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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 - 03/13/09) 1 The draft ASCO/ONS Standards for Safe Chemotherapy Administration were posted for public comment from January 27, 2009 to March 13, 2009. 322 public comments were received during the public comment period and are summarized in the table below. Public comment results were used to further refine the standards - standards listed below are not final. To access the final ASCO/ONS standards, go to: ASCO/ONS Chemotherapy Administration Safety Standards article. Standard Definition and Percent Number of Selected Comment(s)/Themes Action Instructions for “Yes” Comments Standards Votes 1. Practice has processes for Note: throughout the 95 45 1. Add safe handling procedures into Edit/Include oversight, verification of standards, any use of standards or reference them(5) training, and continuing the term ‘practitioner’ is 2. Standards should be written for all education for clinical staff. defined as: practice settings not just outpatient(6) A. Orders for parenteral and Licensed independent 3. Many small practices will not have an RN oral chemotherapy are written practitioner, or allow for education time and signed by licensed including physicians, 4. RN should be the minimum practitioner independent practitioners who advance practice allowed to administer chemotherapy are determined to be qualified nurses (nurse 5. Don’t understand term ...
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1. Add safe handling procedures into standards or reference them(5) 2. Standards should be written for all practice settings not just outpatient(6) 3. Many small practices will not have an RN or allow for education time 4. RN should be the minimum practitioner allowed to administer chemotherapy D’ “ ” 6. B. should also include oral 7. Pharmacists should be listed in the licensed independent practitioner category
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 - 03/13/09) The draft ASCO/ONS Standards for Safe Chemotherapy Administration were posted for public comment from January 27, 2009 to March 13, 2009. 322 public comments were received during the public comment period and are summarized in the table below. Public comment results were used to further refine the standards - standards listed below are not final. To access the final ASCO/ONS standards, go to: ASCO/ONS Chemotherapy Administration Safety Standards article . Standard Definition and Percent Number of Selected Comment(s)/Themes Instructions for “ ” Comments Standards Votes 1. Practice has processes for Note: throughout the 95 oversight, verification of standards, any use of training, and continuing ‘ ’ education for clinical staff. defined as: A. Orders for parenteral and Licensed independent oral chemotherapy are written practitioner, and signed by licensed including physicians, independent practitioners who advance practice are determined to be qualified nurses (nurse by the practice site according practitioner or clinical ’ nurse B. Parenteral chemotherapy specialist), and /or drugs are prepared by a physician assistants, as pharmacist, pharmacy determined by state law. technician or nurse determined to be qualified according to the Chemotherapy is ’ administered by C. Only qualified clinicians qualified administer chemotherapy. licensed registered D. Practice site has a nurses, physicians, nurse comprehensive educational practitioners, clinical program for new staff nurse specialists, or administering chemotherapy, physician assistants. including a competency Qualifications for assessment, OR the practice practice are determined site uses an off-site educational by credentials, education program regarding and competency © 2009 by American Society of Clinical Oncology
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
chemotherapy administration assessment in that ends in competency chemotherapy assessment. administration. E. Practice site has a standard The practice site mechanism for monitoring establishes the minimum chemotherapy administration qualifications of those competency at specified who administer chemo- intervals. therapy, that includes F. All clinical staff maintain specific educational current certification in basic life preparation. support. Chemotherapy administration education must include all routes of administration used in the practice site (e,g. parenteral, oral, intrathecal, intraperitoneal, intravesicular). An example of an offsite educational program is the ONS Chemotherapy and Biotherapy Course. Annual competency ‐ ended. recomm
© 2009 by American Society of Clinical Oncology
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
2. One staff member is Pharmaceutical services 86 identified at the practice site include drug ordering, as the individual responsible storage, quality control for oversight of pharmaceutical of preparation, and services. disposal. 3. Chemotherapy drugs are Note: Additional labeling 92 labeled immediately guidance is upon preparation, including at available from ISMP: minimum: A. patient full name http://www.ismp.org/to B. unique patient identifier ols/guidelines/label C. full generic drug name Formats/comments/defa D. drug administration route ult.asp E. total dose to be given F. total volume required to administer this dosage G. date of administration H. date and time of preparation 4. Practices that administer intrathecal medication maintain policies specifying that intrathecal medication will: A. Not be prepared during preparation of any other agents. © 2009 by American Society of Clinical Oncology
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1. Give example of type of staff, physician, Delete RN, practice manager. Also, qualifications and whether or not they are licensed. 2. Identify who could be the back-up staff 3. A multidisciplinary approach should be used for the oversight. 4. Use the term coordination of pharmaceutical services 1 .Some drug dispensing machines (Pyxis) do Edit/Include not allow flexibility in labeling 2. Clar “ ” Give example. Small offices may not understand the need for this plus patient name. 3. Add: a. length of infusion b. rate c. expiration date and time d. hazardous label- bright color
1. ISMP,JCAHO, and WHO, all recommend Include use of mini-bags(50ml) 2. Should include a strong statement about vinca alkaloids as in WHO Statement (5 ) 3. Use a slip tip syringe instead of leur-lock 4. Boldly labeled in red or other bright color h “ Ih ” 5. JCAHO recommends double checks with
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
