Lecture 24 - pharmacoepidemiology Flashcards
what are the processes after introduction of a new medicine?
new medicine
marketing authorisation - EMA or MHRA
Health Technology Appraisal (SMC or NICE)
Local Formulary consideration and subsequent implementation
what are licensing conditions ?
EMA (European Medicines Agency)
MHRA – Medicines and Healthcare Regulatory Authority
Restrictions within the license
Risk Management Plans
Manufacturer responsibility
what is an example of health technology consortium?
Scottish medicine consortium
consortium of Area Drug and Therapeutics Committees (ADTCs) of 14 NHS Boards
provides Health Technology Assessment (HTA) for all new medicines and indications
part of Healthcare Improvement Scotland (HIS)
what are the functions of the SMC ?
mew medicines assessment: all new medicines, new indications/ license extensions and new formulation. provide advice as close as possible to the lauch.
horizon scanning- support health broad financial planning by providing intelligence on emerging medicines
Describe the SMC assessment process.
manufacture submits new medicine
Critical appraisal of data by pharmacist and economist
NDC presentation of case yer or no
The company can respond to this decision, possibly providing clarification or new analysis
SMC meeting presentation fo final case and decision
final advice issues on sec website
what us drug utilisation and pahrmacoepidemiology?
Drug Utilisation Research
studies on the marketing, distribution, prescription and use of drugs in a society
Pharmacoepidemiology
- the study of the utilisation and effects of drugs in large numbers of people
what are different databases that can allow prescribing information system to support evidence generation ?
National databases such as hospital records, maternity records, outpatient records, laboratory records, and the national death registry feed into the PIS. Additionally, it incorporates data from other databases, including disease audits, children’s education records, lifestyle studies, medical screening programs, and sociodemographic information
what can risk prediction tools do?
Create prediction models for the risk of acquiring a healthcare associated infection (HAI)
Vision: real time data were available, could aid clinical decision making at point of GP consultation/hospital admission
what do we have nationally in our medical toolkit ?
PIS; Prescribign infirmation system
HEPMA hospital medicines utilisation database
SACT systemic anticancer Treatments
Homecare
