Patient NameDOB: 11/05/YYYY

Proton Pump Inhibitor (PPI) Case Review

Parameter / Findings / Bates Ref / PDF Ref
First name / XXXX / XXXXXX Kidney & other providers_000001 / 1
Initial / C
Last name / XXXX
DOB / 11/05/YYYY
Gender / M
Proton Pump Inhibitor (PPI) Use Details / Reason for prescription: Gastro esophageal reflux disease
Start Date: Not known
*Reviewer's comment: As per the first available record dated 02/10/YYYY, current medication list include Nexium, hence we do not know the exact start date of proton pump inhibitor medication
Duration:
  • Per Pharmacy Records: 02/10/YYYY-12/20/YYYY
  • Per Medical Records: 02/10/YYYY, 02/17/YYYY, 04/10/YYYY, 07/06/YYYY, 06/09/YYYY, 09/29/YYYY4, 10/29/YYYY, 12/04/YYYY, 12/05/YYYY, 12/16/YYYY, 12/23/YYYY, 10/28/XXXXXX, 06/16/YYYY
Stop Date: Not known(Per last available record dated 06/16/YYYY, patient was on Prevacid 15 mg)
Dosage:
  • Nexium: 40 mg (As on 02/10/YYYY) /20 mg (As on 02/17/YYYY)
  • Prevacid: 30 mg (As on 02/10/YYYY) / 15 mg (As on 06/09/YYYY)
  • Omeprazole 20 mg (As on 04/10/YYYY)
/ Ostroms drug list - 6 pages_000001
Ostroms drug list - 6 pages_000001, 000002, 000003, Lakeshore Clinic records 2.12.10 to 7.06.12_000025-000029, 000020-000024, 000013-000019, 000002-000007, XXXXXX Kidney & other providers_000020-000022, 000018-000019, 000015-000017, 000040-000041, Everett Clinic Records 12.04.14 to 5.09.16 _000002-000004, 000006-000007, 000008-000016, 000018 / 295, 296, 297, 271-275, 266-270, 259-265, 248-253, 20-22, 18-19, 15-17, 48-50, 52-53, 54-62, 40-41, 64
Did the patient have any pre-existing conditions, allergies or contraindications for Proton Pump Inhibitor (PPI)?
(Kidney disease or failure/dementia)? / Nil
Weight, Height, BMI Details of the patient (At the time of Proton Pump Inhibitor (PPI) use) / Height: 5’ 8”
Weight: 210 lbs
Body Mass Index (BMI): 30.46 kg/m2 / Lakeshore Clinic records 2.12.10 to 7.06.12_000027 / 273
What was the injury due to Proton Pump Inhibitor (PPI) (Kidney disease or failure/dementia)? / Date of Diagnosis: 04/10/YYYY
Hospitalization for the adverse event: Yes
Length of Hospital Stay:
Lab values: As on 12/05/YYYY (Original lab report not available)
Test Name / Result / Reference range/Units
Sodium / 135 / 135-145 mmol/L
Co2 / 17 / 21-32
Potassium / 4.6 / 3.5-6.3 mmol/L
Hemoglobin / 8.7 / 13.7-16.7 g/dl
Chloride / 3.5 / 98-109 mmol/L
Treatment/management. Any complications? Yes
  • 05/07/YYYY: Renal insufficiency: Patient has long history of renal insufficiency (Prior two years’ records from YYYY-YYYY are not available for review), frequent urinary tract infection related to prior bladder cancer, surgical changes.
  • 07/06/YYYY: Edema, discontinuation of diuretic back in YYYY by either his Nephrologist or Urologist. Hydrochlorothiazide 12.5 mg. Followup with his Nephrologist. He has close followup with his Nephrologist.
