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PURPOSE: Essential cancer medicine stock outs are occurring at an increasing frequency worldwide and represent a potential barrier to delivery of standard therapy in patients with cancer in low- and middle-income countries. The objective of this study was to measure the impact of cancer medicine stock outs on delivery of optimal therapy in Botswana. METHODS: We conducted a retrospective analysis of patients with common solid tumor malignancies who received systemic cancer therapy in 2016 at Princess Marina Hospital, Gaborone, Botswana. Primary exposure was the duration of cancer medicine stock out during a treatment cycle interval, when the cancer therapy was intended to be administered. Mixed-effects univariable and multivariable logistic regression analyses were used to calculate the association of the primary exposure, with the primary outcome, suboptimal therapy delivery, defined as any dose reduction, dose delay, missed cycle, or switch in intended therapy. RESULTS: A total of 378 patients met diagnostic criteria and received systemic chemotherapy in 2016. Of these, 76% received standard regimens consisting of 1,452 cycle intervals and were included in this analysis. Paclitaxel stock out affected the highest proportion of patients. In multivariable mixed-effects logistic regression, each week of any medicine stock out (odds ratio, 1.9; 95% CI, 1.7 to 2.13; P <.001) was independently associated with an increased risk of a suboptimal therapy delivery event. CONCLUSION: Each week of cancer therapy stock out poses a substantial barrier to receipt of high-quality cancer therapy in low- and middle-income countries. A concerted effort between policymakers and cancer specialists is needed to design implementation strategies to build sustainable systems promoting a reliable supply of cancer medicines. [ABSTRACT FROM AUTHOR]

Background: Cancer drug shortages represent a complex global issue with potentially adverse survival outcomes. Up to 98% of oncologists and pharmacists surveyed in North America reported at least 1 drug shortage in the prior year and 66% reported at least one patient who had clinical care impacted by the shortage. In low- and middle-income countries (LMICs), these shortages are even more frequent. No studies to our knowledge have evaluated the impact of chemotherapy stock-out on receipt of standard cancer therapy in LMICs. Aim: Quantify the association between the duration of chemotherapy stock-out and the risk of having a suboptimal therapy delivery event, compared with standard delivery of therapy among cancer patients in Botswana. Methods: Prevalent cohort study of patients with cervical, breast, prostate, esophagus, Kaposi sarcoma, head and neck cancers, lung, uterine, ovarian and colorectal cancers who received any systemic therapy between 01/01/16-12/31/16 at Princess Marina Hospital, Botswana. Primary exposure was stock-out duration per cycle interval calculated by generating a code for the six different patterns for chemotherapy stock-out, using stock data at the Central Medical Stores. Primary outcome was suboptimal therapy delivery defined as a dose reduction, dose delay or switch in intended therapy. We measured statistical associations using two sample t -test and mixed effects univariate and multivariate logistic regression models. Results: 378 patients were identified who met diagnostic criteria and received systemic chemotherapy in 2016. Of these, 293 received commonly prescribed standard regimens who contributed 1452 cycle intervals and were included in our analysis. Majority of the patients (48%) had breast cancer. The mean duration of stock-out for receipt of standard therapy without events was 3.2 days (95% CI: 2.8-3.7) compared with 7.8 days for patients who had a suboptimal therapy delivery event (95% CI: 6.6-9) (P < 0.0001). Male sex, age < 65 and HIV-positive status were also significantly associated with an increased risk of experiencing dose reduction, change in therapy or switch in therapy. Adjusting for these factors in a mixed effects logistic regression, each week of stock-out was independently associated with an 80% increased risk of having a suboptimal therapy delivery event (OR=1.8 (95% CI: 1.6-2.0, P < 0.0001)). Conclusion: Chemotherapy stock-out is independently associated with an 80% increased risk of a patient experiencing dose reduction, change in therapy or delay in therapy. The risk increases with longer duration of stock out. Given prior data showing that these events lead to worse survival outcomes, our further analysis is focusing on quantifying risk of stock-out on survival outcomes in this population. to determine whether interventions promoting standard therapy delivery are warranted to optimize survival outcomes. [ABSTRACT FROM AUTHOR]

Objective: Cancer drug stockouts occur at high frequencies globally, however, their effects on treatment are understudied in sub-Saharan Africa (SSA). We aimed to determine whether causes of suboptimal cancer treatment prescriptions differed between periods of stockout and full treatment supply., Design: A retrospective cohort study of systemic therapy prescriptions for patients diagnosed with the twelve most common solid tumour cancers treated in 2016., Setting: Princess Marina Hospital in Gaborone, Botswana., Participants: Patients in the retrospective cohort who experienced any suboptimal treatment events, defined as ≥7 days delay or switch from guideline-concordant initiated therapy., Primary and Secondary Outcome Measures: Frequency of delays and patterns of prescription changes for specific regimens and cancer types., Results: 167/378 patients contributed to 320 suboptimal events (115 therapy switches, 167 delays and 38 events with both), over 1452 total chemotherapy cycles received. Events during stockout were 43% delays, 43% switches and 14% both during stockout periods and 67.2% delays, 24.4% switches and 8.4% both during non-stockout periods (p<0.001). Majority of switches involved de-escalation of initially prescribed guideline-recommended regimens in patients with breast cancer, Kaposi sarcoma and patients with colorectal cancer, which occurred more frequently during periods of drug stockouts. Among patients with breast cancer, substitution of docetaxel for paclitaxel event occurred exclusively during paclitaxel drug stockout. Delays of ≥7 days events were most frequent in breast cancer patients receiving paclitaxel during stockout, and combination doxorubicin and cyclophosphamide even during periods of non-stockout., Conclusions: The aetiology of suboptimal events differed during stockout and non-stockout periods. Prescription patterns that involved de-escalation of initiated therapy and substitution of paclitaxel with docetaxel occurred frequently during periods of drug stockout. Further research needs to be conducted to understand the impact of stockout on survival and barriers to maintaining essential cancer medicines supplies in SSA, and the factors driving frequent delays in therapy delivery., Competing Interests: Competing interests: SD, SG, DIS, TBR, PM, LNS and YMM have nothing to disclose. WBB reports personal fees from Genentech, outside the submitted work; Robert Gross reports grants from NIH, during the conduct of the study; personal fees from Pfizer, outside the submitted work; AD reports grants from Pfizer, grants from Novartis, grants from Genentech, grants from Calithera, outside the submitted work., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)