Electronic Medical Records and Patient Safety

Electronic medical record (EMR) systems and electronic health records (EHR) have been purported to reduce patient mortality, reduce medical errors, increase health care savings and improve health.  This appears, in part, to be a result of decreased medication errors that could result in adverse drug reactions (ADRs).  One benefit is that electronic prescribing helps to save lives.  Could it be that there is less of a problem in reading the physicians' poor hand writing?


A study published in the Journal of Political Economy stated that a 10% increase in the use of electronic records in hospitals would save 16 newborns for every 100,000 live births.  This would result in the saving of 6,400 infants per year in the US.


According to the Centers for Disease Control and Prevention, in 2011, 57% of office-based physicians had EMR systems.

Adoption of EMR/EHR systems by office-based physicians has increased

According to a 2009 Harvard School of Public Health press release, the most commonly cited barriers to adoption of these systems were found to be:

• inadequate capital for purchase (73%)

• concerns about maintenance costs (44%)

• resistance from physicians (36%)

• unclear return on investment (32%)

• lack of staff with adequate IT expertise (30%)

The press release was based on an article published in the New England Journal of Medicine.  The first author of the NEJM article gave an interview discuss EHR which can be viewed here.

Adverse drug reactions leading children to the Emergency Department

The aim of the study was to determine the incidence of adverse drug reactions (ADR) that led children to hospital emergency care in a university hospital in São Paulo, SP. Medical charts (MC) of patients seen at the pediatric emergency department were selected according to International Classification of Diseases (ICD) codes consistent with ADR. Of 23,286 cases studied, 2,409 records were selected. An ADR was observed in 83 (0.36%) MC. Most ADR occurred in children aged 1-5 years with a slight predominance in males (51.8%). The drugs most commonly involved were antibiotics for systemic use (53.0%), vaccines (9.6%) and analgesics (7.2%). Most ADR were dermatological (54.2%) or gastrointestinal (22.9%) manifestations. Two ADR were considered severe (2.4%) while 61.4% were mild and 36.1% were moderate. The incidence was lower than in the literature, probably because it is a retrospective study that used the ICD for selecting the data assessed. The characteristics of ADR are similar to those found in other countries. Interventions are needed to improve the diagnosis and the use of antibiotics, as they were the drugs most involved in the ADR observed. Research in hospital emergency is important to acknowledge ADR that occur outside the hospital setting and may help to identify the most severe ones. Despite limitations, the method requires few resources and materials, and is a good alternative to initial diagnosis. The present study should be followed by studies with higher sensitivity to detect these reactions in order to propose prevention measures.

New EU Pharmacovigilance Legislation and Signal Detection

The new European Union Pharmacovigilance legislation was published in December 2010 and regulations go into effect in early July 2012.  A number of significant changes will take place.  The Regulations and Directives are legally binding.

One of the major changes is found in signal detection.  Industry will now need to have specific measures in place that document the process of signal detection.  Issues that need to be considered are the frequency of monitoring data, prioritization of signals...and a documented process.

This change has potential advantages and disadvantages.  Capturing and identifying signals in a timely fashion is essential.  The benefit to early detection of an Adverse Drug Reaction (ADR) is the possibility of improving patient safety.  ADR determination is based on a number of pharmacological and medical considerations.  Sometimes an ADR determination is made after a number of events are detected.  For serious and rare ADRs it is reasonable to make a determination with fewer events; one event may be enough to make an ADR association between the drug and the adverse reaction.

Considering the Benefit : Risk ratio or profile is quite important.  As in many of life's situations there are associated benefits and risks to any medical intervention.  Before starting a treatment or having a procedure these need to be taken into consideration.  The same holds true during the development of a product; the pros and cons must be weighed during this period as well as into the later stages of the product's lifecycle.  Patients who are on a treatment or who have received a medical device need to understand the potential impact of the detection of a signal that is related to their treatment or medical device in order to make an informed decision regarding choices that they may make in their healthcare.

For some people the benefit will be of greater importance than a possible risk.  Others will not want to take on the risk associated with a particular treatment.