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CONTENTS : Introduction Aims of pharmacovigiance The scope of pharmacovigilance Pharmacovigilance Programme of India Adverse drug reaction Classification of ADRs Mechanisms for ADRs Prediposing factors for ADRs Causalty assessment Reporting, evaluation, monitoring, preventing & management of ADRs Role of pharmacist in management of ADR

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WHO definition: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The etymological roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.” This applies throughout the life cycle of a medicine equally to the pre-approval stage as to the post-approval.

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

The ultimate goals of pharmacovigilance are :

The ultimate goals of pharmacovigilance are The rational and safe use of medical drugs The assessment and communication of the risks and benefits of drugs on the market Educating and informing of patients

The scope of pharmacovigilance:

The 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, rational and more effective (including cost-effective) use, and Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public

Pharmacovigilance Programme of India:

Pharmacovigilance Programme of India The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aid of Ministry of Health & Family Welfare, Government of India in collaboration with Indian Pharmacopoeia commission, Ghaziabad has started Pharmacovigilance programmefor protecting the health of the patients by assuring drug safety in India. The programme shall be coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC). The centre will operate under the supervision of a Steering Committee headed by the Drug Controller of India.


ADVERSE DRUG REACTION Adverse Drug Reaction : A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. Adverse Event : Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. Side Effect :Any unintended effect of a pharmaceutical product occurring at doses normally used in man which is related to the pharmacological properties of the drug.

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Classification of ADRs ( Rawlin and Thompson classification) TYPE A : Dose related. They are extension of the pharmacological effect. They are also called predictable or anticipated events. They are most frequent and less serious. Residual effect of VECURONIUM SALBUTAMOL and tachycardia TYPE B : Non dose- related. These are called pharmacologically unexpected, unpredictable, or idiosyncratic adverse reactions. They are generally more serious and less frequent. Penicillins rash – AINES

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TYPE C : Dose and time related . Related to cumulative drug use--for or chronic example, NSAID induced renal failure. Associated with long-term use. – NSAIDS induced renal failure. Gynecomastia and Ranitidine Captopril and cough TYPE D : Delayed effect . - Delayed reactions such as carcinogenesis and teratogenesis . - Apparent only some time after use of drug. Thalidomide in first trimester and phocomelia limb defects .

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TYPE E : End-of-use Withdrawal. Related to discontinuation which is too abrupt. Barbiturates. Addisonian crisis after steroid withdrawal. Angina pectoris after stopping -blockers. TYPE F : Failure of therapy which can be due to diverse causes such as: Prescription, diagnosis, missed selection of the medicine or doses. Inadequate information on the consumption. Cultural aspects. Quality of drugs. Intrinsic failures to the molecule. There is not a 100% effective drug or 100% safe There is not a 100% effective drug or 100% safe

Severity of ADR::

Severity of ADR: Minor : No need of therapy, antidote, or hospitalization Moderate : Requires drug change , specific treatment, hospitalization Severe : Potentially life threatening; permanent damage, and prolonged hospitalization. Lethal : Directly or indirectly leads to death MODERATE SEVERE LETHAL LETHAL


MECHANISMS FOR ADRs As research better explains the biochemistry of drug use, less ADRs are Type B ('idiosyncratic') and more are Type A (pharmacologically predictable). Common mechanisms are: Abnormal pharmacokinetics due to genetic factors comorbid disease states Synergistic effects between either a drug and a disease two drugs

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PREDISPOSING FACTORS FOR ADRs The main clinical factors which increase the chance that patients will experience an adverse reaction are listed below: Age - the elderly and neonates are at greatest risk Gender - women are generally at greater risk Race - ethnic origin may affect drug metabolism

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Impaired excretory mechanisms - reduced hepatic and/or renal function Specific diseases - e.g. asthma and beta-blockers Polypharmacy - drug interactions Any previous history of an adverse drug reaction.


CAUSALITY ASSESSMENT [DIFFERENT SCALES USED ] By means of Algorithms: Various methods can be adopted for causality assessment : Naranjo’s algorithm Kartch Lasagna`s algorithm WHO probability scale Spanish quantitative imputation scale Kramer's scale Jones scale European ABO system Bayesian system

Naranjo’s Algorithm:

Naranjo’s Algorithm questions Yes No Don’ know score 1, Are there previous conclusive reports of ADR? +1 0 0 2, Did the adverse event appear after the suspect drug was administered? +2 -1 0 3, Did the ADRimprove when the drug was discontinued? +1 0 0 4, Did the adverse reaction reappear when the drug was readministered ? +2 -1 0 5, Are there alternate causes that on their own could have caused the reaction? -1 +2 0

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questions Yes No Don’t know score 6, Did the reaction appear when a placebo was given? -1 +1 0 7, Was the drug detected in the blood (or other fluids) in concentrations known to be toxic ? +1 0 0 8, Was the ADR more severe when the dose was increased or less severe when Decreased? +1 0 0 9, Did the patient have a similar reaction to the same or similar drugs in any previous e xposure? +1 0 0 10, Was the adverse event confirmed by any objective evidence ? +1 0 0 Total=

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INTERPRETATION TO TOTAL s Total scores of 9 or more mean that ADR is highly probable. Scores from 5 to 8 mean that ADRis probable. Scores from 1 to 4 that ADR is possible. Scores of zero or less mean that ADR is doubtful

WHO probability scale :

