Disclosures, Disclaimers and Important Information
Important information about our pharmacogenetic testing services
Clinical Validity Disclaimers
Personalized Prescribing Inc. (PPI) provides medication recommendations based on gene-drug interactions that have been validated by international pharmacogenetics consortia, including the Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Dutch Pharmacogenetics Working Group (DPWG).
Where gene-drug interactions have not been fully validated by these organizations, information is shared with clear disclaimers and is provided exclusively to healthcare providers for their professional consideration.
The clinical validity of pharmacogenetic testing continues to evolve as new research emerges. PPI is committed to updating its testing protocols and recommendations as new evidence becomes available from peer-reviewed scientific literature and regulatory bodies.
Limitations of Pharmacogenetic Testing
It is important that patients and healthcare providers understand the following limitations:
- Pharmacogenetic testing analyzes specific genetic variants and does not represent a comprehensive analysis of all possible genetic factors that may influence drug response.
- Genetic information is only one factor that influences an individual's response to medication. Environmental factors, drug-drug interactions, age, weight, organ function, diet, and co-existing medical conditions also play significant roles.
- Test results do not guarantee the efficacy or safety of any particular medication for an individual patient.
- Rare or novel genetic variants may not be detected by current testing methodologies.
- The absence of a known pharmacogenetic interaction does not preclude the possibility of an adverse drug reaction.
- Pharmacogenetic testing does not diagnose, prevent, or treat any disease or medical condition.
Healthcare Professional Interpretation
All pharmacogenetic test results produced by Personalized Prescribing Inc. are intended to be interpreted by qualified healthcare professionals. Results should be considered within the broader clinical context of the individual patient, including their medical history, current medications, and overall health status.
PPI assigns an expert psychopharmacist to each patient to provide professional interpretation of results and recommendations. However, all final treatment decisions remain the responsibility of the patient's treating healthcare provider.
Healthcare providers are encouraged to contact Personalized Prescribing Inc. directly if they have questions about the interpretation or application of test results for their patients.
Not a Substitute for Medical Advice
The information and services provided by Personalized Prescribing Inc. are intended for informational and educational purposes only and are not a substitute for professional medical advice, diagnosis, or treatment.
Patients should always seek the advice of their physician or other qualified healthcare provider with any questions they may have regarding a medical condition or treatment. Patients should never disregard professional medical advice or delay in seeking it because of information obtained through pharmacogenetic testing.
If you think you may have a medical emergency, call your doctor, go to the emergency department, or call emergency services immediately.
Regulatory and Compliance Information
Pharmacogenetic testing performed by Personalized Prescribing Inc. is conducted by CAP-accredited and CLIA-certified laboratories in accordance with established quality management standards.
PPI operates in compliance with applicable Canadian federal and provincial regulations, including the Personal Information Protection and Electronic Documents Act (PIPEDA) and Canada's Genetic Non-Discrimination Act (2017).
Pharmacogenetic testing services provided by PPI have not been evaluated or approved by Health Canada as a medical device. The test is offered as a laboratory-developed test under the clinical laboratory's regulatory framework.
Limitation of Liability
To the fullest extent permitted by applicable law, Personalized Prescribing Inc. shall not be liable for any direct, indirect, incidental, special, consequential, or punitive damages arising out of or relating to the use of pharmacogenetic testing services or the reliance on test results.
This includes, but is not limited to, damages for loss of profits, goodwill, use, data, or other intangible losses, even if PPI has been advised of the possibility of such damages.
Intellectual Property
All proprietary algorithms, testing methodologies, report formats, and analytical processes used by Personalized Prescribing Inc. are protected by intellectual property laws. No part of the testing process, report content, or analytical methodology may be reproduced, distributed, or transmitted in any form without the prior written consent of PPI.
Contact Information
For questions or concerns regarding these disclosures, please contact:
Personalized Prescribing Inc.
175 West Beaver Creek Road Unit 24
Richmond Hill, ON L4B3M1
Phone: 1-844-943-0210
Email: info@personalizedprescribing.com