RT Book, Section
A1 Waning, Brenda
A1 Montagne, Michael
SR Print(0)
ID 2643161
T1 Chapter 8. Post-Marketing Surveillance
T2 Pharmacoepidemiology: Principles and Practice
YR 2001
FD 2001
PB The McGraw-Hill Companies
PP New York, NY
SN 9780071355070
LK accesspharmacy.mhmedical.com/content.aspx?aid=2643161
RD 2024/04/23
AB Post-marketing  surveillance  (PMS)  is  the  identification  and  collection  of  information  regarding  medications  after  their  approval  by  the  U.S.  Food  and  Drug  Administration  (FDA).  Systematic  PMS  of  drugs  began  in  the  early  1970s  and  has  increased  substantially  since  then.  The  monitoring  of  drugs  after  their  approval  has  become  necessary  for  many  reasons.  In  the  1950s  and  1960s,  there  were  fewer  drugs  available  and,  thus,  fewer  drugs  to  monitor.  Today,  drugs  are  being  developed  and  consumed  at  increasingly  high  rates.  Other  factors  contributing  to  the  need  for  PMS  include  changes  in  the  FDA’s  approval  process.  As  discussed  in  Chapter  4,  this  lengthy  process  has  been  criticized.  The  FDA  has  responded  by  developing  channels  and  opportunities  for  patients  in  need  to  obtain  critical  drugs.  As  a  result,  the  dangers  associated  with  use  of  some  drugs  may  not  be  determined  in  the  premarketing  phase.