PHARMACY COMPOUNDING MEETING THE UNIQUE NEEDS OF YOUR PATIENT
Steve Hoffart, Pharm. D. Owner, President
[email protected]
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Goals Define pharmacy compounding Describe compounding various
service areas Provide details of the various dosage forms used in
compounding Describe some of the equipment used in compounding
Review the safety and quality steps taken in a pharmacy compounding
laboratory
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What is Compounding? Compounding is the method of preparing
customized medications to help meet unique physician and patient
needs.
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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.
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Also known as a problem solver, a compounding pharmacists
ultimate goal in preparing customized medications is to help the
physician and patient achieve a more positive therapeutic
outcome.
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Pharmacy The art or profession of preparing and preserving
drugs, and of compounding and dispensing medication according to
the prescriptions of physicians. Early 20th Century Webster
Dictionary
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Compounding As defined in the NABP Model State Pharmacy Act:
The preparation, mixing, assembling, packaging, or labeling of a
drug or device (i) as a result of a practitioners prescription drug
order or initiative based on the Practitioner / Patient /
Pharmacist relationship in the course of professional practice, or
(ii) for the purpose of or as an incident to research, teaching, or
chemical analysis, and not for resale or dispensing. Compounding
also includes the preparation of drugs or devices in anticipation
of prescription drug orders based on routine, observed
patterns.
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Manufacturing As defined in the NABP Model State Pharmacy Act:
The production, preparation, conversion, or processing of a drug or
device.and includes any packaging, or repackaging of the
substance(s) or labeling or relabeling of its container, and the
promotion and marketing of such Drugs or Devices. Manufacturing
also includes the preparation and promotion of commercially
available products from bulk compounds for resale by the
pharmacies, practitioners, or other persons.
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Compounding vs. Manufacturing Manufacturing 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 Making the formula match the
patients needs Administer the drug to the sight of action in the
most effective dosage form available
Improve Therapeutic Outcomes by solving the problem: Avoidance
of dyes, preservatives, fillers, actives Palatable liquid
medications Administrable dosage form Avoidance of side
effects
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Improve Therapeutic Outcomes by solving the problem: 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
Bio-identical Hormone Replacement Therapy Same identical
hormones as exist in the human body Natural source Individualized
therapy Avoidance of side effects Clinical benefits Patient
consultation
Podiatry Fungal infections Decubitus ulcers Diabetic neuropathy
Circulation problems Warts and calluses Heel spurs Excessive
perspiration Muscle and joint pain
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Exercise and Sports Injuries Transdermal gels NSAIDs Muscle
relaxants Neuropathic agents Speed Gels Iontophoresis Solutions
Phonophoresis (Ultrasound) Gels Hanks balanced salt solution
Anesthetic sprays and gels Antifungals for athletes foot and jock
itch
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Compounded Dosage Forms Oral capsules and liquids Transdermals
Lollipops and popsicles Troches, tablet triturates and sublingual
drops Rapid dissolve tablets Suppositories, enemas and rectal
rockets
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Compounded Dosage Forms Nasal and optic preparations Topical
creams, ointments, gels, powders and sprays Oral adhesives,
mouthwashes and rinses Sterile products inhalation solutions,
injections, ophthalmics, TPNs
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Compounded Capsules Medications formulated in capsules enable
the patient to get the exact dosage needed, while avoiding unwanted
dyes and fillers.
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Capsules Long acting Immediate release Large doses Drugs no
longer commercially available Drugs not commercially available
Compounded Oral Liquids Preparing medications in a liquid form
allows the patient who cant swallow pills to get the appropriate
medicine in a vast range of flavors, such as tutti-frutti or
vanilla butternut.
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Compounded Oral Liquids 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
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Customized Flavors for People and Pets Compounding pharmacists
can provide hundreds of individual flavors and endless combinations
to satisfy human and pet patients.
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Transdermal Gels A specially prepared emulsion that penetrates
the skin and gets medications into the bloodstream quickly
Effective dosage form for the patient who cant swallow May be used
for systemic or local effects
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Transdermal Drug Delivery Drug Classes Used in Transdermals
NSAIDs Muscle relaxants Antinausea agents Antiviral agents
Anti-inflammatory agents Anesthetics Anti-anxiety agents
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Transdermal Drug Delivery Drug Classes Used in Transdermals
Anti-diabetic agents Antidepressant / anti-psychotic agents
Anti-hypertensive agents Thyroid medication Antihistamines
Anti-infective agents
Medicated Lollipops Nico t ine 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 24- and 30-count molds, provide medication in an
easy-to-take and pleasant- tasting form.
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Compounded Sterile Products 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
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Suppositories
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Putting medicine into suppositories allows the patient who cant
swallow to receive the required drug.
