Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem‐containing medications
Purpose Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next‐morning impairment and recommending lower starting doses particularly for women. This study aimed to assess whether zolpidem DSCs were asso...
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| Veröffentlicht in: | Pharmacoepidemiology and drug safety 2017-06, Vol.26 (6), p.712-721 |
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| container_title | Pharmacoepidemiology and drug safety |
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| creator | Kesselheim, Aaron S. Donneyong, Macarius Dal Pan, Gerald J. Zhou, Esther H. Avorn, Jerry Schneeweiss, Sebastian Seeger, John D. |
| description | Purpose
Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next‐morning impairment and recommending lower starting doses particularly for women. This study aimed to assess whether zolpidem DSCs were associated with prescribing‐pattern changes between January 2011 and December 2013.
Methods
We assessed overall dispensings of zolpidem‐containing products between January 2011 and December 2013 by conducting a time‐series analysis. Analyses were stratified by gender because the DSC contained gender‐specific information. Participants were patients drawn from the Optum Clinformatics data source of commercially insured people in the USA. We evaluated changes in mean prescribed dose of the two drugs and health care utilization metrics.
Results
Each month of the study, more than 80 000 patients received a zolpidem‐containing product and approximately one‐tenth as many received eszopiclone. The two DSCs did not affect the downward trajectory of new zolpidem prescriptions. However, there was an increase in use of lower‐dose forms of zolpidem (30% increase, p |
| doi_str_mv | 10.1002/pds.4215 |
| format | Article |
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Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next‐morning impairment and recommending lower starting doses particularly for women. This study aimed to assess whether zolpidem DSCs were associated with prescribing‐pattern changes between January 2011 and December 2013.
Methods
We assessed overall dispensings of zolpidem‐containing products between January 2011 and December 2013 by conducting a time‐series analysis. Analyses were stratified by gender because the DSC contained gender‐specific information. Participants were patients drawn from the Optum Clinformatics data source of commercially insured people in the USA. We evaluated changes in mean prescribed dose of the two drugs and health care utilization metrics.
Results
Each month of the study, more than 80 000 patients received a zolpidem‐containing product and approximately one‐tenth as many received eszopiclone. The two DSCs did not affect the downward trajectory of new zolpidem prescriptions. However, there was an increase in use of lower‐dose forms of zolpidem (30% increase, p < 0.001), coupled with a reduction in higher‐dose forms (13% decrease, p = 0.03), so that the average dose decreased after the DSCs (from 9.7 mg to 9.4 mg, p < 0.001), a change that was not seen with eszopiclone (from 2.74 mg to 2.74 mg, p = 0.45).
Conclusion
The DSCs related to zolpidem‐containing products shifted prescribing toward the lower‐dose formulations, consistent with the recommendations in the DSCs. Copyright © 2017 John Wiley & Sons, Ltd.</description><identifier>ISSN: 1053-8569</identifier><identifier>EISSN: 1099-1557</identifier><identifier>DOI: 10.1002/pds.4215</identifier><identifier>PMID: 28449404</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adolescent ; Adult ; Aged ; Communications ; Dose-Response Relationship, Drug ; Drug Approval - methods ; Drug dosages ; Drug Prescriptions - standards ; Drug Safety Communications ; Female ; Formulations ; Gender ; Humans ; Hypnotics and Sedatives - therapeutic use ; Impairment ; interrupted‐time series ; Male ; Middle Aged ; Morning ; Patient Acceptance of Health Care ; Pharmacovigilance ; Product safety ; Pyridines - therapeutic use ; Resource utilization ; Risk assessment ; Safety ; United States - epidemiology ; Young Adult ; Zolpidem</subject><ispartof>Pharmacoepidemiology and drug safety, 2017-06, Vol.26 (6), p.712-721</ispartof><rights>Copyright © 2017 John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3165-5d8ebd5bc4eb0849cfad4b2126374855472ee0c71e98fee12aa5ab9f7940e4263</citedby><orcidid>0000-0002-8867-2666</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fpds.4215$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fpds.4215$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28449404$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kesselheim, Aaron S.</creatorcontrib><creatorcontrib>Donneyong, Macarius</creatorcontrib><creatorcontrib>Dal Pan, Gerald J.</creatorcontrib><creatorcontrib>Zhou, Esther H.</creatorcontrib><creatorcontrib>Avorn, Jerry</creatorcontrib><creatorcontrib>Schneeweiss, Sebastian</creatorcontrib><creatorcontrib>Seeger, John D.</creatorcontrib><title>Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem‐containing medications</title><title>Pharmacoepidemiology and drug safety</title><addtitle>Pharmacoepidemiol Drug Saf</addtitle><description>Purpose
Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next‐morning impairment and recommending lower starting doses particularly for women. This study aimed to assess whether zolpidem DSCs were associated with prescribing‐pattern changes between January 2011 and December 2013.
