tag:blogger.com,1999:blog-26370948633267235942024-03-09T03:40:48.366+05:45Notes on Clinical PharmacologyAnupahttp://www.blogger.com/profile/06231026587968567116noreply@blogger.comBlogger7125tag:blogger.com,1999:blog-2637094863326723594.post-73024132858238160852013-01-06T10:30:00.001+05:452013-01-16T14:51:22.543+05:45ADR monitoring in Nepal<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-size: large;"><b>Status of ADR
monitoring programme in Nepal</b></span></div>
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<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
WHO programme for International Drug monitoring is an important
programme to record adverse reaction of drugs worldwide. The Uppsala Monitoring
Centre at Sweden
coordinates the activities. All the member countries send reports generated in
their country by an online system called Vigibase online. Nepal has expressed
its commitment to join as a member and as of September 2005, has got the status
of Associate member. Membership will be granted once Uppsala
monitoring centre (UMC) is satisfied that Nepal is doing ADR reporting
properly. His Majesty's Government, Ministry of Health and Population has
designated Department of Drug Administration (DDA), Kathmandu,
as a national center for ADR Monitoring. </div>
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<br />
<a name='more'></a><br /></div>
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The DDA has prepared an ADR reporting form for reporting
suspected ADRs. At the beginning, the reporting will mainly be for hospitalized
patients as there is no system yet to get information from outpatients. The
treating doctors will record any events of ADRs and the suspected drugs as well
as other information like patient information, concurrent medications, etc. and
report it to the DDA. All such information collected by the DDA will be entered
in the Vigibase system for evaluation. Since it is an online system, the action
is immediate and proper action can be taken for serious adverse effects if the
need arises. </div>
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<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
The UMC, WHO collaborating center for International Drug
Monitoring conducted a training in the study of ADR and related problems, and
introduction to pharmacoepidemiology. The following plans for pharmacovigilance
activities in Nepal
for July, 2005- June 2006 were presented during the training: </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
1. Pharmacovigilance centre as national centre will be
established in Department of Drug Administration (DDA), Ministry of Health,
under Drug Information Section and also regional centres in eastern and western
Nepal
will be established. </div>
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2. Meetings will be conducted with six central hospitals
(tertiary level) and two teaching hospitals for ADR reporting and generation of
ADR reports. </div>
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3. ADR reporting form will be finalized. </div>
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4. ADR reporting form will be distributed to all interested
tertiary level hospitals and teaching hospitals. </div>
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5. Awareness training for pharmacovigiliance will be
conducted in teaching hospitals and tertiary level hospitals. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
6. ADR data reported by prescribers from hospitals will be
entered into vigibase online. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
7. The ADR data generated from vigibase online will be
utilized for the evaluation of product available in the Nepalese market on the
basis of risk/ benefit ratio. </div>
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">8. Some of the serious side effects generated from
vigibase will be published in Drug Bulletin of Nepal (DBN). </span></div>
Anupahttp://www.blogger.com/profile/06231026587968567116noreply@blogger.com3Nepal28.394857 84.124008-48.300868999999992 -81.110367 90 -110.641617tag:blogger.com,1999:blog-2637094863326723594.post-68506223719743624492012-12-31T11:54:00.002+05:452013-01-16T14:51:51.842+05:45Monitoring ADRs: Need and methodes <div dir="ltr" style="text-align: left;" trbidi="on">
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<b style="mso-bidi-font-weight: normal;">Need for ADR
monitoring: </b>ADRs are responsible for significant morbidity and mortality
and can adversely affect a patient’s quality of life. Studies have shown that
ADRs are responsible for a significant number of hospital admissions, with
reports ranging from 0.3% to as high as 11%.<sup> </sup>ADRs also have a
significant impact on the healthcare costs. Studies have estimated that the
occurrence of an ADR increased the cost of patient care by $2262 per patient.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Another study has estimated the cost of preventable ADRs in a
700 bed hospital to be $2.8 million per annum.<br />
<br />
<a name='more'></a><br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
The importance of ADR monitoring has been highlighted time
and again by advent of global tragedies with drugs that were initially believed
to be safe like thalidomide, chloramphenicol, and the COX-2 inhibitor
rofecoxib. ADR monitoring is especially needed because many less common but
significant adverse effects of drugs can go unnoticed during clinical trials
due to limited number of population and controlled environmental settings. In a
prospective spontaneous reporting study conducted to assess the pattern and
severity of ADRs in local population in a South Indian teaching hospital, a
total of 270 suspected ADRs were reported and evaluated from 164 patients. A
total of 3.7% of the hospitalized patients experienced an ADR, 0.7% of the
admissions were due to ADRs and 1.8% had a fatal ADR. </div>
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<![endif]--><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">Very few patients are studied in clinical trials
and only those adverse reactions with a relatively high incidence will be
detected. Furthermore, these adverse events have no background incidence, i.e.
