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November 5, 2012

Reflections on the NECC Compounding Tragedy

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

I, LIKE MOST OF YOU, CONTINUE TO FOLLOW the news out of Framingham, Mass., as more is learned about the operations at the New England Compounding Center (NECC).

What investigators are finding—unsatisfactory conditions, shipping of product before the results of sterility testing were known, and inattention to other known safeguards—deeply upsets me. These types of practices are totally unacceptable anywhere, at any time. The patients who relied on these medications deserved much better, and our sympathies go out to all of the affected patients and their families. But condolences cannot begin to replace their losses. Enhanced safeguards must be put into place so that this does not happen again.

Having said this, however, it’s important to note that I am also concerned that compounding by pharmacists—a practice that is essential to patient care—may be broadly called into question. Compounding and pharmacy are inextricably linked.

From preparing a topical cream to the complex processes involved in preparing sterile products, compounding happens every day in every hospital and health system. What happened at NECC does not reflect the professionalism and commitment to patients provided by pharmacists throughout the country. We cannot allow what happened there to shape the public perception of a critical element of patient care.

ASHP has a long history of pushing for the highest standards for compounding and sterile product preparation in hospitals. In the early 1990s, we began publishing practice recommendations in AJHP. We published the “ASHP Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products (TAB)” in 1993. The TAB established the three-tier risk assessment structure that was later adapted by USP for use in the <797> standards for sterile compounding. Our guidelines on outsourcing sterile compounding services urge pharmacy departments to conduct due diligence when outsourcing compounding services.

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. In addition, state boards of pharmacy will need additional resources to provide strict oversight of compounding pharmacies and provide more transparency.  And when companies cross the line from compounding to manufacturing, there needs to be enhanced coordination between state boards and the U.S. Food and Drug Administration (FDA) to ensure that the necessary regulatory scrutiny is applied.

We know the important role that compounding plays in patient care, but we have a fair amount of work to do to restore the public’s trust after this tragic event. As hospital and health-system pharmacists, we have always taken the lead in medication safety in our practice settings, ensuring that our patients can always depend upon us. ASHP pledges to work diligently to restore that trust and to help prevent a tragic and unfortunate event like this from ever happening again.

September 6, 2012

The Power of Policy: Pathways to the Future

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

SOMETIMES, WHEN PEOPLE THINK of the word “policy,” they think of “red tape,” bureaucracy, or an arduous process. However, when I think about the word policy, a different connotation comes to mind. I think about how much has changed in our profession since I first became an ASHP member 35 years ago, and I reflect upon the policies that helped to get us here.

Clinical pharmacy practice, the entry-level doctor of pharmacy degree, specialization, pharmacists providing direct patient care in clinics and other ambulatory settings, collaborative practice agreements, barcode medication administration, electronic clinical information systems, and so many more advancements in our profession started with just one thought: How can we do things better? And, that thought, driven by policy turned into action, ultimately led to change.

At the root of all professional advancements and change are the policies that guide us there.

Change in pharmacy practice does not just happen. It is carefully crafted, nurtured and re-evaluated over and over – even after success.

Today, ASHP stands strong as an organization adaptable and responsive to the changing needs of our patients as well as the changing demands within health care as whole. And, it is all because of you, our members. You make this happen. Through ASHP’s professional policy process, our members do not just play a significant role in bringing new and innovative ideas to the forefront of pharmacy practice; they are the catalysts for our efforts.

In June, there were several groundbreaking policies that came before the ASHP House of Delegates for debate that will make similar strides for pharmacy practice, including policies related to pharmacist prescribing, board certification, and licensing and training of pharmacy technicians. All of these were inspired by the recommendations of ASHP’s Pharmacy Practice Model Initiative (PPMI). I’d like to share some thoughts about them with you.

While these policies concern different aspects of practice, they have one thing in common: a shared vision for the future of the profession in which pharmacists are essential members of every health care team, helping our patients with our deep and extensive knowledge about all aspects of medication therapy.

The policies regarding pharmacist prescribing puts this activity in context of the pharmacist’s role on the interprofessional team and clearly states that prescribing is a complex function that requires pharmacists to have specific skills and competencies. The policy regarding board certification addresses the growing demand for board-certified pharmacists and sets a new expectation that pharmacists should become certified by the Board of Pharmacy Specialties (BPS) if they practice in a specialty in which BPS offers certification.

And the policies regarding pharmacy technicians take a strong stand on requiring licensure, as well as specialized training for advanced roles. These technician positions are an outgrowth of ASHP’s Pharmacy Technician Initiative and should serve to strengthen ASHP’s advocacy for standards for training, certification, and licensure.

These are just a few examples of the forward-thinking policies that ASHP members have conceptualized and that were brought before the House of Delegates. Although some of these concepts might seem far-reaching to some of us today, it is easy to imagine that these ideas will one day be part of routine practice, and that a new set of future-oriented policies to advance the profession for the betterment of patients will be brought before future ASHP Houses of Delegates. We look forward to working with our members and our state affiliates in creating a future in which these policies are the standard operating procedure.

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

Prescribing:

A) Pharmacist Prescribing in Interprofessional Patient Care

Defines pharmacist prescribing as patient assessment and the selection, initiation, monitoring, adjustment, and discontinuation of medication therapy pursuant to diagnosis of a medical disease or condition; further, The policy also advocates that health care organizations establish credentialing and privileging processes to ensure competency.

B) Qualifications and Competencies Required to Prescribe Medications

Affirms that prescribing is a collaborative process that, if performed collaboratively, requires that competent, interdependent professionals complement each others’ strengths at each step. The policy also suggests the creation of prescribing standards that would apply to all prescribers, and encourages research on the effectiveness of educational processes currently available.

Board Certification:

Board Certification for Pharmacists

This policy, recommended by the ASHP Section of Clinical Specialists and Scientists, supports the principle that pharmacists practicing in formally recognized specialty areas should become BPS certified in that specialty. Among other things, the policy also calls for BPS to prioritize recognition of new specialties in areas that have a sufficient number of PGY2 residencies and existing training programs.

Pharmacy Technicians: 

A) Licensure of Pharmacy Technicians 

Advocates for licensure of pharmacy technicians by state boards of pharmacy, as well as the development of uniform state laws and regulations and mandatory completion of an ASHP-accredited training program as a prerequisite to licensure.

B) Qualifications of Pharmacy Technicians in Advanced Roles 

Advocates that beyond completing an ASHP-accredited training program, certification and licensure, pharmacy technicians working in advanced roles should have additional training and should be required to demonstrate competencies specific to these tasks.

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Once these new policies take root and grow to become the norm across health care and the nation, imagine their impact on the practice of pharmacy and how they will give us new tools to enhance patient care. Further, imagine all the future creative enhancements in the care delivery process that they will set in motion. Think back to some of the policies approved by our House of Delegates in the past and what they have led us to achieve.

Then, begin using these new policies to create the future.

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