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Patient Breaks Hip as a Result of Falling at Home After
Taking Her Prescribed Nortriptyline
Root Cause Analysis Report
Analysis Name: Injury Due to Medication
PROACTOnDemand
P.O. Box 1421
Hopewell, VA 23860
Table of Contents
Appendices (see attached if applicable) Preserve (5P's)
PReserve Event Data
As in any investigative occupation, it is a REQUIREMENT that data (evidence) be collected from the scene andpreserved in such a fashion as is appropriate for further analysis. As with the detective at a crime scene, the areais roped off and the scene preserved for the professionals who will come in and collect the necessary data.
PROACT® utilizes a data collection technique called the 5-P’s. The 5-P’s stand for the following five (5) datacategories: Parts – Physical or tangible evidence. Examples include process equipment,diagnostic equipment, fluid samples, etc.
Paper – Documentation. Examples include procedures, specifications, records,policies, test results, literature searches, etc.
Positional – Elements of time and space. Examples include times of occurrences,location of occurrences, frequency of occurrences, etc.
People - People sought to be interviewed regarding an event. Examples includemanagement, administration, witnesses, engineers, hourly personnel, purchasing,etc.
Paradigms - People’s belief systems that contribute to decision errors. Costreduction is #1, "It’s the manufacturer’s fault", Poor design, etc.
Data Collection
Category
Strategy
Team Member
Collection
Completed
the team for use during the analysis.
Interview the attending physician and the patient concerning the events that led up tothe incident under investigation and bringthe results to the team for correlation withother failure data during the analysis.
Obtain from the patient and bring to the team Ordering the Analysis Team
Another prerequisite to the PROACT® RCA approach is that an appropriate team be formed for the analysis athand. Such an effort involves the following: Providing an unbiased team facilitator - Assigning a person to lead the analysiswho has nothing to gain or lose by the outcome; an expert in the facilitation of thePROACT® RCA methodology.
Amassing a team of cross-functional members - Ensuring that the team itself isnot biased with one perspective; allowing team members to be experts as well asobjective observers.
Establishing a Team Charter (Terminal Objective) for the analysis - Gainingconsensus on a one (1) paragraph statement that outlines the reason the team istogether.
Establishing Critical Success Factors (CSF’s) - Establishing CSF’s that outline howthe team will know when they have been successful.
To identify the root causes of the patient being injured (broken hip) due to Medication side effects.
This includes identifying deficiencies in or lack of management systems. Appropriaterecommendations for root causes will be communicated to management for rapid resolution.
Critical Success Factors
1 - A cross-functional section Of personnel/experts will participate In the analysis 2 - A disciplined RCA approach will be utilized 3 - All analysis hypotheses will be verified Or disproven 4 - Management agrees to fairly evaluate the analysis team's findings and recommendations 5 - No one will be disciplined for honest mistakes Analyze the Event Data
Any undesirable outcome is a result of a series of "cause-and-effect" relationships. The data collected in the 5-P’ssection of this report will ultimately serve as proof (evidence) as to what actually did or did not occur.
A logic tree will be used in the PROACT® RCA approach to graphically express the "cause-and-effect"relationships discussed earlier.In this approach, the top two levels of blocks represent the Event (Level 1) and theModes (Level 2).From level to level represents a "cause-and-effect" relationship.These levels specifically representthe "undesirable outcomes" that did occur (facts only)! From the MODE level, we do not know why they have occurred, just that they did. From this point we becomehypothetical and repeatedly ask the question "How Can?".
As hypotheses are developed in this fashion, we use our 5-P’s data to verify what is true and what is not true.In thisfashion, facts lead our analyses not assumptions. This process is reiterated until we start to uncover the real rootcauses; the reasons that people make decision errors that lead to undesirable outcome.
Root causes originate from flawed systems in which people depend on to make informed decisions. We call theseLatent Root Causes or Organizational Root Causes.Flawed organizational systems lead to poor decisions beingmade by well-intentioned individuals.We call these the Human Root Causes.Decision errors lead to Physical RootCauses, or events or conditions that are visible.
Only when we uncover the Latent Roots or Organizational System Roots are we actually conducting a "real"ROOT CAUSE analysis.
Became Dizzy From anAdverse Reaction to aMedication and Fell Patient Did not FollowManufacturer's Side EffectWarnings for Medication Verification Logs
Hypothesis
Description
Team Member
Verification Method
quot; but did not understand thatthis meant at any time duringthe day. The physicianinstructed the patient not toget out of bed too quickly inthe morning and to sit on theside of the bed for a fewminutes before attempting tostand up. Although this isgood advice, it does notconvey to the patient thatpostural changes at any timeduring the day can triggerorthostatic hypotension,especially at initiation oftreatment or following a recentdose increase.
side effects of the medicationprescribed.
Hypothesis
Description
Team Member
Verification Method
time of the incident underinvestigation.
Look at the potential side effects Nortripyline can cause dizziness time triggering orthostatichypotension, especially atinitiation of treatment orfollowing a recent doseincrease.
Hypothesis
Description
Team Member
Verification Method
this meant at any time duringthe day. The physicianinstructed the patient not toget out of bed too quickly inthe morning and to sit on theside of the bed for a fewminutes before attempting tostand up. Although this isgood advice, it does notconvey to the patient thatpostural changes at any timeduring the day can triggerorthostatic hypotension,especially at initiation oftreatment or following a recentdose increase.
Manufacturer's SideEffect Warnings forMedication Hypothesis
Description
Team Member
Verification Method
sit on the side of the bed for afew minutes before attemptingto stand up.
