What Do You know About Compounding? The Future of Personalized medications

Transcription

1 What Do You know About Compounding? The Future of Personalized medications MAZEN BAISA, PharmD, MBA, ABAAHP, FAARM, CPE, FACA Director of Clinical Services BioMed Specialty Pharmacy The following potential conflict of interest relationships are germane to my presentation: Equipment: None Speakers Bureau: Fagron Academy Stock Shareholder: None Grant/Research Support: None Consultant: None Employment: Biomed Specialty Pharmacy-Cincinnati CPE, FACA Objectives Discuss what compounding is and the different types of compounds Describe the NECC Incident Discuss compounding measures and techniques for safety and quality products Discuss the pharmacology and use of medications for the management of pain, various dermatologic conditions, and BHRT Personalized Medicine Has This Ever Happened to You? Your patient needed a medication that has been discontinued or on a shortage? Your patient is allergic to preservatives, dyes or binders? Your patient treatment requires tailored dosage/ strengths/route? Your patient needed several medications to be combined to increase compliance? Your patient cannot swallow pills? CPE, FACA 1

2 NECC and The Meningitis Outbreak Compounding Federal Regulations Compounding Federal Regulations Compounding Michigan Regulations CPE, FACA 2

3 Compounding Standards Office Use Under the New FDA Rules Current Good Manufacturing Practices (cgmps) Good Compounding Practices (GCPs), formerly known as <1075> Now incorporated into: <795> and <797> USP Standards ( e.g., 795 and 797) State Boards of Pharmacy (Laws and Regulations) Third Party Accrediting Organizations (e.g., PCAB) Your Organizations and Practice Standards Mediocrity vs. Excellence How Important is PCAB? AMA and PCAB PCAB and the VA The U.S. Department of Veterans Affairs only contracts with PCAB accredited compounding pharmacies (VAhandbook1108(08)(k)(2)) CPE, FACA 3

4 USP Chapter 795 and Documentation Compounding Equipment Examples USP <795> Non-Sterile BUD Guidelines Process Verification! In the absence of stability information that is applicable to the specific drug and preparation, the above maximum BUDs are recommended for non-sterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature Continuous Quality Improvement From Good to Bad! VIDEO CPE, FACA 4

5 Compounding: Fulfilling the Unmet Needs Pain BHRT Derm Not a Good Day! Pain DEA and Doctors Pain: The Silent Enemy Heart Disease 12mill CPE, FACA 5

6 Suicidality and Pain Is This Painful? Quality of Life Psychological Morbidity NSAIDs Related Hospitalizations and Deaths Concerns with Oral Pain Rx Renal Cancer Healthcare Intelligence Network Opioids: Things to Worry About The Opioids Dilemma CPE, FACA 6

7 Number of Painkiller Rxs/Person The Opioids Epidemic Under the proposed rule changes, CMS would be allowed to take administrative action against beneficiaries, physicians and pharmacies when a pattern or practice of abusive prescribing is identified. Most Invasive Risk Continuum Interventional techniques Injections Oral medications Topical medications Why would one expose The entire body to the drug if it s only needed in a specific area (e.g., Feet)? Least Invasive CPE, FACA 7

8 Peripheral Nociception Application Route Considerations Micelle/Liposomal Drug Delivery Advantages of Topical Pain Compounds Lowers systemic absorption Combine various medications Direct delivery to pain receptors Avoid first-pass effect & Reduces organ toxicity Produces fewer side effects More advantages of Topical Pain Compounds Treatment Options Lowers adverse drug interactions Minimizes abuse and addiction Reduces opioids tolerance Documented effectiveness and results Improved patient compliance Vol.4 No.1 January/February IJPC CPE, FACA 8

9 Plasma Concentrations of Ketoprofen After Topical and Oral Administration Pain Formulas Examples Musculoskeletal Diclofenac 3%/ DMSO 10%/ Gabapentin 6%/ Amitriptyline 2% Cyclobenzaprine 2%/ Lidocaine 4% Neuropathic Pain with Spasm Ketamine 10%/ Gabapentin 6%/Amitriptyline 2%/ baclofen 2%/cyclobenzaprine 2%/ Diclofenac 3% Lidocaine 5% General Pain Diclofenac 3%/ Gabapentin 6%/Lidocaine 2%/ Prilocaine2% AAPS PharmSciTech. Mar 2010; 11(1): How Are You Feelin? Bio-identical Hormones (BHRT) The Art of Aging Hormones Control cells proliferation, protein manufacture & metabolic rate Most powerful molecules in our bodies Optimal levels essential for health and quality of life Source- The American Academy of Antiaging Medicine CPE, FACA 9

