Cash Formulation Ideas and Brainstorming

Why Compounding Options are Important Medication on backorder or unavailable Side effects of therapy; compliance Treatment failure with current therapy Combination customized prescription can target the problem with multiple mechanisms of action 2016. All Rights Reserved. 2

Why Compounding is Important Compounds offer a variety of clinical options with unique innovative bases and dosage forms Skyrocketing commercial drug prices! Insurance rejections with many commercial drugs Unaffordable copays 2016. All Rights Reserved. 3

Dermatology Warts Warts OTC products treatment failures 17% Salicylic acid gel 15% and 40% patches Office procedures: burning, freezing, surgical removal painful, frequently not effective 2016. All Rights Reserved. 4

Dermatology Warts PCCA Formula #4299 Salicylic acid 20% / Fluorouracil 5% / DMSO Topical Solution PCCA Formula #9403 Fluorouracil 5% / Salicylic Acid 15% / Cimetidine 5% /Deoxy D Glucose 0.2% Topical Lipoderm PCCA Formula #3873 Salicylic Acid 80% Topical Paste * Young S., Cohen GE Treatment of verruca plantaris with a combination of topical Fluorouracil and Salicylic Acid. J AM Podiatric Med Assoc. 2005 July Aug 95(4):366 9. 2016. All Rights Reserved. 6

Dermatology Warts Testimonial from the Apothagram: PCCA Formula #5615 (Cimetidine 10% / Deoxy D Glucose 0.29% / Ibuprofen 2% Topical Lipoderm ). We have many patients with warts come to us with a prescription for this formula, she says. Oftentimes, they are skeptical because they have had the wart for a long period of time, and so far, no other treatment has worked. I love that it is not harmful to the healthy skin surrounding the affected area, she says. We have never had a patient come back to us saying that this formulation hasn t worked! 2016. All Rights Reserved. 7

Dermatology Molluscum My daughter presented molluscum on her entire neck when she was seven years old. In addition to being really itchy and often painful, she was embarrassed with how it looked in such a visible area. We took her to the pediatrician who said that it could take 8 18 months to completely heal. After using the compounded preparation, my daughter s lesions cleared within four weeks. My little patient called it Annie s Miracle Cream since PCCA Pharmacy Consultant Annie DeReese, PharmD, developed the formula, PCCA Formula #11684 (Cimetidine 10% / Tea Tree Oil 2% / EGCg 1% / Deoxy D Glucose 0.2% Topical Anhydrous Lipoderm ), that helped get those bumps off of her! Another example of compounding to the rescue. PCCA Document #98294 Molluscum Contagiosum by Andrea Branvold, MS, RPh (Consultant's Corner, 01 10 Apothagram) 2016. All Rights Reserved. 8

Facial Hair (Hirsutism) Vaniqa Cost to pharmacy 45g ~$150 Must continue use for effects PCCA Formula #11760 Spironolactone 5% Topical Cream (Clarifying ) * We have a female patient who is on testosterone replacement therapy. Her physician also prescribed her oral spironolactone to help with her acne. She said she doesn't like the side effects from the spironolactone. * I GOT A PRESCRIPION SPIRONOLACTONE 5%+NIACINAMIDE 4% CREAM APP TO FACE BID WHAT IS THE FORMULA THANKS * HAVE PATIENT WITH PCOS. FACIAL ACNE IS SPIRONOLACTONE 5% TOPICAL CREAM THE ANSWER? ONCE OR TWICE A DAY? THANKS * Dermatology spironolactone 5% for acne with women with menopause, can it be used for balding 2016. All Rights Reserved. 9

Facial Hair (Hirsutism) PCCA Formula #12290 Finasteride 0.25% Facial Topical Cream (Clarifying ) Hirsutism Topical progesterone? Estriol? Possibly progesterone 1% with azelaic acid 1%, applying 0.25 0.5ml (amount used depends on size of area) 2016. All Rights Reserved. 10

Nail Fungus Commercial Topical Antifungal Nail Preparations Name API Size Potential Cost to Patient Jublia Efinaconazole 10% (topical solution) Umecta Urea 40% (topical emulsion) Kerydin Tavaborole 5% (topical solution) 4 ml ~ $550 7 oz ~ $240 300 10 ml ~ $1,300 See PCCA Document #99251 The Rising Costs of Nail Fungus Prescriptions 2016. All Rights Reserved. 11

