University of Kentucky / UK HealthCare Policy and Procedure. Policy # A14-065

Transcription

1 University of Kentucky / UK HealthCare Policy and Procedure Policy # A Title/Description: Chemotherapy and Hazardous Medication Use Process Purpose: To standardize work processes that incorporate the appropriate level of safeguards for chemotherapy and hazardous drug therapy and alerts practitioners that they are handling chemotherapy or hazardous drugs. Policy Definitions Chemotherapy High Risk Medications Procedure Ordering Prescribing privileges Ordering process Consent Pharmacy Verification Preparation Preparation process Delivery Administration Administration Process Disposal Persons and Sites Affected Policies Replaced Effective Date Review/Revision Dates Appendix 1: Remote Location Administration of Chemotherapy/Hazardous Medication Policy For the purpose of this policy, the term chemotherapy is used to define medications used in the treatment of cancer diagnosis. The term hazardous drugs is used to describe chemotherapeutic agents used in the treatment of non-cancer diagnosis. This policy outlines a tiered approach to precautions needed to safeguard the patient as well as the health care worker. The tiered approach is based on a number of factors. The principal attributes considered in this approach include the following: 1. The inherent toxicity of the drug 2. The complexity of the therapeutic regimen, concurrent medications, and monitoring required Policy # A Chemotherapy and Hazardous Medication Use Process 1

2 3. The job responsibility of the employee (ordering, consenting, preparation, administration, transportation) 4. The degree of product manipulation (manufacturer-supplied container, repackaged, manipulated) 5. The molecular size of the drug (in Da or kda) 6. The nature of the employee s reproductive status Each chemotherapy/ hazardous medication has been considered at each of the medication use process steps (e.g. ordering, consenting, verification, preparation, administration, monitoring, and disposal) to determine the safeguards required. See Appendix 1. Definitions Chemotherapy Chemotherapy (often abbreviated as chemo) is most commonly used in the treatment of cancer with one or more cytotoxic antineoplastic drugs ("chemotherapeutic agents") as part of a standardized regimen. Chemotherapy may be given with a curative intent or it may aim to prolong life or to palliate symptoms. It is often used in conjunction with other cancer treatments, such as radiation therapy or surgery. High Risk Medications High Risk medications are described as chemotherapy or hazardous drugs that are prescribed in regimens that require multiple drugs with varying schedules and duration that require pre/post medications and monitoring to safely manage the patient s therapy. Safeguards required include written orders subsequently entered by a pharmacist. The written order allows for the original regimen ordered to be referenced in the double check process. Electronic order sets with programmed safeguards that have been developed for a specific drug or regimen may be used in lieu of written orders. Because cancer therapies have typically involved multiple drugs and are complex therapies with pre/post meds and monitoring, all chemotherapy medications (for cancer indications) require a written paper order that is subsequently entered by a chemotherapy trained pharmacist. Chemotherapy drugs that are prescribed for non-cancer indications are considered hazardous drugs and are risk stratified based on the complexity of the regimen. Procedure Ordering Orders for high risk chemotherapy/hazardous medications are written on the standard pre-printed Chemotherapy Order Form (Form J443, adult; J473, pediatric; Clinical Documents on CareWeb). The form is filled out completely, including the patient s name, second identifier (either medical record number or date of birth), diagnosis, allergies, height, weight, BSA, protocol or reference (if indicated), regimen, cycle number, therapy start date, and adjunctive medications related to chemotherapy. Failure to fill out the form completely may result in delays of therapy. Policy # A Chemotherapy and Hazardous Medication Use Process 2

