Research and Reports Impact of Pharmacy Intervention on the Use of Proton-Pump Inhibitors in the Hospital Setting Richard Atkins, Lori Smith Objective: Determine effectiveness of pharmacy-driven medical staff training regarding proton-pump inhibitor (PPI) therapy. Design: This study was performed in two parts. Part I evaluated baseline PPI usage within the hospital. Part II evaluated the effect of pharmacy-driven medical staff education on PPI prescribing patterns. Data were collected retrospectively via electronic chart review. Setting: Passavant Area Hospital in Jacksonville, Illinois, is a 99-bed community hospital. Participants: Patients’ profiles were selected if administration of at least one PPI was electronically charted during their hospital stay. Patients discharged from the emergency department were not included in the study. There were a total of 1,089 charts reviewed (Part I: N = 565; Part II: N = 524). The average patient age was 66.5 years. Interventions: Part I results were presented to the pharmacy and therapeutics (P&T) committee and medical staff. A series of three educational presentations were subsequently given to medical staff. Part II results were reported to the P&T committee, with further interventions to be determined after consulting with hospital administration and medical staff. Main Outcome Measure: Improvement of appropriate acute PPI therapy. Secondary outcome measures included duration of acute therapy and continuation of chronic therapy. Results: There was improvement in the appropriate usage of PPI for stress ulcer prophylaxis (SUP) (P = 0.1216), decreased chronic PPI therapy (P = 0.0054), and increased documentation of PPI indication (P = 0.0365). A decrease of appropriate acute duration of PPI for SUP was also observed (P < 0.0001). Conclusions: Appropriate initiation of acute and continuation of chronic PPI therapies improved. Appropriate duration of use declined in SUP patients. Pharmacy

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interventions have an overall positive impact on appropriate use of PPI therapy. Key Words: Adverse effects, Elderly, Gastrointestinal, Longterm care, Pharmacy intervention, Proton-pump inhibitors, Stress ulcer prophylaxis. Abbreviations: AE = Adverse effect, DUE = Drug utilization evaluation, GI = Gastrointestional, P&T = Pharmacy and Therapeutics, PAH = Passavant Area Hospital, PPI = Protonpump inhibitor, SUP = Stress ulcer prophylaxis. Consult Pharm 2013;28;786-92.

Background The prevalent usage of PPI medications is a testament to the effectiveness of this class of medications, but it also introduces risks associated with inappropriate prescriptive and consumptive practices. Long-term use and the associated adverse effects (AEs) with PPI therapy have been a focus of investigation on a national scale. Included among the more serious risks associated with PPI therapy are: respiratory infections, Clostridium difficile colitis, nutrient deficiencies, bone fractures, and rhabdomyolysis.1-5 The improper use of PPI therapy in the acute care setting can have a direct impact on long-term patient care. Once a patient is discharged, confusion as to whether or not to continue a new therapy started in the hospital can lead to unnecessary therapy, medication errors, and increasing health care cost, particularly for Medicare Part A patients. Avoidance of long-term AEs may be limited or avoided completely by interventions in the acute care setting prior to discharge. This study highlights the positive effect pharmacy-driven intervention can have in this setting.

Design In 2010, a retrospective drug utilization evaluation (DUE) was approved to look at the use of PPI therapy in the context of stress ulcer prophylaxis (SUP) at Passavant Area Hospital (PAH). Part I of this study covered July through December 2010. The first half of part I (July to September) combined intravenous (IV) and oral usage of PPI therapy, while the second half of part I focused solely

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on IV use. Oral therapy was not included in the second half because preliminary review of the data obtained in the first half of part I showed that the great majority of SUP was found among patients with IV PPI therapy. The results of these studies were presented to the Pharmacy and Therapeutics (P&T) committee, and it was determined that the data supported a need for intervention in the form of medical staff education. Over the course of the next six months, the pharmacy staff presented educational training concerning PPI usage and the results of part I of the study during three medical staff meetings. Presentations were made at family practice, internal medicine, and surgical staff meetings, with handouts left to be distributed to those not in attendance. A follow-up DUE (part II) was performed from October 2011 to March 2012 for consistency in the collected data: October to December (IV+ oral) and January to March (IV only). There were no further interventions or education performed during part II of the study. Upon completion of the study, all results and statistical analysis were provided to the P&T committee, with further interventions and provider follow-up to be determined after consulting with hospital administration and medical staff.

