-
Je něco špatně v tomto záznamu ?
Impact of EU risk assessment process and administrative regulations for manufacturers of combined hormonal contraceptive prescribing. An analysis of developments in Germany and the implications
I. Selke Krulichová, GW. Selke, U. Eichler, V. Lappe, B. Godman, I. Schubert,
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, práce podpořená grantem
- MeSH
- dospělí MeSH
- farmaceutický průmysl zákonodárství a právo MeSH
- hodnocení rizik * MeSH
- kontraceptiva orální kombinovaná * MeSH
- lékové předpisy * normy statistika a číselné údaje MeSH
- lidé MeSH
- mladý dospělý MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladý dospělý MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Německo MeSH
OBJECTIVE: Combined hormonal contraceptives (CHC) exhibit differing risks for cardiovascular and thrombotic events (VTE). A European referral process confirmed higher VTE risks for 3rd generation gestagens and drospirenone. CHC are now grouped in risk classes (RC) I, II, and III, with RC III having a higher risk than RC I and X (risk not yet known). Marketing authorization holders were obliged to implement pharmacovigilance measures and risk minimization measures including changes of prescribing information. The study assessed whether these activities induced changes in prescription patterns. METHODS: German prescription data for 1.1 million women below 20 years of age were used to analyze the effects of interventions and potential influence factors using logistic regression. Descriptive statistics were calculated for prescriptions for 3.3 million women from January 2011 to March 2016. RESULTS: Shares of RC I and RC X recipients rose substantially over the observation period, while RC III recipient share showed a steady decrease. The referral induced a slightly faster decrease in RC III and increase in RC X. The implementation of pharmacovigilance measures manifested no additional effect. CONCLUSION: The decrease in RC III share already observed before the referral process can be explained with pre-existing discussions around CHC. The effect attributable to the referral was statistically significant, although very small. While evidence for a connection between interventions and prescription change is only indirect, the study shows that routine data are suitable for impact analyses, and monitoring prescribing patterns can be recommended as feedback after regulatory or political interventions. This is being followed up.
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc20006747
- 003
- CZ-PrNML
- 005
- 20200525100524.0
- 007
- ta
- 008
- 200511s2019 xxk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1080/03007995.2018.1541317 $2 doi
- 035 __
- $a (PubMed)30362365
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxk
- 100 1_
- $a Selke Krulichová, Iva $u a Department of Medical Biophysics, Faculty of Medicine in Hradec Králové , Charles University , Hradec Králové , Czech Republic.
- 245 10
- $a Impact of EU risk assessment process and administrative regulations for manufacturers of combined hormonal contraceptive prescribing. An analysis of developments in Germany and the implications / $c I. Selke Krulichová, GW. Selke, U. Eichler, V. Lappe, B. Godman, I. Schubert,
- 520 9_
- $a OBJECTIVE: Combined hormonal contraceptives (CHC) exhibit differing risks for cardiovascular and thrombotic events (VTE). A European referral process confirmed higher VTE risks for 3rd generation gestagens and drospirenone. CHC are now grouped in risk classes (RC) I, II, and III, with RC III having a higher risk than RC I and X (risk not yet known). Marketing authorization holders were obliged to implement pharmacovigilance measures and risk minimization measures including changes of prescribing information. The study assessed whether these activities induced changes in prescription patterns. METHODS: German prescription data for 1.1 million women below 20 years of age were used to analyze the effects of interventions and potential influence factors using logistic regression. Descriptive statistics were calculated for prescriptions for 3.3 million women from January 2011 to March 2016. RESULTS: Shares of RC I and RC X recipients rose substantially over the observation period, while RC III recipient share showed a steady decrease. The referral induced a slightly faster decrease in RC III and increase in RC X. The implementation of pharmacovigilance measures manifested no additional effect. CONCLUSION: The decrease in RC III share already observed before the referral process can be explained with pre-existing discussions around CHC. The effect attributable to the referral was statistically significant, although very small. While evidence for a connection between interventions and prescription change is only indirect, the study shows that routine data are suitable for impact analyses, and monitoring prescribing patterns can be recommended as feedback after regulatory or political interventions. This is being followed up.
- 650 _2
- $a dospělí $7 D000328
- 650 12
- $a kontraceptiva orální kombinovaná $7 D003277
- 650 _2
- $a farmaceutický průmysl $x zákonodárství a právo $7 D004345
- 650 12
- $a lékové předpisy $x normy $x statistika a číselné údaje $7 D011307
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a hodnocení rizik $7 D018570
- 650 _2
- $a mladý dospělý $7 D055815
- 651 _2
- $a Německo $7 D005858
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Selke, Gisbert W $u b AOK Research Institute (WIdO) , Berlin , Germany.
- 700 1_
- $a Eichler, Uwe $u b AOK Research Institute (WIdO) , Berlin , Germany.
- 700 1_
- $a Lappe, Veronika $u c PMV research group, Clinic and Policlinic for Psychiatry, Psychosomatics and Psychotherapy of Children and Adolescents, Cologne University , Germany.
- 700 1_
- $a Godman, Brian $u d Strathclyde Institute of Pharmacy and Biomedical Sciences , Strathclyde University , Glasgow , UK. e Health Economics Centre , Liverpool University Management School , Liverpool , UK. f Department of Laboratory Medicine, Division of Clinical Pharmacology , Karolinska Institute, Karolinska University Hospital Huddinge , Stockholm , Sweden. g Department of Public Health Pharmacy and Management, School of Pharmacy , Sefako Makgatho Health Sciences University , Garankuwa, South Africa.
- 700 1_
- $a Schubert, Ingrid $u c PMV research group, Clinic and Policlinic for Psychiatry, Psychosomatics and Psychotherapy of Children and Adolescents, Cologne University , Germany.
- 773 0_
- $w MED00009520 $t Current medical research and opinion $x 1473-4877 $g Roč. 35, č. 4 (2019), s. 697-704
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/30362365 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20200511 $b ABA008
- 991 __
- $a 20200525100524 $b ABA008
- 999 __
- $a ok $b bmc $g 1525605 $s 1096803
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2019 $b 35 $c 4 $d 697-704 $e 20181130 $i 1473-4877 $m Current medical research and opinion $n Curr Med Res Opin $x MED00009520
- LZP __
- $a Pubmed-20200511
