In 2012, a fungal meningitis outbreak was linked to the New England Compounding Center in Framingham, Mass., where a steroid produced by the facility became contaminated. The Centers for Disease Control and Prevention identified 751 individuals in 20 states sickened by the contaminated injections, including 64 who died.
The lack of medication safety and quality control at this particular compounding center created a public health concern. More than 31 violations were discovered, including mold growing in the compounding room, an air intake vent located 100 feet from a recycling plant and other unsanitary practices. Employees discussed creating thousands of fake prescriptions so that more medication could be made. Approximately 17,000 vials of the fungus-contaminated steroid were produced for distribution.
According to the Food and Drug Administration, “Pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient. Pharmacy compounding, if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication.” About 30 million prescription medications are compounded annually. In the old days, the neighborhood pharmacist mixed medications ordered by a doctor for his patient. Today, compounding has moved to free-standing compounding companies.
The practice of compounding drugs expanded since the 1990s due to the costs and budget constraints of hospitals and medical and surgical practices, many of which now outsource large parts of their drug mixing. While all pharmacies and pharmacists are licensed and regulated by State Boards of Pharmacy, the FDA and CDC have limited power over compounding pharmacies, as they are not required to register with or report problems to the FDA.
The FDA does regulate drug compounding by pharmacies to a degree, requiring a prescription for each patient receiving compounded medication, adherence to pharmacy standards detailed in The National Formulary and the U.S. Pharmacopeia, and the preparation of medications in limited amounts. Compounding pharmacies cannot legally produce drugs for the mass market, which requires FDA oversight, but a growing number of them manufacture specialized drugs that they distribute widely across state lines.
There are risks and benefits to drug compounding. Mixing drugs together changes their composition, and excellent quality control measures need to be in place. Compounded medications often have not been tested for safety and effectiveness in clinical trials. A pharmacist or a compounding facility prepares the product according to a doctor’s prescription. Ideally, the pharmacist evaluates the product to ensure the correct medications have been compounded with the correct dose and concentration for the individual patient.
The U.S. Pharmacopeia Convention sets the standards for customized products for individual patients. Procedures must be in place to maintain sterility (washing hands; wearing gloves; using masks and hair covers; and cleaning all surfaces and implements with bleach, alcohol or high heat). Equipment required includes laminar airflow laboratory hoods, biological containment chambers, nuclear material glove boxes and clean rooms. Storage requires refrigeration, cabinets with air circulation and humidity controls. Pharmacies that compound a large volume of drugs can be accredited through national standards developed by the Pharmacy Compounding Accreditation Board.
It may be difficult to recognize if you are taking a drug made by a pharmacy compounder. Ask your doctor and pharmacist whether the prescribed drug is compounded, why it is being compounded, where it is being compounded and the possible side effects and safety concerns. If you receive a compounded drug, ask the pharmacist if your doctor asked for it to be compounded and find out if an FDA-approved drug is available and appropriate for your treatment. Ask if the pharmacist is familiar with compounding the product in your prescription, and whether he or she has the training, equipment and processes in place to compound it. Many pharmacists are certified in compounding drugs; ask to see the certificate. Find out if it is an accredited compounding facility. Ask about state inspections of the facility, inspection results and the quality control and safety of the product.
Obtain information about proper use and storage of the compounded product. If you experience any problems or adverse events, contact your doctor or pharmacist immediately. Medication compounding risks include particulate, chemical or microbiological contamination; medication dosage or concentration error; and drug incompatibility. Inspect the medication and do not use it if it looks suspicious or if it tastes or smells strange. Report it to the pharmacy and the FDA MedWatch program.
In November 2013, Congress passed the Drug Quality and Security Act, a bill which gives the FDA more power to police compounding pharmacies but which stops short of granting complete authority over pharmacies that mix drugs for individual patients. The bill provides new safeguards regarding quality control and the ability to track medications given to patients, which will be phased in over a decade.
Many of the pharmacists in drug compounding facilities are devoted clinicians who follow the practices set in place by the USP or the Pharmacy Compounding Accreditation Board. You should feel comfortable asking the necessary questions of health care providers prior to the administration of any compounded medication.
The content of this article is for informational purposes only. It is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition.
