1. Compounding

2. COMPOUNDINGCOMPOUNDING Compounding: the preparation, mixing, assembling and packaging or labeling of a drug or device. Extemporaneous Compounding: the on- demand preparation of a drug product according to a physician’s prescription, formula or recipe. Compounding: the preparation, mixing, assembling and packaging or labeling of a drug or device. Extemporaneous Compounding: the on- demand preparation of a drug product according to a physician’s prescription, formula or recipe.

3. 3 Compounding (continued) Nonsterile compounding: done on countertop Common items: creams, ointments, oral suspensions Less common: capsules, suppositories, syringes Nonsterile compounding: done on countertop Common items: creams, ointments, oral suspensions Less common: capsules, suppositories, syringes

4. 4 Compounding Customized medications: elixirs, suspensions, ointments, creams, lotions, capsules, tablets, suppositories Made in specialized compounding pharmacies Solutions Elixirs, suspensions, tinctures Flavoring commonly added to improve taste Customized medications: elixirs, suspensions, ointments, creams, lotions, capsules, tablets, suppositories Made in specialized compounding pharmacies Solutions Elixirs, suspensions, tinctures Flavoring commonly added to improve taste

5. 5 Common Types of Equipment Mortar (dish portion) and pestles (grinding portion) can be glass or porcelain Other compounding station equipment: filter paper, spatulas, beakers/graduated cylinders, glass stir sticks, glass compounding slab, blender, funnel, sink, solvents Mortar (dish portion) and pestles (grinding portion) can be glass or porcelain Other compounding station equipment: filter paper, spatulas, beakers/graduated cylinders, glass stir sticks, glass compounding slab, blender, funnel, sink, solvents

6. 6 Equipment (Continued) Balance scales –Weigh powders –Differ in range of weight and style Electronic scale: –Digital readout of weight –Calibrations are electronic Balance scales –Weigh powders –Differ in range of weight and style Electronic scale: –Digital readout of weight –Calibrations are electronic

7. TYPES OF SCALES Class A Scale –6 mg sensitivity –Accurately weighs between 120 mg and 15 gm Class B Scale –30 mg sensitivity –Accurately weighs between 650 mg and 120 gm Class A Scale –6 mg sensitivity –Accurately weighs between 120 mg and 15 gm Class B Scale –30 mg sensitivity –Accurately weighs between 650 mg and 120 gm

8. 8 Expiration Dates Stability of drug affected by light, air temperature, pH Expiration date found in manufacturer’s literature or compounding books Stability of drug affected by light, air temperature, pH Expiration date found in manufacturer’s literature or compounding books

9. 9 Packaging Containers must: –Be appropriate size –Protect contents –Have childproof caps (not for jars and syringes) –Have appropriate labels Containers must: –Be appropriate size –Protect contents –Have childproof caps (not for jars and syringes) –Have appropriate labels

10. 10 Packaging Syringes –Used to prepare vaginal compounds –Drug loaded in barrel of syringe, cap placed over top Suppository –Base: wax and mineral oil –Made in molds Syringes –Used to prepare vaginal compounds –Drug loaded in barrel of syringe, cap placed over top Suppository –Base: wax and mineral oil –Made in molds

11. 11 Packaging Other containers: –Glass and plastic bottles –Dropper bottles –Jars Other containers: –Glass and plastic bottles –Dropper bottles –Jars

12. 12 Preparation Pharmacies: countertop station for compounding products Technician responsibilities: clean items, ensure good working order Long hair tied back Lab coat and gloves worn No illness, no open wounds Pharmacies: countertop station for compounding products Technician responsibilities: clean items, ensure good working order Long hair tied back Lab coat and gloves worn No illness, no open wounds

13. 13 Preparation (Continued) Recipe book or formula cards: list compounds, weights, step-by-step instructions for common items Additional ingredients: sweeteners, flavorings (such as berry, lemon, or grape), colorings Recipe book or formula cards: list compounds, weights, step-by-step instructions for common items Additional ingredients: sweeteners, flavorings (such as berry, lemon, or grape), colorings

15. 15 Record-keeping Documentation of records under quality assurance of FDA guidelines Documents kept for 3 years from time medication was prepared Documentation of records under quality assurance of FDA guidelines Documents kept for 3 years from time medication was prepared

