clinical pharmacy 4th pharmD

1. REPORTING OF ADRS
PHARM-D 4TH YEAR
CLINICAL PHARMACY
Dr. Pradeepthi.k
Assistant Professor
Department of Pharmacy Practice

2.  After the ADR has been well documented, it should
be reported to those who has special interest in
ADRs.
 They may include the DCGI (Drug Controller
General of In CDSCO (Central Drugs Standard
Control Organization), the individual pharmaceutical
manufacturer, publishers of pharmaceutical or
medical literature, and the medical and
administration of the individual hospital.
 Central Drugs Standard Control Organization
(CDSCO) The CDSCO program has primary
interest in unexpected, significant adverse reaction
drugs and in increased frequencies of serious,
known reactions.

3.  The CDSCO has interest in common ADRs such as
dehydration secondary to diuretics.
 The CDSCO program monitors ADRs that may be
probable or possible as individual reports combines many
individual reports to establish trends or to identify rare
ADRs.
 Lack of ADR reporting by physicians is due to the
following reasons:
 Failure to detect the reaction due to a low level of
suspicion.
 Fear of potential legal implications.
 Lack of training about drug therapy.
 Uncertainty about whether the drug causes the action.

4.  Lack of clear responsibility for reporting.
 Paper work and time involved.
 No financial incentive for reporting.
 Unaware of reporting procedure or little
understanding of it.
 Lack of readily available reporting forms.
 Desire to publish the report.
 Fear that a useful drug will be removed from the
market or given a bad name.
 Complacency and lethargy.
 Guilty feelings because of patient harm.
 Opinion that reaction is not worth reporting.

5. DRUG MANUFACTURER
 The drug manufacturer must keep records of
practitioner experiences with its products. It is the
responsibility of the manufacturer to record ADR
data and notify the pharmacy and medical
professions by letter if unsuspected clusters of
ADRs begin to occur.
 Publication For adverse drug reactions that are
carefully validated in a given patient but which are
not defined in the literature, publication is the best
approach to raising the index of suspicion among
practitioners.
 Once an ADR is clearly documented in the
literature, other practitioners are more likely to
observe it in their patients. Reporting increases the
level of suspicion.

6. INTERNAL REPORTING
 Some ADRs are so predictable that the main use of the reports
of their occurrence is internal.
 These are ADRs that could be prevented with careful monitoring
techniques.
 Their detection may indicate the need for in-service
presentations, newsletters, or increased pharmacist involvement
in drug therapy monitoring.
 In all ADR reporting, patient confidentiality must be maintained.
 If the prescribing physician does not fill out the report, the
individual who does so should notify the physician that a report
is being made.
 Copies of the final evaluation should be sent to any person
notifying the ADR pharmacist of a potential reaction.

7. SPONTANEOUS REPORTING
 There is a need for continuous post-marketing drug
surveillance after a drug is released for use in the
general population.
 Intensive post marketing surveillance programs are
useful in surveying drug use.
 While they provide numerator and denominator data so
that an incidence can be postulated, they are expensive,
do not reflect drug use in all patient types, and may not
detect rare, delayed, or unusual ADRs.
 There remains the need for the individual practitioner to
review drug use for the detection, assessment, and
reporting of ADRs.
 Individual spontaneous reporting frequently alerts all
practitioners to clinically important but unreported ADRs.
 The spontaneous report may lead to more detailed
study to define the incidence, mechanism, and
significance of a given ADR.

8. INDIVIDUAL CASE SAFETY REPORT (ICSR )
 A document providing the most complete
information related to an individual case at a certain
point of time.
 An individual case is the information provided by a
primary reporter to describe suspected adverse
reaction(s) related to the administration of one or
more medicinal products to an individual patient at
a particular point of time.

9. VOLUNTARY REPORTING
 The voluntary reporting system utilizes forms that
are available on the nursing unit or are available
upon request from the pharmacy.
 These may be the forms supplied by the CDSCO or
those designed by a particular hospital.
 Individual practitioners must suspect an ADR,
request the form, fill it out, and send it to the
pharmacy.
 While this method does result in some reports, it is
a low-yield program.

10.  It requires that the individual physician must suspect an
ADR and be motivated to report the reaction.
 Some physicians may not want to spend the time
necessary to complete these forms but may use an
alert system in which the practitioner notifies the
pharmacy that an ADR has occurred and the
pharmacist goes to the patient unit and completes the
necessary forms.
 Another way of increasing utilization of the voluntary
reporting system by physicians is to solicit oral requests
for completion of the forms. The drug information center
may be utilized to promote and receive ADR evaluation
requests.

