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Keytruda Patient
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To ensure patient confidentiality is maintained, all correspondence must refer to the Unique Patient Code only for the purposes of administrating this request.
1. I confirm that I have the experience in the treatment of cancer with systemic therapy inclusive of chemotherapy and/or other anti-cancer treatment modalities.
2. I have read and understood the approved indications of KEYTRUDA® as set out in the KEYTRUDA® local prescribing information/product circular which contains information on adverse reactions reported from the use of KEYTRUDA® in clinical trials and provides guidance on the management of immune-mediated adverse reactions.
3. I confirm that I accept full responsibility for and shall take all steps to maintain appropriate records and ensure appropriate prescription and usage of KEYTRUDA® in accordance with any applicable laws and regulations, the local prescribing information/product circular and this Patient Access Program Enrolment Form.
4. I confirm that I accept full legal liability and responsibility for the use of KEYTRUDA® for patients under my care.
I, the prescribing Physician confirm that I am a specialist in the therapeutic area in the indication in which I am prescribing the product. I have experience in prescribing and managing Immuno-Oncology therapies.
I acknowledge that MSD India may collect, record, and use personal information of the physician and pharmacist and any other persons who contact MSD in relation to this program, for the purposes of this program including by way of electronic messages. If I choose not to provide MSD with my personal information, MSD may not be able to fulfill these purposes. MSD will keep this personal information for the purposes of managing this program and I agree that MSD may retain this information indefinitely. MSD may disclose the personal information to organizations that assist MSD and MSD affiliated companies (which may be in other countries including United States, United Kingdom, and India). I am aware about MSD privacy policy, including how to access and seek correction of the personal information MSD holds about anyone who contacted MSD about this program, how to complain about a breach and how MSD handles such complaints. I can visit the link https://www.msdprivacy.com/in/en/index.html. I being treating physician am responsible to ensure the patient, any physician; pharmacist and any other persons who contact MSD in relation to this program have been informed of this privacy statement and are in agreement.
By providing my contact details, I also consent for MSD to contact me for follow-up information if a safety report is identified. I agree that MSD can contact me via email or telephone to seek further information regarding adverse events.
By completing this form, I warrant that I have obtained the consent of my patient, associated pharmacist or any other persons relating to this request to forward their personal information to MSD, and to Keytruda® patient access program center (Medybiz Pharma Pvt Ltd) or affiliated companies that assist MSD, on their behalf and that their information will be treated the same as outlined above.
I acknowledge that MSD reserves the right to change the terms and conditions of this program at any time.
I understand that this is a patient centric program. MSD will consider each request on an individual 'case by case' basis. The decision to approve a patient enrolment is at the discretion of MSD and this decision will be final.
I understand that I can seek Information about this product which can be found on the latest local Product Circular.
I agree that treatment duration is at the discretion of the prescribing physician.
“I agree to ensure that if I become aware of an adverse event (AE) or product quality complaint following the use of an adverse effect which is attributed to a MSD product, or patients who become pregnant or are lactating whilst taking a MSD product this must be reported to MSD India within 1 business day (by Fax No. - +91-124-4647339, Contact No. - +91-124-4647300, Toll-Free no. - 18001032642 and Email ID - dpoc_india@merck.com). I have noted that AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to this medicinal product. A product quality complaint is any communication that describes a potential defect related to the identity, strength, quality, or purity of a product after it is released/distributed for use by a customer. I agree that MSD can send an email reminder for a reconciliation process that will be carried out on a three-monthly basis for this program. MSD can send a listing of the reports (all adverse events and product quality complaint reports) received from my clinic/hospital over the past three months and request my verification that this is accurate record. Subsequent action may be required if it is found that there are discrepancies and MSD will communicate further about that if & when the discrepancy arises.
If desired, I can obtain from MSD an adverse event training module on how to report AEs and PQC.
All information disclosed within the context of this KEYTRUDA® Patient Access Program shall be treated as confidential by me and shall only be used for the purpose of this Patient Access Program. I will only disclose such information to relevant authorized parties, only under an appropriate obligation of confidentiality.
I have informed the patient and received the patient's consent/assent as a part of this Patient Access Program.
I have informed the patient, and any other persons pertaining to this program including but not limited to the prescribing physician, associated pharmacist and relevant parties, that the personal data, including sensitive personal data such as health data and information collected about him/her in relation to product treatment for this program may be provided to MSD in order to implement this program for the patient, for MSD to obtain safety reporting and, in respect of certain limited personal data, for MSD to comply with its own safety reporting obligations. I have also informed the patient that his/her personal data including sensitive personal data may be reported to regulatory authorities if required by law. The patient and any other persons pertaining to this program including but not limited to the prescribing physician, associated pharmacist and other relevant parties, is informed that his/her personal data may be disclosed to third parties that may be located in countries outside India including United States, United Kingdom and India, which may not have data protection laws equivalent to those in India. I confirm that the patient has explicitly consented to the processing of his/her personal data as described above.
I confirm that I accept full responsibility for and shall take all steps to maintain appropriate records and ensure appropriate implementation of this program in accordance with any applicable laws and regulations and this Patient Access Program.
I will promptly notify MSD and cooperate with MSD in the event of a regulatory audit or inspection that relates to the administration of the product to the patient under this program. This includes but is not limited to the sharing of documentation, inspection reports and consultation with MSD in responses.
I will assist MSD in order to facilitate MSD's or its authorized third-party's or by representatives to examination, inspection and auditing to confirm my compliance with this Patient Access Program, including, but not limited to, providing de-identified patient records and data. I will take any action necessary, as reasonably requested by MSD, to properly correct or address any deficiencies noted.
I represent and warrant that I have not been debarred pursuant to any applicable laws or regulations. Further, there are no proceedings against me that could lead to my debarment. I agree to immediately inform MSD in writing if any such proceeding is threatened or commenced.
I agree to follow the paper version and necessary electronic step by step as and when it gets implemented and implement this Patient Access Program.