Specialty Pharmacy Continuum • Spring 2012
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Copyright 2011 McMahon Publishing Gr
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care and must be a core mission of every pharmacy. For medication error prevention efforts oduction in whole or in part without permission is pr
to be effective, they must become a priority. The first step in setting up an error-reduction • Increase detection and reporting of medica- errors, and proactively take measures to pre- program is to establish a multidisciplinary team to tion errors and potential hazardous drug-use improve medication use. The team must be given Effective results depend on understanding the reasonable time and resources to assess medica- • Explore and understand the root causes of entire medication-use process through varied per- oup unless otherwise noted.
tion safety and implement system-wide changes that make it difficult or impossible for practitio- • Educate practitioners about the system-based ISMP is a nonprofit organization that works ners to make mistakes that reach the patient. This closely with health care practitioners and institu- multidisciplinary team should accept ownership • Recommend methods to facilitate the imple- tions, regulatory agencies, professional organiza- of the medication-use process and enthusiastical- mentation of organization-wide, system-based tions, and the pharmaceutical industry to provide ly embrace the opportunity to improve medica- education about medication errors and their pre- • Respond to potentially hazardous situations vention. ISMP independently reviews medication The goals of the team should include the errors that practitioners and patients have volun- • Learn from errors occurring in other organiza- tarily submitted to the ISMP Medication Error • Promote a culture of safety to lower medication tions through the ISMP Medication Safety Alert! Reporting Program. ISMP is an accessible resource and other published accounts of medication Table 1. Problems Involving Drug Information, Patient Information, and Staff Education
Problem/Discussion Point
• “Wrong patient” medication errors can occur for a variety of reasons at any phase of the • All staff (not just nurses) should use 2 identifiers to identify/verify patients during all patient-associated tasks • Prescribers have entered orders into the wrong patients’ records, or prescribed therapy based on misfiled lab results for another patient.
• Telephone orders have been transcribed incorrectly onto the wrong patients’ records.
-pharmacy staff enter orders and dispense medications; • Patient labels have been applied to the wrong patients’ order forms.
-unit staff and nurses transcribe orders; • Pharmacists have entered orders into the wrong patients’ profiles.
-staff files test results; and-nurses administer medications.
• Design technology systems to limit access to an applicable set of patients, not all patients within the facility.
• A cardiologist prescribed Pradaxa for an outpatient with stage IV chronic kidney disease • Ensure that your computer system(s) is/are updated without adjustment for renal impairment.
with Pradaxa drug interactions and renal dosing • After a follow-up office visit during which tarry stools and a low hemoglobin and hematocrit were identified, the patient was admitted to a critical care unit with a massive GI bleed.
• A nurse used 2 smart infusion pumps to deliver propofol IV at a rate of 225 mcg/kg/min • Employing a technology workaround like this in an because the pumps’ drug library was set with a hard stop at 130 mcg/kg/min.
unintended manner should prompt an immediate peer • Propofol was prescribed for an off-label use (refractory status epilepticus), which required review of the conditions that led to the workarounds. • Make staff aware that the need for a workaround is a clear • The patient exhibited propofol-related infusion syndrome.
signal that a potentially serious medication error might occur.
• Using 2 infusion pumps to exceed a hard stop has been observed in other inappropriate Specialty Pharmacy Continuum • Spring 2012
Table 2. Safety Issues Related to Labeling, Packaging, and Nomenclature
Problem/Discussion Point
• There have been several reports of nurses failing to break the seal that • Start the initial infusion when the pharmacy is open, if possible, separates the 2 chambers, a key step for properly mixing the contents of and dispense for each patient after proper mixing and labeling.
both chambers prior to dispensing and administration.
• If the product is available in its overwrap in automated dispensing cabinets (ADCs) or other areas outside the pharmacy, teach nurses how to activate it using educational resources available at: www.clinimix.com/popups/video.jsp. • Due to a shortage of sodium chloride (NaCl) concentrate (23.4% and 14.6%) in • Perform a failure mode and effects analysis (FMEA) and address vials, compounding pharmacies are supplying these products to some hospitals. potential risks before the product is obtained and placed into use.
