ensure clear identi˛cation, safe prescription and ......PHARMACOVIGILANCE PRINCIPLES 1 Each...
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5 4 3 PHARMACOVIGILANCE & BIOTHERAPEUTIC MEDICINES DEFINITION TRACEABILITY Pharmakon (Greek): medicinal substances Vigilia (Latin): to keep watch “The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem” World Health Organization Biotherapeutic medicines (or biotherapeutics) are medicines whose active ingredients are or are derived from proteins and other substances produced by living organisms. All medicines can cause Adverse Drug Reactions (ADR). Biotherapeutics have unique characteristics, due to their biological nature and complex structure that require special ADR tracking. Certain rare events undetectable during clinical trials prior to the marketing authorization can lead to ADRs or even decreased efficacy. KEY PRINCIPLE 1 Accurate identification of biotherapeutics or manufactured batch is one pillar of a good pharmacovigilance (PV) system ADVERSE DRUG REACTION (ADR) COLLECTION AND SIGNAL DETECTION PV reporting systems should be: easy to use to allow reporting by any parties including patients and HCPs and well-structured to facilitate the meaningful analysis of ADR data on biotherapeutics. Health authorities, NRA, medical researchers and companies to perform analyses at both the product class and individual product level for each biotherapeutic. IFPMA supports pro-active management of potential risks to further mitigate adverse consequences to patients. For effective RMP, a system for identification of medicines, clear prescribing and recording of the information, and good communication to HCPs, patients and their carers are needed. The European Medicines Agency (EMA) recently summarized the scope of a RMP as a defined set of PV activities which: Aim to characterize the safety profile of the medicine; Proactively plan activities to characterize risks and to identify new risks and increase knowledge about the safety profile of the medicine; and Plan and implement risk minimization and mitigation and to assess the effectiveness of these efforts. Considerable effort is needed in not only engaging HCPs, patients and their carers in understanding their role in risk management, but also to explain why risk management is needed and how these safety risks should be considered in the context of their treatment. HCPs should use distinguishable names when prescribing biotherapeutic medicines. This practice will help maintain the role of the physician in selecting a particular therapy for the patient and provide clarity for the pharmacist about what medicine was prescribed. Confusion may lead to automatic substitution and inaccurate attribution of ADRs. Ensuring that all biotechnology manufacturers, adhere to global standards for manufacturing and PV will protect patient safety and maintain the quality of existing PV practices. Each MAH of each biological product must have an established PV system to ensure comprehensive monitoring of the product. 1 2 G D KEY PRINCIPLE 3 KEY PRINCIPLE 4 KEY PRINCIPLE 5 FULL TRACEABILITY THROUGHOUT THE PRESCRIBING, DISPENSING AND ADR REPORTING CHAIN Batch number PRESCRIBING DISPENSING VERIFICATION ADR REPORTING Batch number Globally distinguishable name IN A MULTISOURCE ENVIRONMENT, DISTINGUISHABLE NAMES ENSURE TRACEABILITY Source: Amgen If ADR occurs, INN only If ADR occurs, Brand and INN Physician prescribes by INN only Pharmacist dispenses an available or cheapest biotherapeutic with same INN Reporter does NOT have immediate access to precise product given to patient It is unclear which medicines are linked to ADRs Physician prescribes by brand and distinguishable INN Pharmacist dispenses a stated brand or contacts physician to agree change In event of an ADR, reporter knows exactly which product the patient was dispensed Physicians know which drugs are linked to ADRs Prescribing by brand name and distinguishable International Nonproprietary Name (INN) allows physicians rapid access to the precise product dispensed when reporting ADRs HCP NRA Consumer Log in internal database; Assess & Complete Report as required; External Databases MAH Follow-up information Reporter Check for validity; Include ADR in company database Check for missing information; Follow-up with reporter Input Product Brand Name; More if available Assess seriousness & relatedness; When in doubt: related REPORTING PATH OF AN ADR FROM REPORTER TO FINAL DATABASE HCP = Healthcare Professional NRA = National Regulatory Agency MAH = Marketing Authorization Holder Health Authority Clinician Regulator Marketing Authorization Holder Pharmacist Carers K E Y S T A K E H O L D E R S Globally distinguishable name Globally distinguishable name Source: MSD Patients TO ENSURE BIOTHERAPEUTICS SAFETY 3 RISK MANAGEMENT PLAN (RMP) & RISK MINIMIZATION ELEMENTS 4 ROLES & RESPONSIBILITIES 5 PHARMACOVIGILANCE PRINCIPLES 1 2 Each biotherapeutic should have a distinguishable name to clearly differentiate it from other biotherapeutics to ensure clear identification, safe prescription and dispensing to patients, and accurate reporting and analysis of ADR data (i.e., improve traceability). Healthcare professionals should use the distinguishable name when prescribing and dispensing to ensure that any ADRs reported are assigned to the correct biotherapeutic and batch number. KEY PRINCIPLE 2
Transcript of ensure clear identi˛cation, safe prescription and ......PHARMACOVIGILANCE PRINCIPLES 1 Each...
