Pharmacy Procedures, Drug Handling

1. Pharmacy Procedures, Drug Handling CHAPTER 2 Dr. DipaBrahmbhatt VMD MpH, MS dbrahmbh@yahoo.com

2. OBJECTIVES • OTC vs. prescription drugs • Requirements: prescription and drug labels • Abbreviations • Regulations and warnings - dispensing containers • Procedures for handling and storing drugs • Storage and handling requirements: cytotoxic and hazardous waste • Compounding

3. Responsibility • Regulations • DEA: Drug Enforcement Administration • FDA: Food and Drug Administration • USDA: U.S. Dept. of Agriculture • EPA: Environmental Protection Agency • Store meds, calculate doses, prepare, dispense and record medications

4. OBTAIN DRUGS OTC: safe for animal, the person administering the medication, people coming into contact with the animal, the human food chain and the environment

5. Prescription Drugs • Prescription Drugs • Considered toxic, potentially toxic if misused or too readily misused • Regulated by the FDA and are limited to use under the supervision of a veterinarian or physician • Obtained through vet or prescription • VETERINARIAN/CLIENT/PATIENT RELATIONSHIP (VCPR) • “CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian”

6. Prescription Drugs • “Prescription”: vet direction to pharmacist/ person legally allowed to fill prescription • In vet clinic: drug orders not prescriptions Vet techs cannot write prescriptions but can fill drug orders and dispense medication as instructed by vet

7. Recipe Prescription – 8 ingredients • Drug: Name, Concentration, # of units to be dispensed • Sig (signa): write/label ,directions • Signature veterinarian • DEA registration # is drug is controlled substance +/- refill, cautionary statements

8. Recipe Prescription – 8 ingredients • Name of vet hospital OR Veterinarian • Address, phone # • Clients name and address • Species of animals • +/- name “take thou of” signa Signature veterinarian 8. DEA registration # is drug is controlled substance

9. Prescription Label • Name of vet hospital OR Veterinarian • Address, phone # • Clients name and address • Species of animals • +/- name ID of animal: ID tag, name, microchip number dosage, frequency, route of administration, duration of tx. Cautionary statements

11. Abbreviations b.i.d s.i.d: qd (human) t.i.d

12. Abbreviations • OD, OS, OU • AD, AS, AU • TBL/ Tbsp • 1T = 3t

13. Dispensing Medication • Childproof containers • Illegal? • 1970: Poison Prevention Packaging Act: require special packaging for drugs that my be dangerous to people: Drug manufacturers/ pharmacists • If giving to geriatric patient let them know it is not childproof

14. Drug Storage/ Environment • Temperature • Humidity • Light • Ionizing radiation • Amber colored bottles • Reconstituted drugs • Prone to bacterial contamination • Expiration date • LA vets: trucks

15. CONTROLLED SUBSTANCESSchedule drug • Drugs that are considered to be dangerous because of the potential for human misuse or abuse • Potential for physical addiction • Psychological addiction • Abuse • They are regulated by the DRUG ENFORCEMENT ADMINISTRATION (DEA) via the CONTROLLED SUBSTANCES ACT of 1970. Before this act, drug abuse was defined as the illicit use of an illegal drug or the improper use of a prescription drug. • After 1970, controlled substances were classified into 5 schedules that are based on the potential for abuse. The higher the number (schedule), the lower the risk for abuse.

16. Vet • Details Vet cannot order Opium New prescription, not ordered on phone unless emergency Etorphine HCL dart

17. CONTROLLED SUBSTANCES • FDA (DHHS) regulates the development and approval of drugs, • DEA (Justice Dept.): regulates the laws and rules pertaining to the purchase, storage and use of controlled substances • Vets need to register with the DEA annually • Stored in locked cabinet / safe, mobile vet: locked steel toolbox, records (file with DEA and log every 2 years) • Any address changes are to be reported to the DEA.

18. LOG

19. Controlled substances • Veterinary Technician Role • Order, keep records, maintain storage procedures • Cannot dispense

20. Controlled Substance Medication

21. Storage and Handling Cytotoxic and Hazardous Drugs • Hazards (esp. pregnant women): Birth defects: teratogenic/ mutagenic/ carcinogenic • Antineoplastic agents • Antifungals • Store seperately • OSHA: Occupational Safety and Health Administration • AAHA

22. Exposure • Absorption • Skin • ampules • Inhalation • aerosolized drug: push air into vial • breaking or crushing tablets • ampules • Ingestion • aerosolization or direct contact

23. Good Practice Procedures and Hygiene • Human food next to formalin/ fecal sample/ antineoplastic drugs • Education/ Training staff • OSHA guidelines • Notebook with MSDS : material safety and data sheets • Package insert – drug • SOP: handling, disposing, spills

24. Risk Mitigation • Screw on attachments: syringe/ IV lines • Recheck dose • Accurate catheter placement • Sealable plastic bags dispose syringes, vials, catheters • Leak proof, puncture proof bags • Spill kits • Prepare and administer drugs • Low traffic, well – ventilated area: ventilated hood • Protective attire • High efficiency filter mask • Gloves: double glove, heavy weight gloves: hazardous items • Gown: non-porous, long sleeved • Goggles

25. Laminar airflow hood

26. Compounding • Federal Food Drug and Cosmetic Act: “any manipulation to produce a dose form other than what is approved by FDA” • Occurs when health professionals prepare a specialized drug product to fill an individual patient’s needs when an approved drug is not available

27. Powder and cream

28. Compounding • Uses of compounding • Creating discontinued/ discounted : • diethylstilbesterol –urinary incontinence • Cisapride- cats, megacolon • Creating dosages and strength specific to patient’s weight and health: FDA approved than need to replicate • Creating alternative dose forms such as liquids, ointments, or chewable tablets • KBr elixir/ syrup • Adding flavoring to drugs to make them more appealing to animals • Customizing formulas that combine multiple drugs for one dose administration

29. Compounding • Concerns • Small compounding changes may turn an FDA approved drug into an unapproved drug • Compounded drugs are made without FDA oversight and may pose a risk to the patient • Compounded drugs may not be sterile and can cause infections to patients that use them • Errors in preparing compounded drugs may result in disease or death in patients who use them (potential toxins)

30. Compounding • 1996: Taskforce (vets, pharmacists and regulators): Compliance Policy Guide (CPG) for FDA-CVM • discusses that food-producing animals should not receive drugs that are labeled for humans • No regulatory action if • A legitimate medicinal need ID: Benefit high w/o animal/human safety • VCPR • Appropriate dose regimen for specific species, size, age, or medical condition • No marketed approved animal drug that can treat condition http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm117042.htm

31. Compound Label • Name and address of vet • Date: dispensed and expired • Medically active ingredients • Directions for use • Cautionary statement • Withdrawal time • Indication