Appendix e-1

Case Review Form

Please complete this packet for an epilepsy patient who has had a breakthrough seizure that you feel was likely caused by a switch from a branded to a generic AED or from uncontrolled switching between generic forms of an AED.

When you fill in this chart review, please use actual information that is found in the patient’s chart.

Please print clearly when filling out all information to avoid a call-back.

Date of chart review: _____-_____ 2006

Patient Synopsis:Note: this is the most important aspect of the chart audit. It is important that you provide a comprehensive description of the clinical events for your chart to be accepted.

  1. Patient Synopsis:

Patient Information: Note: The following questions are asked in order to ensure that all necessary information is recorded for this particular patient and so that a complete clinical picture is obtained.

  1. After the initial diagnosis and treatment decision, please describe any additional follow-up regarding the breakthrough seizure that you had with the patient. Please be as specific as possible.
  1. Patient date of birth: ____/____/____ (mm/dd/yy)
  1. Patient gender:

(1)Man

(2)Woman

  1. For how long have you been treating this patient?

______year(s) ______month(s)

  1. Patient Race:

(1)White (non-Hispanic)

(2)Black/African American

(3)Hispanic

(4)Asian

(5)Pacific Islander

(6)Other

  1. Patient Primary Insurance:

(1)Medicare

(2)Medicare HMO

(3)Medicaid

(4)Medicaid HMO

(5)Other HMO

(6)PPO/Traditional Insurance

(7)Self-pay

(8)Other

  1. Date of initial diagnosis of epilepsy: ____/____ (mm/yy)
  1. What type of seizure does this patient experience? Please select all that apply.

(1)Simple partial

(2)Complex partial

(3)Secondarily generalized convulsion (tonic clonic)

(4)Primary generalized convulsion (tonic clonic)

(5)Tonic/atonic (drop)

(6)Myoclonic

(7)Absence

(8)Undefined

(9)Other, if selected please specify: ______

  1. Date of breakthrough seizure: ____/____ (mm/yy)
  1. Please indicate the type of breakthrough seizure below:

(1)Simple partial

(2)Complex partial

(3)Secondarily generalized convulsion (tonic clonic)

(4)Primary generalized convulsion (tonic clonic)

(5)Tonic/atonic (drop)

(6)Myoclonic

(7)Absence

(8)Undefined

(9)Other, if selected please specify: ______

  1. How often was this patient seen in the year before and the year after the breakthrough seizure(s)? If it has been less than one year since the breakthrough seizure(s), please indicate the number of times that you have seen the patient thus far.

_____ times in the year before the breakthrough seizure(s) _____ times in the year after the breakthrough seizure(s)

  1. Please list all prescription medications the patient was taking at the time of the breakthrough seizure (including non-AED medications):
  1. Please list all non-prescription medications, including OTC, vitamins, herbals, and other chemical agents of any kind that the patient was taking at the time of the breakthrough seizure, to the best of your knowledge.
  1. Please name the AED that the patient was taking prior to the medication substitution:

______

  1. For how long did the patient take this AED prior to the substitution?

_____ years ____ months ____ weeks (if less than one month)

  1. Please name the generic AED that the patient was taking at the time of the breakthrough seizure:

______

  1. For how long did the patient take this generic AED prior to the breakthrough seizure?

_____ years ____ months ____ weeks (if less than one month)

  1. Were levels obtained at the time of the breakthrough seizure?

(1)Yes [GO TO Q20]

(2)No[GO TO Q22]

  1. What were the level results?

Medication: ______Level: ______ug/ml

  1. Were the levels…

(1)Peak

(2)Trough

(3)Mid-dose

(4)Unknown

[GO TO Q23]

  1. Please explain why levels were not obtained at the time of the breakthrough seizure.
  1. What were the typical AED levels prior to the substitution? Please provide levels for all AED medications patient was taking prior to the substitution.

Medication: ______Level range: ______ug/ml

  1. What have the typical AED levels been since the substitution? Please provide levels for all AED medications patient has taken since the substitution.

