A SEEMINGLY BENIGN DRUG IN THE SPOTLIGHT: AN EDUCATIONAL INTERVENTION TO REDUCE INAPPROPRIATE USE OF...

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K. Gandhi, MD (Associate), S. Dhital, MD (Associate), S. Khan, MD (Associate), S. Basnyat, MD (Associate), F. Bofarrag, MD (Associate), T. Maduke, MD (Associate), B. Qureshi, MD (Associate), Y. Goite, MD (Associate), F. Balis, MD (Fellow) and H. Kawsar, MD, Ph.D (Fellow) Department of Medicine, St. Luke’s Hospital, Chesterfield, MO A SEEMINGLY BENIGN DRUG IN THE SPOTLIGHT: AN EDUCATIONAL INTERVENTION TO REDUCE INAPPROPRIATE USE OF PPI INTRODUCTION Overutilization of Proton pump inhibitors (PPI) in hospitalized patients is a well-recognized problem. In our previous study at St. Luke’s Hospital, we found that the lack of published guidelines for PPI use in non-critically ill patients results in overutilization of PPI in hospitalized patients. We conducted an educational intervention program to address this problem. METHODS We retrospectively reviewed 200 patient charts who received PPI while admitted to the medical floor at St. Luke’s Hospital in 2014. It showed a high number of patients were on PPI inappropriately. To improve this practice, we conducted an interventional program to educate residents on appropriate use of PPI by emails, flyers, holding brief meetings and providing them with quick reference cards as well as by setting up high risk pharmacy alert for Protonix use on EMR. The effect of this intervention was measured by reviewing EMR of 179 qualified patients admitted to medical floors between March and May 2016. RESULTS The majority of patients were Caucasian (90%) with female predominance (56%). PPI was used or continued appropriately in 92% (84%, pre intervention) patient during admissions and 85% (48%, pre intervention) during discharge. The most common indications for PPI use in our study was gastro- esophagitis or GERD (72%) and history of GI bleeding (12%). Six percent of patients had a history of Barrett’s esophagus or hiatal hernia. There was no documented reason for PPI use in 3% of patients, and 5% of them were discharged home on PPI. DISCUSSION Overutilization of PPI in non-critically ill hospitalized patients is a known problem in medical practice. Use of PPI has been implicated in number of adverse consequences including but not limited to Clostridium difficile infection, pneumonia, and osteoporosis. DISCUSSION In recent studies, PPI was found to be associated with increased in-hospital mortality, increased risk of cardiovascular events, dementia and chronic renal failure (CRF). We studied the magnitude of the problem in our hospital and employed an educational intervention program, which resulted in a significant reduction of inappropriate use of PPI in the hospital. There were several limitations to our study. This was a retrospective study where we noted a lack of proper documentation for outpatient use of PPI. We also were unable to precisely determine for how long the patients were taking PPI as outpatients. Our post interventional data was only from medical residents (a total of 41), as a result, we are unable to determine the effect of the educational intervention on the clinical practice of NPs, hospitalists and PCPs. CONCLUSION PPIs have long been considered as relatively harmless drugs. In recent years, it has been implicated in several adverse effects that increases patient morbidity and mortality along with increased healthcare expenditure. Our data shows that proper education and ongoing surveillance, especially during admission and discharge can significantly reduce overutilization of PPI. REFERENCES 1. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health Syst Pharm. 1999; 56:347-79. 2. Chia, C., Lim, W, and Vu, C. (2014). Singapore Medical Journal Smedj, 55 (7), 363-366. 3. Hussain, S., Stefan, M., Visintainer, P. et al. (2010). Southern Medical Journal, 103(11). 4. Ladd, A., Panagopoulos, G., Cohen, J. et al. (2014). The American Journal of the Medical Sciences, 347(6), 446-451. 5. Heidelbaugh, J., Kim, A., Chang, R. et al. Therapeutic Advances in Gastroenterology, 219-232. 6. Lazarus, B, Chen. Y, Francis P. et al. (2016) JAMA Intern Med. 2016;176(2) 7. 7.Gomm, W., Holt, V K, and Thomé, F (2016); JAMA Neurol. 2016;73(4):410- 416. 8. Protonix® (pantoprazole) prescribing information, Retrieved August 2015 ACKNOWLEDGEMENT We would like to thank Dr. Daina Zhang, Dr. Belmaya Ghale, Dr. Luke Sung, Dr. Ali Entezari, and Dr. Mohamed Gashouta for their contribution during pre-intervention phase of the study. We also thank Dr. Sajid Zafar, MD, Department of Gastroenterology and Hepatology for his valuable advice. Thanks to Ms. Tami Strand, Director of Clinical Performance and Improvement, and Mr. Way Huey, Pharm D, BCPS, FCCM, Assistant Director of Pharmacy Services, for their help with patient data. Residents NPs PCP Hospitalist 33% 30% 19% 16% 28% 24% 16% 29% Prescribers of PPI Inappropriate Appropriate 84% 16% Appropriate Vs Inappropriate Appropriate Inappropriate 48% 42% 10% PPI on discharge Continued Discontinued Unnown Recommendations: Put a STOP Date Additional wks. if needed Esophagitis/Gastritis/GERD – Erosive 8 weeks – STOP 4-8 weeks Esophagitis/Gastritis/GERD - Nonerosive but symptomatic Peptic Ulcer Disease Without H. Pylori 4-8 weeks – STOP 4 weeks With H. Pylori Triple/Dual therapy 14 days -STOP 14 days >= 2 of minor criteria 1. Severe sepsis 2. ICU stay more than 1 week 3. Occult GI bleeding for >=6 days 4. High Dose Glucocorticoid therapy (Hydrocortisone>250, Prednisone >62.5, methylprednisolone >50) 4 weeks – STOP 4 weeks OTC use for Frequent heartburn Use for < 14 days – STOP May repeat after 4 months Chronic NSAID therapy Continue daily – Max 6 months 6 months – STOP Pathological hypersecretory conditions Daily – Possible lifetime use STOP: 1. If C. Diff positive - until treatment completion 2. If does not know why taking it and denies dyspepsia 3. If acute interstitial nephritis develops 5% 85% 10% PPI on discharge Continued Discontinued Unknown 92% 3% 5% Appropriate Vs Inappropriate Appropriate Inappropriate Undetermined Pre Post 16% 3% 84% 92% PPI on Admission Inappropriate Appropriate Pre Post 42% 5% 48% 85% PPI on Discharge Continued Discontinued Pre intervention Post intervention Sample size 200 179 Age 72 72 Gender Male 56% 44% Female 44% 56% Race Caucasian 91% 90% African-Americans 6% 8% Others 3% 2% 72% 12% 6% 4% 3% 3% Reasons for PPI use Esophagitis/Gastritis/ GERD GI Bleeding Hiatal hernia/Barrett's esophagus PUD/H.Pylori Others No Known Indication Table 2. Patient characteristics Table 1. Guidelines for PPI use