WHO probability scale WHO Causality Categories (All points should be reasonably complied with) Certain • Event or laboratory test abnormality with plausible time relationship to drug intake • Cannot be explained by disease or other drugs • Response to withdrawal plausible (pharmacologically, pathologically) • Event definitive pharmacologically or phenomenologically (An objective and specific medical disorder or recognised pharmacological phenomenon) • Rechallenge (if necessary)

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Probable • Event or laboratory test abnormality with reasonable time relationship to drug intake • Unlikely to be attributed to disease or other drugs • Response to withdrawal clinically reasonable • Rechallenge not necessary Possible • Event or laboratory test abnormality with reasonable time relationship to drug intake • Could also be explained by disease or other drugs • Information on drug withdrawal lacking or unclear

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Unlikely • Event or laboratory test abnormality with a time relationship to drug intake that makes a connection improbable (but not impossible) • Diseases or other drugs provide plausible explanations Conditional / Unclassified • Event or laboratory test abnormality • More data for proper assessment needed • Or additional data under examination

Who reports the ADRs?:

Who reports the ADRs? Pharmacists Doctors dentists

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Nurse Drug manufacturer Other health care professionals

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Factors to be reported : New drugs Report all suspected reactions including minor ones For established or well known drugs All serious, unexpected, unusual ADRs Change in frequency of a given reaction ADRs to generics not seen with innovator products ADRs to traditional medicines

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All suspected drug-drug, drug-food, drug-food supplement interactions Statement highlighting marine source of supplements such as glucosamine so that can be avoided by those with allergy to sea food ADRs associated with drug withdrawals ADRs due to medication errors eg vincristine given IT ADRs due to lack of efficacy or suspected pharmaceutical defects


ADR REPORTING: Different forms have been developed for reporting ADRs : MEDWATCH by FDA YELLOW CARD

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Common procedure for reporting the ADR given by FDA

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ADR detection methods Premarketing clinical trials Post approval spontaneous case reports Aggregate population-based data sources Computerized data collections Post marketing studies Case reports

Rationale for ADRs Monitoring :

Rationale for ADRs Monitoring Information on safety and efficacy of a pharmaceutical product once it is marketed is limited to premarketing evaluation , clinical trials (phase I, II and III), animal tests and other factors in the product development process. 1. Phase I trial – Single dose studies in healthy volunteers, using low doses of the drug. Subsequently, larger doses and multiple sequences, the pharmacological and pharmacokinetics properties of a drug are evaluated

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2. Phase II trial – Efficacy is the primary objective of this phase, but safety is also continuously monitored and evaluated. 3. Phase III trial – Evaluation of safety in a group of patients with the disease.

Post Marketing Surveillance:

Post Marketing Surveillance Monitoring of drug safety after introducing into the market through various systems Need 1.To assess risk benefit ratio 2.To confirm safety and efficacy 3.To detect less common adverse effects

Methods of Surveillance:

Methods of Surveillance Anecdotal reporting Voluntary reporting Intensive event reporting Cohort studies (prospective) Case control studies (retrospective) Population statistics Meta-analysis

Prevention of ADR::

Prevention of ADR : Avoid inappropriate drugs in the context of clinical condition Use right dose, route, frequency based on patient variables Elicit medication history; consider untoward incidents Elicit history of allergies [  in patients with allergic diseases] Rule out drug interactions Adopt right technique: Eg slow iv injection of aminophylline Carry out appropriate monitoring [ Eg PT with warfarin ]

Management of the adverse reaction::

Management of the adverse reaction : Confirmation of the ADRs: indicate what assisted in confirming the suspected adverse reactions. For example : i . Drug reactions confirmed by disappearance of the reaction after stopping administration of the drug or reducing the doses. ii. Recovery on withdrawal of suspected drug(s) if no other drug is withdrawn and no therapy given. iii. Recovery follows treatment of the reaction in addition to withdrawal of drug.

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Mention the criteria for regarding the reaction as serious Mention any treatment given to the patient after experiencing the ADRs Outcome: indicate the outcome of the adverse reaction by marking X in the appropriate box with dates in case of fatal outcome.

Role of the Pharmacist :

Role of the Pharmacist Pharmacists should exert leadership in the development, maintenance, and ongoing evaluation of ADR programs. They should obtain formal endorsement or approval of such programs through appropriate committees (e.g., a pharmacy and therapeutics committee and the executive committee of the medical staff) and the organization’s administration. In settings where applicable, input into the design of the pro- gram should be obtained from the medical staff, nursing staff, quality improvement staff, medical records department, and risk managers.

The pharmacist should facilitate; :

The pharmacist should facilitat e; Analysis of each reported ADR, Identification of drugs and patients at high risk for being involved in ADRs, The development of policies and procedures for the ADR-monitoring and reporting program, A description of the responsibilities and interactions of pharmacists, physicians, nurses, risk managers, and other health professionals in the ADR program, Use of the ADR program for educational purposes, Development, maintenance, and evaluation of ADR records within the organization,

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The organizational dissemination and use of information obtained through the ADR program, Reporting of serious ADRs to the FDA or the manufacturer (or both), and Publication and presentation of important ADRs to the medical community. Direct patient care roles for pharmacists should include patient counseling on ADRs, identification and documentation in the patient’s medical record of high-risk patients, monitoring to ensure that serum drug concentrations remain within acceptable therapeutic ranges, and adjusting doses in appropriate patients (e.g., patients with impaired renal or hepatic function).

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