Oral chemotherapy drugs not immune to medication errors

2010 ◽  
2021 ◽  
pp. 107815522110562
Author(s):  
Moataz M Hassan ◽  
Dhabya Al-Marzooq ◽  
Hanan Al-Habsi ◽  
Amna Al-Hashar ◽  
Murtadha Al-Khabori ◽  
...  

Background Safe handling of oral anticancer agents is of great concern. There is a lack of clear, national guidelines on how patients can safely handle and dispose of unwanted medications. We aimed to evaluate the safe handling, storage, and disposal of oral anticancer drugs among cancer patients and caregivers at home. Method This cross-sectional survey of adult cancer patients (or their adult caregivers) used a closed-ended questionnaire from May 2019 to March 2020. Results A total of 257 patients (50 ± 15 years; range: 18–93 years) were enrolled; however, only 91% (233/257) reported self-administering oral anticancer medications. Caregivers were more likely to administer oral anticancer agents for patients ≥60 years than those <40 years old (63% vs. 8%; P = 0.001). Most patients (52%; 133/257) did not wash their hands after administering the drug; 74% (164/222) of the respondents reported that their medications were kept in a bedroom cabinet, while 18% (40/222) stored their medications in a refrigerator, and 5% (12/222) in a kitchen cabinet. A total of 55% (68/124) of patients returned their excess oral chemotherapy medications to the hospitals; however, 36% (45/124) disposed of their unused oral chemotherapy drugs in a household garbage container. Conclusion While two-thirds of patients stored their oral anticancer medications properly, more than half used inappropriate handling procedures. Disposal practices were inconsistent and did not adhere to the reported international guidelines.


2020 ◽  
Vol 26 (3) ◽  
pp. 703-717
Author(s):  
Samantha H Spencer ◽  
Shannon M Menard ◽  
Malgorzata Z Labedz ◽  
Courtney D Krueger ◽  
Katherine V Sarna

2019 ◽  
Vol 104 (7) ◽  
pp. e2.56-e2
Author(s):  
Anna Kinsella ◽  
J Delaney ◽  
◽  

AimPatient information leaflets (PILs) have been a legal requirement in the UK for all medicines for almost 20 years. However, as many of the drugs used in children with cancer are unlicensed or used outside the terms of their licence ‘off- label’, information provided by the manufacturer does not always tell parents/patients everything they need to know about the use of the medicine in children and young people. In 2014, a survey conducted by the Children’s Cancer and Leukaemia Group (CCLG) revealed 92% of parents wanted more drug specific information. The aim of this piece of work was to address these information needs through the development of standardised drug specific factsheets for children and young people with cancer.MethodsInformation was collated on the availability of paediatric drug specific PIL’s at primary treatment centres (PTC’s) in the UK and Ireland. The CLLG and members of the Paediatric Oncology Pharmacists (POP) group worked together in reviewing and comparing a selection of PIL’s already available, in addition to agreeing a standardised format and outline of headings for proposed factsheets. Drafts were produced for 10 of the most common oral chemotherapy drugs used in children. These were reviewed for content, language, punctuation, grammar and structure by a wide range of end users, such as parents of children on treatment, parents of children whose treatment had finished, clinical nurse educators, paediatric oncology/haematology consultants, clinical nurse specialists, ward managers and different members of the POP group. Feedback and comments were collated. Proposed changes suggested were either actioned or reasons for not actioning documented on a change log. This process repeated until a final version was agreed.ResultsOf the 12 PTC’s, 5 had their own oral chemotherapy PIL’s, with the range of leaflets available varying across these five centres. Only 1 PTC had their own intravenous (IV) chemotherapy PIL’s. Information provided varied from centre to centre with drug information also provided from treatment protocols, the Macmillan website or from the manufacturers summary of product characteristics (SPC). Factsheets for the following oral chemotherapy drugs have been produced; chlorambucil, cyclophosphamide, dexamethasone, etoposide, imatinib, lomustine, mercaptopurine, methotrexate, procarbazine and temozolomide. A factsheet on the ‘safe handling of oral chemotherapy’ was developed alongside these to further support parents in managing their child’s oral chemotherapy safely at home.ConclusionUser engagement is paramount in producing information that is clear, accurate, up-to-date, easy to understand and practical. Factsheets are available to order/download free of charge providing equal access to all healthcare professionals, parents/carers and patients across the UK and Ireland, ensuring families are not disadvantaged by geographical treatment location. Current multimedia technology offers the benefit of increased and fast access to information; however, a further survey of families is required to establish whether parents drug information needs have been met though the availability of these factsheets.ReferencesStandardised IV chemotherapy factsheets and additional oral drug factsheets for dasatanib, hydroxycarbamide and isotretinoin are currently in development. MHRA Medicines and Healthcare Products Regulatory Authority (2012) Best practice guidance on patient information leaflets [Online]. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/328405/Best_practice_guidance_on_patient_information_leaflets.pdf (accessed 12 Jun 2018)Shinfield, C. Chief Information Officer. Children’s Cancer and Leukaemia Group. Personal communication. 25thNovember 2015


2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 107-107
Author(s):  
Vicky Simanovski ◽  
Noor Ahmad ◽  
Leonard Kaizer ◽  
Erin Redwood ◽  
Kathy Vu ◽  
...  

