PMID- 22702638
OWN - NLM
STAT- MEDLINE
DCOM- 20121023
LR  - 20211021
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 35
IP  - 7
DP  - 2012 Jul 1
TI  - Impact of regulatory guidances and drug regulation on risk minimization 
      interventions in drug safety: a systematic review.
PG  - 535-46
LID - 10.2165/11599720-000000000-00000 [doi]
AB  - BACKGROUND: Therapeutic risk management has received growing interest in recent 
      years, particularly since the publication of regulatory guidances in 2005 and 
      2006, paralleled with a change in drug regulation. The characteristics of risk 
      minimization interventions (RMIs) that have been implemented or approved remain 
      inadequately explored. OBJECTIVE: The aim of this study was to review RMIs 
      published in the literature or posted on regulatory agency websites over the past 
      10 years, and to assess whether publication of regulatory guidances on risk 
      management is associated with changes in the number and types of interventions. 
      METHODS: Sources were searched for RMIs published/posted between 1 January 2000 
      and 31 December 2009. For the literature search, MEDLINE and EMBASE databases 
      were used using key words related to drug safety (i.e. 'drug toxicity') and the 
      individual RMI names. The website review involved searches of major regulatory 
      authority websites such as the European Medicines Agency, US FDA, Health Canada, 
      the UK's Medicines and Healthcare products Regulatory Agency, Japan's 
      Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods 
      Administration. The following eligibility criteria were applied for inclusion in 
      the review: published/posted between the years 2000 and 2009, inclusive; 
      involving drug products; use in humans; and involving RMIs, or tools used to 
      increase the reporting of adverse events (AEs). Natural healthcare products, 
      devices, diagnostic chemicals, pregnancy registries without follow-up, medication 
      errors and products not used as therapy for illness were not retained. For each 
      source, the following characteristics were extracted: nature of the intervention, 
      target population, therapeutic area, AE(s) of special interest, 
      country/regulatory agency and year of publication. RESULTS: A total of 119 unique 
      interventions were identified in the literature (54 published in 2000-4 and 65 
      published in 2005-9). Interventions included educational material (n = 37; 31%), 
      black-box warnings (n = 22; 19%) and therapeutic drug monitoring (n = 11; 9%). 
      The website review produced a total of 1112 interventions: 326 posted between the 
      years 2000 and 2004, and 786 between the years 2005 and 2009. The main 
      interventions observed were: educational material (n = 956; 86%), black-box 
      warnings (n = 45; 4%) and withdrawals (n = 39; 4%). LIMITATIONS: Additional 
      regulatory resource websites were available in the post-guidances periods that 
      were not available in the earlier years of the pre-guidances periods, and may 
      bias the post-guidances results. Also, not all global regulatory websites were 
      searched. Finally, only English-language websites were searched, limiting the 
      variation of RMIs observed. Classification and categorizing for this particular 
      review may not be consistent with future reviews by other researchers. 
      CONCLUSION: The US is the sole region with a substantial increase in published 
      RMIs during the post-guidances period, while the EU, Japan and the US all 
      indicated an increase in the number of interventions on their websites.
FAU - Nkeng, Lenhangmbong
AU  - Nkeng L
AD  - Faculty of Pharmacy, Universite de Montreal, QC, Canada.
FAU - Cloutier, Anne-Marie
AU  - Cloutier AM
FAU - Craig, Camille
AU  - Craig C
FAU - Lelorier, Jacques
AU  - Lelorier J
FAU - Moride, Yola
AU  - Moride Y
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*legislation & 
      jurisprudence/standards/trends
MH  - Drug and Narcotic Control/*legislation & jurisprudence/methods/trends
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Risk
EDAT- 2012/06/19 06:00
MHDA- 2012/10/24 06:00
CRDT- 2012/06/19 06:00
PHST- 2012/06/19 06:00 [entrez]
PHST- 2012/06/19 06:00 [pubmed]
PHST- 2012/10/24 06:00 [medline]
AID - 2 [pii]
AID - 10.2165/11599720-000000000-00000 [doi]
PST - ppublish
SO  - Drug Saf. 2012 Jul 1;35(7):535-46. doi: 10.2165/11599720-000000000-00000.