Inconsistency seen in safety labeling for generic drugs

An article published in  Pharmacoepidemiology and Drug Safety notes that over two-thirds of generic drugs in the U.S. have safety warning labels that differ from the equivalent brand-name medications.

According to the lead author, Jon Duke, "generic drug labels may contain incomplete or incorrect safety information."  This becomes problematic when the generic label is used by the physician to make prescribing decisions. If side effects, information on durg interactions or other safety issues are not in the label, then the patient may be at an increased risk for adverse events.

Out of more than 1,000 generic drugs, nearly 70% had some discrepancies in their safety labeling. Strikingly,  9% had differences of more than 10 side effects.

Patient safety education for undergraduate medical students

The authors of an article published in BMC Medical Education conducted a survey of the medical literature related to patient safety education in the medical curriculum of medical schools.


The article notes that there are only a few relevant published studies on the inclusion of patient safety education in the undergraduate curriculum in medical schools either as a selective course, a lecture program, or by being integrated into the existing curriculum.  The search included developed countries with advanced health and education systems. 


It is clear that the integration of patient safety education into the existing curriculum in medical schools internationally, provides significant challenges and needs.

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.

Drug Safety

Drug Safety is also known as Pharmacovigilance (PV). The World Health Organization (WHO) has defined PV as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.