Prevelance of SUP overuse in Alexandria hospitals and determination of factors influencing prescribing behavior among physicians

1. Assessment of Risk Factors for Drug Overuse
of Stress Ulcer Prophylaxis in Patients of
Selected Hospitals in Alexandria

2. Assessment of Risk Factors for Drug
Overuse of Stress Ulcer Prophylaxis in
Patients of Selected Hospitals in
Alexandria
By
Nivin Ezzat Mohamed Nasouh Karima
B.Sc. of Pharmaceutical Sciences,
Alexandria University, 2010

3. Supervisors Committee
Prof. Dr. Fayek Salah El Khwsky
Professor of Biomedical Informatics and Medical Statistics
Department of Biomedical Informatics and Medical Statistics
Medical Research Institute
Alexandria University
Prof. Dr. Nabil Lotfy Dowidar
Professor of Experimental and Clinical Surgery
Department of Experimental and Clinical Surgery
Medical Research Institute
Alexandria University
Dr. Omaima Gaber Mohamed Yassine
Assistant Professor of Biomedical Informatics and Medical
Statistics
Department of Biomedical Informatics and Medical Statistics
Medical Research Institute
Alexandria University
Dr. Mohamed Hamdy Ellakany
Lecturer of Anesthesia
Department of Anesthesia
Medical Research Institute
Alexandria University

4. Why Stress Ulcer Prophylaxis?
- Stress Ulcer prophylaxis (SUP) is recommended for
critically ill patients who meet specific criteria.
- In recent years, rates of inappropriate SUP approaching
70% in ICU and general ward.
- Overuse and misuse may result in patient harm and
increased hospitalization costs.

5. Stress Ulcer Definition
Stress Ulcer is defined as
acute superficial inflammatory lesions
of gastric mucosa induced by abnormally elevated
physiological demands such as
Neurologic
Damage
Trauma
Burns
Sepsis

6. Clinical presentations of Stress Ulcer
Occult bleeding Overt bleeding
Clinically important
gastrointestinal bleeding
Identified
through positive
guaiac test
Incidence
15% - 50%
Hematemesis,
Melena, blood in
aspirate of NG
tube
Incidence
5% - 25%
Bleeding
episodes affect
morbidity or
mortality
Incidence
Before 1999; 2% - 6%
Since 2001; 0.1% - 4%

7. Gastrointestinal bleeding is considered significant or life threatening when is it
accompanied by hemodynamic changes;
- Tachycardia
- Hypotension
- Orthostatic changes
- Decrease in hemoglobin concentration by more than 2g/dL
Clinically Important Bleeding

8. Risk factors for
Stress Ulcer
Gastrointestinal bleeding
Major Risks
Minor Risks

9. Therapy for Preventing Stress Ulcer
Antacids1
Sucralfate2
Histamine-2 Receptor Blockers3
Proton Pump Inhibitors4

10. Mechanism of Action

11. Adverse Effects of prophylactic agents
Pneumonia
Clostridium difficile
Kidney disease
Malabsorption
Drug Interactions

12. Pneumonia
The use of AST, particularly with PPIs, causes
a sustained increase in gastric pH to higher
then 4, furthering bacterial colonization of
the stomach and risk of pneumonia.
Risk was reported to be higher during the
first month of PPI therapy, association was
particularly strong within a week, or even
the first 2 days after PPI initiation.

13. Clostridium difficile
Acid suppression affects gut microbiota
composition, causing bacterial overgrowth
and pathogen colonisation including CDI.
FDA required that the package insert for
PPIs contain a warning that PPIs may
increase risk of CDI.

14. Kidney disease
Chronic Kidney Disease (CKD)

15. Malabsorption
Vitamin B12
Magnesium
Calcium
‘Hip fracture’
Iron

16. Drug Interactions
Omeprazole shares the
same hepatic metabolic
pathway, decreasing
activation of Clopidogrel.
Delayed elimination and
potential toxicity when
PPIs are administered with
high dose Methotrexate.

17. Rationale
To the best of my knowledge, there is
insufficient information about adherence to
SUP guidelines in Egyptian patients in
healthcare centers.
Several studies surveyed physicians to assess
their knowledge, attitudes, and factors that
might influence their prescribing of SUP but
unfortunately none of them took place in Egypt.

18. Aim of the
work
Determine physicians’
rationale for SUP
medication’s
prescription in
hospitalized patients
Assessment of the
prevalence of
inappropriate SUP
prescription
among patients
admitted to the
hospital

19. Subjects
and
Methods

20. Subjects
Title
Study Setting
ICU and wards of Public + Private hospital
- Public; Ras El Tin General Hospital
- Private; Andalusia Hospitals
Title
Title
Study Design
Cross sectional study
Study population
Patients admitted to ICU and wards
prescribed any SUP medication with de
novo prescription only

21. Subjects
Inclusion Criteria
Adults aged ≥18 years
Exclusion Criteria
- Patients on AST for treatment of
GI diseases
- Patients with active GI bleeding
- Patients using NSAIDs
- Patients receiving concurrent
antiplatelet and anticoagulant
or dual antiplatelet therapy

22. Subjects
Title
Study Period
All patients admitted during the period
February until June 2017
Title
Sample Size
312 patients
Sampling Technique
Simple random sampling technique

23. Methods
Patient files were reviewed
and a standardized data
collection sheet was used.
All treating physicians were
interviewed through Questionnaires to
collect data regarding;
- Professional Characteristics
- Prescribing behaviour
- Knowledge of SUP indications
- Concern for SUP side effects

