Drugs are designed to provide benefits for health. Before a drug is launched on the market, it must be authorised by the Spanish Ministry of Health and Consumption. In turn, before it is authorised, its effects (either beneficial or adverse effects) must be examined. These studies are the so-called clinical essays.

However, these studies are to some extent limited, as they are made in few patients, during a limited period of time, and in a selected population, so some adverse effects, for instance those being rare or those produced by continuous use, are not detected during clinical essays.

When the drug is launched on the market and is used by the general public, in common practices, adverse effects can be detected through the Drug Surveillance System.

What is an adverse reaction?

An adverse reaction is an unwanted or harmful reaction in normal therapeutic use, following the administration of a traditional medicinal product and is suspected to be related to the product. The reaction may be a known side effect of the traditional medicine or it may be a new previously unrecognised adverse reaction.

Adverse reactions include those that are:

• Fatal
• Life-threatening
• Disabling or incapacitating
• Result in or prolong hospitalisation

What is drug surveillance?

Drug surveillance is a Public Health activity responsible for identifying, quantifying, assessing and preventing risks associated with the use of marketed drugs.

The activity’s results constitute a basis for health authorities to adopt decisions enabling to keep on the market drugs that permit a favourable relationship between benefits for health and risk for adverse reactions that could occur as a result of their use.

All agents engaged in the use of drugs (pharmaceutical laboratories, health authorities, doctors, chemists, infirmary staff, and patients or their carers) are responsible for sharing information to the maximum to use them adequately, and identifying, as soon as possible, severe or unknown adverse reactions to prevent or reduce their frequency or seriousness at the moment when authorisation is obtained.

Reports on adverse reactions

The Spanish Drug Surveillance System is responsible for collecting, assessing and recording suspected adverse reactions in drugs, which are reported by health professionals, and trying to early identify possible risks associated with the use of medicines.

The Drug Surveillance Centre of Catalonia, adhered to the Department of Health, together with other 16 autonomous centres, and other coordinating centre adhered to the Spanish Agency for Drugs, are working with a unique assessment and identification method for risks associated with marketed products.

Adverse reaction reporting is the Spanish Drug Surveillance System’s core duty.

Who can report?

Health professionals should report of medicine’s suspected adverse reactions in a patient in Catalonia.

Direct reporting from patients is not accepted, as a clinical interpretation of results is due. Patients who suspect are affected by a medicine adverse reaction must contact a doctor or pharmacist.

What to report

All suspected medicine adverse reactions should be reported. However, should priorities be set, it is recommended to report, notably:

• All suspected reactions in patients treated with medicines recently introduced (in the last five years).
• All suspected reactions being fatal, life-threatening, resulting in or prolonging patient’s hospitalisation , and also congenital malformations and irreversible effects.

How to report an adverse reaction

Reporting must be made through a standard form known as Yellow Card, which is send to a drug surveillance autonomous centre. You can also report suspected adverse reactions to the Drug Surveillance Centre hotline on 934 274 646.

At present, you can also report adverse reactions by e-mail at:

https://www.icf.uab.es/farmavigila/tarjetag/formulari/targeta.asp

Once you have completed this form, you must send it to the Drug Surveillance Centre of Catalonia by Internet. The information you provide will be kept safe, secure, and confidential. The explorer will inform you when a safe connection is established.

When a case occurs, it can also be reported to the sales delegate, to the corresponding pharmaceutical laboratory medical staff or even it can be published in a biomedical magazine. These possibilities are not exclusive, but the most important thing is to inform health authorities through reporting to a Drug Surveillance Centre.

How does the system work?

When reports arrive to drug surveillance autonomous centres, they are codified, assessed, and recorded in the common data base, the so-called FEDRA (Spanish Drug Surveillance of Adverse Reaction Data). This process is done so that data confidentiality is granted, both from the patient and from the reporter.

Reports are always suspected adverse reactions and causality factors must be analysed, such as the causality between drug therapy and a patient’s clinical event.

Information in FEDRA’s database is regularly assessed to early identify possible security problems derived from the use of drugs. This process is known as signal generation . These signals are contrasted within the Spanish Drug Surveillance System and are reported to the Drug Security Committee, the Spanish Drug Agency, and the Spanish Ministry of Health and Consumption.

On the basis of this information, decisions are taken on drug administration or withdrawal from the market.

Conclusion

On the basis of health professional reporting initiative, information on adverse reactions is collected. Although it is only based on suspected effects that could be possibly associated with the drug used, they serve to give some guidance on new possible risks which enable the creation of work hypothesis. Sometimes, this information is enough for the adoption of regulating measures that consist in the modification of authorised conditions of use, the incorporation of a new contraindication in the product technical sheet, new information on adverse reactions or the product’s withdrawal from the market.