Although this is good advice, itdoes not convey to the patientthat postural changes at anytime during the day can triggerorthostatic hypotension,especially at initiation oftreatment or following a recentdoes increase.
The physician was counting onthe pharmacist to provide thisinformation during ananticipated patient counselingsession when she picked upthe prescription.
Hypothesis
Description
Team Member
Verification Method
few minutes before attemptingto stand up.
Although this is good advice, itdoes not convey to the patientthat postural changes at anytime during the day can triggerorthostatic hypotension,especially at initiation oftreatment or following a recentdoes increase.
The physician was counting onthe pharmacist to provide thisinformation during ananticipated patient counselingsession when she picked upthe prescription.
taken to what was prescribed by nortriptyline 75 mg to be takenthe physician.
once a day at bedtime. Thisis what is being taken and at thecorrect interval and amount.
once a day at bedtime. Thisis what is being taken and at thecorrect interval and amount.
Hypothesis
Description
Team Member
Verification Method
incomplete because it doesnot specify under whatcircumstances that Dizzinessmay occur.
Communicate
Communicate Findings and Recommendations
As with this report, an effective means of communication is necessary to get RCA recommendations approved andimplemented. This primarily involves communicating the conclusions of the RCA and the recommendations as aresult of the RCA.
The elements of this section are intended to communicate the summary of the findings of the RCA formanagement, as well as the detailed recommendations made by the RCA team members for resolution of thecauses identified.
A RCA cannot be successful without the approval and implementation of the analysis recommendations.
Event Summary
A 68 year old female in good health is seen by her family physician following the death of her husband. The patientreports feelings of loneliness, difficulty concentrating, sleep disturbances, decreased appetite and generalizedfeelings of depression. The physician decides to try the patient on a short course of tricyclic antidepressantmedication and prescribes nortriptyline 75 mg at bedtime. The physician instructs the patient not to get out of bedtoo quickly in the morning and to sit on the side of the bed for a few minutes before attempting to stand up.
A few days later, the patient is lying on a chase lounge by her swimming pool enjoying the sun. She decides tocheck her mailbox. After a few steps she gets dizzy and falls on the concrete apron surrounding the pool breakingher hip.
It was determined by the medical staff that a need for a formal analysis to uncover the Root Cause(s) of thisincident be conducted at this time.
Summary of Findings
The root causes of this incident can be directly attributed to the patients inability to determine the potential sideeffects of the prescribed medication. This can be further attributed to the limitations of the amount of information thatcan be put on prescription labels as well as the lack of other types of materials such as pamphlets and instructionssheets. Also the instructions provided to the patient by the pharmacist and the physician were less than adequateto prevent potential mishaps that could occur due to a lack of knowledge concerning the potential side effects ofthe prescribed medication.
PROACT® Description
PROACT® is a methodology developed by Reliability Center, Inc. (RCI) to help users analyze their most importantproblems. The term PROACT® is an acronym for: PR - Preserving Failure DataO - Ordering the AnalysisA - Analyzing the DataC - Communicating Findings and RecommendationsT - Tracking for Results.
Executive Summary Recommendations
Root Cause
Recommendation
Team Member
Estimated
Completed
Completion Date
understands all the potentialside effects of prescribedmedications.
should fully explain all thepotential side effects of anymedication prescribed to thepatient.
denotes possible adversereactions to prescribedmedications and whenapplicable a pamphlet orinstruction sheet (packageinsert) is provided if needed.
medications at the time they areprescribed and tell the patient tocall when anything unusual orunexpected occurs.
Root Cause
Recommendation
Team Member
Estimated
Completed
Completion Date
medications whose warningsand precautions can not fit onthe prescription label.
information pamphlet formedications whose warningsand precautions can not fit onthe prescription label.
Detailed Recommendations
Root Cause
Recommendation
Completed
Pharmacist Unavailable when Prescription was Picked Up Pharmacist did not Competely Explain Side Effects Make sure the patient is aware and completely understands the side effects of prescribed medicationsas detailed in the package insert or in other respectedmedical or pharmacology textbooks.
Physician Expects the Pharmacist to Explain Side Effects No Pamphlet or Instruction Sheet Given with Prescription Root Cause
Recommendation
Completed
Physician did not Completely Explain Side Effects Clearly explain all the potential side effects of prescribed medications and point out the additionalinstructions and warning that may be contained in thepackage insert (pamphlet or instruction sheet) as well asrespected medical or pharmacology textbooks. Asminimum provide the following information: 1. The name of the proposed treatment or procedure.
2. A description of any reasonably foreseeable materialrisks or discomforts (including the incidence or likelihoodof occurrence, if known).
3. A description of the anticipated benefits.
4. A disclosure of appropriate alternative procedures orcourses of treatment, if any, that might be advantageous.
5. Any foreseeable risks should the patient becomepregnant.
6. Ask patient to repeat any special or critical instructions.
7. Ask the patient if he/she has any questions.
No Pamphlet or Instruction Sheet Given with Prescription List of Side Effects will not fit on Prescription Label

Source: http://www.reliability.com/pdf/Nortripytline_rca_report_b.pdf

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PHARMACY FORUM HELD ON 3RD DECEMBER 2010 AT THE HOLIDAY INN RUNCORN Attendees Jo Bateman, Countess of Chester Hospital (JB) Sarah Roden, Western Cheshire PCT (SR) Danny Forrest, Liverpool Heart and Chest Hospital (DF) Victoria Birchall, NHS CL WL Locality (VB) Diane Hornsby Western Cheshire PCT (DH) Dave Thornton, Aintree Hospital (DT) Michael Lloyd, Whiston Hosp

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