B. Be stored, once prepared, in an isolated container or location. C. Delivery to the patient only with other medication intended for administration into the central nervous system. 5. Practice site maintains a record including drug source and lot number, expiration date, and patient for whom the drug was prepared for administration. 6. At least two individuals (including practitioners and/or other personnel approved by the practice site to prepare or administer chemotherapy) independently verify each order for chemotherapy prior to preparation, including confirming: A. drug names B. drug volume C. concentration D. rate of administration E. the calculation for dosing (including the variables used in this © 2009 by American Society of Clinical Oncology
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time-out procedure 6.Be explicit on qualifications for person administering 7. Expiration of sterility should be labeled
1. Add name of person preparing Delete 2. This is a burden to small practices. 3. Large pharmacy will have numbers on huge lots, too much burden to track. 4. How long should information be kept? (5 ) + 1. Add to text: Edit/Include a. Appropriate regimen for diagnosis b. Sequence of meds c. Route of admin d. Regimen, cycle day e. Co-signed 5. Drug volume and concentration may be done in pharmacy and nurse may not be there to verify (20+) 6. Difficult for small practices with one licensed person (20+)
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calculation) 7. At least two individuals (including practitioners and/or other personnel approved by the practice site to prepare or administer chemotherapy) verify each order for chemotherapy between preparation and administration, including: A. expiration dates/times B. appearance/physical integrity of the drugs C. concordance with the prescribed plan 8. Prior to every new A. Pathology report or 90 chemotherapy regimen, cytology report chart documentation includes: confirming malignancy A. Pathologic confirmation of available in the oncology diagnosis medical record. Formal B. Initial cancer stage or statement current cancer of diagnosis based on Status Cancer stage is defined the microscopic at diagnosis. Cancer status examination of material includes a current description by a pathologist; h ’ for hematologic diagnosis/staging, if relevant malignancy, bone (e.g., recurrence, metastases). marrow test results C. Confirmation that the interpreted by a ordering practitioner has done hematology/ oncology a complete medical history and specialist. If original path © 2009 by American Society of Clinical Oncology
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1.Specify type of licensed personnel (10) Edit/Include 2. Add to C. – for right day in cycle 3. Co-sign (4) 4. There is only one nurse on duty (10+) 5. Substitute “ regimen ” for plan 6. Re-verification at change of shift or change of clinician
1. Does all documentation need to be Edit/Include repeated if patient changing regimen after one or two cycles? 2. Give options for outpatient infusion center not linked to specific practice. D’ h h ology each time new regimen started. This should be included on chart. 4. D’ h id tumor but might need bone biopsy for leukemia (10+) 5. Reality is patient may get care from several facilities and not all information is easily obtained especially on first visit. 6 A “ ” assessment in F.
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
exam report is unobtainable, History and physical must note of explanation is in include, at minimum, height, chart. weight, and assessment B. Cancer stage is ‐ as defined at diagnosis. appropriate for the planned Cancer status includes a regimen. Example: patient plan current description of for cisplatin requires h ’ pretreatment assessment of since diagnosis/staging, kidney function. if relevant (e.g., D. Presence or absence of recurrence, metastases). allergies or C. History and physical other hypersensitivity reactions must include, at E. Assess the ability of the minimum, height, patient to understand and weight, and assessment adhere to medication ‐ regimens, including function as appropriate information regarding disease for the planned regimen. and self care. Identify barriers Example: patient to comprehension of plan for cisplatin instruction materials provided requires pretreatment should be appropriate for the assessment of kidney ’ function. literacy. E. Patient education F. Assessment regarding materials provided psychosocial concerns and should be appropriate need for support h ’ G. The chemotherapy regimen level and literacy. plan, including at minimum: F. Documentation of chemotherapy drugs, doses, psycho-social concerns duration and goals of therapy that may influence H. For oral chemotherapy, the patient safety and © 2009 by American Society of Clinical Oncology
7. Clarify, focused H&P or Complete H&P? 8. Add: performance status and 8 G add: supportive therapy
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
frequency of office visits and treatment adherence monitoring is appropriate to may include: the agent and is defined in the • Copy of distress, treatment plan depression, or anxiety screening form in the chart, • ‐ distress, depression, or anxiety • Notes in chart regarding patient coping, adjustment, depression, distress, anxiety, emotional status, family support and ‐ cultural background, socio-economic status. 9. The practice site: References for 94 A. defines standard chemotherapy regimens chemotherapy regimens by must be readily available diagnosis with references to all practitioners readily available. who order and or administer B. identifies a source(s) for chemotherapy in chemotherapy regimens, the practice site. including local or centralized IB‐ h protocols or guidelines. 10. For orders that vary from Exception orders may 93 © 2009 by American Society of Clinical Oncology
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1. Ch “ ” “ / ” Edit/Include 2. Specific regimens should be available to all on the multidisciplinary team
1. Where should this be documented? In the Include
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
standard regimens, include notation that practitioners provide a standard treatment is supporting reference. contraindicated due Reasons for dose modification to preexisting co-or exception orders are morbidity, organ documented. dysfunction, or prior therapy. 11. Practice site has policies Documentation of 83 that determine the ‐ appropriate time interval for laboratory tests may be ‐ part of standardized tests. regimen orders.
