Transcript Ch2newbook - Dr. Brahmbhatt`s Class Handouts

Pharmacy Procedures, Drug
Handling
CHAPTER 2
Dr. Dipa Brahmbhatt VMD MpH, MS
[email protected]
OBJECTIVES
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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
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
OBTAIN DRUGS
Prescription
OTC: safe for
animal, the person
administering the
medication, people
coming into contact
with the animal, the
human food chain
and the
environment
Over the
counter
Extra - Label
Controlled
Substances
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”
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
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
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
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
Cautionary statements
dosage,
frequency,
route of
administration,
duration of tx.
Abbreviations
b.i.d
s.i.d: qd (human)
t.i.d
Abbreviations
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OD, OS, OU
AD, AS, AU
TBL/ Tbsp
1T = 3t
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
Drug Storage/ Environment
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Temperature
Humidity
Light
Ionizing radiation
– Amber colored bottles
• Reconstituted drugs
– Prone to bacterial
contamination
• Expiration date
• LA vets: trucks
CONTROLLED SUBSTANCES
Schedule 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.
• Vet
• Details
Vet cannot order
Opium
New prescription, not
ordered on phone unless
emergency
Etorphine HCL dart
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.
LOG
Controlled substances
• Veterinary Technician Role
– Order, keep records, maintain storage procedures
– Cannot dispense
Controlled Substance Medication
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
Exposure
• Absorption
– Skin
– ampules
• Inhalation
– aerosolized drug: push
air into vial
– breaking or crushing
tablets
– ampules
• Ingestion
– aerosolization or direct
contact
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
Risk Mitigation
• 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
• 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
Laminar airflow hood
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
Powder and cream
• 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
• 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)
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
Compound Label
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Name and address of vet
Date: dispensed and expired
Medically active ingredients
Directions for use
Cautionary statement
Withdrawal time
Indication