Dermatology Nail Fungus PCCA Document # 99278 Compounding Options for Nail Fungus Consultant s Corner by Bruce Biundo Jublia (Efinaconazole 10% solution) 4ml ($645) / 8ml ($1290) 4 weeks post treatment was achieved in 17.8% and 15.2% of efinaconazole recipients compared to 3.3% and 5.5% of patients receiving the vehicle solution PO meds require monitoring of liver function enzymes and can have drug interactions 2016. All Rights Reserved. 12

Nail Fungus PCCA Formula #11839 Ketoconazole 2% / Urea 40% / DMSO Nail Suspension PCCA Formula #4337 Itraconazole 1% / Ibuprofen 2% / DMSO Nail Solution PCCA Formula #7993 Fluconazole 1% / Urea 20% Nail Lacquer PCCA Formula #5347 Itraconazole 1% / Undecylenic Acid 17% (W/V) / Tea Tree Oil 16.7%/ DMSO Nail Solution 2016. All Rights Reserved. 13

Nail Fungus (cont d) PCCA Formula #4462 Tea Tree Oil 5.4%/ Lavender Oil 1%/ Clotrimazole 1%/ Undecylenic Acid 5%/ Urea 5% Topical Cream PCCA Formula #10643 Terbinafine HCl 1%/ Fluconazole 3%/ Ibuprofen 2%/ Itraconazole 1% Nail Suspension 2016. All Rights Reserved. 14

Nail Fungus (cont d) PCCA Formula #11577 Ciclopirox 8% / Fluconazole 1% / Terbinafine HCl 1% Topical Gel PCCA Formula #12253 Ciclopirox 8% / Urea 40% Nail Gel PCCA Formula #0729 Ketoconazole 2% / DMSO Nail Solution PCCA Formula #11990 Itraconazole 1% / Terbinafine HCl 3% / Tea Tree Oil 6.6% / Urea 10% / Biotin 0.6% / DMSO Nail Suspension 2016. All Rights Reserved. 15

Dermatology Hair Loss PCCA Formula #10632 Minoxidil 8.5% / Finasteride 0.1% Scalp Solution PCCA Formula #10935 Minoxidil 10% / Finasteride 0.1% / Tretinoin 0.025% / Fluocinolone Acetonide 0.025% Topical Solution PCCA Formula #11196 Minoxidil 5% / Azelaic Acid 1.5% / Tretinoin 0.025% / Progesterone 0.25% / Finasteride 0.1% Topical Foam (VersaBase ) 2016. All Rights Reserved. 16

Dermatology / Cosmetic / Med Spa Melasma Tri Luma often unavailable 30 gram cost to pharmacy $100 PCCA Formula #10826 Fluocinolone Acetonide 0.01% / Hydroquinone 4% / Tretinoin 0.05% Topical Gel (PracaSil Plus) (BUD Study) Can use different strengths, bases * Torok HM, Jones T Hydroquinone 4% / Tretinoin 0.05% / Fluocinolone 0.01%: A safe and efficacious 12 month treatment for melasma. CUTIS 2005. Jan 75(1)57 62 2016. All Rights Reserved. 17

Dermatology Anesthetics Commercial anesthetics often not strong enough Lidocaine 5% Lidocaine 5% topical ointment (not cream) is very expensive (35gm $170, 50gm $190) PCCA Document #97181 Toxicities Associated with Topical Anesthetics (UPDATED December 2015) 2016. All Rights Reserved. 18

Dermatology / Cosmetic Topical anesthetics PCCA Formula #11652 Benzocaine 20% / Lidocaine 10% / Tetracaine 4% Topical Cream (VersaBase ) PCCA Formula #10117 Benzocaine 20% / Lidocaine 6% / Tetracaine 4% Topical Ointment (Plasticized ) PCCA Document #98634 Compounding Topical Anesthetics Formula Spotlight by Melissa Merrell, PharmD (09 13 Apothagram) 2016. All Rights Reserved. 19

