Oncology Pharmacy Practice Standards. Have CAPhO Standards of Practice Made a Difference? Oncology Pharmacy Practice Standards

Transcription

1 Oncology Pharmacy Practice Standards Have CAPhO Standards of Practice Made a Difference? Larry Broadfield, BScPharm, MHSc, FCSHP Standards for safe handling of cytotoxic agents have been issued by several bodies over the past 0 years ASHP CSHP OSHA NIOSH ISOPP Oncology Pharmacy Practice Standards CAPhO developed practice standards which were released and approved by the membership in October 00 Standards included major areas: Oncology Pharmacy Administration Oncology Pharmacy Distribution Safe Handling of Chemotherapy Drugs Clinical Practice in Oncology Pharmacy National Survey of Canadian Oncology Pharmacy Services Summer 00 Survey designed to determine degree of compliance with CAPhO standards page survey (0 questions) Mostly / questions Sent to 79 hospitals/cancer centres across Canada 0 known major cancer treatment centres 7 community hospitals with small chemotherapy services (known or suspected by author) Input by other CAPhO members to identify sample Reminder letter to non-responders (known sites) National Survey of Canadian Oncology Pharmacy Services Response Rate: 9 responses (%)- generalizability respondents identified that they do not offer oncology pharmacy services responses used for analysis Data entered into Excel (Sept 0) Closed Oct for this analysis Continue to accept data for publication

2 Demographics Practice Setting for Respondents questions Type of hospital/practice site Size of Oncology Pharmacy Service (by number of FTEs) Types of services offered Average staffing levels (large services only) Awareness of CAPhO Standards Answer Other Small community hospital Metropolitan general hospital Academic teaching hospital Provincial cancer hospital Size of Oncology Pharmacy Service Are Oncology Pharmacy Services Part of a Cancer Program in the Hospital? Answer Answer Large (> FTE) Medium (- FTE) 9 Small (< FTE) ne te: Cancer-Specific Hospitals Excluded from this Question Is Oncology Pharmacy Service Independant or Part of Hospital Pharmacy Dep't. Oncology Pharmacy Services Offered: Other oncology subspecialty services Answer Hematopoietic stem cell transplant support 0 Pediatric oncology services Independent Service Hospital Pharmacy Ambulatory clinical pharmacy services Inpatient clinical pharmacy services Chemotherapy order verification Chemotherapy preparation services te: Cancer-Specific Hospitals Excluded from this Question

3 Average Staffing Levels in Large Oncology Pharmacy Services Has Your Department Received a Copy of the CAPhO Standards? Answer Distribution Pharmacists Pharmacy Technicians Number of Staff Support Staff FTE s Clinical Pharmacists Respondents who said YES (%) have assessed their service with the CAPhO Standards Demographics Observation: Many oncology pharmacy departments have not received the CAPhO Standards document Could CAPhO arrange to have copies made available to all (identifiable) hospitals with any oncology pharmacy service? Oncology Pharmacy Administration questions Each question/group of questions based on standard and guideline statements in CAPhO Standard of Practice Questions framed as / or Check All That Apply Spontaneous comments captured in database, but not reported in this analysis. Oncology Pharmacy Service- Mission Goals & Objectives Is there a published statement of mission, goals and objectives for the pharmacy service? 9 70%. Systematic Planning Is there a systematic planning process for the pharmacy department/service? % Answ er Are there statements specific for the oncology pharmacy service? 7 7% Answer 9 Answ er Are the mission, goals and objectives of the pharmacy service consistent with those of the provincial agency? % If so, are threre specific components of the plan that relate to the oncology pharmacy service? % Answ er 0

