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Spontaneous adverse event reports associated with zolpidem
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Abstracts / Research in Social and Administrative Pharmacy 12 (2016) e19–e47
across all settings were considered as key strategies to addressing diabetes management.
Factors influencing patients’ adherence to antidepressant medicines in unipolar depression: A qualitative study P. Srimongkon, P. Aslani, T.F. Chen, Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia Introduction: Non adherence to antidepressant medicines is a major barrier to the successful treatment of unipolar depression. Whilst factors associated with medication adherence have been documented, how these factors relate to the different stages of adherence (i.e. initiation, implementation and discontinuation of treatment) are not known. Aims: This study aimed to explore the positive influencing factors which promote medication adherence as well as the negative factors which reduce medication adherence, at all three stages of adherence (initiation, implementation and discontinuation) to antidepressant medicines used for unipolar depression. Methods: A semi-structured interview guide designed to address the study aims was developed and pilot tested for face and content validity. Participants aged 18 years and over and taking antidepressant medicines for the management of unipolar depression were recruited via community pharmacies in the Sydney metropolitan area and a market research company. Semi-structured, faceto-face interviews were conducted and digitally audio recorded. Verbatim transcripts of the interviews were thematically content analyzed. Data were managed using N-Vivo software. This study was approved by the Human Research Ethics Committee of The University of Sydney. Results: Twenty three interviews have been conducted and analyzed. Preliminary results indicate that a wide range of factors influence medication adherence. At initiation of therapy these positive factors included: severity of depressive symptoms, good support from family and friends, and self-management; negative factors included: fear of adverse reactions and negative information about antidepressant. The factors related to increasing persistence with therapy included: belief in antidepressants, clinical improvement, good relationships with and empathy of health care professionals; factors reducing persistence included: feeling better, and ineffective antidepressants. Discontinuation of therapy was triggered by: experiencing adverse drug reactions, feeling better and lack of support from family and health care professionals. Discussion: A range of factors influence patients’ adherence to antidepressant medications, and these factors vary depending on the stage of adherence. Strategies to address medication adherence in patients with unipolar depression should firstly consider the stage of adherence, followed by the severity of depression.
Spontaneous adverse event reports associated with zolpidem C.K. Wong1, N.S. Marshall2,3, R.R. Grunstein2, D.E. Hibbs1, R.A. Fois1, S.S. Ho1, J.R. Hanrahan1, B. Saini1,2, 1Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia2NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia3Sydney Nursing School, University of Sydney, Sydney, NSW, Australia Introduction: Stimulated reporting occurs when patients and healthcare professionals are influenced or ‘stimulated’ by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. In early 2007, sustained negative media attention surrounding zolpidem in Australia caused a large stimulated reporting event in adverse event data [1]. Likewise, the United States experienced substantial media interest surrounding zolpidem and the development of bizarre idiosyncratic sleep-related behaviours. However the effect of this stimulated reporting on signal generation in the US Food and Drug Administration Adverse Event Reporting System (FAERS) has not been explored. Aims: To investigate and determine if a stimulated reporting event is evident in the FAERS for zolpidem. Methods: The FAERS database between January, 2003 and August, 2012 was analysed using case/non-case methods. Multivariate logistic regression was used to determine year-by-year reporting odds ratios for zolpidem exposure and the following adverse events; parasomnias, movement-based parasomnias, non-movement based parasomnias, amnesias, hallucinations and suicidality. Results: The odds ratios increased significantly after the media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations and suicidality compared to all other drugs, even before the media publicity cluster. Discussion: Similar to Australia, our analyses indicates that a stimulated reporting phenomena occurred in the FAERS database. Clearly media induced panic as well as the “bandwagon effect” may have stimulated the reporting of adverse events. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are being made by health professionals or regulatory bodies.
Reference 1. Ben-Hamou, et al. J Sleep Res 2011;20:559–568.
Abstracts / Research in Social and Administrative Pharmacy 12 (2016) e19–e47
across all settings were considered as key strategies to addressing diabetes management.
Factors influencing patients’ adherence to antidepressant medicines in unipolar depression: A qualitative study P. Srimongkon, P. Aslani, T.F. Chen, Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia Introduction: Non adherence to antidepressant medicines is a major barrier to the successful treatment of unipolar depression. Whilst factors associated with medication adherence have been documented, how these factors relate to the different stages of adherence (i.e. initiation, implementation and discontinuation of treatment) are not known. Aims: This study aimed to explore the positive influencing factors which promote medication adherence as well as the negative factors which reduce medication adherence, at all three stages of adherence (initiation, implementation and discontinuation) to antidepressant medicines used for unipolar depression. Methods: A semi-structured interview guide designed to address the study aims was developed and pilot tested for face and content validity. Participants aged 18 years and over and taking antidepressant medicines for the management of unipolar depression were recruited via community pharmacies in the Sydney metropolitan area and a market research company. Semi-structured, faceto-face interviews were conducted and digitally audio recorded. Verbatim transcripts of the interviews were thematically content analyzed. Data were managed using N-Vivo software. This study was approved by the Human Research Ethics Committee of The University of Sydney. Results: Twenty three interviews have been conducted and analyzed. Preliminary results indicate that a wide range of factors influence medication adherence. At initiation of therapy these positive factors included: severity of depressive symptoms, good support from family and friends, and self-management; negative factors included: fear of adverse reactions and negative information about antidepressant. The factors related to increasing persistence with therapy included: belief in antidepressants, clinical improvement, good relationships with and empathy of health care professionals; factors reducing persistence included: feeling better, and ineffective antidepressants. Discontinuation of therapy was triggered by: experiencing adverse drug reactions, feeling better and lack of support from family and health care professionals. Discussion: A range of factors influence patients’ adherence to antidepressant medications, and these factors vary depending on the stage of adherence. Strategies to address medication adherence in patients with unipolar depression should firstly consider the stage of adherence, followed by the severity of depression.
Spontaneous adverse event reports associated with zolpidem C.K. Wong1, N.S. Marshall2,3, R.R. Grunstein2, D.E. Hibbs1, R.A. Fois1, S.S. Ho1, J.R. Hanrahan1, B. Saini1,2, 1Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia2NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia3Sydney Nursing School, University of Sydney, Sydney, NSW, Australia Introduction: Stimulated reporting occurs when patients and healthcare professionals are influenced or ‘stimulated’ by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. In early 2007, sustained negative media attention surrounding zolpidem in Australia caused a large stimulated reporting event in adverse event data [1]. Likewise, the United States experienced substantial media interest surrounding zolpidem and the development of bizarre idiosyncratic sleep-related behaviours. However the effect of this stimulated reporting on signal generation in the US Food and Drug Administration Adverse Event Reporting System (FAERS) has not been explored. Aims: To investigate and determine if a stimulated reporting event is evident in the FAERS for zolpidem. Methods: The FAERS database between January, 2003 and August, 2012 was analysed using case/non-case methods. Multivariate logistic regression was used to determine year-by-year reporting odds ratios for zolpidem exposure and the following adverse events; parasomnias, movement-based parasomnias, non-movement based parasomnias, amnesias, hallucinations and suicidality. Results: The odds ratios increased significantly after the media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations and suicidality compared to all other drugs, even before the media publicity cluster. Discussion: Similar to Australia, our analyses indicates that a stimulated reporting phenomena occurred in the FAERS database. Clearly media induced panic as well as the “bandwagon effect” may have stimulated the reporting of adverse events. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are being made by health professionals or regulatory bodies.
Reference 1. Ben-Hamou, et al. J Sleep Res 2011;20:559–568.