SlideShare verwendet Cookies, um die Funktionalität und Leistungsfähigkeit der Webseite zu verbessern und Ihnen relevante Werbung bereitzustellen. Wenn Sie diese Webseite weiter besuchen, erklären Sie sich mit der Verwendung von Cookies auf dieser Seite einverstanden. Lesen Sie bitte unsere Nutzervereinbarung und die Datenschutzrichtlinie.
SlideShare verwendet Cookies, um die Funktionalität und Leistungsfähigkeit der Webseite zu verbessern und Ihnen relevante Werbung bereitzustellen. Wenn Sie diese Webseite weiter besuchen, erklären Sie sich mit der Verwendung von Cookies auf dieser Seite einverstanden. Lesen Sie bitte unsere unsere Datenschutzrichtlinie und die Nutzervereinbarung.
What is Pharmacovigilance?
• Pharmakon (Greek) = Medicinal Substances
• Vigilia (Latin) = To keep watch
• Pharmacovigilance, also known as drug safety
is the pharmacological science relating to the
collection, detection, assessment, monitoring,
and prevention of adverse effects with
1960 marketed in 46 countries (hypnotic, prevention of
nausea in pregnancy)
Thousands of congenitally deformed infants were born
as the results of exposures in utero to an unsafe
medicine promoted for use by pregnant mothers.
WHO Pilot Research Project for International Drug
Monitoring held in 1968.
WHO & UMC
• Uppsala monitoring Centre (UMC) is a field
name of the WHO collaborating centre for
international Drug Monitoring.
• It is responsible for management of the WHO
program for International drug Monitoring.
• Nationally adverse effect is analysed and
reports are submitted to WHO through
‘Vigimed’ an e-mail information exchange
• Side effect : any unintended effect of pharmaceutical
product occurring at doses normally used in humans that
is related to the pharmacological properties of the drug.
• Adverse event: any untoward medicinal occurrence
that may present during treatment with a
pharmaceutical product but that dose not necessarily
have a causal relationship with the treatment.
• Adverse reactions : a response to a drug that is
noxious and unintended, and that occurs at doses
normally used in humans for the prophylaxis, diagnosis
or therapy of disease, or for the modification of
For safety of those using herbal medicine, four
complementary actions are required
I. Clear identification of nature of adverse
II. Management of the risks
III. Institution of measures to prevent adverse
IV. Good communication of the risks and
benefits of herbal medicine
WHO Guidelines Objectives
• Support member states in the context of WHO International
Drug Monitoring Programme ,to strengthen national
pharmacovigilance capacity in order to carry out effective safety
of herbal medicine
• Provide technical guidance on principals of good
pharmacovigilance and the inclusion of herbal medicines in
existing national drug safety monitoring systems, and where
these systems are not in place, to facilitate the establishments of
inclusive national drug safety monitoring systems.
• Provide standard definitions of terms relating to
pharmacovigilance , and safety monitoring of herbal medicines.
• Promote and strengthen internationally coordinated information
exchange on pharmacovigilance, and safety monitoring of herbal
medicines among Member States.
• Promote the safe and proper use of herbal medicines.
Aims of Pharmacovigilance
Improve patient care and safety in relation to the use of
medicines and all medical and paramedical interventions.
Improve public health and safety in relation to use of medicines.
Promote understandings, education and clinical training in
pharmacovigilance and its effective communication to public.
WHO AND AYUSH
GUIDELINES FOR SAFETY
MONITORING OF HERBAL
1. Challenges in monitoring the safety of herbal
Regulation, quality assurance and control
2. Safety monitoring of herbal medicines
Sources of reports
Challenges in monitoring the
safety of herbal medicines
• Regulation :-National regulation and
registration of herbal medicines vary from
country to country.
Prescription Non prescription
Quality assurance and control :-
Quality assurance and control measures, such as
national quality specification
standards for herbal materials,
good manufacturing practices (GMP) for herbal
labeling, and licensing schemes for manufacturing,
imports and marketing, should be in place in every
• Weak regulation and quality control may
result in a high incidence of adverse reactions
attributable to poor quality of herbal
medicines, in particular resulting from
adulteration with undeclared potent
substances and/or contamination with
potentially hazardous substances and
• Providers of herbal medicines :-
A variety of health-care professionals serve as
qualified providers of herbal
medicines, according to each country’s national
health-care delivery system and legislative
In those countries where herbal
medicines are classified as:-
o Prescription medicines
• prescribers and dispensers other than
• dentists and pharmacists are sometimes
• current reporting systems.
