Preparation and Handling of Cytotoxic, Hazardous and Potentially Hazardous Medicines Policy

Transcription

1 Department of Health and Human Services SYSTEM PURCHASING AND PERFORMANCE - MEDICATION STRATEGY AND REFORM Preparation and Handling of Cytotoxic, Hazardous and Potentially Hazardous Medicines Policy SDMS Id Number: Effective From: June 2014 Replaces Doc. No: Custodian and Review Responsibility: Contact: Applies to: Policy Type: Policy ID (as assigned by Corporate Document and Information Services) New Review Date: Nov 2015 Keywords: Routine Disclosure: Medication Strategy and Reform Director, Medication Strategy and Reform THO-South, THO-North, THO-North West DHHS Statewide Policy Hazardous, Cytotoxic, Medication, Safety, Related Waste, Carcinogenic Yes Approval Prepared by Sulfi Newbold Medicines Policy Officer May 2014 Through Through Cleared by Anita Thomas Senior Specialist Pharmacist Quality Use of Medicine THO-N Medication Management and Safety Committee THO-NW Medication Safety & Improvement Committee THO-S Quality Use of Medicine Committee John Kirwan Karen Linegar Matthew Daly THO-N Chief Executive Officer THO-NW Acting Chief Executive Officer THO-S Acting Chief Executive Officer May May June June June 2014 Revision History Version Approved by name Approved by title Amendment notes Name Name Name Position Title Position Title Position Title Page 1 of 13

2 Purpose The purpose of this policy is to provide safe direction for the preparation and handling of hazardous or cytotoxic medicines, potentially hazardous medicines, and related waste within all Tasmanian Health Organisation services (THO services). Adequate risk controls must be employed across all THO services when storing, preparing, packaging, transporting, or administering hazardous, cytotoxic or potentially hazardous medicines, and also when handling or disposing of related waste. The safety measures mandated by this policy are intended to protect staff, patients, and the environment. Effective implementation will assist sites to meet the Work Health and Safety Regulations 2012 and the Poisons Regulations 2008 legislative requirements, as well as the National Safety and Quality in Health Care Standard 4 in Medication Safety. Definitions Hazardous Medicines: Therapeutic agents are defined as being hazardous if they are known to present one or more risks to the operator or patient, as defined by the following criteria: Toxic (acute, sub-acute, sub-chronic or chronic) Corrosive Irritating Sensitising Carcinogenic (capable of causing cancer) Mutagenic (capable of causing alterations/damage to genes) Toxic to reproduction, fertility and foetal development Physical characteristics of the agents (such as liquid versus solid) also need to be considered in determining potential for occupational exposure. Hazardous medicines may include, but are not limited to, cytotoxic agents, highly immunosuppressant medicines, and some biological targeted therapies. Cytotoxic Medicines: are a subset of hazardous medicines. Cytotoxic medicines are therapeutic agents that are known to be highly toxic to cells, through causing cell lysis, apoptosis, or inhibition of cell reproduction. By nature, cytotoxic medicines are also teratogenic (capable of causing foetal defects) and should be managed accordingly to ensure staff, operator and patient safety. Cytotoxic medicines are considered hazardous in all forms (solid, liquid or aerosol). Potentially Hazardous Medicines: are therapeutic agents that may include, but are not limited to, biological targeted therapies such as monoclonal antibodies (MAB) or tyrosine kinase inhibitors (TKI), for which the toxicity has not been adequately assessed, or is not fully known. As evidence is not yet available to determine the safety of exposure to these items, they must be treated with a higher level of caution. Hazardous (Low Risk) Medicines: are therapeutic agents that are proven to be non-toxic following some exposure, however there may be some uncertainty with regard to the safety of these products following repeated long-term exposure. This may include items that are sensitising in nature (e.g. penicillins). Related Waste: is residual hazardous or potentially hazardous medication that remains following a patient s treatment, and any materials or equipment contaminated with hazardous, cytotoxic or potentially hazardous medications. This policy does not address management of contaminated human waste. Page 2 of 13

