pharmacovigilance from pharmaceutical administration topic presented by konatham kumar reddy from chilkur balaaji college of pharmacy hyderabad telangana

1. PHARMACOVIGILIANCE
CHIKUR BALAJI COLLEGE OF PHARMACY

2. 
.
DEFINATION:
The science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other drug-
related problem.
PHARMACOVIGILANCE IN INDIA
Tests in animals are insufficiently predictive of human safety
Patients in clinical trials are selected and limited in number, the
conditions of use differ from those in clinical practice and the
duration of trials is limited.
Information about rare but serious adverse reactions, chronic
toxicity, and use in special groups (such as children, the elderly
or pregnant women) or drug interactions is often incomplete or
not available

3. ORIGINS OF PHARMACOVIGILANCE
• The history of pharmacovigilance goes back more than 40 years. In
1965 the eighteenth World Health Assembly. In 1966, 1967 and 1970
the International Drug Monitoring Programme came into being.
• In 2005, 78 member countries are participating in this Programme
and the last decade has seen the participation of numerous developing
countries.
•The programme functions on the basis of national pharmacovigilance
centres coordinated by the WHO Programme for International Drug
Monitoring, which consists of the WHO Collaborating Centre for
International Drug Monitoring, Uppsala and the Pharmacovigilance
Department of WHO, Geneva. Recently, the concerns of
pharmacovigilance have been widened to include herbal, traditional
and complementary medicines, blood products, biologicals, medical
devices and vaccines

4. Many other issues are also of relevance to the science of
pharmacovigilance.
• These include substandard medicines, medication errors, lack of efficacy,
use of medicines for indications that are not approved and for which there is
inadequate scientific basis, case reports of acute and chronic poisoning,
assessment of medicine-related mortality, abuse and misuse of medicines,
and adverse interactions medicines with chemicals, other medicines and
foods and drinks.
• CURRENT PRACTICE IN STATE AND CENTRAL
The success or failure of any pharmacovigilance activity depends on the
reporting of suspected adverse reactions
Spontaneous reporting The definition of spontaneous reporting is as
follows: “A system whereby case reports of adverse drug events are
voluntarily submitted by health professionals and pharmaceutical
companies to the national pharmacovigilance centre.

5. •The success or failure of any pharmacovigilance activity depends on
the reporting of suspected adverse reactions.
•To date, the mainstay of pharmacovigilance has been spontaneous
reporting by health professionals. To detect the full spectrum of
complications from pharmaceutical treatment and to gain a
representative picture, all sectors of the health-care system need to be
involved.
•This includes public and private hospitals, general practice,
pharmacies, nursing homes, retail dispensaries and providers of
traditional medicine.
• Wherever medicines are being used, there should be a readiness to
observe and report unwanted and unexpected medical events. Reports
made by a health professional are an interpretation of information
originally provided by a patient who has experienced the actual benefit
or harm of a medicine taken .

6. • It may also be the result of a direct observation of the effect of a
medicine. Patients who suspect they have been affected by a reaction to
a medicine are normally encouraged to inform their health professionals
to enable them to report to the pharmacovigilance centre.
• In a few countries the national reporting system provides some
opportunity for patient reporting. This is of particular value where there are
disease specific control programmes in operation
Other methods of collecting safety data
There are various other pharmacoepidemiological methods of collecting
safety information.
A number of countries have implemented active surveillance systems to
complement spontaneous reporting. Examples of such systems are:
— prescription event monitoring (PEM) in New Zealand and the United
Kingdom;
— record linkage; and
— case-control studies.

7. 
1. Early detection of hither to unknown adverse reactions and
interactions
2. Detection of increases in frequency of (known) adverse
reactions
3. Identification of risk factors and possible mechanisms
underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk analysis
and dissemination of information needed to improve drug
prescribing and regulation.
AIMS OF PHARMACOVIGILANCE

8. National pharmacovigilance centres:
National pharmacovigilance centres are responsible for:
— promoting the reporting of adverse reactions;
— collecting case reports of adverse reactions;
— clinically evaluating case reports;
— collating, analysing and evaluating patterns of adverse reactions;
— distinguishing signals of adverse reactions from “noise”;
— recommending or taking regulatory action in response to findings
supported by good evidence;
— initiating studies to investigate significant suspect reactions;
— alerting prescribers, manufacturers and the public to new risks of
adverse reactions; and
— sharing their reports with the WHO Programme for International
Drug Monitoring.

