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Annexures

The Study of Pharmacovigilance of HAART in HIV Positive Patients 153

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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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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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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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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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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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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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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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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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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 36 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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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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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.

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