they do not occur either as a natural disease or in response to something other
than the drug. In a real setting, however, many adverse drug reactions tend to
mimic signs and symptoms of non-drug induced diseases. So, in the setting of
clinical trials, it becomes even more difficult to detect an adverse drug
reaction. Therefore, it is important to devise methods to detect ADRs as quickly
as possible after marketing, for confirming that the events detected during
clinical trials are truly ADRs and for assessing their overall incidence, to
detect other less frequent ADRs and to evaluate the balance of benefit and
risk. </span> </div>
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<br /></div>
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<b style="mso-bidi-font-weight: normal;">Methods of</b> m<b style="mso-bidi-font-weight: normal;">onitoring ADR:<sup> </sup></b>Though different
surveillance methods have been devised for ADR monitoring, none has yet proved
completely satisfactory. These programs mostly aim for speed of detection of
the ADRs, estimation of incidence or prevalence in the population, and the
predisposing factors involved. This information can be used to estimate the
benefit: risk ratio and also to prevent such reactions as far as possible. There
are several methods of surveillance of ADRs, which are discussed in brief here.
<span style="mso-spacerun: yes;"> </span></div>
<br />
<br />
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<br /></div>
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<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
I. Anecdotal reporting: It is reporting of ADRs through
anecdotal reports by individual doctors that a patient has suffered some
peculiar effect due to a drug. Such reports need to be verified by further
studies and they sometimes fail to confirm a problem. Still, the skill of
individual observant clinicians is valuable in the detection of ADRs. Some
examples of ADRs detected through this system are: jaundice caused on repeated
administration of halothane, oculomucocutaneous syndrome due to practolol, etc.
</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
II. Voluntary but organized reporting: In the UK, the ‘yellow
card’ is currently used for voluntary reporting of suspected ADRs to the UK
Committee on Safety of Medicines (CSM). These cards are found as detachable
pages in the back of the British National Formulary (BNF). In case of a
suspected ADR, the doctor should complete one of these cards and send it to the
CSM. Although doctors are asked to report adverse reactions to any therapeutic
agent, the CSM is particularly interested in reports on the following types of
reactions: </div>
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1. Reactions to drugs that are marked with the symbol of a
black inverted triangle in the BNF; these are drugs that have not been on the
market for long.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
2. Reactions<span style="mso-spacerun: yes;"> </span>to any
drug when the suspected ADR is serious, including reactions that are fatal,
life threatening, disabling, or incapacitating, or that result in a prolonged
stay in hospital. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
3. Reactions that may represent delayed drug effect. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
4. Congenital abnormalities.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
5. Reactions to all vaccines. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Though this organized voluntary reporting system has provided
extremely useful information on occurrence of ADRs in the national community,
it has some disadvantages as well. The major disadvantages are: </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
1. Difficulty in spotting ADRs that are not known to exist. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
2. Tendency of over reporting recently known ADRs and not
reporting already established ones. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
3. Tendency to under-report, mainly due to lack of time and
pressure of other business. </div>
<br />
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<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
III. Intensive event reporting: It is a hospital based ADR reporting
system in which a group of individuals are designated to screen a defined
population specifically to detect ADRs and then relate them to specific drugs.
These programmes can provide interesting statistics on the occurrence of ADRs
in hospitals but are not generally effective in detecting anything new because
the population studied is relatively small and each patient is studied for only
a short period of time. An example of such programme is the Boston
Collaborative Surveillance Program. </div>
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<br /></div>
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<![endif]--><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">IV. Cohort studies (prospective studies):<span style="mso-spacerun: yes;"> </span>In this method, the patients taking a
particular drug are identified and events are then recorded. Here also, a
relatively small number of patients are studied and there is lack of suitable
control group in which to assess the background incidence of any adverse
events. Also, such studies are very expensive and it is difficult to justify
and organize such studies for every newly marketed drug. </span></div>
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V. Case-control studies (retrospective studies): Here,
patients who present with symptoms or an illness that could be due to an
adverse drug reaction are screened to see if they have taken the drug. The
prevalence of drug taking in this group is then compared in a reference
population who do not have the symptoms or illness. This study is suitable for
determining whether a drug causes a given adverse effect once there is some
indication that it might, but it is not a suitable method for detecting
completely new ADRs. The relationship between maternal stilbestrol ingestion
and vaginal adenocarcinoma was confirmed by this method. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
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<![endif]--><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">VI. Case-cohort studies: This is a hybrid of
prospective and retrospective studies. Here, patients who present with symptoms
or an illness that could be due to an ADR are screened to see if they have
taken the drug and the results are then compared with the incidence of the
symptoms or illness in a prospective cohort of patients who are taking the
drug. This technique has been used, for example, to study the risk of breast
cancer in women taking oestrogens. </span></div>
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<br /></div>
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VII. Use of population statistics: Registers of causes of
death, congenital malformations and other information from other sources like
hospital and other records, are screened for a change in the pattern of deaths.