One compounder provides the concentrated sodium chloride 23.4% solution in • Consider implementing pharmacist double-checks and segregating the storage of these products away from other minibag infusions.
• Packaging the product in a minibag—as opposed to a vial—may lead to the All rights r
mistaken belief that the product can be administered as is, despite labeling that indicates that it must be diluted for IV use.
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• Century Pharmaceuticals lists the strengths on bottles of Dakin’s solution • If Dakin’s solution is being used in your institution, alert staff to the (diluted sodium hypochlorite) as full strength, half strength, and quarter strength.
risk for confusing the terminology used to communicate strength.
• Full-strength Dakin’s solution is a 0.5% solution; half-strength Dakin’s solution is a • Also be aware that using Dakin’s solution in 0.5%, 0.25%, and 0.125% eserved. Repr
0.25% solution; and quarter-strength Dakin’s solution is a 0.125% solution.
concentrations may be toxic. Most hospitals use a modified Dakin’s • Other Dakin’s solution manufacturers primarily label only by percent • A patient on Taxotere received 100 mg/m2 instead of a reduced dose of • Alert pharmacy staff and oncology nurses to the new 20 mg/mL 50 mg/m2 soon after an ambulatory cancer center pharmacy began using Taxotere and 10 mg/mL generic DOCEtaxel (both one-vial products).
the new 20 mg/mL one-vial product instead of the previously used 2-vial • Update databases and internal drug resources to ensure proper oduction in whole or in part without permission is pr
• A generic DOCEtaxel product (Hospira) also now is available as a single • If your computer system allows for order replication from past admissions, work with your IT department to intercept orders in which the strength of the medication has changed.
• For details, visit: http://www.ismp.org/newsletters/acutecare/ articles/20110321_HospiraDocetaxelLetter.pdf • EpiPens are only available in a 2-Pak that includes 2 EpiPens plus a nonfunctioning • If hospitals store EpiPens on units for hypersensitivity reactions, remove the pens from their carton and only store active pens on • The training pen looks similar to, and could be confused with, a real EpiPen in an • There have been numerous reports of mix-ups between B. Braun’s heparin and • Consider using a generic alternative to HESPAN, and refer to hetastarch oup unless otherwise noted.
• Both have red and blue lettering, and they share several letter characters in the • Use bar-coding technology to help prevent packaging or container same sequence (“H-E,” “P-A,” and “N”).
for any pharmacist or organization interested in summarizes many of the significant error-pre- proactively address and prevent errors from implementing the actions recommended herein. vention strategies that were recommended in the Among the many products and services that ISMP ISMP Medication Safety Alert! Acute Care Edition offers is the ISMP Medication Safety Alert! Acute during 2011. The errors presented in the tables are Suggested Reading
Care Edition, a biweekly newsletter that provides actual or potential errors reported to ISMP. Each 1. Cohen MR, ed. Medication Errors. 2nd ed. Washington, DC: timely information related to error prevention. It table consists of 3 columns. The first column lists American Pharmacists Association; 2007.
identifies errors that have been reported by other the medications, devices, or other problemat- 2. Institute for Safe Medication Practices Web site: www.ismp.org.
organizations and offers recommendations to pre- ic issues involved. The second column describes 3. Institute for Safe Medication Practices. ISMP Medication vent those errors from occurring in the pharmacy. the specific error or problem involved. The third Safety Alert! Acute Care Edition newsletters 2011. www.ismp.
The information in Tables 1 to 3 of this review column contains ISMP’s recommendations to org/newsletters/default.asp. Accessed March 19, 2012.
Specialty Pharmacy Continuum • Spring 2012
Table 3. Safety Issues Associated With Order Communication
Problem/Discussion Point
• Although studies show that “ketofol” may be effective and safe for procedural • Conduct a failure mode and effects analysis to assess risks before using • Admixture often occurs on units where sterility may be difficult to maintain.
• Take steps to promote sterility during admixture.