3 Sterile Medicines: Medicines which are required to be free of micro-organisms, pyrogens, and particulate matter. This refers specifically to items where aseptic technique must be employed to reduce microbiological and particulate contamination of the final product, including, but not limited to, preparations destined for intravenous, intrathecal or ophthalmic administration. Non-Sterile Medicines: Whilst measures should be taken to reduce microbiological and particulate contamination, the absolute sterility of the final product is not essential due to a less invasive route of administration. Products include, but are not limited to, preparations destined for oral, rectal or topical administration. Closed-System: A term to inter-changeably refer to either a closed-system device, or closed-system technique. A closed-system serves two functions during medicine preparation: to protect the environment and operator outside the vial from the product within the vial, and to protect the product within the vial from external environmental factors and contaminants. Mandatory Requirements Classification The hazard risk presented from any therapeutic agent (medicine) used in THO services must be assessed. While all medicines require safe handling, if extra safety measures are deemed necessary when handling, preparing, administering, or disposing of a medicine, that medicine must be classified accordingly, and managed within the framework of this policy. Classification of a medicine as being hazardous or cytotoxic, potentially hazardous, or hazardous (low risk) is determined by the inherent risk associated with exposure to that medicine. The management of any medicine classified as hazardous or cytotoxic must be in compliance with the risk controls mandated by this policy, under the section Hazardous or Cytotoxic medicines. Any targeted therapies conjugated to a cytotoxic agent must be considered hazardous and management must include the risk controls mandated under the section Hazardous or Cytotoxic Medicines. Medicines that are classified as potentially hazardous or hazardous (low risk) must be managed with the risk controls mandated by this policy, under the relevant section. All risk controls are mandated for the safety of staff, pharmacy operators, patients, visitors, and the environment. A current list of medicines identified as being Hazardous or Cytotoxic, Potentially Hazardous, or Hazardous (Low Risk), will be developed by THO content specialists, and managed and reviewed by the Statewide Therapeutic Drug Committee (STDC). Page 3 of 13

4 Personal Protective Equipment Staff involved in all handling, preparation, and administration of Hazardous or Cytotoxic, Potentially Hazardous, or Hazardous (Low Risk) medicines must wear personal protective equipment (PPE) whenever potentially in contact with these medicines. Specifications of PPE should be determined by the assessed risk of exposure to any medicine classified as being Hazardous or Cytotoxic, Potentially Hazardous or Hazardous (Low Risk), and the severity of the potential outcome should exposure occur, as outlined by a locally developed PPE protocol, and in accordance with the Work Health and Safety Act Cleaning and Maintenance The equipment and area used to store, prepare, transport, package, and administer Hazardous or Cytotoxic, Potentially Hazardous, and Hazardous (Low Risk) medicines must be cleaned and maintained under a planned schedule, monitored and documented. This includes, but is not limited to, the cytotoxic safety cabinet or isolator, benches and trolley surfaces, counting trays, transport containers, and treatment rooms. Sterile Medicine Preparation Outsourcing Whenever practicable, the Pharmacy Department (Pharmacy) should outsource the preparation of all sterile medicines to a specialist manufacturing company, as per the Pharmaceutical Compounding Services contract. The following mandatory requirements for manufacturing practices within Pharmacy, apply to sterile medicine preparation that cannot be outsourced due to short expiry timeframes, clinic scheduling, emergency treatment orders, or other reasons, as deemed appropriate by the Pharmacy Manufacturing Manager. Pregnant and Breastfeeding Staff Members All safety measures described in this policy are intended to protect staff from incidental occupational exposure to hazardous, cytotoxic or potentially hazardous medications. However, pregnant and breastfeeding staff members should be provided the option of transferring to another work area during this period. Managers must make every effort to accommodate the request of a pregnant or breastfeeding staff member to avoid administration, preparation or handling of hazardous, cytotoxic or potentially hazardous medicines, and seek further advice from DHHS Human Resources if alternative arrangements cannot be made. Hazardous or Cytotoxic Medicines Storage In THO services that store medicines, designated areas must be made available for the storage of hazardous or cytotoxic medicines. These medicines must be stored separately from other medicines, and in accordance with the manufacturer s directions. Designated hazardous or cytotoxic medicine storage areas must be clearly labelled to identify the area as being used for hazardous or cytotoxic medicine storage only. Hazardous or cytotoxic medicines must never be stored with food or in food preparation areas. Page 4 of 13

