2. Establecimiento Educativo Rural
3.5 Recursos: 1 Humanos:
Section A consultant:
Initials Hospital number Age Sex: M/F
Occupation Marital Status: S/M/D/W Tribe Religion: C/M/ATR
Educational status: nil, 1̊ 2̊ 3̊ others_________________________
Section B
Duration of diagnosis of hypertension:__________________________
Duration of treatment:_________________________
Complications of hypertension: yes no.
if yes , please specify: CCF/HHD/ CKD/CVA/ OTHERS……….
Family history of hypertension, yes no don’t know Other co-morbidities : yes no
If yes pls specify. DM /Osteoarthritis / Asthma
Others: please list………
Smoking history Yes / No Alcohol intake Yes / No
135 Section C
B.P pulse
Medication history
Medicines prescribed Dose&Duration Medicines used Dose&duration ACEI
BETABLOCKER CCB
DIURETIC METHYLDOPA ARB
OTHERS
Other prescribed medicines& dose
Indication Medicines used
1.
2.
3.
4 5.
136
137 Reason for change in medicines if any.
______________________________________________________________________________
Non prescription medicines/ herbal preparation/dietary supplement
Drug Indication
Adherence to prescribed medicines; Yes ( ) No( ), Partial ( ) If no/partial, please give reasons
______________________________________________________________________________
____________________________________________________________________________
Section D
Adverse reactions to medicines
Have you ever experienced an adverse reaction to antihypertensive medicine YES ( ) NO ( ) If yes, Please describe
______________________________________________________________________________
______________________________________________________________________________
Was it reported with the yellow forms Yes ( ) No ( )
Action taken: Discontinued meds. Reduced dose, No action others.________________
Did you experience any adverse reaction to any of the prescribed medicines? Yes / No If yes, which drug?
Date started: Date stopped:
Please describe the reaction,
138 ______________________________________________________________________________
______________________________________________________________________________
Have you had any of the following;
Symptom Yes/ No Drug
Fatigue/little initiative Cold hands/feet Dryness of mouth
Dizziness upon standing up Reduced sexual urge
Poor erection Impotence Coughing Other dizziness
Swollen ankles/oedema
Warm feeling/flushes in the face Palpitation
Headache
Muscular cramp/myalgia Insomnia
Nightmares (bad dreams) Weakness
Rash/itching
Urinary incontinence Frequency of micturition Disturbance of taste Nausea
Nervous/restless Dyspnoea Constipation Diarrhoea Depressed
Action taken Discontinued medicine/Reduced the dose Others………..
139 Outcome : Recovered fully/ Recovered with disability/ Hospitalization /Life threatening /others:
please list____________________________________________________________
Any other non prescribed medicine within the period. Yes ( ) No ( ) If yes please list:
Drug Indication Dose Duration
Any concurrent illnesses within this period? Yes ( ) No ( ), if yes please describe.
______________________________________________________________________________
_______________________________________________________________
Any herbal preparation used within the period, Yes ( ) No ( ), if yes please state components, _____________________________________________________________________________
140
Appendix IV
WHO-UMC Causality Categories Causality term Assessment criteria*
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 recognised 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 or verified
* All points should be reasonably complied with
i Appendix V
NARANJO's ALGORITHM
Source: A METHOD FOR ESTIMATING THE PROBABILITY OF ADVERSE
DRUG REACTIONS - NARANJO et al
SCORING FOR NARANJO's ALGORITHM
• > 9 = definite ADR
• 5-8 = probable ADR
• 1-4 = possible ADR
• 0 = doubtful ADR
Appendix VI
Question Yes No Don't know
Are there previous conclusion reports
on this reaction? +1 0 0
Did the adverse event appear after the
suspect drug was administered? +2 -1 0
Did the AR improve when the drug was discontinued or a specific antagonist was administered?
+1 0 0
Did the AR reappear when drug was
readministered? +2 -1 0
Are there alternate causes [other than the drug] that could solely have caused the reaction?
-1 +2 0
Did the reaction reappear when a
placebo was given? -1 +1 0
Was the drug detected in the blood [or other fluids] in a concentration known to be toxic?
+1 0 0
Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?
+1 0 0
Did the patient have a similar reaction to the same or similar drugs in any previous exposure?
+1 0 0
Was the adverse event confirmed by
objective evidence? +1 0 0
Patients who had attended clinic over the ten years and the different medicine classes.
ii
TOTAL ACEI ARB BB CCB DIU AMD ALPHAB OTHERS
1999 185 22 0 54 83 70 26 44 15
2000 205 31 1 51 98 72 22 45 17
2001 219 40 1 71 111 96 30 50 8
2002 241 52 0 77 136 109 43 36 7
2003 271 73 1 80 167 123 45 36 12
2004 302 88 0 101 182 153 47 22 14
2005 348 137 0 110 221 202 45 3 16
2006 445 212 6 129 291 254 51 5 18
2007 528 257 18 139 354 292 57 14 30
2008 635 327 35 150 441 349 67 10 34
Appendix VII
Proportion of sampled hypertensive patients using Fixed Dose Combinations (FDC), as well as different categories of antihypertensive medicine use.
iii Year No FDC
n(%)
Number of medicines n(%)
1 2 3 4 ≥5
1999 185 128(69.1) 39(21.1) 51(27.6) 67(36.2) 25(13.5) 3(1.6) 2000 205 128(62.5) 44(21.5) 69(33.7) 70(33.7) 21(10.2) 2(1.0) 2001 219 153(69.9) 41(18.6) 52(23.7) 85(38.8) 37(16.9) 4(1.8) 2002 241 149(61.8) 46(19.1) 71(29.5) 82(34.0) 35(14.5) 8(3.3) 2003 271 167(61.6) 54(19.9) 69(25.5) 87(32.1) 47(17.3) 14(5.1) 2004 302 180(59.6) 51(16.9) 83(27.5) 103(34.1) 54(17.9) 11(3.6) 2005 348 194(55.7) 51(14.7) 106(30.5) 103(29.6) 69(19.8) 19(5.5) 2006 445 247(55.5) 70(15.7) 128(28.8) 119(26.7) 99(22.2) 29(6.4) 2007 528 300(56.8) 77(14.6) 140(26.5) 145(27.5) 124(23.5) 42(7.9) 2008 635 344(54.0) 88(13.9) 173(27.2) 179(28.2) 135(21.3) 60(9.4)
Appendix VIII
Proportion of hypertensive patients with documented ADR to antihypertensive medicines in their case records.
Year Number %(n) ADR
1999 185 14(7.6)