An assessment of pharmaceutical inspection reports from nursing and residential homes for the elderly in Northern Ireland

Objectives To highlight issues currently being inspected in nursing, residential and dual‐registered homes (care homes) for the elderly in Northern Ireland as part of a pharmaceutical inspection. Methods A cross‐sectional survey and analysis of reports from pharmaceutical inspections in Northern Ireland care homes between January 1999 and December 2000 was undertaken, using reports provided by the four Registration and Inspection Units (R & I Units 1–4) within the region. Reports were reviewed and all recommendations made by inspectors were classified into 11 main categories. Binary logistic regression was used to examine possible relationships between the type of home (nursing, residential or dual‐registered) or the R & I unit and the recommendations made by the inspectors, with corresponding odds ratios and 95% confidence intervals. Key findings Reports from 415 homes (one report per home) formed the final sample for analysis. Each R & I unit used different documentation to conduct a pharmaceutical inspection. Homes received the majority of recommendations from inspectors in the categories ‘Records’ (66.7% of all homes), ‘Policies and protocols’ (39.3%) and ‘Medication’ (31.8%). More recommendations in a number of categories emanated from R & I unit 4 compared with R & I unit 1 (referent). Dual‐registered homes (those registered as a nursing and residential facility) were more likely to receive a recommendation in the categories ‘Storage of medicine’, ‘Order and receipt of medication’ and ‘Equipment’ than nursing or residential homes. Conclusion Inspections of care homes should be standardised in terms of documentation used and facilities should be given guidance on issues that are likely to result in recommendations from inspectors. In the longer‐term, pharmaceutical inspections should move from a focus on structure/process measures to those that emphasise quality in prescribing.     

Treatment of human tumor xenografts with monoclonal antibody 806 in combination with a prototypical epidermal growth factor receptor-specific antibody generates enhanced antitumor activity.

Monoclonal antibody (mAb) 806 is a novel epidermal growth factor receptor (EGFR) antibody with significant antitumor activity that recognizes a mutant EGFR commonly expressed in glioma known as delta2-7 EGFR (de2-7 EGFR or EGFRvIII) and a subset of the wild-type (wt) EGFR found in cells that overexpress the receptor. We have used two human xenograft mouse models to examine the efficacy of mAb 806 in combination with mAb 528, a prototypical anti-EGFR antibody with similar specificity to cetuximab. Treatment of nude mice, bearing s.c. or i.c. tumor human xenografts expressing the wt or de2-7 EGFR, with mAbs 806 and 528 in combination resulted in additive and in some cases synergistic, antitumor activity. Interestingly, mAb 528 was also effective against xenografts expressing the ligand independent de2-7 EGFR when used as a single agent, showing that its antitumor activity is not merely mediated through inhibition of ligand binding. When used as single agents, neither mAbs 806 or 528 induced down-regulation of the de2-7 EGFR either in vitro or in vivo. In contrast, the combination of antibodies produced a rapid and dramatic decrease in the total cell surface de2-7 EGFR both in vitro and in xenografts. Consistent with this decrease in total cell surface de2-7 EGFR, we observed up-regulation of the cell cycle inhibitor p27(KIP1) and a decrease in tumor cell proliferation as measured by Ki-67 immunostaining when the antibodies were used in combination in vivo. Thus, mAb 806 can synergize with other EGFR-specific antibodies thereby providing a rationale for its translation into the clinic.     

Uterine carcinosarcomas and grade 3 endometrioid cancers: evidence for distinct tumor behavior

OBJECTIVE: To compare the clinical behavior and outcome of uterine carcinosarcomas and grade 3 endometrioid carcinomas. METHODS: Data on patients with grade 3 endometrioid adenocarcinomas and uterine carcinosarcomas, from 1988 to 2004, was obtained from the Surveillance, Epidemiology, and End Results database. Mortality was analyzed using Cox proportional hazards models. Survival analysis was performed with the Kaplan-Meier method and log rank test. RESULTS: The cohort included 8,986 women with 5,024 (56%) grade 3 endometrioid carcinomas and 3,962 (44%) uterine carcinosarcomas. Women with uterine carcinosarcomas were older (aged 70 years compared with 66 years; P<.001) and more often nonwhite (23% compared with 15%; P<.001). These women presented with more advanced disease (stage III/IV 41% compared with 31%; P<.001). Multivariable analysis demonstrated that uterine carcinosarcoma histology, advanced age, nonwhite race, and advanced stage were independent predictors of poor survival. Cancer-specific mortality was 45% lower in women with grade 3 endometrioid carcinomas (hazard ratio 0.55; 95% confidence interval [CI] 0.5-0.6). The 5-year cancer-specific survival was lower for women with uterine carcinosarcoma for each disease stage. Survival for stage IC was 38% (95% CI 33-45%) for uterine carcinosarcoma compared with 68% (95% CI 63-73%) for grade 3 endometrioid carcinoma. For stage III, survival was 22% (95% CI 19-26%) for uterine carcinosarcoma compared with 45% (95% CI 41-49%) for grade 3 endometrioid carcinoma. CONCLUSION: Carcinosarcomas present at more advanced stage and have worse survival than grade 3 endometrioid carcinomas. Carcinosarcomas may represent a distinct biologic entity. LEVEL OF EVIDENCE: II.     