  • 06/09/YYYY: Other fluid overload, chronic kidney disease stage 4, severe, benign essential hypertension
  • 06/10/YYYY-05/16/YYYY: Assessed with end stage renal disease, disorders of phosphorus metabolism, urinary tract infection, pyelonephritis, acidosis, graft infiltration and anemia. He is on hemodialysis and taking Prevacid 15 mg
/ Lakeshore Clinic records 2.12.10 to 7.06.12_000008-000012, 000002-000007, XXXXXX Kidney & other providers_000020-000022, 000023, 000018-000019, 000015-000017, 000038-000039, 000040-000041, 000046, 000044, Everett Clinic Records 12.04.14 to 5.09.16 _000002-000004, 000006-000007, 000008-000016, 000026-000027, 000036-000037, 000047-000048, 000058-000059, 000069-000070, 000191-000200 / 254-258, 248-253, 20-22, 23, 18-19, 15-17, 48-50, 52-53, 54-62, 72-73, 38-39, 82-83, 93-94, 104-105, 115-116, 40-41, 46, 44, 237-246
Other side effects of PPI
(Low Magnesium level, Osteoporosis, Hematologic laboratory abnormalities, Birth Defects, Cardiac effects, Birth Defects, etc) / Disorders of phosphorus metabolism, Acidosis, Anemia(As on 09/29/YYYY) / XXXXXX Kidney & other providers_000018-000019 / 18-19
Other Medication Induced Kidney disease or failure/dementia / Nil
Any other medical conditions leading to Kidney disease or failure/dementia / He has end stage renal disease due to diabetes mellitus and obstructive uropathy in the setting of prior bladder cancer / Everett Clinic Records 12.04.14 to 5.09.16 _000191-000200 / 237-246
Prior Medical History / Past medical history: Bladder cancer, gastroesophageal reflux disorder, acute onset diabetes mellitus, hypertension, coronary artery disease, fatty liver disease, melanoma
Past surgical history: Urinary revision with bladder removal, urostomy
Social history: Quit smoking in 1990, one pack per daily, alcohol use less than one (liquor)
Family history: Family history of diabetes and hypertension. Mother had diabetes mellitus.
Allergies: No known drug allergies / Lakeshore Clinic records 2.12.10 to 7.06.12_000026, 000021 / 272, 267
Smoker / Has he/she ever been a tobacco user? Yes / Lakeshore Clinic records 2.12.10 to 7.06.12_000026, XXXXXX Kidney & other providers_000020 / 272, 20
Period of time smoking: 20 years
Heaviness of smoking: One pack per daily
Brand of cigarettes smoked: Not known
Has he/she quit smoking? Yes
When did he/she quit: 1990
Current Condition of the patient / As per available record dated 05/16/YYYY, End stage renal disease from diabetes mellitus and obstruction. Doing well with dialysis but with catheter now after old fistula failed. Current new fistula. Advancing gradually
*Reviewer’s Comments: No further medical records are available after 05/16/YYYY to know the health status of the patient. / Everett Clinic Records 12.04.14 to 5.09.16 _000191-000200 / 237-246
MD Comments / Upon reviewing the records, we find that the patient had significant past history including diabetes, hypertension, and fatty liver. These pre-existing factors also should be considered for the development of CKD. We do not have the relevant past medical records to verify if the patient was already having microalbuminuria and declining GFR in the past. Hence we suggest you to retrieve the missing medical records without which it would not be possible to ascertain liability.