5 Preparation All hazardous or cytotoxic non-sterile preparations must be dispensed for individual patient use and labelled appropriately as cytotoxic where applicable. Preparations should be packaged by Pharmacy staff as required for direct administration to the patient and should not be further modified by clinical staff. (Exceptions to this - such as oral cytotoxic medicines dissolved in an oral dispenser, by nursing staff in clinical areas at the point of administration - must be supported by best-practice guidelines (Society of Hospital Pharmacists Association (SHPA) or similar) with due consideration given to patient, staff and environmental safety.) Pharmacy staff dispensing hazardous or cytotoxic non-sterile preparations must use dispensing tools allocated only for hazardous or cytotoxic medicines, and work at all times within a designated area for the preparation of these medicines. All sterile hazardous or cytotoxic medicines must be prepared by trained Pharmacy staff, in an approved cytotoxic safety cabinet or isolator, in Pharmacy. Packaging and Transportation Hazardous or cytotoxic medicine non-sterile preparations must be packaged in a labelled, sealed, leak-proof container. The container should be fitted with a child-proof lid wherever possible. Sterile medicines that are classified as hazardous or cytotoxic must be packaged in a labelled, sealed, leakproof container, with a second outer leak-proof bag wherever possible. Containers used for transporting liquid hazardous or cytotoxic sterile medicines must be sealable, hard-walled and robust. Containers used for the transportation of liquid hazardous or cytotoxic parenteral medicine must be used only for transporting hazardous or cytotoxic or potentially hazardous medicines that have been double bagged. The transport container must be sealed during transport, and labelled in accordance with the Worksafe Tasmania Code of Practice. A cytotoxic drug spill kit must be readily available to personnel involved in the transportation of liquid (oral, topical or parenteral) hazardous or cytotoxic medicine, and the person responsible for the transportation must be trained in the use of the spill kit. Administration All THO services should ascertain administration risks of specific hazardous or cytotoxic medicines, or risks associated with different administration routes, and document any necessary safety measures in locally developed procedures. Nursing and medical staff involved in hazardous or cytotoxic medicines must be adequately trained in safe handling and administration practices within their scope of practice. (*See Training section of this policy) Wherever possible, hazardous or cytotoxic medicines must be checked by two staff at the point of administration. The medication order should be signed by both staff. Page 5 of 13

6 The treatment protocol for all hazardous or cytotoxic medicine administration should be available during all infusions and for handover at the patient bedside. Patients should be directly supervised wherever possible during hazardous or cytotoxic medicine administration. Signage identifying current hazardous or cytotoxic medicine risk, and the date of clearance, must be placed at the patient bedside. Oral preparations of hazardous or cytotoxic medicines must be handled in a manner which avoids skin contact and liberation of powdered agent into the air. A disposable medicine cup should be used for dosing, or an oral dispenser if dispersed. Parenteral hazardous or cytotoxic medicines should be administered in a quiet environment, preferably a treatment room, with minimal patient/visitor activity. All patients receiving hazardous or cytotoxic medicine infusions should remain in the treatment area for the duration of the infusion wherever practicable. The programming of hazardous or cytotoxic infusion pumps must be independently checked by a second trained nurse or medical officer to include calculation of infusion rate. Verbal medication orders are not acceptable. A spill kit and an extravasation kit must be readily available during administration. Related Waste All waste contaminated with hazardous or cytotoxic medicine is considered a risk to staff, patients and the environment. All such waste, in Pharmacy and in clinical areas, must be separated from general and medical waste, in dedicated hazardous or cytotoxic sharps and waste containers, and disposed of in accordance with Tasmanian legislation. Any amount of hazardous or cytotoxic medicine that is unwanted or expired, oral or parenteral, must be disposed of in a dedicated hazardous or cytotoxic Pharmaceuticals for Destruction (PFD) bin (available in the Pharmacy Department in major, acute care hospitals, and by arrangement in other health care services), and disposed of in accordance with SPP-MSR: Management and Disposal of Unwanted Medicines Policy, and current Tasmanian legislation. Hazardous or cytotoxic medicines must never be disposed of down the sink or in the sewer system. Any PPE that may be contaminated with hazardous or cytotoxic medicine that is not disposable must be processed according to locally developed procedures, and in accordance with the requirements of the contracted PPE supply company. Any equipment used for the handling, preparation, or administration of hazardous or cytotoxic medicine that is not disposable must be managed in accordance with locally developed and documented procedures. Page 6 of 13

