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Annexures
The Study of Pharmacovigilance of HAART in HIV Positive Patients 153
ANNEXURE – 1
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ANNEXURE – 2
PATIENT CONSENT FORM
I, _____________________________ have been explained by the investigator
Rajesh.R and their representative the nature and effect of the research entitled “Study
of Pharmacovigilance of Antiretroviral Therapy in HIV Patients” I have been
provided with information about the study and I have understood the same. I have
been given sufficient time to consider the matter for my participation in the study. I
understand that my participation in the study is voluntary and that I have the right to
withdraw at any time without giving any reason, without my medical care or legal
rights being affected. I understand the procedures of the study as mentioned in the
information sheet. I am also assured of confidentiality of any information concerning
me. I understand that the results which arise out of the study may be used in scientific
communications or publication for further advancement of science. I also understand
that my data will not be used for any purpose other than mentioned above.
___________________________ Date _________
Signature of the research subject
__________________________
Name of the research subject
__________________________ Date _________
Signature & the name of the witness
_____________________________________ Date _________
Signature of the person explaining the consent
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ANNEXURE – 3
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ANNEXURE – 4
WHO CAUSALITY CATEGORIES (PROBABILITY SCALE)
Certain
Event or laboratory test abnormality, with plausible time relationship to drug
intake
Cannot be explained by disease or other drugs
Response to withdrawal plausible (pharmacologically, pathologically)
Event definitive pharmacologically or phenomenologically (i.e. an objective
and specific medical disorder or a recognized pharmacological phenomenon)
Rechallenge satisfactory, if necessary
Probable/ Likely
Event or laboratory test abnormality, with reasonable time relationship to drug
intake
Unlikely to be attributed to disease or other drugs
Response to withdrawal clinically reasonable
Rechallenge not required
Possible
Event or laboratory test abnormality, with reasonable time relationship to drug
intake
Could also be explained by disease or other drugs
Information on drug withdrawal may be lacking or unclear
Unlikely
Event or laboratory test abnormality, with a time to drug intake that makes a
relationship improbable (but not impossible)
Disease or other drugs provide plausible explanations
Conditional/Unclassified
Event or laboratory test abnormality
More data for proper assessment needed, or
Additional data under examination
Unassessable/Unclassifiable
Report suggesting an adverse reaction
Cannot be judged because information is insufficient or contradictory
Data cannot be supplemented.
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ANNEXURE – 5
DEPARTMENT OF PHARMACY PRACTICE (ADR REPORTING UNIT)
KASTURBA HOSPITAL, MANIPAL, 2571201 Extn: 22403
SUSPECTED ADVERSE DRUG REACTION (ADR) NOTIFICATION FORM
Patient‟s Name: ………………… OP Hospital No: ………… IP No. ……………
Dept, Unit & Ward: ……………….. Age (yrs): …… Sex: M/F Weight (kgs): ………
Suspected drug(s): ….……………………………………………………………………
(Generic & Brand Name: Manufacturer)
Route, Dose & Frequency: ………………………………………………………………
Date started (DD/MM/YYYY): / / 20 Date of onset of reaction: / / 20
Brief description of the ADR: …………………………………………………….……..