107 Background: Oral chemotherapy delivery is complex, making safe medication practices a high priority. Cancer Care Ontario, the provincial government agency responsible for continually improving cancer services in Ontario, undertook a jurisdiction-wide quality improvement initiative to ensure that all oral chemotherapy drugs are prescribed using Computerized Prescriber Order Entry (CPOE) or standardized Pre-printed Orders (PPO). The initiative was further enabled by changes to the provincial funding approach that flows facility funding for oral chemotherapy delivery. Methods: All 35 facilities prescribing chemotherapy in Ontario across 14 regions implemented strategies to work towards the common aim of reducing handwritten/verbal oral chemotherapy prescribing to zero by June 30th, 2015. Baseline audits were completed between Sept-Nov 2014; repeat audits were performed between Mar-May 2015. Each facility reported the number of patients that received an oral chemotherapy prescription, and the method of prescribing. Results: At baseline, 30% of audited prescriptions across the province were handwritten or verbal, which decreased to 9% by June 2015. Improvements were seen in thirteen of the 14 regions. Thirteen out of 35 facilities met the aim of 0 handwritten/verbal orders, with an additional 16 facilities seeing an improvement. Alignment with funding mechanisms, an early physician engagement strategy, and education of key stakeholders on CPOE systems were identified as key enablers to implementation. Conclusions: Though the goal of zero handwritten/verbal prescriptions was not met by all facilities, the initiative encouraged a change in implementing safe prescribing practices for oral chemotherapy. Further audits will assess that the gain was sustained and that the provincial goal is achieved. This initiative is part of a larger strategy to standardize care for systemic treatment patients and promote a culture of safety in hospitals. [Table: see text]


Cancer ◽  
2010 ◽  
pp. NA-NA ◽  
Author(s):  
Saul N. Weingart ◽  
Julio Toro ◽  
Justin Spencer ◽  
Deborah Duncombe ◽  
Anne Gross ◽  
...  

2021 ◽  
Vol 17 (5) ◽  
pp. e623-e628 ◽  
Author(s):  
Veronica B. Ajewole ◽  
Oyinkansola Akindele ◽  
Uzoamaka Abajue ◽  
Okwuoma Ndulue ◽  
Jazzmin J. Marshall ◽  
...  

PURPOSE: Over the past 10 years, oral chemotherapy made up about half (45.6%) of all US Food and Drug Administration (FDA)–approved oncolytic and hematologic medications. Given the disparity in incidence and mortality rate because of certain cancers among Black Americans (BAs) in the United States, a review of BA’s representation in the clinical trials that lead to the development and FDA approval of oral chemotherapy drugs becomes imperative. The objective of this study was to evaluate the reporting of race and inclusion of BA in clinical trials that led to the approval of oral chemotherapy medications by the FDA from 2009 to 2019 in the United States. Additionally, we evaluated the inclusion of BAs in clinical trials of three cancer types with the highest disparity rates among BAs (lung, breast, and prostate). METHODS: A retrospective review of all FDA-approved oral chemotherapy drug from 2009-2019 was obtained using the FDA’s Hematology/Oncology Approvals & Safety Notifications website. Reports of racial and demographics inclusion were obtained from the clinical trials registry. RESULTS: Primary outcome: 142 clinical trials led to FDA approval of 81 oral chemotherapy agents between 2009 and 2019, among which 74 (52%) reported on at least one race and were included in our analysis. 35,933 participants were enrolled in these 74 clinical trials, among which 25,684 (71.47%), 6,061 (16.87%), 889 (2.47%), and 826 (2.30%) were White, Asian, Black, and Hispanic, respectively. BAs were also under-represented in the clinical trials of three cancer types with the highest disparity rates among this population. CONCLUSION: BAs were under-represented in clinical trials leading to FDA approval of oral chemotherapy drugs. There should be more BAs in cancer clinical trials to increase the generalizability of the results, improve outcomes, and eventually close the health disparity gap among this patient population.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 263-263
Author(s):  
Robert Harrison Hester ◽  
Lindsey Leigh Farmer ◽  
Rohit Vivek Goswamy ◽  
Natalie Chen ◽  
Sophia Seo-hyeon Lee ◽  
...  