9. 
 Pharmacovigilance is the pharmacological science relating to the
detection, assessment, understanding and prevention of adverse effects,
particularly long term and short term side effects of medicines.
 Pharmacovigilance is the science of collecting, monitoring,
researching, assessing and evaluating information from healthcare
providers and patients on the adverse effects of medications,
biologicals, herbalism and traditional medicines with a view to:
 Identifying new information about hazards associated with medicines
 Preventing harm to the patients.
The Pharmacovigilance effort in the India is coordinated by The Indian
Pharmacopoeia Commission and conducted by the Central Drugs
Standard Control Organization (CDSCO).
CONCEPTS AND DEFINITIONS
PHARMACOVIGILANCE

10. 
 An ADR is a response to a drug which is noxious and unintended
and which occurs at doses normally used in man for prophylaxis,
diagnosis, or therapy of disease or for modification of
physiological function.
 The old term "side effect" has been used in various ways in the
past, usually to describe negative (unfavourable) effects, but also
positive (favourable) effects.
 It is recommended that this term no longer be used and
particularly should not be regarded as synonymous with adverse
event or adverse reaction.
CLASSIFICATION
Type A effects: Augmented pharmacologic effects - dose dependent
and predictable are those which are due to pharmacological effects
ADVERSE DRUG REACTION (ADR)

11. 
Chronic effects refer to situations where the use of a
medicine, often for unknown reasons, increases the
frequency of a "spontaneous" disease.
 Type C effects may be both serious and common (and
include malignant tumours)
Type C effects may be coincidental and often concern
long term effects; there is often no suggestive time
relationship and the connection may be very difficult to
prove.
Type C effects

12. 
 Type B effects :Bizarre effects (or idiosyncratic) - dose independent
and unpredictable (Patient reactions) characteristically occur in only
a minority of patients and display little or no dose relationship.
 They are generally rare and unpredictable, and may be serious and
are notoriously difficult to study.
 Type B effects are either immunological or nonimmunological and
occur only in patients, with - often unknown - predisposing
conditions.
Type A effects tend to be fairly common, dose related (i.e. more frequent
or severe with higher doses) and may often be avoided by using doses
which are appropriate to the individual patient. Such effects can usually be
reproduced and studied experimentally and are often already identified
before marketing.

13. 
Delayed effects (dose independent)
 Carcinogenicity (e.g., immunosuppressants)
 Teratogenicity (e.g., fetal hydantoin syndrome)
Type E effects
End-of-treatment effects
Type F effects
Failure of therapy
Type D effects

14. INDIVIDUAL REPORTING:
 Doctors are the major source of reports.
 Those whose practice is primarily outside hospitals tend to care for
patients for prolonged periods of time and may therefore also see
the occurrence of slowly developing or delayed reactions.
 Since most severe reactions are seen in hospitals, physicians who
are hospital-based are often able to ascertain previous drug
administration, link it to the reaction, and submit a report.
 The physician, during an outpatient or inpatient examination, may
decide that the patient has a recognizable syndrome of signs,
symptoms, and/or laboratory findings and that this syndrome may
be associated with a previously administered drug.
SOURCES OF REPORT

15. 
 COMPREHENSIVE MONITORING:
 Comprehensive monitoring is typically performed in a hospital setting
and the input consists of abstracts of patient identification, drug
administration, and patient reactions.
 Specialized methods are used to ensure that this information is
complete, and case reports or tabulated summary data can be supplied to
the national centre.
POPULATION MONITORING :
 In population monitoring the records of hospital or clinic patients, or
of the entire population of a district, may be employed.
 Such monitoring could be effective when a large stable population is
surveyed in an organized medical care system.·
 As rapid advances are being made in the electronic processing of
patient documentation and records, there may be unusual opportunities to
incorporate a drug monitoring element in these systems.
He / She then report this information to the centre.

16. 
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.
It is complex and expensive, however, and the patient population may not
be large enough for the detection of rare (1 in 10 000-50 000) reactions.
This system would automatically record drug use and patient syndromes or
events, permitting searches for associations between the two. The results of
such searches may be reported to the national centre.

17. 
 Spontaneous reporting is a system whereby case reports of adverse
drug events are voluntarily submitted by health professionals,
pharmaceutical companies or consumers to the national
pharmacovigilance centre
 It is basically the reporting of a suspected adverse reaction on the
initiative of the health professional who becomes aware of the
problem, or on the patient’s initiative. These reports can be
communicated by any means, but in countries with a well-
developed pharmacovigilance system they are most often reported
on the country-specific reporting card.
 The key feature is that reports are initiated by the health
professional (or patient) and not solicited systematically. The type
of reporting described in this document so far should be considered
spontaneous. However, in PHPs, reporting should be more focused
and intensive.
 Such reporting is sometimes referred to as intensified spontaneous
reporting, or ideally, prospective
SPONTANEOUS REPORTING

