Sunday, September 16, 2012

PILL-CVD: Clinical services and keeping ourselves honest

Given the increasing cost and complexity associated with health care delivery, a variety of stakeholders from across the continuum of care (e.g., hospitals, health systems, third party payers, state and federal government agencies) have launched exhaustive efforts to identify strategies that improve outcomes as patients transition from the health care environment to home. Challenges related to medication use -- from cost to compliance to adverse drug events -- serve as a key area of emphasis, especially given their contribution to patient injury and hospital readmissions. For example, adverse events related to medication therapy have been associated with patient injury in up to 40% of hospitalized patients and nearly 20% of patients following discharge [1,2].  Given the expertise of pharmacists in the area of medication safety, many see us as being the health care professionals responsible for leading efforts aimed at overcoming these challenges.  A number of initiatives have been investigated as a result, including medication reconciliation at admission and/or discharge, discharge counseling and education, telephone follow-up, and more.

Recently, the PILL-CVD trial [3] was designed to evaluate whether a combination of these strategies would reduce the number of clinically important medication errors in patients being discharged after an acute coronary syndrome or heart failure exacerbation. Patients (n = 851) were randomized to usual care or a pharmacist-based intervention that included discharge medication reconciliation, discharge counseling, and individualized telephone follow-up after discharge. Although clinically important medication errors were discovered in over half of the patients enrolled in the study, intervention by a pharmacist failed to reduce them when compared to usual care. Patients in the intervention group tended to have fewer potential adverse drug events, but even this difference was not statistically significant.

There were certainly limitations of the study, many of which were discussed by the authors. For example, patients were enrolled at two large academic medical centers, where robust medication reconciliation systems may have made it difficult to demonstrate a difference in the intervention group. Additionally, the patient population was relatively well-educated and demonstrated a high level of health literacy, which may have also impacted outcomes.

While the results of PILL-CVD may have rustled some feathers, I can accept it because I think it helps keep us honest.  Our clinical activities should be just as evidence-based as the therapies we recommend, especially in light of the rising costs of care and the already limited resources in pharmacy and beyond.  We should support, extend, and improve those activities that optimize patient outcomes and abandon those that do not. Where some may see the results of PILL-CVD as a threat to the role of pharmacists in transitions of care, I instead see it as a call to re-focus on those initiatives that do improve medication therapy outcomes, some of which were already included in this study.

As one example, pharmacists in the acute care setting are ideally positioned to perform comprehensive medication reconciliation at discharge. To clarify, I share the view that discharge medication reconciliation is not simply the generation of a medication list, but is instead a vital component of medication therapy management -- that is, an interdisciplinary strategy aimed at optimizing the medication regimen of each individual patient -- an effort that has been associated with improvements in both clinical and economic outcomes in a variety of settings [4].  As such, medications should not be evaluated solely on the basis of whether or not the patient was receiving them during their hospitalization, but whether it is appropriate to continue them based on factors that include safety, efficacy, cost, and compliance.

On the other hand, I maintain that medication counseling performed by acute care pharmacists at the point of discharge is not a very effective -- nor efficient/sustainable -- strategy for improving medication-related outcomes. While small studies have shown some improvements compared to usual care, differences are marginal at best and other studies have shown no impact at all. When I provide discharge medication counseling, I often see individuals and families who are exhausted, buried in paperwork, and overwhelmed with information... but even more importantly, I see people who are eager to leave the hospital. The last thing they want is for yet another health care professional to provide them with even more information they will soon forget -- and understandably so -- in their hurry to get things together and prepare for discharge. So I reluctantly hand them another stack of handouts to file away in a folder along with their discharge summary, upcoming appointments, laboratory results, medication list, etc.

While this may seem discouraging, it just reminds me to remain focused on those activities that do improve patient outcomes, including:
  • Rounding in the intensive care unit [5];
  • Rounding with a cardiology medicine service [6];
  • Collaborative management of anticoagulation [7], blood pressure [8], dyslipidemia [9], and other cardiovascular risk factors [10]; and,
  • Improving medication adherence among high-risk patients [11].

So while the results of PILL-CVD may have been concerning for some, I am encouraged that it will lead us to explore new or alternative strategies for improving medication-related outcomes as patients make the  transition to the ambulatory care environment.  Given significantly limited resources across health care settings and providers who are already stretched thin, it is important that we hold ourselves accountable for performing those clinical activities that are best supported by the available evidence -- even if it means leaving behind some activities that we once held dear.