Medication: ______Level range: ______ug/ml

  1. At the time of the breakthrough seizure, was the patient taking their AED regularly?

(1)Yes

(2)No

  1. Was the patient switched back to their original medication after the breakthrough seizure occurred (i.e., the medication prior to the switch)?

(1)Yes, same dose as before substitution [GO TO Q27]

(2)Yes, lower dose compared to before substitution: Explain in box below and then GO TO Q27

(3)Yes, higher dose compared to before substitution: Explain in box below and then GO TO Q27

(4)No [GO TO Q30]

Use text box below to explain why Q26b or Q26c was selected. After explaining, GO TO Q27.

  1. How soon after the breakthrough seizure occurred did the patient switch back to the original drug that he/she was taking prior to the seizure?

(1)Same day

(2)Within one week

(3)More than one week to two weeks

(4)More than two weeks to one month

(5)Other, if selected please specify date of switch: ____/____ (mm/yy)

  1. Did the patient regained seizure control once the medication was changed back to the original medication?

(1)Yes

(2)No

(3)Not sure

  1. Have the problems that led to the decision to change the patient back to his/her original medication been resolved?

(1)Yes

(2)No

[GO TO Q31]

  1. Please explain why the patient was not switched back to the original medication. Please be as specific as possible.
  1. Please list all AEDs that the patient is currently taking and has used in the past. Please also include dosing information.

Drug / Dose (mg/day) / Dates Medication Taken
(mm/yy) – (mm/yy) / Assessment of Efficacy
  1. What is the patient’s current seizure frequency?

(1)The patient has not experienced a seizure since the breakthrough seizure occurred [GO TO Q36]

(2)More frequent than a few times a week[GO TO Q33]

(3)A few times a week[GO TO Q33]

(4)Once a week[GO TO Q33]

(5)Two to three times a month[GO TO Q33]

(6)Once a month[GO TO Q33]

(7)A few times a year[GO TO Q33]

(8)Once a year or less[GO TO Q33]

  1. How did the overall seizure frequency change after the breakthrough seizure as compared to prior to the breakthrough seizure?

(1)The seizure frequency did not change[GO TO Q36]

(2)Higher seizure frequency since breakthrough seizure[GO TO Q34]

(3)Lower seizure frequency since breakthrough seizure [GO TO Q35]

  1. How much did the seizure frequency increase after the breakthrough seizure?

(1)1 to 50% (up to one and one-half times as often)

(2)51 to 100% (one and one-half to twice as often)

(3)101 to 200% (more than twice to four times as often)

(4)>201% (more than four times as often)

(5)The patient was seizure free prior to breakthrough and is now having seizures.

[GO TO Q36]

  1. How much did the seizure frequency decrease after the breakthrough seizure?

(1)1 to 25% reduction

(2)26 to 50% reduction

(3)51 to 75% reduction

(4)76 to 99% reduction

  1. Which of the following scenarios do you believe caused your patient to have a seizure?

(1)A switch from a branded to a generic AED

(2)Uncontrolled switching between generic forms of an AED

  1. Were there any other factors identified that may have contributed to the breakthrough seizure (such as fatigue, illness, other medications, stressors, etc.)?

(1)Yes, if Yes, please specify: ______

(2)No

  1. Did the patient have driving privileges prior to the breakthrough seizure?

(1)Yes[GO TO Q39]

(2)No[GO TO Q40]

  1. After the breakthrough seizure, were the patient’s driving privileges restricted?

(1)No

(2)Yes, for < 1 month

(3)Yes, for 1 to 3 months

(4)Yes, for >3 to 6 months

(5)Yes, for >6 to 12 months

(6)Yes, for >12 months

(7)The patient has been restricted from driving since the breakthrough seizure.

  1. What impact did the breakthrough seizure have on the patient’s quality of life? This is very important information so please be as specific as possible.
  1. What is your opinion regarding generic substitution of AEDs?

Please provide the information below so that we can send you your honorarium or contact you if we have any questions.

First name: ______Last name: ______

Address: ______

City: ______State: ______Zip: ______

Phone: (____) _____ - ______