3 Hazardous medications with low risk ordering are described as single medication therapy for non-cancer indications that do not need pre/post medications and additional monitoring in order to safeguard the care of the patient. An electronic medication order may be submitted to order low risk medication. Prescribing privileges 1. For Cancer Diagnoses: Chemotherapy orders are signed by an attending certified oncologist (oncology attending physicians and fellows, oncology fellows shall still be signed by the oncology attending; the list is available in the Chief Medical office) and initialed by the person penning order (if different from the person signing the order) before being processed by the pharmacy (See exceptions below) 2. For Non-Cancerous Diagnoses: Attending subspecialty physicians that are not certified oncologists or fellows (on behalf of the attending) may write for hazardous drugs for patients with a non-cancerous diagnosis including but not limited to the following: (a) Ectopic pregnancy, (b) Rheumatoid arthritis, (c) Systemic lupus erythematosus, (d) Certain dermatologic conditions, (e) Certain ophthalmic procedures, or (f) Other auto-immune conditions as identified in the literature. Ordering process Orders written for chemotherapy/hazardous agents follow the following criteria: 1. Written on the standard pre-printed Chemotherapy Order Form (Form J443, adult; J473, pediatric; Clinical Documents on CareWeb) 2. Filled out completely, including the patient s name, 2nd identifier (either medical record number or date of birth), diagnosis, allergies, height, weight, BSA, protocol or reference (if indicated), regimen, cycle number, therapy start date, and adjunctive medications related to chemotherapy 3. Signed by an attending certified oncologist (list available in the Chief Medical Office) and initialed by person penning order (if different person signing order) before being processed by the pharmacy (See exceptions below) 4. Written using only the generic name of the agent and free of any unapproved abbreviations used to identify the agent being prescribed. The pharmacist may clarify chemotherapy orders and write the generic name next to any commonly used abbreviation 5. Free of any number prefixes, such as 5-fluorouracil, which could be misinterpreted as part of the order s dose or schedule requirements and free of trailing zeros 6. Dose is written in metric units and includes the dose formula used: e.g., dose/m2 or dose/kilogram or dose/auc (area under the curve). Policy # A Chemotherapy and Hazardous Medication Use Process 3

4 7. Written as the amount per dose per day (e.g. Cisplatin 20mg/m2 daily x 5 days, or Cytarabine 3000mg/m2 bid on days 1,3 and 5) never written as total amount needed per course of therapy 8. Accompanied by a copy and /or name of a readily available reference or the protocol name and number used in determining the prescribed regimen Consent Chemotherapy medications that are used for cancer indication require separate chemotherapy consent, Consent for Treatment of Cancer with Chemotherapy, CN Consent for chemotherapy is performed by oncology attending physicians and fellows only. Chemotherapy prescribed for non-cancer indications do not require any consent beyond the General Consent, Authorizations and Agreements, Form AM Medications where data is available that indicates known risk of carcinogenicity, mutagenicity, genotoxicity, teratogenicity, reproductive toxicity, organ toxicity, and potency of these drugs is recommended that the risks be discussed with the patient. Each subspecialty attending or fellow involved with ordering or recommending the medication for non-cancer indications, document such discussion. A special consent form, CN-0010, is completed before all first cycles of a cytotoxic chemotherapy regimen for all adult patients receiving treatment for cancer. The Consent for Treatment of Cancer with Chemotherapy, CN-0010 is not required for the following: 1. Patients receiving conditioning chemotherapy for a stem cell or bone marrow transplant who have signed a special consent for transplantation that describes the chemotherapy and stem cell or bone marrow transplant procedure; 2. Patients receiving chemotherapy agents for the treatment of non-malignant conditions such as methotrexate for rheumatoid arthritis; 3. Patients receiving hormonal therapies such as tamoxifen, anastrazole, flutamide, leuprolide, etc.; 4. Patients receiving naked monoclonal antibodies such as rituximab, alemtuzumab, etc.; and 5. Patients receiving biologic agents such as interferon, etc. Pharmacy Verification Chemotherapy and high risk hazardous drugs are verified by a chemotherapy trained pharmacist. A second chemotherapy trained pharmacist shall perform a double check and document the double check in the verification note field of the order. Hazardous drugs used for non-cancer indications that are within reference guidelines may be verified by a licensed pharmacist. Any hazardous medication orders outside the reference guidelines are consulted with a chemotherapy certified pharmacist to be verified. All chemotherapy and hazardous drugs (both high and low risk) require a second pharmacist with the defined training to perform a double check and document the double check in the verification note field of the order. 1. Verification process: Policy # A Chemotherapy and Hazardous Medication Use Process 4

