Abstract
Hospital Pharmacy presents this new feature to keep pharmacists abreast of new publications in the medical/pharmacy literature. Articles of interest will be abstracted monthly regarding a broad scope of topics.
Medication Safety
Preprinted Order Forms Reduce Errors in a Pediatric Emergency Department
One of the suggested interventions for the reduction of medication errors is the standardization of drug therapy, either via the use of preprinted order forms or standardized order computer screens. A controlled, randomized trial in an acute care pediatric facility examined the use of a standardized drug order form in the Emergency Department. The study randomized 18 days into two study groups, days in which regular blank order sheets were used and days during which preprinted, formatted, order sheets were used. All patient charts were reviewed by two medical students and entered into a computerized database, which was then reviewed by two pediatric emergency room physicians who were blinded to the randomization scheme. The preprinted order form separated medications, intravenous (IV) fluids, and inhaled medications. In each area there were columns that were labeled for the date, time, drug name, patient weight, dose in mg/kg, total daily dose, dose to administer, frequency, dosing route, and the physician's signature. During the study period, there were 2,157 patient visits in the Emergency Department. A total of 2,058 (85.4%) charts were available for review with a total of 795 medications ordered. Eight orders were excluded for lack of sufficient information. Of the remaining orders (n = 787), 411 orders were written during regular form days, and 376 on the new standardized format. Overall, 105 (13.3%) errors were found among the total orders. Drug errors were noted in 16.6% of the orders written with the regular form and in 9.8% with the new form. Time was omitted from 23.1% and 12.5% of the regular and new forms, respectively (P < 0.001). Of the errors that occurred with the standardized form, one was classified as severe and 13 as significant. The severe error resulted in a 10fold higher dose of codeine. With the regular form, 36 errors were classified as significant. After controlling for physician training and patient clusters, the new form was associated with a significant reduction in risk for an error (odds ratio = 0.55).
Summary
The use of a preprinted order form resulted in the significant reduction of medication errors in pediatric patients who visited an emergency room.
Kozer E, Scolnik D, MacPherson A, Rauchwerger D, Koren G. Using a preprinted order sheet to reduce prescription errors in a pediatric emergency department: a randomized, controlled trial. Pediatrics. 2005;116(6):1299-1302.
Medication Errors in a Bar Code Repackaging Center
Bar code identification on medications has been suggested as a method for reducing errors in medication dispensing and administration. However, many drugs (approximately 60%) are not available in unit dose form with a bar code. Thus, the repackaging of medications may be associated with their own medication error rate. A study in a pharmacy-based bar code repackaging center evaluated the error rate associated with such work and what the typical errors entailed. The barcode repackaging center was in a 735-bed tertiary care academic medical center. The primary end point was the total number of generated errors in the repackaging center generated during a 6-month study period. Errors were classified as incorrect NDC numbers, incorrect lot number, incorrect expiration date, incorrect medication, and incomplete label. The equipment included an automated machine that repackaged dosage forms, automated machinery that affixed bar code labels to vials and ampules, a bulk container that packaged smaller amounts of liquids, and repackagers for suppositories, nebulized medications, and other items that can not be removed from original containers.
A total of 628,749 medication doses were repackaged and observed during the study period, of which 1.2% (7,520) errors were noted. A total of 97 repackaging batches (ranging from 1 to 750 medication doses) were involved in errors. Of these errors, approximately 40% were noted during the initial product setup by pharmacy technicians and approximately 60% were noted by pharmacists in the final verification. Incorrect lot number (43%) and incorrect NDC number (31.8%) were the two most frequently noted errors. Other errors, less frequently noted, included incorrect expiration date (16.3%) and incomplete label (8.8%). Only 0.1% of the errors were for the incorrect medication.
Summary
A repackaging center based in a pharmacy examined the number and type of errors associated with the repackaging process. This article is of particular interest to pharmacists who are involved in, or considering, medication repackaging and barcoding.
Cina J, Fanikos J, Mitton P, McCrea M, Churchill W. Medication errors in a pharmacy based bar-code-repackaging center. Am J Health Syst Pharm. 2006;63:165-168.
Pharmacy
Changes in Cough Management Practice Guidelines
In early January 2006, the American College of Chest Physicians announced and published the latest revision of the evidence based clinical practice guidelines for the diagnosis and management of cough. The executive summary of this document received a great deal of attention in the public press. This is an extremely helpful document in both its scope and depth. However, of particular interest to pharmacists, is the section on cough suppressants and pharmacologic protussive therapy. Many of the recommendations encourage the limited use of nonprescription products and will result in a different approach to cough management for the patient seeking nonprescription therapy. In patients with chronic bronchitis, products shown to alter mucus characteristics are not recommended, and central cough suppressants (eg, codeine and dextromethorphan) are recommended only for short-term relief of coughing. In patients with cough due to an upper respiratory tract infection, the only inhaled anticholinergic agent recommended for cough suppression is ipratropium bromide. Peripheral, topical, and central cough suppressants are not recommended in this patient group—due to limited efficacy. In patients with acute cough due to the common cold, the use of zinc or OTC combination cold medications (with the exception of older antihistamine-decongestants) are not recommended. Amiloride is recommended to increase cough clearance in patients with cystic fibrosis.