4 . Organization and Management Is there a designated pharmacy leader for the oncology pharmacy service? % 0 0 Any Increase %. Oncology Pharmacy Staffing Needs 9 Any Increase % Any Increase % Any Increase 7% difference by size of service Answer 0 Distribution Pharmacists Pharmacy Technicians Support Staff Clinical Pharmacists Sufficient Small increase Major increase Answer Small Increase -0% of current FTEs; Major increase >0% current FTEs. Oncology Pharmacy Staffing Is there a process for continuous reassessment of human resource requirements for the oncology pharmacy service? 9% 0. Oncology Pharmacy Staffing Are technical and support personnel assignments optimal to minimize oncology pharmacist involvement in technical and clerical tasks? 0 Answer Are there current job descriptions for oncology pharmacy personnel that reflect the specialty nature of oncology pharmacy practice 0 % 0 9 Answer 0 0 Fully Mostly Partially Answer. Oncology Pharmacy Staffing Are there known areas for improvement identified in your pharmacy service planning process? 0 7% Answer Is there a process for oncology-specific training for pharmacy personnel in your institution?. Oncology Pharmacy Staffing Are technicians and/or pharmacists certified by your institution for chemotherapy preparation? Technicians % 79% Answer 7 Pharmacists Answer Are there identified training needs that have not been met by your institution to date? 9 % % Answer Answer At Least One Technician or Pharmacist Is there an oncology-specific education program for clinical pharmacists in your institution? 7% 0 Answer 7 % 0% Answer

5 . Oncology Pharmacy Staffing Are there oncology-specific continuing education programs in your institutions for oncology pharmacists and technicians? 9 Answer. Oncology Pharmacy Staffing Are oncology pharmacy staffing patterns determined by the magnitude of patient needs? 7 Is attendance mandatory for either group? Answer Answer Technicians Pharmacists Answer Is staffing adjusted when patient needs change? Is attendance of oncology pharmacy staff documented? Technicians 9 Answer 0 Pharmacists Answer Answer 9 Oncology Pharmacy Staffing Most respondents identified need for additional staff, especially for clinical pharmacists Many identified suboptimal utilization of technical and support staff Training, education and certification remain areas for improvement in many institutions. Policies and Procedures Are there appropriate oncology-specific policies and procedures in your institution? Answer Which of the following are included in your policies and procedures: Roles and responsibilities of oncology pharmacy staff Improvement and consistency in performance Orientation of new oncology pharmacy staff Safe handling of cytotoxic drugs Other 0 % % % 7% 7 % %. Documentation Are the oncology pharmacy activities documented by the pharmacy service? % Answer Which of the following are routinely documented? Quality control measures for chemotherapy drug admixtures 0 Situations to promote patient safety 7 Drug monitoring plans 9 Determination of any allergies Previous serious adverse drug reactions or interactions 7 Provision of pharmaceutical care.7 Oncology Drug Advisory Committee Is there an instituional committee responsible specifically for oncology drugs and therapeutics % Answer If so, is there a pharmacist designated to participate in this committee? Which of the following areas are considered by the oncology drug advisory committee: Development of practice guidelines Drug orders to prevent drug-related problems 0 Maintenance of a formulary of approved oncology drugs Subtherapeutic or excessive serum drug levels Patient counseling Medication reviews Provision of drug information 0 9 Review of policies and procedures for improvement in drug use Review of errors, near-errors and serious adverse drug reactions Critical evaluation of new and expensive oncology drugs 7

