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?