The document discusses the importance of pharmacovigilance in health care. It defines pharmacovigilance as the science related to detecting, assessing, understanding, and preventing adverse effects of drugs. The main goals of pharmacovigilance are to improve patient safety, assess the risk-benefit profiles of medicines, and encourage their safe and effective use. Pharmacists can play important roles in pharmacovigilance by monitoring for and reporting adverse drug reactions. Pharmacovigilance programs in health systems should include ongoing surveillance, reporting, analysis, and education to prevent adverse drug events.

1. Introduction and Importance In Health Care
Presented by:
Anam Ahsan
Roll no.07

2.  This Program for International Drug Monitoring was established by WHO as a
result of the thalidomide disaster detected in 1961.
 WHO define Pharmacovigilance as:
Pharmacovigilance (PV) is the science and activities relating to the detection,
assessment, understanding and prevention of adverse effects or any other drug-
related problem.
 Pharmacovigilance is concerned with only two outcomes: safety and efficacy. Does
a drug work and is it safe? It touches on almost every aspect of the drug lifecycle -
from preclinical development to post-market surveillance. Pharmacovigilance –
also known as drug safety.

3.  The main purpose of pharmacovigilance is to improve the patient's safety and
enhance his care in terms of the use of medicines, including paramedical
interventions.
 Pharmacovigilance also supports public health programs by providing reliable
information for the efficient assessment of the risk-benefit profile of medicines.
 Contribute to the assessment of benefits, uses, side effects, harm, effectiveness and
risk of medicines.
 Encouraging the safe, rational and more effective (including cost-effective) use of
various medicines.
 Promote education, understanding and clinical training in pharmacovigilance and
its effective availability to the public.

4.  Collecting and managing data on the safety of medicines
 Looking at the data to detect "signals" (any new or changing safety issue)
 Evaluating the data and making decisions with regard to safety issues
 Pro-active risk management to minimize any potential associated risks
 Acting to protect public health (including regulatory action)
 Communicating with and informing stakeholders and the public
 Audit of the outcomes and key processes involved

5. Pharmacovigilance covers the following:
 Drug monitoring
 Pharmaceutical preparations - adverse effects
 Adverse drug reaction reporting
 Product surveillance
 Post-marketing Legislation

6. Besides the above, many other issues are also relevant to
pharmacovigilance such as follows:
 Medication errors
 Substandard medicines
 Lack of efficacy reports
 Use of medicines that are not approved for
 Case reports of acute and chronic poisoning
 Study of drug-related deaths
 Abuse and misuse of medicines
 Adverse affects of medicines with chemicals, other medicines, and food.

7.  There has already been a significant shift in pharmacovigilance due
to some changes in legislation. The new legislation has put a much
greater emphasis on patient safety meaning that pharmacovigilance
has far more of a central role to play.
 An example of this would be the new legislation around the
exchange of safety information between pharma companies and
third parties (such as CROs). It requires that the level of detail
within this communication must increase, and this will no doubt
have not only a large effect on drug safety teams/ divisions but on
the life sciences industry as a whole.

8.  Pharmacists contribute to the drug safety by preventing, identifying,
documenting, and reporting of ADRs
 The role of pharmacist in the department of pharmacovigilance varies with
different countries but, professionally their responsibility remains the
same irrespective of the jurisdiction
 Pharmacist has the potential of reporting ADRs on their own, though
his/her clinical experience may vary with respect to that of a physician
 The process of Pharmacovigilance program can be a success when effective
risk information is communicated back to the health-care workers.
The major step in progressing the prevention of ADRs is to acquaint the
risk-benefit profile of drugs to all the clinical practitioners.

9.  Pharmacists can be deployed to assist in monitoring the safe and effective
use of available medicine, which certainly includes the management of
ADRs.
 Pharmacist act as an open-arm to clinical expertise in sharing of resources
including databases.
 Pharmacist plays an essential role in developing communication materials
like newsletters and other publications through the drug information and
poison centers, which are utilized by different professions and
professionals for disseminating drug alerts and other drug safety
information.
 Pharmacists can assure a positive environment to the patients in
minimizing the medication errors, improve patient safety and quality of
life during the counselling session .

10.  Pharmacist should have a firm knowledge in monitoring and
providing counselling about the use of over-the-counter medications
 Educational training programs and workshops can clarify and
enhance the knowledge of ADR reporting and how causality
assessment of ADR is done. This will enable the pharmacists to play
a prominent role in reporting ADRs and patient safety in the future.

