Issues in medication safety.
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Drug Labeling↗
Biomedical subjects
Randy C Hatton
Publications and source records attributed to Randy C Hatton.
Oral phenylephrine: an ineffective replacement for pseudoephedrine?
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Administration, Oral↗
Automatic replacement of albuterol nebulizer therapy by metered-dose inhaler and valved holding chamber.
PURPOSE: Evidence supporting the delivery of bronchodilators with a metered-dose inhaler and a valved holding chamber (MDI+VHC) in place of a small-volume nebulizer (SVN) is discussed, and the steps taken to accomplish such a conversion program at one institution are described. SUMMARY: Double-blind, randomized studies in patients with acute exacerbations of asthma have demonstrated that higher doses of albuterol delivered by MDI+VHC (4-10 puffs per dose) are as effective as 2.5 mg of albuterol sulfate delivered by SVN. Three double-blind studies support the conclusion that the two methods are equivalent with respect to both efficacy and adverse effects in patients with chronic obstructive pulmonary disease. MDI+VHC offers practical advantages over SVN, including the capacity for home use by the patient, portability, less setup time, and no need for daily disinfection. Pharmacists and respiratory therapists obtained approval through the pharmacy and therapeutics committee for respiratory therapists to convert orders for bronchodilators delivered by SVN to administration by MDI+VHC. The conversion policy allows physicians to override it, but none have exercised this option. On intensive care units (ICUs), the policy resulted in a 53% increase in the use of MDI+VHC during the six-month period after it went into effect. Respiratory therapists have been less thorough in implementing the policy for non-ICU patients. CONCLUSION: Delivery of bronchodilators by MDI+VHC is as effective as delivery by SVN but offers several advantages. A policy to switch patients from SVN to MDI+VHC for bronchodilator administration met with limited success.
Adult↗
Evaluation of drug interaction software to identify alerts for transplant medications.
BACKGROUND: The ability of computerized physician order entry (CPOE) systems to identify clinically significant drug interactions is dependent upon the integrity of the drug information populating the software. A CPOE system with incomplete or inaccurate drug information will fail to identify clinically important drug interactions and, therefore, fail to reduce preventable adverse drug events (pADEs). OBJECTIVE: To evaluate, from the prescribers' perspective, the ability of a common drug interaction database to identify clinically important drug interactions involving drugs used in transplantation. METHODS: The clinical significance of drug interactions involving 5 transplant drugs was evaluated by an expert panel to determine whether alerts should be generated for physicians not involved in the transplant at the time of order entry. Drug interactions included in the analysis were generated from the expert panel, a common drug interaction database, and 2 standard drug interaction references. Responses on the clinical significance were used to calculate the sensitivity, specificity, and positive and negative predictive values for each severity setting of a common electronic drug interaction database. RESULTS: Overall, the database failed to identify approximately 70% of interactions considered significant by the expert panel. Of the alerts that were generated, >85% were considered clinically significant. The database was most deficient in identifying interactions resulting from additive toxicity. CONCLUSIONS: To expect a decrease in pADEs caused by drug interactions, the information used to populate CPOE systems must be validated. Establishing consistency and integrity of this information may be a future role for pharmacists.
Databases as Topic↗
Nature and causes of clinically significant medication errors in a tertiary care hospital.
PURPOSE: Medication errors identified through solicited error reports in general medicine and specialty units of a major tertiary care teaching hospital were studied to identify prevalent patterns and causes. METHODS: Medication error reports by a multidisciplinary team of eight clinicians at adult medical and surgical, hematology and oncology, bone marrow transplantation, and medical and cardiac intensive care units were collected prospectively over a three-month period. The reports were validated in terms of clinical significance, causality, and true presence of an error by two independent reviewers. Cluster analysis of valid reports (reports accepted by both reviewers) was used to identify prominent error patterns. RESULTS: Of 321 medication error reports, 240 were included in the analysis. Of these, 95 represented manifested errors and the rest near misses (not manifested [94] or averted [51]). Most manifested errors involved uncontrolled infections associated with prescribed underdoses of antiinfectives (23%), renal failure associated with prescribed overdoses of antiinfectives (4%), central-nervous-system drug intoxication following prescribed overdoses (4%), or uncontrolled pain associated with prescribed underdoses (4%). Most errors were initiated during prescribing (72%) and were associated with deficits in pharmacotherapy knowledge (39%) or with failure to consider critical patient information (18%). Errors initiated during dispensing and administration were mostly associated with performance deficits (e.g., accidental slips and lapses). CONCLUSION: A limited number of prevalent medication-error patterns described more than half of all reported errors in a hospital and suggested excellent areas for quality improvement. Error causes varied with the node of the medication-use process where they arose and suggested the need for tailored interventions to improve clinicians' performance.
Anti-Infective Agents↗
Evaluation of electronic databases used to identify solid oral dosage forms.
The ability of electronic drug identification databases to identify solid oral dosage forms by their imprint codes was studied. The following seven commercially available electronic drug identification databases were selected to identify 500 solid oral dosage forms by their imprint codes: Clinical Pharmacology (Gold Standard Media, Tampa, FL), eFacts (Facts and Comparison, St. Louis, MO), Ident-A-Drug (Therapeutic Research, Stockton, CA), Identidex (Micromedex, Greenwood Village, CO), Clinical Reference Library (Lexi-Comp, Hudson, OH), Physicians' Desk Reference (PDR) Electronic Library (Medical Economics, Montvale, NJ), and RxList (RxList LLC, San Francisco, CA), Chi-square test was used to compare the percentages of medications identified by each of the seven electronic references. The ability of the databases to identify medication by specific characteristics, such as brand name versus generic, prescription versus nonprescription, commercially available for more than one year versus less than one year, colored versus white drug products, and controlled versus noncontrolled substances was evaluated. A logistic regression model was used to determine the probability of a drug product being identified by one of the electronic references based on these characteristics. All seven electronic databases combined identified 95.6% of the unknown medications by imprint code, color, shape, and scoring. Ident-A-Drug and Identidex identified the most drugs. The PDR Electronic Library and Facts and Comparisons Identified the least number of drugs. Solid oral dosage forms more likely to be identified were those that were on the market for more than a year, brand-name products, and prescription medications. Generic products on the market for less than a year and nonprescription products were particularly difficult to identify. A combination of electronic drug identification databases provides the best method of drug identification in an institutional setting.
