Patient NameDOB: 12/22/YYYY
07/23/YYYY
Viagra Case Review – XXXXXX
Parameter / Findings / Bates RefFirst Name / XXXXXX / V - 4
Initial / M / V - 4
Last Name / XXXXXX / V -4
DOB / 12/22/YYYY / V -4
Medication Taken / Viagra, Levitra, and Cialis / V -474, 250, 246, 277
Viagra Start Date / 04/03/YYYY(Per medical records)
*Reviewer’s comments:In the available medical and pharmacy records, first use of Viagra was noted on 04/03/YYYY and first refill on 04/04/YYYY. However exact start date of Viagra is unknown. / V -474, 439
Dosage / Viagra 50 mg, 100 mg; Levitra 10 mg; Cialis 20 mg / V -474, 439, 447, 277, 250, 246
Total Exposure / 2600 mg (Calculatedfrom available pharmacy records) / V -439, 447
Viagra Discontinued Date / Unknown
*Reviewer’s comments:In the available records last use of Cialis is noted on 04/30/YYYYhowever further medical records are not available to know if Viagra/Cialis was discontinued. / V -250
Viagra Adverse Events
(Whether diagnosed with Melanoma, other skin cancer or any other events) / Yes / V -57-58
Other Cancer Prior To Viagra / Not available
Date of Diagnosis of Melanoma / 03/16/YYYY:Pathology report revealed lentigo malignant melanoma in abdominal wall / V -57-58
Staging of Melanoma / 03/16/YYYY: Clark’s level II / V -57-58
Management of Adverse events / 03/22/YYYY: Underwent wide excision of melanoma of the abdomen / V -41
Smoking history / Never smoker / V -242
Predisposing factors (Fair skin, Blonde hair, Moles, exposure to sun, radiation exposure) / As on 12/05/YYYY: History of sunburn, blistering, some freckles in the sun. The patient is a Fitzpatrick skin type III. Lifetime ultraviolet exposure. / V -507-511
Prior Medical History / Past medical history:Atrial fibrillation, colonic polyps, coronary artery disease, hyperlipidemia, hypertension, recurrent prostatitis
Past surgical history: Tonsillectomy, vasectomy, stent right and left coronary arteries, right shoulder rotator cuff 08/2010
Family History: Father – liver disease, mother- Cancer, Brother – Heart disease
Social history: Never smoker, occasionalalcohol use
Allergies: No known drug allergies / V -242, 118
Condition of The Patient Per Last Available Record / 12/05/YYYY: History of melanoma excised on right abdomen -No recurrence - Has benign nevi of back, chest, abdomen, and extremities - Lesion on left lateral thigh stable in measurement; Actinic keratosis of head and ears, right cheek, face – Liquid nitrogen given on right cheek – Recommended use of sunscreen, shave biopsy of lesion on right anterior arm.
*Reviewer’s comments: Further medical records after 12/05/YYYY are not available for review. / V -507-511
Pharmacy Log:
Date / Drug / Rx. Doctor / NDC Code / Pharmacy / Dosage / Quantity / Total Exposure / Manf. Name (Web Search based on NDC code) / Link to Records04/04/YYYY / Viagra / YYYY, M.D. / 00069421030 / YYYY Pharmacy / 50 mg / 6 / 300 / Pfizer / V -439
06/27/YYYY / Viagra / YYYY, M.D. / 00069421030 / YYYY Pharmacy / 50 mg / 6 / 300 / Pfizer / V -439
07/14/YYYY / Viagra / YYYY, M.D. / 00069421030 / YYYY Pharmacy / 50 mg / 20 / 1000 / Pfizer / V -447
03/02/YYYY / Viagra / YYYY, M.D. / 00069421030 / YYYY Pharmacy / 50 mg / 20 / 1000 / Pfizer / V -447
Total exposure: 2600 mg
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 missingPharmacy records / Unknown / 04/03/YYYY, 02/07/YYYY-04/30/YYYY / To know duration and total exposure of Viagra, Cialis and Levitra / Confirmatory / Per medical records first use of Viagra noted on 04/03/YYYY and last use of Cialis noted on 04/30/YYYY. Pharmacy records from YYYY-YYYY are only available.
