Pharmacy Procedures, Drug Handling

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Pharmacy Procedures, Drug Handling

• CHAPTER 2
• Dr. Dipa Brahmbhatt VMD MpH, MS
• dbrahmbh_at_yahoo.com

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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

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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

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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
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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

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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
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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
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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
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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
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(No Transcript)
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Abbreviations
b.i.d s.i.d qd (human) t.i.d
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Abbreviations

• OD, OS, OU
• AD, AS, AU
• TBL/ Tbsp
• 1T 3t

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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

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Drug Storage/ Environment

• Temperature
• Humidity
• Light
• Ionizing radiation
• Amber colored bottles
• Reconstituted drugs
• Prone to bacterial contamination
• Expiration date
• LA vets trucks

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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.

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• Vet
• Details

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

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LOG
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Controlled substances

• Veterinary Technician Role
• Order, keep records, maintain storage procedures
• Cannot dispense

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Controlled Substance Medication
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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

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Exposure

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

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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

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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

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Laminar airflow hood
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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
  patients needs when an approved drug is not
  available

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Powder and cream
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Compounding

• Uses of compounding
• Creating discontinued/ discounted
• diethylstilbesterol urinary incontinence
• Cisapride- cats, megacolon
• Creating dosages and strength specific to
  patients 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

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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)

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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/Complia
  ncePolicyGuidanceManual/ucm117042.htm

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Compound Label

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