LABELLING IN PHARMACOVIGILANCE
INTRODUCTION
Drugs and vaccines are taken for the prevention and treatment of various diseases. Besides providing their benefits these medical products also show different side effects which are unexpected and undesirable.
PHARMACOVIGILANCE
Pharmacovigilance /drug safety is a branch of pharmaceutical science that includes the monitoring and prevention of adverse effects of pharmaceutical products. The word pharmacovigilance is derived from the Greek word pharmakon-drug and vigil on-to keep an eye on. It mainly involves the collection of data, analysing it, and taking measures to prevent any negative effects.
Pharmacovigilance is the process that occurs throughout the life cycle of a drug from the first developed molecule and even after it is released into the market. In this way, pharmacovigilance especially focuses on adverse drug reaction.
ADVERSE DRUG REACTIONS
An adverse drug reaction is defined as an unpleasant or harmful reaction that is caused due to the use of a medical product either a drug or vaccine.
ADVERSE DRUG EVENT
Adverse drug event is defined as damage caused by the drug or vaccine due to its appropriate or inappropriate use considering that adverse drug reactions are a fragment of these events where harm occurs without an intermediary by a drug under its normal dose or appropriate use. All the drugs and vaccines before getting into the market undergo attentive testing for efficacy and safety. This safety and efficacy are achieved through clinical trials before the pharmaceutical products are authorized by the authorities for public use. Clinical trials involve the study of these products in very small numbers with few populations within a short duration. As a result, only, a few side effects will be known.
The long-term effects of the drugs can be known after a long duration of its use in a considerable size of the population. the study of these side effects and adverse effects of drugs that emerge either in a short period or long duration is known as pharmacovigilance. Adverse drug reactions are more unpredictable and harmful than side effects.
Side effects can either be beneficial or harmful whereas the adverse effect is usually undesirable and harmful.
LABELLING
A label provides the information either written or printed on the package /container of the drug. Labelling is the process of including information approved by the authorities for the use of products. It defines certain information about the products. The information provided on the label should be in harmony with the applicable product license.
Information provided on the label is from extensive clinical research which designates the safety and efficacy of the products for their use in human beings.
INFORMATION INCLUDED ON LABELS OF MEDICINES
A label is considered a good label if it contains all the information such as
Name of the particular medication
Doses and route of administration
Pharmacology of the drug
Instructions for usage and indications
Details of any adverse reactions
Contraindications of the drug
Warnings if any
Precautions
Information of ingredients
Safety of children
Other information like manufacturing date, expiry date, batch number, and shelf life.
BENEFITS OF LABELLING
Labelling is useful in many ways as it provides basic information for the identification products, information on ingredients, use or purpose of the drug, the safety of children, possible side effects, and adverse drug reactions.
Educates its user about consumption like how to take medicine to be swallowed or chewed.
Storage information.
Warning about possible risks and hazards.
Helpful in reporting an adverse event related to medicine.
And also, the label plays an important part in the advertisement and promotional activity of a particular brand.
LABELLING IN PHARMACOVIGILANCE
The label of a drug or vaccine provides all the relevant information regarding a particular medicine. Thus, correct labelling is helpful for prescribers in prescribing appropriate medicine and in ensuring the safe and rational use of medicines.
Labelling should be immediately changed or replaced if any change is established in existing safety information of the drug product.
EVALUATING OR ASSESSING LABELLING
Assessment involves arbitrating whether any adverse drug reaction is already known and documented or observed in patients who are undergoing therapy with the medical product which is under investigation. It ensures the rapid nature of a patients report individually.
ICSR-individual case study report.
It establishes the immediate nature of ICSR by preparing the regulatory due schedule for submission to the health care authority. For example, in SUSAR (suspected, unexpected/unlabelled/unlisted) ‘U’ is crucial in classifying an individual case study report as either to expedited or non-expedited case. As a result, this concept is required for detecting expedited cases (SUSAR/CSR) which follow the order for case preparation and submission to respective health authorities. During the assessment of marketed products, the terms listed /labelled are used. During the assessment of developmental drugs or investigational molecules, the term expectedness is used.
REFERENCE SAFETY INFORMATION (RSI)
It is a document containing an accruing list of all adverse events noted/observed during a clinical trial. This document contains details of adverse events like seriousness/non-seriousness along with complete information on their nature and frequency.
INVESTIGATOR’S BROCHURE (IB)
During the process of drug development and medical device development, the IB is a conception document outlining the complete information about investigational products obtained during a clinical drug trial. IB is the name of the document/file used for this purpose.
CONCEPT OF ASSESSMENT
WELL DOCUMENTED
An adverse drug reaction or adverse drug event is known to be well documented only when it is completely a known event and the severity, nature, specificity, and outcome are consistent with the available safety information present in the RSI document.
NOT WELL DOCUMENTED
When a completely new adverse drug reaction or adverse drug event is experienced by the patient rather than the event or reaction already listed as per the RSI document it is considered unexpected or unlabelled.
LABELLED
If any adverse drug reaction or adverse drug event accomplished by the patient is well documented in its corresponding region-specific reference safety information (RSI) for that medical product.
UNLABELLED
If any adverse drug reaction / adverse drug event accomplished by the patient is strange and not well documented in corresponding region-specific reference safety information (RSI) for those medical products. Region-specific RSI documents contain the safety information belonging to a medical product which was originated at the regional level.
EXPECTED
If any adverse drug reaction is already experienced by any subject in a clinical trial because of the molecule used during investigation in IB. then the adverse reaction is considered expected.
UNEXPECTED
If any adverse drug reaction is not well documented in IB and encountered by the subject then it is considered unexpected. Change in the frequency of listed/expected adverse event occurrences is also considered a new aspect for already known reactions. This is usually reported during the collection of safety reports and case analyses.
CONCLUSION
Medical product labelling and the package leaflet provides the patient with important information about their medicine to allow the safe and effective use of product, whether it may be an OTC medicine or drugs prescribed by doctor.
References
Student Name: Syed Shafa Raoof
Student ID: 028/022023
Qualification: Pharm. D
e-Mail ID: syedsahafa06@gmail.com
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