A decade of effective drug safety monitoring led by the BC-CfE

posted on October 16, 2018

Ten years ago, the BC-CfE officially launched the BC-CfE’s Pharmacovigilance Initiative to closely monitor the safety of HIV antiretroviral drug treatment. Drug safety monitoring is integral to ensuring the effective implementation of the successful made-in-BC Treatment as Prevention (TasP) strategy to increase access to HIV testing and treatment.

Assistant Director of the BC-CfE, Dr. Rolando Barrios is the Principal Investigator of the Pharmacovigilance Initiative. He also leads BC-CfE programs in patient safety and continuous quality improvement. Bottom line, Dr. Barrios is constantly looking to improve on existing systems and practices—not leaving out any details.

Alongside Dr. Barrios, BC-CfE Pharmacovigilance Research Coordinator Katherine Lepik, a pharmacist, is responsible for tracking, analyzing and following up on adverse reactions (side effects) to antiretroviral drugs. This involves meticulously investigating such reports—which can come directly from health care providers, caregivers and patients themselves.

“This is a system that helps to confirm the safety and efficacy of the HIV drug treatment program,” said Dr. Barrios. “The more information we gather the more we are able to directly improve patient care.”

For example, the Pharmacovigilance Initiative has recently published work in the scientific journal AIDS describing the side effects of integrase inhibitors, a relatively new class of antiretrovirals. The initiative has also published a series of communications to warn clinicians and patients about dangerous drug interactions with HIV medications. Adverse reaction reports received by the Pharmacovigilance Initiative can also help guide clinical decisions made by physicians and nurse practitioners. Health care providers can receive information about their patients’ adverse drug reaction history through the BC-CfE’s Drug Treatment Program (DTP).

The DTP is instrumental in providing universal access to HIV treatment in the province as part of the TasP strategy. “In BC, the centralized management of HIV medications allows the BC-CfE to work closely with HIV care providers to monitor antiretroviral safety trends and identify early warning signals of possible problems,” said Lepik. The history of the Pharmacovigilance Initiative runs closely parallel to the timeline of the implementation of TasP in BC. In 2006, Dr. Julio Montaner introduced the concept of TasP in a paradigm-shifting paper published in The Lancet, calling for providing immediate, universal access to HIV treatment upon diagnosis.

The scientific and medical community had not yet coalesced around the idea of earlier HIV antiretroviral treatment—at the time, many were still delaying initiation of treatment in order to reduce what was thought could be harmful side effects. However, HIV medications had improved from the earlier days of the epidemic and continue to improve today.

In 2007, the Pharmacovigilance Initiative began as a demonstration project funded by the Canadian Patient Safety Institute and then was officially launched at the BC-CfE in 2008.

“The Pharmacovigilance Initiative informs and supports the province-wide STOP HIV/AIDS Initiative, launched in 2013,” said Dr. Barrios. “STOP aims to expand access to HIV testing, care and treatment across BC, in particular for the most vulnerable populations. We want to bring people living with HIV access to the best treatments available, most suited to their individual needs.”

Drug safety monitoring is a cornerstone for the BC-CfE in expanding access to treatment for individuals living with HIV. “We continue to be vigilant, with a special focus on new drug safety monitoring,” said Lepik. The Pharmacovigilance Initiative is now closely monitoring the safety of generic antiretroviral therapies and pre-exposure prophylaxis (PrEP). The emergence of generics has allowed for expanded provincial coverage of PrEP for eligible individuals in seven Canadian provinces. In January of this year, the Government of BC announced it would be offering universal coverage of PrEP at no cost to clients in order to help curb the spread of HIV among at-risk groups.

Adverse drug reports can be submitted directly to the BC-CfE website.

Tags:

STOP HIV/AIDS

Quality and Safety

Treatment as Prevention®

Rolando Barrios

Katherine Lepik

BC Centre for Excellence in HIV/AIDS

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A decade of effective drug safety monitoring led by the BC-CfE

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