6 Answer. Treatment Guidelines Are there treatment guidelines developed by the cancer program at your instiution or by your provincial cancer agency? If so, is there an oncology pharmacist participating in the guideline development? 9 7 9% %.9 Medication Safety Are there measures in your oncology pharmacy service to ensure medication safety? 7 90% Answer Which measures are included by your oncology pharmacy service? Use of pre-printed physician orders Pre-printed orders include relevant protocol elements 9 Use of oncology-specific physician electronic order entry Dose verification for chemotherapy orders against a standard regimen 7 Use of a checklist for dispensing of cancer chemotherapy Independent dosage calculation by the pharmacist 70 Confirmation that doses do not exceed limits before administration Use of standardized generic terminology Process to identify potential drug interations Pharmacist involvement in patient education.0 Medication Incident and Medication Discrepancy Reporting Are there policies and procedures in place to avoid or minimize medication incidents in your institution?. Quality Assurance Program Is there a quality assurance program in your oncology pharmacy service? 7 % % Answ er Are there any cancer chemotherapy-specific policies and procedures? 7% Answer 9 If yes, does this service evaluate chemotherapy preparation, dispensing and/or clinical Answ er services for cancer patients? Is there a process for reporting any discrepancies in chemotherapy ordering, dispensing or administration? 7% % 0 Answ er Answer. Adverse Drug Reaction Reporting Is there an adverse drug reaction reporting system used in your institution? 70 %. Resource Management and Financial Control Is there sufficient space, facilities, equipment and supplies to ensure a SAFE working environment for staff? 9% Answer Is the oncology pharmacy service directly involved in budgeting and financial management of the service? Answer 9% If yes, is there a process to identify and report serious/life treatening, or unexpected ADRs for cancer chemotherapy patients? Answer Does this include research management (e.g clinical trials support services)? 0 7% 9% 9 Answer

7 . Cost Containment Is the oncology pharmacist involved in measures to contain drug therapy costs for individual patients and for the oncology pharmacy service?. Medication Use Evaluation and Reporting Systems Is there a process for medication use evaluation utilized by the oncology pharmacy service? % % 0 Answer Answer Do MUE processes include relevant patient outcomes in the evaluations? Which of the following methods are used for cost containment: 7 0% Formulary management Application of evidencebased guidelines 9 Answer Does the oncology pharmacy service use a reporting system for ongoing cancer drug costs, oncology pharmacy service activities, relevant workload measurement, and clinical outcomes? Monitoring and managing budgets Data collection and analysis Answer % Oncology Pharmacy Administration Areas for Improvement (suboptimal compliance) designated oncology pharmacy leader % Small and % Larges services Poor compliance with Quality Assurance Program for oncology pharmacy Only 7% have ADR reporting system that looks for serious chemotherapy ADRs Safe working environment- should be nearly 00% compliance (9%) Low compliance with oncology MUE availability Oncology Pharmacy Distribution 7 questions, same design. Oncology Pharmacy Distributions System Are all cancer chemotherapy drugs prepared by the oncology pharmacy service? 9%. Pre-Printed Medication Orders & Electronic Order Entry Is chemotherapy ordered on pre-printed orders or computerized physician order entry in your institution? PPO 7% Answer Are all pharmacy personnel who prepare cancer chemotherapy drugs trained and certified? CPOE % 7% Neither 0 Answer Which types of systemic therapy are ordered on standardized PPOs? Is the certification renewed regularly (e.g. annually)? 7% 0 Answer Are there up-to-date written policies and procedures for the safe handling of cancer drugs? All chemotherapy doses Selected chemotherapy only (standard regimens) Chemotherapy to be given in the home Answer 7 79% Supportive care medications for hospital administration Supportive care medications for home administration 9 9 7

8 . Pre-Printed Medication Orders Which of the following are included on your PPOs or electronic order entry system: name of the approved regimen and its indication. Electronic Order Entry & Pre-Printed Medication Orders Which types of systemic therapy are ordered by electronic order entry? All chemotherapy doses each generic chemotherapy drug and supportive drug(s) Selected chemotherapy only 0 dosing and administration instructions for each drug Chemotherapy prescriptions for retail pharmacy Supportive care medications for hospital a process to ensure accuracy of dose calculations 9 Supportive care prescriptions for retail pharmacy a process to identify potential drug interactions 7 Does the electronic order entry system identify minimum and maximum allowable? approval for each regimen/ppo by a multidisciplinary committee annual review and revision Answer a copy for the individual health record authorization by the prescriber and according to the patient s needs. 7 Do the PPOs or electronic order entry system include other protocol elements? written according to institutional polices and procedures Answer. &. Medication Order Review and Labels Each chemotherapy order is verified by the oncology pharmacist. Checking Medication Preparation and Labeling The dispensing label is verified by an oncology pharmacist against the physician's order. 9 9 % 7 90% Answer Answer Chemotherapy order entry generates a dispensing label The final drug product is verified against the dispensing label before dispensing. 7 % 0 Answer 9% Answer Product checking is done by: The dispensing label includes all necessary information an oncology pharmacist only 7 7% a pharmacist only either a pharmacist or a technician 9 Answer another health professional Oncology Pharmacy Distribution Generally high compliance with standards Need to improve certification levels and especially recertification Use of PPOs could be improved through provincial standards (where they do not currently exist) Could CAPhO warehouse samples of current PPOs to assist those who do not use them? Oncology Pharmacy Distribution Chemotherapy product checking 9 respondents (%) allow product checking by a pharmacy tech (all but were Medium or Large practice sites) respondents (7%) allow product checking by another health professional (all but were Medium/Large sites) This CAPhO standard may need to be reconsidered (give some alternate options?)

