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Elaine Ladd, PharmD, ABAAHP April 9, 2016

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Presentation on theme: "Elaine Ladd, PharmD, ABAAHP April 9, 2016"— Presentation transcript:

1 Elaine Ladd, PharmD, ABAAHP April 9, 2016
Achieving Patient-Focused Care and Innovative Solutions through Compounding Elaine Ladd, PharmD, ABAAHP April 9, 2016

2 This Talk Will Cover… Definition of compounding
Differentiating dosage forms based on patient needs Identifying how to writing for a compound

3 What is Compounding?

4 General Description Individualized unique medications, dosages, and delivery systems. Compounders work closely with practitioners and patients to solve medication related problems.

5 What is Pharmaceutical Compounding?
The custom preparation of medications –designed to meet individual patient needs. Combines legally obtainable ingredients and/or appropriate vehicles, which have not been specifically excluded from human or animal use by the FDA, USDA, or EPA.

6 THE TRIAD Pharmacist Practitioner Patient
Professional information exchange. Problem solving

7 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 Administering the drug to the sight of action in the most effective dosage form available

8 Why is pharmaceutical compounding important to medical practice?
Limited availability of medications in various dosage forms or strengths. Ability to prepare custom doses, combination medications, and drug delivery systems Palatability →convenience → compliance → better outcomes Discontinued medications.- Medications often brought back years later in new formulation and higher prices.

9 Importance- continued
Only resource for obtaining medication that is Dye-free, Preservative-free, Sugar-free, or Flavor-free. Providers may want to create something unique and exclusive for their practice

10 How to Choose a Compounding Pharmacy?

11 Fear, Understanding, Doubt (FUD)
Ask questions like these listed below. X Is your staff properly trained and evaluated in non-aseptic manipulation skills, gowning technique and compounding room use? Do you have systems in place for handling complaints and investigating adverse events? Do you purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers? Do you obtain Certificate of Analyses for all formula ingredients? Do you maintain both master formulas and lot-specific worksheets for all compounds? Can you immediately trace a prescription back to the original formula log sheet and the source of ingredients? Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist? Do you verify the potency of finished compounds via weight, volume and yield checks and can share the results within 48 hours? Are your pharmacists, technical and customer care staff dedicated to compounding?

12 PCAB Accreditation Mission: to promote, develop, and maintain principles, policies and standards for the practice of pharmacy compounding in the public interest and to apply these in the accreditation of pharmacies that offer pharmacy compounding to improve the quality and safety of pharmacy compounding provided to the general public. Why this is important: Standard operating procedures QA: Routine potency testing, CQI program, quality chemical Exceeding the minimum requirements This is how you know that formulations are prepared with the highest of quality standards.

13 Safety Measures

14 End product testing/Quality Control
Eagle Analytical (Houston, TX) Validate formulations Validate aliquots Validate potency Validate performance reliability and accuracy

15 Unguator This electronic mortar and pestle can mix at speeds of up to 2,500rpms for any programmed time. It also allows us to dispense the finished preparation in the actual mixing container which is fitted with a "varionozzle" to reduce the size of the dispensing opening. The bottom of the jar is pushed "up" thereby expressing the cream or gel, through the opening. It therefore has the characteristics of a tube and jar, providing a very hygienic delivery system that also provides added protection to the cream, ointment or gel, which ensures the life of the finished preparation. 15

16 Resonant Acoustic® Mixer (RAM)
Low frequency, high-intensity acoustic energy combined with G-Force Thoroughly and accurately powders with repeatable results from mix-to-mix

17 Bar coding For Accuracy
To ensure accuracy we use a barcoding system which insure that my lab technicians choose the correct formula and the correct chemicals the balances are tied into the system so that we know exactly the qty weight out.