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PHARMACOVIGILANCE & BIOTHERAPEUTIC MEDICINES DEFINITION
TRACEABILITY
Pharmakon (Greek): medicinal substancesVigilia (Latin): to keep watch
“The science and activities relating to the detection, assessment, understanding, and prevention of adverse e�ects or any other drug-related problem” World Health Organization
Biotherapeutic medicines (or biotherapeutics) are medicines whose active ingredients are or are derived from proteins and other substances produced by living organisms.
All medicines can cause Adverse Drug Reactions (ADR).Biotherapeutics have unique characteristics, due to their biological nature and complex structure that require special ADR tracking. Certain rare events undetectable during clinical trials prior to the marketing authorization can lead to ADRs or even decreased e�cacy.
KEY PRINCIPLE 1
Accurate identi�cation of biotherapeutics or manufactured batch is one pillar of a good pharmacovigilance (PV) system
ADVERSE DRUG REACTION (ADR) COLLECTION AND SIGNAL DETECTION
PV reporting systems should be:
easy to use to allow reporting by any parties including patients and HCPs andwell-structured to facilitate the meaningful analysis of ADR data on biotherapeutics.
Health authorities, NRA, medical researchers and companies to perform analyses at both the product class and individual product level for each biotherapeutic.
IFPMA supports pro-active management of potential risks to further mitigate adverse consequences to patients.
For e�ective RMP, a system for identi�cation of medicines, clear prescribing and recording of the information, and good communication to HCPs, patients and their carers are needed.
The European Medicines Agency (EMA) recently summarized the scope of a RMP as a de�ned set of PV activities which:
Aim to characterize the safety pro�le of the medicine;
Proactively plan activities to characterize risks and to identify new risks and increase knowledge about the safety pro�le of the medicine; and
Plan and implement risk minimization and mitigation and to assess the e�ectiveness of these e�orts.
Considerable e�ort is needed in not only engaging HCPs, patients and their carers in understanding their role in risk management, but also to explain why risk management is needed and how these safety risks should be considered in the context of their treatment.
HCPs should use distinguishable names when prescribing biotherapeutic medicines. This practice will help maintain the role of the physician in selecting a particular therapy for the patient and provide clarity for the pharmacist about what medicine was prescribed.
Confusion may lead to automatic substitution and inaccurate attribution of ADRs. Ensuring that all biotechnology manufacturers, adhere to global standards for manufacturing and PV will protect patient safety and maintain the quality of existing PV practices.
Each MAH of each biological product must have an established PV system to ensure comprehensive monitoring of the product.
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G D
KEY PRINCIPLE 3
KEY PRINCIPLE 4
KEY PRINCIPLE 5
FULL TRACEABILITYTHROUGHOUT THE PRESCRIBING, DISPENSINGAND ADR REPORTING CHAIN
Batch number
PRESCRIBING DISPENSING
VERIFICATION
ADR REPORTING
Batch number
Globallydistinguishable
name
IN A MULTISOURCE ENVIRONMENT, DISTINGUISHABLE NAMES ENSURE TRACEABILITY
Source: Amgen
If ADR occurs, INN only
If ADR occurs, Brand and INN
Physician prescribesby INN only
Pharmacist dispenses anavailable or cheapest
biotherapeuticwith same INN
Reporter does NOT haveimmediate access to
precise product given to patient
It is unclear which medicines are linked
to ADRs
Physician prescribes by brand and
distinguishable INN
Pharmacist dispenses a stated brand or contacts
physician to agree change
In event of an ADR, reporter knows exactly
which product thepatient was dispensed
Physicians knowwhich drugs are linked
to ADRs
Prescribing by brand name and distinguishable International Nonproprietary Name (INN) allows physicians rapid access to the precise productdispensed when reporting ADRs
HCP
NRA
Consumer
Log in internaldatabase; Assess& Complete Report as required;
External Databases
MAH
Follow-up information
Reporter
Check forvalidity;
Include ADRin company
database
Check for missing
information;Follow-up with
reporter
Input Product Brand Name;
More if available
Assessseriousness
& relatedness; When in doubt:
related
REPORTING PATH OF AN ADR FROM REPORTER TO FINAL DATABASE
HCP = Healthcare Professional
NRA = National RegulatoryAgency
MAH = Marketing AuthorizationHolder
HealthAuthority
Clinician
RegulatorMarketing
AuthorizationHolder
Pharmacist
Carers
KE
Y STAKEHOLDERS
Globallydistinguishable
name
Globallydistinguishable
name
Source: MSD
Patients
TO ENSURE BIOTHERAPEUTICS SAFETY
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RISK MANAGEMENT PLAN (RMP) & RISK MINIMIZATION ELEMENTS4
ROLES & RESPONSIBILITIES5
PHARMACOVIGILANCE
PRINCIPLES
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2Each biotherapeutic should have a distinguishable name to clearly di�erentiate it from other biotherapeutics to ensure clear identi�cation, safe prescription and dispensing to patients, and accurate reporting and analysis of ADR data (i.e., improve traceability). Healthcare professionals should use the distinguishable name when prescribing and dispensing to ensure that any ADRs reported are assigned to the correct biotherapeutic and batch number.
KEY PRINCIPLE 2