7 Potentially Hazardous Medicines Storage Potentially hazardous medicines may be stored with other medicines, in accordance with the manufacturer s directions. Preparation Non-sterile preparations identified as being potentially hazardous must be handled with the same risk controls as mandated for hazardous and cytotoxic medicines including the use of single-purpose equipment, and staff safety training. All such risk controls must be monitored and documented at each site. As first preference, sterile medicines classified as being potentially hazardous should be prepared in a dedicated biological safety cabinet or similar. Preparation in such a biological safety cabinet must be by fully trained Pharmacy staff, using best aseptic technique, as outlined in a locally developed protocol. Cleaning of the area, and maintenance of equipment used to prepare potentially hazardous medicines should be planned, monitored and documented. Alternatively, if a dedicated biological safety cabinet is not available, a cytotoxic safety cabinet or isolator must be used for the preparation of all sterile medicines classified as potentially hazardous. Where a cytotoxic safety cabinet or isolator is used for the preparation of hazardous or cytotoxic medicines and potentially hazardous medicines, a closed-system must be used for the preparation of both potentially hazardous and hazardous or cytotoxic medicines within that cytotoxic cabinet. Preparation of potentially hazardous medicines in a cytotoxic safety cabinet or isolator must be by fully trained Pharmacy staff, using appropriate aseptic technique, and wearing appropriate PPE, as outlined in a locally developed procedure. Cleaning procedures and equipment maintenance must also be planned, monitored and documented. Packaging and Transportation As the inherent risk of potentially hazardous medicines is not fully known, all medicines classified as potentially hazardous must be labelled, packaged and transported with the same risk controls as hazardous or cytotoxic medicines. Administration For the safety of patients, staff, and visitors, the same risk controls that are mandatory for the administration of hazardous or cytotoxic medicines must be employed for the administration of potentially hazardous medicines. Related Waste Waste that may be contaminated with potentially hazardous medicines must be managed with the same risk controls as stipulated for hazardous or cytotoxic medicines. Any unwanted or expired potentially hazardous medicine must be disposed of with the same management method as stipulated for hazardous or cytotoxic medicines. Page 7 of 13

8 Hazardous (Low Risk)Medicines Storage Medicines identified as being hazardous but with low associated risks hazardous (low risk) may be stored with other medicines and in accordance with the manufacturer s directions. Preparation Safety measures should be considered and documented for the extemporaneous preparation of hazardous (low risk) medicines where aerosol exposure is a likely risk to the operator. Safety measures for the preparation of hazardous (low risk) medicines must include documented staff safety training as part of staff orientation (i.e. before any potential exposure). Sterile medicines identified as being hazardous (low risk) should, as first preference, be prepared in a laminarflow cabinet, by Pharmacy staff who have been fully trained in aseptic compounding, using best aseptic technique. The use of a closed-system is mandatory if preparing hazardous (low risk) medicines in a horizontal laminar-flow hood, as stipulated in Appendix A. The laminar-flow cabinet used for hazardous (low risk) medicine preparation must be cleaned at completion of the task before other medicine preparation begins. In circumstances where it is impracticable to prepare hazardous (low risk) medicines in a laminar-flow cabinet, sterile medicine that is classified as hazardous (low risk) can be prepared by trained staff, either in Pharmacy or in a clinical setting, using a closed-system and best aseptic technique. Staff safety training must be completed as part of staff orientation (i.e. before potential exposure), be appropriately documented, and recorded. This practice for the preparation of hazardous (low risk) medicine is appropriate for a maximum of FIVE vials only per preparation. Packaging and Transportation Safety measures for the packaging and transportation of hazardous (low risk) medicines should be the same as enforced for other general medicines. THO services may consider added risk controls for packaging and transportation of hazardous (low risk) medicines if deemed appropriate by the Pharmacy Manufacturing Manager, in consultation with the Pharmacy Site Manager. Any added risk controls should be documented in a locally developed protocol. Administration Medicines classified as hazardous (low risk) must be administered with the same care and safety measures as enforced for other general medicines. Page 8 of 13