This might stimulate an investigation of a possible drug- related cause. For
example, the increase in deaths among young asthmatics in the early 1960s
seemed attributable to the increased use of bronchodilator aerosols containing
non- selective adrenoceptor agonists. Subsequently, a similar increase in
deaths in young asthmatics in New
Zealand was attributed to the chronic use of
<span style="font-family: Symbol; mso-ascii-font-family: "Times New Roman"; mso-char-type: symbol; mso-hansi-font-family: "Times New Roman"; mso-symbol-font-family: Symbol;"><span style="mso-char-type: symbol; mso-symbol-font-family: Symbol;">b</span></span><sub>2</sub>-adrenoceptor
agonists. These findings have probably been a factor in the emphasis on
prophylactic use of inhaled steroids, reserving <span style="font-family: Symbol; mso-ascii-font-family: "Times New Roman"; mso-char-type: symbol; mso-hansi-font-family: "Times New Roman"; mso-symbol-font-family: Symbol;"><span style="mso-char-type: symbol; mso-symbol-font-family: Symbol;">b</span></span>- adrenoceptor agonists
for symptom relief. </div>
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<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
VIII. Record linkage: Here, the idea is to bring together a
variety of patient records like: </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. General practice records of illness events</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. General practice records of prescriptions</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
iii.
Hospital records of
illness events<span style="mso-spacerun: yes;"> </span>and</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
iv.
Hospital records of
prescriptions. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
In this way, it may be possible to match illness events with
drugs prescribed. An example of the use of record linkage is the prescription-
Event Monitoring Scheme, in which all the prescriptions issued by selected
practitioners for a particular drug are obtained from the Prescription Pricing
Authority. The prescribers are then asked to report any events in the patients
taking the drug (whether attributable to ADRs or not) to those running the
scheme. This scheme is less expensive and time consuming than other
surveillance methods. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
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IX. Meta- analysis: If many studies of an ADR have been
performed, a meta- analysis of all available data can be done to determine
whether there is an association. </div>
<br />
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Anupahttp://www.blogger.com/profile/06231026587968567116noreply@blogger.com1Nepal28.394857 84.12400821.255708 73.796859500000011 35.534006 94.4511565tag:blogger.com,1999:blog-2637094863326723594.post-82859751491751441242012-12-31T11:27:00.001+05:452013-01-16T14:52:11.753+05:45Severity Assessment of ADRs<div dir="ltr" style="text-align: left;" trbidi="on">
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<b style="mso-bidi-font-weight: normal;">Severity assessment of
ADRs:</b><sup> </sup>The term severity is often used to describe the intensity
of a medical event, as in grading ‘mild’, ‘moderate’ and ‘severe’. Severity
assessment categorizes the ADRs as mild, moderate, or severe based on the based
on the steps taken for the management of the ADRs.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Karch and Lasagna classified severity into minor, moderate,
severe and lethal as defined below:</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Minor: no antidote, therapy or prolongation of
hospitalization required.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. Moderate: requires a change in drug therapy, specific
treatment or an increase in hospitalization by at least 1 day. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
iii. Severe: potentially life threatening, causing permanent
damage or requiring intensive medical care. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
iv. Lethal: directly or indirectly contributes to the death
of the patient. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<a name='more'></a><br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
The USFDA classifies an ADR as serious when it results in
death, life- threatening causes, or prolongs hospitalization, causes a
significant persistent disability, results in a congenital anomaly, or requires
intervention to prevent permanent damage.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Hartwig et al categorized ADRs into seven levels as per their
severity. Level 1 & 2 fall under mild category, level 3 & 4 under
moderate and level 5, 6 & 7 fall under category severe. <b>(See below)</b></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
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<div align="center" class="MsoNormal" style="text-align: center;">
<br /></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><span lang="PT-BR" style="font-size: 14.0pt; mso-ansi-language: PT-BR;">ADR
severity assessment scale</span></b></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><span lang="PT-BR" style="mso-ansi-language: PT-BR;">(Modified Hartwig and
Siegel)</span></b></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span lang="PT-BR" style="mso-ansi-language: PT-BR;">Mild</span></b></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Level 1:
The ADR requires no change in treatment with the suspected drug.</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">OR</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Level
2:<span style="mso-spacerun: yes;"> </span>The ADR requires that the suspected
drug be withheld, discontinued or otherwise<span style="mso-spacerun: yes;"> </span>changed. No antidote or other
treatment is required, and there is no increase in lenght of stay. </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span lang="PT-BR" style="mso-ansi-language: PT-BR;">Moderate </span></b></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">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 lenght of stay. </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">OR </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Level 4
(a): Any level 3 ADR that increases lenght of stay by at least one day. </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">OR</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Level 4
