WHO Drug Information:In Catalonia, spontaneous reporting was established, and continues to be developed, as part of a broader communications strategy of drug monitoring between the Clinical Pharmacology Un
it and prescribers. It also encompasses a continuous education activity, mainly for health professionals, health managers, policy makers, and politicians working in the health sector. A major contribution of the clinical pharmacology unit to public health was a change in prescription patterns in Catalonia. In 1984, many of the most highly prescribed pharmaceutical products in the health system lacked evidence of therapeutic efficacy, or were simply irrational fixed-dose combinations.
In comparison, the most highly prescribed medicines in 2007 had betterevidence of efficacy.
The initial pharmacovigilance system received very strong institutional support from the Ministry of Health, which understood the need for collaboration with
health professionals independent from the Ministry of Health and public administration, and of communication and making alliances with people working in Universities and hospital structures because of their closer access to prescribers. Spain’s integration into the European Union was also positive in establishing regulatory measures for the licensing of new drugs and safety monitoring.
The programme was then extended to other Spanish regions and the Spanish
Agency for Medicines and Health Products (AEMPS) now maintains a central
database, FEDRA, containing 140 000 reports. All the 17 Pharmacovigilance
Regional Centres regularly publish bulletins with information on their findings
and on drug safety issues.
In all these twenty-seven to twenty-eight years since its establishment, the Spanish pharmacovigilance system has produced many important results in the field of public health.
Examples of signals leading to market withdrawals :
agranulocytosis – cinepacide
hepatitis – bendazac
Guillain Barré syndrome – gangliosides
hepatitis – droxicam
hypersensitivity and hepatotoxicity –
glafenine
agranulocytosis – pyrithyldione
hepatotoxicity – ebrotidine
rhabdomyolysis – cerivastatin
liver toxicity – nimesulide
hepatitis – green tea extract
extrapyramidal and psychiatric
reactions – veralipride.
Examples of signals leading to changes in approved indications
and conditions of use:
Parkinsonism and depression –
cinnarizine and flunarizine
taste disorders – citiolone
acute dystonic disorders – clebopride
TB infection – infliximab
(This last signal was generated by a Sao Paulo University Hospital, where a Pharmacovigilance system was set up with the collaboration of the Catalan Institute of Pharmacology.)
Of note, many of the drugs involved had no evidence of efficacy, and this benefitrisk assessment was straightforward. In addition, many of the adverse reactions were type B (not related to the expected pharmacological effect, not dose-related, etc.).
Traditionally, monitoring of medicines safety has mainly relied on spontaneous
reporting, especially for detecting type B effects. In Spain, spontaneous reporting also proved to be helpful in clearing the market of irrational and useless medicines.
– and even harmful and ineffective drugs. However, although spontaneous
reporting has proved to be useful in detecting these type B reactions and
some type A effects, the surveillance of medicines safety should include other
pharmacoepidemiological methods. Since the drug-induced disease burden consists mainly of type A effects, the challenge is a risk evaluation of these, not only in relative terms but in the amount of deaths or hospitalizations caused by drugs in our societies.
The following represent examples of pharmacoepidemiological methods used
in recent years to asses some important drug safety problems:
1. Randomized clinical trials (RCTs) and meta-analysis of randomized clinical trials for assessing the relationship between:
• Hormone replacement therapy and breast cancer, myocardial infarction,
thromboembolic disease, cerebrovascular accidents.
- Epoetins and hypertension and cardiovascular risk.
2. Longitudinal follow-up of unselected patients for assessing the relationship
between risk of haemorrhage and use of oral anticoagulants.
3. Observational studies, meta-analysis of observational studies and meta-analysis of RCTs for assessing the risk of myocardial infarction with rofecoxib, other COX-2 and other NSAIDs .
4. Spontaneous reporting, observational studies, and meta-analysis of RCTs for
gastrointestinal bleeding and NSAIDs and antiplatelet drugs.
5. Meta-analysis of RCTs for assessing the risk of myocardial infarction and death with inhaled anticholinergic drugs.
Special attention must also be paid to drug utilization patterns; not only how
much medicine is consumed, but how it is consumed in real practice.
Reporting and publication of adverse drug reactions is a responsibility of
regulatory agencies. However, adverse effects of medicines are experienced first
hand in clinical practice, and therefore pharmacovigilance is mainly a matter of collaboration and communication within the health system and health care provider organizations and among all other partners of the health care system.
The Spanish pharmacovigilance system was conceived not only for regulatory
purposes but also as part of a broader communication strategy between the
university and prescribers.
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EN EL SIGUIENTE MENSAJE EN ESPAÑOL: TRADUCTOR INTERNET.
A ESTA "ASOCIACION" NOS CONSTA: QUE TANTO EN LA AGENCIA EUROPEA DEL MEDICAMENTO Y COMO SE LEEN AQUI, OMS, A LA " FUNDACIÓ INSTIRUT CATALÁ DE FARMACOLOGIA", BUENO CON LAS PABRABRAS EXACTAS, NO SABRIA DECIRLOS " SON ESTUDIADOS Y TENIDOS MUY ENCUENTA, TODOS SUS ESTUDIOS Y SE CUENTAN CON SUS ESTUDIOS PARA CUALQUIER DECISIÓN QUE SE VAYA A TOMAR "SOBRE LOS MEDICAMENTOS" EN AMBOS ORGANISMOS EUROPEOS E INTERNACIONES.