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K. Gandhi, MD (Associate), S. Dhital, MD (Associate), S. Khan, MD (Associate), S. Basnyat, MD (Associate), F. Bofarrag, MD (Associate), T. Maduke, MD (Associate), B. Qureshi, MD (Associate), Y. Goite, MD (Associate), F. Balis, MD (Fellow) and H. Kawsar, MD, Ph.D (Fellow)

Department of Medicine, St. Luke’s Hospital, Chesterfield, MO

A SEEMINGLY BENIGN DRUG IN THE SPOTLIGHT: AN EDUCATIONAL INTERVENTION TO REDUCE INAPPROPRIATE USE OF PPI

INTRODUCTION

Overutilization of Proton pump inhibitors (PPI) in hospitalized patients is a well-recognized problem. In our previous study at St. Luke’s Hospital, we found that the lack of published guidelines for PPI use in non-critically ill patients results in overutilization of PPI in hospitalized patients. We conducted an educational intervention program to address this problem. METHODS

We retrospectively reviewed 200 patient charts who received PPI while admitted to the medical floor at St. Luke’s Hospital in 2014. It showed a high number of patients were on PPI inappropriately. To improve this practice, we conducted an interventional program to educate residents on appropriate use of PPI by emails, flyers, holding brief meetings and providing them with quick reference cards as well as by setting up high risk pharmacy alert for Protonix use on EMR. The effect of this intervention was measured by reviewing EMR of 179 qualified patients admitted to medical floors between March and May 2016. RESULTS

The majority of patients were Caucasian (90%) with female predominance (56%). PPI was used or continued appropriately in 92% (84%, pre intervention) patient during admissions and 85% (48%, pre intervention) during discharge. The most common indications for PPI use in our study was gastro-esophagitis or GERD (72%) and history of GI bleeding (12%). Six percent of patients had a history of Barrett’s esophagus or hiatal hernia. There was no documented reason for PPI use in 3% of patients, and 5% of them were discharged home on PPI. DISCUSSION

Overutilization of PPI in non-critically ill hospitalized patients is a known problem in medical practice. Use of PPI has been implicated in number of adverse consequences including but not limited to Clostridium difficile infection, pneumonia, and osteoporosis.

