contsub/contsubsjan06.pdf 7. Kim-Jung, Linda PharmD. A Microgram of Prevention is Worth a Milligram of Cure: Preventing Medication Errors in Animals. http://www.fda.gov/animalveterinary/resourcesforyou/ucm214772.htm

References Cont 9. Florida Statutes Chapter 465. http://www.myfloridalicense.com/dbpr/servop/testing/documents/ch0465.pdf 10. Florida Statutes Ch 474. http://www.myfloridalicense.com/dbpr/servop/testing/documents/ch0474.pdf 11. Florida Statutes Ch 893. http://www.myfloridalicense.com/dbpr/servop/testing/documents/ch0893.pdf 12. Lenz, Skip PharmD., FACVP. Rules and Laws of Dispensing Prescription Drugs by Florida Veterinarians. Florida Veterinary Medical Association. 2007 13. White-Shim, Lynn DVM. Email August 9, 2010. 14. Woodrow, R. Essentials of Pharmacology for Health Occupations. 5 th Ed. New York: Thomson Delmar Learning; 2007. 15. Eide, Megan L. PharmD. Phone interview. 1/8/2015 16. Floridaspharmacy.gov, FAQs Regarding the DEA Rescheduling of Hydrocodone Combination Products (HCPs). 17. Floridaspharmacy.gov, DEA Classifies Tramadol a Controlled Substance.