9 Related Waste Waste contaminated with residual hazardous (low risk) medicines should be disposed of promptly, upon cessation of preparation or administration, in the method appropriate for medical waste, in accordance with state legislation. Any unwanted or expired hazardous (low risk) medicine, sterile and non-sterile, must be disposed of in a PFD bin (available in Pharmacy departments of major, acute care hospitals), in accordance with SPP-MSR: Management and Disposal of Unwanted Medicines Policy, and current state legislation. Opened/part doses of hazardous (low risk) medicines can be disposed of via sharps containers in Pharmacy and in clinical areas. Hazardous (low risk) medicines must not be disposed of down the sink or in the sewer system. Roles and Responsibilities/Delegations It is the responsibility of Pharmacy and Nursing managers to collaboratively develop local procedures and protocols that detail PPE, cleaning and maintenance schedules, equipment used for preparation, packaging, transportation, and administration, and all practices associated with disposal of hazardous or potentially hazardous medicines and related waste, while adhering to the mandatory requirements of this policy. It is the responsibility of managers to ensure adequate resources are provided for staff to perform in their duties safely at all times. Adequate training must be established for all medical, nursing, pharmacy, and ancillary staff involved in the handling of hazardous, cytotoxic and potentially hazardous medicines, and related waste, to confirm that all relevant staff understand the risks associated with exposure of these medicines to themselves, others, and the environment. Training should be completed as part of staff orientation, and before any potential exposure to the medicines. It is the responsibility of all staff involved with the handling of all types of hazardous or potentially hazardous medicines to be in compliance at all times with this policy, and all local protocols that follow from this policy, to ensure maximum protection from exposure to these medicines. It is the responsibility of all staff to use best practice techniques, exercise high cautionary controls, and demonstrate at all times an understanding of the requirements of current Tasmanian legislation in relation to these medicines. The Statewide Therapeutic Drug Committee (STDC) will manage and review the list of medicines classified as hazardous, as held for the purposes of this policy. Risk Implications Medicines classified as hazardous, cytotoxic, potentially hazardous, or hazardous (low risk) are regarded to present some risk to staff, patients, or the environment. Adhering to the mandatory requirements of this policy will reduce the associated risks of exposure to these medicines. This ensures the safest working environment for staff, the safest clinical setting for patients and visitors to Tasmanian public health services, and a reduction to the environmental impact caused by hazardous or potentially hazardous agents. Page 9 of 13

10 The Tasmanian Health Organisations are committed to maintaining legally responsible practices within all public health services, and compliance with this policy will assist sites to meet the legislative requirements of the Poisons Act 1971 and the Work Health and Safety Act This is a statewide policy and must not be re-interpreted so that subordinate policies exist. Should discreet operational differences exist, these should be expressed in the form of an operating procedure or protocol. Failure to comply with this policy, without providing a good reason for doing so, may lead to disciplinary action. Training Training must be provided by all sites for medical, nursing, pharmacy and ancillary staffs who are involved in the handling, preparation or administration of hazardous or cytotoxic, potentially hazardous, or hazardous (low risk) medicines and related waste. Training must equip staff to perform in their role with evidence-based, safe, legally compliant practices. In Pharmacy, parenteral hazardous or cytotoxic, potentially hazardous, and hazardous (low risk) medicines must only be prepared by Pharmacy staff members who have undertaken appropriate training in aseptic and cytotoxic medication reconstitution and handling, as appropriate to the nature of the medication. All medical, nursing and pharmacy personnel must ensure they are familiar with this policy. Staff members must not be involved in the handling, transporting, preparation, administration or disposal of waste of any hazardous or cytotoxic medicine, without appropriate training to ensure the protection of the operator, the environment and the patient. Staff must also engage with regular training in hazardous or cytotoxic medicines management to update and refresh working knowledge, and conduct internal evaluations and reviews of methods and equipment. Audit All THO services must document and monitor all procedures pertaining to the safe handling of hazardous or cytotoxic, potentially hazardous, and hazardous (low risk) medicines (*See Appendix B). Logs should be maintained as evidence of scheduled cleaning of areas and equipment used for the preparation and administration of these medicines, held for a minimum of TWO years, and made available for audit by agency managers and accreditors as necessary. All locally developed procedures that reflect the mandatory requirements of this policy, while also enforcing further controls deemed necessary by Pharmacy and Nurse Managers according to the individual needs of the sites, must be reviewed regularly, and made available for audit by agency managers and accreditors as necessary. This policy will be included in the work program of the DHHS Internal Audit function. This work program is approved by the Audit and Risk Committee and will assess underlying systems and procedures for compliance with the requirements of this policy. The overall focus of this assessment will be one of continuous improvement to DHHS activities. Page 10 of 13