Medical Chronology of Hospitalization Events
(Including Operative Procedure, Reason for Surgery, Complications, Pathology, Findings)
DATE / PROVIDER / OCCURRENCE/TREATMENT / BATES REF01/04/YYYY-01/16/YYYY / Multiple Providers / Multiple visits for hypertension, and depression, left nasal al lesion, leukoplakia, and pharmacyrecords:
01/04/XXXXX:Denies any change in sexual frequency. Though admittedly, it is not as frequent as it was 20 years ago.
02/20/yyyy:Has superficial lesion on left nasal ala which scabs over when he picks at it – On examination, there is a very superficial hemangioma left nasal ala for which no treatment is offered though suggested to watch for it in future.
09/13/yyyy: Seen for tiny lesion on left ala of the nose which has been present for several months – Under Xylocaine anesthesia a superficial biopsy of 2 mm lesion is performed. Base is cauterized with silver nitrate. Lesion is frozen for 1 minute with the cryosurgical unit – Specimen submitted to pathology
04/03/YYYY: Viagra 50 mg
04/04/YYYY-03/02/YYYY: Viagra 50 mg refilled(Pharmacy refill)
01/16/YYYY: Concerned of a spot on his lower lip – On examination of lower lip reveals a small area of leukoplakia about 4 mm in diameter on the mid portion of lower lip – Diagnosis: Hopefully this is premalignant actinic keratosis - Referred to Dr. XXXXX for biopsy.
*Reviewer’s comments: Above visits are combined and only significant details pertaining to Viagra case review have been elaborated. / V- 467, 469, 474, 273, 439, 447
*Reviewer’s comments:Interim medical records from 01/16/YYYY-02/24/YYYYpertaining to Viagra case review are not available for review.
02/24/YYYY / XXXXX, M.D. / Visit to check mole:
Examination reveals a 5 mm darkly pigmented skin nodule on the right abdomen. It is roughly circular inshape with irregular outline. Pigmentation is uniform. However, it is significantly darker than any other mole on his trunk.
Assessment: Rule out early melanoma
Plan: Will return for punch biopsy of the lesion. / V- 478
03/11/YYYY / XXXXX, M.D. / Follow-up visit for shave biopsy:
Patient comes in to have a biopsy of a suspicious mole done.
Physical examination: 4 mm punch biopsy is submitted to pathology
Plan: Daily antibiotic ointment and band aid; Follow-up by phone in 1 week / V - 275
03/16/YYYY / XXXXX Medical Foundation
XXXXX, M.D. / Pathology report:
Diagnosis:
Skin biopsy, abdominal wall: Lentigo malignant melanoma.
Clark’s Level II- Thickness: 0.31 mm
Resection margins: Incompletely excised
Prognostic indicators:
Mitotic Rate: Low
Ulceration: Absent
Regression: Indeterminate
Lymphocytic response: Moderate
Angiolymphatic invasion: Absent / V - 57-58
03/16/YYYY / Telephone note:(Illegible notes)
Diagnosed with lentigo malignant melanoma – Appointment with Dr. XXXXXon 03/18/YYYY / V- 275
03/19/YYYY / XXXXX, M.D. / Correspondence to Dr. XXXXX, M.D. regardingabnormal mole:
Patient presents with an abnormal mole. He describes this as being dark black with a red border. This had changed. It had increased in size. He has recently undergone a punch biopsy of this and this demonstrated a melanoma. This was a fairly thin, Clark’s II melanoma and additionally was only 0.31 mm in thickness.
Physical examination: Abdomen is soft. There is a well healing incision noted in the right lower quadrant. There are no lymph nodes which I can note in either the right axillary or the right groin area.