DISCUSSION

In recent studies, PPI was found to be associated with increased in-hospital mortality, increased risk of cardiovascular events, dementia and chronic renal failure (CRF). We studied the magnitude of the problem in our hospital and employed an educational intervention program, which resulted in a significant reduction of inappropriate use of PPI in the hospital. There were several limitations to our study. This was a retrospective study where we noted a lack of proper documentation for outpatient use of PPI. We also were unable to precisely determine for how long the patients were taking PPI as outpatients. Our post interventional data was only from medical residents (a total of 41), as a result, we are unable to determine the effect of the educational intervention on the clinical practice of NPs, hospitalists and PCPs. CONCLUSION

PPIs have long been considered as relatively harmless drugs. In recent years, it has been implicated in several adverse effects that increases patient morbidity and mortality along with increased healthcare expenditure. Our data shows that proper education and ongoing surveillance, especially during admission and discharge can significantly reduce overutilization of PPI. REFERENCES

1. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health Syst Pharm. 1999; 56:347-79. 2. Chia, C., Lim, W, and Vu, C. (2014). Singapore Medical Journal Smedj, 55 (7), 363-366. 3. Hussain, S., Stefan, M., Visintainer, P. et al. (2010). Southern Medical Journal, 103(11). 4. Ladd, A., Panagopoulos, G., Cohen, J. et al. (2014). The American Journal of the Medical Sciences, 347(6), 446-451. 5. Heidelbaugh, J., Kim, A., Chang, R. et al. Therapeutic Advances in Gastroenterology, 219-232. 6. Lazarus, B, Chen. Y, Francis P. et al. (2016) JAMA Intern Med. 2016;176(2) 7. 7.Gomm, W., Holt, V K, and Thomé, F (2016); JAMA Neurol. 2016;73(4):410- 416. 8. Protonix® (pantoprazole) prescribing information, Retrieved August 2015

ACKNOWLEDGEMENT We would like to thank Dr. Daina Zhang, Dr. Belmaya Ghale, Dr. Luke Sung, Dr. Ali Entezari, and Dr. Mohamed Gashouta for their contribution during pre-intervention phase of the study. We also thank Dr. Sajid Zafar, MD, Department of Gastroenterology and Hepatology for his valuable advice. Thanks to Ms. Tami Strand, Director of Clinical Performance and Improvement, and Mr. Way Huey, Pharm D, BCPS, FCCM, Assistant Director of Pharmacy Services, for their help with patient data.

Residents NPs PCP Hospitalist

33% 30%

19% 16%

28% 24%

16%

29%

Prescribers of PPI Inappropriate Appropriate

84%

16%

Appropriate Vs Inappropriate Appropriate Inappropriate

48%

42%

10%

PPI on discharge Continued Discontinued Unnown

Recommendations: Put a STOP Date Additional wks. if needed

Esophagitis/Gastritis/GERD – Erosive 8 weeks – STOP 4-8 weeks Esophagitis/Gastritis/GERD - Nonerosive but symptomatic Peptic Ulcer Disease Without H. Pylori 4-8 weeks – STOP 4 weeks

With H. Pylori Triple/Dual therapy 14 days -STOP 14 days

>= 2 of minor criteria

1. Severe sepsis 2. ICU stay more than 1 week 3. Occult GI bleeding for >=6 days 4. High Dose Glucocorticoid therapy (Hydrocortisone>250, Prednisone >62.5, methylprednisolone >50)

4 weeks – STOP 4 weeks

OTC use for Frequent heartburn Use for < 14 days – STOP May repeat after 4 months Chronic NSAID therapy Continue daily – Max 6 months 6 months – STOP Pathological hypersecretory conditions Daily – Possible lifetime use

STOP: 1. If C. Diff positive - until treatment completion 2. If does not know why taking it and denies dyspepsia 3. If acute interstitial nephritis develops

5%

85%

10%

PPI on discharge Continued Discontinued Unknown

92%

3% 5%

Appropriate Vs Inappropriate Appropriate Inappropriate Undetermined

Pre Post

16% 3%

84% 92%

PPI on Admission Inappropriate Appropriate

Pre Post

42%

5%

48%

85%

PPI on Discharge Continued Discontinued

Pre intervention Post intervention Sample size 200 179 Age 72 72

Gender Male 56% 44% Female 44% 56%

Race Caucasian 91% 90% African-Americans 6% 8% Others 3% 2%

72%

12%

6% 4% 3% 3%

Reasons for PPI use

Esophagitis/Gastritis/GERD GI Bleeding

Hiatal hernia/Barrett's esophagus PUD/H.Pylori

Others

No Known Indication

Table 2. Patient characteristics

Table 1. Guidelines for PPI use