Read This Next
Lotte Hotel Seoul
2014 / February 2014
Jun 1, 2016All Reads on This Topic
Read Them All
Introducing
FX Excursions
FX Excursions offers the chance for once-in-a-lifetime experiences in destinations around the world.
#globility
Insta FeedDaily
Mar 28, 2024New Adriatic Yacht Cruise and Tour Itineraries Unveiled for 2025
Set sail through crystal-clear waters and explore ports, islands and more on three new yacht cruise and tour itineraries in the Adriatic Sea from Riviera River Cruises. New 2025 itineraries combine yacht cruises with onboard accommodations and land extensions with hotel stays in Croatia, Bosnia and Herzegovina. Itineraries also include tours of charming coastal towns and stops in national parks and swimming hole locations.
Sponsored Content
Share Your Travel Preferences with Global Traveler in a Short Survey & Win
Learning more about our readers’ travel habits and preferences ensures Global Traveler delivers the content you desire. As the travel industry has adapted and changed over the last few years, it’s more important than ever to connect. To best meet your short- and long-term travel content needs, please help us!
March 2024
Mar 28, 2024Cruise Lines Elevate the Onboard Fine-Dining Experience
It’s been a long time since the food on cruise ships resembled the bland, uninspired fare that gave onboard dining a bad name. These days, cruise passengers can look forward to menus created by Michelin-starred chefs made with top-quality ingredients served in stunning spaces. Choices abound as well. In addition to elegant main dining rooms, cruise ships have created a huge array of specialty restaurants that focus not only on perfectly executed traditional European and North American dishes but flavors and experiences from around the globe as well. In fact, meals served aboard cruise vessels have gotten so good, they’re drawing passengers onto ships: According to a recent report by luxury travel planning network Virtuoso, advisors report after Europe (specifically Italy and France), the No. 2 dining destination for travelers is aboard an ocean or river cruise. “This shows how cruise lines have really stepped up their culinary game, with consulting chefs and new restaurants and making that a focal point,” said Misty Belles, vice president, Global Public Relations, Virtuoso.
Daily
Mar 28, 2024Athens’ National Museum of Contemporary Art Opens What if Women Ruled the World? Exhibition
National Museum of Contemporary Art Athens was founded in 1997 and is supervised and subsidized by the Hellenic Ministry of Culture and Sports. The museum began its operation in 2000, when it acquired the first artwork of its collection and the first temporary exhibition took place.
Sponsored Content
Briggs & Riley: Elevate Your Journey with Quality Luggage
Embracing a life well lived often means embracing a life well-traveled. Every journey becomes a canvas for experiences that shape our lives and at the heart of every adventure lies the indispensable companion: quality luggage.
Daily
Mar 28, 2024AmaWaterways Debuts Specialty Summer Cruises in Europe
AmaWaterways recently unveiled its lineup of experiences and exclusive offers for its 2024 Summer European river cruise season, and the list includes 20 Celebration of Wine Cruises, with two hosted by Samantha Brown and Chef Joanne Weir; and three Loyalty Appreciation Cruises.
Hotel Indigo La Paz Puerta Cortés Review
eFlyer Reviews
Mar 27, 2024Japan Airlines Purchases 32 Airbus, 10 Boeing
eFlyer News
Mar 27, 2024eFlyer News
Mar 27, 2024China Airlines Expands North American Network with Non-Stop Flights to Seattle
China Airlines will begin offering non-stop flights to Seattle (SEA) from Taipei (TPE) starting July 14. The new route expands the carrier’s passenger services to the northwestern United States by offering five weekly flights via the Airbus A350-900.
Sponsored Content
Unearth Seoul’s Hidden Gems
Filled with hidden treasures waiting to be discovered, Seoul invites travelers to unearth its many gems, and Seoul Tourism Organization is here to help travelers do just that. Through thoughtfully created initiatives like the Theme Tourism County Competition, Seoul Tourism Organization works closely with local districts to identify and showcase what makes each district unique and charming in all seasons.
eFlyer Deals
Mar 27, 2024Sleep Sanctuary at Sandestin Golf & Beach Resort
In West Florida, indulge in a stay at Sandestin Golf and Beach Resort. This season, the hotel’s Sleep Sanctuary offer promises premium, beachfront accommodations; and sleep-enhancing amenities. Amenities include two aroma bracelets, a handmade soap, a bath bomb and foaming sugar scrub from Artful Soap Co.
ShareThis