9 Safe Handling of Chemotherapy Drugs Standards for Safe Handling of Cancer Chemotherapy Drugs. The oncology pharmacy service handles cytotoxic drug doses in a practice site, which ensures safe handling and distribution 7 questions 0 9% Answer. There are standardized policies and procedures for the safe handling of cytotoxic drugs 7 90% Answer. All cancer chemotherapy drug admixtures are prepared in a Class B biological safety cabinet 9% 0 Answer. Biological Safety Cabinet. Biological Safety Cabinet Which of the following apply to the BSC(s) used in your institution: Is cancer chemotherapy EVER prepared in a horizontal laminar airflow hood? The BSC is located in a clean room with minimal air turbulence Certified annually by an accredited technician every months 79 9% Certified annually by an accredited technician every months Answer Routine BSC operations include: Biologic agents are NEVER prepared in the same BSC as used to prepare chemotherapy Continuous running of the blower hous daily, 7 days a week 7 9 % Keeping the viewing window at the proper position Intake and exhaust grills are not blocked during operation Daily check of magnetic gauges to ensure proper operation Answer Regular smoke pattern testing inside the BSC 0 Is there a process to ensure that the biologic agents do not contaminate chemotherapy doses The BSC is cleaned and disinfected at least once daily 7 The BSC is thoroughly decontaminated at least once weekly 9. Equipment for Drug Preparation Sterile disposable equipment is used for all cancer chemotherapy drugs and sterile doses 9%. Equipment for Drug Preparation Closed-system devices (e.g. PhaSeal) are used for cytotoxic drug admixture and administration. 9 % Answer Drug preparation equipment is chosen to ensure product sterility and optimal safety for the workers 0 7% 9% Answer Answer If closed-system devices are not used, is this because: Luer-lok devices are used wherever possible 9% Answer n-pvc equipment is used when required for specific drugs % Answer Equipment is not available Equipment is too expensive Decision by oncology pharmacy service not to used closed-system Unaware of closed-system equipment 0 0 9

