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Pharmacovigilance: A worldwide master key for drug safety monitoring:

Pharmacovigilance : A worldwide master key for drug safety monitoring Prepared by: Khushboo.G.Parmar M. Pharm. CP sem -III Department of Clinical Pharmacy 1

Pharmacovigilance: A worldwide master key for drug safety monitoring:

Pharmacovigilance: A worldwide master key for drug safety monitoring No medicinal product is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty. 1. What is Pharmacovigilance ? WHO definition: Detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.  Pharmaco –Vigilance Pharmaco = medicine Vigilance = to watch This applies throughout the life cycle of a medicine equally to the pre- approval stage as to the post-approval. alert watchfulness wakefulness watchfulness in respect of danger; care; caution; circumspection The process of paying close and continuous attention. 2

Overall introduction: :

Overall introduction: Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. 3

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. Adverse drug reactions (ADRs) are an important consideration when assessing a patient's health. The goal for all health care providers must be to minimize the risk of ADRs as much as possible. Steps to achieve this include understanding the pharmacology for all drugs prescribed and proactively assessing and monitoring those patients at greatest risk for developing an ADR. Pharmacovigilance must effectively be practiced by all health providers in order to avoid ADRs. 4

2. Background: :

2. Background: 5

3. Pharmacovigilance in India:

3. Pharmacovigilance in India 6

Benefit & risk: evolving concepts :

Benefit & risk: evolving concepts Rapid induction of NCEs and High tech Pharma products in the market throw up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base so it is important to have Standardized pharmacovigilance  and drug safety monitoring  programme for the nation RISK BENEFIT One man's meat is another man's poison !!! 7

4. Why do we need pharmacovigilance? :

4. Why do we need pharmacovigilance ? Reason 1: Humanitarian concern – a) Insufficient evidence of safety from clinical trials b) Animal experiments Reason 2 Medicines are supposed to save lives a) Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Reason 3: ADRs are expensive!! Adverse drug reactions as cause of admission to hospital; prospective analysis of 18820 patients. a) 6.5% of admissions are due to ADRs. b) Seven, 800-bed hospitals are occupied by ADR patients. c) Cost of drug related morbidity and mortality exceeded $177.4 billion in 2000 d) ADR related cost to the country exceeds the cost of the medications themselves 8

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Reason 4: Promoting rational use of medicines. Reason 5: Ensuring public confidence Reason 6: Ethics -To know of something that is harmful to another person who does not know, and not telling, is unethical 9

5. P’covigilance method: :

5. P’covigilance method: 10

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6. National Scenario::

6. National Scenario: The Medical Colleges (both Government & Private) are the corner stone of the Pharmacovigilance Programme of India. They act as  peripheral Adverse Drug Reaction Monitoring & reporting  (ADR) Centres, responsible for collecting the ADR reports , performing the follow up with the complainant to check completeness of the ADR reports as per Standard Operating Procedures and to enter the Data in the prescribed software (Vigiflow) to report to National coordinating Centre at IP Commission . 12

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In India, National P’covigilance Program was officially established by the honorable health minister Dr. Anbumani Ramadoss on 23 rd November, 2004 at New Delhi. 26 peripheral centers 5 regional centers 2 zonal centers Peripheral centers will record adverse event and send it to regional centers. They in turn collect and analyze the data received from peripheral centers and submit to zonal centers. Zonal centers analyze data and submit the information to national PV center. Zonal center also provide training, general support & co-ordinate functioning of regional centers. 13

7. Pharmacovigilance Programme Of India (PvPI) Launched in July 2010:

7. Pharmacovigilance Programme Of India (PvPI) Launched in July 2010 The Pharmacovigilance Programme of India (PvPI) was initiated by the the Central Drugs Standard Control Organisation (CDSCO), New Delhi on 14/7/2010 under the aegis of Ministry of Health & Family Welfare, Government of India with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Co-Ordination Centre (NCC) for monitoring Adverse Drug Reactions (ADR) in the country for safe-guarding Public Health. To ensure implementation of this programme in a more effective way, the National Coordination Centre has been shifted from the All India Institute of Medical Sciences (AIIMS), New Delhi to the Indian Pharmacopoeia Commission , Ghaziabad , (U.P.) on 15-04-2011. The National Coordinating Centre is operating under the supervision of Steering Committee to recommend procedures and guidelines for regulatory interventions. 14

8. Steering Committee :

8. Steering Committee Pharmacovigilance Programme of India 15

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9. WHO Programme for International Drug Monitoring, International Scenario: WHO HQ + 6 Regional offices WHO Collaborating Centre, Uppsala National centres 17

Collaboration with World Health Organization-Uppsala Monitoring Centre (UMC) :

Collaboration with World Health Organization-Uppsala Monitoring Centre (UMC) WHO and UMC work with and provide technical support to more than 94 countries worldwide. The long term objective of the PvPI is to establish a  ‘ Centre of Excellence ’  for Pharmacovigilance in India.  To achieve this objective, the PvPI National Coordinating Centre will collaborate with the WHO Collaborating Centre - Uppsala Monitoring Centre (UMC) based in Sweden. 18

