Risk Management Plans: are they a tool for improving drug safety?

被引:30
作者
Frau, Serena [1 ]
Pous, Maria Font [1 ]
Luppino, Maria Rosa [2 ]
Conforti, Anita [3 ]
机构
[1] Dialogo Farm, Dept Pharmaceut, Verona Local Hlth Unit, I-37122 Verona, Italy
[2] Univ Messina, Pharmacol Unit, Dept Clin & Expt Med & Pharmacol, Messina, Italy
[3] Univ Verona, Clin Pharmacol Unit, I-37100 Verona, Italy
关键词
Risk management; Risk assessment; Safety management; Surveillance programs; Hazard; Postmarketing product surveillance;
D O I
10.1007/s00228-010-0848-8
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-marketing safety issues. Of the 90 new Chemical Entities approved through a centralised procedure by the EMA during 2006 and 2007, 15 of them were selected and their safety aspects and relative RMPs analysed. All post-marketing communications released for safety reasons related to these drugs were also considered. A total of 157 safety specifications were established for the drugs assessed. Risk minimisation activities were foreseen for 5 drugs as training activities. Post-marketing safety issues emerged for 12 of them, leading to 39 type II variations in Summary of Product Characteristics (SPC). Nearly half of such variations, 19 (49%), concerned safety aspects not envisaged by the RMPs. Besides this, 9 Safety Communications were published for 6 out of 15 drugs assessed. The present study reveals several critical points on the way RMPs have been implemented. Several activities proposed by the RMPs do not appear to be adequate in dealing with the potential risks of drugs. Poor communication of risk to practitioners and to the public, and above all limited transparency for the total assessment of risk, seem to transform RMPs into a tool to reassure the public when inadequately evaluated drugs are granted premature marketing authorisation.
引用
收藏
页码:785 / 790
页数:6
相关论文
共 10 条
  • [1] [Anonymous], EPARs for authorised medicinal products for human use: Urorec
  • [2] Paying for drug approvals - Who's using whom?
    Avorn, Jerry
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2007, 356 (17) : 1697 - 1700
  • [3] Safe Drugs and the Cost of Good Intentions
    Eichler, Hans-Georg
    Abadie, Eric
    Raine, June M.
    Salmonson, Tomas
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2009, 360 (14) : 1378 - 1380
  • [4] Garattini S, 2010, BMJ-BRIT MED J, V340, P842
  • [5] How can we regulate medicines better?
    Garattini, Silvio
    Bertele', Vittorio
    [J]. BMJ-BRITISH MEDICAL JOURNAL, 2007, 335 (7624): : 803 - 805
  • [6] Patients and the public deserve big changes in evaluation of drugs
    Garattini, Silvio
    Chalmers, Iain
    [J]. BRITISH MEDICAL JOURNAL, 2009, 338
  • [7] Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory Approval
    Giezen, Thijs J.
    Mantel-Teeuwisse, Aukje K.
    Straus, Sabine M. J. M.
    Egberts, Toine C. G.
    Blackburn, Stella
    Persson, Ingemar
    Leufkens, Hubert G. M.
    [J]. DRUG SAFETY, 2009, 32 (12) : 1175 - 1187
  • [8] *MHRA CHM, 2009, MHRA DRUG SAF UPDATE, V8, P6
  • [9] 2008, FDA DRUG SAFETY NEWS, V2, P12
  • [10] EUDRALEX A, V9