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Suppositories and Enemas Rectal or vaginal use Helpful to
patients who have difficulty in swallowing, nausea/vomiting
Injections cause pain, anxiety Rapid local affect Hemorrhoids
Irritable Bowel Syndrome (Crohns disease) Anesthetic,
anti-inflammatory, steroid agents Reported absorption route for
many drugs Prevents 2/3 of first-pass effect
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Medicated Powders Any combination of an antifungal, antibiotic,
antiviral, steroid or an anesthetic with an oral adhesive could be
compounded.
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Compounded Topical Formulations Creams Water-in-oil emulsions
Oil-in-water emulsions Ointments Anhydrous vehicles: PEG,
Petrolatum Gels Carbomer, HEC, HPC, HPMC Sprays Specialty deodorant
stick or lipstick forms Penetration agents to enhance effects
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The Polyox Bandage 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
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The Rectal Rocket 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
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Compounding Equipment
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Electronic (Digital) Balance This device is absolutely
necessary for efficient and accurate compounding.
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Capsule Machine The Jaansun capsule machine provides
pharmacists with a more time efficient and accurate method of
making capsules. It is designed to avoid labor-intensive hand
punching, and accommodates oil-filled capsules, with the capacity
to make up to 300 capsules at a time.
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Troche Mold This dosage form provides sublingual or buccal
administration in a variety of flavors.
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Electronic and Electro Mortar & Pestles The electronic and
electro mortar & pestles provide pharmacists with the modern
way to compound creams, gels and ointments.
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Ointment Mill The ointment mill reduces particle size of
powders, crystals and creams into a smooth, finished compound.
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Lollipop Mold The lollipop mold enables pharmacists to make
medicated lollipops using a variety of bases, such as sorbitol,
gelatin and polyethylene glycol.
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Rec t al Suppository Mold The rectal suppository mold can be
used to make six suppositories at a time. The shape of the
suppository is designed to keep it in the rectal orifice in direct
contact with the hemorrhoid. The mold also features an air vent for
each suppository, enabling the dosage form to stay in place for an
extended period of time. The air vent is created using a removable
metal plate which aids in removing the suppositories from the
mold.
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Quality & Confidence in Compounded Products
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Quality Standards Safety and quality are of the utmost
importance in compounding. Precautions are taken in the pharmacy to
offer maximal protection for both the compounder and the patients
who will receive the compounds.
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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
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PCAB Pharmacies in Texas 17 total Abrams Royal Pharmacy
Community Pharmacy Compounding Corner Pharmacy, Inc. Granbury
Compounding Harvest Drug & Gift Hotze Pharmacy Kings
Compounding Pharmacy Myers Drug, Inc. Magnolia Pharmacy Oakdell
Pharmacy Richies Pharmacy & Medical Specialty Compounding Texas
Compounding Pharmacy Thrifty Health & Compounding Pharmacy True
Custom Pharmacy Unique Pharmaceutical Village Compounding
Pharmacy
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Safety in the Compounding Pharmacy Safety and quality are of
the utmost importance in compounding. Precautions are taken in the
pharmacy to offer maximal protection for both the compounder and
the patients who will receive the compounds.
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Quality & Safety Steps in the Compounding Laboratory
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
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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.
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Quality & Safety Steps in the Compounding Laboratory All
chemicals used in a formula are triple- checked 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
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Quality & Safety Steps in the Compounding Laboratory
Consistency is maintained by adding helpful notes to formulas to
assist the pharmacist and his/her staff in the future. Customized
log forms are created for compounded products. Clear identification
of final products and patients who received them is important in
the case of a recall or complaint.
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Quality & Safety Steps in the Compounding Laboratory A
training program regarding hazard codes and recommended safety
equipment for handling bulk chemicals is established. Procedures
for cleaning chemical spills are well- known by all members of the
pharmacy team. Proper safety clothing, including masks, gloves, lab
coats and hair bonnets, are worn when compounding.
Menopausal Signs & Symptoms Hot flashes Hair loss Dry skin
Sleep disruption Night sweats Anxiety Vaginal dryness Vaginal
atrophy Foggy Thinking Weight Gain Irritability Memory loss
Depression Nervousness Diminished sex drive Painful intercourse
Urinary incontinence Heart palpitations Loss of scalp hair Unwanted
hair growth
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Andropause Sign & Symptoms Decreased urine flow Depression
Mental fatigue Night sweats Low libido Apathetic, burned out Loss
of muscle mass Erectile Dysfunction Weight gain in waist Low
Stamina Sleep disturbances
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Bio-Identical Hormones 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
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Goals of Balanced Hormone Restoration #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.
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Restoration Therapy 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
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Topical Pain Management
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Transdermal Dosage Forms 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
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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.
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Transdermal - Ingredients
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SENATE BILL 959 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
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SENATE BILL 959 Includes: 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
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SENATE BILL 959 What can you do? www.
protectmycompounds.com
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What can compounding do for your practice? Questions??? For
additional information on compounding contact Steve Hoffart at
(281) 356-9089 or [email protected][email protected]