Past Medical History & Risk Factors / Cardiac problems (coronary artery disease, hypertension, cardiac stent placement, CABG): Coronary artery disease / Lakeshore Clinic records 2.12.10 to 7.06.12_000026 / 272
Stroke: Not available
Hyperlipidemia: Not available
Others: Not available

Proton Pump Inhibitor (PPI) Medication Chart

Date / Drug Name / Dosage / Prescriber’s name / Dispensing Pharmacy / Link to Records
02/10/YYYY / Lansoprazole / 30 mg / XXXXXX, M.D / XXXXXX / Ostroms drug list - 6 pages_000001
03/15/YYYY / Lansoprazole / 30 mg / XXXXXX, M.D / XXXXXX / Ostroms drug list - 6 pages_000001
06/24/YYYY / Lansoprazole / 30 mg / XXXXXX, M.D / XXXXXX / Ostroms drug list - 6 pages_000002
10/06/YYYY / Lansoprazole / 30 mg / XXXXXX, M.D / XXXXXX / Ostroms drug list - 6 pages_000003
12/19/YYYY / Lansoprazole / 30 mg / XXXXXX, M.D / XXXXXX / Ostroms drug list - 6 pages_000003
12/20/YYYY / Lansoprazole / 30 mg / XXXXXX, M.D / XXXXXX / Ostroms drug list - 6 pages_000003

Missing Medical Record:

What Records are Needed / Hospital/
Medical Provider / Date/Time Period / Why we need the records? / Is Record Missing Confirmatory or Probable? / Hint/Clue that records are missing
Medical Records substantiating the injury / Unknown / YYYY-YYYYYYYY-YYYY / To know the hospitalization for kidney injury / Probable / As per available medical records, patient had end stage renal disease
Pharmacy Records / Unknown / Prior to YYYY – till date / To know the Nexium and Omeprazole usage / Confirmatory / As per available record patient used Nexium and Omeprazole

Detailed Chronology

DATE / PROVIDER / OCCURRENCE/TREATMENT / Bates Ref / PDF REF
02/10/YYYY / XXXXXX
XXXXXX, DO / Office Visit For Sinusitis:
Patient complained of Gastroesophageal reflux disorder (GERD) symptoms continue to come and go. He is asking about follow up on use of medications today. Nexium had been previously partially effective, but he continues to have troubles and would like to look to other alternatives. He complained of sinus pressure, ears being blocked, nasal congestion, and frontal headache.
Current medication: Nexium 40 mg
Vitals: Height: 5’ 8”, Weight: 210 lbs, BMI: 30.46 kg/m2
Assessment:
GERD, prescribed Prevacid 30 mg
*Reviewer's comment: Above it is mentioned that patient used Nexium, hence we do not know the exact start date of proton pump inhibitor medication / Lakeshore Clinic records 2.12.10 to 7.06.12_000025-000029 / 271-275
*Reviewer’s Comments: Interim medical records from 02/10/YYYY-02/17/YYYY are not available to know the status of the patient.
02/17/YYYY / XXXXXX
XXXXXX, DO / Office Visit For Sinusitis:
Patient has ongoing issues with chronic GERD symptoms. Difficulties with insurance coverage. Had been on Nexium in the past, but her insurance coverage issues had changed to prescription Omeprazole which was only partially helpful. Over the counter Prilosec has not been very helpful at all.
Current medications:Prevacid 30 mg
Assessment/Plan:
  • Patient had chronic GERD. Relates that his insurance is no longer covering previously effective Prevacid. Omeprazole/Prilosec was of only minimal benefit for him. He recalls distant use of Nexium in the past.
  • Prescribed Nexium 20 mg
/ Lakeshore Clinic records 2.12.10 to 7.06.12_000020-000024 / 266-270
04/10/YYYY / XXXXXX
XXXXXX, DO / Office Visit For Sinusitis:
GERD follow up problems and concerns. Insurance will not cover prescription and he has tried all the over the counter medications with no relief. Nexium cost $700, insurance will not cover it. He also complained of headache symptoms related to chronic sinusitis. He complained of musculoskeletal symptoms. He notes no problems with any antihypertensive medication side effects.
Current medications:Prevacid 30 mg, Nexium 20 mg
Positive history for target organ damage include ASHD (either angina, prior myocardial infarction, prior CABG) and renal insufficiency
Physical exam: Head: Some minor discomfort with palpation over the maxillary sinuses.
Assessment/Plan:
  • GERD, patient seems fairly confused about his medication history. Describe utilizing a questionable over the counter product that was partially helpful. He describes fairly good control on Nexium in the past. Apparently his insurance does not cover any PPI medications. He relates that Prevacid was not very effective at all. Omeprazole was partially effective for him.
