Approaches to overcome challenges in running

PvP by involving stakeholders at different levels

Prof. S. Ziaur Rahman (MD, PhD, MAMS, FIMSA)

Department of Pharmacology

Jawaharlal Nehru Medical College

Aligarh Muslim University, Aligarh

ADR Reporting Systems

•Having a proper and effective ADR reporting system is crucial for every country: • Reduce potential health hazards such as morbidity and mortality

• Patient’s safety

• Reduce economic burden associated with these hazards

•Most commonly used ADR reporting system worldwide including India • spontaneous and voluntary reporting

• Backbone of reporting systems

• Monitoring & analysis of spontaneous adverse drug reactions: A challenge

Source: Alshakka et al., 2014

Other reporting systems

•Methods that Complement Spontaneous Reporting Systems • Cohort event monitoring / observational event monitoring

system • New Zealand Intensive Medicines Monitoring Programme

• UK Prescription Event Monitoring

• Targeted spontaneous reporting • patients on treatment for drug-resistant TB or those switching from first-

line to second-line antiretroviral therapy (ART)

Challenges at the level of different stakeholders:

• Health Professionals

• Physicians, Pharmacists, Nurses, PMS

• Hospital Administration

• Pharmaceutical Industries / Manufacturers

• Drug Regulatory Authorities

• AMCs / ADR Monitoring Committee

• Consumers

Challenges from health professionals

Why should I lose time to send a report of adverse drug reactions?

Challenges & Solutions at the level of Physicians

• If physician doesn’t know indications, regimens, route of administration, time frames and /or dosage of most of the medicines • How can we expect to understand the difference of ADRs & Drug errors

• Poor / Lack of awareness towards ADRs monitoring

• Extra work burden in a routine clinical activities

• Practices of prescribing multiple drugs to patient

• Regularly introduction of new drugs for treatment, diagnosis or prophylaxis

• Insufficient Training & Education to identify ADRs • Less familiarity with ADR reporting procedure

• ADR collection form (user friendly)

• Appropriate method selection

• Lack of interest, sense of responsibility, professionalism rather than care & responsibility

• Underestimate the importance of ADR reporting

• Callousness, reluctant & indifferent attitude • Perception and Belief: Need not to report recognized ADRs / single report would make

no difference

• Lack of communication on what to, how to & where to report ADRs

• Lack of knowledge about AMCs & PvPI

• Under reporting • Boosting, Encouragement

Inaccurate reporting / Duplication of report

• If reporting, don’t know how the reporting can be useful in promoting patient safety

• Poor co-ordination and co-operation between hospital authority, health professionals and ADR monitoring member committees

• Colleague’s negative reporting nature significantly discourage others to report ADRs

Challenges face by other Health Professionals: need spark for solution!

Some more challenges!

• Ignorance of spontaneous reporting ADR utility and its objectivity

• Uncertainty of ADR diagnosis [suspicious diagnosis but not confirmed]

• Desire to publish as rare case report rather than reporting it / Problems with publication in medical journals

• Potential conflicts derived from reporting ADRs [Problems of patient’s confidentiality]

• Problems of legal liability / Fear of litigation and possible judicial claims

• Lack of impunity and culture of reporting

• Recognition and Rewarding

NCC-PvPI coordinating with IMA NCC-PvPI coordinating with Nursing Council of India (July 16, 2014)

Challenges at Hospital Administration’s Level

•Supportive

•Felicitate ADR reporting

•ADR Boxes at each wards and at prominent places

•Database on ADR

•Availability of substandard & spurious drugs in Hospital’s Drug Store

Hospital Administration: challenges & solutions

Challenges from the drug manufacturer’s side

• Poor post marketing surveillance of prescribed and non prescribed drugs

• Confusion regarding PSUR

• Structure of AERS in compliance with international safety reporting guidance (ICH E2B2) issued by ICH

• Confusion in terminologies like MedDRA

• Adverse events in AERS are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA)

Challenges from the drug manufacturer’s side

• AERS data does have limitations

• No certainty that reported event was actually due to the product

• FDA does’nt require that causal relationship between a product and event be proven

