chemotx safety Flashcards
Cytotoxic Drug Dosing – What is at stake?
- Cytotoxic Drugs – Narrow Therapeutic Window
- Maximize cell kill within the range of toxicity
- Prevent or slow development of new malignant and potentially resistant cells
- Over-exposure (too much drug)
- Toxicity - Adverse Drug Reactions (ADRs)
- Remember dose limiting toxicities
- Can be life threatening!
- Under-exposure (not enough drug)
- Not enough “Cell Kill”
- Treatment resistance (lost time)
- Cancer progression (can be life threatening or limiting)!
Oncology Refresher - Cytotoxic Agents
- Cytotoxic medications (classic “chemotherapy”)
- Have a narrow therapeutic window
- Exerts beneficial effects by destroying cells
- Does not target or discriminate
- Rapidly dividing cells are typically more susceptible
- Rationale for malignant cell kill
- Can destroy some healthy or “good” cells too
- Dose limiting toxicities (DLT)
- Bone marrow/myelosuppression (common DLT)
- Neutropenia – infections
- Thrombocytopenia – bleeding
- Anemia – SOB, cardiac arrest
- Organ Toxicities (eg cardiotoxicity, neurotoxicity, nephrotoxicity, hepatotoxicity)
- Usually dosed based on “Body Surface Area” (BSA)
Medication Safety in Oncology
* Institute for Safe Medication Practices Canada (ISMP Canada)
- Independent, national not-for-profit agency committed to the advancement of
medication safety in all health care settings. - Mandate includes analyzing medication incidents, making recommendations for the
prevention of harmful medication incidents, and facilitating quality improvement
initiatives. - Partner in the Canadian Medication Incident Reporting and Prevention System
(CMIRPS) - Voluntary Reporting of Medication Incidents
Medication Safety - Definitions
* Medication Incident
- Medication Incident
- Any preventable event that may cause or lead to inappropriate medication
use or patient harm while the medication is in the control of the healthcare
professional, patient, or consumer. - Simplified:
- A mistake with medication, or a problem that could cause a mistake with medication
ISMP Canada Safety Bulletin; March 2010
Medication Incidents Involving Cancer Chemotherapy Agents
* ISMP voluntary reported chemo related incidents (2002-09)
* 519 incidents
* 7.7% (40) had an outcome of patient harm
* 4 (0.8%) had an outcome of patient death
Seven Main Themes of Chemo Related Incidents:
* Scheduling of Patient Treatment (3%)
* Prescribing (11%)
* Order Entry or Transcription (10%)
* Clinical Assessment and Communication of treatment changes (5%)
* Dispensing (27%)
* Administration of Medication (34%)
* Monitoring (11%
- Critical Incident – ISMP Canada
definiton
An incident resulting in serious harm (loss of life, limb, or vital organ) to the
patient, or the significant risk thereof. Incidents are considered critical when
there is an evident need for immediate investigation and response.
Root Cause Analysis (RCA)
* Definition of Root Cause Analysis:
- An analytic tool that can be used to perform a comprehensive, system
based review of critical incidents. - Include the identification of the root and contributory factors,
determination of risk reduction strategies, and development of action
plans along with measurement strategies to evaluate the
effectiveness of the plans. - ISMP Canada leads the Root Cause Analysis (RCA) for selected
medication incidents such as the critical incident in Case #1
- Goals of Root Cause Analysis:
- Focus of RCA
Goals of Root Cause Analysis:
* WHAT Happened?
* HOW and WHY did it Happen?
* What can be done to REDUCE the likelihood of RECURRENCE and make care
SAFER?
* What was LEARNED?
* Focus of RCA
* Systems and processes
* Understanding that individuals involved did not intentionally act to cause
harm
* Does NOT assign blame
Inattentional Blindness
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Changes Implemented from RCA
- Independent Double Check Processes
- Definition - procedure in which two clinicians separately check alone and apart from
each other, then compare results - Helps avoid confirmation bias
- Incorporate checklists and calculations into medication order forms/worksheets
- Create a structured process to document when doing double checks
- training incorporated into staff orientation and recertification
- Use mental estimation to check calculations
- Minimize distractions in workplace
- Avoid inattentional blindness
- Implementation of Process Changes
- Easy to calculate worksheets
- Elastomeric pump to reduce chance of “infusional variance”.
Vincristine
- MOA is interference with mitotic spindle function.
- QUICKLY (>5 minutes) binds to tubulin thus blocking its polymerization into
microtubules - Inhibits mitosis in metaphase
- INTRAVENOUS (IV) administration ONLY
- Neurotoxicity is caused by interference with microtubule function
resulting in blocking axonal transport which causes degeneration of
axon in neurons - Vincristine has poor penetration of the Blood Brain Barrier (BBB)
- Dose limiting toxicity is Peripheral and Autonomic Neuropathy but not
usually CNS toxicity
Vincristine Administration Errors
- Multiple ERRORS of Vincristine administered INTRATHECALLY have occurred globally over the last 5 decades
- First reported case in 1968
- Since then 66 cases of this error (worldwide) are reported in the literature (as of 2007) and
almost all have resulted in death. - Estimated that total sum of worldwide cases is 120 (with 44 in US and Canada)
Vincristine administered intrathecally is deadly!
