Nav: Home

Investing in drug safety monitoring could avoid complications -- and save medical costs

May 16, 2017

May 16, 2017 - Increased investment in "pharmacovigilance surveillance"--systems to proactively monitor safety problems with new medications--has the potential to avoid harmful drug effects while lowering healthcare costs, according to a study in the June issue of Medical Care. The journal is published by Wolters Kluwer.

Three recent cases in which serious safety issues led to medication withdrawals illustrate the potential return on investment of building a more effective pharmacovigilance surveillance system, according to the report by Krista F. Huybrechts, PhD, of Brigham and Women's Hospital, Boston, and colleagues. They write, "Our analyses demonstrate a pivotal and economically justifiable role for active pharmacovigilance in protecting the health of the public."

Detecting 'Early Signals' Could Have Avoided Drug Adverse Events The researchers analyzed three important instances of major adverse drug events that led to medications being taken off the market. In each case, early signs of medication safety hazards could have been picked up from clinical trials and/or spontaneous reports. However, these problems went unrecognized, with continued patient exposure leading to avoidable complications and costs.

The highest-profile example was the "COX2 inhibitor" rofecoxib (marketed as Vioxx), widely used for arthritis treatment. In more than five years on the market, approximately 105 million rofecoxib prescriptions were filled by US patients. Over time, it became clear that this medication was associated with a substantially increased risk of acute myocardial infarction (heart attack).

But this adverse effect could have been detected as early as one year after rofecoxib appeared on the market, based on analyses of actual healthcare utilization data available at the time. Early signal detection based on active pharmacovigilance surveillance could have averted 27,500 myocardial infarctions, Dr. Huybrechts and colleagues estimate.

In the other two cases, active surveillance might have avoided 190 cases of a rare but serious complication called rhabdomyolysis in patients taking the cholesterol-lowering drug cerivastatin (Baycol); and 264 cases of liver failure attributable to the diabetes drug troglitazone (Rezulin). The authors note that there were questions about the true benefits of all three drugs, and that other treatment options were available.

Earlier recognition of these safety issues could have resulted in savings in direct medical costs of $773 to $884 million for rofecoxib, $3 to $10 million for cerivastatin, and $38 to $63 million for troglitazone. Those figures don't consider indirect financial costs such as missed work time--not to mention the human costs of experiencing a potentially serious complication.

The researchers believe their findings illustrate the potential return on investment in pharmacovigilance surveillance programs--a function that is historically "overburdened and under-funded." In the United States, investment in pharmacovigilance is estimated at about $42.5 million per year.

While the frequency of new drug safety concerns is unpredictable, "It is clear that major adverse drug events are not rare," Dr. Dr. Huybrechts and coauthors write. "Investment in active drug surveillance offers protection against the occurrence of such events, which are bound to recur."
Click here to read "The Potential Return on Public Investment in Detecting Adverse Drug Effects."

Article: "The Potential Return on Public Investment in Detecting Adverse Drug Effects" (doi: 10.1097/MLR.0000000000000717)

About Medical Care

Rated as one of the top ten journals in health care administration, Medical Care is devoted to all aspects of the administration and delivery of health care. This scholarly journal publishes original, peer-reviewed papers documenting the most current developments in the rapidly changing field of health care. Medical Care provides timely reports on the findings of original investigations into issues related to the research, planning, organization, financing, provision, and evaluation of health services. In addition, numerous special supplementary issues that focus on specialized topics are produced with each volume. Medical Care is the official journal of the Medical Care Section of the American Public Health Association

About Wolters Kluwer

Wolters Kluwer N.V. (AEX: WKL) is a global leader in information services and solutions for professionals in the health, tax and accounting, risk and compliance, finance and legal sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with specialized technology and services.

Wolters Kluwer reported 2016 annual revenues of €4.3 billion. The company, headquartered in Alphen aan den Rijn, the Netherlands, serves customers in over 180 countries, maintains operations in over 40 countries and employs 19,000 people worldwide.

Wolters Kluwer shares are listed on Euronext Amsterdam (WKL) and are included in the AEX and Euronext 100 indices. Wolters Kluwer has a sponsored Level 1 American Depositary Receipt program. The ADRs are traded on the over-the-counter market in the U.S. (WTKWY).