Plan: I have discussed with him wide excision. This will be done under a Local Anesthetic on 03/22/YYYY. / V -295
03/22/YYYY / XXXXX Surgery Center
XXXXX, M.D. / Operative report of wide excision of melanoma of the abdomen:
Pre and postoperative diagnosis:Melanoma of the abdomen
Anesthesia: Local with intravenous sedation
Procedure performed:Wide excision of melanoma of the abdomen
Operative procedure:An elliptical skin incision was made which completely excised this previous excision site with 1-cm margins. This was carried down through the subcutaneous tissues and into the subcutaneous fat. This was excised sharply. Bleeding was controlled using electrocautery. This required undermining in all four sides. The two ends were then brought into apposition using 3-0 Vicryl in the subcutaneous tissues followed by Steri-Strips for the skin. This was tolerated well. The blood loss was less than 50 cc. / V- 41
03/22/YYYY / XXXXX Surgery Center / Records related to hospitalization: Anesthesia record, assessment, orders / V - 40, 44, 43
03/22/YYYY / XXXXX Surgery Center / Discharge instructions:(Illegible notes)
Medications: Darvocet N prescribed for pain
Dressing/wound care:May remove dressing after ______reapply___
Other instructions:Leave Steri-Strips in place- Will fall off
Follow-up: In 2 weeks
*Reviewer’s comments: Discharge summary is not available for review. / V - 42
03/24/YYYY / XXXXX Medical Foundation
XXXXX, M.D. / Pathology report:
Diagnosis:Skin, abdomen:
- No evidence of residual malignant melanoma.
- Reactive changes consistent with history of previous surgical excision.
04/02/YYYY / XXXXX, M.D. / Correspondence to XXXXX, M.D. regarding follow-up on melanoma:
Patient underwent a wide excision of his melanoma site. The pathology from this reveals all cancer removed. His wound is healing well today. / V - 301
05/03/YYYY / XXXXX of Central States
XXXXX, M.D. / Pathology report:
Date of biopsy: 04/28/YYYY
Clinical data: Melanoma versus seborrheic keratosis
Diagnosis: Irritated seborrheic keratosis, right shoulder, anterior
*Reviewer’s comments: Records corresponding to biopsy of the right shoulder and reason for biopsy are not available for review. / V - 360
*Reviewer’s comments: Interim medical records from 05/03/YYYY-02/07/YYYY are reviewed and noted no significant details hence combined at the end of chronology and not elaborated.
02/07/YYYY / XXXXX, M.D. / Visit for chronic itching of feet and sexual dysfunction:
Patient is having some sexual difficulties and request help with this problem. We have discussed erectile dysfunction in the past.
Assessment:Sexual dysfunction
Plan:Samplesof Levitra 10 mg given / V - 277
11/04/YYYY / Memorial Hospital of XXXXX
XXXXX, M.D. / Hospitalization for unstable angina:
Past surgical history: Removal of malignant melanoma, considered completely cured
Impression: History of malignant melanoma, cured
*Reviewer’s comments: Only significant details elaborated from above hospitalization records. / V - 117-119
*Reviewer’s comments: Interim medical records from 11/04/YYYY-12/04/YYYY are reviewed and noted no significant details hence combined at the end of chronology and not elaborated.
12/04/YYYY / XXXXX of Central States
XXXXX, M.D. / Pathology report:
Date of biopsy: 11/30/YYYY
Clinical data: Rule out atypical nevus – Chest, left
Diagnosis: Junctional melanocytic nevus
*Reviewer’s comments: Records corresponding to biopsy of the chest and reason for biopsy are not available for review. / V - 375
*Reviewer’s comments: Interim medical records from 12/04/YYYY-07/17/YYYY are reviewed and noted no significant details hence combined at the end of chronology and not elaborated.
07/17/YYYY-04/30/YYYY / Multiple Providers / Multiple visits forgout, hypertension,atrial fibrillation, dyslipidemia:
07/17/YYYY: Medication list: Viagra 100 mg (Sildenafil citrate)
04/09/YYYY-04/30/YYYY: Medication list: Cialis 20 mg (Tadalafil)
*Reviewer’s comments: Above visits are combined and only significant details pertaining to Viagra case review have been elaborated. / V - 193-198, 242-251
*Reviewer’s comments: Interim medical records from 04/30/YYYY-12/05/YYYY are reviewed and noted no significant details hence combined at the end of chronology and not elaborated.
12/05/YYYY / XXXXXX, M.D. / Follow-up visit status post biopsy left chest junctional melanocytic nevus:
Personal history of skin cancer, melanoma, actinic keratosis, sunburn, blistering
Problem 1: Seborrheic keratosis on back and right arm:The lesion has been present for several months before 09/YYYY. It is described as becoming larger, some itching. Symptoms are not present.