• Practitioners may be unfamiliar with the contrived name and not find it in any • Establish a standard ratio to guide the mixing process.
• Refer to the product using each drug’s official name, not “ketofol.” • Ratios for combining the 2 drugs vary.
• Include both drug names and an expiration date on syringes of the product.
• A syringe containing “ketofol” looks like a syringe containing just propofol.
• ISMP and the American Society for Health-System Pharmacists sent a warning • Dose colistimethate sodium ONLY as colistin base, with a dosage reduction
through the National Alert Network (NAN) about dosing errors involving colistimethate sodium for injection, a prodrug of colistin with a high potential • Consider restricting ordering to infectious disease specialists or intensivists.
to induce nephrotoxicity and neurotoxicity.
• Use preapproved guidelines or order sets with colistin-base dosing only.
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• The strength of colistimethate sodium is labeled in terms of the colistin base, • Dose limits should be established, with immediate investigation required for doses outside hospital guidelines.
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• Recently, a physician ordered the dose as the prodrug, but the dose was • For the full NAN alert, visit: www.ismp.org/sc?k=nanalerts.
dispensed as colistin base, which resulted in an overdose. The patient developed complications, including acute renal failure, and later died.
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• Drug names that end with the letter “L” have contributed to overdoses.
• Advise prescribers, pharmacists, and nurses to leave sufficient space • The lower case “l” has been misread as the numeral “1” and misread as part between the numeric dose and the drug name.
• This recommendation also applies to electronic prescribing and standard • For example, lisinopril 2.5 mg can be misread as lisinopril 12.5 mg if there is order sets because typed drug names and doses also can result in errors if inadequate space between the last letter of the drug name and the numerical sufficient space is not provided between the drug name and dose/strength.
• Dosing errors associated with prescribing, dispensing, or administering milliliter • Provide protocols for managing acute hyperthyroidism, protecting the oduction in whole or in part without permission is pr
doses of Lugol’s solution have occurred when just a few drops were indicated.
thyroid during exposure to radioactive iodine, and preoperative use of • Contributing factors include unfamiliarity with the drug, which is infrequently prescribed, and unexpected dosing units because adult doses are typically • Include iodine solution dosing information in protocols and order-entry expressed in milliliters, not drops.
• Dispense each dose of iodine solution in a prefilled syringe.
• If a bulk bottle must be dispensed, affix a warning: “The total volume in the container would be toxic if taken as a single dose.” • A nurse typed “PCN” for a penicillin-allergic patient into the allergy pick-list section • If PCN-200 is still listed as an option (type “PCN” in your allergy pick list and inadvertently selected “PCN-200.” to find out), either remove it manually or work with your computer system • PCN-200 was a grapefruit seed extract product that was discontinued several oup unless otherwise noted.
• An electronic prescription for penicillamine was ordered for a 9-year-old patient • Consider the use of tall man lettering for penicillAMINE.
who tested positive for Streptococcus.
• Incorporate the brand name and the purpose of the medication on the • The nurse practitioner intended to order penicillin, not the chelating agent. • Create an alert that will inform the practitioner that penicillAMINE is a look-alike/sound-alike (LASA) medication.
• Pyridoxine (vitamin B6) was prescribed and pyridium (phenazopyridine) was • Medication listings for pyridoxine in computer systems should be modified to help distinguish it from pyridium and other medications.
• The drug names look alike, and the products are both available as 100 mg tablets.
• An example modification is “vitamin B-6 pyridOXINE” on the screen, and • Typing “PYR…,” into computerized drug order systems calls up pyridium, pyridoxine, pyridium can be listed as phenazopyridine.
and other products that begin with PYR, making selection errors more likely.
• Dangerous mix-ups between TEAspoon and milliliter dosages are common and have • ISMP would like to see the complete elimination of TEAspoonful, been happening for many years, particularly in outpatient pharmacies.
