Knowthe Facts: Important Information About “Pharmacy Manufactured” Medications (NAPSA)—Are you getting the medication your doctor prescribed for you? For some Americans, the answer is “no,” and they have unknowingly received pharmacy manufactured, or compounded, medications. Compounding is the term used to describe what occurs when a pharmacist, in consultation with, and at the request of a physician, adjusts the preparation of a medication to ensure that it is medically appropriate for the patient’s need. For example, a pharmacist can add flavoring to make medication more palatable. The practice of pharmacy manufacturing has been around for centuries and is legal. What is not legal, however, is the pharmacy manufacturing of medicines, that bypass the physician and patient involvement. Manypatients and even physicians are unaware that this substitution has taken place. Legally compounded drugsprovide important customized treatments to people who otherwise could not or would not take their medication. When some pharmacists go a step further by mass manufacturing the drugs, they may actually endanger patients who unknowingly receive these drugs. Most medications American patients receive from their pharmacist are FDA approved, having undergone scientific testing and a rigorous review and approval process, and the companies that make the medications have passed Most medications American patients receive from their pharmacist are FDA approved, having undergonescientific testing and a rigorous review and approvalprocess, and the companiesthat make the medicatins have passed inspections at the manufacturingfacility where they are made. @ inspections at the manufacturing facility where they are made. However, pharmacy manufactured medications do not undergo the rigorous review and inspection process. They may be manufactured under non-sterile conditions, or may not contain accurate amountsof the active ingredient. A study conducted by the FDA found 34 percent of pharmacy manufactured products containedless than, or more than, the FDA approved amountof the active ingredient. In fact, three deaths have been associ- ated with illegal compounding. The FDA has seen a dangerous increase in the number of people with asthma who have received pharmacy manufactured medications. Asthma patients are particularly at risk, especially those who rely on a device called a nebulizer to deliver the medicine they need to their lungs to help them breathe easier. Nebulizers are beneficial for many asthma sufferers, but especially the very young and veryold, to deliver moist medicated mist to their airways. “The primary concern we have with pharmacy manufacturing of medications for inhalation is the risk to patients’ health who unknowingly receive these pharmacy manufactured products under the guise of compounding,” according to Philip Marcus, MD, MPH, Chief, Division of Pul- monary Medicine, St. Francis Hospital, Roslyn, NY. “These products are formulated in a manner that differs from the FDAapproved product and little, if anything, is known about the effectiveness and safety of these products. Physicians and patients should be aware of the potential safety risks associated with the ‘illegal’ products, including additives such as alcohol, sterility concerns and subpotency.” Consumers should remember that legitimate compounded medications are not sold on the Internet, and they are not mass-marketed. They should pay attention to the medication they receive at the pharmacy, and ask their doctor if the packaging or appearance of the medication has changed from a previousprescription, or if they are unsure about medications they received. People interested in learning more about this subject can visit www.knowthedifference.org, or consult www.breatherville.org/ medicalcenter, or contact the Asthma and Allergy Network at 866-227-2934.
