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Pharmacovigilance: science or bureaucracy?

To get started it is worth looking at the ways in which “bureaucracy” is used. According to Google definitions bureaucracy has 4 meanings: System of government in which most of the important decisions are taken by state officials rather than by elected representatives; State or organization governed or managed as a bureaucracy; The officials in a bureaucracy, considered as a group or hierarchy; Excessively complicated administrative procedure.

Lingua Inglese

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Farmacovigilanza: scienza o burocrazia?

Di che cosa stiamo parlando?

Per iniziare vale la pena di considerare come viene usata la parola “burocrazia”. Secondo Google definitions, burocrazia ha quattro significati:

Lingua Italiano

5 Percent Dextrose Injection USP in PAB Container by B. Braun Medical: Recall - Leakage and/or Particulate Matter

Intravenous administration of a non-sterile product can result in serious infections that may be life-threatening.

Lingua Italiano

OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc: FDA Safety Communication - Do Not Use

Patients and other users of the affected device are at risk for serious adverse health consequences, such as burns and death.

Lingua Italiano

Compounded Products by Reliable Drug Pharmacy: Recall - Potential for Mislabeling and Lack of Quality Assurance

Stop using recalled product immediately and arrange for the return of unused product.

Lingua Italiano

Best Bentonite Clay by Best Bentonite: FDA Alert - Risk of Lead Poisoning

Exposure to lead can cause serious damage to the central nervous system, kidneys, and immune system.

Lingua Italiano

NOW Health Group Dietary Supplements: Recall - Mislabeling

People with an allergy or severe sensitivity to soy risk serious or life-threatening allergic reaction if they consume these products.

Lingua Italiano

Nota Informativa Importante su Zydelig (idelalisib) (23/03/2016)

L'Agenzia Italiana del Farmaco rende disponibili nuove e importanti informazioni sulle limitazioni all’uso di Zydelig (idelalisib) per il
trattamento della leucemia linfatica cronica (LLC) e del linfoma
follicolare (LF) recidivato in seguito ai nuovi risultati delle
sperimentazioni cliniche.

Lingua Italiano

Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications

FDA is warning about several safety issues with the class of opioid pain medicines, including serotonin syndrome, adrenal insufficiency, and androgen deficiency.

Lingua Italiano

Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter

Administration of product with particulates may result in localized inflammation, allergic reaction including anaphylaxis, granuloma formation, microembolic effects, or delay of therapy.

Lingua Italiano

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