×

CPRD StudyPrimary Care PASS Study

Evaluating prescriber concordance with prescribing: results from a post-marketing study in primary care setting.

At launch (2005), ivabradine (Procoralan©) was indicated for treatment of chronic stable angina pectoris in patients with normal sinus rhythm, with a contraindication and/or intolerance for beta-blockers.

CPRD StudyPrimary Care PASS Study

ISOP-0215

Disproportionality analyses are used in spontaneous reporting systems to support signal detection.

CPRD StudyPrimary Care PASS Study

Application of the International Society on Thrombosis and Haemostasis (ISTH) classification of major bleeds within a Post Authorization Safety Study.

Haemorrhage is a frequent complication of anticoagulant (AC) use. In order to compare incidences between trials a definition of major bleeds (MB) in non surgical studies was developed by the International Society on Thrombosis and Haemostasis (ISTH) in 2005.

CPRD StudyPrimary Care PASS Study

Applying the Ready Reckoner tool for assessing antipsychotic prescribing within a post- authorisation safety study.

In the UK, the Ready Reckoner algorithm is a tool used in psychiatric clinical practice to monitor antipsychotic dosing in patients with complex antipsychotic regimens.

CPRD StudyPrimary Care PASS Study

Antipsychotic use in older adults with dementia: results from a Post-Authorisation Safety Study

The UK National Institute for Health & Care Excellence recommends that antipsychotics can be used in elderly patients under strict guidelines, however use is associated with serious safety concerns (including cerebrovascular accidents (CVA)).

CPRD StudyPrimary Care PASS Study

Use of antipsychotics in mental health secondary care setting versus primary care: results from two post-marketing safety studies

Generalisability of results from Modified Prescription-Event Monitoring (M-PEM) studies conducted in primary-care may be limited by excluding patients with complex characteristics (underlying/concurrent disease, medications) exclusively managed in hospital.

CPRD StudyPrimary Care PASS Study

Defining risk profiles in special populations -results from a post authorisation safety study of Seroquel XL© conducted in England

A risk management plan of quetiapine extended release (XL) had a need to describe use & monitor long-term (12+ months) safety in the primary care setting.

CPRD StudyPrimary Care PASS Study

Potential for underdosing of antipsychotics in primary and mental health care: findings from post- authorisation safety studies on Seroquel XL©

UK guidelines state that the lowest possible dose of antipsychotics should be used and titrated to the lowest effective dose.

CPRD StudyPrimary Care PASS Study

Observational Assessment of Safety in Seroquel (OASIS) – rates and patterns of common events

The Observational Assessment of Safety in Seroquel (OASIS) study (ENCePP Study reg.5412) aimed to extend the post-authorisation safety knowledge of quetiapine extended release (Seroquel XL©) in the mental health secondary care setting, as prescribed by psychiatrists in new user adult (>18 years) patients with Schizophrenia or Bipolar Disorder compared to quetiapine immediate release (IR).

CPRD StudyPrimary Care PASS Study

Patient-generated data and digital engagement – Social Media: its impact and contribution to pharmacovigilance

Patient adverse event reports (PAER) reports have been shown to positively contribute to the ongoing benefit: risk versus assessment of medicines.