Methods
We assessed overall dispensings of zolpidem‐containing products between January 2011 and December 2013 by conducting a time‐series analysis. Analyses were stratified by gender because the DSC contained gender‐specific information. Participants were patients drawn from the Optum Clinformatics data source of commercially insured people in the USA. We evaluated changes in mean prescribed dose of the two drugs and health care utilization metrics.
Results
Each month of the study, more than 80 000 patients received a zolpidem‐containing product and approximately one‐tenth as many received eszopiclone. The two DSCs did not affect the downward trajectory of new zolpidem prescriptions. However, there was an increase in use of lower‐dose forms of zolpidem (30% increase, p < 0.001), coupled with a reduction in higher‐dose forms (13% decrease, p = 0.03), so that the average dose decreased after the DSCs (from 9.7 mg to 9.4 mg, p < 0.001), a change that was not seen with eszopiclone (from 2.74 mg to 2.74 mg, p = 0.45).
Conclusion
The DSCs related to zolpidem‐containing products shifted prescribing toward the lower‐dose formulations, consistent with the recommendations in the DSCs. Copyright © 2017 John Wiley & Sons, Ltd.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Communications</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Approval - methods</subject><subject>Drug dosages</subject><subject>Drug Prescriptions - standards</subject><subject>Drug Safety Communications</subject><subject>Female</subject><subject>Formulations</subject><subject>Gender</subject><subject>Humans</subject><subject>Hypnotics and Sedatives - therapeutic use</subject><subject>Impairment</subject><subject>interrupted‐time series</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Morning</subject><subject>Patient Acceptance of Health Care</subject><subject>Pharmacovigilance</subject><subject>Product safety</subject><subject>Pyridines - therapeutic use</subject><subject>Resource utilization</subject><subject>Risk assessment</subject><subject>Safety</subject><subject>United States - epidemiology</subject><subject>Young Adult</subject><subject>Zolpidem</subject><issn>1053-8569</issn><issn>1099-1557</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkctKxTAQhoMo3sEnkIAbN9WkTU6TpZzjDQQFdR3SdHpOpE1r0irHlXs3PqNPYupt4WqG-T9-ZuZHaI-SI0pIetyV4YillK-gTUqkTCjn-erY8ywRfCI30FYID4RETbJ1tJEKxiQjbBO9TRfazSFg63DnIRhvC-vmWLsSL0DX_cJoDzgq7eAN4KG3tX3RvW0d1lUPHp_NTvDMD3N8qyvol3jaNs3grPliRt-ntn4aLV_aurMlNB-v76Z1vbZunDZQ_rI7aK3SdYDdn7qN7s9O76YXydX1-eX05CoxGZ3whJcCipIXhkFBBJOm0iUrUppOspwJzlmeAhCTU5CiAqCp1lwXssrjxcAitY0Ov3073z4OEHrV2GCgrrWDdgiKCplxnnEmInrwD32If3BxO0UlYZOMi0xGav-HGop4j-q8bbRfqt83RyD5Bp5tDcs_nRI1xqdifGqMT93MbseafQJtjZAD</recordid><startdate>201706</startdate><enddate>201706</enddate><creator>Kesselheim, Aaron S.</creator><creator>Donneyong, Macarius</creator><creator>Dal Pan, Gerald J.</creator><creator>Zhou, Esther H.</creator><creator>Avorn, Jerry</creator><creator>Schneeweiss, Sebastian</creator><creator>Seeger, John D.</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7TK</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-8867-2666</orcidid></search><sort><creationdate>201706</creationdate><title>Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem‐containing medications</title><author>Kesselheim, Aaron S. ; Donneyong, Macarius ; Dal Pan, Gerald J. ; Zhou, Esther H. ; Avorn, Jerry ; Schneeweiss, Sebastian ; Seeger, John D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3165-5d8ebd5bc4eb0849cfad4b2126374855472ee0c71e98fee12aa5ab9f7940e4263</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Communications</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Approval - methods</topic><topic>Drug dosages</topic><topic>Drug Prescriptions - standards</topic><topic>Drug Safety Communications</topic><topic>Female</topic><topic>Formulations</topic><topic>Gender</topic><topic>Humans</topic><topic>Hypnotics and Sedatives - therapeutic use</topic><topic>Impairment</topic><topic>interrupted‐time series</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Morning</topic><topic>Patient Acceptance of Health Care</topic><topic>Pharmacovigilance</topic><topic>Product safety</topic><topic>Pyridines - therapeutic use</topic><topic>Resource utilization</topic><topic>Risk assessment</topic><topic>Safety</topic><topic>United States - epidemiology</topic><topic>Young Adult</topic><topic>Zolpidem</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kesselheim, Aaron S.