18. 
 As well as producing data on rates, cohort event monitoring is
particularly effective at identifying previously unrecognized and
unsuspected adverse reactions and defining the associated risk factors.
 A cohort is built up of all patients receiving the medicine together with
demographic data. This requires a record of patients to whom the
medicine is administered.
 The means of recording this information will be best established when
planning the PHP and may vary depending on the country the
programme and the medicine being monitored.
 Normally a cohort of 10 ,000 patients is sufficient to provide adequate
statistical power, but larger numbers may be needed to enable adequate
study of particular subgroups of interest. This method has been
described as “prescription event monitoring” (PEM) .The term “PEM”
is inappropriate for use in most PHPs and this method is better referred
to as “cohort event monitoring”.
COHORT EVENT MONITORING

19. 
 It was reported that worldwide, more than 50% of all medicines
are prescribed, dispensed, or sold inappropriately, while 50% of
patients fail to take them correctly. Moreover, about one-third of
the world’s population lacks access to essential medicines.
 Overuse of drugs and injections: occurs as a consequence of
overprescribing as well as overconsumption. It concerns
particularly the use and prescription of antibiotics, anti-
diarrhoeals, painkillers, injections and cough and cold
preparations. Injections have long had a special connotation as
particularly powerful and fast acting medicines.
IRRATIONAL DRUG
COMBINATIONS

20. 
 The number of drugs per prescription is often more than needed, with
an average of 2.4 up to ten drugs, while generally one or two drugs
would have sufficed.
 Multi-drug use is also common among consumers who purchase their
drugs (over the counter drugs).
Incorrect drug use:
 Involves the wrong drug for a specific condition (e.g. antibiotics or
antidiarrhoeals for childhood diarrhoea), drugs of doubtful efficacy
(e.g. antimotility agents for diarrhoea), or use of drugs in the wrong
dosage (which is often the case with antibiotics, ORS and
antimalarials).
 Incorrect drug use occurs in the sense of incorrect prescribing as well
as inappropriate use by consumer
Multi-drug use or polypharmacy:

21.  Lack of information: Unlike many developed countries we don’t
have regular facilities, which provide us with up to date,
unbiased information on the currently used drugs. The majority
of our practitioners rely on medical representatives. There are
differences between pharmaceutical concern & the drug
regulatory authorities in the interpretation of the data related to in
 . Faulty & inadequate training & education of medical
graduates: Lack of proper clinical training regarding writing a
prescription during training period, dependency on diagnostic
aid, rather than clinical diagnosis, is increasing day by day in
doctors.dications & safety of drugs.
REASON FOR IRRATIONAL USE
OF DRUGS

22.  Medical practitioners & other health professional giving less time
to the patient & not explaining some basic information about the
use of drugs
 Lack of diagnostic facilities/Uncertainty of diagnosis: Correct
diagnosis is an important step toward rational drug therapy.
Doctors posted in remote areas have to face a lot of difficulty in
reaching to a precise diagnosis due to non availability of
diagnostic facilities. This promotes poly-pharmacy.
Demand from the patient: To satisfy the patient
expectations and demand of quick relief, clinicians prescribe
drugs for every single complaint. Also, there is a belief that
“every ill has a pill” All these increase the tendency of
polypharmacy.
Poor communication between health
professional & patient:

23. 
 Some of the public health and economic consequences of irrational
use of drugs are:
 Adverse, possibly lethal effects, e.g. due to antibiotic misuse or
inappropriate use of drugs in self-medication.
 Limited efficacy, e.g. in the case of under-therapeutic dosage of
antibiotics, tuberculosis or leprosy drugs.
 Antibiotic resistance, due to widespread overuse of antibiotics, as
well as their use in under-therapeutic dosage.
 Drug dependence, e.g. due to daily use of painkillers and
tranquilizers.
 Risk of infection (due to improper use of injections): injection-
related disorders are abscesses, polio, hepatitis and AIDS.
 Waste of resources: Reduced availability of other vital drugs and
increased cost.
 Irrational drug use and its consequence- the antimicrobial misuse
problem:
IMPACT OF IRRATIONAL USE OF
DRUGS

24. The WHO says that antimicrobial resistance is one of the world’s most
serious public health problems being faced. A major reason, of the
irrational use of medicines according to WHO, worldwide, more than
50% of all medicines are prescribed, dispensed or sold inappropriately
and 50% of patients fail to take them correctly. The consequence of this
is seen directly with the misuse of antibiotics
1. Enalapril + Losartan =
Some irrational fixed dose drug combinations available in the
Indian market
Combining two drugs affecting the same pathway is
irrational; it doesn’t add to
2. Domperidone +
Rabeprazole;
Domperidone=
Esomeprazole
Increased incidence of rhabdomyolysis.
3.Simvastatin + Nicotinic
acid; Atorvastatin +
Nicotinic acid
probability of myopathy is increased

25. THANK YOU