• Prescription medicines
• In many countries, prescriptions are not required
• herbal medicines since these are categorized as
• medicines or products suitable for self-care.
• All providers of herbal medicines should play a role in
monitoring the safety of non-prescription herbal
• Nurses are becoming increasingly involved in this
area and are making a valuable contribution to safety
Lack of proper knowledge of herbal
• Providers of medicines, such as physicians, nurses
and pharmacists, may have little training in and
understanding of how herbal medicines affect the
health of their patients, who are often also taking
other medicines, prescription or non-prescription.
• Health professionals who work in poisons centers
and health information services also need to be
informed about herbal medicines.
Patient/consumer attitudes to herbal
• a misconception that “natural” means “safe”.
• Patients who use herbal medicines and other
medicines together, as is often the case, will often
not mention the use of herbal medicines to their
• Likewise, patients commonly fail to mention the use
of other medicines to their providers of herbal
Safety monitoring of herbal
Source of Reports:-
• The most common sources of information on
adverse events and reactions to medicines are
clinical trials and spontaneous reports
• In many countries, providers of herbal medicines
other than physicians, dentists,
pharmacist, nurses are excluded from reporting
Reports from health-care professionals.
Reports from consumers.
Reports from other sources.
HERBAL PRODUCTS TARGETED FOR
Herbal products in the following categories:-
According to their regulatory status
I. Herbal medicines in the prescription
II. Herbal medicines in the non prescription
III. Other herbal product intended for use in
According to their registration/marketing status
I. herbal medicines undergoing the new drug development
process: in clinical trials prior to national drug regulatory
II. herbal medicines undergoing the new drug development
process: under post-marketing safety surveillance
III. herbal medicines undergoing re-evaluation under the
current protocol: in clinical trials
Its an unsolicited communication by health professionals
or consumers, pharmaceutical company to NCC or other
organisation (CDSCO, AMCs) that describes one or more
suspected ADRs in a patient given a medicinal product
that doesn’t drive from study or any organised data
collection scheme. Presently PvPI is following
spontaneous reporting system to collect data on drug
Adverse drug reactions can be
monitored through two ways:-
a)Active surveillance system
b)Passive surveillance system
PASSIVE SURVEILLANCE:- Health professionals
are encouraged to report adverse reactions
which they believe are related to drug directly
-Regulatory authority directly
-The company marketing the suspected product
• ACTIVE SURVEILLANCE:-
Requires a continuous pre-organised process.
Ex: as in CEM (Coherent event monitoring),
systems for intensified follow up of selected
PSUR- Periodic safety update report.
PVPI is under control of:-
Directorate general of health services.
Indian Pharmacopoeia Commission (GZB).
National Coordination Centre (NCC).
Separate forms are available to record
adverse drug reactions associated with:-
a)transfusion of blood
b)blood and blood related products
c)Adverse event following immunization(AEFI)
ADR form consist of:-
a)Patients information:- Patients initials, age, sex,
b)Suspected adverse drug reactions:-
Date of reaction started, date of recovery, reaction
Dechallenge details, rechallenge details,
concomitant drugs, relevancy tests, seriousness of
the reaction, outcomes.
In case complete information is not available then fill
all the Essentially Required Items(ERI) for a quality ICSR.
In case ERI not available make sure that form contain all
the mandatory fields.
age at onset of reaction
date of onset of reaction
ESSENTIALLY REQUIRED ITEMS:-
Patient initials, gender, date of onset of reaction, suspected
medication, dose, date of therapy started, indication of use,
seriousness, outcomes, rechallenge and dechallenge details,
reporter’s information and date of report.
WHO CAN REPORT?
Healthcare professionals and non healthcare professionals like
consumers can report suspected adverse drug reaction.
Pharmaceutical companies can also send ICSRs specific for their
product to NCC.
WHY TO REPORT ?
It is a moral responsibility as a
healthcare professional to work
in the interest of public health.
The safety of more than 1.2billion
is a concern and must be taken
seriously. Use of multi-modal
practices, poor patient
compliancesare the other factors
requires ADR reporting.
• Spontaneous report
• Establishment of AMC(Adverse Drug Monitoring
• Data Flow
• Assessment of Individual Case Safety Reports
• Utilization of Data
• Reporting Requirements in Special Population
• (a) Pregnancy
• (b) Breastfeeding
• Pediatric and Geriatrics
• Reporting in the event of a Public Health Emergency
A spontaneous Report is an unsolicited by
healthcare professionals or consumers ,
pharmaceutical company to National
Coordination Center or other organization(
Control Drug Standard Central Organization
,Adverse Drug Monitoring Center )that describe
one or more suspected ADR in a patient given a
medicinal product that does not drive form
study or any organized data collection scheme .