5 (a) The pharmacist shall confirm that the order has been prescribed according to the ordering criteria above. The pharmacist shall contact the attending physician to request that any order not meeting these criteria be changed. The physician shall make changes regarding drug, dosing parameters, route, diagnosis, or patient name and second identifier. A pharmacist may change the order with pharmacy verbal order read back regarding dose (if greater than 5% of the original order), infusion time, height/weight, dates of therapy. If there is a discrepancy in the medication order, the nurse caring for the patient is notified of the problem and the possible delay in the delivery of the medication. (b) Base solution may be changed at the discretion of the pharmacist. (c) Corrected carboplatin doses (GYN service) based on AUC and GFR may be calculated by the pharmacist and documented on the original order by the pharmacist. The pharmacist shall read back the change from the actual written transcription to the physician. The guideline for telephone orders is followed (refer A Patient Care Orders). 2. Once the prescribing criteria have been met, the pharmacist is responsible for verifying the accuracy of the order by (a) Reviewing the diagnosis and prescribed regimen (b) Calculating the patient s BSA, unit conversions, patient-specific dose and frequency (c) Reviewing base fluid, administration times and supportive care medications (d) Obtaining the signed Consent for Treatment of Cancer with Chemotherapy. If the Consent for Treatment of Cancer with Chemotherapy has not been completed for a new regimen, the pharmacist shall not dispense the chemotherapy. The physician who authored the orders shall be contacted, and an oncologist/oncology fellow and the patient shall complete the consent form. Once the pharmacist has received a copy of the Consent for Treatment of Cancer with Chemotherapy, he or she shall (i) Document completion of the informed consent form in the pharmacy computer system (in the diagnosis field enter ICS:<Drug names><date> ), (ii) Store the copy of the completed consent form and chemotherapy orders, (iii)proceed with the preparation and dispensing of the chemotherapy. 3. All changes to original orders are documented on a chemotherapy order form. Addendums or changes to orders are documented according to hospital policy. A copy is placed with the chemotherapy work card and original order. Changes to the order made by the physician (as above) are double checked by a second pharmacist. 4. Unless specified, the pharmacist shall determine the vehicle and the volume of the diluent to be used based upon the protocol or reference, drug stability and infusion guidelines listed in the package insert or the literature. 5. The pharmacist shall review all appropriate lab values & document these on the chemotherapy work card. 6. Upon completion of the verification process, the pharmacist or chemotherapy trained technician shall prepare a chemotherapy work card for use in preparing the prescribed Policy # A Chemotherapy and Hazardous Medication Use Process 5

6 doses. One card is filled out for each patient. The following information is documented: patient name and record number, date of birth, height, weight, body surface area, diagnosis, allergies, protocol number, drug, drug volume, diluent, administration schedule, administration directions, special instructions (e.g. protect from light, glass only, etc.) The compounding technician or pharmacist shall double check the calculation when preparing every dose and record the compounded dose on the inside of the work card. Changes in subsequent doses are noted on the card or a new card may be generated. 7. A copy of the order is attached to the chemotherapy work card. The order is then entered into the pharmacy computer system under the patient s medication profile. The labels are double-checked for accuracy by the compounding technician or pharmacist for all doses. All syringe labels contain the final concentration of the product (e.g. Doxorubicin 50mg/25ml). All mini-bag or large volume parenteral labels include the volume of each component as well as a total volume and rate of administration. 8. To allow tracking of cumulative doses and serial dose administration, chemotherapy doses have duplicate labels generated with appropriate sticker attached for nursing documentation (completed with date and time hung, date and time taken down, and signature; placed on a progress form). The appropriate duplicate label accompanies all doses for cancer indications. 9. Two pharmacists shall check the chemotherapy work card, computer entry, and labels for all new chemotherapy orders and all new or repeat pediatric chemotherapy orders. Prior to initiation of each chemotherapy cycle and/or chemotherapy dose change within a cycle, a second pharmacist shall review the computer entries against the original order and work card. The pharmacist preparing the chemotherapy work card and the one double checking the order shall record their pharmacist number on the chemotherapy order (for written orders) or electronically in the pharmacy computer system (for CPOE). The verification process is followed completely before any dose can be dispensed. Chemotherapy work cards are then forwarded to the technician for dose preparation. 10. Home health chemotherapy orders written by UK Oncology physicians are checked, as previously outlined, by the pharmacist before the order being faxed or sent to the home health agency. Preparation 1. Chemotherapy and High-Risk Hazardous Drug are medications that have labeling in the manufacturer s package insert or in its Material Safety Data Sheet specifying handling requirements plus at least one (1) of the following qualifications: (a) An available injectable agent classified on the Centers for Disease Control and Prevention NIOSH list and not included on the Low-Risk Hazardous Drug or Reproductive-Risk Hazardous Drug lists or intentionally excluded due to determination of nonhazardous status (b) Structure and/or pharmacology consistent with drugs that may be carcinogenic or mutagenic or cause organ toxicity at low dosages (c) Consensus inclusion on the UHC Hazardous Drugs List or designation by a UHC member hospital s director of pharmacy as hazardous Policy # A Chemotherapy and Hazardous Medication Use Process 6