……………………………………………………………………………………………………
……………………………………………………………………………………
Notified by …………………………………………………… Date: / / 20 (Name, Department and Unit)
Kindly complete and return this form to the Department of Pharmacy Practice (ADR REPORTING UNIT), Kasturba Hospital, Manipal OR
complete the ADR Notification Form available on www.khinfo.edu so that the ADR could be documented in the ADR REPORTING UNIT and
additional relevant information about the ADR could be provided to notifier. P.T.O
Additional notes or comments:
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ANNEXURE – 6
DEPARTMENT OF PHARMACY PRACTICE
(MCOPS) KASTURBA HOSPITAL, MANIPAL – 576 104
ADVERSE DRUG REACTION REPORTING AND DOCUMENTATION
FORM
Patient Name: HP No. Department:
Age: Sex: Weight: IP/OP: Unit:
Reason for admission:
Known allergies:
Brief description of the Reaction:
Date of onset of Reaction:
Management of Adverse Drug Reaction:
Drug withdrawn Dose altered No change
Treatment given:
Specific Symptomatic Nil
Outcome: Fatal Recovery Continuing
Unknown Other
Dechallenge: Rechallenge:
No dechallenge No rechallenge
Definite improvement Recurrence of symptoms
No improvement No occurrence of symptoms
Unknown Unknown
Drugs used prior to reaction
Date started Dose Route and Frequency
Tick suspected drug(s)
Indication Date stopped
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Patient interviewed: Yes No
Thank you note provided: Yes No N/A
Alert card provided: Yes No N/A
Suspected drug (s):
Causality:
A) Naranjo‟s Scale
Definite Possible
Probable Unlikely
B) WHO Probability Scale
Certain Unlikely
Probable/likely Conditional/unclassified
Possible Unassessable/ unclassifiable
Severity (Hartwig et al. Scale):
Mild: Moderate: Severe:
Level 1 Level 3 Level 5
Level 2 Level 4 (a) Level 6
Level 4 (b) Level 7
Predictability:
Predictable Non Predictable
Preventability (Modified Schumock and Thornton‟s Scale):
Definitely Preventable Probably Preventable Not Preventable
Predisposing Factors:
Age Gender Genetic
Intercurrent Disease Multiple Drug Therapy Others (specify)
References consulted:
Name of the Reporter: Signature:
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ANNEXURE – 7
WHO ADVERSE REACTION TERMINOLOGY (WHO-ART)
SYSTEM-ORGAN CLASSES AND CODES
Skin and appendages disorders……………………………. 0100
Musculo-skeletal system disorders………………………... 0200
Collagen disorders………………………………………… 0300
Central & peripheral nervous system disorders………….... 0410
Autonomic nervous system disorders……………………... 0420
Vision disorders…………………………………………... 0431
Hearing and vestibular disorders………………………….. 0432
Special senses other, disorders……………………………. 0433
Psychiatric disorders……………………………………… 0500
Gastro-intestinal system disorders………………………... 0600
Liver and biliary system disorders ……………………….. 0700
Metabolic and nutritional disorders……………………… 0800
Endocrine disorders………………………………………. 0900
Cardiovascular disorders, general………………………… 1010
Myo-, endo-, pericardial & valve disorders……………… 1020
Heart rate and rhythm disorders…………………….......... 1030
Vascular (extracardiac) disorders………………………... 1040
Respiratory system disorders…………………………….. 1100
Red blood cell disorders…………………………………. 1210
White cell and Reticuloendothelial system disorders……... 1220
Platelet, bleeding & clotting disorders…………………... 1230
Urinary system disorders………………………………… 1300
Reproductive disorders, male……………………………. 1410
Reproductive disorders, female………………………….. 1420
Foetal disorders………………………………………….. 1500
Neonatal and infancy disorders………………………….. 1600
Neoplasms……………………………………………….. 1700
Body as a whole - general disorders……………………... 1810
Application site disorders………………………………... 1820
Resistance mechanism disorders………………………… 1830
Secondary terms – events………………………………... 2000
Poison specific terms…………………………………….. 2100
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ANNEXURE – 8
SUBJECT INFORMATION SHEET
Title of Study: The study of pharmacovigilance of highly active antiretroviral
therapy in HIV positive patients
Investigators: Mr.R.Rajesh, Senior grade Lecturer, Department of Pharmacy Practice,
Manipal college of Pharmaceutical sciences representative of Dr.Muralidhar Varma,
Asst Professor and Dr.Sudha Vidyasagar Professor and head department of medicine ,
Kasturba Hospital , Manipal.
Phone No: 9845069639
Background
You/Your relative are being requested to take part in this study to evaluate the
educational intervention or on adverse drug reactions (side effects) of anti HIV drugs
used for the treatment of HIV infection. Please take your time to read this document
and make your decision. You may choose to discuss this study with your friends,
family, family doctor, and your study doctor. Make sure that all your questions are
answered before agreeing to take part in this study. If you decide to take part in this
study you must co-operate with your study doctor and follow [his/her] instructions.
Why is this study being done?
Drugs to treat HIV infection help body to fight infections and it is used to stop illness
getting worse, it reduces the amount of virus in the body, and keeps it at a low level.
Drugs to treat HIV infection may develop (not necessary that all patients or you will
develop) certain side effects, which may occur in some patients. You are informed of these
side effects so that you could recognize these at an earlier stage, if it occurs and report to the
doctor. This will help your doctor to make necessary modifications in your medications, if
required. The main purpose of this study is to monitor the adverse effects (side effects)
of drugs used for the treatment of HIV infection which given to your patient or you.
How many subjects will take part in the study?