263 Background: Barriers to safe delivery of oral chemotherapy in a safety net hospital population include lack of health insurance, delays in medication delivery, and language barriers. Baseline chart review at the Lyndon B. Johnson Hospital oncology clinic revealed sparse documentation of oral chemotherapy education and compliance. Our team conducted the present quality improvement project to improve documentation of toxicity assessment, patient education, and compliance with the oral chemotherapy agents capecitabine, palbociclib, and sorafenib by 25% from October through December 2020. Methods: A set of standardized questions designed to assess for the above domains were generated in the form of an auto-populated electronic medical record phrase ("dot phrase," see Figure 1). Using weekly timed email notifications, physicians were reminded to incorporate these questions in their documentation during clinic visits. Chart review was performed to assess usage frequency of the dot phrase. A post-intervention survey was administered to assess providers' experience with use of the dot phrase, and assess barriers to consistent documentation. Results: 41 patients over 3 months were identified as taking the oral chemotherapy drugs capecitabine (68%), palbociclib (29%) or sorafenib (3%). 63% were non-English speakers. 49% had breast cancer, 39% GI cancers, and 12% other cancers. 12% of clinic visits correctly incorporated use of the dot phrase. Education on the dosing and schedule for oral chemo was addressed for 48% of patients, documentation of adverse effects was performed for 34% of patients, and assessment of medication adherence was documented for 22% of patients. While 73% of providers felt that documentation of oral chemotherapy compliance is important, 70% cited failure to remember to incorporate the dot phrase in real time as the primary reason for failure to use the dot phrase for oral chemotherapy documentation. Conclusions: Despite providers' view of documentation of oral chemotherapy toxicities and compliance as important, low uptake of the dot phrase was observed. The main barrier to use of the dot phrase was providers' forgetting to incorporate the dot phrase prior to and during their clinic charting. Future efforts should focus on automated reminders and regular assessments to increase compliance to this important quality domain. [Table: see text]


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7564-7564
Author(s):  
W. O. Mwanda ◽  
J. Orem ◽  
P. Fu ◽  
C. Banura ◽  
J. Kakembo ◽  
...  

7564 Background: Dose-modified chemotherapy for AR-NHL in the pre-HAART era has been shown to be equally efficacious and less myelotoxic [N Engl J Med 1997;336:1641 (mBACOD); J Clin Oncol 2001;19:2171 (mCHOP)]. In resource-constrained settings, intravenous chemotherapy and supportive care of the AIDS/cancer patient are challenging (J Natl Cancer Inst 2002;94:718). Methods: We embarked on a pilot feasibility trial of dose-modified oral chemotherapy [lomustine 50 mg/m2 D1 (C1 only); VP-16 100 mg/m2 D1–3; and cyclophosphamide/procarbazine 50 mg/m2 each D22–26 at 6-week intervals (1 cycle) for 2 cycles] in HIV-infected patients with biopsy-proven AR-NHL in East Africa. Results: A total of 52 pts (23 Uganda; 29 Kenya) were registered to study. The majority of pts were female (56%) with median age 39 yrs (range 18–64); poor PS (2 or 3) - 62%; high grade lymphoma (65%); advanced stage (III or IV) - 67%; and B symptoms (79%). At study entry median CD4 count was 207/μL and HIV-1 viral load 98,857 copies/ml. Nineteen pts (37%) had access to ARV. A total of 74.5 cycles of therapy were administered to 49 pts (median 2; range 0.5–2). The regimen was well tolerated. There were 4 episodes of febrile neutropenia and 3 treatment-related deaths (6% mortality rate). Overall objective response rate is 67% (CR/uCR 49%); median survival 8.2 months (range <1.0 to 52.5+ mos.); and 22 patients remain alive as of 10/7/05. Conclusions: Dose-modified oral chemotherapy is efficacious, has comparable outcome to that in the US in pre-HAART era, an acceptable safety profile, and is pragmatic in the resource-limited setting. Further investigation of the oral regimen vs. mCHOP is warranted. [Supported in part by NIH grants: CA83528, AI36219, CA70081, and TW00011. Bristol-Myers Squibb and Sigma Tau Pharmaceuticals provided the chemotherapy drugs for this trial.] (J. Black, PhD, formerly DCTD, NCI, Bethesda, MD, USA). No significant financial relationships to disclose.


1999 ◽  
Vol 14 (6) ◽  
pp. 14-14
Author(s):  
Peg Skelly

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