Establishment of an AMC ( Adverse
Drug Monitoring Center )
• A letter of Intent is required to b submitted by
the Heads of the Institutions to participate in
this nationwide programmed to monitor drug
safety . After examining the suitability , the
concerned center may be inducted as AMC
under PvPI(Pharmacovigilance Program in
• Once the medical institute is enrolled as an
AMC , the AMC starts reporting ADRs to
NCC.(National Coordination Centre )
• ICSRs uploaded in VigiFlow
ICSRs uploaded in VigiFlow at
NCC for Quality
Assessment of individual case safety
• The quality of the ICSR will be assessed for
completeness of information and it will be
reviewed for :
1. Quality of documentation
4. Identification duplicate reports
5. Causality assessment
Utilization of the Data
• Data collected in pharmacovigilance can b
used in variety of ways :
1. Signal generation and strengthening
2. Risk management
3. Drug regulation
Reporting Requirement in special
1. Pregnancy : The clinical trial program of a medicinal
product under development rarely includes pregnant
women, unless the product is intended specifically for
use during pregnancy. All pregnant women coming for
routine pre –natal check-ups must be monitored by a
healthcare professionals for medication use .
2. Breastfeeding: All lactating mother exposed to
medicinal product should be monitored to collect
information on outcome of lactation on neonates and
Pediatric and Geriatrics
• The collection of safety information in the pediatric and geriatric
population is important as ADRs can lead to significant morbidity
and death among these populations .
• Immunization is one of the most common and widely used public
health interventions in pediatric population.
• On other hand geriatric population is at higher risk of developing
ADRs due to factors like polypharmacy and co-morbidities.
• The pediatric and geriatric population are more vulnerable to some
• Therefore, data collection from these program will provide a
national database for drug safety information in these vulnerable
• To ensure safe and effective medicines for children and elderly
,efforts are needed at different levels (CDSCO, pharmaceutical
industries , health care professionals , and parents ).
Reporting in the Event of a public
• A public health emergency is a public health
threat duly recognized either by the WHO or
Ministry of Health and Family Welfare
Government of India . In the event of a public
health emergency , regular reporting
requirements may be amended .
What is a Drug interaction?
• A Drug interaction may be defined as a situation
when a substance/condition(usually another
drug, food, or any disease) alters the effect of the
major drug that is taken.
• The effects observed include:
Increase in the activity of
Decrease in the activity of drug(Antagonism)
Production of a new effect altogether which
cannot be produced by its own (i.e. when taken
• Various types of drug interactions include:
BIO DRUG-FOOD INTERACTION
BIO DRUG-DISEASE INTERACTION
What is the cause?
Accidental misuse or due to
lack of knowledge
Diet and lifestyle
• The concurrent use of drugs/herbs may mimic/magnify or oppose the
effect of drug.
• Possible cases of herb-drug interactions include "bleeding when
Warfarin is administered along with Gingkobiloba or Garlic".
• Majority of the general population consume herbal drugs because:
• They are considered safe for use
• They are readily available
• BUT some tests are the evidences that EVEN HERBAL DRUGS ARE NOT
COMPLETELY SAFE such as:
• Preclinical studies(using animal models)
• Single case reports
• Multiple case reports, etc.
• This implies that like modern medicines the herbal drugs also requires
vigilance for monitoring the interactions and adverse drug reactions.
• Herbs are often
raising the potential of
• Some common Herb-
ALFA-ALFA (Medicago sativa)
1. Warfarin (Anticoagulant) Effectiveness of
Warfarin(contains large amount
of Vitamin K)
2. Contraceptives (Birth control
Effectiveness of birth control
3. Prednisolone, Corticosteroids,
4. Photosensitizing agents Increases sensitivity to light
ALOE (Aloe Vera)
DRUG ALOE GEL
1. Digoxin (Cardio tonic) Increases the toxicity of digoxin
2. Anti-diabetic drugs Hypoglycemia
1. Hepatotoxic drugs Increases toxicity
2. Antidiabetic drugs Decreases blood sugar level
GARLIC (Allium sativum)
1. Isoniazid Reduces absorption of isoniazid
2. Antiviral Drugs Increases metabolism of antiviral
3. Oral Contraceptives Increases breakdown of
estrogen, dereases effect of oral
GREEN TEA (Camellia sinensis)
DRUG GREEN TEA
1. Stimulant drugs (Cocaine,
Increases heart rate
Increases blood pressure
2. Oral Contraceptives Increases side effects of oral
3. Hepatotoxic Drugs Increases risk of liver damage
4. Anticoagulants Synergistic effect (slows down
ST. JOHN'S WORT
DRUG ST. JOHN'S WORT
2. Digoxin (Cardiotonic) Induction of intestinal efflux
3. Saquinavir, Indonavir
Induction of Cyt P3A4
4. Oral Contraceptives Induction of Cyt P3A4
ARTIMISRIN (Arimisia annua)
Omeprazole Decreases bioavailability
CONCLUSION• Not all herbs and supplements are safe.
