Transcript General Compounding

PHARMACY COMPOUNDING
MEETING THE UNIQUE NEEDS OF
YOUR PATIENT
Steve Hoffart, Pharm. D.
Owner, President
[email protected]
What is Compounding?
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Compounding is the method of preparing
customized medications to help meet unique
physician and patient needs.
Compounding pharmacists focus on providing innovative
patient care. This may involve compounding an eye drop
in a sterile lab, preparing medications for animals, or
providing bio-identical hormone replacement therapy.
Also known as a problem solver, a compounding
pharmacist’s ultimate goal in preparing customized
medications is to help the physician and patient achieve
a more positive therapeutic outcome.
Compounding vs. Manufacturing
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Manufacturing
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No specific patient in mind when drug is produced
Has prescribers matching patients to the product
available
Economic considerations limit choices in drug dosages
and dosage forms
Compounding
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Making the formula match the patient’s needs
Administer the drug to the sight of action in the most
effective dosage form available
[email protected]
Improve Therapeutic Outcomes…
…by solving the problem:
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Avoidance of dyes, preservatives, fillers, actives
Palatable liquid medications
Administrable dosage form
Avoidance of side effects
Improve Therapeutic Outcomes…
…by solving the problem:
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Dose, dosage form, or medication not commercially
available
Combination or sustained-release therapy to
improve compliance
Cost-effective therapy
Unique dosage form designed for specific problem
Compounded Dosage Forms
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Oral capsules and liquids
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Transdermals
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Lollipops and popsicles
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Troches, tablet triturates and sublingual drops
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Rapid dissolve tablets
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Suppositories, enemas and rectal rockets
Compounded Dosage Forms
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Nasal and optic preparations
Topical creams, ointments, gels, powders
and sprays
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Oral adhesives, mouthwashes and rinses
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Sterile products
 inhalation
solutions, injections,
ophthalmics, TPNs
Compounded Capsules
Medications formulated in
capsules enable the
patient to get the exact
dosage needed, while
avoiding unwanted dyes
and fillers.
Capsules
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Long acting
Immediate release
Large doses
Drugs no longer commercially available
Drugs not commercially available
Capsules
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Bio-Identical Hormones
Thyroid Replacement
Low Dose Naltrexone
Nonconstipating Iron Replacement
Quinine/Magnesium Combo
Compounded Oral Liquids
Preparing medications in a liquid form allows the patient
who can’t swallow pills to get the appropriate medicine in a
vast range of flavors, such as tutti-frutti or vanilla butternut.
Compounded Oral Liquids
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Difficulty swallowing
 Medication not available as liquid
 Infants, children, geriatrics, hospice
Avoid unwanted ingredients
 Free of alcohols, dyes, preservatives and sugars
Increased compliance
 Much more palatable preparations with choice of
multiple sweeteners and flavors
Anhydrous formulations
 May be used if aqueous stability a concern
Customized Flavors for People and Pets
Compounding pharmacists can provide hundreds
of individual flavors and endless combinations
to satisfy human and pet patients.
