The COVID-19 pandemic has been an important moment for pharmacovigilance and pharmacology in terms of their role in drug safety and drug use monitoring in clinical practice. Pharmacovigilance professionals and pharmacology researchers have a lot of knowledge on approved medications, many of which have been or are presently undergoing clinical trials for redeveloping. In order to improve medication or vaccine efficacy and guarantee patient safety, this information can be applied and translated to improve dosage and treatment plans, as well as adverse events after vaccination. Pharmacology and pharmacovigilance are two critical components of the pharmaceutical industry. Oftentimes, pharmacology and pharmacovigilance frequently overlap yet serve specific goals. While pharmacology investigates the science of medications, investigating their causes, effects, and interactions inside the body, pharmacovigilance focuses on assuring patients’ safety and well-being by monitoring and managing adverse drug responses.[1]  

 Pharmacology vs. Pharmacovigilance: Key Insights

Pharmacology is the basis for drug development. It investigates how drugs interact with biological systems, providing insight into their methods of action, therapeutic benefits, and potential side effects. This topic includes everything from the molecular complexities of drug-receptor interactions to the overall effects of drugs on the human body. It is the scientific foundation that governs the development of new treatments and the improvement of existing ones. Pharmacology consists of two subfields, pharmacokinetics and pharmacodynamics. [2]  

Pharmacovigilance is the first priority while medications are being used. In order to protect patient safety, this profession concentrates on identifying, evaluating, comprehending, and minimizing hazardous medication issues. Active pharmacovigilance can identify risk factors for adverse reactions in specific patient populations, including the elderly (age >  65 years), women including those in pregnancy or breastfeeding, children, polypharmacy subjects, or patients with substance use disorder.[1] Pharmacovigilance can also be referenced as post-market surveillance. For instance, one significant development in pharmacovigilance occurred in 2004 when the painkiller rofecoxib (Vioxx) was taken off the market. It was removed for the safety of others after post-market surveillance showed an increase in cardiovascular risks, despite its effectiveness in pain management. [3] 

We live in a society where millions of prescriptions are filled every day, pharmacovigilance is protective, guaranteeing that medications are safe and effective for the populations they serve. It diminishes the disconnect between clinical research and practical applications, often highlighting serious concerns that were not discovered during initial experiments. 

Supporting Pharmacovigilance with Pharmacology 

Pharmacology provides the information needed that pharmacovigilance uses to identify safety issues. Here are some instances of how understanding pharmacological processes can help address safety: 

Serotonin Reuptake Inhibitors (SSRIs)

Paroxetine (Paxil) and fluoxetine (Prozac), are commonly used antidepressants called serotonin reuptake inhibitors. This mechanism allows for a greater availability of the serotonin neurotransmitter. Pharmacovigilance has identified risks such as an increase in suicidality in younger individuals, while pharmacology focuses on their potential for the treatment of depression. This knowledge has ultimately contributed to the implementation of black box warnings in SSRIs and the close monitoring of pediatric and teenage patients.[4]

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)  

The mechanism of action of NSAIDs like naproxen and diclofenac inhibits cyclooxygenase (COX) enzymes, reducing inflammation and pain. However, pharmacovigilance has revealed hazards such as gastrointestinal bleeding and cardiovascular problems linked to long-term or high-dose use. This has inspired the origin of COX-2 selective inhibitors, which have fewer gastrointestinal issues but should still be used with caution due to cardiovascular concerns. [5]

Anticoagulants (Warfarin) 

Vitamin K-dependent clotting factors are inhibited by the anticoagulant warfarin. Clinicians can modify dosages according to the patient's prothrombin time (INR) thanks to pharmacology’s comprehensive grasp of how this drug functions. Pharmacovigilance, however, has emphasized the significance of monitoring for any bleeding risks and drug interactions. For example, the metabolism of warfarin may be altered when administered concurrently with antibiotics, leading to necessary dose modifications to prevent hemorrhagic effects.[6]

Biologics and immunotherapy 

Treatment possibilities have been transformed by monoclonal antibodies, such as immune checkpoint inhibitors used in cancer therapy. Pharmacology describes how these medications strengthen the immune response against tumors by targeting particular pathways, such as PD-1/ PD-L1. However, immune-related adverse events such as pneumonitis or colitis have been found by pharmacovigilance, which has led to guidelines for controlling these side effects while preserving the effectiveness of treatment. [7]

Thalidomide

Initially, thalidomide was marketed and prescribed as a sedative able to produce a deep sleep without risk of dependency or hangover. This drug was tested in rodents and did not establish a median lethal dosage, which caused the false belief that it was nontoxic to humans. Harmful teratogenic effects were not accounted for back then when these trials were conducted in the 1950s. Thalidomide became well-known for its anti-emetic effects in pregnant women suffering from morning sickness. In addition, this drug was available without prescription and affordable. In Germany, it became a top-selling sedative and an estimated 14 tons were sold in 1960. Only a year later, two doctors conducted independent observations linking thalidomide with congenital malformation. Thalidomide was then taken off the marketplace for a period of time. A majority of the malformations occurred 34-49 days after the last menstrual period, and 40% of affected infants died within a year of treatment. Thalidomide has had a mechanism of action that has not been completely understood for decades. It is mostly known for its action on tumorous plasma cells. In addition to inhibitory effects on the malignant plasma cell, thalidomide enhances the immune system effector cells, suppresses the development of new blood vessels, inhibits multiple cytokine mediators and interferes with bone marrow plasma cell interaction. In 1998 and 2006, the FDA approved thalidomide to be used for the treatment of multiple myeloma in the United States. Pharmacovigilance was conducted diligently after this unfortunate situation attributing to the remarketing of thalidomide and ensuring patient safety.[8]