11 Attachments 1 Appendix A Hazardous Medicine Preparation 2 Appendix B A checklist of protocols or procedures to be developed at each site References 1 Work Health and Safety Act 2012 (Tasmania) 2 Work Health and Safety Regulations 2012 (Tasmania) 3 Poisons Act 1971 (Tasmania) 4 Poisons Regulations 2008 (Tasmania) 5 DHHS: Incident Reporting and Management Policy 6 SPP-MSR: Management and Disposal of Unwanted Medicines Policy 7 Work Safe Tasmania: Managing Risks of Hazardous Chemicals in the Workplace: Code of Practice (December 2012) 8 Work Safe Tasmania: Labelling of Workplace Hazardous Chemicals (December 2012) 9 SHPA: Standards of Practice for the Safe Handling of Cytotoxic Drugs in Pharmacy Departments 10 SHPA: Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments 11 Clinical Oncological Society of Australia (COSA): Position Statement: Safe handling of monoclonal antibodies in healthcare settings 12 Worksafe Victoria: Handling Cytotoxic Drugs in the Workplace (January 2003) 13 Government of Western Australia Department of Health: Guidelines for the administration of intravesical cytotoxic and immunotherapeutic drugs within the hospital setting 14 The Department of Tourism, Arts and the Environment: Approved Management Method for Clinical and Related Waste (Tasmania 2007) 15 SHPA: Australian Don t Rush to Crush Handbook (2011) Page 11 of 13

12 Hazardous or Cytotoxic (1). Prepared in a Cytotoxic Cabinet. Fully trained Pharmacy Staff Operator PPE Documented cleaning procedures Final product double-bagged Appendix A Hazardous Medicine Preparation Potentially Hazardous (1). Prepared in a vertical Laminar-Flow Cabinet, or (2). Prepared in a Cytotoxic Cabinet (that is also used for Hazardous or Cytotoxic medicine preparation), using a closedsystem for all medicine preparation within that Cabinet. Fully trained Pharmacy Staff Operator PPE Documented cleaning procedures Final product double-bagged Hazardous (Low Risk) (1). Prepared in a vertical Laminar-Flow Cabinet, by fully trained Pharmacy Staff, or (2). Prepared in a horizontal Laminar- Flow Cabinet, by fully trained Pharmacy Staff, using a closed-system, or (3). Prepared outside of a Laminar-Flow Cabinet by fully trained Pharmacy or Nursing staff, using a closed-system wherever possible*, for a maximum of FIVE vials. Operator PPE Examples: Methotrexate Trastuzumab Penicillin Classification Key Documented cleaning procedures The preference for sterile medicine preparation is determined by the consideration given to these factors: operator safety, patient safety, environmental safety, product integrity, product sterility, ease of operator technique and manipulation, work flow, treatment scheduling, and cost. Green Option (1): Indicates the preferred method of preparation as it best represents the safest option with the above factors best being met. Amber Option (2): Indicates the second preference for the method of preparation. This method potentially compromises one or more of the factors above, while still operating within the scope of safety. Red Option (3): Indicates the third (the least favourable) preference for the method of preparation and potentially compromises two or more of the factors above, while still operating within the scope of safety. Notes *A closed-system should only be omitted from medicine preparation (where specified) in circumstances in which the closed-system compromises the integrity of the therapeutic agent (e.g. causes excessive frothing). Page 12 of 13

13 ***Text in Automatic Black indicates mandatory risk controls within each classification. Appendix B A Checklist of Hazardous Medicine Protocols Personal Protective Equipment (PPE) specifications for: o Dispensing, re-packaging or general handling of: o Extemporaneous manufacture or preparation of: Hazardous (low risk) medicines o Administration of: o Handling medicine related waste for: Cleaning and Maintenance specifications and schedules for: o Equipment used to dispense: o Area used to dispense: o Pharmacy equipment and area used to prepare or manufacture sterile and non-sterile: o Ward/clinic equipment and area used to prepare or manufacture sterile and non-sterile: o Ward/clinic equipment and area used to administer: Page 13 of 13