Pharmacy Compounding Meeting the unique needs of your patient

1. Pharmacy Compounding Meeting the unique needs of your patient Steve Hoffart, Pharm. D. Owner, President steveh@magnoliapharmacy.com

2. What is Compounding? • Compounding is the method of preparing customized medications to help meet unique physician and patient needs.

3. 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.

4. 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.

5. 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 patient’s needs • Administer the drug to the sight of action in the most effective dosage form available

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

8. 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

9. 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

10. 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

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

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

13. Capsules • Bio-Identical Hormones • Thyroid Replacement • Low Dose Naltrexone • Nonconstipating Iron Replacement • Quinine/Magnesium Combo

14. 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.

15. 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

16. Customized Flavors for People and Pets Compounding pharmacists can provide hundreds of individual flavors and endless combinations to satisfy human and pet patients.

17. 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

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

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

20. Transdermal 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

21. Medicated Lollipops • Local effects • Anesthetic • Antifungal • Antiviral • Anti-inflammatory • Saliva stimulant • Healing agents

22. Medicated Lollipops • Systemic effects • Anti-anxiety • Antipyretic • Analgesic • Narcotic • Non-narcotic

23. Medicated Lollipops • Nicotine lollipops for smoking cessation • Tetracaine lollipops for sore throat pain • Phentermine lollipops for weight loss

24. 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.

25. 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

26. Suppositories

27. Suppositories Putting medicine into suppositories allows the patient who can’t swallow to receive the required drug.

28. 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

29. Medicated Powders Any combination of an antifungal, antibiotic, antiviral, steroid or an anesthetic with an oral adhesive could be compounded.

30. 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

31. 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

32. 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

33. Quality & Confidence in Compounded Products

34. 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

35. PCAB 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 • OakdellPharmacy • Richie’s Pharmacy & Medical • Specialty Compounding • Texas Compounding Pharmacy • Thrifty Health & Compounding Pharmacy • True Custom Pharmacy • Unique Pharmaceutical • Village Compounding Pharmacy

36. 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

37. 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.

38. 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

39. Bio-Identical Hormone Restoration Hormone Restoration Therapy

40. Would you pass this car?

41. 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

42. 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

43. 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

44. 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.

45. 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

46. Topical Pain Management

47. 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

48. 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.

50. Transdermal - Ingredients