Public Health, Pharmacovigilance, and Pharmacology 

Pharmacology and pharmacovigilance work together to improve public health by assuring pharmaceutical efficacy and safety.  The COVID-19 pandemic serves as a prime example in this situation because it has been the most recent crucial public health issue.The mRNA vaccines from Moderna and Pfizer -BioNTech were created based on pharmacological concepts. Scientists looked into how mRNA might direct cells to produce spike protein , which would trigger an immune reaction. Rare but significant side effects were found like thrombotic events, heart failure and myocarditis, especially in young males. This called for better vaccine delivery and consent.   [9]

Certifications like the Board-Certified Medical Affairs Specialist (BCMAS) aids in informing healthcare professionals about pharmacology and pharmacovigilance. These credentials equip teams with improved knowledge and skills in medical affairs, promoting a better understanding of patient safety protocols, regulatory requirements, and drug development. Modules for developing skills in drug mechanism and safety profiles, signal identification and risk management are offered by this accreditation. Comprehensiveness in safety profiles and drug mechanisms enables a better understanding of clinical data to anticipate safety concerns. Signal detection will strengthen the ability to identify adverse events early and develop effective response plans. Lastly, the certification assists in improving communication among pharmacologists, healthcare professionals, and pharmacovigilance teams resulting in better patient outcomes. Receiving such certificates allows professionals to stay on top of industry standards. [10]

Challenges and Future Plans

Challenges 

The large amount of practical data collected each day can make it difficult to recognize relevant safety signs. Drugs are used in a variety of populations with different environmental, cultural characteristics and genetics, impacting safety evaluations. The fast development of complicated medicines associated with nanotechnology requires fresh standards for pharmacovigilance and pharmacology. 

Future Plans 

New technologies are emerging contributing to pharmacovigilance. Furthermore, large data analysis algorithms can process safety data collected from healthcare social networks and forums, general social networking, and search logs to provide a more comprehensive view of the public on drugs and vaccines. This can then be used to develop public health campaigns on drug/vaccine safety, disease prevention, or vaccine hesitancy reduction. [1] 

Conclusion 

Together, the interconnection between pharmacology and pharmacovigilance ensures that the advantages outweigh the risks in practical settings, while pharmacology provides the pharmacodynamic/pharmacokinetic foundation of the functions of a drug. The evolution of medicine, protection of public health, improvement of patient outcomes are tied to these domains and can be properly displayed through certifications like BCMAS. 

References

1. Crescioli, G., Bonaiuti, R., Corradetti, R., Mannaioni, G., Vannacci, A., & Lombardi, N. (2022). Pharmacovigilance and Pharmacoepidemiology as a Guarantee of Patient Safety: The Role of the Clinical Pharmacologist. Journal of clinical medicine, 11(12), 3552. https://doi.org/10.3390/jcm11123552

2. Talbot, J. C., & Nilsson, B. S. (1998). Pharmacovigilance in the pharmaceutical industry. British journal of clinical pharmacology, 45(5), 427–431. https://doi.org/10.1046/j.1365-2125.1998.00713.x

3. Sibbald B. (2004). Rofecoxib (Vioxx) voluntarily withdrawn from market. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 171(9), 1027–1028. https://doi.org/10.1503/cmaj.1041606

4. McCain J. A. (2009). Antidepressants and suicide in adolescents and adults: a public health experiment with unintended consequences?. P & T : a peer-reviewed journal for formulary management, 34(7), 355–378. https://pmc.ncbi.nlm.nih.gov/articles/PMC2799109/

5. Liang, S., Wang, X., & Zhu, X. (2024). Insights from pharmacovigilance and pharmacodynamics on cardiovascular safety signals of NSAIDs. Frontiers in pharmacology, 15, 1455212. https://doi.org/10.3389/fphar.2024.1455212

6. Vega, A. J., Smith, C., Matejowsky, H. G., Thornhill, K. J., Borne, G. E., Mosieri, C. N., Shekoohi, S., Cornett, E. M., & Kaye, A. D. (2023). Warfarin and Antibiotics: Drug Interactions and Clinical Considerations. Life (Basel, Switzerland), 13(8), 1661. https://doi.org/10.3390/life13081661

1. Ramos-Casals, M., Brahmer, J. R., Callahan, M. K., Flores-Chávez, A., Keegan, N., Khamashta, M. A., Lambotte, O., Mariette, X., Prat, A., & Suárez-Almazor, M. E. (2020). Immune-related adverse events of checkpoint inhibitors. Nature reviews. Disease primers, 6(1), 38. https://doi.org/10.1038/s41572-020-0160-6

2. Rehman, W., Arfons, L. M., & Lazarus, H. M. (2011). The rise, fall and subsequent triumph of thalidomide: lessons learned in drug development. Therapeutic advances in hematology, 2(5), 291–308. https://doi.org/10.1177/2040620711413165

3. Haussner, W., DeRosa, A. P., Haussner, D., Tran, J., Torres-Lavoro, J., Kamler, J., & Shah, K. (2022). COVID-19 associated myocarditis: A systematic review. The American journal of emergency medicine, 51, 150–155. https://doi.org/10.1016/j.ajem.2021.10.001

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