24. Data Collection Sheet
Sample Number
Patient's ID
Hospital Type
Patient's Location "Department"
Age
Gender
Medical History
Diagnosis
Laboratory Values
Rational for Prophylaxis (mark if risk factor exists)
Respiratory failure (Mechanical ventilation ≥48 hours).
Coagulopathy (Platelet count <50,000 mm3, INR >1.5, or PTT >20seconds).
History of gastric ulceration or bleeding during year before admission.
Head injury (Patients with Glasgow coma score of ≤10) or (inability to obey simple commands).
Thermal Injuries (>35% of body surface area).
Hepatic failure (Total bilirubin level >5 mg/dL, AST >150 U/L (3× ULN), or ALT >150 U/L (3× ULN)).
Multiple trauma (Multiple trauma with Injury Severity Score of ≥ 16).
Hepatic or renal transplantation / Partial hepatectomy / Renal insufficiency
Spinal cord injuries.
Having at least 2 of the following risk factors:
- Sepsis
- ICU stay longer than 1 week
- Occult bleeding lasting 6 days or Longer
- Use of more than 250 mg hydrocortisone or the equivalent therapy daily.
Prophylactic agent used
Class; Generic name;
Dose / Frequency
Route of administration
Enteral Access Yes / No
Treating Physician
SUP Indicated?

25. Statistical Analysis
Qualitative
variables were
described by
Number and
Percent
Quantitative
variables were
described by
Mean and SD
Association between
qualitative variables
was tested using
Pearson’s Chi-
square test
Two logistic regression
models were built to detect
whether significant factors
in the bivariate model still
maintain their significance in
the multivariate model
Odds ratio and its
corresponding 95%
confidence interval were
calculated in both models for
independent variables

26. Results

27. Results
Section I - Patients
- Characteristics of patient’s
sample, appropriateness of
prescription, and prophylactic
agents used.
- Factors affecting appropriateness
of SUP prescription
Section II - Physicians
- Characteristics and knowledge of
the survey participants
- Factors influencing physicians’
prescribing behavior

28. Results - Patient

29. Results - Patient
Frequency distribution of major and minor risk factors for Stress Ulcer from total present risks (n=265) among
the study sample, Alexandria, 2017.
*Green bars represent ‘Major risk factors’ while Yellow bars represent ‘Minor risk factors’.

30. Results - Patient
Distribution of prophylactic agent used
for SUP among the study sample,
Alexandria, 2017.
Proton Pump Inhibitors Vs. H2-Blockers
among the study sample, Alexandria,
2017.

31. Results - Patient
Route of administration used for
SUP among study sample,
Alexandria, 2017.

32. Results - Patient
Statistically
Significant

33. Results - Patient
Prescription appropriateness of
Stress Ulcer Prophylaxis among the study
sample, Alexandria, 2017.

34. Results - Patient
Statistically
Significant

35. Results - Patient
SUP appropriateness according
to department of admission
among the study sample,
Alexandria, 2017.

36. Results - Patient
Statistically
Insignificant

37. Results - Patient
Multivariate analysis for factors associated with inappropriate SUP prescription
Age of the patient was inversely associated to inappropriate SUP prescription. Every year
increase in the patient’s age was associated with a 3% decrease in the risk of being
inappropriately prescribed.
Department of admission, patients admitted to wards were 3.5 times more likely to receive
inappropriate SUP prescription than those admitted to the ICU.

38. Results - Physicians

39. Results - Physicians

40. Results - Physicians
When asked about possible
complications regarding use
of SUP agents;
- Only 10.7% (6
physicians) were able to
identify the three side
effects correctly
- 44.6% (25 physicians)
stated that they either
didn’t know, didn’t
believe, or gave totally
wrong answers

41. Results - Physicians
Statistically
Significant

42. Results - Physicians
Statistically
Significant

43. Results - Physicians
Statistically
Significant

44. Results - Physicians
Multivariate analysis for factors associated with high SUP prescribing
Physicians with poor knowledge were 8.5 times more likely to be high prescribers relative to
those with good knowledge.
Physicians who were unconcerned about SUP side effects were 6.2 times more likely to be
high prescribers than those who are concerned.

45. Conclusions

46. Conclusions
The results obtained indicates that
some healthcare centers in
Alexandria, Egypt like other previous
studies, suffer from widespread
misuse of SUP in hospital practice.

47. Conclusions
SUP was over-prescribed in ICU and medically hospitalized patients as
apparently Physicians
1- Overestimate the risk of
stress-induced GI bleeding
2- Lack true knowledge of SUP indications
3- Underestimate potential harms associated
with the use of SUP

48. Recommendations

49. Recommendations
To reduce the risk of initiating and continuing inappropriate SUP
- Educate house staff about this problem, with special emphasis on
evaluating and re-evaluating the need for SUP at every level of care.
- Every healthcare should have well designed protocol that contains
all proper indications for SUP.

50. Recommendations
Pharmacists should have a pivotal role by
1. Making sure these guidelines are adhered to
2. Routinely monitor and intervene in SUP
prescription
3. Regular educational sessions to update physicians
about latest guideline recommendations

51. Recommendations
Recommendations for further research
- Further larger multi-centered studies to obtain results
that could better reflect the prescription patterns in
Alexandria, Egypt.
- Impact of clinical pharmacy educational interventions
could be studied in different patient settings.

52. Recommendations
Recommendations for further research
Patients could be followed up after hospitalization
to detect any adverse effects or complications from
SUP.