“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

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

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

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

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

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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