10 Bio-identical Hormone Restoration is Common Sense If a hormone is missing, replace it! If present but insufficient, optimize it! Type 1 Diabetes: bioidentical insulin Hypothyroidism: bioidentical T 4 Growth hormone def.: bioidentical GH Adrenal insufficiency: bioidentical cortisol But what about hormones lost to aging? Estrogen deficiency Hot flashes Sleep disturbances Dry skin Foggy thinking Heart palpitations Painful intercourse Low libido Night sweats Vaginal dryness/atrophy Headaches Memory lapses Yeast infections Depression Bone loss Deficiency Symptoms Progesterone deficiency Swollen breasts Headaches Anxiety Irregular menses Cramping Infertility Acne Weight gain Low libido Mood swings Depression PMS Fuzzy thinking Joint Pain No Two Patients Are Alike Individual differences in biochemistry, genetic influence, and environmental influences must be considered Bioidentical (Human identical) Hormones) The Bioidentical Hormones Debate Are chemically converted from yams or soy and are identical in composition and function to human hormones Are not patentable Have been used in Europe (and the US) for over 60 years Have been extensively researched Estradiol, progesterone, and testosterone are FDA approved drugs In balance, they do NOT have the same risks as commercial HRT CPE, FACA 10

11 In Biochemistry little changes can make a big difference Premarin Conjugated Equine Estrogens (CEE) Human Horse Estradiol 17β Dihydroequilin 17β CEE contains at least 10 estrogens, only 3 are human. CEE contains 3x more Dihydroequilin than Estradiol. DHE has 10% higher binding affinity for est. receptors. DHE binds far less to SHBG and has a slower metabolic clearance The most abundant estrogen in CEE is Equilin sulfate. Kuhl H, Climacteric 2005;8(Suppl 1):3 63 Progesterone vs. Progestins Progestin Zoo Progesterone MPA (Provera ) Megestrol Progesterone Every progestin has a different spectrum of androgenic, estrogenic, glucocorticoid, and progestational effects! Kuhl, Climacteric 2005;8(Suppl 1) Metabolism pathway CPE, FACA 11

12 Transdermal versus Oral Estrogen BHRT Compound Rx Order ( e.g.,) J Womens Health (Larchmt) Feb;21(2): doi: /jwh Epub 2011 Oct 19 Curr Opin Hematol Sep;17(5): doi: /MOH.0b013e32833c07bc Why Bio-identical Hormones? Individualized therapies Multi- hormones combinations Various dosage forms More affordable Athlete's Foot It produces a rash and may cause the skin to peel, burn, crack, or become scaly The scale on the plantar surface impedes or limits the absorption of the traditional antifungal agent Dermatology CPE, FACA 12

13 Athlete s Foot Various synergistic combinations are used for antifungal therapy Warts Resistant warts have been treated successfully with compounded topical medications avoiding discomfort associated with freezing, scraping, electrocautery and laser therapy Formula example- Urea 20% + Lactic Acid 2% + Salicylic Acid 5% + Vitamin E1% + Ciclopirox 0.55% cream Warts Warts Compound formula may include: Acyclovir - Inhibits viral growth Deoxy-D-Glucose (DDG) - a glucose analog with antiviral activity inhibiting viral replication Salicylic Acid - keratolytic agent softens the skin layers that form a wart 5 Fluorouracil Chemotherapy agent that prevents viral cell replication Beta Glucan- Immune system booster Wart Cream Salicyclic Acid 5% + Acyclovir 5% + 2-Deoxy-D-Glucose 1% + Ibuprofen 2% + Beta Glucan 0.1% + 5 Fluorouracil 2.5% Applied to wart area twice a day, cover with band aid Wounds Wound Types Surgical wounds Pressure ulcers Diabetic ulcers Burns Trauma wounds CPE, FACA 13

14 Anesthetic Bupivacaine HCI Lidocaince HCI Prilocaine HCI Antifungal Fluconazole Itraconazole DEBRIDING Collagenase Papain Urea Treating wounds prophylactically with antiinfective, antifungal, debriding, anesthetic, vasodilators and proliferative agents may help the body s natural wound healing process, reduce additional complications and subsequent doctors visits Proliferative Remodeling Allantoin Aloe Vera Beta Glucan Hyaluronic Acid Phenytoin Antiinfective Clindamycin HCI Gentamicin Sulfate Levofloxacin Metronidazole Mupriocin Tobramycin Vancomycin Acne Hyperhidrosis Psoriasis Eczema Many more Other Derm Conditions Vasodilators Nifedipine Pentoxifylline Verapamil Choosing Your Compounding Specialist What's their expertise? Do they comply with the regulations? What type of equipment do they use? What are the sources of their chemicals? Do they conduct testing and quality control? What type of bases do they utilize? What kind of support do they provide? CPE, FACA 14