the unique needs of your patient Steve Hoffart Pharm D Owner President stevehmagnoliapharmacycom Goals Define pharmacy compounding Describe compounding various service areas Provide details of the various dosage forms used in compounding ID: 776071
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Pharmacy Compounding Meeting the unique needs of your patient
Steve Hoffart, Pharm. D. Owner, Presidentsteveh@magnoliapharmacy.com
Slide2Goals
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
Slide3What is Compounding?
Compounding is the method of preparing customized medications to help meet unique physician and patient needs.
Slide4Compounding 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.
Slide5Also 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.
Slide6Pharmacy
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
Slide7CompoundingAs 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 practitioner’s 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
.
Slide8Manufacturing 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.
Slide9Compounding 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 patient’s needs
Administer the drug to the sight of action in the most effective dosage form available
Slide10kelly@amchouston.com
Slide11Improve Therapeutic Outcomes……by solving the problem:
Avoidance of dyes, preservatives, fillers, actives
Palatable liquid medications
Administrable dosage form
Avoidance of side effects
Slide12Improve 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
Slide13Service Areas
Slide14Meeting Unique Needs In:
HospicePain ManagementBio-identical Hormone Replacement TherapyDentalDermatologyVeterinary
Slide15Meeting Unique Needs In:
PodiatryOncologyOphthalmologyPediatricsNeurologyNutritionalSports medicineAnd many more…..
Slide16Hospice
Alternative routes of administrationIndividualized pain management Nausea & vomitingInhalation therapyEmergency kitsMouth ulcersSaliva stimulantsAdjunctive therapies
Slide17Bio-identical Hormone Replacement Therapy
Same identical hormones as exist in the human bodyNatural sourceIndividualized therapyAvoidance of side effectsClinical benefitsPatient consultation
Slide18Dental Needs
HemostaticsBleaching gelsRoot canal & dry socket mixturesTopical anestheticsPre-procedure sedativesRepository antibiotics for abscessesPlaque removal rinsesAdhesivesSedatives
Slide19Podiatry
Fungal infectionsDecubitus ulcersDiabetic neuropathyCirculation problemsWarts and callusesHeel spursExcessive perspirationMuscle and joint pain
Slide20Exercise and Sports Injuries
Transdermal gelsNSAIDsMuscle relaxantsNeuropathic agentsSpeed GelsIontophoresis SolutionsPhonophoresis (Ultrasound) GelsHank’s balanced salt solutionAnesthetic sprays and gelsAntifungals for athlete’s foot and jock itch
Slide21Compounded Dosage Forms
Oral capsules and liquids
Transdermals
Lollipops and popsicles
Troches, tablet triturates and sublingual drops
Rapid dissolve tablets
Suppositories, enemas and rectal rockets
Slide22Compounded 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
Slide23Compounded Capsules
Medications formulated in capsules enable the patient to get the exact dosage needed, while avoiding unwanted dyes and fillers.
Slide24Capsules
Long acting
Immediate release
Large
doses
Drugs no longer commercially available
Drugs not commercially available
Slide25Capsules
Bio-Identical Hormones
Thyroid Replacement
Low Dose Naltrexone
Nonconstipating
Iron Replacement
Quinine/Magnesium Combo
Slide26Compounded Oral Liquids
Preparing medications in a liquid form allows the patientwho can’t swallow pills to get the appropriate medicine in avast range of flavors, such as tutti-frutti or vanilla butternut.
Slide27Compounded 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
Slide28Customized Flavors for People and Pets
Compounding pharmacists can provide hundreds of individual flavors and endless combinations to satisfy human and pet patients.
Slide29Transdermal Gels
A specially prepared emulsion that penetrates the skin and gets medications into the bloodstream quicklyEffective dosage form for the patient who can’t swallow May be used for systemic or local effects
Slide30Transdermal Drug Delivery
Drug Classes Used in
Transdermals
NSAIDs
Muscle relaxants
Antinausea
agents
Antiviral agents
Anti-inflammatory agents
Anesthetics
Anti-anxiety agents
Slide31Transdermal Drug Delivery
Drug
Classes Used in
Transdermals
Anti-diabetic agents
Antidepressant / anti-psychotic agents
Anti-hypertensive agents
Thyroid medication
Antihistamines
Anti-infective agents
Slide32Transdermal Drug Delivery
Female Hormone Replacement
Estrogen, Progesterone, Testosterone
Male Testosterone Replacement
Nausea Gels
Promethazine and
ondansetron
Pain Gels
NSAIDS, muscle relaxants, Ketamine, topical anesthetics
Shingles Cream
Deoxy
-D-Glucose, Gabapentin, Amitriptyline,
Ketoprofen
,
Tetracaine
Poison Ivy Cream
Hydrocortisone,
Pyrilamine
, Benzocaine, Menthol, Calamine, Zinc Oxide
Slide33Medicated Lollipops
Local effectsAnestheticAntifungalAntiviralAnti-inflammatorySaliva stimulantHealing agents
Slide34Medicated Lollipops
Systemic effectsAnti-anxietyAntipyreticAnalgesicNarcoticNon-narcotic
Slide35Medicated Lollipops
Nicotine lollipops for smoking cessationTetracaine lollipops for sore throat painPhentermine lollipops for weight loss
Slide36Troches
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.
