Remarks to the Second Learning Session of the Patient Safety and Clinical Pharmacy Collaborative

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by HRSA Administrator Mary K. Wakefield

May 13, 2010
Gaithersburg, Md.

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Thank you, Jimmy (Mitchell, director of HRSA's Office of Pharmacy Affairs) for that kind introduction – and for your years of service to HRSA, and dedication to this collaborative.

Thank you, as well, to the hundreds of committed professionals who are tuning in today to take part in this nationally broadcasted session on Patient Safety and Clinical Pharmacy.

Finally, and especially, I want to thank Marsha Henderson of the U.S. Food and Drug Administration for coordinating and facilitating this event today, in partnership with HRSA, which is coming to you live from the FDA Technical Center in Gaithersburg, Md.

As many of you know, it was my great privilege to serve on the U.S. Institute of Medicine committee that produced the landmark 2000 study, To Err is Human.

And as the staff at HRSA will tell you, I am obsessive on the subject of patient safety. As a nurse, it has been my professional calling, of course, but also a personal passion as an administrator and educator. Like you, I know we can do better. How we get there will be due in no small part to sessions like the ones we're having today.

I am also confident in our ability to improve patient safety because of the expected growth of the HRSA-supported Community Health Center system over the next few years.

Under the Patient Protection and Affordable Care Act recently passed by Congress and signed by the President, we are making an historic investment in community health centers to help them as much as double the number of patients they serve to 40 million.

When it comes to delivering high-quality, cost-effective, and safe primary care to underserved Americans, the health centers are a very good model. So we look forward to seeing that network grow.

The relevance of this in today's discussions is that the health centers already serve the largest patient population in any health care system today, public or private. And they are the primary health care home for millions of high-risk patients not served by traditional providers.

So any improvement we can make there in clinical pharmacy and patient safety is bound to have a significant impact.

Here's why your efforts matter. According to a recent review of the literature in the Journal of Patient Safety:

• Nine out of 10 Medicare beneficiaries today are on prescription medications – and nearly half of them are using five or more prescriptions at the same time;
• Conservatively, it is estimated that one out of 10 hospital in-patients have experienced an adverse drug reaction – so many, in fact, that it is a leading cause of death and injury among hospitalized patients; adverse drug reactions also account for perhaps as much as 2.5 percent of all emergency room visits.
• There are at least 1.5 million adverse drug reactions in the U.S. every year – and as many as 8 out of 10 result from human error in what we traditionally have viewed as “basic processes,” like filling a prescription.

It turns out those processes often aren't as simple as we thought, particularly when we take into consideration the marked uptick in the volume of medications; increases in their use; and the multiple drug interactions that can result.

As our colleagues at the FDA have noted, pharmaceuticals are now “the most common intervention in health care” – so much so that an average-sized community hospital can expect to dispense 6 million doses in a typical year.

Now – with the Baby Boom Generation aging into the health care system in such tremendous numbers – we are witnessing a shift in public health toward a far greater emphasis on the long-term pharmacological treatment of chronic illnesses.

Later today, you'll be hearing much more about this from Dr. Kyu Rhee, HRSA's Public Health Officer. But for now, let me just say that this steepening curve towards a chronic care model underscores why it's so important that we get systems in place now.

With the cost of adverse drug reactions to the health care system approaching $9,000 per event, this is a patient safety issue and an economic issue. We have the most expensive health care system in the world, and this is one of the contributing reasons.

It is worth noting that this concern is shared across the federal government – by the CDC, AHRQ, CMS, NIH, the Indian Health Service, the VA, and certainly the FDA – and by a broad cross-section of the health care community.

Among many other participants here today, and among those with seats on the Leadership Coordinating Council, we have such well known and respected organizations as:

• The Heinz Foundation; the Hartford Foundation; the National Kidney Foundation; and the Graham Center;
• The American Academy of Nurse Practitioners; the American Academy of Family Physicians; the National Rural Health Association; the American Pharmacists Association; and the American Association of Colleges of Pharmacy;
• 43 Hospitals; 79 Community Health Centers; 8 Health Departments; many schools of pharmacy and community pharmacists … it's a very long list.