10. Need to humanize what we do, :

10. Need to humanize what we do, Let's talk about patient safety, not just medicine safety Ask the right question Instead of asking 'Is the medicine safe' Need to ask: Is the patient safely taking this medicine? 19

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20 11. Functions Receive and manage ADR data Develop tools; innovate Analyse: Signal detection :Identification of previously unknown drug reactions Communicate Support countries: train; search; technical assistance

12. Pharmacovigilance system :

12. Pharmacovigilance system Records medication related errors Analyses those errors Implements interventions Promotes patient safety Prevent 'preventable errors‘ Records medication related errors Analyses those errors Implements interventions Promotes patient safety Prevent 'preventable errors' 21

13. Importance of pharmaco-vigilance :

13. Importance of pharmaco-vigilance Safety monitoring of medical product. P’ceutical parameters and adverse effect. ADR reporting Post-monitoring 22

14. Scope of Pharmacovigilance: :

14. Scope 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 the use of medicines. Contribute to the assessment of benefit, harm, effectiveness and risk of medicines , encouraging their safe use, rational and more effective (including cost-effective) use. Promote understanding , education and clinical training in pharmacovigilance and its effective communication to the public. 23

15. For herbal medicines:

15. For herbal medicines Pharmacovigilance is essential for developing reliable information on the safety of herbal medicines The existing systems were developed for synthetic medicines and require some modification to address the specific differences of medicinal herbs. A 'natural' or herbal product must be safe simply because it is not synthetic which means that the safety element of monitoring for such medicines can be overlooked because of the tag associated with such products. 24

16. Role of clinical pharmacist in p’covigilance::

16. Role of clinical pharmacist in p’covigilance: Provide medical history Create database Monitoring patient Improving patient compliance Documentation of case for future reference Follow up of patients to assess outcomes Overall management Creating awareness Encouraging health professional and patients Patient and health care professional education. 25

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27 CASE STUDY: PS (33 yrs old) goes to her doctor complaining of malaise, sore throat, mouth ulcer, and headache . Her urine and electrolyte are normal but a blood count shows low WBC count (2500 cells/mm3) . Agranulocytosis is suspected. PS is taking carbimazole 40mg daily for hyperthyroidism for the last 4 week and has been on oral contraceptives for several years.

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28 DISCUSSION: Therapy for hyperthyroidism generally starts at a high daily dose of 15–40 mg of carbimazole continued until the patient has normal thyroid function, and then reduced to a maintenance dose of 5–15 mg. Treatment is usually given for 12–18 months followed by a trial withdraw. ADRs for carbimazole and other thiourea antithyroid drugs occur most frequently during first 8 week of treatment. This patient had developed these signs and symptoms during the 4 th week of treatment . The mechanism of carbimazole induced agranulocytosis is not clear. It is expected to be both immunological and dose related. Agranulocytosis is the decrease in the WBC count as in this case 2500 cells/mm3. The normal range for WBC is 4000-11000 cells/mm3. Side effects of carbimazole are neutropenia, bone marrow suppression, sore throat, headache, malaise and mouth ulcer. It also decreases the estrogen production .

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29 Cause foetus hyperthyroidism. So should not be given to the pregnant women . This patient having the adverse effect of carbimazole is agranulocytosis which is severe adverse effect of it. For the prevention of this adverse effect the dose should be decreased to 20mg daily . And again the symptoms not disappear then stop the therapy with carbimazole. Female having the higher risk of agranulocytosis. Antibiotics like penicillin, chloramphenicol, co-trimazole, and cephalosporin can also be used for agranulocytosis. Although not treated then transfusion of granulocyte is advisable. In patient preventing with fever or sore throat, it is advisable to withdraw the drug till symptoms resolve n shifted to another drug. The patient should be screened for any possible infection & treated with antibiotic if needed. The clinical pharmacist should guide the patient that if any adverse effect or sign and symptoms as mentioned above is observed then immediate consult the physician.


REFERENCES: S.K.Gupta, N.K.Ganguly. Basic principles of clinical research and methodology, Institute of clinical research, 1st edition. Page no: 177-198 H.P.Tipnis, Amrita Bajaj. Clinical Pharmacy. 2nd edition-2010. page no: 271-283 K.G.Revikumar, B.D.Miglani. A textbook of pharmacy practice; 1 st edition-2009. Page no:233-257 Kamlesh Kohli, Madhur Gupta, Sheela Tejwani. Contemporary perspective on clinical pharmacy; 1 st edition-2006. Page no: 58-64 Vishal Bansal. Clinical research fundamental and practice; 1 st edition-2010. Page no: 151-173 30

PowerPoint Presentation: pharmacovigilance _intro.htm ‎ ‎ Pharmacovigilance 6788929882.pdf › ... › J Young Pharm › v.2(3); Jul-Sep 2010 SK Gupta, Textbook of Pharmacovigilance, first edition; 2011. page no: 28-38‎ 31

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