Dermatology Psoriasis / Eczema Psoriasis / eczema PCCA Formula #11788 Zinc Pyrithione 0.2% / Clobetasol Propionate 0.05% / Cyanocobalamin 0.07% Topical Cream (XemaTop ) PCCA Document #99157 XemaTop in Psoriasis tissue * Sadeghian G1, Ziaei H, Nilforoushzadeh MA. Treatment of localized psoriasis with a topical formulation of zinc pyrithione. Acta Dermatovenerol Alp Pannonica Adriat. 2011;20(4):187 90. 2016. All Rights Reserved. 22

Dermatology Acne BenzaClin (Clindamycin 1% / Benzoyl Peroxide 5% gel) $300 $400 Benzamycin (Erythromcyin 5% / Benzoyl Peroxide 5% gel) $150 $450 * Reminder do not copy commercial products 2016. All Rights Reserved. 23

Acne Dermatology PCCA Formula #12065 Clindamycin 1% / Benzoyl Peroxide 5% / Niacinamide 5% Topical Cream (Clarifying ) PCCA Formula #11589 Benzoyl Peroxide 10% / Erythromycin 3% Topical Cream (Clarifying ) PCCA Formula #12064 Erythromycin 3% / Benzoyl Peroxide 5% / Biotin 0.1% Topical Cream (Clarifying ) 2016. All Rights Reserved. 24

Acne Documents PCCA Document #99132 How to Write a Compounded Prescription Dermatology Acne / Problem Skin (Clarifying Base) Rosacea PCCA Document #99184 Cash Friendly Options for Dermatological Compounding (Parts 1 & 2) Rosacea December Apothagram Consultant Corner by Nat Jones 2016. All Rights Reserved. 25

Dermatology Rosacea Metronidazole 1% gel 60 gm ($200 $250) Clarifying Base may help reduce the appearance of red blotchy skin often seen in patients with rosacea PCCA Formula #11709 Niacinamide 4% / Metronidazole 1% Topical Cream (Clarifying ) 2016. All Rights Reserved. 26

Dermatology Rosacea Compounded alternative for Azelaic Acid is Potassium Azelaoyl Diglycinate; use 1:1 PCCA Formula #11635 Niacinamide 5% / Biotin 0.1% / Potassium Azelaoyl Diglycinate 6% Topical Cream (Clarifying ) PCCA Formula #11639 Potassium Azelaoyl Diglycinate 15% / Niacinamide 5% Topical Cream (Clarifying ) 2016. All Rights Reserved. 28

Dermatology Soolantra (Ivermectin 1% cream) 30 gm ($400) Rejected by insurance Clarifying Base and niacinamide may help appearance of red blotchy skin PCCA Formula #11991 Ivermectin 1% / Niacinamide 4% Topical Cream (Clarifying ) 2016. All Rights Reserved. 29

Dermatology Vitiligo and Psoriasis Methoxsalen (Oxsoralen ) topical unavailable commercially PCCA Formula #0819 Methoxsalen 1% Topical Solution PCCA Formula #9336 Methoxsalen 0.6% Topical Ointment Capsules #50 $2500 FYI 2016. All Rights Reserved. 30

Dermatology Inflammation / skin infections Alcortin A, Vytone,Aloquin Hydrocortisone 2% / Iodoquinol 1% cream (#24 x 2 gram packets $3500!!) PCCA Formula #0438 Iodoquinol 1% / Hydrocortisone 0.5% Topical Cream PCCA Formula #2415 Iodoquinol 3% / Hydrocortisone 1% / Coal Tar Topical Cream In formula development: Iodoquinol combinations 2016. All Rights Reserved. 31

Dermatology Scars Scars PracaSil Plus PCCA Document #98719 Compounding Ideas / Formulations Marketing Sheet Scars PCCA Document #98678 PracaSil Plus Marketing & Repackaging / Labeling Guidelines 2016. All Rights Reserved. 32

We Need Your Help to Collect More Case Studies! PCCA Document #99237 Case Study / Reports Template, PCCA Science (WORD FILE EMAIL ONLY) Must use PCCA base Questionnaire Before / after pictures 2016. All Rights Reserved. 33

