Awareness and compliance with pharmacovigilance requirements amongst UK oncology healthcare professionals.

Since 2013, once a medicine receives marketing authorisation in the European Union, it is labelled with an inverted black triangle indicating all adverse reactions should be reported. Our aim was to explore understanding of the black triangle and compliance with adverse event (AE) reporting requirements by UK oncology healthcare professionals (HCPs). A questionnaire was electronically distributed to oncology pharmacists (P) via the British Oncology Pharmacy Association, to oncologists (O) through the Association of Cancer Physicians and also to nurses (N) via the UK Oncology Nursing Society. Overall, 125 (42 O, 61 P, 22 N) clinicians participated. The purpose of the black triangle was unknown by 26% (55% O, 5% P, 28% N) and 54% did not alter their AE reporting in the presence of a black triangle. Once the black triangle was removed, only 38% were aware which AEs should be reported, 46% did not report all serious AEs for established medicines, including life-threatening or disabling AEs. Reasons for non-reporting were decision making on what to report (45%); time consumed by reporting (41%); AEs perceived as not serious enough (35%) and follow-up process (23%). Understanding of the pharmacovigilance framework among respondent groups was variable. Across all groups, AEs appear substantially under-reported. Reasons identified in the study include the time consuming nature of AE reporting and a lack of understanding around the black triangle and AE reporting process. There is a need to further support HCP education on AE reporting coupled with a review of the current reporting process to ensure maximal engagement.

Locoregional relapse after breast cancer: most relapses occur late and are not clinically detected.

There remains controversy over follow-up after breast cancer. The National Institute for Clinical Excellence (NICE) in the United Kingdom recommends 2-3 years of follow-up for the detection of locoregional relapse. Guidelines in North America advocate much longer follow up periods. Clinicians in the UK have been reluctant to implement the NICE guidelines. Previous studies report that the rate of relapse peaks in the first 3-5 years before falling off. In this study, a retrospective analysis of rate of relapse and method of detection in 198 patients treated with conservation surgery between 1995 and 2001 has been undertaken. Median follow-up was 5.9 years. Rate of relapse is essentially constant for 10 years, with most relapses occurring after 3 years. The majority of relapse in this cohort is detected by means other than routine clinical examination, with only 16.66% of relapse detected this way. The guidelines for follow-up in the UK need revision. If follow-up is to be provided, this needs to continue for at least 10 years, if not beyond. This study casts doubt on the value of routine clinical examination.

Patients' expectations for follow-up in breast cancer--a preliminary, questionnaire-based study.

The current National Institute for Clinical Excellence (NICE) guidelines recommends that only 2-3 years of follow-up after breast cancer be provided. Clinicians are unwilling to implement these guidelines. However, little has been done to establish patients expectations before they embark on their regular follow-up programme. We have sought the opinions of patients in a questionnaire-based prospective cohort study. Expectations for length and frequency of follow-up were established in women prior to attending their first scheduled follow-up review 1 year after treatment. In addition, patients were asked their opinions on what clinics were designed to achieve. An attempt was made to establish whether patients would be happy with less follow-up when informed of the inefficiency of routine clinic visits. Most women expect some follow-up, but expectations for length and frequency vary dramatically. Most believe follow-up is for the detection of relapse, but very few see psychological support or side effect detection as being central to clinicians' aims. One third of women would be happy to not come back to clinic at all when told how infrequently routine clinical examination detects metastatic disease.

Rhabdomyosarcoma relapse in an unusual site.

Lower genitourinary tract rhabdomyosarcoma is the most common soft tissue sarcoma in children. Recurrence is common but usually occurs at the original site. A case of a young boy with recurrent rhabdomyosarcoma at an unusual site (glans penis) is presented.