Slide37Compounded Sterile Products
Injections – aqueous and oil vehiclesB12, Methylcobalmin, Lipovite, HCGOphthalmics – solutions, suspensions, sprays, and ointments TPNs and IV admixturesInhalation solutionsCombine multiple ingredients to improve complianceIrrigating solutions
Slide38Suppositories
Slide39Suppositories
Putting medicine into suppositories allows the patient who can’t swallow to receive the required drug.
Slide40Suppositories and Enemas
Rectal or vaginal useHelpful to patients who have difficulty in swallowing, nausea/vomiting Injections cause pain, anxietyRapid local affectHemorrhoids Irritable Bowel Syndrome (Crohn’s disease)Anesthetic, anti-inflammatory, steroid agentsReported absorption route for many drugsPrevents 2/3 of first-pass effect
Slide41Medicated Powders
Any combination of an antifungal, antibiotic, antiviral, steroid or an anesthetic with an oral adhesive could be compounded.
Slide42Compounded Topical Formulations
CreamsWater-in-oil emulsionsOil-in-water emulsionsOintmentsAnhydrous vehicles: PEG, PetrolatumGelsCarbomer, HEC, HPC, HPMCSpraysSpecialty deodorant stick or lipstick formsPenetration agents to enhance effects
Slide43The Polyox Bandage
Designed for oral useSuperior oral bandage Stays in place for hours even if “rubbed”Many classes of drug usedAntihistamine, anesthetic, antiviral, antifungal, anti-inflammatory, etc., or combinationsAlso used for wound careNo touching of wound for applicationNo removal of new tissue growthAdvantageous in oozing wound
Slide44The Rectal Rocket
Designed to get the drug(s) to the sight of actionHolds drug(s) at sight of action for an extended period of time (air vent included)Hydrocortisone-Lidocaine formula for hemorrhoids
Slide45Compounding Equipment
Slide46Electronic (Digital) Balance
This device is absolutely necessary
for efficient and accurate compounding.
Slide47Capsule 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.
Slide48Troche Mold
This dosage form provides sublingual or buccal administration in a variety of flavors.
Slide49Electronic and Electro Mortar & Pestles
The electronic and electro mortar & pestles providepharmacists with the modern way to compound creams, gels and ointments.
Slide50Ointment Mill
The ointment mill reduces particle size of powders, crystals and creams into a smooth, finished compound.
Slide51Lollipop Mold
The lollipop mold
enables pharmacists to make medicated lollipops using a variety
of
bases, such as sorbitol, gelatin and polyethylene glycol.
Slide52Rectal 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.
Slide53Quality
&
Confidence in Compounded
Products
Slide54Quality 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.
Slide55Quality 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
Slide56PCAB Pharmacies in Texas – 17 total
Abrams Royal Pharmacy
Community Pharmacy
Compounding Corner
Pharmacy
, Inc. ®
Granbury Compounding
Harvest Drug & Gift
Hotze
Pharmacy
King’s Compounding Pharmacy
Myers Drug, Inc.
Magnolia Pharmacy
Oakdell
Pharmacy
Richie’s Pharmacy
&
Medical
Specialty Compounding
Texas Compounding Pharmacy
Thrifty Health & Compounding Pharmacy
True Custom Pharmacy
Unique Pharmaceutical
Village Compounding Pharmacy
Slide57Safety 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.
Slide58Quality & 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
Slide59Quality & 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.
Slide60Quality & 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
Slide61Quality & 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.
Slide62Quality & 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.
Slide63Hormone Restoration Therapy
Bio-Identical Hormone Restoration
Slide64Would you pass this car?
Slide65Menopausal Signs & Symptoms
Hot flashesHair lossDry skinSleep disruptionNight sweatsAnxietyVaginal drynessVaginal atrophyFoggy ThinkingWeight Gain
Irritability
Memory loss
Depression
Nervousness
Diminished sex drive
Painful intercourse
Urinary incontinence
Heart palpitations
Loss of scalp hair
Unwanted hair growth
Slide66Andropause 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
Slide67Bio-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
Slide68Goals 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.
Slide69Restoration 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
Slide70Topical Pain Management
Slide71Transdermal 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
Slide72Transdermal – 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.
Slide73Slide74Slide75Slide76Slide77Slide78Transdermal - Ingredients
Slide79SENATE 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
Slide80SENATE 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
Slide81SENATE BILL 959
What can you do?
www. protectmycompounds.com
Slide82What can compounding do for your practice?Questions???
For additional information on compounding contact Steve Hoffart at (281) 356-9089 or steveh@magnoliapharmacy.com