Implementing the Safe Handling of Oral Anti-cancer Drugs ...

1 Anti-cancer Drugs . Implementing the Safe Handling of Oral Anti-cancer Drugs (OACDs). in Community pharmacies : A Pan-Canadian Consensus Guideline Authors: Dr. Kathy Vu1,2, Ms. Heather Logan3, Ms. Erika Brown3, Ms. Suzzette Oriasel2. INTRODUCTION Cancer Care Ontario (CCO) community pharmacy practice, launched the Systemic Treatment oncology pharmacy practice, Community pharmacists will Provincial Plan 2014 - 2019 health system design, as well as encounter more oral Anti-cancer which aims to improve the individuals who represent patients Drugs (OACD) in their pharmacies . safety, quality, and accessibility of and their families (the Task Approximately 46%1 to 60%2 of systemic treatment in Ontario. Force ). The guideline provided cancer Drugs that are coming out One of the priority areas is to recommendations for each point of the oncology pipeline are oral ensure the safety and quality of of medication lifecycle where agents.

2 OACD are commonly THCD dispensed in community exposure to the drug can occur. It used alone or in combination pharmacies . To address this priority addressed manufacturer packaging with intravenous (IV) systemic focus, CCO collaborated with the and labelling, receiving and treatment as part of a regimen. Canadian Association of Provincial unpacking, storage, preparation These agents may also be Cancer Agencies (CAPCA) and Handling , verification and referred to as take-home cancer and the Canadian Pharmacists dispensing, disposal and waste Drugs (THCD) as it allows the Association (CPhA) to develop the management, spill protocols, patient a more convenient and Safe Handling of Oral Anticancer personal protective equipment, less invasive approach to cancer Drugs in Community pharmacies : training and education, staffing, and treatment at home.

3 With the A Pan-Canadian Consensus incident reporting. shift in the delivery of treatment Guideline to provide guidance to the community setting, around the safe dispensing and The guideline is intended to there is concern regarding the Handling of oral Anti-cancer Drugs supplement mandatory legislative management of occupational in low-volume settings unique to standards. It complements hazard risk associated with the community pharmacy setting. existing legislation, regulation, and inadvertent exposure to these professional practice standards. Drugs in a community pharmacy The guideline was informed by When there is inconsistency setting. existing evidence and through or conflict between the discussions with executive level recommendations, the mandatory RATIONALE FOR community pharmacy leaders. or more restrictive requirements THE GUIDELINE Each recommendation was should take precedence.

4 Reviewed and revised through Ontario has a decentralized an iterative process to obtain dispensing model, therefore THCD consensus. It was also reviewed may be filled at any community by more than 30 external The full published pharmacy in Ontario. While organizations with mandates guideline is available standards and guidelines have in patient or medication safety, at: https://www. been developed to ensure safe occupational health and safety, dispensing and administration of transportation of hazardous Drugs , sites/ccocancercare/. IV chemotherapy, there are few and/or pharmacy practice. The files/guidelines/full/. published for OACD with specific whole process was guided by a OACDs_in_Community_. considerations for dispensing in group of experts with knowledge community in medication and patient safety, PAGE 22 ~ SUMMER 2017 ~ PHARMACY CONNECTION.

5 Anti-cancer Drugs . RECOMMENDED STARTING POINTS pharmacists in all practice settings. This two-part program (Essentials of Oncology and Advanced It is expected that the full implementation of these Oncology) aims to provide standardized education guidelines will be challenging because of their for pharmacists to ensure safe and high quality care complexity, the novelty with respect to established to cancer patients and their caregivers. For more practice and the infrastructure needed to support information, visit their implementation. As part of the work of developing the recommendations, feedback on implementation timelines was requested from those Staff should be encouraged and given an opportunity responsible for change management (see Figure 3). to participate in continuing education programs as appropriate for their knowledge, skills, and job functions.

