An Adverse Drug Reaction Surveillance Program (ADRSP) was implemented by the pharmacy department of the University of Maryland Medical System to address the institution's underreporting of adverse drug reactions. The program aims were to increase the number and quality of significant adverse drug reaction (ADR) reports by facilitating and standardizing the reporting process, to more actively involve the pharmacy staff, and to create a comprehensive database, thus enabling the intervention of future untoward events. During the program's first 2 years, the number of ADR reports more than doubled, primarily due to increased pharmacists' participation. The ADRSP has facilitated the reporting process, enhanced the submission of ADR reports to the FDA, and helped prevent ADRs.
{"title":"An ADR surveillance program: increasing quality, number of incidence reports.","authors":"M J Orsini, P A Orsini, D B Thorn, J N Gallina","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>An Adverse Drug Reaction Surveillance Program (ADRSP) was implemented by the pharmacy department of the University of Maryland Medical System to address the institution's underreporting of adverse drug reactions. The program aims were to increase the number and quality of significant adverse drug reaction (ADR) reports by facilitating and standardizing the reporting process, to more actively involve the pharmacy staff, and to create a comprehensive database, thus enabling the intervention of future untoward events. During the program's first 2 years, the number of ADR reports more than doubled, primarily due to increased pharmacists' participation. The ADRSP has facilitated the reporting process, enhanced the submission of ADR reports to the FDA, and helped prevent ADRs.</p>","PeriodicalId":12354,"journal":{"name":"Formulary","volume":"30 8","pages":"454-61"},"PeriodicalIF":0.0,"publicationDate":"1995-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21023197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To increase adverse drug reaction reporting, the Pharmacy Department Quality Assessment and Improvement Committee at the University of Iowa Hospitals and Clinics created an abbreviated wall-mounted adverse drug reaction card on "tear-off" pads. This report discusses strategies the Committee identified in order to attain its goal.
{"title":"Increased adverse drug reaction reporting through wall-mounted ADR reporting cards.","authors":"B A Szymusiak-Mutnick, M B Ross","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>To increase adverse drug reaction reporting, the Pharmacy Department Quality Assessment and Improvement Committee at the University of Iowa Hospitals and Clinics created an abbreviated wall-mounted adverse drug reaction card on \"tear-off\" pads. This report discusses strategies the Committee identified in order to attain its goal.</p>","PeriodicalId":12354,"journal":{"name":"Formulary","volume":"30 8","pages":"471-3"},"PeriodicalIF":0.0,"publicationDate":"1995-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21023199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Formulary recently conducted a survey of 2,000 of its readers to uncover what forces are at play in their formulary decision-making processes. Topics included general philosophies toward formulary decision making, philosophies toward adding and deleting products, influences on the process, trends related to product reviews, formulary management strategies, drug information educational strategies, and new approaches to the formulary decision-making process. Some 295 surveys (14.75%) were returned. Highlights and analyses of the survey findings are presented for your review and comparison with your practice setting's approaches.
{"title":"Results of our national survey. Current formulary decision-making strategies and new factors influencing the process.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Formulary recently conducted a survey of 2,000 of its readers to uncover what forces are at play in their formulary decision-making processes. Topics included general philosophies toward formulary decision making, philosophies toward adding and deleting products, influences on the process, trends related to product reviews, formulary management strategies, drug information educational strategies, and new approaches to the formulary decision-making process. Some 295 surveys (14.75%) were returned. Highlights and analyses of the survey findings are presented for your review and comparison with your practice setting's approaches.</p>","PeriodicalId":12354,"journal":{"name":"Formulary","volume":"30 8","pages":"462-70"},"PeriodicalIF":0.0,"publicationDate":"1995-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21023198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"FDA says 'Look at the facts' when judging its record on drug approvals.","authors":"B Gatty","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":12354,"journal":{"name":"Formulary","volume":"30 7","pages":"412, 411"},"PeriodicalIF":0.0,"publicationDate":"1995-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21023196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The FDA's approval of filgrastim (granulocyte colony-stimulating factor [G-CSF]) for accelerated recovery of neutrophil counts following chemotherapy has prompted discussions regarding the cost and benefits associated with such expensive new therapies. One method to evaluate the cost effectiveness of a therapy is decision analysis, which provides a quantitative method of cost analysis. Using the principles of decision analysis, we created a decision-analysis tree for evaluating the cost effectiveness of G-CSF therapy. Based on data gathered from a retrospective review of ambulatory oncology patients, we found that routine administration of G-CSF to all outpatients receiving chemotherapy is not cost effective, although it would be justifiable for some patients.