7 (d) Medications that are low risk and will be manipulated (solid dose forms of antineoplastic, cytotoxic, or hormonal medications that will be crushed, opened, aerosolized, or manipulated other than for the purposes of administration directly from their current container) (e) Examples of high-risk hazardous drugs are chemotherapy drugs such as cyclophosphamide, fluorouracil, mechlorethamine, and vincristine and respiratory therapy drugs such as ribavirin and pentamidine. (f) The preparation and reconstitution of high-risk hazardous drugs shall be performed only by chemo/hazardous drug preparation trained personnel employing aseptic technique. All high-risk hazardous drugs are prepared in an exhausted Class II type B or Class III biological safety cabinet except where pharmacologically contraindicated. 2. Low-Risk Hazardous Drugs are medications that pose a lower risk to the safety of health care workers if exposure occurs. Inclusion criteria for this category are: (a) Solid dosage forms of antineoplastic, cytotoxic, or hormonal medications in an unaltered state (not crushed, opened, aerosolized, or manipulated other than for the purposes of administration directly from their current container, that is, as a capsule or tablet) (b) Parenteral dosage forms where there is limited evidence of toxicity, but the mechanism of action or drug class is conducive to potential toxicity or the molecular size of the product is large enough that the risk of transdermal or trans-mucosal absorption is unlikely if the drug aerosolizes or droplets are released during preparation and if proper post preparation hand-washing and work space cleaning occurs. (c) Manipulation of low risk hazardous medications may require safeguards to protect the employee. This includes repackaging of a medication from the original dose form supplied by the manufacturer for patient administration to another dose form. i. Oral tablets and capsules: Restrictions include crushing, dissolving, suspending, opening capsules, or splitting tablets; restrictions exclude repackaging small amounts of bulk-supplied tablets into unit-dose packaging ii. Oral liquids: Restrictions include mixing from powders or diluting; restrictions exclude repackaging small amounts of bulk-supplied liquid into oral unit-dose cups, bottles, or syringes iii. Injectable products: Restrictions include drawing up the ready-toadminister dose into a syringe 3. Reproductive-Risk Hazardous Drugs are medications that have a specific warning for women and/or men who are trying to conceive, women who are pregnant, or women who are breast-feeding (reproductive category employee). The reproductive-risk hazardous drug category includes medications that have the potential to impair fertility; medications that are teratogenic, genotoxic, or cause developmental toxicity; or medications with existing recommendations for women who are pregnant or lactating. Examples are agents classified as Pregnancy Category X and D by the Food and Drug Administration (FDA), where the risk incurred is relative to the level of exposure to the agent and its intrinsic toxicity (if the hazardous drug is high risk, the high-risk status takes precedence over the Policy # A Chemotherapy and Hazardous Medication Use Process 7