10 . Personnel. Personnel Personnel are knowledgeable about specific procedures for preparation and handling of cancer chemotherapy agents There is an eyewash station immediately accessible to the chemotherapy preparation area. 0 Answer 9% 9 7 7% Preparation, reconstitution, administration and disposal of cancer chemotherapy drugs are ONLY be performed by trained personnel Answer 0 Answer 9% There is a safety shower reasonably accessible to personnel preparing chemotherapy drugs % Personal protective equipment is available and routinely used by personnel preparing cancer chemotherapy. 0 Answer There is ABSOLUTELY NO eating, drinking, gum chewing, food storage in the chemotherapy preparation area 77 Answer 9% 9% Answer There is a policy to transfer personnel who are attempting to conceive or father a child, or who are breastfeeding, to alternate duties 7 % 0 Answer. Receiving and Storage of Chemotherapy Drugs Are there are procedures for personnel safety during the receipt, transportation, handling & storage of chemo drugs? 9% Answer Do personnel who open a container to unpack or handle chemotherapy products wear protective gloves/clothing? 7% Answer Are all chemotherapy products stored in closed containers, on shelves with ledges that are not above eye level?.7 Preparation of Cytotoxic Drugs Cytotoxic drugs are prepared and admixed using techniques specific to this group of drugs Answer Cytotoxic drug preparation procedures are used to ensure product sterility and optimal occupational safety 0 Answer The pharmacy department maintains a list of hazardous (cytotoxic) drugs that require special handling 79 9% 9% 0 % 9 % 9 Answer Is the storage area is separate from other drug products and does it have sufficient external air ventilation? Answer The preparation of cytotoxic drugs in the BSC is organized to minimize the movement of products 0 7% 77 9% Answer Answer.9 Transport of Cytotoxic Agents.9 Transportation of Cytotoxic Agents Are there are procedures in place for the safe transport and secure delivery of cytotoxic drugs? Are pneumatic tubes or other mechanical transport systems used to transport cytotoxics.? 7 Answer 7 % Answer 9% 7 Are there precautions to prevent breakage, minimize exposure and contain spills? If yes, is there a process to decontaminate the transport system in the event of a chemo spill? 7 9% Answer If yes, which precautions are used in your institution Placing cytotoxic drugs in leak proof containers, and sealable plastic bags Transportation by a tray or cart 9 Use of Luer-Lock syringe caps 70 Is there quick access to a spill kit and are trained workers to handle cytotoxic spills during transportation? 7% 7 Answer Does your institution prepare cytotoxic drug doses to be transported outside the institution? 0 Answer When cytotoxic agents are transported outside the institution, which safety procedures are used? Same precautions as used inside institution Use of appropriate packaging materials 7 Cytotoxic labels of packaged drugs for transportation Compliance with dangerous goods transportation acts

11 .0 Cytotoxic Waste Are there policies for identification, containment, collection, segregation and disposal of cytotoxic waste? 9 % 9.0 Cytotoxic Waste Is cytotoxic waste collected, stored and removed from the facility in an appropriate manner? 0 9% Answer Are all cytotoxic drug waste separated from general waste? 79 9% 0 Answer Is cytotoxic waste destroyed in an incinerator approved for the destruction of cytotoxic drugs? Answer Is cytotoxic waste is placed in thick plastic bags or leak-proof containers labeled with the cytotoxic symbol? 0 9% % 0 Answer Are cytotoxic waste receptacles kept in all areas where cytotoxic drugs are prepared or administered? Answer If not incinerated,cytotoxic waste is transported to and buried in a licensed hazardous waste dump. 79 9% 0 Answer. Cytotoxic Spills Are cytotoxic spills cleaned up immediately using spill management and clean up procedures? 7 9% Answer Are there properly trained personnel in all areas where cytotoxic spills are possible? 7% 7 Answer Are spill kits accessible at each area where hazardous drugs are handled? 77 9% Answer Are all cytotoxic spills documented, including identification of all personnel exposed to the spill? 9 70% 0 Answer Safe Handling of Chemotherapy Drugs Generally high compliance with standards Over 0% prepare biological agents (e.g. BCG) in the chemo hood, but most have process for decontamination Update CAPhO Standard to offer options? Low utilization of Closed System Devices Need to improve personnel safety measures during receiving, transportation and storage of chemotherapy drugs Safe Handling of Chemotherapy Drugs List of hazardous drugs- Could CAPhO publish a standard list on the website? Clinical Practice in Oncology Pharmacy 7 Questions