  • Combination of daily Omeprazole and Carafate will give him some better control. If symptoms persist, despite continuous PPI and mucosal barrier medication, would consider referral back for gastroenterology follow up and recheck.
  • Prescribed Omeprazole 20 mg.
/ Lakeshore Clinic records 2.12.10 to 7.06.12_000013-000019 / 259-265
05/07/YYYY / XXXXXX
XXXXXX, DO / Office Visit For Ringing In Ears:
Patient had GERD, cost concerns. Labs requested from his Nephrologist, Dr. XXXXXX. He would like to have those done at this office, but has questions about process, phlebotomist.
Physical exam: Head: Some minor discomfort with palpation over the maxillary sinuses
Assessment/Plan:
  • Renal insufficiency: Patient has long history of renal insufficiency, frequent urinary tract infection related to prior bladder cancer, surgical changes.
  • GERD, difficulties with medication coverage for GERD problems. Protonix has been helpful, but no coverage under his present formulary plan. Discussed insurance coverage issues and ongoing proper medical care.
/ Lakeshore Clinic records 2.12.10 to 7.06.12_000008-000012 / 254-258
07/06/YYYY / XXXXXX
XXXXXX, DO / Office Visit For Dizziness:
Patient complained of dizziness for 4-5 days. Sudden balance problems. He states yesterday he was vomiting due to the dizziness, yesterday was the worst day. He vomits multiple times yesterday; he was unable to lay down at all. Every time he lay down he had trouble sitting back up due to the dizziness. Sitting up is better, If he looks up he feels like he might pass out, dizziness gets worse. Wife wonders if it is a pinched nerve, has had similar symptoms in the past.
He had previously been on diuretic for blood pressure, edema. Diuretic was discontinued by his Nephrologist. They want to discuss cost issues regarding treatment for GERD.
Physical exam: Extremities: 1+ edema of the bilateral ankles. Neurologic: Vertigo symptoms are reproduced with sudden head movement, Hallpike maneuver.
Assessment/Plan:
  • Vertigo, most consistent with a viral labyrinthitis. As this time with nausea, he is interested in pursuing symptomatic treatment. Prescribed Meclizine Hcl 25 mg
  • Edema, discontinuation of diuretic back in YYYY by either his Nephrologist or Urologist. He relates that edema is uncomfortable and he is not willing to consider compression stockings at this time. Posterior trial intermittent use of low-dose diuretic for symptomatic control. Hydrochlorothiazide 12.5 mg. Followup with his Nephrologist. He has close followup with his Nephrologist.
  • GERD, having no difficulties with present Prevacid medication. Discussed issues with costs, formulary insurance coverage problems recently. Prescribed Prevacid 30 mg.
/ Lakeshore Clinic records 2.12.10 to 7.06.12_000002-000007 / 248-253
*Reviewer’s Comments: Interim medical records from 07/06/YYYY-05/07/YYYY are not available to know the status of the patient.
05/07/YYYY / XXXXXX Kidney Specialists / Lab Report:
GFR: 16(Low), Sodium: 139, Potassium: 6.5, AGAP: 19(High), BUN: 64(High), Creatinine: 3.9(High), WBC: 11.5(High), RBC: 3.56(Low), Hemoglobin: 11.0(Low), Hematocrit: 33.9(Low), Glucose: 92, Calcium 9.1, Chloride 105 / XXXXXX Kidney & other providers_000006-000010 / 6-10
06/09/YYYY / XXXXXX Kidney Specialists
XXXXXXXXXXXX, M.D / Office Visit For Chronic Kidney Disease And Hypertension:
Patient complained of chronic kidney disease stage 4, hypertension, recurrent urinary tract infection, obstructive uropathy.