• Like conventional medicines, dietary
supplements may cause side effects, trigger
allergic reactions or interact with
prescription and non- prescription
medicines or other supplements.
• Using supplements with medications could
lead to harmful or even life threatening
• One should consult a doctor or a pharmacist
to know about the safety of a supplement
• Other than vitamins and minerals, the long
term effects of most dietary supplements
are not known.
• DRUG INTERACTION: A drug interaction is a situation in which a substance
affects the activity of a drug, i.e. the effects are increased or decreased, or
they produce a new effect that neither produces on its own.
• DRUG-NUTRIENT INTERACTION: A drug-nutrient interaction occurs when a
drug affects the use of a nutrient in the body.
• DRUG-FOOD INTERACTION: A food-drug interaction occurs when a food,
or one of its components, interferes with the way a
drug is used in the body.
• BIOAVAILABILITY: It is defined as the degree to which a drug reaches the
circulation and becomes available to the target organ or tissue.
• ADVERSE EFFECT: Any unwanted or undesirable effect of a drug.
• Medicines can treat and cure many health Problems. However they
must be taken properly to ensure that they are safe and effective.
• Many medicines have powerful ingredients that interact with the
human body in different ways. Diet and lifestyle can sometimes
have significant impact on drugs.
• A drug interaction is a situation in which a substance affects the
activity of a drug, i.e. the effects are increased or decreased, or
they produce a new effect that neither produces on its own.
• Drug interactions can alter the pharmacokinetics or
pharmacodynamics of a drug.
• These interactions may occur out of accidental misuse or due to
lack of knowledge.
n• Majority of food-drug interactions are caused by food induced
changes in the bioavailability of drug.
• Food can alter the pharmacokinetics of drugs i.e.
• Therapeutically important critical interactions are those that:
1. Alter the therapeutic response to the medication.
2. Cause severe drug toxicity.
3. Alter nutritional status.
food/nutrition effects on drugs:
• Grape fruit juice inhibits metabolism of many
drugs: it inactivates metabolizing intestinal
enzymes resulting in enhanced activity and
• Its effect persists for 72 hours making it
problematic to separate the drug and
Food/nutrient effects on drug: maois
• Monoamine oxidase inhibitor(MAOI) interacts
with food( tyramine, dopamine, histamine)
• These are deaminated rapidly by MAO;
MAOIs prevent breakdown of tyramine and
• Significant intake of high tyramine foods like
cheese, cured meats etc on MAOIs can
precipitate hypertensive crisis.
Food/nutrient effects on drug: caffeine
• Increases adverse effects of stimulant such as
theophylline, amphetamine causing nervousness,
tremors and insomnia.
FOOD/NUTRIENT EFFECTS ON DRUG: WARFARIN
• Warfarin (anticoagulant) when taken with
vegetables containing vitamin k interferes with
the effectiveness and safety of warfarin therapy,
with cooked onions increase warfarin activity.
food/nutrient effects on drug: alcohol
• In combination with some drugs produce
• With NSAIDS it can increase risk of liver
damage or stomach bleeding.
Drug side effects that affect food status
• Appetite changes
1. Decrease appetite cardiovascular drugs
2. Increase appetite anti convulsants
o Oral taste and smell captoprill (anti hypertensive) ,
o Dry mouth amytriptyline( anti depressants)
o Glucose level
1. Decrease glucose level metformin,glimepiride( anti
2. Increase glucose level furosemide
o G.I. effect aspirin, NSAIDS
• Pharmacognosy- G.E. Trease and W.C.
Evans. Saunders Edinburgh, New York
• Pharmacognosy & Phytochemistry by Biren
• WHO guidelines on safety monitoring of herbal
medicines in pharmacovigilance systems