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.

Androgen deprivation and prostate cancer

Saylor and Smith of the Massachusetts General Hospital Cancer Center in Boston, Massachusetts have an article that is coming out in the Journal of Urology in January 2013 which discusses adverse effects of androgen deprivation therapy (ADT).  Their review focuses on the more recently described metabolic complications of ADT including obesity, insulin resistance and lipid alterations as well as the association of androgen deprivation therapy with diabetes and cardiovascular disease.

They found that ADT causes a decrease in lean mass (muscle) and an increase in the mass of fat.  This was associated with a decrease in insulin sensitivity and increase in LDL, HDL and triglycerides.  This is associated with an increase in the incidence of diabetes and cardiovascular disease.

The benefit versus the risk of ADT must be considered when considering treatment, and it is recommended to screen for risk factors associated with diabetes and cardiovascular disease  and treat as indicated, thus mitigating the adverse effects that can be associated with ADT.

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.

Outsourcing Pharmacovigilance

Not long ago many within Pharma thought that Drug Safety was an evil, unnecessary cost center. Over time the perception has changed and it's now recognized that Pharmacovigilance is an important function which is essential to protect the patient, public and product. Nevertheless, budget restraints and the rising costs of maintaining a professional workforce have led many across the industry to consider outsourcing. There's yet another reason for outsourcing: The shear volume of data coming in which needs to be collected at call centers, entered into databases, queried, cleaned, analyzed and reported makes this a task that must be shared round the clock and globe.

Reporting A Safety Issue in the US

The U.S. Food and Drug Administration (FDA) is the agency that is accountable for protecting and promoting public heath in the United States. It does this by setting regulations, conducting inspections and analyzing adverse events (AEs). The FDA maintains a computerized database where information related to AEs is stored and then analyzed. This database is called the Adverse Event Reporting System (AERS). The FDA monitors the AEs in the database to determine if there are signals that could represent a health risk to the patients and public. The reporting of AEs is done on a voluntary basis by healthcare providers, patients and the public. Manufacturers of medications are required to report information related to AEs that they become aware of either through the conduct of clinical trials or that occur spontaneously in patients taking medicines that are marketed by the company. Reporting of Adverse Events can be done as follows: Consumers and Healthcare Providers can report Adverse Events online or using a form available through the FDA by clicking here or pasting the following URL into their web browser: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

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.