(b): The ADR is the reason for admission. </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;"> </span><b style="mso-bidi-font-weight: normal;"><span lang="PT-BR" style="mso-ansi-language: PT-BR;">Severe </span></b></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Level 5:
Any level 4 ADR that requires intensive medical care. </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">OR </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Level 6:
The ADR causes parmanent harm to the patient. </span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">OR</span></div>
<div class="MsoNormal">
<br /></div>
<span lang="PT-BR" style="font-family: "Times New Roman"; font-size: 12.0pt; mso-ansi-language: PT-BR; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-US;">Level 7: The ADR either directly or indirectly
leads to the death of the patient. </span></div>
Anupahttp://www.blogger.com/profile/06231026587968567116noreply@blogger.com1Nepal28.394857 84.12400821.256676 73.796859500000011 35.533038 94.4511565tag:blogger.com,1999:blog-2637094863326723594.post-73298649502469785072012-12-30T15:08:00.002+05:452013-01-16T14:52:40.116+05:45Causality assessment of ADRs<div dir="ltr" style="text-align: left;" trbidi="on">
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<br />
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">Causality assessment
of ADRs</b></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Determining which adverse event is caused by drugs with reasonable
certainty is an essential though difficult part of documenting ADRs. The
development of a symptom or detrimental outcome while taking a medication does
not establish the drug as the cause of the injury. Likewise, development of an
event or a disease remotely in time from the use of a drug does not exonerate
the therapy from being the source of the problem. In order to initiate
appropriate measures to prevent further occurrence of ADRs, it is necessary to
identify the causative drug. This can be done by carrying out the causality
assessment of the suspected drug. Causality assessment is carried out to
establish a causal relationship between a drug and ADR.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<a name='more'></a><br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Causality assessment of ADRs is the structured and
standardized assessment of individual patients/ case reports of the likelihood
of a causal relationship between suspected drugs and adverse medical events. In
the early 1980s, in an attempt to reduce ambiguity in the evaluation of adverse
drug reactions, different standardized causality assessment scales were
introduced<span style="mso-spacerun: yes;"> </span>at pharmacovigilance centers
in many centers in many countries around the world.<sup> </sup>The assessment
of reported ADRs takes place in two stages:</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. The assessment of individual case reports and </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. Interpretation of aggregated data. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
In the first stage, routine causality assessment is made upon
receipt of the case report based on a general system that is intended for all
reactions and all drugs. It assesses all the possible relevance and quality of
the report, like unknown reactions, seriousness, etc. During the second stage
of aggregated assessment, causality assessment is likely to be repeated with
all available data and the use of a specific etiological- diagnostic system may
be more appropriate. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Currently, a wide variety of causality assessment scales
exist, which attribute clinical events to drugs in individual patients or in
case reports. These include World Health Organization (WHO) assessment scale,
Naranjo’s scale, Karch and Lasagna’s scale, European ABO system, Bayesian
Neural network, etc. Each of such scales have their own advantages and
limitations and the categorization of causal relationship between a drug and a
suspected ADR varies with the scale adopted. A worldwide procedure for
causality assessment of suspected ADRs is yet to be established. The causality
categories vary with the countries as different countries use different
causality categories. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="mso-spacerun: yes;"> </span>WHO Collaborating
Center for International
Drug Monitoring has used six different terms for causality categorization, with
a set of definitions as follows: </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">1. Certain:</b> A
clinical event, including a laboratory test abnormality, occurring in a
plausible time relationship to drug administration, and which cannot be explained
by concurrent disease or other drugs or chemicals. The response to withdrawal
of the drug (dechallange) should be clinically plausible. The event must be
definitive pharmacologically or phenomenologically, using a satisfactory
rechallenge procedure if necessary. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">2. Probable: </b>A
clinical event, including a laboratory test abnormality, with a reasonable time
sequence to administration of drug, unlikely to be attributed to concurrent
disease or other drugs or chemicals, and which follows a clinically reasonable
response on withdrawal (dechallange). Rechallenge information is not required
to fulfill this definition. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">3. Possible</b>: A
clinical event, including a laboratory test abnormality, with a reasonable time
sequence to administration of drug but which could also be explained by
concurrent disease or other drugs or chemicals. Information on drug withdrawal
may be lacking or unclear. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">4. Unlikely:</b> A
clinical event, including a laboratory test abnormality, with a temporal
relationship to drug administration which makes causal relationship improbable,
and in which other drugs, chemicals or underlying disease provide plausible
explanations. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">5. Conditional/
Unclassified:</b> A clinical event, including a laboratory test abnormality,
reported as an adverse reaction, about which more data is essential for a
proper assessment or the additional data are under examination. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">6. Unassessable/