16. 16 Techniques for Compounding: Weighing Components of typical balance: –Paper and weights –Tweezers for grasping metal weight –Arrest knob locks balance in place Components of typical balance: –Paper and weights –Tweezers for grasping metal weight –Arrest knob locks balance in place

17. 17 Techniques for Compounding: Measuring Pharmacy balances are sensitive –Airflow—keep to minimum –Glass lid cuts air currents Spatula: used to pick up small amounts; lightly tapping to flick few granules at a time Compounding: time consuming, accuracy important Pharmacy balances are sensitive –Airflow—keep to minimum –Glass lid cuts air currents Spatula: used to pick up small amounts; lightly tapping to flick few granules at a time Compounding: time consuming, accuracy important

18. 18 Measuring cont’d Liquids: simple steps to ensure proper volume –Water molecules will cling to sides of container –Have liquid at eye level –Read at bottom of liquid line (meniscus) Liquids: simple steps to ensure proper volume –Water molecules will cling to sides of container –Have liquid at eye level –Read at bottom of liquid line (meniscus)

19. 19 Compounding Techniques Ointment: hydrophobic base – Petroleum jelly mixed with drug Creams: hydrophilic base –Eucerin, Aquaphor Ointment: hydrophobic base – Petroleum jelly mixed with drug Creams: hydrophilic base –Eucerin, Aquaphor

20. 20 Compounding Techniques (Continued) Capsules –Punch method techniques slow and arduous –Capsule machines load capsules quickly and accurately Capsules –Punch method techniques slow and arduous –Capsule machines load capsules quickly and accurately

21. LAMINAR FLOW HOODS Establishes and maintains an ultraclean work area for the preparation of IV admixtures.

22. How the Flow Hoods Operate 1.Room air is drawn into a prefilter to remove relatively large contaminants, such as dust or lint. 2.The air is then channeled through a high efficiency particulate air (HEPA) filter that removes even smaller particles (microns). 3.The purified air then flows over the work surface. 4.The constant flow of air from the hood prevents room air from entering. 1.Room air is drawn into a prefilter to remove relatively large contaminants, such as dust or lint. 2.The air is then channeled through a high efficiency particulate air (HEPA) filter that removes even smaller particles (microns). 3.The purified air then flows over the work surface. 4.The constant flow of air from the hood prevents room air from entering.

23. TYPES OF FLOW HOODS Vertical Hood –Air flows from the top to the bottom –Most of the purified air leaves the front of the hood but some does exit the back and sides. Horizontal Hood –Air flows from the back towards the front, where the operator is. –This prevents room air from entering the hood. Vertical Hood –Air flows from the top to the bottom –Most of the purified air leaves the front of the hood but some does exit the back and sides. Horizontal Hood –Air flows from the back towards the front, where the operator is. –This prevents room air from entering the hood.

24. MAINTAINENCE OF HOODS Should be kept on at all times. If it shuts down it must be in operation for 30 mins before use. Wipe the hood with 70% isopropyl alcohol ONLY!!! Should be cleaned at the beginning of the shift and when a spill occurs. Should be kept on at all times. If it shuts down it must be in operation for 30 mins before use. Wipe the hood with 70% isopropyl alcohol ONLY!!! Should be cleaned at the beginning of the shift and when a spill occurs.

25. Check for Understanding Discuss with your neighbor…. What factors would a pharmacy need to consider when deciding whether to offer compounding services? Possible Answers: Involves financial, staffing, inventory, and customer demand considerations. Pharmacist must be willing to be trained and continue education in compounding skills. Pharmacist must be willing to be engaged in physician-patient-pharmacist relationship with intended goal of providing customized meds. Some financial investment: site renovations and purchasing of compounding equipment. Will have to maintain inventory of raw drug chemicals. Will be necessary to have access to or develop compounding formulas. Pharmacist will need to be committed to take the time necessary to compound correctly, including training and supervision of technicians Discuss with your neighbor…. What factors would a pharmacy need to consider when deciding whether to offer compounding services? Possible Answers: Involves financial, staffing, inventory, and customer demand considerations. Pharmacist must be willing to be trained and continue education in compounding skills. Pharmacist must be willing to be engaged in physician-patient-pharmacist relationship with intended goal of providing customized meds. Some financial investment: site renovations and purchasing of compounding equipment. Will have to maintain inventory of raw drug chemicals. Will be necessary to have access to or develop compounding formulas. Pharmacist will need to be committed to take the time necessary to compound correctly, including training and supervision of technicians