1. Pharmacy Compounding Meeting unique physician and patient needs Raylene L. Mote Pharm. D. Inland Compounding Pharmacy 24747 Redlands Blvd., Suite F 909 478-3842 Raylene @inlandcompounding.com © 2001 PCCA. All Rights Reserved.

2. What is Compounding? Compounding is the traditional 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 compounding lab, an injection for impotency, preparing medications for veterinarians, or providing natural 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. Pharmacy 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

6. Compounding As 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.

7. Manufacturing 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.

8. 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

9. The Triad Patient Physician Pharmacist The foundation of the profession…the key to compounding

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

11. Service Areas

12. Meeting unique needs in: Hospice Pain Management Natural Bio-identical Hormone Replacement Therapy Veterinary applications - Household pets - Equine - Zoos - Exotics Dental Dermatology

13. Meeting unique needs in: Podiatry Oncology Ophthalmology Pediatrics Neurology Nutritional Sports medicine And many more…..

14. Hospice Alternative routes of administration Individualized pain management Nausea & vomiting Inhalation therapy Emergency kits Mouth ulcers Saliva stimulants Adjunctive therapies

15. Bio-identical Hormone Replacement Therapy Same identical hormones as exist in human body Natural source Individualized therapy Avoidance of side effects Proven benefits Patient consultation

16. Compounding is Essential in Veterinary Medicine Lack of approved veterinary drugs Some human drugs inaccessible or no longer available –Discontinuation of commercial products by manufacturer Weight and species variations Compliance problems –Taste, dosage form, volume, smell

17. Veterinary Compounding (cont’d) Concentration of commercial products Efficacy of commercial products Appropriate product not available (several drugs not combined as vet needs) Appropriate vehicle may be irritating Resistance to available preparations

18. Dental Needs Hemostatics Bleaching gels Root canal & dry socket mixtures Topical anesthetics Pre-procedure sedatives Repository antibiotics for abscesses Plaque removal rinses Adhesives Sedatives

19. Podiatry Fungal infections Decubitus ulcers Diabetic neuropathy Circulation problems Warts and calluses Heel spurs Excessive perspiration Muscle and joint pain

20. Exercise and Sports Injuries Transdermal gels –NSAIDs –Muscle relaxants –Neuropathic agents –Speed Gels Iontophoresis Solutions Phonophoresis (Ultrasound) Gels Hank’s balanced salt solution Anesthetic sprays &gels Anti-fungals for athlete’s foot and jock itch

21. Dosage Forms

22. Compounded Dosage Forms Oral capsules and liquids Transdermals Lollipops and popsicles Troches, tablet triturates and sublingual drops Suppositories, enemas and rectal rockets Nasal and otic preparations Topical creams, ointments, gels, powders and sprays Oral adhesives, mouthwashes and rinses Sterile products –inhalation solutions, injections, ophthalmics, TPNs

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

24. 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.

25. Compounded Oral Liquids Difficulty swallowing –Medication not available as liquid –Infants, children, geriatrics, hospice Avoid unwanted ingredients –Free of dyes, sugar, alcohol and preservatives Increased compliance –Much more palatable preparations with choice of multiple sweeteners and flavors Anhydrous formulations –May be used if aqueous stability a concern

26. Customized Flavors for People and Pets Compounding pharmacists can provide more than 100 human and pet flavors to satisfy patients.

27. 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

28. Transdermal Drug Delivery Drug Classes Used in Transdermals Analgesics Narcotics Non-narcotics Atypical analgesics –Sympatholytic agent –NMDA-Calcium channel blocker –AMPA-Sodium channel blocker –Alpha agonist –Gaba agonist –Mu agonist –Substance P blocker

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

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

31. Transdermal Drug Delivery Drug Classes Used in Transdermals Agents used for –Autism –Erectile dysfunction –Psoriasis –Arthritis –Migraine headaches –Cancer –Veterinarian use

32. Medicated Lollipops Local effects –Anesthetic –Anti-fungal –Antiviral –Anti-inflammatory –Saliva stimulant –Healing agents

33. Medicated Lollipops Systemic effects –Anti-anxiety –Antipyretic –Analgesic Narcotic Non-narcotic

34. Medicated Lollipops Combination effects –Smoking deterrent –Cold preparations Cough suppressant Decongestant Antihistamine Sore throat –Antibiotic –Antihistamine

35. Troches Soft gelatin-flavored troches, like gummy bears, or chewable troches, provide medication in an easy-to-take and good tasting form.

