the department cycle, phase 5 pharmacovigilance
Posted: Mon Dec 23, 2024 8:30 am
Etymologically, the term has a double origin. On the one hand, it comes from the Greek word “pharmakeia” used for drugs, medicines and remedies; on the other, vigilance comes from the Latin “vigilantia” which means vigilance and attentive gaze.
What is the process that a drug follows for its use and distribution?
For a drug to be approved for human use, it goes through a series of stages, or drug cycle:
Phase I: Basic research
At this stage, a substance is proposed as a potential drug and its therapeutic target is established, that is, which molecule the drug is directed at. This stage is complex, since the discovery of a new drug is not easy, and it is a long process with a very low success rate. It is estimated that only 250 out of every 10,000 molecules from the basic research stage move on to the preclinical research phase.
Phase II: Preclinical
In this phase, the selected compound is analyzed in the laboratory to assess the safety of its administration in humans and its biological activity. The aim is to find out how the drug is distributed or eliminated from the body and to understand its effects, at different doses, on different organs and systems, among other objectives. To do this, tests are carried out on cells in culture, the drug is formulated and pharmacology and toxicology studies are carried out.
Phase III: Clinical
This phase of clinical research is necessary to find out how the drug works in people and to find out if it is a suitable and effective drug in treating the disease, with an optimal safety profile. It is a relatively long stage, where the safety of the compound is demonstrated, the appropriate doses are sought and the efficacy and safety of the experimental treatment are evaluated on a population selected for the study. It provides the basis for the approval of the drug.
Phase IV: Approval and Registration
At this stage, the application for marketing authorization for the drug is submitted to the relevant regulatory agencies.
Phase V: Continued surveillance
Once the drug has been approved and after its commercialization, continuous monitoring is carried out to study its effectiveness and safety in daily clinical use, since, when it comes onto the market, its use expands to thousands or millions of patients around the world, very different from each other, producing conditions and possible interactions not previously identified. This is the pharmacovigilance stage .
This detailed monitoring of any incidents that the product landline number format philippines may cause allows for the modification of information regarding recommendations for use, modification of information contained in side effects and allows the drug to be withdrawn from the market if necessary. This therefore guarantees patient safety.
Who participates in pharmacovigilance?
It is everyone's responsibility . It is a shared responsibility of health authorities, the pharmaceutical industry, healthcare professionals and citizens themselves. Its success depends on the collaboration of all the parties involved.
The Spanish Pharmacovigilance System was created in response to the need to monitor potential problems related to the use of medicines. In Spain, the old Medicines Law of 1990 already included the importance of health professionals participating in the protection of health, but it was not until 2002 when it was regulated by law (RD 711/2002, of July 19). Currently, this RD 711/2002 has been repealed and replaced by Royal Decree 577/2013, of July 26, which regulates the pharmacovigilance of medicines for human use .
Doctors, pharmacists, nurses and other health professionals are required to report any suspected adverse reaction to medications and send it urgently to the corresponding Regional Pharmacovigilance Centre.
Following notification, the Agency's technical committee for pharmacovigilance assesses the importance of the reaction and adopts appropriate measures, which may include temporary or permanent withdrawal of the drug and, of course, informs all health care agents involved.
Although it is the competent authorities that must report and act in the event of discovering a possible adverse reaction, patients must also notify their doctor or pharmacist of any reaction apparently related to a medicine they are taking, in order to actively contribute to the safety of everyone.
Pharmacovigilance guarantees the safety of a medicine , since it ensures that the adverse effect detected has a much lower incidence than the benefit of its administration.
pharmacovigilance
Pharmacovigilance of vaccines
The Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), made up of the Autonomous Pharmacovigilance Centres and coordinated by the Spanish Agency for Medicines and Health Products (AEMPS), continuously assesses suspected adverse reactions reported in Spain with all authorised medicines, including vaccines.
Vaccines are special medicines and so is their regulation. Since millions of people are vaccinated, it is necessary to know about any adverse events that occur some time after vaccination and to analyse, among other factors, whether they occur more frequently than what is expected to occur in the general population. For this reason, any adverse event associated temporally after administration is recorded, without there being any suspicion that the vaccine may have caused it, since they may be medical problems that coincide in time or that are related to the act of vaccination itself.
In the event that the number of events recorded after vaccination is higher than what we expect to occur in the population, a broad and detailed evaluation is carried out with all the information available in the EU; the notifications collected in Spain are part of the European evaluations. Thus, the AEMPS, a public and independent body, together with the rest of the EU agencies and the coordination of the European Medicines Agency (EMA), carries out a continuous evaluation of the data to detect adverse reactions not identified during the clinical trials of the vaccines.