Dental Oral ulcers Apthasol no longer on market Amlexanox accelerates the healing of aphthous ulcers through an unknown mechanism. Although pain associated with aphthous ulcers is reduced, Amlexanox possesses no direct analgesic properties. 2016. All Rights Reserved. 35

MucoLox *Note Perceived by pharmacists as too expensive Quality of life is a huge factor at certain points Most common call is that patient needs pain control to last longer 2016. All Rights Reserved. 36

Mucositis Commercial products: Caphosol 900mL is $200 cost to a pharmacy PCCA Formula #5488 Calcium Chloride 0.052% Buffered Saliva Substitute PCCA Formula #11400 Supersaturated Calcium Phosphate Oral Rinse (MucoLox ) Recommended directions for use: 2 3ml four times a day. Hold for 2 minutes and expectorate. Begin at onset of cancer treatment May increase to up to 10 doses per day if pain from mucositis is experienced 2016. All Rights Reserved. 37

Commercial products: MuGard Mucositis 240mL is $550 cost to a pharmacy PCCA Document #98928 MucoLox Technical Report: Assessment of Mucoadhesive Properties of MucoLox Using a 3D Model of the Human Oral Mucosa 2016. All Rights Reserved. 38

Mucositis MucoLox Formulas Commonly Requested Formulas for Patients with Oral Mucositis Pain from Chemotherapy / Radiation PCCA Formula #11144 Stanford Modified Mouthwash (MucoLox ) PCCA Formula #11145 Stanford Mouthwash (MucoLox ) PCCA Formula #11133 Misoprostol 0.0024% / Diphenhydramine HCl 0.1% / Lidocaine HCl 1% Oral Rinse (MucoLox ) PCCA Formula #11128 Doxepin HCl 0.5% Mouthwash (MucoLox ) (FormulaPlus BUD Study) 2016. All Rights Reserved. 39

Mucositis MucoLox Formulas (cont d) Commonly Requested Formulas for Patients with Oral Mucositis Pain from Chemotherapy / Radiation PCCA Formula #11382 Lidocaine HCl 1% / Beta Glucan 0.5% / Dexpanthenol 1% / Vitamin E Acetate 2% / Glutamine 2% Popsicle (MucoLox ) PCCA Formula #11134 Misoprostol 0.0024% / Ketoconazole 1% Compound Oral Rinse (MucoLox ) PCCA Formula #11132 Lidocaine HCl 2% Oral Rinse (MucoLox ) PCCA Formula #11120 Beta Glucan 0.5% / Dexpanthenol 1% / Vitamin E Acetate 2% Oral Rinse (MucoLox ) 2016. All Rights Reserved. 40

Mucositis Oral ulcers Polyox 301 bandage Can add Misoprostol 0.0024% / Lidocaine 2% / Triamcinolone 0.1%, and Stevia (sweetener) * Ahluwalia A1, Baatar D1, Jones MK1, Tarnawski AS2. Novel mechanisms and signaling pathways of esophageal ulcer healing: the role of prostaglandin EP2 receptors, camp, and pcreb. Am J Physiol Gastrointest Liver Physiol. 2014 Sep 15;307(6):G602 10. doi: 10.1152/ajpgi.00177.2014. Epub 2014 Jul 24. 2016. All Rights Reserved. 41

Rectal Steroids Anucort HC, suppository Hydrocortisone 25mg generic may have availability problems and price range is unstable between #12, #24, #100 Rectal rockets, PCCA Formula #3515 Lidocaine 2% / Hydrocortisone 1% Base MBK / Wax Suppository (Rectal Rocket) * Vail J1. The rectal rocket: a two day treatment for hemorrhoids. Int J Pharm Compd. 2007 May Jun;11(3):194 9. 2016. All Rights Reserved. 43

Hospice Nausea PCCA Formula #9776 Lorazepam 1 mg/ml / Diphenhydramine HCl 12.5 mg/ml / Haloperidol 2 mg/ml / Metoclopramide 20 mg/ml Topical Lipoderm (BUD Study) * Bleicher J1, Bhaskara A. Lorazepam, diphenhydramine, and haloperidol transdermal gel for rescue from chemotherapy induced nausea/vomiting: results of two pilot trials. J Support Oncol. 2008 Jan;6(1):27 32 2016. All Rights Reserved. 45