Comments welcomed and encouraged.

  1. Krahenbuhl-Melcher A, Schlienger R, Krahenbuhl S, et al. Drug-related problems in hospitals: a review of the recent literature. Drug Saf. 2007;30(5):379-407.
  2. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998; 279(15):1200-1205.
  3. Kripalani S, Roumie CL, Schnipper JL, et al; for the PILL-CVD Study Group. Effect of a pharmacist intervention on clinically important medication errors after hospital discharge: a randomized trial. Ann Intern Med. 2012 Jul 3;157(1):1-10.
  4. Isetts BJ, Schondelmeyer SW, Cipolle RJ, et al. Clinical and economic outcomes of medication therapy management services: the Minnesota experience. J Am Pharm Assoc (2003). 2008 Mar-Apr;48(2):203-11; 3 p following 211.
  5. Leape LL, Cullen DJ, Clapp MD, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA. 1999;282:267-270.
  6. LaPointe NM, Jollis JG. Medication errors in hospitalized cardiovascular patients. Arch Intern Med. 2003 Jun 23;163(12):1461-6.
  7. Dager WE, Branch JM, King JH, et al. Optimization of inpatient warfarin therapy: impact of daily consultation by a pharmacist-managed anticoagulation service. Ann Pharmacother. 2000;34:567-572.
  8. Carter BL, Ardery G, Xu Y, et al. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med. 2009 Nov 23;169(21):1996-2002.
  9. Tsuyuki RT, Johnson JA, Taylor JG, et al. A randomized trial of the effect of community pharmacist intervention on cholesterol risk management: the Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP). Arch Intern Med. 2002 May 27;162(10):1149-55.
  10. Santschi V, Chiolero A, Paradis G, et al. Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Arch Intern Med. 2011 Sep 12;171(16):1441-53.
  11. Murray MD, Young J, Brater DC, et al. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007 May 15;146(10):714-25.


Alex Barker said...

Great summary Brent,
So what kind of intervention do you think would have made a difference in this setting?
I wonder if there would have been a difference in care if the intervention included a follow up 6 months (1 year?) after admission.
What are your thoughts?

Brent N Reed said...

Regarding your first question, I think I would have liked to know more about what the discharge medication reconciliation process entailed. As I mentioned in the original post, I think the concept of discharge medication reconciliation as simply being the creation of discharge list is somewhat short-sighted and underutilizes a pharmacist's unique knowledge and skills. Rather than asking "The patient was taking these medications during his hospitalization -- have they been included on his discharge list?", we should instead be saying "The patient was taking these medications during his hospitalization and here is how we can optimize the regimen for safety, efficacy, cost, and compliance." I think this is what will take medication reconciliation to the next level -- being more in line with the goals of medication therapy management. However, it is difficult to tell from this study which kinds of interventions were being made. We already know (from previous studies) that had pharmacists been allowed to manage the drug therapy in collaboration with physicians and other health care providers, it would have likely improved outcomes... but again, difficult to tell what kind of role pharmacists had in the actual medication therapy decisions.

Your second question hints at a concept that I think would benefit a lot of patients in the long-run -- the idea of a longitudinal health "coach", who would periodically check in on patients' progress with medications, making adjustments as necessary, referring for additional follow-up when required, promoting compliance, etc. I think this is more in line with what was done during the Asheville Project and other similar initiatives. Besides, I think the hope that a single intervention could lead to a significant difference in long-term outcomes is a little ambitious -- perhaps outcomes would have been better had an intervention occurred at discharge, 1-week post-discharge, 30-days post-discharge, and perhaps every 3-6 months thereafter -- again, reflecting a more longitudinal approach to medication therapy management rather than a one-and-done approach.

Alex Barker said...

Completely agree with you.

I'm creating a County employee wellness program (+900) and we are hoping to collect that kind of "coaching" data.
We'd love to show pharmacist intervention of evaluating therapy (not med rec = "uh, yea, he's got a completed discharge list") and improving outcomes (weight, A1c, glucose, etc.)

Brent N Reed said...

I am definitely interested in hearing more about the results of your program -- and I imagine the data would be publishable as well. Keep me in the loop when that information starts coming back.