• Reports do not always contain enough detail to properly evaluate an event

• FDA does not receive all adverse event reports that occur with a product

• AERS cannot be used to calculate the incidence of adverse event

• Many factors can influence whether or not an event will be reported

• The time a product has been marketed and publicity about an event

• Poor coordination between health professionals and drug manufacturer

Challenges from the drug manufacturer’s side

Common challenges of running and reporting ADRs from the patient side

• Unawareness, poor knowledge & low education regarding possibility of ADRs • Inappropriate use of medicines

• Influence of commercial advertising

• Self-medication

• Comorbid conditions or concomitant diseases

• How to report ADRs and where to submit ADRs

• Lack of acknowledgement and incentive

• Poor follow up of patient

• Lack of counseling to patient regarding their disease treatment and ADRs

• Patient confidentiality issues

• Only few countries currently accept patient reports • Developing countries have urgent need to improve Pharmacovigilance systems

• Consumer reporting is highly acceptable and should be encouraged in developing countries

Challenges at a patient’s level

Challenges with ADR Monitoring Committees/ AMCs

Monitoring and managing ADRs surveillance systems: Causality assessment / difficulty in making causality

High false positive rates Analysis of reported ADRs to be done by selected ADR

committee member Use of local surveillance (tracking and reporting) system run by

ADR monitor committee Use of standardized reporting forms Reporting of serious and recurring ADRs to regulatory

authorities Transfer of all ADR Data (VigiFlow) to DRA

Challenges…..

Challenges faced by Drug Regulatory Authorities

NCC: Office IP

Challenges faced by Drug Regulatory Authorities

• Coordination with various stakeholders and committee members • Signal Review Committee (18 members)

• Quality Review Committee

• TSR • RNTCP (11.10.2013), ART/NACO (15.9.2014)

• Adverse Effects Following Immunization /AEFI (1986)

• Materiovigilance Programme of India (6.7.2015)

• Haemovigilance Programme of India (10.12.2012)

• Pv for ASU Drugs (2008)

• Transfer of ADR Data (VigiFlow) to UMC / Manufacturers

• Collection of online and offline ADRs data from various AMC

• Sufficient numbers of AMCs?? 150 (107 Govt. + 43 Non Govt.) • Coordination of AMCs

• Drugs are sold without prescriptions in many medical shops

• Several preparations containing herbal medicines are sold as allopathic drugs and vice versa

• Reporting ADRs caused by herbal, traditional and alternative remedies

• Difficult to trace the use of these medicines

• Active surveillance to identify ADRs

• ADR monitoring in rural areas

• Financial limitations and shortage of staff

• Influence to MCI • No intensive teaching about ADR reporting in the UG curriculum • Reinforcement of ADR monitoring in internship and postgraduate studies

Challenges & Solutions…

• Pharmacovigilance workshops • Health care professionals/Pharmaceutical Associations should be initiated

• Physicians, pharmacists and nurses to provide guidance and for recognizing and reporting ADRs

• Facilitate ADR reporting by e-mail, and mobile app.

• Educational intervention: • Increase awareness of ADRs

• Enable healthcare professionals to incorporate knowledge into clinical practice

• Incorporation in the syllabus of UG and PG courses of medicine/pharmacy

Quick look into the solution:

• 'Pharmacovigilance Unit' at each hospital for disbursement & collection of ADR reporting forms

• Strong collaboration between Dept. of Pharmacology & other clinical departments • To help ensure proper and efficient ADR reporting

• To provide Pharmacovigilance awareness programs

• Periodical meetings of experts from AMCs under PvPI with all stake holders • To boost reporting and for effective co-ordination

• Separate column be provided for ADR reporting in patient medication chart

• Each hospital should have a data-base on ADRs • Possible to be accessed

Remedies (Contd.):

• GoI may pass a law for making ADR reporting mandatory for: • Physicians

• Pharmacists (hospital, clinical & community)

• Associating ADR reporting with appreciation • Incentives who’s reporting ADRs not associated with human errors

• Felicitation of physicians for maximum ADR reporting in a year

• Assurance of non-involvement in legal matters, if they arise

• Positively changing the mind-set • ADR reporting becomes an accepted and understood routine

Finally…

Thank You

World Patient Safety Day (9 December)