What is a RAMS form?

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The Pharmacovigilance method used by the National Pharmacovigilance Program is spontaneous notification, which consists of communicating to the ISP, by a health professional, health care center or health registration holders, the suspicions of adverse drug reactions of which it becomes aware, including dependence, abuse, misuse and lack of efficacy.

In Chile, two systems are in place for reporting suspected adverse drug reactions to the National Pharmacovigilance Center, the Manual Reporting System and the Online Reporting System. Regardless of which route is used, it is important to keep in mind that each individual case should be reported only once.

Information related to the notification process, deadlines and means of reporting can be found in the Instructions for the Notification of Suspected Adverse Drug Reactions and in the Safe Vaccination Guide.

The online notification system or RAM Network is intended to facilitate the notification process for health professionals in health care centers, and at the same time it constitutes a local registration system for adverse reactions reported by the center, it favors the internal management of notifications and communication with the National Center for Pharmacovigilance.

How to notify a RAM?

2. How should citizens report? Citizens can report suspected adverse drug reactions either through a healthcare professional or directly through the electronic form (https://www.notificaRAM.es).

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What is Notifacedra?

Noti-FACEDRA is a software tool that will allow the online notification process of suspected adverse drug reactions to the National Pharmacovigilance Centers in Central America and the Dominican Republic.

When do I report an adverse drug reaction?

When there is a suspicion of a possible relationship between the signs and symptoms of an adverse reaction in the patient and the use of a drug. Do not limit yourself because the adverse reaction is common or seemingly insignificant, as reporting it may help identify drug safety problems.

Clozapine pharmacovigilance

Its objective is to generate early “alerts” about the possibility that a drug may be the cause of an adverse reaction. Suspicions are requested, not certain diagnoses, and all healthcare professionals are required to report their suspicions because only if they appear repeatedly will they cease to be suspicions.

The Spontaneous Reporting Program is a pharmacovigilance method based on the reporting, collection, recording and evaluation of reports of suspected adverse drug reactions.

The notification forms are sent to the Pharmacovigilance Center where the ADRs are evaluated, coded and incorporated into a national database (FEDRA) which in turn is connected to the WHO central database. The analysis of this information allows health authorities to take specific regulatory measures in the event of adverse reactions, including withdrawal from the market.

Which agency is responsible for performing adverse drug reaction reporting functions?

Institute of Public Health of Chile.

What adverse reactions are to be reported?

SUSPECTED adverse reactions associated with any type of authorized drug (conventional prescription and non-prescription drugs, magistral formulas, officinal preparations, vaccines, homeopathic drugs, medicinal plants) should be reported.

Where to report adverse effects?

What should I do if I detect that an adverse event has occurred after vaccination? You should report it to the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H). You can do this directly or through a health care professional (e.g., physician, pharmacist or nurse).

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Facedra

An adverse drug reaction (ADR) is any unwanted and unintended noxious response that occurs after the administration of a drug, at doses commonly used in humans to prevent, diagnose or treat a disease and those resulting from dependence, abuse and misuse of drugs (use outside the terms of the marketing authorization and medication errors).

It is important to differentiate between ADRs and adverse events, since they are not always the same thing. In the case of an ADR, there is a suspicion that the undesirable event that has occurred was caused by the drug (hypoglycemia after the administration of insulin), whereas in the case of an adverse event there is no need for a causal relationship with the drugs administered (for example, trauma due to a sudden fall of a person who was taking antihypertensives).

In the USA, ADRs are the 4th-6th cause of death, account for more than 10% of the causes of hospital admissions and 15-20% of hospital budgets are spent on the treatment of ADRs.

How long does it take for the side effects of a drug to wear off?

Some last for a few days or weeks and others continue throughout treatment and even after treatment has ended. Some occur within the first few days or weeks of taking a medication. Others only become obvious after months or years of therapy. WHO SUFFERS FROM SIDE EFFECTS?

What harm is generated by adverse events associated with drug use in general?

These events may cause harm to the patient as they cause incapacity at discharge, patient monitoring, pharmacological treatment or transient intervention, hospitalization and/or temporary prolongation, near-death event: anaphylaxis, cardiac arrest, death of the patient.

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What to do in case of suspected adverse drug reactions?

If you experience adverse reactions while taking your medication, write them down and call your physician. The National Center for Pharmacovigilance will receive it, perform the respective analysis and evaluation, and enter the information into the National Database of Suspected ADRs.

Pharmacovigilance report

Revista Alergia México is the official organ of the Colegio Mexicano de Inmunología Clínica y Alergia, A. C. and the Sociedad Latinoamericana de Alergia, Asma e Inmunología. The journal is open to members of the College and the medical community for the dissemination of medical-scientific knowledge.

The main purpose of the Revista Alergia México is to publish the knowledge resulting from original research in Allergy and Clinical Immunology and to disseminate updated and relevant information regarding trends, methodologies and techniques used in the investigation of immunological diseases.