Methods This study and its methods were approved by the hospital’s P&T committee. Submission of this article was approved by PAH’s Internal Research Review Committee. Consent forms allowing the use of patient information was obtained on admission from each individual whose chart was reviewed in the study. The methods used in both parts of the study were identical. Data for the study were obtained through retrospective chart review. Patient profiles were identified, with a report generated through the pharmacy information system, which listed all inpatients who had received PPI therapy. All patient charts listed on the report were included in the study except patients discharged directly from the emergency department, and demographic information of patients was included in the DUE (Table 1). The electronic medical record was used to review inpatient charts retrospectively. First, patients who had chronic PPI

therapy prior to admission were reviewed for an appropriate indication. Of those beginning acute PPI therapy on admission, a distinction was made between those receiving therapy for SUP and for other causes. SUP was assumed if “GI prophylaxis,” or a similar statement, was found in the patient’s chart, or if the PPI was ordered without concomitant documentation stating a specific gastrointestinal (GI)-related condition. Admissions that had PPI therapy for SUP were further reviewed to determine if the patient met criteria for initiation and appropriate duration of SUP. Three sets of criteria, which were derived from guidelines published by the Eastern Association for the Surgery of Trauma and published by the American Society of Health-System Pharmacists, were used.6,7 The first criterion was to determine the appropriate setting for SUP, i.e., whether the patient was in the intensive care unit (ICU) during administration. The second criterion was to determine the appropriate indication for SUP. Criterion was met if the patient had one of the following: • Mechanical ventilation for longer than 48 hours • Coagulopathy defined as a platelet count < 50,000 • An international normalized ratio > 1.5, or activated partial thromboplastin time > 2 x control • Traumatic brain injury • A major burn injury defined as greater than 35% body surface area affected • A recent history of GI bleed or ulceration, documented within the last year • Multiple trauma • Hepatic failure or partial hepatectomy • Perioperative transplantation • A Glascow Coma Score < 11 • Spinal cord injury Criterion was also met with at least two of the following: • Sepsis • An ICU stay expected to last more than one week • Occult bleeding • High-dose IV or oral steroids defined as more than 250 mg hydrocortisone or equivalent

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Research and Reports The third criterion was to determine appropriate duration of therapy consisting of one of the following: • Cessation of mechanical ventilation • Transfer out of ICU and or the hospital • Able to tolerate an oral diet • Completion of seven days of therapy Figures 1 and 2 contain individual results from Parts I and II. Once all data were compiled, statistical analysis was performed to compare results from pre- and posteducation DUEs. Given the retrospective design and the nature of the data, a two-tailed chi-square test was used to determine P-values for statistical significance. The online calculator QuickCalcs (Graphpad Software) was used for calculations (Table 2).

Results and Discussion Demographic analysis showed no significant difference between parts I and II with relation to patient age or gender. The average age of all participants was 66.5 years, with almost 60% of all patients being older than 64 years of age. Women were more prevalent than men in both parts of the study, at approximately 60% of the population. The youngest participant was 16 years of age, and the oldest was 97 years of age at the time therapy was administered (Table 1). Interpretation of the statistical information in Table 2 is based on the following null hypothesis: Education to medical staff regarding PPI therapy, especially relating to the practice of SUP, would have no effect on prescriptive patterns for this medication class. In other words, significant P-values (≤ 0.05) indicate that the change seen has a 95%

Figure 1. Data for Part 1 (July 1, 2010, to December 31, 2010)

Abbreviations: GI = Gastrointestional, N/A = Not applicable, SUP = Stress ulcer prophylaxis.

