Pharmacovigilance
What is Pharmacovigilance and why is it so important?
Pharmacovigilance is the process and science that monitors drug safety and acts to reduce risks and increase drug benefits.
Pharmacovigilance includes:
- The collection, management and analysis of safety information for medicines.
- Monitoring information to detect “signals” or security issues.
- Any action to protect patients and public health.
- Communication with health professionals or regulatory authorities (eg INFARMED).
What is an adverse event?
An adverse event is any unfavorable medical occurrence in a patient or an individual to whom a medicament has been administered and which does not necessarily have a causal relationship with this treatment. This may include (but is not limited to):
- Side effects with medicines (eg rash, redness, edema).
- Illness (eg contracting infection after administration of a medicine).
- Aggravation of a disease.
Which may or may not be related to the medicine.
What is an adverse drug reaction?
The adverse reaction to a drug (ADR) is defined as any unintentional harmful or undesirable response to a drug in which it is possible to observe a causal relationship between the use of the drug and the occurrence of the adverse reaction. Thus, ADR is considered a type of adverse event. Adverse reactions can be serious (eg life-threatening, prolonged hospitalization) or non-serious.
Reporting suspected adverse drug reactions allows the detection of signs associated with drug safety, which may lead to:
- Detection of new adverse drug reactions.
- Change in frequency of adverse reactions already known.
- Identification of new drug interactions.
- Questions relating to the method of use of the medicinal product.
- Better knowledge of the drug profile.
Who should report adverse drug reactions?
Mainly doctors, pharmacists, nurses or other health professionals. In the event of a suspected adverse reaction, including side effects not indicated in the package leaflets, the patient may share the case with his or her healthcare professional, nurse or pharmacist so that the person can notify the competent authorities or notify the INFARMED through the contacts below. When reporting side effects, you are helping to provide more information about drug safety.
INFARMED, I.P.
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisboa
Tel.: +351 217 987 373
Medication Line: 800 222 444 (toll-free line)
Fax: + 351 217 987 397
Website: http://extranet.infarmed.pt/page.seram.frontoffice.seramhomepage
E-mail: farmacovigilancia@infarmed.pt
Surveillance of Medical Devices
Health professionals or users may communicate to SPCare any incidents resulting from the use of medical devices distributed by SPCare. You can also contact INFARMED, I.P., Health Products Surveillance Unit
Tel.: +351 217 987 145
Fax: +351 211 117 559
E-mail: dvps@infarmed.pt
Health professionals may submit reports of suspected adverse reactions associated with medicinal products distributed by SPCare and any incidents resulting from the use of medical devices distributed by SPCare through its toll-free 800 203 826 or farmacovigilancia@spcare.pt or by contacting one of the urgency numbers on this portal.
Implementation of Safety Devices in the Packaging of Medicines
According to the World Health Organization, between 100,000 and 1 million people are victims of counterfeit drugs every year. In Portugal, drug purchases on the Internet are the big problem.
There are several levels of intervention by the European Union to protect the legal supply chain. These include the implementation of safety devices on the packaging.
As from 9 February 2019, prescription medicines in general must have a unique identifier (DATAMATRIX) and an adulteration prevention device in all countries of the European Union.
The principles of the pan-European coding and serialization system for medicinal packaging are as follows:
- Application of safety devices: inviolable packaging and unique serial number.
- Ensuring the same level of security throughout the distribution chain.
- Implementation of a harmonized coding and identification system throughout Europe.
- Interoperability between national product verification systems.
- Verification of all packaging’s serialized at the dispensing point, and there may be intermediate checks depending on the risk or in exceptional situations.
- Maximization of the potential benefits of packaging serialization by integrating batch and validity into the coding system.
- Protection of data privacy.
- Simple, robust and cost-effective solution.
QUALITY
The wholesale distribution is an activity that integrates the circuit of the medicine for human use, or circuit of the medical device, and is therefore subject to obtaining an authorization to exercise it, with INFARMED, I.P. The wholesale distribution authorization implies compliance with Good Distribution Practices. SPCare meets the quality requirements of pharmaceutical distributors and is regularly inspected by national health authorities, INFARMED.
SPCare:
Aut. n.º AO41/H/2008
Aut. n.º 005/DM/2012
Alloga:
Aut. N.º A025/03/H/001/2003
Address: Rua Claudio Galeno – Edif. Alloga
Cabra Figa 2635 – 154 Rio de Mouro