unclassified:</b> A report suggesting an adverse reaction which cannot be
judged because information is insufficient or contradictory, and which cannot
be supplemented or verified. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">Naranjo’s scale:<sup> </sup></b>A
simple method to assess the causality of ADRs in a variety of clinical
situations was developed by Naranjo et al in 1981. In this scale, the
probability that the adverse event was related to drug therapy was classified
as definite, probable, possible or doubtful, with each classification having
the following definition:</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">I. Definite</b>: A
reaction that:</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
1. Followed a reasonable temporal sequence after a drug or in
which a toxic drug level had been established in body fluids or tissues</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
2. Followed a recognized response to the suspected drug and</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
3. Was confirmed by improvement on withdrawing the drug and
reappeared on re-exposure.<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">II. Probable</b>: A
reaction that: </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
1. Followed a reasonable temporal sequence after a drug</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
2. Followed a recognized response to the suspected drug</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
3. Was confirmed by withdrawal but not by re- exposure to the
drug and </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
4. Could not be reasonably explained by the known
characteristics of the patient’s state.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">III. Possible: </b>A
reaction that: </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
1. Followed a temporal sequence after a drug</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
2. Possibly followed a recognized pattern to the suspected
drug and </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
3. Could be explained by characteristics of the patient’s
disease </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">IV. Doubtful</b>: A
reaction that was likely related to factors other than a drug. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="mso-spacerun: yes;"> </span><b style="mso-bidi-font-weight: normal;">Categorization of ADRs using Naranjo scale: </b>Different factors used
to establish a causal association between drugs and adverse events <i style="mso-bidi-font-style: normal;">viz</i> temporal sequence, pattern of
response, withdrawal, re-exposure, alternative causes, placebo response, drug
levels in body fluids or tissues, dose- response relationship, previous patient
experience with the drug, and confirmation by objective evidence are analyzed
and scored using the Naranjo ADR scale<b> (See below)</b>. Each question can be answered positive
(yes), negative (no), or unknown/ inapplicable (do not know). The ADR is
assigned to a probability category from the total score as: Definite: ≥ 9,
probable: 5 to 8, possible: 1 to 4, doubtful: ≤ 0.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
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<div align="center" class="MsoNormal" style="text-align: center;">
<br /></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<br /></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><span lang="PT-BR" style="mso-ansi-language: PT-BR;">Criteria for
determining causative drug’s relationship to ADR</span></b></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><span lang="PT-BR" style="mso-ansi-language: PT-BR;">(Naranjo Algorithm) </span></b></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span lang="PT-BR" style="mso-ansi-language: PT-BR;"> </span></b><span lang="PT-BR" style="mso-ansi-language: PT-BR;">The total
score calculated from this table defines the category as: possibly (total score
1-4), probably (total score 5-8), definitely (total score > 9)</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br />
<b style="mso-bidi-font-weight: normal;"><span lang="PT-BR" style="mso-ansi-language: PT-BR;"></span></b></div>
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<span lang="PT-BR" style="mso-ansi-language: PT-BR;">S. No</span></div>
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<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div align="center" class="MsoNormal" style="text-align: center;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Particulars</span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Yes </span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">No </span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Do not
know </span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
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<span lang="PT-BR" style="mso-ansi-language: PT-BR;">1.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Are there previous conclusive reports on this
reaction?</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .45in;" valign="top" width="43"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">2.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Did the adverse event appear after the
suspected drug was administered? </span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+2</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">-1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .45in;" valign="top" width="43"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">3.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Did the advrse reaction improve when the drug
was discontinued or a specific antagonist was administered? </span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .45in;" valign="top" width="43"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">4.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Did the adverse reaction reappear when the
drug was readministered? </span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+2</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">-1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 5;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .45in;" valign="top" width="43"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">5.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Are there alternative causes (other than the