Transdermal Gels
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A specially prepared emulsion that penetrates the skin and gets
medications into the bloodstream quickly
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Effective dosage form for the patient who can’t swallow
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May be used for systemic or local effects
Transdermal Drug Delivery
Drug Classes Used in Transdermals
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NSAIDs
Muscle relaxants
Antinausea agents
Antiviral agents
Anti-inflammatory agents
Anesthetics
Anti-anxiety agents
Transdermal Drug Delivery
Drug Classes Used in Transdermals
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Anti-diabetic agents
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Antidepressant / anti-psychotic agents
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Anti-hypertensive agents
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Thyroid medication
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Antihistamines
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Anti-infective agents
Transdermal Drug Delivery
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Female Hormone Replacement
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Male Testosterone Replacement
Nausea Gels
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NSAIDS, muscle relaxants, Ketamine, topical anesthetics
Shingles Cream
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Promethazine and ondansetron
Pain Gels
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Estrogen, Progesterone, Testosterone
Deoxy-D-Glucose, Gabapentin, Amitriptyline, Ketoprofen, Tetracaine
Poison Ivy Cream
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Hydrocortisone, Pyrilamine, Benzocaine, Menthol, Calamine, Zinc Oxide
Medicated Lollipops
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Local effects
 Anesthetic
 Antifungal
 Antiviral
 Anti-inflammatory
 Saliva
stimulant
 Healing
agents
Medicated Lollipops
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Systemic effects
 Anti-anxiety
 Antipyretic
 Analgesic
Narcotic
Non-narcotic
Medicated Lollipops
Nicotine lollipops for
smoking cessation
 Tetracaine lollipops for
sore throat pain
 Phentermine lollipops
for weight loss
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Troches
Soft gelatin-flavored
troches, such as those
prepared in the 24and 30-count molds,
provide medication in an
easy-to-take and pleasanttasting form.
Compounded Sterile Products
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Injections – aqueous and oil vehicles
 B12, Methylcobalmin, Lipovite, HCG
Ophthalmics – solutions, suspensions, sprays, and
ointments
TPNs and IV admixtures
Inhalation solutions
 Combine multiple
ingredients to improve
compliance
Irrigating solutions
Suppositories
Suppositories
Putting medicine
into suppositories
allows the patient
who can’t swallow
to receive the
required drug.
Suppositories and Enemas
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Rectal or vaginal use
Helpful to patients who have
difficulty in swallowing,
nausea/vomiting
Injections cause pain,
anxiety
Rapid local affect
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Hemorrhoids
Irritable Bowel Syndrome (Crohn’s disease)
Anesthetic, anti-inflammatory, steroid agents
Reported absorption route for many drugs
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Prevents 2/3 of first-pass effect
Medicated Powders
Any combination of an antifungal, antibiotic, antiviral,
steroid or an anesthetic with an oral adhesive could be
compounded.
Compounded Topical Formulations
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Creams
 Water-in-oil
emulsions
 Oil-in-water emulsions
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Ointments
 Anhydrous
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vehicles:
PEG, Petrolatum
Gels
 Carbomer,
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HEC, HPC, HPMC
Sprays
Specialty deodorant stick or lipstick forms
Penetration agents to enhance effects
The Polyox Bandage
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Designed for oral use
Superior oral bandage
 Stays in place for hours even if “rubbed”
Many classes of drug used
 Antihistamine, anesthetic, antiviral,
antifungal, anti-inflammatory, etc., or
combinations
Also used for wound care
 No touching of wound for application
 No removal of new tissue growth
 Advantageous in oozing wound
The Rectal Rocket
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Designed to get the drug(s)
to the sight of action
Holds drug(s) at sight of
action for an extended
period of time (air vent
included)
Hydrocortisone-Lidocaine
formula for hemorrhoids
Quality & Confidence in Compounded
Products
Quality Standards
PCAB accreditation means the
pharmacy has independent,
external validation that it meets
nationally accepted quality
assurance, quality control, and
quality improvement standards.
www.pcab.org
PCAB Pharmacies in Texas – 17 total
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Abrams Royal Pharmacy
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Oakdell Pharmacy
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Community Pharmacy
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Richie’s Pharmacy & Medical
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Compounding Corner Pharmacy, Inc. ®  Specialty Compounding
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Granbury Compounding
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Harvest Drug & Gift
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Hotze Pharmacy
Thrifty Health & Compounding
Pharmacy
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King’s Compounding Pharmacy
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True Custom Pharmacy
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Myers Drug, Inc.