All patients of either sex who are diagnosed with HIV infection and prescribed with
antiretroviral drugs (HIV drugs) and patients who are willing to participate will be
enrolled in this study.
How long will I be in the study?
You will be enrolled in this study from the day of admission till day of discharge from
the hospital and during the follow up visits at outpatient department (OPD).
What is involved in the study?
You/patient participation in this study involve the following procedure: After
prescription of drugs as per your doctor‟s advice the investigator will assess for
adverse effects of prescribed drugs, laboratory data or assessment of knowledge,
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attitude, belief, practice (KABP) of your disease, medication, adherence behavior and
you will be educated about your disease, name of ART medications, importance of
compliance to ART with awareness of common adverse effects to ART and drug
related counseling, patient information leaflets will be provided as per the study.
Study Schedule: 4 years
What are the risks of the study?
No risks involved by taking part in the study.
Are there benefits in taking part in the study?
People taking part in this study may recognize adverse effects as earlier; it helps your
doctor to make necessary modifications in your medications, if required. The knowledge
gained from you by taking part in this study may help in improving therapy.
What other choices are there?
If you choose not to participate in this study, there will be no change in your
treatment. Your decision regarding not to participate in the study will not affect your
standard treatment. You please talk to your study doctor and/or your regular doctor if
you have any question about the benefits and risk of this study.
What about privacy?
Confidentiality will be maintained throughout the study. Your identity will not be
disclosed. If the study is published in a medical journal or scientific publication for
further advancement of sciences and your identity will not be disclosed.
What are my medical costs?
No extra cost will be added to your treatment cost due to your participation in this
study.
Compensation:
No compensation will be given for participation in this study.
What are my rights as a participant?
Taking part in this study is voluntary. You may choose not to take part in this study,
or you may choose to leave the study at any time. The quality of your medical care
will not change if you decide not to take part in this study or if you decide to leave the
study early.
Whom do I call if I have questions or problems during follow up visit?
Mr R.Rajesh Department of Pharmacy Practice, KH, Manipal 576104 or Ph: 0820-
2922403.
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ANNEXURE – 9
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CRITERIA FOR DETERMINING THE PREDICTABLITY OF AN ADR
A. Patients who have had the drug on previous occasions:
If the drug was previously well- tolerated at the same dose and route of
administration, the ADR is not predictable.
If there was a history of allergy or previous reactions to the drug; the ADR is
predictable.
B. Patients who have never have had the drug previously:
Incidence of ADR reported in product information or other literature
determines its predictability.
Incidence Rate Description Predictability
More than 10% Very common Predictable
1-10% Common Predictable
0.1-1% Uncommon Not Predictable
0.01-0.1% Rare Not Predictable
Less than 0.01% Very Rare Not Predictable
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ANNEXURE – 11
CRITERIA FOR DETERMINING THE PREVENTABILITY OF AN ADR (Modified Shumock and Thornton)
SECTION A
Answering “yes” to one or more of the following implies that an ADR is
definitely preventable
1. Was there a history of allergy or previous reactions to the drug?
2. Was the drug involved inappropriate for the patient‟s clinical condition?
3. Was the dose, route or frequency of administration inappropriate for the
patient‟s age, weight or disease state?
If answers are all negative to the above, then proceed to Section B.
SECTION B
Answering “yes” to one or more of the following implies that an ADR is
PROBABLY preventable
1. Was required therapeutic drug monitoring or other necessary laboratory tests
not performed?
2. Was a documented drug interaction involved in the ADR?
3. Was poor compliance involved in the ADR?
4. Was a preventative measure not administered to the patient?
5. If a preventative measure was administered, was it inadequate and/or
inappropriate? Answer „no‟ if this question is non-applicable.
If answers are all negative to the above, then proceed to Section C.
SECTION C
The ADR is not preventable.
