Report an adverse reaction to an antiretroviral drug

The Importance of monitoring adverse drug reactions

Adverse drug reactions (“side-effects”) to antiretroviral medications can affect patients’ health and interfere with treatment success. All drugs are tested for safety before they are approved for sale in Canada; however, the pre-marketing clinical trials cannot study enough patients to be able to detect adverse drug reactions that are rare, take a long time to develop, or mainly affect particular groups of patients (e.g. women, seniors, or specific ethnic groups). These toxicities are usually discovered after a drug is used in the general population.

Ongoing monitoring of adverse drug reactions is required to detect unexpected toxicities as soon as possible, so health care providers and patients can be warned of new safety concerns.

The BC-CfE Pharmacovigilance Initiative

Established in 2008, the BC Centre for Excellence in HIV/AIDS (BC-CfE) Pharmacovigilance Initiative collects, evaluates, and analyzes reports of drug toxicity and uses this information to understand and prevent drug-related problems.

How to submit an adverse drug reaction report

Reports of suspected adverse drug reactions may be submitted by a health care provider or patient by completing an Antiretroviral Adverse Drug Reaction Report form and faxing or mailing it to the address shown on the form. Please do not use e-mail to send any information containing patient identifiers.

What to report: Any symptoms or abnormal laboratory test results you believe might be caused by an antiretroviral (HIV) medication. It is particularly important to report reactions which are:

Severe (prevent the patient from carrying out usual daily activities).
Serious (potentially life-threatening or requiring a hospital visit).
Unexpected (the reaction may not have been reported before, or is considered to be rare).

Privacy and Confidentiality

Adverse drug reaction reports submitted to the BC-CfE Pharmacovigilance Initiative are handled with the same high level of security as prescriptions for HIV drugs. Information from reports is stored in the BC-CfE Registry, a very secure, computerized database. For more information about privacy and security, refer to the Patient information sheet for Drug Treatment Program participants.

Information from adverse drug reaction reports is used in the following ways:

To protect patient safety and support clinical care, a brief summary of the adverse drug reaction is included in the patient’s BC-CfE Patient Profile Summary. This summary of antiretroviral treatment history is provided only to health care professionals who are directly involved in a patient’s care. Healthcare providers may request a Patient Profile Summary by calling the BC-CfE Drug Treatment Program, telephone 604-806-8515.
De-identified adverse drug reaction information is used by the Pharmacovigilance Initiative to monitor drug safety. De-identified reports of serious or unexpected reactions are also submitted to the Health Canada Vigilance program, Canada’s national drug safety monitoring program. When health information is de-identified, we remove any information which could be used to identify or locate a person (such as name, birth date, personal health number).

Information for Patients

If you submit an adverse reaction report to the BC-CfE Pharmacovigilance Initiative, your doctor will not automatically receive a copy of this report. It is very important to tell your doctor about any health problems you are having.

If you think you are having a reaction to your HIV medications, or are having problems taking your medications, see your doctor or consult your pharmacist as soon as possible. If you are having a severe reaction, call an ambulance (phone 911). In most cases, you should keep taking your medications until you get advice from a doctor or pharmacist who specializes in HIV care. Pharmacists at the St. Paul’s Hospital Ambulatory Pharmacy are available to provide HIV medication advice to patients and health care providers (phone: 1-888-511-6222). Regular service hours are Monday to Friday, 8 a.m. to 5 p.m. After hours, a pharmacist is on call for emergency situations.

Information for Health Care Providers

Health care providers may choose to report suspected antiretroviral adverse drug reactions to the BC-CfE Pharmacovigilance initiative in the following ways, instead of completing the Antiretroviral Adverse Drug Reaction Report form:

Report on the HIV Drug Treatment Program Prescription Request form:

The HIV Drug Treatment Program Prescription Request form is completed by the patient’s physician whenever a change in antiretroviral regimen is requested.
If a medication change is requested due to a suspected antiretroviral adverse reaction or intolerance, describe the suspected drugs and reaction in the “Reason(s) for medication change” section of the HIV Drug Treatment Program Prescription Request form.

Report on the HIV Drug Treatment Program Antiretrovrial Treatment Interruption/Adherence Alert form:

An HIV Drug Treatment Program Antiretrovrial Treatment Interruption/Adherence Alert is mailed to the clinician who last prescribed HIV medication if the patient fails to refill his or her medication for more than two months after the expected refill date.
If the patient has stopped or is poorly adherent to antiretroviral medication due to a suspected antiretroviral adverse reaction or intolerance, describe the suspected drugs and reaction in designated section of the form and mail or fax to the address on the top of the form.

Report by telephone:

To submit a confidential adverse drug reaction report by telephone, contact the BC-CfE Pharmacovigilance Initiative Research Coordinator at 604-806-8663.

Obtain information about antiretroviral adverse drug reactions

The BC-CfE Pharmacovigilance Initiative research coordinator can assist health care providers by providing information about known or emerging antiretroviral-related drug toxicities. Pharmacovigilance personnel will not release patient-specific information, except to health care providers who are directly involved in the patient’s care (such as the patient’s physician, pharmacist or nurse practitioner), for the purpose of protecting patient health and safety.

For general advice on prescribing HIV medication, consult:

Physician consultation (24-hour infectious disease consultation service): 1-800-665-7677
Pharmacist consultation (Monday to Friday, 8 a.m. to 5 p.m.; after hours for emergency situations): 1-888-511-6222
See also the Healthcare Resources section of the BC-CfE website.