Wednesday, October 10, 2012

10/10/12: Meningitis/Steroid Injection Recall News -Doctors Rethink Use of Custom Pharmacies

An interesting read from the WSJ:

The outbreak of a rare form of meningitis is prompting some doctors to rethink their use of a specialized type of pharmacy that created steroid injections tied to 119 illnesses and 12 deaths.
MedStar Health, a health-care provider that includes Georgetown University and Washington Hospital Center in Washington, D.C., said it is reconsidering its currently limited use of compounding pharmacies, which create alternative versions of medicines, such as liquid forms of pills.

More at the source:

What is a compounding pharmacy?

Compounding is the practice of preparing drugs in new forms. For example, if a drug manufacturer only provides a drug as a tablet, a compounding pharmacist might make a medicated lollipop that contains the drug. Patients who have difficulty swallowing the tablet may prefer to suck the medicated lollipop instead.
Another form of compounding is by mixing different strengths (g,mg,mcg) of capsules or tablets to yield the desired amount of medication indicated by the physician, physician assistant, Nurse Practitioner, or clinical pharmacist practitioner. This form of compounding is found at community or hospital pharmacies or in-home administration therapy.

What does the FDA have to say about compounding pharmacies?

The FDA views traditional pharmacy compounding as the combining, mixing, or altering of ingredients to create a customized medication for an individual patient in response to a licensed practitioner’s prescription.1 In its simplest form, it may involve taking an approved drug substance and making a new formulation to meet the medical needs of a specific patient. For example, it may involve formulating the product without a dye or preservative in response to a patient allergy. Or it might involve making a suspension or suppository dosage form for a child or elderly patient who has difficulty swallowing a tablet or a capsule. These traditional forms of pharmacy compounding are an important component of our pharmaceutical armamentarium.

Although these products technically may be considered unapproved new drugs because they differ from the approved formulation of the drug, FDA has exercised enforcement discretion to allow these legitimate forms of pharmacy compounding, which are regulated under state laws governing the practice of pharmacy.

Although compounding was widespread when the FD&C Act was first enacted in 1938, there were no provisions specifically dedicated to compounding, as distinguished from manufacturing of drugs. After the 1962 amendments to the Act expanded the universe of drugs that require FDA pre-market approval to include drugs that are not already generally recognized by experts as effective, courts have interpreted expansively the Act’s provisions to require pre-market approval of virtually all prescription drugs. It is widely recognized, however, that compounded drugs could not meet the approval requirements, in part because they traditionally are made in small amounts for individual patients according to a prescription. In addition, it is usually not feasible to study them in clinical trials to establish their safety and efficacy or prepare new drug applications for all of the different types of compounded products that might be prescribed.