SIGNIFICANCE OF POSTMARKETING SURVEILLANCE IN PHARMACOVIGILANCE
INTRODUCTION:
In the realm of pharmaceuticals, ensuring the safety and efficacy of marketed drugs is of paramount importance. While pre-marketing clinical trials provide valuable information, they cannot fully capture the complete safety profile of a medication. This is where post-marketing surveillance, an essential component of pharmacovigilance, steps in. In this blog, I will delve into the significance of PMS in PV and explore how it safeguards public health.
POST MARKETING SURVEILLANCE (PMS):
Post-marketing surveillance refers to the process of monitoring the drugs once they reach the market, after the successful completion of clinical trials.
The purpose of conducting PMS is to identify previously unrecognized adverse and positive effects.
PMS helps to correlate the strength of the exposed drug with that of the adverse events. PMS also ensures the continuous consumer acceptance of the products and financial viability.
WHAT ARE PMS STUDIES:
PMS is also called as post-authorization safety studies (PASS) or phase 4 studies.
In contrast to the controlled settings of premarketing trials, these studies are not rigorously controlled and can provide valuable info on the use of drugs in the general population as well as in special patient populations (elderly patients, pregnant, breastfeeding women, children, patient with multiple comorbidities)
As Pharmacovigilance activity is used to evaluate the effectiveness of risk management measures, these studies may be planned as a requirement in risk management plan (RMP)
PHARMACOVIGILANCE(PV):
PV is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
OBJECTIVES OF PV:
Monitoring the use of medicines in everyday practice with the aim to identify unrecognized ADRs and changes in the patterns of adverse effects.
Carrying out risk-benefit analysis for medicines and suggesting suitable relations, when needed.
Providing regular updates to healthcare professionals and patients regarding the safe and effective use of medicines.
SIGNIFICANCE OF PMS IN PV:
DETECTING RARE ADVERSE EVENTS:
During clinical trials, drugs are typically tested on a relatively small sample size under controlled conditions. This limited exposure may fail to detect rare adverse events that may only become apparent once the drug is widely used. Post-marketing surveillance enables the identification of these infrequent but potentially serious adverse reactions by collecting and analysing real-world data from a larger patient population. By doing so, regulatory authorities and pharmaceutical companies can take appropriate measures to address these adverse events promptly, such as issuing warnings or even recalling a drug if necessary.
ASSESSING LONG-TERM SAFETY:
Many adverse events manifest over prolonged periods of drug usage or emerged due to drug interactions with other medications or specific patient populations. Post-
marketing surveillance enables the continuous monitoring of drug safety in the real-world setting, allowing for the identification of long-term effects and the accumulation of data and drug interactions. This information is crucial for healthcare professionals, enabling them to make informed decisions regarding drug selection, dosage adjustments, and the management of potential risks.
IDENTIFYING PREVIOUSLY UNDETECTED SIDE EFFECTS:
In clinical trials, adverse events are often identified based on pre-defined criteria, and the focus is primarily on known side effects. However, post-marketing surveillance can shed light on unexpected or previously undetected side effects. Real-world evidence from diverse patient populations and healthcare settings can uncover new patterns of adverse reactions, leading to an enhanced understanding of the drug safety profile. This information allows regulatory authorities and pharmaceutical companies to update product labels, provide appropriate warnings, and take necessary corrective actions.
EVALUATING DRUG EFFECTIVENESS:
PMS not only focuses on safety but also provides valuable insights into a drug’s real-world effectiveness. Clinical trials may not fully capture the true effectiveness of a drug since they are conducted under controlled conditions with specific patient populations. PMS collects data on a broader scale, including patients with comorbidities and varying demographics, providing a more comprehensive assessment of the drug’s therapeutic benefits. This information helps healthcare professionals make evidence-based decisions regarding treatment options and optimize patient outcomes.
ENHANCING PHARMACOVIGILANCE SYSTEMS:
PMS contributes to the improvements of the pharmacovigilance system by fostering a feedback loop between healthcare providers, patients, regulatory authorities, and pharmaceutical companies. It encourages reporting of adverse events by healthcare professionals and patients, leading to a better understanding of drug safety and increased awareness among stakeholders. The data gathered from post-marketing surveillance play a vital role in signal detection, risk assessment, and risk management, ultimately strengthening the overall pharmacovigilance framework.
REPORTING SYSTEMS:
YELLOW CARD: UK run by MHRA (medicines and healthcare products regulatory agency)
MedDRA: Canada
FAERS (THE FDA ADVERSE EVENT REPORTING SYSTEM): MEDWATCH: US
BENEFITS OF PMS:
The ability to study the following:
Low-frequency reactions (not identified in clinical trials)
High-risk groups
Long-term effects
Drug-drug and drug-food interactions
Increased severity and reporting frequency of known reactions.
SOURCES OF PMS INFORMATION:
Expert user groups
Customer surveys
Customer complaints and warranty claims
Post-clinical evaluation market clinical trials.
Literature reviews
The media
CONCLUSION:
Post-marketing surveillance is an indispensable component of pharmacovigilance that plays a critical role in ensuring the safety and efficacy of drugs in real-world settings. By detecting rare adverse events, assessing long-term safety, identifying previously undetected side effects, and evaluating drug effectiveness, post-marketing surveillance enhances our understanding of a drug’s safety profile and helps mitigate risks. It serves as a proactive measure to safeguard public health by enabling the timely identification and management of emerging safety concerns.
Pharmacovigilance focuses on ADR reporting, along with spreading the knowledge among healthcare professionals and patients for minimizing the risks.
PMS fulfills the post-approval requirements of assessing and monitoring the potential risks associated with the use of pharmaceutical products in a large population.
REFERENCES:
https://acornregulatory.com
Introduction to post-marketing drug safety surveillance; LT Andrew Fine, PharmD, BCPS
Arthur N et al. The importance of pharmacovigilance-safety monitoring of medicinal products.
Student Name: Grandhi Raveena
Student ID: 088/052023
Qualification: Pharm. D
e-Mail ID: raveenapooji29@gmail.com
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