TABLEspoonful, and other non-metric dosing, as well as the elimination • ISMP received a report in which a pharmacist accidentally provided instructions on of the abbreviations “tsp” and “tbsp,” which are easy to confuse.
the prescription label for a child to receive 3.5 TEAspoonfuls of a liquid antibiotic for • Doses expressed using mL are recommended to eliminate the risk for ohibited.
• FDA, ISMP, and the Pennsylvania Patient Safety Authority have received reports of • FDA approved revisions to the Prescribing Information (www.
harmful errors involving HYDROmorphone injection.
purduepharma.com/PI/prescription/DilaudidInjectionsPI.pdf), container • Many errors have been associated with dose conversions from morphine to labels, and carton labeling for DILAUDID and DILAUDID-HP (Purdue HYDROmorphone, packaging confusion, and high starting doses for opioid-naive Pharma), which will also affect generic parenteral HYDROmorphone.
• Alert prescribers that the IV starting dose has been reduced to 0.2-1 mg (previously 1-2 mg), and that a dose-conversion table is in the Prescribing Information to help convert from other opioids to HYDROmorphone.
Specialty Pharmacy Continuum • Spring 2012
Table 4. Medical Devices and Other Discussion Items
Problem/Discussion Point
• Numerous infants did not receive the Haemophilus influenzae type b • Pharmacies should dispense the 2 vials together using a rubber band or by component of PENTACEL, a 2-part vaccine packaged in cartons containing placing the 2 vials in a ziplock bag.
vials of liquid DTaP-IPV (diphtheria, tetanus, pertussis-inactivated polio virus) • Affix an auxiliary label to the carton to remind staff to use both vials.
and vials of lyophilized Haemophilus influenzae (ActHIB). • To confirm administration of both of the components, staff should document the • Nurses administering the 2-part vaccine failed to use the DTaP-IPV National Drug Code number for each vial in the vaccine log before administration.
component to dilute and mix with the lyophilized ActHIB powder component • Documenting the actual administration of the vaccine should always occur after • The purpose of bar-code scanning is defeated when it occurs after drug • Hospitals should monitor for back scanning practices, identify the causes if it administration—a practice called back scanning, which is one of the observed occurs, and make the necessary system changes to prevent this practice, including workarounds used to reduce workload during the drug administration process.
but not limited to educating nurses about the risks associated with this practice.
• Employing this workaround increases the risk for wrong drug, wrong dose, • If a drug must be given under urgent conditions, the safest method is to scan the All rights r
wrong time, wrong route, and wrong patient errors.
patient and medication bar codes, and create a new task on the electronic medication administration record (eMAR) to trigger later documentation Copyright 2011 McMahon Publishing Grof drug administration.
• The national drug shortage of common electrolyte solutions in certain • Follow a formal verification process for purchasing alternative products.
strengths and sizes has forced many pharmacists to replace their standard • Ensure that necessary changes are made within computer software that drives eserved. Repr
injectable solutions with different products.
various medication-use systems, such as IV compounders and robots, automated dispensing cabinets, computerized order-entry systems, smart pumps, and any other affected technology.
• Several days after receiving Lilly Humalog insulin cartridges and pen device • Visually inspect each pen and insulin cartridge before dispensing it to the in a clinic, a patient presented to the emergency department with elevated • Verify that the locations of teaching cartridges and insulin cartridges are • After opening the pen to determine if the insulin cartridge was empty or separated to avoid dispensing errors.
oduction in whole or in part without permission is pr
defective, staff found that the pen contained a teaching cartridge filled with • Suggestions have been presented to Lilly pertaining to the color of the teaching pens and cartridges to help distinguish them. • When a teaching cartridge is put in the pen device, you cannot see the drug name or banded colors that differentiate the teaching cartridges from actual insulin cartridges.
• In several instances, practitioners did not understand that “U-100” refers to • Educate staff regarding insulin concentration, the differences between insulin the concentration; they also did not realize there was a difference between and parenteral syringes, and how to measure doses.
insulin and parenteral syringes, and they were unaware of the role insulin • Restrict insulin preparation and administration to those who have shown • In one case, 4 mL of regular insulin was administered instead of 4 units.
• Ensure insulin syringes are readily available in all patient care units.