11.  Nurses are also valuable resources in detecting ADRs.
 They see patients under a variety of conditions and may
be the first and only individuals to suspect an ADR.
 They may initiate the alert system either in writing or
verbally. If individual pharmacists serve as liaisons with
individual nursing units, the relationship can be utilized to
explain the ADR program and to solicit evaluations of
suspected ADRs

12. HOW TO START AN ADR PROGRAMME OR
INITIATE IT?
 An ADR program is a good way to begin clinical
services.
 The program can start with advertising the voluntary
reporting system and progress to prospective monitoring
and prevention.
 After deciding to participate in an ADR program, a
protocol should be developed which can be presented to
the proper hospital committees.
 The pharmacy and therapeutics committee is an
appropriate place to start.
 Pharmacy and Therapeutics Committee
 The program description presented to the pharmacy and
therapeutics committee should be tailored to each
institution but should contain certain basic components.
These include:

13.  A standard protocol on ADR reporting
 A brief description of the significance and incidence of
ADRs
 A description of the current program and how well this
program is functioning
 A description of the proposed changes in the system
 How and by whom the new program will be implemented
 The personnel, time, and costs of the system
 How ADRs will be detected
 To whom the ADRs will be reported and
 How the program will upgrade patient care in that
hospital.
 The proposal should be positive, emphasizing the
importance of detecting ADRs so that current and future
patient care may be improved.

14.  The proposal should be positive, emphasizing the
importance of detecting ADRs so that current and future
patient care may be improved.
 The initial step would be to encourage the voluntary
reporting of ADRs.
 The pharmacist should ensure that appropriate forms are
available at all nursing units and follow up with a
memorandum or presentation to all professional staff (e.g.,
physicians, nurses, pharmacists, etc.) on the importance
of reporting ADRs, together with an explanation as to how
the reporting forms should be used.
 Anyone suspecting an adverse drug reaction should notify
the ADR pharmacist and request a complete review of the
patient's drug therapy plan with concomitant ADR
reporting.

15.  It may be necessary to raise the level of awareness to the
importance of ADRs and to the reporting mechanism. This
can be done through articles in the department of pharmacy
newsletters, memoranda, and presentations.
 It may also be necessary to repeat periodically the
awareness program as initial enthusiasm wanes or new
staff begins practice in the institution. In addition, the
 ADR pharmacist could arrange with the medical records
department to hold all patient records indicating iatrogenic
disease or ADR.

16.  A particular diagnosis that might be drug-induced, e.g.,
hyperkalaemia, could be monitored.
 The results from these detection systems should be
reported back to the pharmacy and therapeutics committee
and publicized in the pharmacy department's newsletters.
 Particularly interesting or significant ADRs should be
described in newsletters or in conferences. Trends in ADRs
would indicate an area for an educational program.

17. WHAT IS AUDIT COMMITTEE?
 The ADR pharmacist might also want to coordinate activities
with the audit committee.
 This would allow individual agents to be studied intensively
for short periods of time. With the data generated by the
detection system, the activities of the ADR pharmacist could
be expanded to include ADR prevention.
 There may be several approaches to ADR prevention.
 If pharmacists are not available to review every patient and
every drug, it may be desirable to monitor drugs with narrow
therapeutic ranges. For example, all patients receiving
aminoglycoside antibiotics could be monitored.

18.  The laboratory would alert the ADR pharmacist to any high
drug serum levels that could potentially represent an ADR.
 An alternative to single drug monitoring is to monitor all of the
patients on a single team or admitted by a single physician.
 The pharmacist could identify a physician who is favorably
predisposed to pharmacy input and initiate ADR surveillance
and monitoring of that physician's patients.
 The move to prevention rather than just detection will be a
greater benefit to patient care.
 If an ADR program is to be successful, the ADR pharmacist
must be dedicated to making it work. It will require that the
pharmacist follow up on reports of suspected ADRs and
provide feedback to the reporter.
 All of this may require that the pharmacist devote time to the
ADR program that is outside of normal working hours.

19.  If successful, an ADR program can be of considerable
benefit to patient care.
 It can be professionally rewarding and can lead to greater
involvement of the pharmacist in patient care.
 Figure 14.3 illustrates the interrelationships of activities
involved in the initiation of an ADR program.

20. HOW TO IMPLEMENT OF AN ADR REPORTING
 Prior to implementing an ADR program, the health
care facility must educate its staff on the importance
and significance of the program.
 The pharmacy department is in an excellent
position to provide this education because of its
involvement in the pharmacy & therapeutics
committee (P&T Committee), pharmacokinetic
dosing, drug utilization evaluation (DUE), and drug
distribution.
 The pharmacy department can be an excellent
resource for developing an ADR program, as well
as providing data about ADRs to the P&T
Committee.

21. GUIDELINES FOR STARTING A PROGRAM INCLUDE
THE FOLLOWING.
 Develop definition and classifications for ADRs that work for
the institution.
 Assign responsibility for the ADR program within the
pharmacy and throughout other key departments. A
multidisciplinary approach is an essential factor.
 Develop a program with approval from the pharmacy
department, medical staff. nursing department, as well as
other appropriate areas within the facility. Co- operation is
essential in initiation of a successful program.
 Promote awareness of the program.
 Promote the awareness of ADRs and the importance of
reporting such events.
 Develop policies and procedures for handling ADRs being
sent to the CDSCO. Indicate who is responsible for sending
them.
 Establish mechanisms for screening ADRs. These
mechanisms should include retrospective reviews, concurrent
monitoring, as well as prospective planning for high-risk
groups.