18 Overview of Dosage Forms

19 Dosage Forms Oral suspensions & capsules Creams, ointments & lotions
Transdermal gels Troches, lozenges, chap sticks & lollipops Otic medications Rectal Rockets and suppositories Inhalations Nasal sprays or solutions Bandages

20 Dosage Forms Topi-Click Applicator Syringes, Troches Tetracaine Sucker
Sterile Preparation 20

21 The accordion puffer for mucosal and wound bandage
Mucosal Bandage Anesthetics Antifungals Antibiotics Steroids We use this accordion puffer for wide variety of problem especially the ENT drs. \ The base that we mostly use for dentists is what we call mucosal bandage. A poly ox base similar to denture adhesive.

22 The accordion puffer for mucosal and wound bandage

23 Flavors to Mask Unpleasant Tastes
Sour Raspberry Pineapple Oily (almond/veg/cod liver oil) Aromatic rhubarb Sasparilla Wintergreen Peppermint Lemon/orange Anise Salty Citric acid Raspberry Cinnamon Chocolate Orange Bitter Acacia Licorice

24 Flavored Oral Medication
Suspensions/Solutions Flavored Oral Medication Antibiotics Mouth Rinses Antifungals

25 Lollipops Unique dosing method. Patient control. Convenient. (Sugar-free sorbitol candy) Tetracaine, Lidocaine, Nicotine, Ginger, Anti-fungals

26 Sprays Mouth Sprays tetracaine Lip Balms Clotrimazole
DDG (natural anti-viral) Custom blends of lip balms with antiviral, antibiotics, anesthetics etc. Sunscreans can be added.

27 Capsules, Rapid Dissolve and Sublingual Tablets
Oil-filled (Vitamin E oil) Powder (microcrystalline, ginger) Sublingual tablets, RDT Dissolve under tongue – to 15 minutes Goes into blood stream, avoids first-pass metabolism Do not drink or eat for minutes

28 Flavored Oral Medication
Troche Flavored Oral Medication Pilocarpine – Dry Mouth Electrolyte – Dry Mouth Anesthetics – Pain A wide variety of medication in a wide variety of flavors. Typically like a gummy bear like base that melts slowly in the mouth to deliver medication directly to the mucosa.

29 Rectal Rocket

30 Transdermal Bases Used for absorption through the skin

31 Transdermal Gels Gels form liposomes that carry the drug down between the cells of the dermis and epidermis. Transdermal gels can be used to carry pain medications into muscles and nerves, or to carry hormones into the blood stream or fat layer for slower release.

32 Liposomes

33 Medications used in Transdermal Gels for Pain Management
Ketoprofen (10-50%) Diclofenac (1-10%) Ibuprofen (10-40%) Indomethocin (10-40%) Piroxicam (0.5-2%) Guaifenesin (10-40%) Bupivicaine (2-5%) Lidocaine (2-10% Tetracaine (0.5-10%) Ketamine (5-10%) Amantadine (5-20%) Orphenadrine (5-10%) Haloperidol (0.5-2%) Gabapentin (5-10%) Carbamazepine 5% Phenytoin (2-10%) Clonidine ( %) Morphine (1-5%) Cyclobenzaprine (1-3%) Amitriptyline (2-10%) Baclofen 2% Nifedipine (2-16%) Dextromethorphan (5-10%)

34 Topical Bases Ointments Creams Lotions Pastes Gels Sprays and Foams

35 Topical Bases Used for conditions on the surface of the skin with the exception of BHRT

36 Prescription Problems Solved!

37 What Challenges Do You Face?

38 Example: Xerostomia Pilocarpine Electrolyte troches Sublingual drops
Sublingual tablets Lollipops Rectal gels Suppositories Electrolyte troches Sodium chloride Potassium chloride Calcium lactate Magnesium sulfate Sodium bicarbonate Sodium phosphate

39 Components of a Compound Rx
Generic drug name – NEVER use branded product name Dose patient is to take Pharmacist can determine concentration/strength if needed 5% = 50mg/gram Gram = ml = cc Directions Never use “UD” DAW Day supply Refills

40 Creating Solutions

41 Pharmacists are a Resource
Call with questions and ideas They may not always know, but have MANY ways to find out With the patient, pharmacist and practitioner working together, prescription problems can be solved

42 Questions?


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