12 . Professional Knowledge and Skills There are oncology pharmacists who are knowledgeable about cancer care 7 0%. Team Work The oncology pharmacist(s) provide direct patient care Answer Activities of the oncology pharmacist(s) on the cancer care team include: % Answer In the Large Services, there is an average of. Oncology pharmacists (range up to 0) Participation in patient care rounds Interdisciplinary team conferences; Informal discussions; 0 Other. 9 The oncology pharmacists are assigned to cancer site groups/tumour boards 9 Answer %. Pharmaceutical Care The oncology pharmacists provide clinical services based upon the pharmaceutical care model % 7 Answer There are processes to ensure seamless care from transition between inpatients & outpatients. % Answer 7 There is a process to identify patients most likely to benefit from pharmaceutical care services. 7 % Answer. Pharmaceutical Care There is a process to prioritize pharmaceutical care for patients with greater needs % Answer There is a process to identify and prevent or address drug-related problems % Answer The oncology pharmacist interviews cancer patients to obtaining medication histories All Most 0 Selected 9 ne Answer. Pharmaceutical Care There is a process for the oncology pharmacists to identify outcomes from drug therapy 7 % There is a process to ensure that oncology pharmacists document pharmaceutical care activites 9 % 0. The oncology pharmacists provides patient care consultations upon request Rarely Often 9 Answer. Patient Counseling The oncology pharmacists actively provide patient medication counselling All Most Selected 9 ne Answer Each systemic therapy patient is seen at least once by the oncology pharmacist 7% 7 Answer The oncology pharmacist uses both verbal counselling and written materials 0 7% 9 Answer The oncology pharmacist ensures patient & family know about handling home chemotherapy waste 0% 9 Answer

13 .-. Drug Info, Research & Clinical Trials. The oncology pharmacist provides appropriate drug information 7 % Answer.7 The oncology pharmacist is involved in oncology clinical trials 0 % Answer 9. The oncology pharmacist is actively involved in research Never 7% Rarely Sometimes Often 9 Regularly Answer 9.9 Education and Staff Development There is a process to ensure oncology pharmacy staff participate in continuing education programs 7% 0 Answer Participation in educational programs is documented 9 % 0 Answer There are educational programs available to oncology pharmacy staff 0% 7 Answer One or more oncology pharmacist has achieved formal accreditation 7 0% Answer.0 Pediatric Oncology Pharmacy The oncology pharmacy service includes pediatric oncology patients Major focus of practice % Some pediatric patients pediatric patients 0 Answer The pediatric oncology pharmacist involve the family in pharmaceutical care services. The pediatric oncology pharmacist is involved with monitoring disease management 7 The pediatric oncology pharmacist applies all relevant age-specific dosing guidelines The pediatric oncology pharmacist verifies orders for administration in the home 7 9 The pediatric oncology pharmacist is involved in therapeutic drug monitoring 0 Clinical Practice in Oncology Pharmacy Many improvements needed in clinical care delivery % deliver no clinical services (9% in Large, % in Medium or Small) 9% have no process for seamless care % have no process to identify patients at greatest need for clinical services and 0% have no process to prioritize delivery of clinical services % do not meet the standard of at least one oncology pharmacist visit per patient Clinical Practice in Oncology Pharmacy CAPhO should consider development of training programs for oncology pharmacy clinical skills, pharmaceutical care delivery, seamless care delivery Continue emphasis on knowledge transfer (drug info)- 0% identify pharmacists have the knowledge but only 7% have CE programs to maintain knowledge Develop a National Oncology Pharmacy Curriculum? Clinical Practice in Oncology Pharmacy Need to share practical experiences in clinical programs Consider in NOPS program planning? Need to prioritize research in the area of oncology clinical pharmacy practice Need to promote measurement of clinical services New benchmark for WMS- %age patients seen by oncology pharmacist? As clinical/pharmaceutical care services are developed, expand CAPhO Standards?

14 Has there been progress? A similar survey was done in 9 ( yrs) Published in Can J Hosp Pharm, 99 sites identified- 7 responses (%) Over half identified desired increase for staffing (pharmacists, technicians) Key areas for future development (ranked): Improved clinical services Standardization of pharmacy procedures ** Improved drug information services ** Increased staffing for oncology pharmacy Improved staff education ** Patient medication counseling/education ** Areas where there appears to have been improvement Conclusions Survey based on CAPhO Standards % Response- Generalizable Good compliance with most key standards on administration Most respondents identify some staffing needs Generally high compliance with key standards on distribution and safe handling Clinical services clearly need improvement in many areas Potential roles for CAPhO suggested Survey results will be submitted for publication