ESTUDOS DA UTILIZAÇÃO DE MEDICAMENTOS | SÉRIE EDUCAÇÃO FARMACÊUTICA EM ONCOLOGIA

Summary

This video script explains the importance of medication studies, highlighting their role in understanding how pharmaceutical products behave in organisms. It details the phases of drug research, from non-clinical testing in animals to the four clinical trial phases involving human participants. The script emphasizes the significance of clinical trials in ensuring drug safety and efficacy, with a focus on pharmacovigilance in phase 4. It also discusses the pharmacist’s role in ensuring rational drug use and their contribution to health policy and therapeutic decisions in healthcare institutions.

Takeaways

• 😀 Medications are pharmaceutical products used for prophylactic, curative, palliative, or diagnostic purposes.
• 😀 Pharmacoepidemiology studies the use and effects of medications on large populations.
• 😀 Studies of drug utilization aim to examine the commercialization, distribution, prescription, and use of medications in society.
• 😀 Drug utilization studies help ensure the safe use of medications by the population in need of treatment.
• 😀 Clinical studies are divided into non-clinical and clinical phases, with the non-clinical phase involving animal testing before human trials.
• 😀 The clinical phase is divided into four stages, assessing safety, efficacy, and long-term effects of medications on human populations.
• 😀 Phase 1 of clinical studies tests a drug on a small group of healthy volunteers to assess safety.
• 😀 Phase 2 involves a larger group of patients to evaluate the efficacy and further investigate the safety of the drug.
• 😀 Phase 3 compares a new treatment with the standard treatment, involving hundreds to thousands of patients in randomized trials.
• 😀 Phase 4 studies monitor long-term effects and rare side effects of medications once they are approved and marketed.
• 😀 Phase 4 studies, also known as post-marketing surveillance, help identify any previously unobserved side effects and confirm the long-term therapeutic value of a medication.

Q & A

What is pharmacovigilance, and why is it important?

Pharmacovigilance refers to the monitoring and assessment of the long-term effects of medications once they are on the market. It is important because it helps identify new adverse reactions or confirm the frequency of known reactions, ensuring the ongoing safety of medications for the population.

What are the main phases of clinical trials?

Clinical trials are divided into four main phases: Phase 1 focuses on safety in small groups of healthy volunteers; Phase 2 evaluates efficacy and further safety in a larger group of patients; Phase 3 compares the new treatment to existing treatments in large groups; Phase 4 monitors long-term effects after the medication is approved and available to the public.

What is the purpose of non-clinical studies in drug development?

Non-clinical studies, which include testing substances in appropriate software and animal models, are conducted before human trials. Their main purpose is to observe how the substance behaves in an organism and ensure it is safe before advancing to human testing.

What is the role of a pharmacist in pharmacoepidemiology?

Pharmacists play an essential role in pharmacoepidemiology by actively participating in studies that assess the use and effects of medications. They help ensure the safe and rational use of medicines, which directly contributes to public health.

Why are clinical trials randomized in Phase 3?

In Phase 3, clinical trials are randomized to ensure unbiased results. This means patients are randomly assigned to either a control group receiving the standard treatment or an investigational group receiving the new medication, ensuring that the comparison is fair and the outcomes are reliable.

What happens if a drug does not meet expectations in Phase 1 of a clinical trial?

If a drug does not meet safety expectations in Phase 1, it may be withdrawn from further testing. Phase 1 trials aim to determine whether the drug is safe for human use, and failure to meet safety standards can result in the discontinuation of the drug's development.

How does Phase 2 of clinical trials differ from Phase 1?

Phase 2 trials involve a larger group of patients and focus on assessing the efficacy of the drug, not just its safety. The goal is to determine whether the drug works for treating a specific condition, while also gathering more data on its safety and potential toxicity.

What are the goals of Phase 4 studies?

Phase 4 studies, also known as post-marketing surveillance, aim to confirm that the results from earlier trials are applicable to the broader population. They also monitor long-term effects and identify any new adverse reactions once the drug is widely available.

How are medications selected for use in a hospital setting?

Medications in hospitals are typically selected by a pharmaceutical therapeutic committee, which considers several factors such as cost, the profile of patient needs, and the effectiveness of the drugs. This ensures that the selected medications best serve the patient population in the institution.

What is the role of the World Health Organization (WHO) in defining the studies of drug utilization?

The WHO defined studies of drug utilization in 1977, emphasizing the importance of understanding how medications are marketed, distributed, prescribed, and used in society. These studies focus on the medical, social, and economic consequences of medication use.