</creatorcontrib><creatorcontrib>Donneyong, Macarius</creatorcontrib><creatorcontrib>Dal Pan, Gerald J.</creatorcontrib><creatorcontrib>Zhou, Esther H.</creatorcontrib><creatorcontrib>Avorn, Jerry</creatorcontrib><creatorcontrib>Schneeweiss, Sebastian</creatorcontrib><creatorcontrib>Seeger, John D.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Pharmacoepidemiology and drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kesselheim, Aaron S.</au><au>Donneyong, Macarius</au><au>Dal Pan, Gerald J.</au><au>Zhou, Esther H.</au><au>Avorn, Jerry</au><au>Schneeweiss, Sebastian</au><au>Seeger, John D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem‐containing medications</atitle><jtitle>Pharmacoepidemiology and drug safety</jtitle><addtitle>Pharmacoepidemiol Drug Saf</addtitle><date>2017-06</date><risdate>2017</risdate><volume>26</volume><issue>6</issue><spage>712</spage><epage>721</epage><pages>712-721</pages><issn>1053-8569</issn><eissn>1099-1557</eissn><abstract>Purpose
Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing the risk of next‐morning impairment and recommending lower starting doses particularly for women. This study aimed to assess whether zolpidem DSCs were associated with prescribing‐pattern changes between January 2011 and December 2013.
Methods
We assessed overall dispensings of zolpidem‐containing products between January 2011 and December 2013 by conducting a time‐series analysis. Analyses were stratified by gender because the DSC contained gender‐specific information. Participants were patients drawn from the Optum Clinformatics data source of commercially insured people in the USA. We evaluated changes in mean prescribed dose of the two drugs and health care utilization metrics.
Results
Each month of the study, more than 80 000 patients received a zolpidem‐containing product and approximately one‐tenth as many received eszopiclone. The two DSCs did not affect the downward trajectory of new zolpidem prescriptions. However, there was an increase in use of lower‐dose forms of zolpidem (30% increase, p < 0.001), coupled with a reduction in higher‐dose forms (13% decrease, p = 0.03), so that the average dose decreased after the DSCs (from 9.7 mg to 9.4 mg, p < 0.001), a change that was not seen with eszopiclone (from 2.74 mg to 2.74 mg, p = 0.45).
Conclusion
The DSCs related to zolpidem‐containing products shifted prescribing toward the lower‐dose formulations, consistent with the recommendations in the DSCs. Copyright © 2017 John Wiley & Sons, Ltd.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>28449404</pmid><doi>10.1002/pds.4215</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-8867-2666</orcidid></addata></record> |
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| ispartof | Pharmacoepidemiology and drug safety, 2017-06, Vol.26 (6), p.712-721 |
| issn | 1053-8569 1099-1557 |
| language | eng |
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| source | MEDLINE; Wiley Online Library All Journals |
| subjects | Adolescent Adult Aged Communications Dose-Response Relationship, Drug Drug Approval - methods Drug dosages Drug Prescriptions - standards Drug Safety Communications Female Formulations Gender Humans Hypnotics and Sedatives - therapeutic use Impairment interrupted‐time series Male Middle Aged Morning Patient Acceptance of Health Care Pharmacovigilance Product safety Pyridines - therapeutic use Resource utilization Risk assessment Safety United States - epidemiology Young Adult Zolpidem |
| title | Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem‐containing medications |
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