22.  Develop forms for data collection and reporting or other
mechanisms for reporting.
 Establish procedures for evaluating ADRs. Routinely
review ADRs for trends.
 Monitor ADRs continuously and concurrently. Develop
preventive interventions.
 Report all finding to P&T Committee.
 Develop strategies for decreasing the incidence of
ADRs (depending on the opportunities presented by the
ADRs reported).

23. WHO SHOULD REPORT
 Healthcare Professionals are the preferred source
of information in pharmacovigilance, for example
physicians, family practitioners, medical specialists,
and dentists.
 Nurses and other health workers may also
administer medicines and should report relevant
adverse drug reactions experienced by the patients.
 Pharmacists can play an important role in the
stimulation of reporting and in the provision of
additional information (for example, on co-
medication and previous medicine use

24.  Patients & their relatives can also report their experienced
adverse drug reactions directly to JPC, or through their
healthcare professionals. In this case seek the patient
permission to contact their healthcare professionals for
additional information and data verification.
 Marketing authorization holder (MAH), being primarily
responsible for the safety of their products, they are
obligated to report serious adverse drug reactions they
receive about their products to JPC. While the Non-
serious ADRs should be included in the periodic safety
update report (PSURs).

25. CHARACTERISTICS OF GOOD CASE REPORT
 The quality of the reports is critical for appropriate
evaluation of the relationship between the product
and adverse reactions, thus good case reports
include the following elements:
 1. Description of the adverse reaction or disease
experience, including time to onset of signs or
symptoms and the seriousness of the reaction/s;
 2. Suspected and concomitant medicines details
(i.e., Name, concentration, dose, dosage form, rout
of administration, indication for use, duration of
use& batch number especially for vaccines),
including over-the-counter medications, dietary
supplements, and recently discontinued
medications;

26.  3. Patient characteristics, including the name or initials,
age, sex, weight, and baseline medical condition prior to
product therapy, co-morbid conditions, use of concomitant
medications, relevant family history of disease, and
presence of other risk factors;
 4. Documentation of the diagnosis of the reactions,
including methods used to make the diagnosis;
 5. Clinical course of the reaction and patient outcomes
(e.g., hospitalization or death);
 6. Relevant therapeutic measures and laboratory data at
baseline, during therapy, and subsequent to therapy,
including blood levels, as appropriate;

27.  7. Information about response to dechallenge and
rechallenge; and
 8. Any other relevant information (e.g., other details
relating to the reaction or information on benefits received
by the patient, if important to the assessment of the
reaction).
 The reporting form should be obtained from PVPI and at
least four sections should be completed to have a valid
report.
 In other words these four sections are the minimum
information which allows the case report to be valid
subsequently to be entered onto the national ADR
database and become available for signal generation in
order to facilitate evaluation of cases.
 When one or more of these information are missing, the
case should be followed up in order to validate the report
and complete its processing as described above.

28. THE FOUR SECTIONS TO VALIDATE THE INDIVIDUAL
CASE REPORT (ICSR) ARE AS FOLLOW:
 An identifiable patient
 Patient initials
 Sex
 Weight
 Age at time of reaction or date of birth

29.  Suspected medicine
 Name (INN and brand name)
 Strength (concentration)
 Dose, Frequency
 Dosage form
 Route of administration
 Indication for use
 Duration of use, date started, date stopped
 Batch number (especially for vaccines)

30.  Suspected adverse reaction
 Description of the reaction
 Expectedness of the reaction (in accordance with
the approved product information)
 Seriousness of the reaction
 Date the reaction started, stopped
 Outcomes attributed to adverse reaction
 Relevant tests/laboratory data (if available)

31.  An identifiable reporter
 Name, initials
 Address
 Contact details
 Qualification (if healthcare professional)

32. WHAT SHOULD BE REPORTED
 If it is suspected that a patient has experienced an
ADR it should be reported using a Yellow Card.
 ADRs resulting from prescription medicines, herbal
remedies, and OTC medications can all be
reported..
 Causality does not need to have been established.
 For new medicines report all the suspected
reactions, including minor ones. (medicines are
considered “new” up to five years after marketing
authorization)
 For established medicines or well-known
medicines report all serious or unusual suspected
adverse reactions, (see definition of a serious
reaction, expectedness of reactions.

33.  Report if an increased frequency of a given reaction is
suspected.
 Report all suspected ADRs associated with drug-drug, drug
food or drug-food supplements (including herbal and
complementary products) interactions.
 Report when suspected ADRs are associated with medicine
withdrawals.
 Report ADRs occurring from overdose or medication error.
Report ADRs in special fields of interest such as medicine
abuse and medicine use in pregnancy (teratogenicity) and
during lactation.
 In children under the age of 18, all suspected ADRs
occurring, should be reported regardless of whether the
medicine is licensed for use in children. Children are often not
exposed to medicines during clinical trials and many medicines
are used in children even if they are not licensed for this
purpose. This means that monitoring of medicine safety is
particularly important for this age group. As soon as possible

34. THANK YOU