He has been having issues with increased edema and shortness of breath since his last hospitalization. I thought the edema may be due to his increase in Hydralazine so I had asked him to decrease his dose from 75 mg to 50 mg (previous dose). I had asked him to take 1 of the 50 mg tablets that I thought he had. The wife did not have the pills with her and reduced his dose to 1 of the 25 mg tablets that he had.
I have increased his oral Torsemide on 2 occasions, most recently to 60 mg on Friday for 4 days then down to 40 mg after that. He was seen earlier in the week by his PCP Dr. XXXXXX and was felt to have fluid over load by exam and chest x-ray (Report not available). This would be an increase from his prior dose of 20 mg. He was given a new prescription of Lasix 20 mg. Have encouraging him to start dialysis but he has been resistant.
Current medication:Prevacid 15 mg
Physical exam: General: Mild respiratory distress. Extremities: 3+ edema
Labs reviewed:
  • 05/28/YYYY: Urine culture: Enterococcus. Sensitive to Cefazolin
  • 05/23/YYYY: Sodium 133, Potassium: 4.2, Co2: 20, Chloride: 4.0, Hemoglobin: 9.0, Platelet: 101
  • 05/21/YYYY: Sodium 138, Potassium: 5.1, Co2: 20, Chloride: 4.4, Hemoglobin: 8.0, Platelet: 67
  • 05/20/YYYY: Sodium 136, Potassium: 6.7, Co2: 20, Chloride: 3.9, Hemoglobin: 9.8, Platelet: 97
  • 05/07/YYYY: Sodium 139, Potassium: 6.5, Co2: 19, Chloride: 3.9, Hemoglobin: 11.0
  • 04/23/YYYY: Cloudy Yellow, small blood, positive nitrite, leukocyte trace, loads of bacteria, many WBC, few normal RBC. Urine culture: Multiple organisms.
  • 04/16/YYYY: Sodium 138, Potassium: 5.0, Co2: 21, Chloride: 4.5
  • 02/26/YYYY: Sodium 137, Potassium: 4.8, Co2: 17, Chloride: 4.1
  • 01/16/YYYY: Sodium 140, Potassium: 4.7, Co2: 21, Chloride: 3.6
  • 01/13/YYYY: Sodium 138, Potassium: 7.2, Co2: 17, Chloride: 4.1, Hemoglobin: 11.3
  • 12/05/YYYY: Sodium 135, Potassium: 4.6, Co2: 20, Chloride: 3.5, Hemoglobin: 8.7
  • 10/14/YYYY:Urinary Protein to Creatinine Ratio (UPCR): 4.7
*Reviewer’s Comments: Original lab reports are not available for review.
Assessment/Plan:
  • Other fluid overload, we do not have a pulse oximetry to check his oxygen saturation. Admitted and started on dialysis
  • Chronic kidney disease stage 4, severe, he has a functioning left fore arm fistula. Dr. XXXXXX had wanted to access his fistula prior to starting hemodialysis.
  • Benign essential hypertension, stable control though slightly suboptimal. He has not tolerated increases in doses of his blood pressure medication. Start hemodialysis and fluid removal. Emergency room called and informed. Will let Dr. XXXX know he is likely being admitted and will start dialysis
/ XXXXXX Kidney & other providers_000020-000022 / 20-22
06/10/YYYY / XXXXXX Vascular
XXXXXX, M.D / Office Visit For Removal Of Hemodialysis Catheter:
Patient here for removal of his tunneled hemodialysis catheter. He reports dialyzing via the left wrist AVF without issue.