drug) that could solely have caused the reaction? </span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">-1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+2</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .45in;" valign="top" width="43"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">6.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Did the reaction reappear when a placebo was
given? </span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">-1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .45in;" valign="top" width="43"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">7.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Was the drug detected in the blood (or other
fluids) in a concentration known to be toxic? </span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .45in;" valign="top" width="43"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">8.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Was the reaction more severe when the dose
was increased, or less severe when the dose was decreased? </span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 9;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .45in;" valign="top" width="43"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">9.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Did the patient have a similar reaction to
the same reaction or similar drugs in any previous exposure? </span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 10; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .45in;" valign="top" width="43"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">10.</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 315.0pt;" valign="top" width="420"><div class="MsoNormal" style="line-height: 150%;">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">Was the adverse event confirmed by objective
evidence? </span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">+1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: .5in;" valign="top" width="48"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 45.0pt;" valign="top" width="60"><div class="MsoNormal">
<span lang="PT-BR" style="mso-ansi-language: PT-BR;">0</span></div>
</td>
</tr>
</tbody></table>
<br />
<br /></div>
Anupahttp://www.blogger.com/profile/06231026587968567116noreply@blogger.com1Nepal28.394857 84.12400821.256614 73.796859500000011 35.5331 94.4511565tag:blogger.com,1999:blog-2637094863326723594.post-8971105546171246522012-12-30T14:53:00.000+05:452013-01-16T14:53:18.465+05:45ADRs: Predisposing factors<div dir="ltr" style="text-align: left;" trbidi="on">
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<br />
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Factors predisposing to ADRs may relate either to the properties
of the drug or to the characteristics of the individual. Different factors
predisposing to ADRs are discussed below: </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<a name='more'></a><br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<i style="mso-bidi-font-style: normal;">1. Multiple drug
therapy:</i> The incidence of ADRs has been known to increase sharply with the
number of drugs taken. E.g. occurrence of synergistic effects and additive
effects.<br />
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<i style="mso-bidi-font-style: normal;">2. Age:</i> The very
old and the very young are more susceptible to ADRs. In the elderly, physiologic
changes due to ageing and chronic disease states often contribute to impaired
drug metabolism, which can lead to increased incidence of ADRs. Neonates and
children also differ from adults in the way they handle and respond to drugs,
making them more susceptible to ADRs. E.g. neonates are more prone to adverse
effects of chloramphenicol, Ryes syndrome due to aspirin in children and
increased ADRs due to hypnotics, diuretics, etc in elderly. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<i style="mso-bidi-font-style: normal;">3. Gender</i>: women
are generally more susceptible to ADRs then men. E.g. women are more
susceptible to blood dyscrasias due to phenylbutazone and chloramphenicol than
men. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal">
<i style="mso-bidi-font-style: normal;">4. Intercurrent
diseases</i>: Patients with impaired renal or hepatic function are at
substantially increased risk of developing ADRs to drugs metabolized and
eliminated by these organs. Other specific</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
disease states like human immunodeficiency virus (HIV)
positive patients are also known to suffer an increased incidence of ADRs. E.g.
increased occurrence of ADRs due to antitubercular drugs in human
immunodeficiency virus (HIV) positive patients. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<i style="mso-bidi-font-style: normal;">5. Race and genetic
polymorphism</i><b style="mso-bidi-font-weight: normal;">:</b> Inherited factors
that affect the pharmacokinetics of drugs can also predispose to an
individual’s risk of ADRs. E.g. increased incidence of ADRs due to isoniazid
and other cytochrome P450 metabolized drugs in poor metabolizers. </div>
</div>
Anupahttp://www.blogger.com/profile/06231026587968567116noreply@blogger.com2Nepal28.394857 84.12400821.256490499999998 73.796859500000011 35.5332235 94.4511565tag:blogger.com,1999:blog-2637094863326723594.post-69418723317885901592012-12-28T11:59:00.000+05:452013-01-16T14:53:44.603+05:45Classification of Adverse Drug Reactions <div dir="ltr" style="text-align: left;" trbidi="on">
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<br />
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
There are several ways of classifying ADRs. The simplest one is that
proposed by Rawlins and Thompson<sup> </sup>which was later modified by Wills
and Brown.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
I<i style="mso-bidi-font-style: normal;">. Rawlins and Thompson
classification:</i> In this classification, the ADRs are categorized into two classes
<i style="mso-bidi-font-style: normal;">viz</i> type A and type B reactions.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br />
<a name='more'></a><br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
1. Type A reactions: These include the reactions that are
predictable from the drug’s known pharmacology and are usually dose dependent.
