The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites.

Technology enabling drug serialisation technology was introduced by regulators to enhance security in pharmaceutical supply chain and protect drugs from infiltration by falsified and substandard medicines. The introduction of systems for serialisation required huge financial outlays manufacturers of pharmaceuticals. This study investigated the impact of serialisation on the operational efficiency and productivity in Irish pharmaceutical sites. A qualitative study was conducted with 11 manufacturing sites in Ireland. The participating companies operated a total of 114 pack-lines, representing approximately 65% of the automated packing lines in the country. The study found that serialisation had a negative effect on packaging production line OEE and line availability and on the individuals cost per unit of packaged pharmaceuticals. The research results estimated that the capital costs of serialisation were four times greater than those estimated by the regulators. There was a 4.1 cents average cost per pack for serialisation with high volume sites reporting an annual cost of serialisation of up to €4.5 m per annum and a 2.7% increase in the average cost of goods sold. A pattern whereby where many pharmaceutical manufacturers are transitioning from smaller batch production and moving toward larger batch production sizes in order to increases efficiencies was identified. The research also proposed the use of a serialisation depreciation factor as a method to determine the impact of serialisation on the cost of goods sold. This is the first study of its kind into the cost of serialisation from a manufacturer's viewpoint and studying the effects of serialisation on productivity, line availability and operational efficiency.

A randomized open comparison of long-acting injectable risperidone and treatment as usual for prevention of relapse, rehospitalization, and urgent care referral in community-treated patients with rapid cycling bipolar disorder.

OBJECTIVE: To compare adjunctive long-acting injectable risperidone plus treatment as usual (RLAI+TAU) versus TAU alone for relapse, rehospitalization, and urgent care events in patients with bipolar disorder in routine care settings. METHODS: This was a 12-month randomized open comparison of RLAI+TAU (n = 20) and TAU alone (n = 25) in adults with rapid cycling, Mini International Neuropsychiatric Interview-confirmed bipolar I/II disorder and 4 or more illness relapses in the preceding 12 months. Clinical outcome was assessed every 2 weeks using the Longitudinal Interval Follow-up Evaluation instrument. Psychopathology and quality of life were assessed monthly using the Young Mania Rating Scale, Montgomery-Asberg Depression Rating Scale, Quick Inventory of Depressive Symptoms-Self Report 16 and Quality of Life, Enjoyment, and Satisfaction Questionnaire. Relapse was defined using symptom severity, necessary clinical adjustment of medications, and urgent care referrals. Relapse rates and duration were calculated per person per year of follow-up. All treatments were provided by community-based clinicians. RESULTS: There were no significant between-groups differences in the total number or duration of relapse events (any cause) or in the number of manic or depressive relapses. Thirteen of 14 urgent care events (hospitalization, emergency department visit, intensive outpatient, or respite care referral) occurred with TAU alone (92.3%). Urgent care referral (P < 0.04) and necessary medication change rates (P = 0.01) were significantly lower in the RLAI+TAU group. There were no significant between-groups differences in the duration of follow-up, hospitalization rates, or psychopathology over time. CONCLUSIONS: Rates of any-cause relapse may not differ significantly between RLAI+TAU and TAU alone; however, RLAI may reduce the need for urgent care referrals or the frequency of medication adjustments to prevent relapse in community-treated patients with rapid cycling bipolar disorder. Additional investigation is warranted.

A randomized, double-blind, sham-controlled trial comparing two screening devices for radiation contamination.

OBJECTIVES: This exploratory study compared the screening ability of a newly introduced radiation detection portal with a traditional Geiger counter for detection of radiation contamination in the setting of a mass casualty training exercise. METHODS: Following a pretrial evaluation of interobserver reliability for Geiger counter use, 30 volunteers were randomly assigned to don gowns containing three disks, each of which was either a sham resembling the radioactive samples or an actual cesium-137 sample; each subject participated a minimum of four times with different gowns each time. Each subject underwent standard radioactivity screening with the Geiger counter and the portal. RESULTS: Interobserver reliability was excellent between the two Geiger counter screeners in the pretrial exercise, correctly identifying 101 of 102 sham and radioactive samples (κ = 0.98; 95% confidence interval [CI] = 0.94 to 1.00). For radioactively labeled subjects across all bodily locations, the portal (43/61, or 70.5%; 95% CI = 58.1% to 80.5%) was less sensitive than the Geiger counter screening (61/61, or 100%; 95% CI = 92.9% to 100%), which resulted in a portal false-negative rate of 29.5%. For radiation detection in the posterior thorax, the portal radiation screening (4/19, or 21.1%; 95% CI = 8% to 43.9%) was less accurate than the Geiger counter (19/19, or 100%; 95% CI 80.2% to 100%). In contrast, there were no major differences between the portal and the Geiger counter for radiation detection at the left shoulder, right shoulder, or sham (nonradiation) detection. There were no false-positive detections of the sham-labeled subjects for either device, yielding a specificity of 100% for both screening modalities. CONCLUSIONS: Geiger counter screening was more sensitive than, and equally specific to, radiation detection portal screening in detecting radioactively labeled subjects during a radiation mass casualty drill.

Creating isolation surge capacity.

This article describes how a five-hospital, 800-bed, health system developed a plan to convert existing space into isolation surge capacity, using commercially available equipment and consultative technical expertise, financed by a government grant.