• In another case, 50 units of regular insulin, rather than 5 units, was added • Pharmacy should prepare, label, and dispense insulin in minibags for hyperkalemia treatment and in a standard concentration for infusions.
• In a third case, a patient with hyperkalemia received only the insulin portion • An independent double-check should be conducted before dispensing and oup unless otherwise noted.
of the treatment but did not receive the 50% dextrose injection.
• Monitor patient’s response to insulin by obtaining blood glucose levels.
• When a child went to the refrigerator to get a juice bottle, he picked up his • Dispense oral liquid medications with an oral syringe adapter that allows medicine bottle containing TAMBOCOR (flecainide, Medicis) and was able the child-resistant bottle cap to be replaced without removing the adapter.
to access the suspension and drink most of it because the child-resistant • Even with adult liquid medications, this precaution is critical to prevent a child • Errors like this could happen with any oral liquid medication prescribed • Join the Up and Away and Out of Sight Campaign (www.upandaway.org/), and help remind consumers about safe medication storage.
• A 6-week-old infant died in late 2010 after receiving a parenteral nutrition • Establish policies that require pharmacists to compound PN during the day shift (PN) solution that contained 60 times more sodium than prescribed.
to maximize the safety with which these solutions are prepared and dispensed.
• The PN that was prescribed included 14.7 mEq of sodium chloride and • Synchronize the order and format of listing ingredients in PN order sets, the pharmacy computer system, the compounder software, and the PN label to help ohibited.
• The order was faxed to the pharmacy after midnight and a pharmacy prevent errors caused by jumping back and forth.
technician entered it into the automated compounder software.
• Install, test, and maximize automated dose limit warnings in the pharmacy • The technician accidentally entered the prescribed dose of calcium computer system and automated compounder order-entry system.
(“982” mg) into the mEq field for sodium.
• If your PN software supports warning limits, fully implement them. Produce • The technician then prepared the PN using the automated IV compounder product labels and associated work labels for compounded solutions that include and placed the label with the erroneous sodium content onto the PN.
the actual dose/strength of the base solution and each additive, not just the • Unfortunately, the pharmacist did not detect the error when checking the volume amounts needed to prepare the products.
• Perform several verification processes of the PN order in the pharmacy; verify the • A different label with the sodium content listed as 14.7 mEq was placed over PN product, additives, and expected versus actual weight of the final PN product. the label produced by the compounder software that listed the actual amount of sodium (982 mEq) in the solution.
• The nurse who eventually started the PN solution was unable to detect • Patient tragedies caused by medical errors can shake involved practitioners • Develop a crisis management plan that includes a formal infrastructure for second victim support before it is needed.
• The impact is felt in their private lives, in interactions with professional • Second victims have the right to be treated with respect, to participate in the colleagues, and in the context of their social life.
process of learning from the error, to be held accountable in a just culture, • These second victims of errors suffer a medical emergency equivalent to not be abandoned by the organization, and to be supported by their peers • The instant patient harm occurs, involved practitioners also become patients • For details regarding the deployment of a second victim rapid-response team of the organization—patients who often suffer in silence.
and other resources, visit: http://www.ismp.org/newsletters/acutecare/articles/ 20110714.asp.

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Test Report No. 70.452.12.312.01-00 2012-03-26 ORIGINAL 6/F.,YAODA BLDG.,289 SHIFU RD.,318000 TAIZHOU,ZHEJIANG,CHINAThe sample(s) was (were) submitted by applicant and identified. Test result: Refer to the data listed in following pages Test specification: Conclusions: EN 71-1: 2011 Mechanical and Physical Properties EN 71-2: 2011 Flammability Migration of certa

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Management of PDA in RDS In healthy term infants and preterm infants without RDS constriction and closure of the ductus arteriosus is complete within 48 hours of delivery in 90% of cases and in 100% by 96 hours.1,2 Closure is often delayed in preterm infants with RDS and is inversely related to gestational age. In one study 42% of infants < 1000g developed a significant PDA and this dec

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