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.

Feature
Sep 19, 2019

Wilderness Safaris Reopens Jao Camp

Following a complete renovation, Wilderness Safaris’ Jao Camp reopened in Botswana’s Okavango Delta.

To New Heights

United Airlines announces a number of new routes.

News
Sep 19, 2019

Best U.S. Cities for Oktoberfest Celebrations

WalletHub compared the 100 largest U.S. cities across 24 key metrics to determine the best destinations for an upcoming Oktoberfest celebration. The brand’s study found the estimated cost for an American to attend Oktoberfest in Munich, Germany, is $5,000. Munich boasts a $1.43 billion annual economic impact on Munich. During Oktoberfest, nearly 2 million gallons of beer are consumed and more than 510,000 whole roast chickens eaten.

Feature
Sep 19, 2019

Qantas Will Start Using a Dreamliner on Santiago–Sydney Route

Qantas will start using a Boeing 787-9 Dreamliner on its Sydney–Santiago route starting in late June 2020.

The Island of the Knights

Welcome to Rhodes, a medieval treasure beautifully preserved throughout the centuries. Rhodes is the capital of the Dodecanese, an island ideal not only for those who want to relax, but also for those looking for an action-packed holiday! With its bright green hills, rich green valleys and uninterrupted line of golden beaches, Rhodes is truly a blessed place. “The sun island” has more sunshiny days and milder temperatures throughout the year than any other location in Greece. It is, after all, one of the country’s easternmost places and among the first to welcome summer on its impressive beaches. Add in the excellent facilities for tourism, the island’s special blend of cosmopolitan and traditional, and numerous cultural and archaeological sites, the most important being the Medieval (Old) Town, a UNESCO World Heritage site, and you’ve got the perfect holiday destination. While on Rhodes, don’t miss a daytrip to nearby Sými. An island of sponge divers and seamen, Sými used to have 30,000 inhabitants before the Second World War and was the richest island in the Dodecanese, despite its small size. Today, Sými attracts many visitors thanks to its beautifully preserved Neo-Classical buildings and the famous Archangel Michael monastery at Panormitis.

Daily
Sep 19, 2019

Travel Bundles Make it Easy to Attend International NFL Games

On Location Experiences makes it easy for travelers to head to London or Mexico City for upcoming NFL games. Tottenham Hotspur Stadium hosts the Chicago Bears and Oakland Raiders Oct. 6, and the Carolina Panthers and Tampa Bay Buccaneers Oct. 13; Wembley Stadium hosts the Cincinnati Bengals and Los Angeles Rams Oct. 27, and the Houston Texans and Jacksonville Jaguars Nov. 3; and Estadio Azteca hosts the Kansas City Chiefs and Los Angeles Chargers Nov. 18.

eFlyer News
Sep 18, 2019

LOT Polish Airlines Adds New Route to Delhi

LOT Polish Airlines is offering travellers more options for travel between Asia and Europe.

TAP Air Portugal Adds 15 Flights Each Week From U.S., Canada

TAP Air Portugal is adding 15 new weekly flights from the United States and Canada by summer 2020,  a new record for the carrier of 71 weekly flights between North America and Portugal.

eFlyer Lead
Sep 18, 2019

Shangri-La Hotel, Sydney Makes Sustainability Bounds

Hotel brands all over the world have pushed for sustainability. For many, it began with reducing single-use plastics, like straws. InterContinental recently announced the end of in-room miniature toiletries.