11.  WHO’s definition of an adverse drug reaction, which has been in use
for about 30 years, is
“A response to a drug that is noxious and unintended and occurs at
doses normally used in man for the prophylaxis, diagnosis or therapy
of disease, or for modification of physiological function”.
Or
“An appreciably harmful or unpleasant reaction, resulting from an
intervention related to the use of a medicinal product, which predicts
hazard from future administration and warrants prevention or
specific treatment, or alteration of the dosage regimen, or withdrawal
of the product.”

12. Adverse drug reactions (adverse effects) are any unwanted effects of a
drug. There are several different types:
 Dose-related
 Allergic
 Idiosyncratic

13.  Dose-related adverse drug reactions represent an exaggeration of
the drug's therapeutic effects.
 For example, a person taking a drug to reduce high blood pressure
may feel dizzy or light-headed if the drug reduces blood pressure too
much. A person with diabetes may develop weakness, sweating,
nausea, and palpitations if insulin or an oral antidiabetic drug
reduces the blood sugar level too much. This type of adverse drug
reaction is usually predictable but sometimes unavoidable.
Dose-related reactions are usually not serious but are relatively
common.

14.  Allergic drug reactions are not dose-related but require prior exposure
to a drug. Allergic reactions develop when the body's immune system
develops an inappropriate reaction to a drug (sometimes referred to as
sensitization).
Idiosyncratic adverse drug reactions
 Idiosyncratic adverse drug reactions result from mechanisms that are
not currently understood. This type of adverse drug reaction is largely
unpredictable. Examples of such adverse drug reactions include
rashes, jaundice, anemia, a decrease in the white blood cell count,
kidney damage, and nerve injury that may impair vision or hearing.

15.  Type A Reactions Type A (augmented) reactions result from an
exaggeration of a drug’s normal pharmacological actions when given
at the usual therapeutic dose and are normally dose-dependent.
Examples include respiratory depression with opioids or bleeding
with warfarin.
 Type B Reactions Type B (bizarre) reactions are novel responses that
are not expected from the known pharmacological actions of the
drug. These are less common, and so may only be discovered for the
first time after a drug

16.  Type C Reactions Type C, or ‘continuing’ reactions, persist for a
relatively long time. An example is osteonecrosis of the jaw with
bisphosphonates.
 Type D Reactions Type D, or ‘delayed’ reactions, become apparent
some time after the use of a medicine. The timing of these may make
them more difficult to detect. An example is leucopoenia, which can
occur up to six weeks after a dose of lomustine.
 Type E Reactions Type E, or ‘end-of-use’ reactions, are associated
with the withdrawal of a medicine. An example is insomnia, anxiety
and perceptual disturbances following the withdrawal of
benzodiazepines.

17.  Pharmacists in organized health care systems should develop comprehensive,
ongoing programs for monitoring and reporting adverse drug reactions (ADRs).
 An ADR-monitoring and reporting program should include the following features:
1. The program should establish
A. An ongoing and concurrent (during drug therapy) surveillance system based
on the reporting of suspected ADRs by pharmacists, physicians, nurses, or
patients.
B. A prospective (before drug therapy) surveillance system for high-risk drugs
or patients with a high risk for ADRs
C. A concurrent surveillance system for monitoring alerting orders. Alerting
orders include the use of “tracer” drugs that are used to treat common ADRs
2. Prescribers, caregivers, and patients should be notified regarding suspected
ADRs.

18. 3. Information regarding suspected ADRs should be reported to the
pharmacy for complete data collection and analysis, including the
patient’s name, the patient’s medical and medication history, a
description of the suspected ADR
4.High-risk patients should be identified and monitored. High-risk
patients include but are not limited to pediatric patients, geriatric
patients, patients with organ failure.
5. Drugs likely to cause ADRs (“high-risk” drugs) should be identified,
and their use should be monitored. Examples of drugs that may be
considered as high risk include aminoglycosides, amphotericin,
antineoplastics, corticosteroids, digoxin, heparin, lidocaine.

