[From the "note limitative" to the "registri AIFA"]

Recenti Prog Med. 2013 Jun;104(6):229-35. doi: 10.1701/1295.14322.
[Article in Italian]

Abstract

In Italy, over the past 10 years, we have had a proliferation of registers associated with the reimbursement of drugs by the National Health Service. The regulatory path that made them grow comes from the so-called "note limitative" and treatment plans associated with the use of certain drugs. From these experiences different types of registries have been created that collect, at the time of prescription, information about the safety and appropriateness of use of medication where a benefit-risk profile in the general population is still not well defined. The critical analysis of some of these experiences can present positive and negative aspects associated with a regulatory reality now used in clinical practice nationwide.

MeSH terms

  • Alzheimer Disease / drug therapy
  • Anti-Infective Agents / therapeutic use
  • Cholinesterase Inhibitors / therapeutic use
  • Drug Industry*
  • Humans
  • Italy
  • Protein C / therapeutic use
  • Psoriasis / drug therapy
  • Recombinant Proteins / therapeutic use
  • Registries*
  • Sepsis / drug therapy

Substances

  • Anti-Infective Agents
  • Cholinesterase Inhibitors
  • Protein C
  • Recombinant Proteins
  • drotrecogin alfa activated