Well, influenza season is officially upon us. Our institution has been participating in a multi-centered GlaxoSmithKline (GSK) study looking at pharmacokinetics and efficacy of IV zanamivir for severe influenza virus in pediatric patients, which was very helpful last year during the influenza season. It appears that everyone had "good" recruitment last year, so only a limited number of age groups are still open for the study.
Fortunately, GSK has announced that compassionate use IV zanamivir will be available to patients with severe influenza who do not qualify for the GSK-sponsored study. Unfortunately, that means that IV zanamivir will have to be obtained under an emergency investigational new drug (EIND) application... Which we all know, will occur on a Friday afternoon and all hell breaks loose. If you happen to have a nice ID pharmacist on your team, that usually means he/she will be stuck doing the application. (Hopefully I don't sound too bitter from too many EIND encounters.)
To combat this issue, we are planning on obtaining an overall institutional review board (IRB) approval for expanded access. This may only eliminate one step in the whole process, but for us, often seems to be the most rate-limited step in an EIND. GSK was very helpful in that they were willing to provide a copy of the Physician Document Guide which helped us in writing our informed consent.
We've also developed a step-by-step guide/checklist for our ID physicians as to standardize their process and to ensure everything is completed.
We've also developed a step-by-step guide/checklist for our ID physicians as to standardize their process and to ensure everything is completed.
Hopefully this is helpful to someone!
Step-by-Step Guide:
Expanded Access for IV Zanamivir for Patients with Severe Influenza Illness
1. Consider obtaining IRB approval for multiple use
- Advantages:
- Streamlines the first step of emergency IV zanamivir use (won’t have to fill out IRB paperwork multiple times, informed consent form already approved, won’t have to find an IRB Board Member on the weekend to approve)
- Also will know what to expect from the GSK paperwork and will help with standardizing approach
- Disadvantages: will have to undergo full Human Subjects Review (maybe not for all institutions)
2. Obtain Informed Consent from patient legal guardian
- Review Physician Document Guide for information to include into the Informed Consent Form
- Also obtain Informed Consent for Sharing Clinical Data with GSK (separate from your institutional Informed Consent)
3. Contact Investigational Drug Services to inform them that someone may qualify for the study
- As a pharmacist, it would be nice to do this early as to avoid surprises and to streamline receipt of medication, preparation, etc.
4. Contact the GlaxoSmithKline (GSK) Clinical Support Help Desk (CSHD)
- Call: 1-877-221-2913
- Other (Option 4)
- Other (Option 6)
- Talk with an agent of GSK to obtain the compassionate use information (will need your e-mail and a contact number)
5. CSHD will provide an information package that contains the following (4 items):
- 1. GSK Zanamivir Aqueous Solution: Compassionate Use Treatment Request Documents (PDF file)
- 2. Physician Document Guide (DOCX file)
- i. Somewhere in this document, you can find the GSK Informed Consent for Sharing Clinical Data
- 3. Patient Medication Request Form (DOCX file)
- 4. Request for Additional Treatment Form (DOCX file)
- Required paperwork to submit to FDA (4 articles):
- 1. Filled out Patient Medication Request Form (from GSK)
- The “EIND Number” and “Name of Person Granting the EIND” will initially be blank
- 2. Form 1571
- 3. Form 1572
- 4. Your CV as the sponsor-investigator (for completion of Form 1572)
- Submit the paperwork
- If during business hours (8:00AM – 4:30PM EST, Monday – Friday), you can submit via
- i. E-mail: DAVPEINDREQUEST@fda.hhs.gov OR
- ii. Fax: 301-796-9883
- Call 301-796-1500 to notify someone that you submitted by fax
- c. If after business hours (weekdays after 4:30PM EST, weekends, or holidays)
- Call FDA Emergency Coordinator at 1-866-300-4374 or 301-796-8240 to facilitate or grant the EIND request
- NOTE: You may not receive an EIND if obtained after hours. Provide the manufacturer the name of the person who granted/authorized the EIND for release of the drug.
- Remember to provide contact information (e-mail, phone number, pager) if questions arise!
7. After obtaining EIND or the name of the person granting the EIND, send the Patient Medication Request Form to GSK CSHD at gskclinicalsupportHD@gsk.com or by fax (see information packet for fax number)
- Remember to provide your contact information (e-mail, phone number, pager) if questions arise! GSK will contact you to correct the forms if necessary.
- Provide an address/contact person to send IV zanamivir
- GSK will provide and estimated time of arrival
- Coordinate with institutional Investigational Drug Services (also a reason to contact early so they'll know it is coming)
8. Follow-up for FDA EIND Submission (Part 1 of 2)
- Part 1: Mail original FDA paperwork that was e-mailed/faxed to the Division of Antiviral Products to the following address:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Antiviral Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
9. If additional treatment is required, submit the “Request for Additional Treatment Form” to gskclinicalsupportHD@gsk.com
10. Follow-up patient and complete Case Report Form (will be provided by GSK after submission of Patient Medication Request Form)
- It appears that physical exams are not specifically requested by GSK, but GSK requests information regarding adverse drug events (non-severe and severe) that may be related to the medication and not necessarily due to disease progress (review Physician Document Guide for specifics)
- Submit to gskzanamivircup@ppdi.com
11. Follow-up for FDA EIND Submission (Part 2 of 2)
- At the completion of treatment or if the patient dies, submit a request to withdraw the EIND along with the FDA Form 1571 to the following address:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Antiviral Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
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