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Compounding Legislation: Your Voice Urgently Needed Now!

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

It’s hard to believe that after the many deaths and illnesses associated with the alleged practices at the New England Compounding Center last Fall, the bipartisan Senate bill (S.959) that is designed to prevent a tragic repeat could be facing tremendous opposition.

ASHP strongly supports this legislation. Yet, it appears that opposition to the Senate bill is forming, because certain interests want to protect the status quo, which we believe could be at the expense of protecting patients from another compounding tragedy.

These special interests are also threatening to severely limit how pharmacists in hospitals and health systems serve and protect patients. ASHP supports the provision in the bill that exempts health systems from being designated as compounding manufacturers. Without this important exemption, many hospitals and health systems would have to register with the Food and Drug Administration (FDA) as compounding manufacturers, since anticipatory compounding is required for us to meet the needs of our sickest and most vulnerable patients.  Also, without the exemption, many hospitals would not be able to prepare compounded preparations and send them to their wholly owned outpatient clinics, surgery centers, smaller inpatient facilities, and medical office practices.   This is a critical distinction, based on the fact that hospitals and health systems are fully accountable for the comprehensive care of the patient – as compared to a compounding manufacturer that sells its products across state lines without a prescription or knowledge of the patient to a third party for administration.

This distinction between health systems and compounding manufacturers is based on very important differences:

• Hospitals and health systems have well-established quality improvement, infection control, and risk management committees, as well as adverse event monitoring and reporting systems.

• Health systems must comply with the Centers for Medicare & Medicaid Services (CMS) Hospital Conditions of Participation and are accredited by quality improvement organizations such as The Joint Commission and DNV Healthcare, both of whom have deemed status with CMS.

• Hospitals and health systems have Pharmacy and Therapeutics Committees that control approved drug formularies.

We must protect the important work that pharmacists do in hospitals and health systems to take care of their patients.  In addition, hospital pharmacists and other providers must be assured that when they need to purchase compounded products from outside suppliers that they can expect to receive products that are safe and effective for their patients.  Therefore, we must enact into law urgently needed regulatory control over compounding manufacturers to prevent another tragedy.

You can make a difference. Your voice really matters to your elected Senators and Representatives in Congress!

ASHP has made it as easy as just a few clicks on your computer for your voice to be heard.

Go to ASHP’s advocacy page and make a difference for patient safety!

Tell your Senators that you want them to vote “YES” in support of S. 959.  This legislation creates a new category, “compounding manufacturer,” which will be regulated by the FDA. Hospitals and health systems are considered traditional compounders in the legislation and will remain under the purview of state boards of pharmacy and other accrediting bodies.

Tell your Representative that the House should take a similar approach to the legislation and give the FDA the tools it needs to prevent another tragedy.

Your support today can go a long way in getting this important legislation passed!