FX Excursions

FX Excursions offers the chance for once-in-a-lifetime experiences in destinations around the world.

Compounded Medications

Jan 28, 2014
2014 / February 2014

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.

Introducing

FX Excursions

FX Excursions offers the chance for once-in-a-lifetime experiences in destinations around the world.

Explore Excursions

#globility

Insta Feed
Daily
Feb 13, 2025

Florida’s Amrit Ocean Resort Launches Wellness Retreat Series

Situated on Florida’s Singer Island, recently opened Amrit Ocean Resort launches a wellness retreat series. Held monthly, this series aims to inspire longevity. The first retreat kicks off Feb. 27.

Experience Next-Level Travel with Condor Airlines’ New A330neo Fleet

Condor Airlines completely renewed its long-haul fleet, featuring its new Airbus A330neo. Designed to elevate your travel experience, the A330neo is equipped with cutting-edge technology and offers unrivaled comfort, ensuring an exceptional journey for every passenger. With its striking signature striped livery, the A330neo not only promises a memorable flight but also enhances the start of your vacation from the moment you step aboard.

Daily
Feb 13, 2025

Aman to Open Its First Property in Bangkok

More than 35 years after opening its first property, Amanpuri, in Phuket, Aman returns to Thailand with the opening of Aman Nai Lert in Bangkok. Set to debut April 2, the 52-suite property lies within privately owned Nai Lert Park, offering guests a secluded haven in the middle of the bustling city, much like sister property Aman New York.

Daily
Feb 12, 2025

Colorado Dragon Boat Film Festival Returns in March

Celebrating the best of Asian and Asian American filmmaking, Colorado’s Dragon Boat Film Festival is a fun mix of screenings by established and emerging artists. The theme of this year’s event is Honoring Our Past to Guide Our Future, held March 14–16 at Denver Sie Center.

Sailing the Ionian Sea: Explore Greece’s Nautical Gems

Sailing the Ionian Sea is an enchanting way to experience Greece's breathtaking islands and pristine waters. Known for its favorable winds, calm seas and stunning landscapes, the Ionian Sea offers a paradise for both experienced sailors and those looking to explore for the first time. From lively beaches to secluded bays, these waters have something for every traveler seeking adventure and relaxation.

Destinations / North America
Feb 12, 2025

Escape to the Carefree Vibe of Mexico’s Isla Holbox

On a tiny island off the northern coast of the Yucatán Peninsula, remote life takes on new meaning. Cars are nowhere to be found, internet connections are sporadic at best, and visitors have no choice but to unplug and indulge in natural wonders.

eFlyer Deals
Feb 12, 2025

Last-Minute Valentine’s Day Deal at The Benjamin Royal Sonesta Hotel

Still looking for a Valentine’s Day offer? The Benjamin Royal Sonesta Hotel, in New York City, has the LOVE Ben promotion available. With this offer, enjoy a stay in the hotel’s signature suite, as well as a private, late-night MoMA tour for two (with transportation included).

Discover the Pristine Beauty of the Sporades Islands

Nestled in the northwest Aegean Sea, the Sporades Islands are a hidden gem of Greece, offering breathtaking natural beauty and unique experiences for every traveler. Comprised of four main islands — Skiathos, Skopelos, Alonissos and Skyros — this island cluster is renowned for its lush pine forests, crystal-clear waters and idyllic beaches.

eFlyer Deals
Feb 12, 2025

Take the Ultimate Romantic Trip with Newport Harbor Island Resort’s New Offer

Take a Valentine’s Day or romantic trip back to the days of gilded mansions and cobblestone streets at Newport Harbor Island Resort in Newport, Rhode Island. This ocean-facing property has a special Valentine’s Day offer for couples.