8 reproductive-risk status). Staff involved with preparation or administration shall observe the personal protective equipment recommendations. The required personal protective equipment includes: gown, double nitrile gloves, face shield (if there is a splash risk), respirator (if an aerosol). Preparation process 1. The technician responsible for preparing the doses shall gather the order, chemotherapy work card, patient-specific labels, medication, and associated supplies. 2. The technician is responsible for completing the chemotherapy work card indicating: the time and date the product was prepared, the drug used, the drug concentration, volume of drug used, and the lot number/expiration date from the drug vial. The technician shall initial the work card and perform all calculations associated with the compounding process. If an oral chemotherapy drug is to be physically manipulated or repackaged into a larger gel cap the process is done in a biological safety cabinet (vertical flow hood) to prevent inhalation exposure. 3. All final parenteral chemotherapy medications need to be spiked with the appropriate tubing set in the chemo hood, excluding IV push syringes, leucovorin, mesna, and drugs that will not be spiked before administration (intra-arterial & intrathecal). 4. Upon completing the preparation process, the final product is labeled. All vials, mini-bags and/or syringes used in the preparation of the dose shall be checked by a pharmacist. The syringes for each drug and/or solution used in preparing the product (including syringes used to dilute drug vials) are pulled back to indicate the measured volume. Needles are recapped and left on the syringes before placing in the bin. 5. All pharmacy-prepared chemotherapy agents shall be double-checked. If the pharmacist is involved in the preparation of the dose, a pharmacist who did not prepare the dose shall perform the final check. This may require the assistance of other pharmacists. 6. The pharmacist reviewing the prepared dose shall check each prepared dose and associated supplies and label against the original order and chemotherapy work card. The pharmacist, working independently, shall verify that the final preparation includes: (a) The correct drug has been used, (b) The drug was reconstituted correctly using the correct volume and diluent, (c) The volume of drug used was accurately measured for the prescribed dose, (d) The label is correct in regards to patient, dose number, unit, patient visit identification number, drug components, route, rate, concentration, storage conditions, expiration date, caution statements (any dose that is prescribed to be administered by any route other than intravenous (e.g. intrathecal) shall bear a statement indicating the appropriate route for administration), final container integrity, correct type of final container (e.g. syringe and/or mini-bag type), (e) All intrathecal doses are placed in a separate transport bag, (f) Any IVP doses in syringe are less than three quarters full, to minimize the risk of a chemo spill, (g) The maximum syringe size dispensed is 30ml, Policy # A Chemotherapy and Hazardous Medication Use Process 8

9 (h) The pharmacist shall write their P/R number on the chemotherapy work card and product label to signify product verification. 7. Following the pharmacist double check, the chemotherapy dose is placed in a brown plastic sleeve, to protect it from light, and then placed in a sealable chemotherapy transport bag. A label with the patient's name (first and last) and location is placed on the outside of the transport bag. The pharmacist shall initial the transport bag label to indicate that they have matched the patient name on the final product with the name on the outside label of the transport bag. PLEASE NOTE: To prevent the nurse from using the outside label for identifying the bag contents, DO NOT place a duplicate computer generated label or any other type of label that bears a drug name on the outside of the transport bag. Delivery The pharmacy shall deliver the chemotherapy/hazardous medication dose and a duplicate order label according to the risk stratification: 1. Chemotherapy/biotherapy agents for oncologic patients will be delivered by pharmacy to: (a) MCC inpatients patient s locked anteroom (b) MCC outpatients charge nurse (c) Chemotherapy/biotherapy outside MCC MCC inpatient or outpatient charge nurse (d) Pediatrics 4 West chemo room 2. Chemotherapy/biotherapy agents for non-oncologic patients will be delivered by pharmacy to that patient s specific bin. Administration 1. Chemotherapy/Hazardous medication orders involve multiple steps and shall be processed in an orderly and consistent manner to verify that all information is checked for accuracy and communicated appropriately. (a) Before administration, the nurse responsible for administering the dose, together with a second trained health-care professional, shall verify the labeled dose against the current order. If the dose is in a syringe, the nurse shall confirm the calculated drug dose volume matches the actual volume contained in that syringe. The nurse shall also inspect the color of the agent in the syringe to confirm that it is of normal appearance. Documentation of this verification process is indicated by the nurses initialing beside the charted time in the Medication Administration Record (inpatient) and Nursing Assessment Record (outpatient-adult) (b) For patients receiving multiple-day regimens, the pharmacist, in collaboration with the nurse or pharmacist on-service, will communicate any changes in the patient s therapy, or clinical status that would alter the chemotherapy regimen. If any modification is necessary, the pharmacist responsible for compounding the product will be notified and the computer entry will be modified to reflect the change. The pharmacist responsible for preparing future doses will record all changes on the chemotherapy work card. Policy # A Chemotherapy and Hazardous Medication Use Process 9