Summary
This consensus statement is beneficial in recommending evidence-based guidelines for the diagnosis and management of cough. It is particularly useful in nonprescription management.
American College of Chest Physicians. Diagnosis and management of cough. Executive Summary. ACCP evidence based clinical practice guidelines. Chest. 2006; 129 (1 suppl):1S-23S.
Formoterol Delivery Decreased by Exposure to Heat
Study of drug delivery, particularly aerosolized medications, are often conducted under optimal study conditions. However, conditions during actual patient use are often varied and unrelated to study conditions. There have been several anecdotal reports of distorted formoterol capsules after exposure to high temperatures when mailed to patients. These events were mostly reported in the summer months in southwest US (Arizona), where temperatures reached over 100°F. This study evaluated the effects of high temperatures on the integrity of formoterol, tiotropium, and fluticasone/salmeterol capsules. Capsules were exposed to room temperature (control) and to 104 to 158°F for up to 3 hours. Visual inspection of the formoterol capsules after heat exposure revealed gross distortion of the capsules, as well as clumping of powdered material within the capsule. In addition, the mean weight of the formoterol capsules decreased after heat exposure when compared to those that were not heated. Heat also produced a decrease in the dose delivered. In contrast, there were no changes noted in the tiotropium or fluticasone/sameterol dosage forms. The authors recommended caution in the transport of drugs that may be heat sensitive.
Summary
Formoterol capsules are affected by exposure to severe heat, decreasing the amount of drug delivered. Heat resistant packaging or attention to storage should be addressed with the transport of this drug. Patients should also be counseled not to store the drug in their car during extreme heat.
Robbins RA, Thomas AR, Proctor LM, Hoyt JC, Hayden JM. Heat decreases formoterol delivery. Chest. 2005;128:4036-4040.
Dietary Supplement Policies in Acute Care Facilities
Despite the popularity of dietary supplements in the community setting, there is not much information published on the use or acceptance of these drugs in acute care settings. A recent online survey examined the presence and nature of institutional policies and practices in 1,252 pharmacies in acute care facilities. A total of 63 surveys were not completed due to invalid E-mail addresses. The response rate for the remaining 1,189 was 25.4% (n = 302). The majority of the surveyed facilities were community (not for profit) hospitals (71%) with between 100 and 499 beds (61%). Almost all the institutions (92%) were Joint Commission on Accreditation of Health Care Organizations (JCAHO) accredited. Of these responses, most (62%) indicated that they had developed and implemented a policy regarding dietary supplements. A total of 22% had not planned or discussed such a policy, and 11% indicated that a policy was being developed. The remaining 5% indicated other plans. In institutions where a policy was in place, 30% of the respondents indicated that the use of dietary supplements were prohibited. A total of 77% of respondents reported that patients could use their own supply of dietary supplements if they were ordered by an authorized prescriber. In the majority of cases (79%), supplies of these products were typically stored in nurses' stations or patient drawer. Other sites included the bedside (33%), the Pharmacy Department (24%), or a unit-based drug cabinet (13%). It is important to note that most institutions (82%) reported adverse events to these products via the established reporting program for drug adverse events. Other reporting programs included via an incident reporting system (46%), FDA MedWatch program (33%), and JCAHO sentinel event reporting (26%). Only 6% indicated that there was not a formal report program for supplements. The most common information resources employed in the surveyed institutions included Internet resources (66%), Natural Medicine Comprehensive Database (34%), AltMedex (23%), other (21%), Herbal Companion to AHFS DI (21%), Complete German E monographs, and the PDR for Herbal Medicines (18%).
Summary
An online survey of hospitals evaluated policies for the use of dietary supplements across the nation. This information is particularly useful for pharmacy directors.
Bazzie KL, Witmer DR, Pinto B, Bush C, Clark J, Deffenbaugh J Jr. National survey of dietary supplement policies in acute care facilities. Am J Heath Syst Pharm. 2006;63:65-70.
Legal
Ketorolac Associated Left Foot Drop
A 61-year-old male inpatient admitted with low back pain was administered IM ketorolac, which he claimed resulted in left foot drop related to resultant damage to a nerve. The patient claimed that this was a result of the administration technique used and failure to protect the nerve. According to this report, the hospital denied negligence. A jury returned a verdict for the defense.
Injection of Toradol blamed for left foot drop-New York defense verdict. Med Malpr Verd Settl Exp. 2005;21:18.