09/YYYY: Though present stable withhistory as above
12/YYYY:Patientstates has noticed a new spot on the left chest
Problem 2: Actinic keratosis of the ears evaluation:The lesion has been present for several months before 05/YYYY.It is described as changing- Rough & scaly.Symptoms are pain.
11/YYYY:States new lesion on lip, scabs
03/YYYY: Doing well some still present
06/YYYY: Stable
09/YYYY: Has noticed rough areas on ears
08/2011:States unaware of any new or changing lesions since last dos.
04/YYYY:States has noticed a red spot on the right forearm that itches
06/YYYY: States has noticed a few new spots on the face, lesion right forehead is somewhat tender and similar in texture to similar spots
12/YYYY: States roughness present on the right cheek – Liquid nitrogen (LN2) to similar lesions.
Problem 3: Skin cancer screening exam: There are no other new or changing lesions. No moles have been removed. There is a history of sunburns, some freckle in the sun. The patient is a Fitzpatrick skin type III. Lifetime ultraviolet exposure is significant after reviewing social history with patient. He didhave melanoma biopsied and removed within the last two months on the right abdomen. He states Clark level 2 is what he thinks it is depth wise.
Physical examination: Waxy tan plaques of back and upper extremities, face. Brown and tan macules of back, chest, abdomen, and extremities with even pigmentationandsmooth, distinct borders -Number ismore than 50;Erythematous keratotic plaques with scale on face
Left lateral thigh 20x 15 mm brown plaque sharp border; Face and nose examined with actinic damage noted
External ears: Erythematous keratotic plaques of face, ears
Abdomen: Right abdomen with linear scar with no recurrence
Assessment: Skin cancer screen
Benign nevi of back, chest, abdomen, and extremities: 06/YYYY lesion on left lateral thigh stable in measurement
History of melanoma excised on right abdomen: No recurrence
Actinic keratosis of head and ears, right cheek, face: LN2 on right cheek
Discussion and medical decision making:Need for sunscreen including Titanium dioxide, Zinc oxide and Parsol 1789 daily use recommended. Shave biopsy of lesion on right anterior arm.
Prescriptions: Hydrocortisone, Protopic ointment and Nystatin topical ointment
*Reviewer’s comments: Further medical records after 12/05/YYYY are not available for review. / V - 507-511
07/18/YYYY-04/23/YYYY / Multiple Providers / Records not relevant to Viagra Case Review:
Blank pages, consent, correspondence, cover pages, labs, medical bills, pathology report, procedure report, telephone conversation, rhythm strips, ultrasound, pharmacy dispensing/medication refill, consultation report
Bates ref: V - 514, 520-521, 328-330, 515, 512, 517, 519, 522, 523, 516, 87-88, 111, 513, 518, 524, 449-450, 113, 361, 6, 466, 468, 470, 471, 47, 48, 257, 49, 259, 335-336, 260, 52, 261, 262, 262, 263, 472, 264, 265, 266, 270, 338-341, 94-95, 473, 258, 475, 342-343, 98-99, 298, 267, 268, 100-101, 476, 102-104, 105-107, 108-110, 271, 53, 272, 354, 274, 286, 3, 55, 4, 477, 356, 362-363, 364, 278, 365-366, 279, 479, 480-482, 483-500, 7-8, 9, 120-123, 430, 139, 501-503, 280, 66, 303-304, 67, 281, 68-71, 282, 141, 504, 72-73, 10, 144-145, 124-125, 114, 11, 146, 505, 149-150, 151-152, 506, 464, 142, 147-148, 154, 74, 75-77, 78, 79, 156, 80, 432, 309, 12, 81-82, 159, 312-313, 83-86, 389-392, 207-209, 218-220, 283, 457-458, 310, 284-285, 210-212, 165-167, 20-21, 22-24, 14-16, 17-19, 396-401, 32, 25, 213, 34-37, 236-237, 168-171, 214-216, 172, 305-307, 173, 241, 126-128, 129-130, 131-132, 174-178, 133, 179-184, 221-222, 223-224, 321-322, 185-192, 217, 134-137, 199-201, 238, 239, 323-324, 202-205, 420-423, 325-327, 253-255, 459-462, 451-456, 448, 440-446, 276
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