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ANNEXURE – 12
INDIVIDUAL CASE RECORD FORM (ICRF)
1. Hospital ID: 2. IP ID: 3.Age:
4. Sex: Male Female
5. Use of alcohol: Social Never Habitual
6. Smoking status: Past smoker Never Current smoker
7. CD4 Count:
Base line count:
CD4 Count 6 Months (Cells/ul):
CD4 Count 12 Months (Cells/ul):
CD4 Count 24 Months (Cells/ul):
CD4 Count 36 Months (Cells/ul)
CD4 Count 48 Months (Cells/ul):
8. Literacy status: Literate Illiterate
9. Employment status: Employed Unemployed
10. Weight in (Kg):
11. Type of treatment: HAART PMTCT PEP
12. HAART Regimen:
13. Duration of use of ART:
14. Concomitant Medicines:
15. Traditional Medicines: Yes No OC: Yes No
16. Opportunistic Infection status:
TB HPZ Candidiasis Pneumonia Syphilis CMV
Toxoplasmosis TB Meningitis Crypt Meng Crytosporidiosis
17. Co-morbid conditions:
Malnutrition Anaemia Alcohol abuse Substance abuse
Depression TB Renal disease Liver disease Heart Disease
Hepatomegaly Splenomegaly Bacterial infections
18. ADR‟s Observed: Yes No
19. Suspected ART drug for ADR:
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20. Outcome of therapy Due to ADRs:
Change of therapy Required prolonged hospitalization:
Recovered without change of therapy Ongoing Death Other outcomes
21. Reporters Details: Doctor Pharmacist Nurses
22. Pregnancy status: Yes No Uncertain
23. Death status: Yes No
24. Died due to:
a) ADR b) Contradictory c) Unrelated to medicine d) Death unknown
25. Rechallenge status:
a) No rechallenge b) Recurrence c) No Recurrence d) Unknown outcome
26. Dechallenge status:
a) No dechallenge b) Definite Improvement c) No Improvement
d) Unknown
27. Patient Loss to follow-up: Yes No
28. Outcome of ADR:
Resolved Resolving Resolved with sequelae Not Resolved
Worse Died Unknown Medicine continued Dose reduced
29. Management of ADR:
a) Drug withdrawn b) Dose altered c) No change
30. Treatment for ADR:
a) Specific treatment b) Symptomatic treatment c) Nil
31. Severity of ADR:
Mild Level 1 & Level 2 Moderate Level 3,4 a,b Severe Level 5-7
Not severe
32. Seriousness of Reported ADRs:
Died Life threatening Hospitalization Permanent disability
Congenital anomaly
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33. Duration of onset:
34. WHO Probability Scale:
Certain/Definite Probable Possible Unlikely Uncassified
Unclassifiable
35. Naranjo‟s Scale: Definite Probable Possible Unlikely
36. Predictability of ADR: Predictable Non Predictable
37. Preventability: Definitely preventable Probably Preventable
Not Preventable
38. Predisposing factors
a) Age: Yes No
b) Intercurrent Disease: Yes No
c) Gender: Yes No
d) MDT: Yes No
E) Genetic: Yes No
39. Poly pharmacy as a cause of ADR:
Minor (2-3drugs) Moderate (4-5drugs) Major (>5drugs)
40. Occurrence of ADRs:
ADRs during Hospital stay ADRs at the time of admission
Previous Exposure of ADRs ADR is a reason for hospital admission
41. Number of ADRs reported in a single patient:
42. System-organ disorder class:
0100 1810 0200 0300 0410 0420 0500 0600 0700
0800 1040 1210 1220 1230 1830 1300 0431 0432
0433 0900 1010 1020 1030 1100 2000 1410 1500
1600 1700 8200 2100
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43. Reasons for Non Adherence to the treatment:
Side effects Share with others Forgot Felt better Too ill
Privacy Drug stock-out Pt. lost travel Unable to pay
Alcohol Depression others
44. Hemoglobin level Grading:
45. Hepatotoxicity Grading:
46. HBsAg Positive status: Yes No
47. Lab-investigations Chart
Lab-investigations Baseline Follow -ups
1 2 3 4
Hemoglobin level
AST (5-40 U/L)
ALT (5-40 U/L)
ALP (40-140 U/L)
Neutrophil
Platelets
Urea (8-35mg/dl)
Creatinine (0.6-1.6 mg/dl)
Viral load
Total Bil(0.2-1.3 mg/dl)
Direct Bil(.0-0.4 mg/dl)
T_Protein(6-8g/dl)
Albumin(3.5-5g/dl)
Globulin(1.8-3.4g/dl
Lactate(5-22mg/dl)
Amylase(28-100u/L)
Lipase(5-80u/L)
Cholesterol(120-220mg/dl)
Triglycerides(40-140mg/dl)
HDL (30-65mg/dl)
LDL(60-160mg/dl)
TC/HC(2.5-5)
FBS (60-110mg/dl)
RBS(60-150mg/dl)
PPBS (90-140ma/dl)
Total WBC(4000-11000cells/cumm)
Lymphocyte count (18-44%)