12. Practice site maintains a Practice may provide 93 policy for how options for consent chemotherapy informed (e.g., use of chart consent is obtained and documentation of documented. patient consent vs. a signed patient consent form) that allow for variation among practitioners in the practice site. 13. The practice site maintains If the practice site 90 a policy for quality control of administers chemotherapy that is prepared chemotherapy that is offsite. prepared offsite ‘ -’ h practice has written standards for quality © 2009 by American Society of Clinical Oncology
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notes or orders? 2. Should this include off label uses?
1.Provider s should determine test intervals Edit/Include 2. Even guidelines state different intervals, currently too controversial 3. Should be site or regimen specific. Set minimum interval into policy 4. Too rigid- to much patient and physician variance “ ” 1. State that the practitioner should record Include discussion points in chart 2. Is a new consent required when the treatment plan changes? 3. This could be merged with #19. 4. How long is a signed consent valid?
1.ASHP recommends that offsite pharmacies Include be accredited 2. ASHP writing white paper about brown-bagging 3. Fifteen out of nineteen comments stated that off site preparation should not be allowed because it is not safe
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
control of that chemotherapy. 14. Practice site does not allow Verbal orders are not 90 verbal orders for chemo- permitted to start, therapy. change, stop, or hold chemotherapy.
15. Practice site maintains and Standardized forms may 85 uses standardized, be incorporated ‐ ‐ in ‐ forms or computer software or electronic genera ted forms for health records. chemotherapy prescription writing (oral and parenteral). 16. Order forms inclusively list Brand names should be 91 all chemotherapy included in orders agents in the regimen and their only where there are individual dosing multiple products or parameters. All medications when including the within the order set brand name otherwise are listed using full generic assists in identifying a names and follow Joint unique drug formulation. Commission standards regarding abbreviations. Complete orders must include: When chemotherapy A. patient full name orders are generated B. unique patient identifier using electronic C. date ordering, electronic D. diagnosis orders must integrate all E. regimen name and cycle of these elements. © 2009 by American Society of Clinical Oncology
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1. Use for dose reduction only Edit/Include 2. Use only for hold or stop chemotherapy orders 3. Sites with 5 locations and 3 physicians need verbal orders. 1. Important to do but difficult for small Edit/Include practices-could ASCO help? 2. Important but not feasible even in hospitals 3. Wait until more have electronic records-this is a goal 1.Add dose calculation, state dose for 24 Edit/Include hours 2. A must! 3.BSA standard calculation 4. Give dose in mg/m2 5. Could allergies be listed in H&P particularly EM’ ? 6. Can order be written for more than on cycle. New one written for next cycle. Write order in daily dose. 8. Include order of drug administration if more than one. 9. Add frequency and types of lab tests.
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
number F. protocol name and number (if applicable) G. appropriate criteria to treat (e.g. based on relevant labs and toxicities) H. allergies I. height, weight, and any other variables used to calculate the dose The order must either J. dosage include reference to doses do not include the methodology of the trailing zeros; use a dose calculation or leading zero for doses the practice site must less than one maintain standard milligram equations (for example, K. route and rate (if applicable) calculation of of administration creatinine clearance). L. schedule M. duration N. cumulative lifetime dose, if applicable O. supportive care treatments appropriate for the regimen (including ‐ hydration, growth factors, and hypersensitivity medications) 17. Orders for oral and Note: this standard does 91 parenteral chemotherapy not prevent shou ‐ ‘ ’ may not be prewritten for electronic medical © 2009 by American Society of Clinical Oncology
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1.Unclear, vague (20) 2. Change to: new order for each cycle 3. State a date like monthly
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
more than the written records; however, chemotherapy plan allows. appropriate practitioner authorization is required (e.g., before each cycle). Practice site should also consider situations where ‐ h ‐ for the patient. 18. Prior to initiation of Patient education 92 chemotherapy, each materials should be patient is given written appropriate for the documentation including, ’ / at minimum: literacy, A. Information regarding patient/caregiver his/her diagnosis understanding. B. Goals of therapy C. Planned duration of chemotherapy drugs and schedule D. Information on possible short and long term side effects E. Written emergency contact Patients are informed information, including: about regimen or How to use practice ‐ call system symptoms that require Symptoms that should notification and how and trigger a call to whom Who should be called notification should be in specific circum- given. © 2009 by American Society of Clinical Oncology
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1.Add verbal to the standard Edit/Include 2. This is one of the most important standards 3. Goals are not often written. 4. Change “ initiation ” to “ first dose ” of chemotherapy 5. Consider the feasibility for small and private practices 6. Not all is given in writing sometimes not appropriate 7. ASCO should supply tools!
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