6 We recommend that clinical verification of a THCD prescription should be done by a pharmacist with experience and training in cancer treatment. If such a pharmacist is not available onsite, it is important that another experienced and trained pharmacist is available for consultation. The use of a clinical checklist is highly recommended. Cancer Care Ontario developed a checklist that can be customized and adapted for the purpose of documentation (see aspx?fileId=362139). Figure 3: Expected Implementation by External Review Similarly, all staff who handle hazardous Drugs should Respondents (n=32) have training at the start of their job and routinely when job functions change or after a prolonged To address the need to balance safety and feasibility absence. Pharmacy managers should ensure that a of incorporating the recommendations into practice, trained backup staff is available for unpacking and the Task Force took a pragmatic approach and dispensing of OACDs in case of absences.

7 Considered alternatives that minimize contamination and eliminate confusion to enhance adoption of the B. Create a list of hazardous Drugs encountered recommendations. An example is wearing two pairs of in the pharmacy gloves when Handling OACDs to eliminate confusion over the number of gloves and the associated task. Drugs that are considered hazardous to humans In doing so, there is a risk of non-adherence to or animals are associated with one of the following double gloving and potential inconsistencies with characteristics: 1) carcinogenicity; 2) teratogenicity other guidelines. However, the Task Force felt that a or other developmental toxicity; 3) genotoxicity; 4). consistent approach was important, thus the message reproductive toxicity; 5) organ toxicity at low doses;. is to wear gloves when Handling OACD with less and 6) structure and toxicity profiles of new Drugs emphasis on the number of gloves.

8 That mimic existing Drugs determined by the above criteria4. OACDs pose hazards through dermal We recommend that pharmacy staff, managers absorption, inhalation, and ingestion via contaminated and owners review the guideline and have open surfaces. Coated tablets or capsules that are solid discussions to understand the concerns and where to and intact without modifications when administered focus resources to implement the recommendations. to patients may pose less significant However, We further suggest starting with the following, unless uncoated tablets are at risk of forming dust when there are other priority areas identified. subjected to stress ( when poured in and out of a container, and repeatedly counted), which can A. Train staff contaminate the CCO collaborated with the Leslie Dan Faculty of While there is no single list of hazardous Drugs Pharmacy at the University of Toronto, and the that is accepted worldwide, the National Institute of Canadian Association of Pharmacy Oncology (CAPhO) Occupational Safety and Health (NIOSH) produces and to develop the Oncology Program for Pharmacists: updates a list periodically that can be used as a guide A Person-Centred Approach to Cancer Care for from which to develop a workplace or setting-specific PHARMACY CONNECTION ~ SUMMER 2017 ~ PAGE 23.

9 Hazardous drug list based on an unpacking of OACD shipments and These containers should be made inventory of the Drugs handled storage where access is restricted available where OACD are handled and the potential for exposure. to staff who have received and disposed of by incineration by Guidance on how these workplace- appropriate training. However, an appropriate company. specific lists should be developed since space may be limited within is available through NIOSH at the community pharmacy setting, D. Evaluate available tools and all activities involving OACD current compounding practices antineoplastic/pdf/hazardous- should (at minimum) be done in a designated, low-traffic area that In some cases, the prescribed dose is clearly marked off and labelled of an OACD is not commercially We suggest that the Designated distinctly to indicate extra caution available and compounding is Manager or a delegate and staff is required.

10 We further recommend required. Class I Biological Safety compile a list of hazardous Drugs that storage of OACD in the Cabinet (BSC) is recommended for that require additional caution ( dispensary be segregated from all the compounding of non-sterile segregated space or the use of other non-hazardous Drugs . This hazardous Drugs . When a personal protective equipment). will help to limit staff exposure, containment cabinet is not available This list should be posted in all lower the risk of medication error for non-sterile compounding, areas of the pharmacy where there through incorrect selection of consider other alternative may be contact with OACD ( medication, and provide a visual tools and practices to minimize receiving, storage, dispensing and indication that special Handling is contamination to the work area disposal areas).