10 (c) The pharmacist and nurse shall monitor all clinically relevant parameters throughout the patient's admission, contact the medical staff to request more information if necessary, and provide consultation if needed. (d) After the patient discharge, the chemotherapy work card and copy of the order is filed. 2. Nurse Administration Requirements (a) Only chemotherapy-trained nurses shall administer chemotherapy to patients or review chemotherapy orders. (Note: Chemotherapy medications are for cancer indications). (b) Only chemotherapy trained pharmacist shall verify/review chemotherapy orders. (c) Continuation of home medication of an oral chemotherapy for a cancer indication shall be administered by a chemo trained nurse. (d) Chemotherapy/biologically trained nurses shall administer or review monoclonal antibodies for cancer indication. (e) Hazardous medications for non-cancer indications shall be administered according to their risk stratification documented on the chemotherapy/hazardous medication use process database. i. High hazardous risk medications - Chemotherapy/biologically trained nurses shall administer hazardous medications to patients or review hazardous medication orders. ii. Low hazardous risk medications standard administration procedures is followed. Nurse double check is required. (f) Continuation of home medication of an oral chemotherapy/hazardous medication for a non-cancer indication may be administered by standard nurse administration procedures. (g) Chemotherapy or biologically trained nurses shall administer or review high hazardous risk monoclonal antibodies for non-cancer indications. (h) Standard nurse administration procedures shall be used to administer low hazardous risk monoclonal antibodies for non-cancer indications. Administration Process 1. Review of Chemotherapy/Hazardous medication Orders before Administration (a) The registered nurse (RN) shall verify that there is a signed consent for the current chemotherapy regimen. If there is no signed consent for the current therapy the RN shall contact the physician. A consent form, CN-0010, is completed only before first cycles of a cytotoxic chemotherapy regimen for all adult patients receiving treatment for cancer. (b) All chemotherapeutic agents shall be checked for accuracy before their administration at the patient s bedside. This check shall be performed before each and every dose given to the patient. Policy # A Chemotherapy and Hazardous Medication Use Process 10

11 (c) The RN shall initiate chemotherapy order or regimens only after electronic or written orders that have been signed by the physician have been received. Verbal orders shall NOT be accepted. (d) Upon receipt of chemotherapy orders, the RN shall collaborate with the pharmacist to determine both which and when pre-meds and hydration shall be administered, and when the chemotherapeutic agents shall be given. 2. Review of the Chemotherapy Dose (a) Upon receipt of the chemotherapy or high hazardous risk medication dose, the administering RN and another chemo/biologically- trained RN or chemo-trained pharmacist shall compare the drug label and the Medication Administration Record (MAR or emar, if the record is electronic) to the chemotherapy/hazardous medication order (electronic or written). (b) The administering RN shall view the information on the chemotherapy hazardous bag or syringe and the MAR or emar, while the other staff member (RN or pharmacist) shall view the chemotherapy/hazardous med order. The staff member handling the chemotherapy/hazardous med dose shall wear protective nitrile gloves. (c) Each staff member (RN or pharmacist) shall compare and verify that the following information is correct at the bedside prior to administration: i. Patient Identification: Name, birth date, and medical record number; ii. Calculated Dosage; iii. Concentration; iv. Volume; v. Diluent; vi. Patient s height, weight and body surface area (BSA); and vii. Rate of Infusion (d) After confirming that there is a signed consent for the chemotherapy regimen, that the chemotherapy/hazardous med and MAR or emar match the electronic or written order, both reviewers shall initial the MAR next to the time of administration for MAR. In emar the administering RN shall mark the med as done. The verifying RN shall be assigned under co-signature in emar. The verifying RN will sign-on to SCM under their username and sign the order. (e) The duplicate order label shall be signed by both verifying persons (i.e., chemotherapy trained RN or chemotherapy trained pharmacist) and placed on the MAR or emar. Place the sticker on a blank History & Physical (H&P); place the patient s identification label on the H&P. (f) If an error or discrepancy is noted when checking the order: The RN shall contact the physician and the pharmacy to correct the order. (g) If an error or discrepancy is noted between the chemotherapy drug and its corresponding order, the RN shall immediately notify the pharmacist and complete an incident report. Policy # A Chemotherapy and Hazardous Medication Use Process 11

