Informed Consent
Provided to One Tenacity
1. The Pillcheck Pharmacogenetic Testing Service
Your health is influenced by your genetics, which can also affect how you respond to medications. Two people can take the same drug but have very different reactions. Pillcheck is a pharmacogenetic service offered by One Tenacity that analyzes your genetic profile to provide insights into how you may respond to various medications. It offers personalized recommendations, helping you and your healthcare providers find the safest and most effective treatments quickly. This can lead to better health outcomes with less time spent on trial and error.
Purpose of DNA collection: The service provides a genetic test to generate your Pillcheck Report, which lists your predicted response to all Pillcheck-covered drugs. The service also includes a one-time review of your medications and genetic profile by a consulting pharmacist specializing in pharmacogenetics and medication management counselling. This is summarized in a Pharmacist Review letter you can share with your doctor.
Health information collection: You will receive a secure online account to access your Pillcheck information and results anytime. As part of the service, we ask you to fill out a Medical Profile in your Pillcheck account. This includes your basic health information, medications, vitamins and supplements. While providing this personal information is optional, it greatly assists the consulting pharmacist in delivering personalized and actionable medication recommendations tailored to you. Without the Medical Profile, your Pharmacist Review letter will be general and may not address your specific health concerns.
DNA collection: A Pillcheck DNA sample collection kit will be mailed to your address. You collect DNA by gently swabbing the inside of your mouth (cheek) with a small sponge (like a cotton swab). Then, mail your sample to the lab in the prepaid envelope provided in the kit.
DNA analysis: Pillcheck analyzes your DNA for common variations in specific genes that have been demonstrated to affect the response to or risk of drug-related complications with many prescribed medications. It is not an allergy test and does not assess immune reactions to medications. Pillcheck is not designed to provide diagnosis of a genetic disease, nor does it provide information about ancestry. Sample analysis is performed in Canada. Once the test is complete, your DNA sample is destroyed within 30 days.
Stored data: Your genetic profile will be stored in One Tenacity’s systems for the purpose of updating your Pillcheck Report to reflect the most up-to-date clinical guidelines and expanded Pillcheck drug list over time. One Tenacity will not use your DNA or personal information for any unrelated purpose without your explicit consent. All data is stored in Canada, and your genetic data is stored separately from your personal information in our encrypted systems.
Report Updates: Your report is updated periodically as new evidence for existing medications and information on new ones becomes available. We will notify you by email when your Pillcheck Report is updated. Please keep your contact information up to date.
2. Potential Risks
You should be aware of the following potential risks:
Without counselling from a licensed healthcare practitioner, some individuals may misunderstand the nature of pharmacogenetic services and misinterpret their results.
The Pillcheck service is based on current scientific knowledge of genetic variations involved in drug response. However, there may be other genetic variations potentially affecting your drug response that are not yet identified.
There may be other risks that are currently unforeseen.
3. Secure Sharing of Your Data and Consent Withdrawal
By signing this consent, you agree to allow One Tenacity and a consulting pharmacist to access your Pillcheck Report and the medical information you provided for the purpose of performing a personalized medication review.
If you were referred to us by your employer, know this is an exclusive relationship between Pillcheck and you. This consent does not include sharing personal information with your employer.
If you were referred to us by your physician, clinic, or pharmacy and use their discount code, you allow us to share your report with the referring party.
Through Pillcheck’s electronic tools, you can also grant other trusted healthcare providers secure access to your Pillcheck Report.
If at any time you decide to withdraw your consent, you may email service@pillcheck.ca to request the deletion of your health and genetic data from One Tenacity systems.
Except as expressly set forth in this Informed Consent, your personally identifying results will not be shared by Pillcheck with any third party, including your insurer or benefits provider and employer.
4. Conditions of Use and Limitations
By signing this Informed Consent, you understand that:
The Pillcheck service uses a laboratory-developed test (LDT). Similar to other LDTs used by physicians for guidance, your Pillcheck results can provide data to physicians and pharmacists that allow them to make more informed decisions about treatment optimization at their professional discretion.
Pillcheck does not provide medical advice, diagnosis or treatment and does not replace your healthcare provider. Always consult your doctor if you have any questions regarding your medical condition and before starting, stopping, or altering the dosage of any medication prescribed to you.
Medication changes and dosage recommendations provided by Pillcheck are based on current scientific knowledge. As scientists identify new genetic markers affecting drug response, another analysis may be required. The sample you submitted is not stored, and re-analysis may require additional samples.
Additional factors like diet, lifestyle, allergies, and other health conditions may affect your drug response. Pillcheck recommendations do not account for these environmental influences.
While the Pillcheck test is optimized to ensure accuracy for Canada’s ethnically diverse population, it is possible that our analyses may not capture some rare or unknown genetic variations.
The accuracy of DNA analysis depends on several factors outside the laboratory’s control, including how well you follow the cheek swab collection instructions. Insufficient quantity of DNA for laboratory analysis or incomplete results are likely if you smoke, eat, drink or brush your teeth shortly before collecting the sample.
Personal information, including genetic data, is protected by privacy legislation and will not be disclosed by One Tenacity without your explicit consent unless required by legal order.
One Tenacity cannot be held liable for any drug reactions or side effects caused by medications.
5. Consent to Use Data for Process Improvement
By signing this consent, you permit One Tenacity to include your anonymized data in aggregated data analysis to improve service delivery for you and other clients, which includes sharing aggregated data with business partners and collaborators for commercial research purposes. You will not be compensated as a result of the analysis or research performed using your anonymized genetic or drug response data. Any discoveries, or new products or services, resulting therefrom shall be the exclusive property of One Tenacity.
6. One Tenacity Contact Information
If you have any other concerns or questions, please contact our privacy officer at info@onetenacity.com