* First signs are leg weakness, leg pain and loss of the tendocalcaneus reflex
* Autonomic dysfunction with urinary retention
* Symptoms of meningitis (neck stiffness and high fever)
* CNS failure (respiratory failure and death)
- Treatment
- Immediate CSF lavage and glucocorticoids (mostly unsuccessful)
- PREVENTION of this error IS KEY!
- ISMP, WHO, The Joint Commission, and others have published letters, alerts, and recommendations
- The cause of many of the errors appears to be related to mistaking IV Vincristine for an intrathecal medication.
- All ERRORS of Vincristine being administered intrathecally have occurred when Vincristine was prepared in a syringe.
Strategies to Avoid Vincristine Errors
- Dilute Vincristine in a volume ideal for IV infusion (50mL NS)
- Minibag, precludes administration intrathecally
- Ensures drug will look distinctly different than a product prepared for Intrathecal
Administration - Conduct a “time out”
- at least 2 health care professionals independently verify and document, patient, drug, dose, route.
- Distinguish medications for intrathecal administration
- Delivered/placed in a designated separate area
- Package intrathecal products in another bag labeled “FOR INTRATHECAL USE ONLY” and package can only be removed by the person administering the drug
- Clear labeling
new processes
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Extravasation of Vesicants
Definition or Extravasation:
Definition of a Vesicant
Definition or Extravasation:
* Escape of a chemotherapeutic agent from a vessel into the surrounding tissues by
leakage OR
* Involuntary injection of a drug into the tissues
Definition of a Vesicant
* Drugs that may cause severe and lasting tissue injury and necrosis
* Examples include:
* Anthracyclines (Doxorubicin, Daunorubicin, Epirubicin, Idarubicin)
* Vinca Alkaloids (Vincristine, Vinblastine, Vinorelbine)
Symptoms of Extravasation of Vesicants
- Pain and/or local burning at the infusion site
- Erythema, itching, swelling
- Symptoms may increase over time to:
- Discoloration and induration skin
- Blistering
- Necrosis
- Ulceration
- Involvement of underlying tissues
Extravasation Treatment
- Stop Injection Immediately
- Disconnect the tubing but leave the needle/catheter!
- Attempt to aspirate as much drug as possible with a clean syringe
attached to the needle. - Consider antidote administration if available?
- Remove needle
- Elevate limb, gentle pressure to site
- Apply warm or cold compresses depending on the drug
Extravasation Prevention
* Prevention is KEY
- Extravasation Kit present when cytotoxics are given
- Central Administration (preferred)
- Infuse NS before and after
- Ensure blood return
- Peripheral Administration:
- New IV site in limb (prefer not hand) in a large vein away from tendons or joint (large vein in mid forearm is ideal)
- Use a catheter (not a butterfly needle)
- Ensure blood return
- Keep IV site visible
- IV free flowing with NS and flush after
- Encourage patient to communicate pain or discomfort at the infusion site
- In multidrug protocols, give the vesicant first if possible
Errors with Oral Cytotoxic
- Oral chemotherapy has ease of administration but can be just as toxic
(and deadly) as IV - Many healthcare organizations have focused intensely on improving
safety with parenteral chemotherapy but have done less to ensure
safe practices with oral.
ISMP Recommendations
- Single dose only
- Provide patient counselling
- Provide written instructions
- Provide alerts in pharmacy software “Single Dose Only”
- Enhance Labels with dosing frequency directions and warnings
Three main themes identified and unique challenges for
specific practice settings were highlighted.
* Medication Name Mix-ups
* Lack of specialized knowledge
* Lack of Safe Handling Procedures
Medication Name Mix-ups
- Examples:
- Nexavar® (sorafenib) and Nexium® (esomeprazole)
- Temodol® (temozolomide) and Tramadol
- Hydroxyurea and Hydroxyzine
- Cyclophosphamide and Cyclosporine (aka “Cyclo”)
- Procarbazine and Carbamazepine
Lack of Safe Handling Procedures
- Oral (just like parenteral) chemotherapy agents are hazardous
substances!!!! - Use designated devices and personal protective equipment during
preparation, dispensing, and administration - To protect healthcare providers, patients, family members
- Example:
- A pharmacist dispensed diclectin (pyridoxine and doxylamine) using the same
counting tray that had been used earlier to fill a prescription for hydroxyurea - The pharmacist did not properly clean the tray between prescriptions
Lack of Specialized Knowledge
- 2014 publication in Journal of Oncology Pharmacy Practice
- A survey was distributed to pharmacists practicing in the community setting
across Canada in PEI, New Brunswick, Nova Scotia, Ontario, and Manitoba - These are the provinces where oral anticancer agents are predominantly dispensed by the
community pharmacies - Alberta not included as dispensing is done only in AHS Cancer Control Pharmacies
- 352 survey responses
- 19% had attended a CE event related to oncology in the past 2 years
- 24% were familiar with the doses of oral anticancer agents
- 9% felt comfortable educating patients on anti-cancer agents
Medication Error Culture
- Be a part of a culture of SAFETY
- Understand we are all human and unfortunately medication errors will
continue to occur - Share our experiences to learn from them and to create safer
environments for ourselves, our colleagues and our patients - Organizational, National, and International Reporting
- Minimize risk by educating ourselves and others
- ISMP – Canada Newsletter
- The Joint commission – Sentinel Event Alert
- Human Factors Engineers