12 Disposal (h) The RN shall only administer the chemotherapy/hazardous drug after the order has been corrected and the chemotherapy /hazardous drug order have been rechecked with another chemo-trained RN or pharmacist, per the procedure listed above. 1. Regulations enforced by the US Environmental Protection Agency (EPA) and the Kentucky Division of Waste Management have been implemented at UKHC. 2. Those drugs that have been prepared for patient use and qualify as either a hazardous or equivalent waste will be provided with a special warning on the label, indicating the waste code and the proper disposal (e.g. P-listed or U-listed drug, NOTE: DISPOSE in BLACK hazardous waste container P000 Waste Code). 3. Packaging materials, gowns, gloves, and other disposable items that are used during preparation or administration but are not contaminated are disposed of as regular trash. Persons and Sites Affected Enterprise Chandler Good Samaritan Kentucky Children s Ambulatory Department Policies Replaced Chandler HP Good Samaritan Kentucky Children s CH Ambulatory KC Other Pharmacy PH06-13; MC08-01 Effective Date: 02/04/2014 Review/Revision Dates: 02/04/2014 Approval by and date: Date Name Kimberley Hite, Director of Medication Safety and Quality, Review Team Leader Date Name Patty Hughes, Director, Oncology Services, Co-Review Team Leader Name Marcus Randall, MD, Chief, Ambulatory Services Name Colleen Swartz, Chief Nurse Executive Name Bernard Boulanger, MD, Chief Medical Officer Name Anna L. Smith, Chief Administrative Officer Name Michael Karpf, MD, Executive Vice President for Health Affairs Date Date Date Date Date Policy # A Chemotherapy and Hazardous Medication Use Process 12

13 Appendix 1: Remote Location Administration of Chemotherapy/Hazardous Medication If an adult patient receives a dose of chemotherapy or hazardous medication in a non- Markey Cancer Center location (e.g., acute care floor or intensive care unit), the following procedure for order verification shall be followed: Chemotherapy and Hazardous Medication Administration Algorithm outside UK HealthCare s Markey Cancer Center RN assigned to patient verifies requirements according to the chemotherapy/hazardous medication use process database. RN assigned to patient verifies written/electronic orders for chemotherapy/hazardous medication have been signed by appropriate Attending MD/fellow (on behalf of attending) and signed consent for current chemotherapy regimen, according to the C/HMUP. If a chemo-certified/biologically trained RN is required, the RN assigned to patient notifies his or her PCM/HOA PCM (from the patient s unit) and HOA review chemotherapy/hazardous med order and consent. Does the patient have cancer? If YES can they move to MCC? If NO proceed with algorithm. What time is chemotherapy scheduled? If time can t be adjusted determine administration time If outside normal business hours (8am- 5pm), can chemo time be adjusted to fall within this timeframe? Ordering service is contacted by HOA or PCM (where patient located). HOA will work with CSO PCM to arrange for chemotherapy trained/biologically trained pool nurse to administer chemo. If no chemotherapy trained /biologically trained pool nurse is available, the HOA will contact the PCM of MCC2, MCC3, BMT, or MCC OP for assistance. If one unit is unable to assist, that PCM or designee will contact another PCM at MCC until all inpatient/outpatient resources are assessed. When a chemo/biologically trained nurse is identified, the HOA shall have the patient s nurse contact the appropriate administering unit to coordinate the pre-hydration and premeds. If no resources available at all the HOA will notify the ordering service (attending) and inform them of the need for an alternate date or time. *The nursing staff or MDs are NOT to contact MCC directly for administration of chemotherapy. Policy # A Chemotherapy and Hazardous Medication Use Process 13