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July 30, 2013

Compounding Legislation: Your Voice Urgently Needed Now!

Filed under: Current Issue,From the CEO,Quality,Regulation — Tags: , , , , — jmilford @ 12:29 pm
Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

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!

July 1, 2013

Moving Closer to Achieving Our Vision

Abramowitz-PREFERRED-Featured

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

In the last 20 years, the ASHP House of Delegates has debated and passed important proposals like support for the entry-level Pharm.D., universal health insurance, mandatory reporting of medication errors and “just culture,” collaborative practice, and the implementation of health information technology.

In recent years, the ASHP House of Delegates has approved policies that set future goals for residency training for all practitioners in direct patient care roles; defined the role of pharmacist prescribing in interprofessional patient care; called on federal officials to take action on compounding, drug shortages, REMS, and meaningful use standards; and pushed for standardized education, certification, registration, and licensure requirements for pharmacy technicians.

These policies touch every facet of pharmacy practice and have a profound impact on medication use in this country. ASHP’s professional policies offer a vision for the future of the profession in which pharmacists are essential members of every health care team and where medication use is optimal, safe and effective for all people, all of the time.

Last month, the ASHP House of Delegates approved more than 20 new professional policies during its session at the 2013 Summer Meeting in Minneapolis. Along with passing measures that support training in team-based patient care for student pharmacists and residents and the reclassification of hydrocodone combination products under the Controlled Substances Act, delegates also took strong positions on compounding safely and achieving provider status for pharmacists.

These actions are emblematic of the leadership that ASHP has taken on key medication-use issues throughout its history. ASHP’s professional policies provide a solid foundation for the Society to pursue transformative solutions to the issues that affect our ability to care for our patients.

In particular, the newly approved policies on compounding by health care professionals and pharmacist recognition as health care providers highlight this principle.

Compounding

ASHP is actively engaged in federal efforts to close gaps in the regulatory oversight of pharmaceutical compounding activities. We’ve worked closely with members of Congress and congressional staff on legislation that we expect the Senate to vote on this month; namely, the Pharmaceutical Quality, Security, and Accountability Act. While this legislation addresses federal authority, our new policy focuses on the laws and regulations that govern traditional compounding that occurs in hospitals, clinics, and other areas within health systems. It advocates for the adoption of applicable standards of the United States Pharmacopeia by state legislatures and boards of pharmacy.

The laws and regulations governing compounding vary from state to state. It is essential for the safety of all patients that all pharmacies that compound medications, regardless of the setting, adhere to the very highest standards. A uniform standard will help to ensure that the medications our patients receive are safe and that they are not harmed by agents that are intended to help them.

Pharmacist Recognition as a Health Care Provider

Pharmacists are health care providers. You demonstrate that each day. But we have some work to do to fix antiquated federal and state laws that place unnecessary limits on patients having access to the care we provide.

Our new policy on pharmacist recognition as a health care provider makes a strong case for changing the status quo. It points to the pharmacist’s role as a medication expert who provides safe, accessible, high-quality, cost-effective care. The policy also highlights that, as health care providers, pharmacists improve access to patient care and bridge existing gaps in care.

Achieving recognition as providers for pharmacists is ASHP’s top advocacy priority. We are devoting substantial time and energy with our partner pharmacy organizations to push for changes in the Social Security Act that will recognize the valuable role we play in the health care system.

Please take a look at the summaries of these policies below, and review the other professional policies that were recently finalized by the ASHP House of Delegates:

Pharmacist Recognition as a Health Care Provider

To advocate for changes in federal (e.g., Social Security Act), state, and third-party payment programs to define pharmacists as health care providers; further, to affirm that pharmacists, as medication-use experts, provide safe, accessible, high-quality care that is cost effective, resulting in improved patient outcomes; further, to recognize that pharmacists, as health care providers, improve access to patient care and bridge existing gaps in health care; further, to collaborate with key stakeholders to describe the covered direct patient-care services provided by pharmacists; further, to pursue a standard mechanism for compensating pharmacists who provide these services.

Compounding by Health Professionals

To advocate that state laws and regulations that govern compounding by health professionals adopt the applicable standards of the United States Pharmacopeia.

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I also encourage you to spend some time thinking about what you envision for the future of practice and what is needed to bring us closer to that goal. Share your thoughts with me in the comments section of this column or by sending an email to ceo@ashp.org. Members serve as the catalyst for our policy initiatives. Your input can help bring us even closer to achieving the vision we have for patient care.

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