For more information about our solutions and organization, visit, follow us on Twitter, Facebook, LinkedIn, and YouTube.

Wolters Kluwer Health

Related Clinical Trials Articles:

Why we should trust registered clinical trials
In a time when we have to rely on clinical trials for COVID-19 drugs and vaccines, a new study brings good news about the credibility of registered clinical trials.
Inclusion of children in clinical trials of treatments for COVID-19
This Viewpoint discusses the exclusion of children from coronavirus disease 2019 (COVID-19) clinical trials and why that could harm treatment options for children.
Review evaluates how AI could boost the success of clinical trials
In a review publishing July 17, 2019 in the journal Trends in Pharmacological Sciences, researchers examined how artificial intelligence (AI) could affect drug development in the coming decade.
Kidney patients are neglected in clinical trials
The exclusion of patients with kidney diseases from clinical trials remains an unsolved problem that hinders optimal care of these patients.
Clinical trials beginning for possible preeclampsia treatment
For over 20 years, a team of researchers at Lund University has worked on developing a drug against preeclampsia -- a serious disorder which annually affects around 9 million pregnant women worldwide and is one of the main causes of death in both mothers and unborn babies.
Underenrollment in clinical trials: Patients not the problem
The authors of the study published this month in the Journal of Clinical Oncology investigated why many cancer clinical trials fail to enroll enough patients.
When designing clinical trials for huntington's disease, first ask the experts
Progress in understanding the genetic mutation responsible for Huntington's disease (HD) and at least some molecular underpinnings of the disease has resulted in a new era of clinical testing of potential treatments.
New ALS therapy in clinical trials
New research led by Washington University School of Medicine in St.
Telemedicine helps improve participation in clinical trials
Videos and creative uses of other visuals provide a novel way to obtain informed consent during clinical trials to improve participants' understanding and retention of trial information, according to a study by Nemours Children's Health System presented at the American Thoracic Society (ATS) Annual Conference.
Not enough women included in some heart disease clinical trials
Women are underrepresented in clinical trials for heart failure, coronary artery disease and acute coronary syndrome but proportionately or overrepresented in trials for hypertension, atrial fibrillation and pulmonary arterial hypertension, when compared to incidence or prevalence of women within each disease population, according to a study in the Journal of the American College of Cardiology.
More Clinical Trials News and Clinical Trials Current Events

Trending Science News

Current Coronavirus (COVID-19) News

Top Science Podcasts

We have hand picked the top science podcasts of 2020.
Now Playing: TED Radio Hour

Listen Again: Meditations on Loneliness
Original broadcast date: April 24, 2020. We're a social species now living in isolation. But loneliness was a problem well before this era of social distancing. This hour, TED speakers explore how we can live and make peace with loneliness. Guests on the show include author and illustrator Jonny Sun, psychologist Susan Pinker, architect Grace Kim, and writer Suleika Jaouad.
Now Playing: Science for the People

#565 The Great Wide Indoors
We're all spending a bit more time indoors this summer than we probably figured. But did you ever stop to think about why the places we live and work as designed the way they are? And how they could be designed better? We're talking with Emily Anthes about her new book "The Great Indoors: The Surprising Science of how Buildings Shape our Behavior, Health and Happiness".
Now Playing: Radiolab

The Third. A TED Talk.
Jad gives a TED talk about his life as a journalist and how Radiolab has evolved over the years. Here's how TED described it:How do you end a story? Host of Radiolab Jad Abumrad tells how his search for an answer led him home to the mountains of Tennessee, where he met an unexpected teacher: Dolly Parton.Jad Nicholas Abumrad is a Lebanese-American radio host, composer and producer. He is the founder of the syndicated public radio program Radiolab, which is broadcast on over 600 radio stations nationwide and is downloaded more than 120 million times a year as a podcast. He also created More Perfect, a podcast that tells the stories behind the Supreme Court's most famous decisions. And most recently, Dolly Parton's America, a nine-episode podcast exploring the life and times of the iconic country music star. Abumrad has received three Peabody Awards and was named a MacArthur Fellow in 2011.