We now have 110 multidisciplinary teams, representing over 350 organizations from 41 states – partly supported by almost $2 million in contributions and financial support from our private partners.

This is an extraordinary outpouring of commitment, and I want to thank you all for it.

The evidence very clearly shows that this initiative already has reaped significant gains; and I am confident that by our third year, which begins this fall, we will have come a long way toward integrating a national model for clinical pharmacy services that includes:

• medication reconciliation;
• on-going patient counseling;
• medication therapy management;
• disease state management;
• and more.

As ambitious as that may sound, I think we have every reason for optimism. Convened in this collaborative are experts in pharmacy affairs, medication management, and other important disciplines; the problem before us is very well documented and understood; and we have already seen impressive results among high-risk patients, including:

• 70% reductions in potential adverse interactions;
• 80% reductions in adverse drug events; and…
• An aggregate improvement of 30-40% in the number of patients whose health conditions are now under control across a range of chronic diseases, using standardized measures – such as A1C levels; blood pressure; LDL; INR ranges; depression scores; and viral load.

So our teams have shown that real progress is possible; and we now have in Washington an Administration that is committed to providing us with the most important tools we need.

For example, under the Recovery Act last year, President Obama not only invested $2.5 billion in HRSA to expand and integrate primary care service delivery and train a new generation of providers, he also committed to invest $19 billion more in digital health records.

I don't need to tell anyone here about the potential of Health IT to predict and prevent prescription errors and adverse drug interactions.

Among the immediate benefits of the President's investments in HRSA was $500 million for infrastructure upgrades to the Health Center system, a substantial portion of which will go into telehealth and Health Information Technology equipment.

As I said a moment ago, this investment will have far-reaching impact because HRSA supports 7,900 health center clinics nationwide that provide primary care to nearly 19 million patients – with an expected doubling of that number over the next five years as health reform takes hold.

As a “platform” for innovation, and a “test bed” for the widespread application of best practices and evidence-based clinical methodologies, Health Centers, Critical Access Hospitals and other providers are poised to carry out this critical work in partnership with all of you.

They are here today – along with senior hospital managers and health departments – determined to solve these patient safety challenges.

As we all know, prescription drugs carry tremendous potential for managing diseases, easing pain and extending the lives of a coming wave of aged and elderly patients. But these same medications also have potential to do grave harm.

The Administration is also putting almost $20 million into integrating new technology into our health professions education programs to produce the next generation of digitally literate clinicians; and $1.5 million into supporting the efforts of the Federation of State Medical Boards to reduce regulatory roadblocks that have slowed the advancement of telehealth and other technologies across state lines.

Overarching all of these recent investments, as I said a moment ago, the Administration is spearheading an effort to digitize health records nationwide.

So, really, I think that there has never been a more promising time for the work of this collaborative – and others like it – to take root and extend throughout the health care system to:

• improve data collection, correlation, and inter-disciplinary collaboration;
• to enhance patient safety, while at the same time containing and cutting costs;
• and to reaffirm a public health emphasis that seeks to improve the well-being of populations through education, behavioral change and prevention.

Finally, our staff in the Office of Pharmacy Affairs wanted me to mention two items before we get down to work today:

• If you know of anyone out there – any interested party or entity – that is not currently on a team, please do urge them to enroll for PSPC 3.0 in the fall. The enrollment package is available on our web site.
• For current teams, we want you to know that there are performance awards. So please remember to share your results with us – your best practices; any pitfalls you may encounter; and certainly the insights you gain over the coming months.

On behalf of HRSA and the FDA, and our fellow agencies in federal government – and on behalf of the millions of patients who deserve a better, safer, more responsive health care system – thank you all for coming out and participating today.