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Unique Pharmaceutical
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Village Compounding Pharmacy
Texas Compounding Pharmacy
Quality & Safety Steps in the
Compounding Laboratory
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Formulas are thoroughly read and discussed prior
to compounding
Calculations are double-checked when preparing
a formula
An electronic balance with a printer attachment is
used to confirm proper weighing of chemicals
Quality & Safety Steps in the
Compounding Laboratory
A Workstation Hood is
used to provide maximum
protection when
compounding. These
countertop hoods are
designed for manipulating
potent powders, such as
hormones; mortar and
pestle compounding; and
encapsulating powders.
Quality & Safety Steps in the
Compounding Laboratory
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All chemicals used in a formula are triplechecked throughout the compounding process
The finished compound is labeled immediately
in order to confirm the identity of the compound
prior to dispensing
Compounds are worked on one at a time to
avoid confusion and possible mislabeling of a
product
Bio-Identical Hormone Restoration
Hormone Restoration Therapy
Would you pass this car?
Menopausal Signs & Symptoms
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Hot flashes
Hair loss
Dry skin
Sleep disruption
Night sweats
Anxiety
Vaginal dryness
Vaginal atrophy
Foggy Thinking
Weight Gain
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Irritability
Memory loss
Depression
Nervousness
Diminished sex drive
Painful intercourse
Urinary incontinence
Heart palpitations
Loss of scalp hair
Unwanted hair growth
Andropause Sign & Symptoms
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Decreased urine flow
Depression
Mental fatigue
Night sweats
Low libido
Apathetic, burned out
Loss of muscle mass
Erectile Dysfunction
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Weight gain in waist
Low Stamina
Sleep disturbances
Bio-Identical Hormones
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The term “bio-identical” indicates that the chemical
(molecular) structure of the replacement hormone is
identical to that of the hormone that exists
intrinsically in the human body
Goals of Balanced Hormone Restoration
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#1:Treat the symptoms of Menopause or Andropause
#2: Protection of various body systems
 Cardiovascular
 Lipid Profile
 Blood Pressure
 Nervous system
 Immune system
 Bones and muscles
 Eyes, skin, hair, etc.
Restoration Therapy
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Establish need through testing and symptom
evaluation
Correct underlying problems affecting hormone levels
or causing symptoms through functional deficiencies
 Lifestyle: diet, exercise, nutrition
Replace hormones exogenously as needed
Monitor symptoms and re-test levels
Topical Pain Management
Transdermal Dosage Forms
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Single or combination drugs
Different base choices
Avoids first pass effect
Decreased risk of drug interactions
Decreased risk of abuse
Decreased risk of GI side effects
Transdermal – Multiple Ingredient Study
Lipoderm® Transdermal Is Only Proven Base To Deliver
Up to Four Medications At Once
HOUSTON – March 08, 2012 – Professional
Compounding Centers of America (PCCA), has announced the
results of a landmark study on Lipoderm transdermal bases.
The first-of-its-kind study, performed by PRACS
Institute/Cetero Research in North Dakota, confirmed that
simultaneous delivery of up to four pharmaceutical
medications can be achieved through a transdermal vehicle.
Additional details, including links to study results, are
available at www.pccarx.com/lipoderm.
Transdermal - Ingredients
SENATE BILL 959
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Current legislation being considered in the Senate in
response to pharmacy disaster
43 patients died from fungal tainted steroid injection
Long standing issues ignored by the FDA and
Massachusetts State Board of Pharmacy
Congress felt need to enact legislation to prevent this
type of situation in the future
SENATE BILL 959 Includes:
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Limits amount of medications a compounding
pharmacy can provide to a physician for office use
If compounded item used in office, all names of
patients must be given to pharmacy in 14 days
Enables the FDA to create of do not compound list of
medications
Exempts requirements on hospitals, health-systems,
home infusion, and insurance company pharmacies
SENATE BILL 959
What can you do?
www. protectmycompounds.com
What can compounding do for your
practice?
Questions???
For additional information on
compounding contact Steve
Hoffart at (281) 356-9089 or
[email protected]