Hospice (Nausea) Nausea PCCA Formula #11330 Chlorpromazine HCl 10% Topical Lipoderm PCCA Formula #8986 Ondansetron 4mg/0.1ml Lipoderm ActiveMax * Obata Y1, Ashitaka. A statistical approach to the development of a transdermal delivery system for ondansetron. Int J Pharm. 2010 Oct 31;399(1 2):87 93 2016. All Rights Reserved. 46

Hospice (Nausea) Nausea PCCA Formula #9491 Promethazine HCl 25mg/gm Topical Lipoderm (BUD Study) * Bassani AS,, Banov D Ms, Lehman PA Msc. Evaluation of the percutaneous absorption of promethazine hydrochloride, in vitro, using the human ex vivo skin model. Int J Pharm Compd. 2008 May Jun;12(3):270 3. 2016. All Rights Reserved. 47

Oncology Radiation burn PCCA Formula #11396 Ketoprofen 2% / Lidocaine 2% / Misoprostol 0.0024% / Phenytoin 2% / Aloe Vera 0.2% Topical Gel (PracaSil Plus) PCCA Document #98741 PracaSil Plus Case Study: Radiation Burn Skin PCCA Document #98870 PracaSil Plus Case Study: Open Wound Burn after radiation 2016. All Rights Reserved. 49

Oncology PCCA Document #97874 Compounding Ideas / Formulations Marketing Sheet Oncology PCCA Document #99083 Hand Foot Syndrome Consultant's Corner by Andy Glasnapp (11 15 Apothagram) PCCA Document #99174 Nutritional Support for Cancer Therapy Patients Consultant's Corner by Nat Jones (08 15 Apothagram) 2016. All Rights Reserved. 50

Pain Muscular pain PCCA Formula #10154 Magnesium Sulfate Heptahydrate 10% Topical Lipoderm ActiveMax Inflammatory pain PCCA Formula #9448 Ketoprofen 10% Topical Lipoderm (BUD Study) Can add cyclobenzaprine, baclofen Can add an anesthetic 2016. All Rights Reserved. 51

Pain Neuropathic pain PCCA Formula #10835 Ketamine HCl 5% / Gabapentin 10% / Clonidine HCl 0.2% Baclofen 2% Topical Lipoderm (BUD Study) * Tam E1, Fu. Transdermal lidocaine and ketamine for neuropathic pain: a study of effectiveness and tolerability. Open Neurol J. 2012;6:58 64. Epub 2012 Jun 28. 2016. All Rights Reserved. 52

Diabetic neuropathy Pain PCCA Formula #8541 Ketamine 10% / Gabapentin 6% / Clonidine 0.2% / Nifedipine 2% Topical Lipoderm PCCA Formula #11019 Ketamine HCl 10% / Gabapentin 6% / Tizanidine HCl 0.2% Nifedipine 2% Topical Lipoderm ActiveMax * Semenchuk MR1, Sherman S. Effectiveness of tizanidine in neuropathic pain: an open label study. J Pain. 2000 Winter;1(4):285 92. 2016. All Rights Reserved. 53

Pain PCCA Document #98006 Compounding Ideas / Formulations Marketing Sheet Pain Management PCCA Document #97967 Compounding Ideas / Formulations Marketing Sheet Podiatry PCCA Document #98742 How to Write a Compounded Prescription Pain Management 2016. All Rights Reserved. 54

Acyclovir PCCA Document #99136 Acyclovir Marketplace Changes Create New Opportunities for Compounders PCCA Document #99134 How to Write a Compounded Prescription Acyclovir (Herpes) 2016. All Rights Reserved. 55

General Compounding / Herpes Infection Genital herpes / fever blisters / shingles Zovirax 5% cream #5 gm ($650.00) Zovirax 5% ointment #30gm ($1200) Acyclovir 5% ointment (generic) #30 gm ($400) 2016. All Rights Reserved. 56

Formulas with Acyclovir Genital herpes PCCA Formula #11986 Acyclovir 5% / Lidocaine 2% Topical Cream (VersaBase ) PCCA Formula #11413 Acyclovir 5% / Lidocaine HCl 5% / Deoxy D Glucose 2% Vaginal Gel (MucoLox ) 2016. All Rights Reserved. 57