Pharmacovigilance therefore ensures that all medicines authorised for human use, including vaccines, are safe and that the probability of an adverse effect occurring is minimal, with the benefit provided by the treatment always being much greater.
What is the process that a drug follows for its use and distribution?
For a drug to be approved for human use, it goes through a series of stages, or drug cycle:
Phase I: Basic research
At this stage, a substance is proposed as a potential drug and its therapeutic target is established, that is, which molecule the drug is directed at. This stage is complex, since the discovery of a new drug is not easy, and it is a long process with a very low success rate. It is estimated that only 250 out of every 10,000 molecules from the basic research stage move on to the preclinical research phase.
Phase II: Preclinical
In this phase, the selected compound is analyzed in the laboratory to assess the safety of its administration in humans and its biological activity. The aim is to find out how the drug is distributed or eliminated from the body and to understand its effects, at different doses, on different organs and systems, among other objectives. To do this, tests are carried out on cells in culture, the drug is formulated and pharmacology and toxicology studies are carried out.
Phase III: Clinical
This phase of clinical research is necessary to find out how the drug works in people and to find out if it is a suitable and effective drug in treating the disease, with an optimal safety profile. It is a relatively long stage, where the safety of the compound is demonstrated, the appropriate doses are sought and the efficacy and safety of the experimental treatment are evaluated on a population selected for the study. It provides the basis for the approval of the drug.
Phase IV: Approval and Registration
At this stage, the application for marketing authorization for the drug is submitted to the relevant regulatory agencies.
Phase V: Continued surveillance
Once the drug has been approved and after its commercialization, continuous monitoring is carried out to study its effectiveness and safety in daily clinical use, since, when it comes onto the market, its use expands to thousands or millions of patients around the world, very different from each other, producing conditions and possible interactions not previously identified. This is the pharmacovigilance stage .
This detailed monitoring of any incidents that the product landline number format philippines may cause allows for the modification of information regarding recommendations for use, modification of information contained in side effects and allows the drug to be withdrawn from the market if necessary. This therefore guarantees patient safety.
Who participates in pharmacovigilance?
It is everyone's responsibility . It is a shared responsibility of health authorities, the pharmaceutical industry, healthcare professionals and citizens themselves. Its success depends on the collaboration of all the parties involved.
The Spanish Pharmacovigilance System was created in response to the need to monitor potential problems related to the use of medicines. In Spain, the old Medicines Law of 1990 already included the importance of health professionals participating in the protection of health, but it was not until 2002 when it was regulated by law (RD 711/2002, of July 19). Currently, this RD 711/2002 has been repealed and replaced by Royal Decree 577/2013, of July 26, which regulates the pharmacovigilance of medicines for human use .
Doctors, pharmacists, nurses and other health professionals are required to report any suspected adverse reaction to medications and send it urgently to the corresponding Regional Pharmacovigilance Centre.
Following notification, the Agency's technical committee for pharmacovigilance assesses the importance of the reaction and adopts appropriate measures, which may include temporary or permanent withdrawal of the drug and, of course, informs all health care agents involved.
Although it is the competent authorities that must report and act in the event of discovering a possible adverse reaction, patients must also notify their doctor or pharmacist of any reaction apparently related to a medicine they are taking, in order to actively contribute to the safety of everyone.
Pharmacovigilance guarantees the safety of a medicine , since it ensures that the adverse effect detected has a much lower incidence than the benefit of its administration.
pharmacovigilance
Pharmacovigilance of vaccines
The Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), made up of the Autonomous Pharmacovigilance Centres and coordinated by the Spanish Agency for Medicines and Health Products (AEMPS), continuously assesses suspected adverse reactions reported in Spain with all authorised medicines, including vaccines.
Vaccines are special medicines and so is their regulation. Since millions of people are vaccinated, it is necessary to know about any adverse events that occur some time after vaccination and to analyse, among other factors, whether they occur more frequently than what is expected to occur in the general population. For this reason, any adverse event associated temporally after administration is recorded, without there being any suspicion that the vaccine may have caused it, since they may be medical problems that coincide in time or that are related to the act of vaccination itself.
In the event that the number of events recorded after vaccination is higher than what we expect to occur in the population, a broad and detailed evaluation is carried out with all the information available in the EU; the notifications collected in Spain are part of the European evaluations. Thus, the AEMPS, a public and independent body, together with the rest of the EU agencies and the coordination of the European Medicines Agency (EMA), carries out a continuous evaluation of the data to detect adverse reactions not identified during the clinical trials of the vaccines.
Pharmacovigilance therefore ensures that all medicines authorised for human use, including vaccines, are safe and that the probability of an adverse effect occurring is minimal, with the benefit provided by the treatment always being much greater.