Automated Pharmacovigilance: Improving Patient Safety

By Carl N. Long

Why is pharmacovigilance of the utmost importance to patients? It's essential if you are being treated for influenza and your doctor wants to prescribe Tamiflu. This drug carries with it a significantly increased risk of loss of consciousness. It is important when you are a parent whose child is taking Nimesulide, a non-steroidal anti-inflammatory. China's State Food and Drug Administration recently banned use of this drug for children under 12 years of age because of the risk of liver and/or kidney damage. It is crucial your oncologist is removing a tumor and using an agent like bevacizumab, which may cause excessive bleeding and healing complications.

What do these diverse situations have in common? They are the result of effective pharmacovigilance, a multi-tiered effort on the part of doctors, nurses, pharmaceutical companies, hospitals, clinics, and, of course, patients to detect, assess, and prevent adverse drug reactions. Pharmacovigilance depends on human input, and the humans depend on advanced technological solutions in order to ensure the entire process works as it should. Because of the tremendous volume of data, software and cloud-based technologies are vital in creating an efficient, reliable, and accurate system.

What is the goal of pharmacovigilance? It can help mitigate financial damage to pharmaceutical companies if a drug has to be recalled or restricted. It ensures that firms meet the proper regulations. The goals are many, but the most important by far, is to ensure that medication is as safe as possible for patients. You cannot eliminate all risk; it is impossible to predict how a mechanism as complex and individual as the human body will react to any one drug or how that drug will interact with any other drug in all circumstances. The goal of pharmacovigilance, then, is not to eliminate risk but to reduce it. This can be done by removing a product from the market, restricting its use, or confirming its efficacy and safety record.

Pharmacovigilance is crucial:

1 During clinical trials, drugs are tested on small and controlled sample populations. The numbers needed to accurately detect adverse drug reactions are simply infeasible in these tests. Because of this, a drug's adverse effects may not be seen until it is on the market.

2 At least 60 percent of adverse drug reactions are preventable.

3 In some countries, the cost of ADRs (which include medical care) is greater than the cost of the medications themselves. That is, some countries spend more treating ADRs than they do on the original drugs.

According to recent estimates, between 3 and 10 percent of all hospitalizations are due to adverse drug events and/or reactions. Patient Advocate reports that over 2 million people every year experience an ADR, and 100,000 deaths are attributable to this cause. Pharmacovigilance is the science and discipline of reducing these numbers and making medication safer.

Automation plays a central role in effective pharmacovigilance. The volume of reports of ADRs is staggering and a streamlined process is crucial in aggregating this data and translating it into useful information. One example that illustrates the obvious need for technology is in signal detecting. This is when doctors, hospitals, clinics, patients, or pharmaceutical companies report adverse reactions to a drug that have not previously been documented. Automated systems facilitate spontaneous reporting, which is the core of pharmacovigilance by creating better signal detection standards, helping with earlier detection and analysis of signals, and offering tremendous savings in terms of money, time, and manpower.

There are software and web-based programs to help companies meet their pharmacovigilance goals. These allow one to:

1 Track benefit/risk rations and determine if a product is safe much more quickly.

2 Experience a more intuitive, user-friendly data intake process to facilitate spontaneous reporting.

3 Effectively handle product complaints and other reports.

4 Process complaints about products and drugs.

5 Maximize budget and provide effective pharmacovigilance even in small firms.

6 Link into local and global information, sharing and accessing important data.

This technology ensures that even smaller firms can provide effective pharmacovigilance and aid in efforts to detect and prevent adverse drug events.

There is an increasing need for pharmacovigilance, and thus an increasing need for new technologies to keep pace with the growing demands of the field. Not only does technology save companies billions of dollars and untold man hours, it makes the business of saving lives much more effective. Automated systems make it more likely that steps like signal detection and spontaneous reporting will occur with consistency.

Any medical procedure or treatment has associated risks. It is impossible to negate them, but it is more than possible to mitigate them by sharing information. The ultimate goal of pharmacovigilance information technology is to keep the process working and to keep data moving.

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