Side note: Commercial Product for Herpes Labialis Xerese Acyclovir 5% + hydrocortisone 1% cream A patient requested a petrolatum free base 5 grams ($1000.00) PCCA Formula #11989 Acyclovir 5% / Lidocaine 2% / Hydrocortisone 2.5% Topical Cream (VersaBase ) 2016. All Rights Reserved. 58

Formulas with Acyclovir Fever blisters PCCA Formula #0937 Acyclovir 5% / Lidocaine 1% Lip Balm Shingles PCCA Formula #11398 Acyclovir 5% / Ketoprofen 5% / Amitriptyline HCl 2% / Bupivicaine HCl 1% / Gabapentin 6% Topical Gel (PracaSil Plus) 2016. All Rights Reserved. 59

Vaginal Dryness (cont d) Non hormonal compounded alternatives PCCA Formula #11118 Hyaluronic Acid 5 mg/gm Compound Vaginal Gel (MucoLox /VersaBase Gel) PCCA Document #98289 Treatment Options for Vaginal Atrophy: What Do the New Studies Show? by Annie DeReese (Consultant's Corner, 01 11 Apothagram) 2016. All Rights Reserved. 62

Women s Health PCCA Documents #99227 Estrogen Vaginal Preparations Consultant's Corner by Andrea Branvold Herr (07 16 Apothagram) #99204 Women's Health and What You Need to Know by Sara Hover Consultant's Corner (05 15 Apothagram) 2016. All Rights Reserved. 63

Vulvodynia Prolonged contact time with the mucosa (MucoLox ) and multi drug therapy may be beneficial to help with pain (another quality of life example) PCCA Formula #11108 Amitriptyline HCl 2% / Baclofen 2% Vaginal Gel (MucoLox ) PCCA Formula #11109 Ketamine HCl 0.5% / Diazepam 1% / Baclofen 2% Vaginal Gel (MucoLox / VersaBase ) PCCA Formula #11110 Gabapentin 6% Vaginal Gel (MucoLox / VersaBase ) 2016. All Rights Reserved. 64

Women s Health PCCA Documents PCCA Document #97886 Compounding Ideas / Formulations Marketing Sheet BHRT PCCA Document #97920 Compounding Ideas / Formulations Marketing Sheet Female Sexual Dysfunction & Libido PCCA Document #98287 Compounding Ideas / Formulations Marketing Sheet Women's Health 2016. All Rights Reserved. 65

Vet Atopic Dermatitis and Complications Apoquel (oral) has been on short supply Options: PCCA Formula #12314 Tranilast 1% Topical Gel (ZoSil ) (Vet) PCCA Formula #12311 Pramoxine HCl 1% / Hydrocortisone 1% Topical Gel (ZoSil ) (Vet) PCCA Formula #12302 Diphenhydramine HCl 2% / Tranilast 1% Topical Gel (ZoSil ) (Vet) PCCA Formula #12080 Triamcinolone Acetonide 0.015% Topical Gel (ZoSil ) (Vet) 2016. All Rights Reserved. 66

Vet Atopic Dermatitis and Complications Apoquel (oral) has been on short supply Options: PCCA Formula #12402 Pramoxine HCl 1% Topical Spray (RheoSpray ) (Vet) PCCA Formula #12403 Tranilast 1% Topical Spray (RheoSpray ) (Vet) 2016. All Rights Reserved. 67

Veterinary Antibiotic ear gels PCCA Formula #10357 Enrofloxacin 2% / Ketoconazole 2% / Triamcinolone 0.5% Poloxamer Otic Gel PCCA Document #99094 PCCA VOD Overview #98537 Dog Ear Model 2016. All Rights Reserved. 68

Veterinary PCCA Document #98338 Compounding Ideas / Formulations Marketing Sheet Veterinary / Canine PCCA Document #98340 Compounding Ideas / Formulations Marketing Sheet Veterinary / Feline PCCA Document #98339 Compounding Ideas / Formulations Marketing Sheet Veterinary / Equine 2016. All Rights Reserved. 69