{"title":"Use of decision analysis to evaluate the costs and benefits of filgrastim (G-CSF) therapy.","authors":"J A Peroutka, A H Mutnick","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The FDA's approval of filgrastim (granulocyte colony-stimulating factor [G-CSF]) for accelerated recovery of neutrophil counts following chemotherapy has prompted discussions regarding the cost and benefits associated with such expensive new therapies. One method to evaluate the cost effectiveness of a therapy is decision analysis, which provides a quantitative method of cost analysis. Using the principles of decision analysis, we created a decision-analysis tree for evaluating the cost effectiveness of G-CSF therapy. Based on data gathered from a retrospective review of ambulatory oncology patients, we found that routine administration of G-CSF to all outpatients receiving chemotherapy is not cost effective, although it would be justifiable for some patients.</p>","PeriodicalId":12354,"journal":{"name":"Formulary","volume":"30 7","pages":"394-5, 400-4"},"PeriodicalIF":0.0,"publicationDate":"1995-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21023195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
B G Peters, B J Goeckner, J J Ponzillo, W S Velasquez, A L Wilson
Asparaginase is an effective treatment for patients with acute lymphocytic leukemia (ALL). Unfortunately, asparaginase therapy is associated with a high incidence of hypersensitivity reactions (up to 73%), including life-threatening anaphylaxis, and its half-life of approximately 20 hours necessitates daily administration. Pegaspargase, a modification of L-asparaginase, has a longer half-life (357 hours), a decreased incidence of hypersensitivity reactions, and when doses every 14 days, provides comparable efficacy to asparaginase; however, it is much more expensive per single-dose vial ($980.00 vs $52.38). To determine the pharmacoeconomic impact of the two agents, we conducted a cost-minimization analysis for three common adult ALL protocols. Results showed that pegaspargase was significantly less costly to payers on an inpatient or outpatient basis and warranted addition to our formulary.
{"title":"Pegaspargase versus asparaginase in adult ALL: a pharmacoeconomic assessment.","authors":"B G Peters, B J Goeckner, J J Ponzillo, W S Velasquez, A L Wilson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Asparaginase is an effective treatment for patients with acute lymphocytic leukemia (ALL). Unfortunately, asparaginase therapy is associated with a high incidence of hypersensitivity reactions (up to 73%), including life-threatening anaphylaxis, and its half-life of approximately 20 hours necessitates daily administration. Pegaspargase, a modification of L-asparaginase, has a longer half-life (357 hours), a decreased incidence of hypersensitivity reactions, and when doses every 14 days, provides comparable efficacy to asparaginase; however, it is much more expensive per single-dose vial ($980.00 vs $52.38). To determine the pharmacoeconomic impact of the two agents, we conducted a cost-minimization analysis for three common adult ALL protocols. Results showed that pegaspargase was significantly less costly to payers on an inpatient or outpatient basis and warranted addition to our formulary.</p>","PeriodicalId":12354,"journal":{"name":"Formulary","volume":"30 7","pages":"388-93"},"PeriodicalIF":0.0,"publicationDate":"1995-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21023194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The P & T Committee at Trinity Lutheran Hospital, a 320-bed, community/teaching hospital in Kansas City, MO, has developed dosing and monitoring guidelines for foscarnet sodium (Foscavir) and trimetrexate glucuronate (Neutrexin)--two drugs used to treat patients with opportunistic infections associated with the human immunodeficiency virus (HIV). Presented in this Experience Brief is a short discussion of these drugs, the rationale for guideline development, and the actual dosing and monitoring protocols devised.