36. Troches Local effects for better therapeutic outcome –Antiviral or antifungal Anti-inflammatory –Anesthetic Healing agents –Saliva stimulant Sublingual / buccal absorption –Convenience –Faster onset of action –No “first pass” effect –No stomach acid degradation

37. Tablet Triturates Rapid onset –Migraine headache –Emesis (canine use) –Erectile dysfunction Sublingual absorption –No first pass effect –No stomach acid degradation Cost effective Convenient

38. Compounded Sterile Products Injections -- aqueous and oil vehicles Ophthalmics -- solutions, suspensions, sprays, and ointments TPNs and IV admixtures Inhalation solutions –Combine multiple ingredients to improve compliance Irrigating solutions

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

40. Suppositories and Enemas Rectal or vaginal use Difficulty in swallowing Nausea/vomiting Injections cause pain, anxiety Rapid local affect –Hemorrhoids –Irritable Bowel Syndrome (Crohn’s disease) –Anesthetic, anti-inflammatory, steroid agents Good absorption route for many drugs –Prevents 2/3 of first pass effect

41. Topical Sticks and Tubes Dispensing medication in deodorant stick or chapstick-like containers allows the patient to self-administer drugs easily for PRN doses. Tubes allow creams, ointments and gels to be relatively light and oxidation free.

42. Medicated Powders Try a combination of an antifungal, antibiotic, antiviral, steroid and an anesthetic with an oral adhesive for canker sores or other oral lesions.

43. 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

44. The Polyox Bandage Designed for oral use Superior oral bandage –Stays in place for hours even if “rubbed” Used for any drug therapy desired –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

45. 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) Combine anesthetic and anti-inflammatory drugs, or use for healing

46. Nasal and Otic Preparations Nasal –Rapid absorption of drug –Pump metered spray bottle delivers accurate dose of drug –Studies show good absorption route Otic –Anhydrous vehicles PEG, Sweet Oil, Propylene Glycol, Glycerin –Combine multiple medications Anesthetic, anti-inflammatory, anti- biotic, anti-fungal, anti-viral, steroid, etc. Gels –Carbomer, HEC, HPC, HPMC

47. Compounded Inhalation Solutions Combination therapies for improved compliance Formulations not commercially available Veterinary applications

48. Medication Baby Bottle The medication baby bottle is an effective device to get accurate doses into an infant.

49. Compounding Equipment

50. Electronic (Digital) Balance This device is absolutely necessary for efficient and accurate compounding.

51. Capsule Machine The capsule machine provides pharmacists with a better way to make capsules. It is designed to avoid labor-intensive hand-punching, and accommodates oil-filled capsules, with the capacity to make up to 100 capsules at a time.

52. Troche Mold This dosage form provides rapid sublingual administration in a variety of flavors.

53. Tube Sealer The tube sealer provides an efficient way to seal plastic tubes, bags, suppository shells and sleeves.

54. Electronic and Electro Mortar & Pestles The electronic and electro mortar & pestles provide pharmacists with the modern way to compound creams, gels, ointments and suspensions.

55. Ointment Mill The ointment mill mixes powders, crystals and creams into a smooth, finished product.

56. Homogenizer A homogenizer is a high-performance dispersing instrument suited to a variety of applications, including the reduction of particle size for suspensions (including parenteral compounds) and lotions.

57. Lollipop Mold The lollipop mold enables pharmacists to make lollipops with a variety of substances, such as sorbitol, gelatin, polyethylene glycol and sucrose bases.

58. Rectal Suppository Mold The rectal suppository mold can be used to make six suppositories at a time. The shape of the suppository ensures that it will stay 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 the body for up to six hours. The air vent is created using a removable metal plate which aids in removing the suppositories from the mold.

59. Filtration System The large volume filtration system can be used for aqueous and non-aqueous (oil) solutions.

60. Flow Hood The flow hood enables pharmacists to conduct various types of sterile compounding, such as chemo, ophthalmic or injectable medications.

61. Questions??? For more information, please call Raylene Mote at (909) 478-3542 or e-mail raylene@inlandcompounding.com. © 2001 PCCA. All Rights Reserved.