Roche Releases New Pandemic Planning Guide for U.S.-Based Businesses; On-Line Toolkit Designed to Help Navigate Key Issues, Aid Decision-Making
Posted on: Monday, 17 July 2006, 12:00 CDT
Roche today released a comprehensive guide to help facilitate pandemic influenza planning among U.S.-based businesses, many of which are not yet fully prepared for the potential public health crisis and its impact on their organizations, according to several recent surveys. The new, 70-page on-line Toolkit (www.PandemicToolkit.com) provides information and practical advice in response to questions posed by business managers about the avian flu threat in general, and the role of antivirals, in particular. Roche manufactures Tamiflu(R) (oseltamivir phosphate), the only oral antiviral medication that has shown activity in vitro and in animal studies against the H5N1 strain of bird flu, which experts fear could cause a global influenza pandemic.
According to the U.S. Department of Health and Human Services (HHS), in the event of a pandemic, businesses will play a key role in protecting employees' health and safety as well as limiting the negative impact to the economy and society.(1) The Federal Government's implementation plan emphasizes the role of the private sector in preparedness, noting that because the private sector owns and maintains approximately 85 percent of the U.S. critical infrastructure, it is imperative that plans include procedures to mitigate the potential disruptions caused by an influenza pandemic.(2)
"Through formal research and discussions with American business leaders in various sectors, Roche has identified knowledge gaps in how to prepare the best corporate response plans," said George Abercrombie, President and CEO, Hoffmann-La Roche Inc. "Roche has been deeply involved in addressing the pandemic threat, not only as maker of Tamiflu, but also as a pharmaceutical company that makes life-saving medicines and employs thousands of people around the world. While every organization has special needs, we have basic knowledge and expertise that could be of significant value in creating the most effective plans."
Potential impact on organizations includes lost employee productivity (e.g., increased absenteeism), disruption in supply chains, operations and facilities shutdown, and a drop in demand for products and services (Congressional Budget Office, December 2005).
While many businesses have been grappling with these challenges, Roche has been talking with them, conducting research across various sectors (including healthcare, transportation, utility, food service, financial, retail and manufacturing) to identify not only extent of preparedness, but also questions or concerns. The feedback showed not only varying knowledge levels, but also many common questions, ranging from the likelihood of an avian flu pandemic to specific questions about Tamiflu, including its role, efficacy, supply and distribution in the U.S.
To help answer these and many other questions, Roche has compiled information, insights and practical tools like self-tests and checklists, to assist companies in decision-making. The new Toolkit provides a 'one-stop' resource, with information outlined in six major sections:
1. Influenza Background: Seasonal and Avian Flu
The Role of Tamiflu in Corporate Preparedness
While the government has not laid out specific recommendations for businesses regarding the purchase of antivirals, experts including the World Health Organization (WHO) and HHS agree that Tamiflu and other antivirals are an essential part of any plan to help control the spread of a pandemic flu virus and potentially reduce illness, hospitalizations and deaths.(3),(4)
According to Deputy Assistant Secretary for Critical Infrastructure Protection at the U.S. Treasury Department, D. Scott Parsons, "We must change the way businesses within the financial services sector think about business continuity." Testifying before a House Subcommittee on June 29th regarding pandemic planning within the financial services sector, Parsons also said, "A firm cannot simply move to back-up facilities and restore operations, because it is likely those facilities are also experiencing challenges associated with the pandemic. Contingency planning must now take into consideration efforts to mitigate the spread of influenza within the firm or a department. Among the key issues for consideration are the stockpiling of masks, gloves and antiviral agents, additional hand washing stations for employees, and identifying and isolating employees who may be sick."(5)
"Tamiflu can play a critical role in corporate preparedness strategies, such as protection of the workforce and operational continuity, but many companies don't know how to even approach the possibility of purchasing, storing and distributing prescription medications to employees in the U.S.," Abercrombie comments. "For those considering stockpiling Tamiflu, the Toolkit answers basic questions about the product, along with key considerations and practical advice, including our 7-step process for distributing Tamiflu to Roche employees."
Roche has taken extensive steps to ensure its own business continuity and continued manufacturing of Tamiflu and other life-saving medicines during a pandemic outbreak. The company-wide commitment to contingency planning, driven by top management, includes:
-- Special plans for continuing and maximizing production and distribution of Tamiflu;
-- Procedures to minimize disruption of production and supply for life-saving drugs; and
-- Extensive planning against worst-case scenarios, which will be tested in simulation exercises.
To date, Roche U.S. has received inquiries from more than 115 U.S.-based companies, large and small in a variety of industries, and orders from close to 60 companies for Tamiflu, in quantities ranging from a few hundred to hundreds of thousands of treatment courses.
The Toolkit is available at www.PandemicToolkit.com. For more information, businesses may contact Roche via phone: Pandemic Planning Hotline 888-394-2838 or email: Nutley.TAMIFLU_Inquiry@Roche.com.
Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, CA, is a systemic treatment for the most common strains of influenza (types A and B). Tamiflu is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients one year and older who have been symptomatic for no more than two days. Tamiflu is also indicated for the prophylaxis of influenza in patients one year and older.
In treatment studies in adult patients, the most frequently reported adverse events (incidence greater than 1%) were nausea and vomiting. Other events reported numerically more frequently in patients taking Tamiflu compared with placebo were bronchitis, insomnia and vertigo. In treatment studies in patients one to 12 years old, the most frequently reported adverse event (incidence greater than 1%) was vomiting. Other events reported more frequently in patients taking Tamiflu compared with placebo included abdominal pain, epistaxis, ear disorder and conjunctivitis.
In prophylaxis studies in adult patients, adverse events were similar to those seen in the treatment studies. Events reported more frequently in patients taking Tamiflu compared with placebo (incidence greater than 1%) were nausea, vomiting, diarrhea, abdominal pain, dizziness, headache and insomnia. In a household prophylaxis trial that included patients one to 12 years old, adverse events were consistent with those observed in pediatric treatment studies, with GI events being the most frequently observed.
Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population. Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.
In post-marketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu.
Vaccination is considered the first line of defense against influenza.
Tamiflu is available for the treatment of influenza in more than 80 countries worldwide.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
(3) http://www.hhs.gov/pandemicflu/plan/pdf/S07.pdf (p. 3)
(4) http://www.who.int/csr/disease/avian_influenza/avianinfluenza_ factsheetJan2006/en/index.html#clinical (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)
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