19.  6. A method for ranking ADRs by severity should be established.
 7. A description of each suspected ADR and the outcomes from the event should be
documented in the patient’s medical record.
 8. Serious or unexpected ADRs should be reported to the Food and Drug
Administration (FDA) or the drug’s manufacturer (or both).
 9. All ADR reports should be reviewed and evaluated by a designated
multidisciplinary committee (e.g., a pharmacy and therapeutics committee).
 10. Continuous monitoring of patient outcomes and patterns of ADRs is imperative.
The process should include the following:
a. Feedback to all appropriate health care staff,
b. Continuous monitoring for trends, clusters, or significant individual ADRs,
c. Educational efforts for prevention of ADRs,
d. Evaluation of prescribing patterns, patient monitoring practices

22. HISTORY:
 The Joint Commission was renamed The Joint Commission
on Accreditation of Hospitals in 1951, but it was not until 1965,
when the federal government decided that a hospital meeting Joint
Commission accreditation met the Medicare Conditions of
Participation, that accreditation had any official impact.
 In 2007 the Joint Commission on Accreditation of Healthcare
Organizations underwent a major rebranding and simplified its
name to The Joint Commission. The rebranding included the name,
logo, and tag line change to "Helping Health Care Organizations
Help Patients."

23.  The Joint Commission, formerly known as the Joint Commission on
Accreditation of Healthcare Organizations, standards for hospital
accreditation are a set of measures used to help hospitals assess and
improve their performance.
 Joint Commission standards for hospital accreditation are located in
the Comprehensive Accreditation Manual for Hospitals. Each of the
standards has one or more EPs, or elements of performance.
 The Joint Commission standards that have the greatest impact on
hospital environment and performance include those related to life
safety, environment of care and emergency management.

24. Life safety measures a hospital’s ability to respond to fires
and other emergencies.
Environment of care measures areas such as security,
hazardous materials and waste, medical equipment,
utility systems and environmental safety
Emergency management measures a hospital’s ability to
plan for and respond to various types of emergencies

25. The purpose of the Joint Commission on Accreditation of
Healthcare Organizations standards for hospital
accreditation is to provide measurable performance goals
that help hospitals provide high-quality care for patients, as
the Joint Commission explains. Its stated mission is to
improve the quality and value of health care.
Standards are developed in collaboration with the Centers
for Medicare & Medicaid Services, other government
agencies, medical practitioners, health care providers, other
experts and consumers, advises the Joint Commission.

27. REFERENCES:
1. https://www.ema.europa.eu/en/humanregulatory/overview/pharmaco
vigilance-overview
2. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/p
harmvigi/en/
3. https://www.sciencedirect.com/topics/medicine-and dentistry/
pharmacovigilance
4. https://medical-dictionary.thefreedictionary.com/pharmacovigilance
5. https://ec.europa.eu/health/human-use/pharmacovigilance
6. http://www.pharmaceutical-drug manufacturers.com
/articles/pharmacovigilance-and-importance.html
7. https://www.proclinical.com/blogs/2017-8/what-is-
pharmacovigilance-and-why-is-it-important
8. https://www.slideshare.net/RamakrishnaK5/pvigilance
9. https://globalpharmatek.com/blog/importance-of-pharmacovigilance/
10.https://academic.oup.com/ajhp/article/74/8/606/5103382

28. REFERENCES:
11. https://www.ncbi.nlm.nih.gov/pubmed/1107260
12. https://www.pharmacologyeducation.org/clinical-pharmacology/adverse drug-
reactions
13. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/adverse-
drug-reaction-monitoring-reporting.ashx
14. https://www.tga.gov.au/reporting-adverse-events
15. https://catalog.data.gov/dataset/adverse-event-reporting-system-aers-c77d7
16. https://www.merckmanuals.com/home/drugs/adverse-drug-reactions/types-of-
adverse-drug-reactions
17. https://www.msdmanuals.com/home/drugs/adverse-drug-reactions/types-of-
adverse-drug-reactions
18.https://assets.publishing.service.gov.uk/government/uploads/system/uploads/att
achmentdata/file/752688/Guidance_on_adverse_drug_reactions.pdf
19. https://www.reference.com/business-finance/jcaho-standards-hospital-
accreditation-Jcaho+Hospital+Accreditation+Standards&qo=cdpArticles
20. https://www.reference.com/article/purpose-jcaho-standards-hospital-
accreditation-jcaho+Hospital+Accreditation+Standards&qo=cdpArticles

29. REFERECES:
21. http://www.faqs.org/tax-exempt/IL/Joint-Commission-On-Accreditation-Of-
Healthcare-Organizations.html
22. http://jama.jamanetwork.com/article.aspx?articleid=367766
23. Roles of Pharmacist in Pharmacovigilance: A Need of the Hour Rajanandh MG*,
Praveen Kumar V and Yuvasakthi S Department of Pharmacy Practice, Sri
Ramachandra University, Porur, Chennai-600 116, Tamil Nadu, India
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