Their incidence and morbidity are generally high while mortality is usually,
but not invariably low. Examples are bradycardia with <span style="font-family: Symbol; mso-ascii-font-family: "Times New Roman"; mso-char-type: symbol; mso-hansi-font-family: "Times New Roman"; mso-symbol-font-family: Symbol;"><span style="mso-char-type: symbol; mso-symbol-font-family: Symbol;">b</span></span> adrenoceptor blockers,
hemorrhage with anticoagulants, hypoglycaemia with sulphonylureas, etc. Some
type A reactions have a long latency, like teratogenicity, chloroquine
retinopathy, delayed effects like vaginal adenocarcinoma in daughters of women
who received diethylstilbestrol during pregnancy, etc. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
2. Type B reactions<b style="mso-bidi-font-weight: normal;">: </b>These
are aberrant or bizarre effects that cannot be predicted on the basis of the
drug’s pharmacology. These reactions are generally unrelated to dosage and
though comparatively rare, they often cause serious illness and death. These
reactions are often not observed during conventional pharmacological and
toxicological screening programmes and consequently account for many drug withdrawals
from the market. Some examples are: malignant hyperthermia of anaesthesia,
anaphylaxis due to penicillin, and many immunological reactions. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">Limitations of Rawlins
and Thompson classification</b>: Some of the major limitations of Rawlins and
Thompson classification are mentioned below:</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
1. Everything that is not type A is classified as type B,
rendering the later a highly heterogenous group with little in common. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
2. Certain ADRs do not fit into either category comfortably;
hence it is difficult to decide whether such ADRs are type A or type B. </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;"><span style="mso-spacerun: yes;"> </span></b></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
II<i style="mso-bidi-font-style: normal;">. Wills and Brown
classification</i><b style="mso-bidi-font-weight: normal;">: </b>To overcome the
limitations of Rawlins and Thompson classification, adverse reactions are
classified into nine categories based on their mechanism. In this
classification, the term ‘medicine’ has been used in preference to ‘drug’ to
ensure that reactions secondary to the method of administration or excipients
are clearly incorporated within the definition. Table 1 gives the types and
common features of the ADRs as per the Wills and Brown classification. </div>
<div align="center" class="MsoNormal" style="line-height: 150%; text-align: center;">
<b style="mso-bidi-font-weight: normal;">Table 1. Wills and Brown classification of
ADRs </b></div>
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<b style="mso-bidi-font-weight: normal;">S. No. </b></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; height: 31.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 104.15pt;" valign="top" width="139"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<b style="mso-bidi-font-weight: normal;">Classification of
ADR</b></div>
</td>
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<b style="mso-bidi-font-weight: normal;">Features</b></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; height: 31.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 167.15pt;" valign="top" width="223"><div align="center" class="MsoNormal" style="line-height: 150%; text-align: center;">
<b style="mso-bidi-font-weight: normal;">Examples</b></div>
</td>
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1</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 90.85pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 104.15pt;" valign="top" width="139"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Type A (Augmented)</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 90.85pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 171.2pt;" valign="top" width="228"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Relatively common</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. Pharmacologically predictable</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
iii. Dose related</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
iv. Improves if medicine is withdrawn </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; height: 90.85pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 167.15pt;" valign="top" width="223"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Hypoglycemia with sulfonylureas</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. Bradycardia with <span style="font-family: Symbol; mso-ascii-font-family: "Times New Roman"; mso-char-type: symbol; mso-hansi-font-family: "Times New Roman"; mso-symbol-font-family: Symbol;"><span style="mso-char-type: symbol; mso-symbol-font-family: Symbol;">b</span></span>- blockers, etc. </div>
</td>
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<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 30.9pt;" valign="top" width="41"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
2</div>
</td>
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Type B (Bugs)</div>
</td>
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i. Involves interaction with a microorganism </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. Pharmacologically predictable</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
iii. Improves if medicine is withdrawn </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
</td>
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i. Dental caries with sugar coated tablets</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. resistance due to overuse of any one antibiotic, etc.</div>
</td>
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<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 30.9pt;" valign="top" width="41"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
3</div>
</td>
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Type C (Chemical)</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 171.2pt;" valign="top" width="228"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Related to drug concentration</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. An irritant reaction</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 167.15pt;" valign="top" width="223"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span lang="FR" style="mso-ansi-language: FR;">i. Extravasation
reactions </span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span lang="FR" style="mso-ansi-language: FR;">ii. Phlebitis,
etc. </span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 30.9pt;" valign="top" width="41"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
4</div>
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Type D (Delivery)</div>
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i. Caused by method of administration or nature of
formulation</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. Improves if medicine is withdrawn or method of delivery
changed</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 167.15pt;" valign="top" width="223"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Inflammation or infection around implant particles</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. Infection at site of injection, etc. </div>
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5</div>
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Type E (Exit)</div>
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i. Pharmacologically predictable</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii.Begins only when the medicine is stopped or dose is
reduced</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
iii. Improves if medicine is reintroduced</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 167.15pt;" valign="top" width="223"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Withdrawal reactions due to opoids, benzodiazepines,
clonidine, <span style="font-family: Symbol; mso-ascii-font-family: "Times New Roman"; mso-char-type: symbol; mso-hansi-font-family: "Times New Roman"; mso-symbol-font-family: Symbol;"><span style="mso-char-type: symbol; mso-symbol-font-family: Symbol;">b</span></span>-
blockers, etc.</div>
</td>
</tr>
<tr style="mso-yfti-irow: 6;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 30.9pt;" valign="top" width="41"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
6</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 104.15pt;" valign="top" width="139"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Type F (Familial)</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 171.2pt;" valign="top" width="228"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="mso-spacerun: yes;"> </span>occurs only in the
genetically predisposed</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 167.15pt;" valign="top" width="223"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Hemolytic anemia with primaquin in G6PD deficient
individuals, etc.</div>
</td>
</tr>
<tr style="mso-yfti-irow: 7;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 30.9pt;" valign="top" width="41"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
7</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 104.15pt;" valign="top" width="139"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Type G (Genotoxicity)</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 171.2pt;" valign="top" width="228"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
causes irreversible genetic damage</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 167.15pt;" valign="top" width="223"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Teratogenic agents like thalidomide causing genetic
damage in the fetus, etc. </div>
</td>
</tr>
<tr style="mso-yfti-irow: 8;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 30.9pt;" valign="top" width="41"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
8</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 104.15pt;" valign="top" width="139"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Type H (Hypersensitivity)</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 171.2pt;" valign="top" width="228"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Requires activation of immune system </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. Improves if medicine is withdrawn</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 167.15pt;" valign="top" width="223"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Anaphylaxis with penicillin</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. allergic skin reactions with antimicrobial agents, etc.
