Protecting your patient from compounding errors

By Robyn Boyle, RPh
Published November 2, 2017

Key Takeaways

The image of a pharmacist with a mortar and pestle in hand preparing a medication is old as the practice of pharmacy, which has its roots in ancient times. Compounding has long been recognized as an important component of pharmacy practice, although less so in our modern industrialized world. A preparation may need to be compounded for various reasons, such as to make an oral solution from a tablet, to prepare topical ointments and creams with specific ingredients, or to deal with manufacturer shortages or recalls.

In recent years, several incidents have been reported that have increased scrutiny of compounding pharmacies and outsourcing facilities. In 2013, at least 15 people in two Texas hospitals developed bacterial infections that were linked to IV infusions of calcium gluconate. In September 2017, a UCLA pharmacy closed after it was discovered that more than 1,000 IV bags were made with expired ingredients and the pharmacy failed to meet standards for quality assurance and product testing.

The incident that received the most attention occurred in 2012 at the New England Compounding Center (NECC), which prepared injections of preservative-free methylprednisolone acetate (MPA). Syringes of MPA contaminated with fungus were linked to a nationwide fungal meningitis outbreak as well as joint and spinal infections causing more than 70 deaths and sickening another 750 people. The pharmacy co-owner was convicted of fraud and conspiracy and was sentenced to 9 years in federal prison. The supervisory pharmacist was found guilty of racketeering, racketeering conspiracy, mail fraud and other charges, and will be sentenced early next year.

In response to the NECC tragedy, Congress enacted the Drug Quality and Security Act (DQSA) in 2013 which preserves access to safely compounded medications for people who need them, while helping to protect patients from risks of preparations produced under dangerous and illegal conditions. Under the DQSA, outsourcing facilities that compound in bulk and sell products across state lines without a specific patient prescription must register with the FDA and are subject to FDA oversight and inspection.

In general, state boards of pharmacy will continue to have responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs, including hospital pharmacies. After the NECC incident, most states have increased regulation and inspections for compounding pharmacies.

In addition, the FDA encourages health care providers to report adverse events or quality problems experienced with the use of compounded drugs to FDA’s MedWatch Adverse Event Reporting program.

But questions remain: Should pharmacists continue to compound when thousands of medications are manufactured under the regulation of the FDA with strict quality assurance guidelines? Obviously, the need for patient-specific formulations still exists and it’s unlikely that pharmacists will ever stop compounding altogether.

So, how can physicians protect their patients from compounding issues and errors? Physicians who prescribe products requiring compounding can contact the pharmacist directly to ask questions and learn about their process and compounding procedures to gain peace of mind. Pharmacists will explain exactly what ingredients are used, how it is prepared, and answer any other questions about the compounded product. In the end, the desired patient outcome is everyone’s goal.

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