A: Pharmacogenetics (PGx) is the study of how genes affect a person's response to medications. Over 90% of North Americans have at least one genetic variation affecting their response to medications. A drug that works for some people might have a different effect in others. This can range from a lack of drug efficacy to fatal adverse drug reactions.
Pharmacogenetic testing is becoming routine at leading healthcare centers in the United States, including Vanderbilt Healthcare system, University of Florida, Mayo and Cleveland clinics. PGx is also used by a growing number of research hospitals, such as CAMH, SickKids, Montreal Heart Institute, and London Health Sciences.
Pillcheck helps doctors determine the correct medication and dose based on each patient’s metabolism, resulting in improved efficacy of medications and reduced risk of adverse effects. This precision medicine approach reduces patient recovery time, improves drug safety, and informs treatment strategies, especially for individuals on multiple medications.
A: Pillcheck medication optimization service includes:
- Pharmacogenetic test that uses a simple, non-invasive saliva cheek swab to collect DNA
- Personalized Pillcheck Report flagging medications of higher risk and listing predicted response to over # commonly prescribed medications for a wide variety of conditions. Each page includes links to the original reference sources.
- Review of the patient’s medications and professional opinion letter prepared by a pharmacogenetics-trained clinical consulting pharmacist summarizing PGx considerations for current and future therapy
Pillcheck is a pharmacogenetics service that supports physicians in deciding which medications to select or avoid, and assists with selection of optimal therapeutic strategies. It enables service requisition, bioinformatics analysis, and secure sharing of reports according to the highest standard in health data management.
The Pillcheck recommendations are based on drug monographs provided by FDA, Health Canada, as well as guidelines developed by the Clinical Pharmacogenetic Implementation Consortium , which is an international group of leading clinical pharmacologists, physicians, and genomics experts.
The platform provides life-long value to individuals because each Pillcheck customer receives semi-annually updates covering more medications according to the expanding clinical guidelines.
A: Physicians already take into consideration many factors, including patient age, weight, liver and kidney function when making prescribing decisions. A patient’s pharmacogenetic profile is another factor to consider as drug-gene interactions are similar to drug-drug interactions and may significantly affect a patient’s response to treatment and the risk of side effects. Knowing which medications pose an increased risk of side effects at standard dose can help prescribers to adjust dose within accepted therapeutic ranges or select alternative medication.
Pillcheck results are provided as additional references to support physician’s prescribing decisions. It is up to the physician’s professional judgment how best to apply this information in the overall context of a patient’s medical conditions, history, and other medical data available to the treating physician.
A: While everybody may benefit from Pillcheck at some point in their lives, the people who are helped most immediately are:
- Patients taking 3 or more medications, of which one is on the Pillcheck list
- Patients starting known “high-risk medications”, such as opioids or antidepressants
- Switching medications or having dosage adjustments
- Experiencing unwanted side effects and/or low clinical response
- Fearful of taking medications due to risk of side effects or complications.
A: Cheek swab sample collection can be completed at the patient’s home and mailed to the lab via a prepaid return envelope.
Pillcheck samples are currently processed at the Dynacare lab in Laval, Quebec. This lab has the following accreditations:
- ISO 15189: International accreditation for Medical laboratories
- COLA is a medical lab accreditation demonstrating compliance with CLIA requirements (US federal regulations governing the operation of medical laboratories). www.cola.org. Of note, CLIA is an American certification that is needed only for serving US customers, and CLIA does not apply in Canada.
Pillcheck bioinformatics system was independently validated by several clinical diagnostic laboratories in US, Canada and EU.
A: Individuals have full ownership and control over their Pillcheck test results. Personal data is not shared without prior authorization as described in the Informed Consent Form. Only the individual can decide who has access to the report and can revoke access at any time or request deletion of the information.
Privacy of genetic and personal data is protected by the Bill S201, HIPAA and PIPEDA regulations. Pillcheck service is fully compliant with these regulations. Except as expressly set forth in the patient’s Informed Consent, results will not be shared with any third party, including insurance company and employer.
For more details please refer to our Privacy Policy and Consent Form.
A: Health benefits and insurance companies may cover the cost of Pillcheck service as an optional benefit. Pillcheck results do not impact coverage decisions.
Pillcheck does NOT assess any genes related to disease risk or disease diagnostics and does not affect patients’ insurance. Only specific, well-identified DNA variations related to drug response are analyzed by Pillcheck. Once the test is complete, any remaining DNA is destroyed after 30 days.
For more details please refer to our Privacy Policy and Consent Form.
A: Healthcare providers can access Pillcheck reports through the secure Pillcheck Portal. Please contact info@pillcheck.ca to request access. Report sharing is governed by the patient’s consent.
A: Local: Pillcheck tests are performed in Canada, and all patient and genomic data is stored locally in the HIPAA compliant secure data centers.
Broad clinical relevance: By including validated clinically-relevant genes, Pillcheck supports evidence-base prescribing for mental health, pain management, neurology, cardiology, gastroenterology, and many other conditions.
Ease of use for clinicians:
- Pillcheck includes online review of patient medications by a licensed clinical pharmacist who is specially trained in pharmacogenetics.
- Pertinent findings summarized in a concise Pharmacist Opinion Letter and include actionable insights on therapy adjustment for consideration by prescribing physicians.
- Physicians who sign up for a secure, web-based account in the Pillcheck Portal can access the full detailed report for patients who grant access via their Consent form. NO special software, licensing, or EMR integration required.
High accuracy: The Pillcheck genotyping panel is optimized to maximize sensitivity and specificity, and to ensure accurate results for ethnically diverse population in Canada by including multiple ethnic-specific alleles.
A: The Pillcheck test retails for $599 (plus applicable taxes) and can be used for the patient’s lifetime to improve treatment efficacy and reduce the risk of side-effects. Drug response testing is not currently covered by provincial health plans because it is new to the Canadian market. Reimbursement by the provincial health plan will be determined over time once the demand for these services is assessed.
Other options for coverage:
- Leading disability insurance providers cover the cost of Pillcheck for selected individuals on disability suffering from mental health or chronic pain.
- Some benefits plans cover the cost of Pillcheck as a covered health benefit to members.
- Pillcheck is an eligible medical expense for income tax deduction and can be paid through Health Spending Account (HSA).
Pillcheck may be available to a person on a disability claim through his or her disability management provider. Studies have shown that pharmacogenetics can support recovery and the successful return to work.
✔ The disability case manager facilitates the Pillcheck requisition for the claimant, pays for the cost, and sends a copy of the Pillcheck Pharmacist Opinion Letter to the claimant’s physician.
✔ Pillcheck results are provided as additional insights to support a physician’s prescribing decisions. It is between the patient and the physician’s professional judgment how best to apply this information in the overall context of a patient’s medical conditions and history, and other medical data available.
✔ Pillcheck results have no impact on drug or disability insurance claims.
✔ Participation is purely voluntary and subject to the claimant’s informed consent.
✔ The case manager has access to the Pharmacist Opinion Letter summary and has no access to the claimant’s detailed genetic results. Data access is explained in the informed consent form.
The person on disability can contact his or her case manager to find out about eligibility for Pillcheck coverage.