</div>
</td>
</tr>
<tr style="mso-yfti-irow: 9; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 30.9pt;" valign="top" width="41"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
9</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 104.15pt;" valign="top" width="139"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Type U (Unclassified)</div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 171.2pt;" valign="top" width="228"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Mechanism not understood<span style="mso-spacerun: yes;">
</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 167.15pt;" valign="top" width="223"><div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
i. Taste disturbances with simvastatin</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
ii. Nausea and vomiting with gaseous anesthetic, etc. </div>
</td>
</tr>
</tbody></table>
</div>
Anupahttp://www.blogger.com/profile/06231026587968567116noreply@blogger.com5Nepal28.394857 84.12400821.258156999999997 73.796859500000011 35.531557 94.4511565tag:blogger.com,1999:blog-2637094863326723594.post-59737191061671426582012-12-28T11:31:00.001+05:452013-01-16T14:54:16.399+05:45Adverse Drug Reactions (ADR)<div dir="ltr" style="text-align: left;" trbidi="on">
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<div style="text-align: center;">
<span style="font-size: large;"><b><u>ADVERSE DRUG REACTIONs (ADRs)</u></b></span></div>
<br />
It has been recognized since the
earliest times and now universally accepted that no drug is free from side
effects and that drug therapy itself can be a significant cause of morbidity
and mortality.<br />
<br /></div>
<div class="MsoNormal" style="line-height: 150%;">
<b style="mso-bidi-font-weight: normal;">Definition of adverse drug reaction (ADR)</b><sup> </sup><span style="mso-spacerun: yes;"> </span><br />
An ADR is basically any undesirable effect of
a drug beyond its anticipated therapeutic effects occurring during clinical
use. </div>
<div class="MsoNormal" style="line-height: 150%;">
<br />
Several definitions of ADR exist in
literature, including those of World Health Organization (WHO), Karch and
Lasagna, American Society of Health- system Pharmacists (ASHP), and United
States Food and Drug Administration (USFDA).</div>
<div class="MsoNormal" style="line-height: 150%;">
<br />
<a name='more'></a><br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
WHO<b style="mso-bidi-font-weight: normal;"> </b>defines ADR as
a response to a drug which is noxious and unintended, and which occurs at doses
normally used in man for the prophylaxis, diagnosis, or therapy of disease, or
for the modification of physiological function.<span style="color: black;"></span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="color: black;"><span style="mso-spacerun: yes;">
</span></span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
Karch and Lasagna<b style="mso-bidi-font-weight: normal;"> </b>have
defined an ADR as any response to a drug that is noxious and unintended and
that occurs at doses used in man for prophylaxis, diagnosis, or therapy,
excluding failure to accomplish the intended purpose.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
American Society of Hospital Pharmacists (ASHP)<b style="mso-bidi-font-weight: normal;"> </b>has defined an ADR as any unexpected,
unintended, undesired, or excessive response to a drug that </div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
I. Requires discontinuing the drug (therapeutic or
diagnostic),</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
II. Requires changing the drug therapy,</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
III. Requires modifying the dose (except for minor dosage
adjustments),</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
IV. Necessitates admission to a hospital,</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
V. Prolongs stay in a health care facility,</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
VI. Necessitates supportive treatment,</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
VII. Significantly complicates diagnosis,</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
VIII. Negatively affects prognosis, or</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
IX. Results in temporary or permanent harm, disability or
death.</div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
<br /></div>
<div class="MsoNormal" style="line-height: 150%; text-align: justify; text-justify: inter-ideograph;">
United States Food and
Drug Administration (USFDA) has defined an ADR as<span style="mso-spacerun: yes;"> </span>any events relating to drugs or devices in
which the patient outcome is death, life-threatening (real risk of dying),
hospitalization (initial or prolonged), disability (significant, persistent, or
permanent), congenital anomality, or required intervention to prevent permanent
impairment or damage.</div>
</div>
Anupahttp://www.blogger.com/profile/06231026587968567116noreply@blogger.com0Nepal28.394857 84.12400821.256243499999997 73.796859500000011 35.5334705 94.4511565