What are the key components of the risk-management plan?
The main components of the risk-management plan are preventive measures and surveillance. Preventive Measures include: • education • tailored distribution • Schedule III control under the Controlled Substances Act (CSA) • child resistant packaging • supervised dose induction The risk management plan uses many different surveillance approaches. Some active methods include plans to: • Conduct interviews with drug abusers entering treatment programs. • Monitor local drug markets and drug using network areas where these medicines are most likely to be used and possibly abused. • Examine web sites. Additionally data collection sources can indicate whether Subutex and/or Suboxone are implicated in abuse or fatalities. These include: • DAWN —The Drug Abuse Warning Network. This is run by the Substance Abuse and Mental Health Services Administration (SAMHSA) which publishes a collection of data on emergency department episodes related to the use of illegal drugs or non-medical use of a legal d