According to the U.S FDA (2014), a medicationblunder is a flop in the treatment procedure that results in or causeharm to the patient. They can occur in various circumstances such aswriting the prescription (illegibility), administering theformulation (wrong medication, detailing as well as name). Besides,directing or taking the drug (wrong measurement, course, recurrenceas well as length) observing treatment (incorrect change orneglecting to adjust treatment when fundamental), fabricating thedefinition required (wrong quality or deluding bundle andcontaminants). Further, it can also occur while choosing a medicineeither irrationally, inappropriately, under-prescribing,overprescribing and ineffective prescribing.
There are four fundamental sorts ofprescription blunders. Information based mistakes happen because ofthe absence of learning. A case is offering penicillin to a patientwithout figuring out if they are unfavorably susceptible or not.Memory-based errors or lapses include prescribing penicillin to apatient knowing that the patient is averse but forgetting. They aredifficult to elude sometimes, but they can be stopped. Action-basedblunders or slips include selecting a bottle containing diltiazem onthe pharmacy shelf rather than the intended one containing diazepam.Rule-based faults occur when a depraved directive is used or when agreat rule is misapplied. An example is when oral treatment isprescribed to a patient with dysphagia resulting to treatment failureor lung aspiration.
In the United States, 1.7% of remedies givenfrom the group drug stores contained medicine blunders. That meansthat approximately 50 million prescriptions out of over three billionprescriptions dispensed each year contained errors with wrong labeland instructions being the major contributors. According to the Foodand Drug Association, death rates from medication errors in the USare increasing.
The introduction of the error inclusive ofparticular occurrence(s), type (dose, route, etc.), significance.
In 2013, the U.S FDA cautioned the therapeuticservices experts about potential solution mistakes which are comingabout because of disarray on the nonproprietary name for bosommalignancy drug Kadcyla (Ado-trastuzumab emtansine). Kadcyla isutilized as a part of the treatment of HER2-positive breast growththat is threatening and has spread to other body parts of thepatient. The people influenced have typically gotten prior treatmentwith a taxane chemotherapy and Herceptin. Kadcyla includestrastuzumab which is an anti-cancer HER2 treatment associated withDM1, a medication that meddles with the development of malignancycells.
The drug Herceptin (trastuzumab) another breastcancer medicine is stirred up with Kadcyla (Ado-trastuzumabemtansine). Some outsider distributions, wellbeing data frameworks,for example, electronic health record, drug store requesting,wholesale seeking and drug store medicine preparing frameworks,compendia references, and Internet locales are utilizing the UnitedStates Adopted Name "trastuzumab emtansine" inaccuratelyand overlook the prefix "ado" and the hyphen. The dosingand the treatment systems for Kadcyla and Herceptin are entirelydiverse, accordingly, befuddling these two medications could promptdosing blunders and noteworthy mischief to the patients.
The impact of the Error on the Individualand Group.
The mix-up of the drugs Kadcyla and Herceptincan lead to dosing errors. In clinical trials, dosing errors such asoverdosing have been reported to cause one death after three weeks.Adverse drug reactions are also evident in the medication error.Dosage errors can lead to adverse drug reactions such asthrombocytopenia which can be resolved if recognized early enough.Further, hypersensitivity to Herceptin can be fatal in some cases andinfusion-related reactions characterized by symptoms such astachycardia, flushing, and chills. Occasionally the medication errorcan lead to adverse events such as deterioration in a concurrentillness. The individuals or the group affected by HER2 breast cancerwill not get the required treatment when Kadcyla is confused withHerceptin.
Impactof the error on the healthcare system as a whole
According to U.S FDA, the mix-up of Kadcyla andHerceptin resulted in mortality for some patients which taints theimage of the healthcare system. Litigation claims from the victimshave led to increased costs regarding additional expenses incurred infurther treating and settling the cases that arise from themedication. The WHO (2014) reported that over 1 billion dollars areused in treating the medication errors.
Correctiveactions that have been initiated in direct relation to this error
In the prevention of the Kadcyla and Herceptinmix-up error, the U.S FDA recommended that medication informationsubject editors identify drug products by the nonproprietary titlesand FDA-approved proprietary labels that are utilized in FDA-approveddrug labels. The publishers’ routine automated updates that don’tcatalog the “ado” prefix may disregard and inverse the manualmodification enhancing the error. Therefore, health careprofessionals should watch out and curb the error. ISMP, 2013recommended that Kadcyla is listed by its generic name using a hyphenbetween ado and trastuzumab. Further, both brand and generic namewere to be included, and finally, awareness was recommended to beincreased in third party publications and information systems.
Further, adverse events should also be reportedfor the correct product. Patients are advised to detail medicationblunders and side consequences from the drug Kadcyla to the FDAMedWatch program by using the information provided in the “ContactFDA” segment on their site. They are also advised to talk to theirhealth care professional when they have concerns or questions aboutKadcyla and Herceptin.
Also, the FDA gave instructions that Kadcylaand Herceptin are not similar products and therefore, they should notbe substituted both ways. Kadcyla recommended dose is 3.6 mg/kgdispensed by intravenous infusion as a single proxy every 21 days.Higher doses than the recommended should not be administered.Herceptin’s recommended load up the dose is 8 mg/kg followed by acontinuance dose of 6mg/kg after every 21 days.
Result(s)of corrective action
Sincethe endorsement of Kadcyla on February 22, 2013, no drug blunders onperplexity amongst Herceptin and Kadcyla (U.S FDA, n.d). However,amid clinical trials that assessed Kadcyla security and adequacybefore the endorsement, pharmaceutical errors occurred.
FDA,U. (2013). FDA warns about the potential medication errors resultingfrom confusion
regardinga nonproprietary name for breast cancer drug Kadcyla (Ado-trastuzumab
ISMP,(2013). Confusion about the generic name of the HER2-targeted drugKADCYLA (Ado-trastuzumab emtansine). .). Retrieved fromhttp://www.ismp.org/NAN/files/20130417.pdf.
REMS,R. R. N. (2014). Ado-Trastuzumab Emtansine (Kadcyla®). Pbm.va.gov
WorldHealth Organization. (2014). Reporting and the learning systems formedication errors:the role of pharmacovigilance centers.