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Figure 2. Data for Part II (October 1, 2011, to March 30, 2012)

Abbreviations: GI = Gastrointestinal, N/A =Not applicable, SUP = Stress ulcer prophylaxis.

or greater probability that the difference may be attributed to pharmacy interventions. Results showing statistically significant changes include the following: ratio of chronic to acute PPI usage, increased documentation of diagnoses for chronic therapy, and increased duration of therapy. No significant change was observed with regard to the ratio of acute therapy prescribed for GI or for SUP. Though statistically “insignificant,” a substantial change (55.2%) was seen among SUP patients whose therapy was initiated appropriately. The ratio of chronic to acute PPI usage showed a relative rate reduction of 21.6% (P = 0.0054), indicating that fewer patients who received a PPI during their stay received it as a continuation of chronic therapy. The implication is that either there was a decrease in chronic PPI therapy or prescribers increased the use of PPI therapy for acute conditions.

Charting of indications for chronic PPI therapy also showed significant improvement. The rate increased 39%, with a P-value = 0.0365. Acknowledging that part I was performed without prescriber knowledge, the significant trending of increased charted indications in part II may have improved simply because prescribers knew their practices were being reviewed. Accurate documentation was highlighted during the pharmacy-led education meetings as being critical to the accuracy of the study and its overall viability. Although improved patterns of prescriber documentation were not the focus of the study, it was a benefit that can be correlated to pharmacy intervention. Regarding duration of therapy, it was surprising to see a very significant increase in inappropriate duration of therapy with PPI use for SUP. An overall 79% decrease in appropriate duration was observed (P < 0.0001).

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Research and Reports

Table 1. Patient Demographics Demographic Total (N) Mean age (years) Age range (years) > 64 years of age (% of N) < 65 years old (% of N) Men (% of N) Women (% of N)

Part I

Part II

Total Study

565 66.1 16-97 327 (57.9) 238 (42.1) 221 (39.1) 344 (60.9)

524 65.9 19-95 309 (59.0) 215 (41.0) 211 (40.3) 313 (59.7)

1,089 66.5 16-97 636 (58.4) 453 (41.6) 432 (39.7) 657 (60.3)

Table 2. Statistical Analysis Comparing Parts I and II Category

Part I N = 565

Part II N = 524

P-Value*

Relative Rate Reduction

1) PPI therapy Chronic:Acute (Ratio) 2) Chronic indication Charted:Uncharted (Ratio) 3) Acute indication Acute GI:SUP (Ratio) 4) SUP criteria Met:Unmet (Ratio) 5) Criteria met and duration Met:Unmet:NA (Ratio) 6) Criteria unmet and duration Met:Unmet:NA (Ratio) 7) (5 + 6) (Ratio)

367:198 (1.85) 294:73 (4.03) 148:50 (2.96) 20:30 (0.67) 12:5:3 (2.40) 19:10:1 (1.90) 31:15:4 (2.07)

310:214 (1.45) 263:47 (5.60) 167:47 (3.55) 24:23 (1.04) 10:10:4 (1.00) 5:17:1 (0.29) 15:27:5 (0.56)

0.0054

21.6%

0.0365

-39%

0.2706

-19.9%

0.1216

-55.2%

0.1316

58.3%

0.0002

84.7%

< 0.0001

72.9%

*Two-tailed P-value calculated on www.graphpad.com using a chi-squared test. Abbreviations: GI = Gastrointestinal, N = Total number of profiles reviewed, NA = Not applicable, PPI = Proton-pump inhibitor, SUP = Stress ulcer prophylaxis.

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A few possible explanations include: failure of education to stress importance of appropriate length of therapy, poor medication reconciliation practices when transitioning levels of care, and length of time from education to DUE completion. Of the three medical staff meetings, the surgical and internal medicine groups were highly attended while the family practice group had poor attendance. At PAH it is common practice for ICU patients to be treated via consultation with a surgeon or an internal medicine specialist. When the patient leaves the ICU, care transfers back to the primary care physician. It was commonly observed that the medication reconciliation forms were filled out by a prescriber other than the physician who had initially prescribed PPI for SUP. Also, the biggest trend of inappropriate duration took place within the second half of part II. This discrepancy may be the result of the chronological gap between the last pharmacy education intervention and the end of the study. Statistically nonsignificant findings included the ratio of acute cause for PPI use: GI vs. SUP (P = 0.2706), and an increase in appropriate use of PPI for SUP (P = 0.1216). In acute cases, there was a 20% increase in PPI therapy specifically for a GI-related indication during the inpatient stay. There was also an overall increase of 55.2% in appropriate initiation of SUP. This effect may be the result of chance, improved documentation, or changes in prescriber practice. A possible reason for this change was to accommodate the educational request for a charted diagnosis to support drug use, even though no actual difference in prescribing practices occurred. Of note, the increase in appropriate PPI use in SUP was statistically significant in the first half of part II (P = 0.0012). However, this trend dropped dramatically in the second half of part II (P-value = 0.35). This timeline indicates that the shift in practices may be attributed to the chronological gap between the education and latter portion of the study.