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ANNEXURE – 13
KABP QUESTIONNAIRE
1. Do you know how HIV disease is transmitted?
Yes No
2. How many medications a normal antiretroviral therapy has?
One Two More than two Don‟t Know
3. Are you aware of duration of antiretroviral therapy?
Yes No Don‟t Know
4. Is your HIV disease contagious?
Yes No Don‟t Know
5. What are the common symptoms of HIV disease?
Weight loss Ulcers Difficult breathing
All of the above Don‟t Know
6. What are the common adverse effects of antiretroviral therapy?
Anemia Diarrhea Fatigue All of the above Don‟t Know
7. Is there a best treatment for your HIV disease?
Yes No Don‟t Know
8. Do you know how long antiretroviral therapy to be continued?
Long duration therapy Short duration therapy
Very short duration therapy Lifelong Therapy Don‟t know
9. What does antiretroviral therapy do?
Yes Improves immunity No not improves immunity
Antiretroviral therapy not always a cure Don‟t Know
10. What are the common causes that lead to the cassation of antiretroviral
therapy?
Poor adherence Economical burden ADRs/ drug allergy
All of the above Don‟t Know
11. Have you been educated about the importance of antiretroviral therapy?
Yes No
12. In case of experiencing an adverse effect to antiretroviral therapy what needs
to be done?
Dose reduced Contact physician immediately Stop taking the drug
Dose tapered and stopped Don‟t Know
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13. Is it all right, if you miss a dose of antiretroviral therapy?
Yes, all right No, it should not be missed Don‟t Know
14. Do you think antiretroviral therapy is life saving?
True/yes False/ no Don‟t Know
15. Do you think antiretroviral therapy can be discontinued once the symptom
of HIV disease improves?
True/yes False/ no Don‟t Know
16. Do you think patient information leaflet on antiretroviral therapy is
necessary for you?
Yes No Don‟t Know
17. Do you think antiretroviral therapy have to be taken regularly?
Yes No Don‟t Know
18. What you do when you experience signs and symptoms of Anemia with
antiretroviral therapy?
Report to the doctor immediately Stop antiretroviral therapy Don‟t Know
19. Do you think you can stop taking the antiretroviral therapy once you feel
better?
Yes, it can be stopped No, it should be continued Don‟t Know
20. Do you know how many different medications (with name) you are currently
taking?
Yes Remember only few Don‟t Know
21. What do you do when you have Diarrhea?
Stop eating food Keep drinking fluids Don‟t Know
22. What do you do when you experience nausea while taking antiretroviral
therapy?
Take the pill with food Stop taking the pill Take the pill without food
Don‟t Know
23. Do you skip your antiretroviral medications?
Yes, very often No Sometimes
24. What do you do if you miss your antiretroviral medications?
Skip Take when remember Skip if it‟s time for next dose
Double the next dose
25. Does anyone help you in taking your antiretroviral medications regularly?
Yes No
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PICTOGRAMS OF ADVERSE EFFECTS OF ANTIRETROVIRAL THERAPY
Adverse effects Pictogram Adverse effects Pictogram
Diarrhea
Skin rash
Vomiting
Peripheral
Neuropathy
Headache
Abdominal pain
Constipation
Decreased
appetite
Anemia
Lipodystrophy
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Adverse effects Pictogram Adverse effects Pictogram
Fever
Diaphoresis
Dizziness
Myalgia
Alopecia
Decreased
weight
Peripheral
edema
Muscle pain
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ANNEXURE – 46
SEVERITY OF ADRs (MODIFIED HARTWIG & SIEGEL SCALE)
Mild
Level 1: The ADR require s no change in treatment with the suspected drug.
Level 2: The ADR requires that the suspected drug be withheld, discontinued or
otherwise changed. No antidote or other treatment is required and there is
no increase in length of stay.
Moderate
Level 3: The ADR requires that the suspected drug be withheld, discontinued or
otherwise changed, and /or an antidote or other treatment is required. There
is no increase in length of stay.
Level 4 (a): Any Level 3 ADR that increase length of stay by at least one day.
Level 4 (b): The ADR is the reason for admission.
Severe
Level 5: Any level 4 ADR that requires intensive medical care.
Level 6: The ADR causes permanent harm to the patient.
Level 7: The ADR either directly or indirectly leads to the death of the patient.