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“A Conversation About Compounding Pharmacies”
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“A Conversation About Compounding Pharmacies”
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What is “Compounding”?
• Compounding is part of standard pharmacy practice
– Compounding is the preparation / formulation of medication not available from a manufacturer
– Pharmacists combine different prescription / non-prescription ingredients to formulate a therapy which better suits a patient’s needs
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Why is compounding necessary?
• Existing product from manufacturers is not available in preferred dosage / administration form
– Pre-filled syringes, single-dose vials, pre-mixed IV bags are favored
– Dosing strength needs to be less or more
– An additional ingredient needs to be added
• Not all therapies are stable, they are formulated as needed
• Some patients require “non-standard” therapies
– Available product formulations do not suit a patient and / or needs to be administered differently
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What types of compounded products are common?
• Medication that is compounded and dispensed via:
– IV bag
– Syringe
– Single-dose vial
• Creams, ointments, solutions
• Suppositories
• Capsules
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Don’t all pharmacies compound drugs?
• Most chain/grocery retail pharmacies perform basic compounding with a very narrow selection of drugs (no IM/IV medications are prepared)
– Flavoring is added to liquid medications
– Oral therapies are prepared by adding sterile water to the drug
• Some independent retail pharmacies promote themselves as “compounding pharmacies”
– They actively practice compounding as a way to differentiate themselves from chain/grocery drugstores
– They typically produce topical creams, ointments and solutions
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What other pharmacies compound drugs?
• Hospitals, specialty pharmacies and home infusion facilities are capable of advanced compounding
– This typically involves formulating IM/IV drug therapy
– It requires specific pharmacy training, proper equipment, a sterile pharmacy workspace and specialized handling / storage of medications before, during and after preparation
• There are also larger, “institutional” or “closed door” compounding pharmacies
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How are larger “institutional” compounding pharmacies different? • Their customers may not have the equipment, sterile workspaces or
enough pharmacy staff to produce compounded medication
• They do not provide walk-in, retail pharmacy service
• The product they produce is shipped to various entities including:
– Home Infusion Companies
– Long Term Care Facilities
– Physician Offices / Clinics / Surgical Centers
– Psychiatric Care Facilities
– Prison Infirmaries
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Who are some of the better known compounding pharmacies?
• There are many national, regional and locally-based institutional compounding pharmacies, some of the larger ones are:
– Ameridose
– Cantrell Drug Company
– Central Admixture Pharmacy Service Inc./CAPS
– CuraScript
– Omnicare
– PharMedium
– Wedgewood Pharmacy
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Why are compounding pharmacies in the news? • Some government and industry stakeholders think the FDA should
more assertively regulate compounding pharmacies
• There is debate as to whether they should be classified as pharmacies or manufacturers
• There are significant issues when they do not:
– Closely follow safe, sterile pharmacy practice which impacts quality and patient care
– Abide by local, state or federal clinical and commerce regulations
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What is the outlook?
• Compounding is an ongoing part of standard pharmacy practice and plays an important role in the healthcare industry
• Individualized patient care and a wider array of treatment options continues to drive demand for compounded medications
• Health and safety are integral to quality patient care; clinician and regulatory involvement will continue to assess and improve the performance of compounding pharmacies
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