Capsules↗
Nature of preventable adverse drug events in hospitals: a literature review.
A literature review was conducted to identify the drug classes, types of errors, and types of adverse outcomes related to preventable adverse drug events (pADEs). Studies were identified by keyword search of MEDLINE and International Pharmaceutical Abstracts and by a manual search. The search was limited to peer-reviewed literature reporting pADEs in hospitalized patients and the frequencies of at least one pADE characteristic. The frequencies of pADEs and their characteristics were summarized using median and range. Ten studies published between 1994 and 2001 were included in the review. The reported median frequency of pADEs was 1.8% (range, 1.3-7.8%), and the median preventability rate of ADEs in the hospitals was 35.2% (range, 18.7-73.2%). Cardiovascular drugs were implicated for 17.9% of pADEs (range, 4.3-28.1%). Most pADEs occurred in the prescribing stage of the medication-use process and were dose related. Inappropriate prescribing decisions and patient monitoring were the most frequently identified causes of pADEs. The most common adverse outcomes were allergic reactions, hepatic or renal problems, cardiovascular problems, hematologic problems and bleeding, and central nervous system problems. Frequently reported examples of pADEs included antihypertensive overdose associated with bradycardia or hypotension, antiinfectives prescribed despite a history of allergy, warfarin overdose and inappropriate monitoring resulting in hemorrhage, and opioid overdose or underdose associated with respiratory depression or poor pain control, respectively. Despite the heterogeneity of pADEs, the results of this literature review suggest that a few types of drugs, errors, and adverse outcomes constitute a substantial proportion of pADEs. Targeting these high-priority areas could significantly reduce the overall frequency of pADEs.
Adverse Drug Reaction Reporting Systems↗
Identifying clinically significant preventable adverse drug events through a hospital's database of adverse drug reaction reports.
The ability of a hospital's adverse drug reaction (ADR) database to identify common and repeated patterns of preventable adverse drug events (ADEs) was analyzed. ADR reports collected from 1994 through 2000 were extracted from a teaching hospital's ADR database. Reports were assessed concurrently in accordance with seven previously published explicit criteria for preventability. Only cases considered clinically significant were included in this analysis. Events that occurred in the ambulatory care setting were excluded. Preventable ADEs were categorized by drug or drug class, type of medication error, and the subsequent adverse outcome. Novel in this analysis was the linking of these three descriptors. Of the 2571 ADR reports assessed, 415 ADEs were deemed preventable. Of the preventable ADEs, 98 were not analyzed because they occurred in the ambulatory care setting, leaving 317 preventable ADEs in 275 inpatients (mean age +/- S.D., 48.5 +/- 23.9 years) for analysis. Although 93 drugs were associated with these ADEs, only 10 drugs accounted for more than 60% of the events. Analysis and categorization by type of error and outcome suggested that three high-priority preventable ADEs accounted for 50% of all reports: (1) overdoses of anticoagulants or insufficient monitoring and adjustments (according to laboratory test values) were associated with hemorrhagic events, (2) overdosing or failure to adjust for drug-drug interactions of opiate agonists was associated with somnolence and respiratory depression, and (3) inappropriate dosing or insufficient monitoring of insulins was associated with hypoglycemia. Analysis of a hospital ADR database identified prevalent and preventable clinically significant ADEs.
Adverse Drug Reaction Reporting Systems↗
Evaluation of online drug references for identifying over-the-counter solid oral dosage forms.
OBJECTIVE: To evaluate six drug references for their usefulness in identifying over-the-counter (OTC) solid oral dosage forms (SODFs). DESIGN: Retrospective evaluation of a convenience sample of requests for product identification. SETTING: Drug information center that accepts information requests from health care providers and law enforcement officials throughout the state in which it is located. PARTICIPANTS: Researchers. INTERVENTIONS: Using a convenience sample of 68 nonprescription drugs and 41 dietary supplements obtained from the drug information center's question and answer database, researchers sought to identify the SODFs using six drug-identification online databases. MAIN OUTCOME MEASURE: Likelihood of identifying a SODF with a given reference, reported as the percentage identified and the corresponding 95% confidence interval. RESULTS: Overall, 88.2% of nonprescription drugs could be identified using all six references. The highest percentage of nonprescription drugs (77.9%) were identified using Identidex, followed by Ident-A-Drug (67.6%), Drug Identifier (45.6%), RxList (39.7%), Lexi-Drug ID (33.8%), and Clinical Pharmacology (17.6%). Using Ident-A-Drug and RxList together led to the identification of two fewer nonprescription drugs than did Identidex at approximately 5% of the cost. Only 15 (37.5%) of the dietary supplements had an identifying imprint on the dosage form, and 7 (46.6%) of the imprinted products were identified. But overall, only 17.1% (7 of 41) of dietary supplements could be identified, as none of the products without imprints could be positively identified. CONCLUSION: Using these six online references, nonprescription drugs could be identified more frequently than could dietary supplements. The lack of imprints on many dietary supplements is an impediment to identification of these products.
Administration, Oral↗