PHARMACY COMPOUNDING MEETING THE UNIQUE NEEDS OF YOUR

PHARMACY COMPOUNDING MEETING THE UNIQUE NEEDS OF YOUR PATIENT Steve Hoffart, Pharm. D. Owner, President steveh@magnoliapharmacy. com

What is Compounding? 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 • • • 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

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Improve Therapeutic Outcomes… …by solving the problem: Avoidance of dyes, preservatives, fillers, actives Palatable liquid medications Administrable dosage form Avoidance of side effects

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

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

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

Compounded Capsules Medications formulated in capsules enable the patient to get the exact dosage needed, while avoiding unwanted dyes and fillers.

Capsules Long acting Immediate release Large doses Drugs no longer commercially available Drugs not commercially available

Capsules 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 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 A specially prepared emulsion that penetrates the skin and gets medications into the bloodstream quickly Effective dosage form for the patient who can’t swallow May be used for systemic or local effects

Transdermal Drug Delivery Drug Classes Used in Transdermals NSAIDs Muscle relaxants Antinausea agents Antiviral agents Anti-inflammatory agents Anesthetics Anti-anxiety agents

Transdermal Drug Delivery Drug Classes Used in Transdermals Anti-diabetic agents Antidepressant / anti-psychotic agents Anti-hypertensive agents Thyroid medication Antihistamines Anti-infective agents

Transdermal Drug Delivery Female Hormone Replacement � Male Testosterone Replacement Nausea Gels � NSAIDS, muscle relaxants, Ketamine, topical anesthetics Shingles Cream � Promethazine and ondansetron Pain Gels � Estrogen, Progesterone, Testosterone Deoxy-D-Glucose, Gabapentin, Amitriptyline, Ketoprofen, Tetracaine Poison Ivy Cream � Hydrocortisone, Pyrilamine, Benzocaine, Menthol, Calamine, Zinc Oxide

Medicated Lollipops Local effects � Anesthetic � Antifungal � Antiviral � Anti-inflammatory � Saliva stimulant � Healing agents

Medicated Lollipops 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

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.

Compounded Sterile Products Injections – aqueous and oil vehicles � B 12, 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 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 (Crohn’s disease) � Anesthetic, anti-inflammatory, steroid agents � Reported absorption route for many drugs � 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 Creams � Water-in-oil emulsions � Oil-in-water emulsions Ointments � Anhydrous vehicles: PEG, Petrolatum Gels � Carbomer, HEC, HPMC Sprays Specialty deodorant stick or lipstick forms Penetration agents to enhance effects

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

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

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 Abrams Royal Pharmacy Magnolia Pharmacy Community Pharmacy Oakdell Pharmacy Richie’s Pharmacy & Medical Specialty Compounding Texas Compounding Pharmacy Compounding Corner Pharmacy, Inc. ® Granbury Compounding Harvest Drug & Gift Hotze Pharmacy Thrifty Health & Compounding Pharmacy King’s Compounding Pharmacy True Custom Pharmacy Myers Drug, Inc. Unique Pharmaceutical Village Compounding Pharmacy

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

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 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 Therapy

Would you pass this car?

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

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

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

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.

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

Topical Pain Management

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

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 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: 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, healthsystems, 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 steveh@magnoliapharmacy. c om