Off-Label Risperidone Use in Pediatric Patient
A pediatric patient was initially treated for several years with thioridazine for significant behavioral problems (unspecified), which included head banging and self-injurious activity. After 2 years of thioridazine therapy, the patient was switched to risperidone. The patient's mother claimed that this was an off-label use of the drug and resulted in the development of tardive dyskinesia. In addition, it was claimed that the patient developed significant loss of cognitive function. The defendants claimed that the patient did not develop tardive dyskinesia and that the complications arose from premature birth, which required surgery to repair torticollis, facial asymmetry and a hernia. They also noted that there was a family history of a movement disorder. Expert evidence was presented that both supported and opposed the use of this drug in the pediatric population. According to this report, a jury returned a verdict for the defense.
Improper prescription of Risperdal for child-tardive dyskinesia-Florida defense verdict. Med Malpr Verd Settl Exp. 2005:21:24.
Journal Scan: General Topics
Recent Articles of Interest to Practitioners
Giaquinta D. Effective use of antibiotics in managed care. Manag Care Interface. 2005;18:35,36,48.
Hoyert DL, Matthews TJ, Menacker F, Strobino DM, Goyer B. Annual summary of vital statistics: 2004. Pediatrics. 2006;117:168-183.
Bagshaw SM, McAlister FA, Manns BJ, Ghali WA. Acetylcysteine in the prevention of contrast-induced nephropathy: a case study of the pitfalls in the evolution of evidence. Arch Intern Med. 2006;166:161-166.
Rief W, Avorn J, Barsky AJ. Medication attributed adverse effects in placebo groups. Arch Intern Med. 2006;166:155-160.
Reisberg B, Doody R, Stoffler A, Schmitt F, Farris S, Mobius HJ. A 24-week open-label extension stuffy of memantine in moderate to severe Alzheimer disease. Arch Neurol. 2006;36:49-54.
Alford DP, Compton P, Samet JH. Acute pain management for patients receiving maintenance methadone or buprenorphine therapy. Arch Intern Med. 2006;144:127-134.
Fomin I, Caspi D, Levy V, Varsano N, et al. Vaccination against influenza in rheumatoid arthritis: the effect of disease modifying drugs, including TNF alpha blockers. Ann Rheum Dis. 2006;65:191-194.
Yager JD, Davidson NE. Estrogen carcinogenesis in breast cancer. N Engl J Med. 2006;354:270-282.
Phillips MS, William RJ. Improving the safety of neuromuscular blocking agents: a statement from the USP Safety Medication Use Expert Committee. Am J Health Syst Pharm. 2006;63:139-142.
Ray WA, Stein CM. Reform of drug regulation-beyond an independent drug-safety board. N Engl J Med. 2006;354:194-201.
Dodick DW. Clinical practice. Chronic daily headache. N Engl J Med. 2006;354:158-165.
Cummings JL. What can we learn from open-label extensions of randomized clinical trials. Arch Neurol. 2006;63:18-19.
Zarin DA, Tse T, Ide NC. Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med. 2005;353:2779-2287
Mitchell LB, Exner DV, Wyse DG, et al. Prophylactic oral amiodarone for the prevention of arrhythmias that begin early after revascularization, valve replacement, or repair: PAPABEAR: a randomized controlled trial. JAMA. 2005;294:3093-3100.
Kruger P, Fitzsimmons K, Cook D, Jones M, Nimmo G. Statin therapy is associated with fewer deaths in patients with bacteremia. Intensive Care Med. 2006;32:75-79.
Manzoni P, Arisio R, Mostert M, et al. Prophylactic fluconazole is effective in preventing fungal colonization and fungal systemic infections in preterm neonates: a single center, 6-year, retrospective cohort study. Pediatrics. 2006;117:e22-e32.
Paul C, Cork M, Rossi AB, Papp KA, Barbier N, de Prost Y. Safety and tolerability of 1% pimecrolimus cream among infants: experience with 1133 patients treated for up to 2 years. Pediatrics. 2005;117:e118-e128.
Nikas SN, Voulgari PV, Alamanos Y, et al. Efficacy and safety of switching from infliximab to adalimumab: a comparative controlled study. Ann Rheum Dis. 2006;65:257-260.
Gerbino PP, Brixner D, Sbarbaro J, Nicolau D. Appropriate antibiotic therapy for community acquired respiratory tract infections. Manag Care Interface. 2005;18:41-48.
American Academy of Pediatrics Committee on Infectious Diseases. Recommended childhood and adolescent immunization schedule-United States, 2006. Pediatrics. 2006;117:239-240.
Clark RH, Bloom BT, Spitzer AR, Gerstmann DR. Empiric use of ampicillin and cefotaxime, compared with ampicillin and gentamicin, for neonates at risk for sepsis is associated with an increased risk of neonatal death. Pediatrics. 2006;117:67-74.
Chang AB, Lasserson TJ, Kiljander TO, Connor FL, Gaffney JT, Garske LA. Systematic review and meta-analysis of randomized controlled trials of gastro-oesophageal reflux interventions for chronic cough associated gastroesophageal reflux. BMJ. 2006;332:11-17.
Thurlimann B, Keshaviah A, Coates AS, et al. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005;353:2747-2757.
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