Physical exam: Tunneled catheter in place right side
Assessment/Plan: Successful removal of tunneled IJ hemodialysis catheter. Was given post catheter removal instructions. / XXXXXX Kidney & other providers_000023 / 23
07/10/YYYY / Unknown Provider / Lab Report:
Sodium: 140, Potassium: 4.3, Chloride: 101, CO2: 27, AGAP: 17(High), Glucose: 107, BUN: 37(High), Creatinine: 5.5(High), POC Hemoglobin: 10.2(Low), POC Hematocrit: 30(Low) / XXXXXX Kidney & other providers_000011-000014 / 11-14
09/01/YYYY / XXXXXX Laboratories / Lab Report:
Calcium Phosphate: 58(High), Glucose: 163(High), Urea: 67, Bun: 52(High), Creatinine: 7.1(High), Phosphorus: 6.3(High), Calcium phosphate: 57(High), RBC: 2.62(Low), Hemoglobin: 9.0(Low), Hematocrit: 25.1(Low), RDW: 16.4(High) / XXXXXX Kidney & other providers_000001-000002 / 1-2
09/15/YYYY / XXXXXX Laboratories / Lab Report:
Hemoglobin: 9.4(Low) / XXXXXX Kidney & other providers_000003 / 3
09/29/YYYY / XXXXXX Kidney Specialists
XXXXXXXXXXXX, M.D / Follow Up Visit For End Stage Renal Disease:
Patient continuous have some issues with access occasional infiltration. He is no longer has a catheter in. He is having some low blood pressure. He is getting O2 while on dialysis and this is helping some. He is getting around 3L US. He is taking TUMS. We filled out the forms for Renvela, but neither of us has heard anything back. He is down to 25 mg of Atenolol on non hemodialysis days.
Medication:Prevacid 15 mg
Physical exam: General: Mild respiratory distress. Extremities: 3+ edema
Lab Report:
08/04/YYYY: Sodium 139, Potassium: 4.0, Co2: 20, Chloride: 8.3, Calcium: 9.0, Phosphorus: 6.9, Calcium phosphate: 57, Hemoglobin: 9.6, Kt/V: 1.0 (Report not available)
Assessment/Plan:
  • Other fluid overload, improved. Low blood pressure now. Will stop Atenolol and see how his blood pressure reacts.
  • Benign essential hypertension
  • End stage renal disease, adequacy is low. Will review order and consider increasing time or larger dialyzer
  • Disorders of phosphorus metabolism, not taking Renvela. Will start phos-lo
  • Acidosis, mild, improved
  • Anemia in chronic kidney disease, below goal. ESA and iron per protocol.
/ XXXXXX Kidney & other providers_000018-000019 / 18-19
10/08/YYYY / XXXXXX Diagnostics / Lab Report:
Glucose: 209, Ferritin: 790, Hemoglobin: 9.8, Hematocrit: 27.9, RDW: 16.5, Platelet: 101, BUN: 53, Creatinine: 7.2, Sodium: 135, Bicarbonate: 21, Phosphorus: 5.7 / XXXXXX Kidney & other providers_000004-000005 / 4-5
10/29/YYYY / XXXXXX Kidney Specialists
XXXXXXXXXXXX, M.D / Follow Up Visit For End Stage Renal Disease:
Patient continuous have some issues with access occasional infiltration. He did have an angioplasty(Report not available) recently and his fistula is still problematic according to him. He does not know if he has a follow up with Dr. XXXXXX or not. His blood pressures are much better off the Atenolol. He is taking TUMS. Started him on phos-Lo, but he has having nausea, so he went back on the TUMS. He is being treated for another urinary tract infection and Pneumonia (PNA). He is not bleeding much better, but some
Medication:Prevacid 15 mg
Physical exam: General: Mild respiratory distress. Lungs: Decreased breath sounds. Extremities: 3+ edema
Assessment/Plan:
  • Other fluid overload, improved to euvolemic
  • Benign essential hypertension, at goal
  • End stage renal disease, adequacy was better and at goal last month, no available data for October. November labs coming up. Will review order and consider increasing time or larger dialyzer. Access issues, will have see Dr. XXXXXX soon
  • Disorders of phosphorus metabolism, improved taking TUMS as binders
  • Acidosis, mil, improved
  • Anemia in chronic kidney disease, below goal. ESA and iron per protocol. Levels improving
  • Continue to watch intake of high phosphorus foods
  • Follow up in two weeks
/ XXXXXX Kidney & other providers_000015-000017 / 15-17