{"title":"Dosing guidelines for foscarnet and trimetrexate.","authors":"J M Wooten, K Chase, M C O'Connor, R B Henry","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The P & T Committee at Trinity Lutheran Hospital, a 320-bed, community/teaching hospital in Kansas City, MO, has developed dosing and monitoring guidelines for foscarnet sodium (Foscavir) and trimetrexate glucuronate (Neutrexin)--two drugs used to treat patients with opportunistic infections associated with the human immunodeficiency virus (HIV). Presented in this Experience Brief is a short discussion of these drugs, the rationale for guideline development, and the actual dosing and monitoring protocols devised.</p>","PeriodicalId":12354,"journal":{"name":"Formulary","volume":"30 6","pages":"349-52"},"PeriodicalIF":0.0,"publicationDate":"1995-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21016494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Collaborative efforts among several departments and the P & T Committee resulted in an IV to oral conversion program for select antimicrobials in our 580-bed county teaching hospital. This criteria-based program was designed to monitor and educate physicians on the appropriateness of parenteral antimicrobial prescribing, ensure rapid transition from IV to oral therapy, and contain costs. In the first 2 months of the program, 78 patients were converted from IV to oral administration with an estimated savings of $12,935. Of the ordering physicians, 66 (84.6%) accepted the interventions. All patients who switched administration routes were successfully treated with an oral agent. This program also has had a positive effect on patient outcomes and physician prescribing habits.
{"title":"Criteria-based antimicrobial i.v. to oral conversion program.","authors":"A U Okpara, J J Maswoswe, K Stewart","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Collaborative efforts among several departments and the P & T Committee resulted in an IV to oral conversion program for select antimicrobials in our 580-bed county teaching hospital. This criteria-based program was designed to monitor and educate physicians on the appropriateness of parenteral antimicrobial prescribing, ensure rapid transition from IV to oral therapy, and contain costs. In the first 2 months of the program, 78 patients were converted from IV to oral administration with an estimated savings of $12,935. Of the ordering physicians, 66 (84.6%) accepted the interventions. All patients who switched administration routes were successfully treated with an oral agent. This program also has had a positive effect on patient outcomes and physician prescribing habits.</p>","PeriodicalId":12354,"journal":{"name":"Formulary","volume":"30 6","pages":"343-8"},"PeriodicalIF":0.0,"publicationDate":"1995-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21016493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To successfully design and implement disease management programs, clinicians must understand the disease's natural course and cost drivers, base the diagnosis and treatment on the disease process and not the reimbursement schedules, educate and reinforce compliance to improve treatment outcomes, and focus on commonly occurring and costly chronic diseases. This article describes a 7-step process for developing a disease management program based on those concepts. The changing role and functions of the P & T Committee in disease management programs are also presented.
{"title":"Designing a disease management program: how to get started.","authors":"E R Gonzalez, V S Crane","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>To successfully design and implement disease management programs, clinicians must understand the disease's natural course and cost drivers, base the diagnosis and treatment on the disease process and not the reimbursement schedules, educate and reinforce compliance to improve treatment outcomes, and focus on commonly occurring and costly chronic diseases. This article describes a 7-step process for developing a disease management program based on those concepts. The changing role and functions of the P & T Committee in disease management programs are also presented.</p>","PeriodicalId":12354,"journal":{"name":"Formulary","volume":"30 6","pages":"326-8, 331-3, 337-40"},"PeriodicalIF":0.0,"publicationDate":"1995-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21016492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}