Creating opportunities for patient participation in managing medications across transitions of care through formal and informal modes of communication

BackgroundCommunicating about medications across transitions of care is important in older patients who frequently move between health care settings. While there is increasing interest in understanding patient communication across transitions of care, little is known about older patients'' involvement in formal and informal modes of communication regarding managing medications.ObjectiveThe aim of this paper was to explore how older patients participated in managing their medications across transitions of care through formal and informal modes of communication.MethodsThe study was conducted across two metropolitan hospitals: an acute hospital and a geriatric rehabilitation hospital in metropolitan Melbourne, Australia. A focused ethnographic design was used involving semi‐structured interviews (n = 50), observations (203 h) and individual interviews or focus groups (n = 25). Following thematic analysis, data were analysed using Fairclough''s Critical Discourse Analysis.ResultsData analysis revealed two major discursive practices, which comprised of an interplay between formal and informal communication and environmental influences on formal and informal communication. Self‐created patient notes were used by older patients to initiate informal discussion with health professionals about medication decisions, which challenged traditional unequal power relations between health professionals and patients. Formal prompts on electronic medication administration records facilitated the continuous information discourse about patients'' medications across transitions of care and encouraged health professionals to seek out older patients'' preferences through informal bedside interactions. Environmental influences on communication comprised health professionals'' physical movements across private and public spaces in the ward, their distance from older patients at the bedside and utilization of the computer systems during patient encounters.ConclusionOlder patients'' self‐created medication notes enabled them to take on a more active role in formal and informal medication communication across transitions of care. Older patients and family members did not have continuous access to information about medication changes during their hospital stay and systems often failed to address older patients'' key concerns about their medications, which hindered their active involvement in formal and informal communication.Patient or Public ContributionOlder adults, family members and health professionals volunteered to be interviewed and observed.     

The consequences of risk reducing salpingo-oophorectomy: the case for a coordinated approach to long-term follow up post surgical menopause

Women with germline mutations in BRCA1 and BRCA2 genes have significantly increased lifetime risks of breast and ovarian cancer. To manage both the ovarian and breast cancer risks the current recommendation is undergo a risk reducing salpingo-oophorectomy (RRSO) prior to natural menopause. To date, studies have focussed on quality of life and sexual dysfunction in women who undergo RRSO, but few have reported on the wider physical consequences. We performed a questionnaire study in women with BRCA 1 or 2 gene mutations known to the Peter MacCallum Familial Cancer Centre. We gathered information about ovarian surgery, ongoing follow-up, management of risk factors including osteoporosis, and current severity of menopausal symptoms. Two hundred and nineteen women were surveyed. One hundred and forty-three of 157 responding participants (91?%) reported having RRSO. Sixty one were pre-menopausal at RRSO. Post surgical follow-up rates were generally low, and a minority of women reported recent bone density imaging or pharmaceutical prevention or treatment of osteoporosis. Menopausal symptoms appeared generally mild. No significant differences in symptom severity were observed in women who underwent a pre-menopausal RRSO compared to RRSO after natural menopause. These data indicate that a formalised follow-up protocol is necessary to optimally manage the consequences of a RRSO.     

Management of diabetes in primary care: A structured-care approach

Background: In the Irish Midland Health Service Executive (HSE) Diabetes Structured Care Project, additional resources were targeted at general practice in the absence of a local hospital-based specialized diabetes unit. Objective: We assessed the performance of the Midland HSE Diabetes Structured Care programme in 2003, bench-marked against Primary Care Trust (PCT) data from the 2003/2004 National Diabetes Audit for England. Methods: Data on 947 patients (72% of eligible patients) from all 20 general practices participating in the structured-care programme were collected retrospectively over a 12-month period. The data included demographic and clinical variables as well as key process-of-care and intermediate outcome indicators used in the National Diabetes Audit for England. Results: The level of recording of process-of-care measures was near or above the upper quartile for PCTs in England. The proportion of patients with HbA_1c concentrations at target levels (<6.5%) in the Midlands HSE project (26.8%) was virtually identical to the upper quartile level for PCTs in England (27.4%). The proportion of patients reaching target total cholesterol levels (<5.0 mmol/l) (54.6%) was close to the mean for PCTs in England (56.6%), and performance with regard to target blood pressure levels was equally poor in both the Midlands HSE (18.0%) and in PCTs in England (20.8%).

Conclusion: Primary-care-led structured care, with relatively limited but well-focused investment, can achieve quality of care for patients with diabetes, comparable to international best practice.