Conclusions Pharmacy intervention to avoid improper use of PPI therapy in the acute setting can lead to potential avoidance of adverse events and unnecessary costs in the long-term. As shown by this study population, the majority of patients receiving PPI therapy consist of the elderly. This is of particular importance since this population is frequently affected by polypharmacy and is prone to a higher incidence of AEs because of age-related physiologic strain. Education provided by the pharmacist to the medical staff regarding PPIs with relation to SUP and associated long-term AEs was successful in producing measurable positive results. Specifically, documentation of indication for PPI therapy improved, prescribing trends in relation to SUP improved, and decreases were seen in total patients on long-term PPI therapy. However, duration of acute PPI therapy beyond the time the underlying acute cause is resolved continues to be a problem and may contribute to unnecessary medication-related adverse events. This study highlights that educational intervention by pharmacists is effective and may be most effective with regular follow-up to prescribers. Interventions are not limited to, but may include: regular pharmacy-sponsored education seminars, administrative measures to ensure all medical staff receives training, and regular follow-up for prescriber accountability with regard to PPI use in the acute care setting. Other interventions to improve appropriate duration of PPI therapy for SUP may include automatic discontinuation of PPI therapy on discharge from the hospital or in transition of level of care. Interventions may be used to increase safe and appropriate use of PPI therapy, decrease the risk for long-term AEs, and decrease unnecessary costs to patients, health systems, and insurers.

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Research and Reports Richard Atkins, PharmD, CGP, is staff pharmacist, Passavant Area Hospital, Jacksonville, Illinois. Lori Smith, PharmD, is director of pharmacy, Passavant Area Hospital. Disclosure: No funding was received for the development of this manuscript. The authors have no potential conflicts of interest. The purpose of the study was to determine the effectiveness of medical staff training regarding the use of proton-pump inhibitors (PPI) for stress ulcer prophylaxis (SUP) and to provide data for quality improvement opportunities. The overall aim was to promote patient wellness, both during and after inpatient care. For correspondence: Richard Atkins, PharmD, Passavant Area Hospital, 1600 W. Walnut St., Jacksonville, IL 62650; Phone: 217-2459541 ext. 3394; Fax (work): 217-479-5711; E-mail: richard.atkins@ passavanthospital.com. © 2013 American Society of Consultant Pharmacists, Inc. All rights reserved.

References 1. Herzig SJ, Howell MD, Ngo LH et al. Acid-suppressive medication use and the risk for hospital-acquired pneumonia. JAMA 2009;301:2120-8. 2. Eom CS, Jeon CY, Lim JW et al. Use of acid-suppressive drugs and risk of pneumonia: a systematic review and meta-analysis. CMAJ 2011;183:310-9. 3. Dial MS. Proton pump inhibitors use and enteric infections. Am J Gastroenterol 2009;104:S10-S16. 4. Food and Drug Administration. FDA drug safety communication: possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors. Accessed May 25, 2010. 5. Food and Drug Administration. FDA drug safety communication: low magnesium levels can be associated with long-term use of proton pump inhibitor drugs (PPIs). Accessed February 2, 2011. 6. Guillamondegui OD, Gunter OL, Bonadies JA. Practice management guidelines for stress ulcer prophylaxis. Eastern Association for the Surgery of Trauma. Chicago, IL 2008. 7.American Society of Health-System Pharmacists, ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health Syst Pharm 1999;56:347-79.

Doi:10.4140/TCP.n.2013.786.

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Impact of pharmacy intervention on the use of proton-pump inhibitors in the hospital setting.

Determine effectiveness of pharmacy-driven medical staff training regarding proton-pump inhibitor (PPI) therapy...
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