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ORDERING RELENZA
RELENZA Stockpiling FAQs
The information here is specific to your ordering and stockpiling of RELENZA. Many of your questions can be answered in the About RELENZA or other sections of this Web site.
Is there an adequate supply of RELENZA?
Is RELENZA appropriate for my employees/organization?
How much RELENZA should my organization order?
How can our employees obtain a RELENZA prescription?
Options for obtaining employee prescriptions
What are the storage requirements for RELENZA?
Where should my organization store RELENZA?
When should RELENZA be distributed to our employees?
How can I distribute RELENZA to our employees?
Distribution options
If you have questions regarding pandemic planning or need help in beginning a stockpiling program for your organization, please contact GlaxoSmithKline Pharmaceuticals Customer Relations at 1-866-475-8222, option No. 2. Orders can be faxed to 215-599-9179.
Is there an adequate supply of RELENZA?
Yes. GlaxoSmithKline is currently increasing capacity to help governments and other organizations prepare for a global flu pandemic, including investing $2 billion to conduct research and expand production capacity for both RELENZA and a pandemic vaccine. GlaxoSmithKline has added several manufacturing lines to meet current demand for RELENZA and, as a result, has already supplied significant quantities of RELENZA to meet stockpile orders, with sufficient capacity to fulfill additional orders.
Is RELENZA appropriate for my employees/organization?
It is important to consider a patient’s medical history to determine if RELENZA is appropriate for that individual. This flowchart represents GlaxoSmithKline’s decision-making process only. It is only intended for use as a reference.
Please see RELENZA Indications and Important Safety Information.
How much RELENZA should my organization order?
It’s critical that you stockpile enough antiviral to sustain your organization during the course of the pandemic. You need to consider the number of employees to cover, any family members, outside support staff and vendors, as well as the duration and number of pandemic waves that may occur. In any given geographic region, each wave could last 3 to 5 months, and a second wave could appear anywhere from 1 to 3 months after the first disappears.[37]
There is a calculation formula you can use in the How to Order RELENZA section of this site. Also consider the following questions when deciding how much RELENZA to order:
Next, choose employee coverage options and determine quantities for specific departments:
- Entire organization
- Senior employees
- Essential employees to business continuity
- Public representative employees
Then consider which, if any, outside stakeholders may qualify for coverage and determine necessary quantities:
- Employee’s family
- Contractors
- Vital suppliers
- Community affiliates
- Employer retirees
It is important to consider a patient’s medical history to determine if RELENZA is appropriate for that individual.
How can our employees obtain a RELENZA prescription?
Prescriptions for RELENZA can be obtained from:
- Primary care physician
- Employee health center
Remind your employees that RELENZA is available through prescription only and that they need to consult their healthcare provider to determine if RELENZA is an appropriate medicine for them.
Options for obtaining employee prescriptions:
- Primary healthcare provider completes screening questionnaire with individual patient, collects additional history, conducts a physical exam, and notifies your organization of preferred antiviral option
- Appropriate healthcare provider (nurse, pharmacist, or physician) completes screening questionnaire with individual, collects additional history, and conducts a physical exam
- An appropriate healthcare provider reviews only those screening questionnaires with potential concerns and collects additional history and physical exam information if needed
- Prescribing done on large, organization-specific sites used as prescribing “hubs” for site-based employees and dependents, plus nearby nonsite-based persons. Portion of site is used for program that provides easy access and security controls
- “Mobile” prescribing clinics move between locations (eg, regional sales offices or rented space) and prescribe in convenient locations for dispersed employee groups
What are the storage requirements for RELENZA?
RELENZA should be stored at a room temperature of 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C). Keep out of reach of children. Do not puncture any RELENZA ROTADISK® blister until taking a dose using the DISKHALER®. Product shelf life: 5 years.[38]
For storage guidelines of US Pharmacopeia, click here.
Where should my organization store RELENZA?
When deciding where to store RELENZA, ensure that all recommended storage requirements are met. Consider some of these storage suggestions:
- Organization health clinic
- Physician’s office
- Retail pharmacy
- Community health clinic
- Distributors
- Mail pharmacy
Note: Investigate other options that may exist for your organization. Once a location is chosen, practice the following guidelines for maintaining the storage locations:
- Include DEA number on all boxes
- Keep a controlled substance registration on file
- Follow RELENZA product storage guidelines
- Follow US Pharmacopeia storage guidelines
- Provide adequate space to meet quantity and pandemic plan demands
To keep track of orders and storage, download the Antiviral Stock Control Spread Sheet.
When should RELENZA be distributed to our employees?
A thorough discussion of the preferred option for timing of distribution and use of antivirals should be agreed upon and documented. Many options are available; some include:
- Distribution upon receiving RELENZA product
- When public health officials declare a specified pandemic phase as referred to by the World Health Organization. Click here for more information
- When predetermined events occur as outlined in your pandemic plan
Click here for the World Health Organization’s sample Timeline of Actions by Pandemic Phase.
How can I distribute RELENZA to our employees?
Every organization should have its own plan regarding distribution. Consider all the logistics and challenges that need to be met to ensure your employees receive their assigned doses. During your organization’s pandemic planning phase, determine how you would coordinate the distribution of RELENZA from the storage location to your employees. Be sure to share this plan with your distributors and storage facility as well.
Distribution options:
- Distributed on organization sites in person at time of visit with healthcare provider in Phase 5 (or Phase 4 if approved)
- Distributed by pharmacy benefit manager or other third party after patient evaluation and prescription
- Distributed by mail or courier directly from organization stockpile/warehouse via standard channels after patient evaluation and prescription
- Distributed directly by primary care providers or other nonorganization healthcare providers
Note: RELENZA is available through prescription only. You need to consult a healthcare provider to determine if RELENZA is appropriate for those you want covered.
next:
How to Order RELENZA
Important Safety Information About RELENZA
RELENZA IS NOT RECOMMENDED FOR TREATMENT OR PROPHYLAXIS OF INFLUENZA IN INDIVIDUALS WITH UNDERLYING AIRWAY DISEASE (SUCH AS ASTHMA OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE).
- Serious cases of bronchospasm, including fatalities, have been reported during treatment with RELENZA in patients with and without underlying airway disease. Many of these cases were reported during postmarketing, and causality was difficult to assess
- RELENZA SHOULD BE DISCONTINUED IN ANY PATIENT WHO DEVELOPS BRONCHOSPASM OR DECLINE IN RESPIRATORY FUNCTION; immediate treatment and hospitalization may be required
- Safety and efficacy have not been demonstrated in patients with high-risk underlying medical conditions
- Patients should be instructed in the use of the delivery system. Instructions should include a demonstration whenever possible
- If treatment with RELENZA is considered for a patient with underlying airway disease, the potential risks and benefits should be carefully weighed. If a decision is made to prescribe RELENZA for such a patient, this should be done only under conditions of careful monitoring of respiratory function, close observation, and appropriate supportive care including availability of fast-acting bronchodilators
- Common adverse events in treatment and prophylaxis studies with RELENZA were nausea, diarrhea, sinusitis, viral respiratory infections, headaches, nasal signs and symptoms. The incidence of these adverse events was similar in both groups for RELENZA and placebo-treated groups
- Please see complete Prescribing Information for RELENZA
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