Importance of pharmacovigilance and reporting of adverse drug events

Importance of pharmacovigilance and reporting of adverse drug events IMA urges its 2.8-lakh members to report each and every adverse drug reaction to reduce incidence of preventable deaths New Delhi, January 12 2016: Recently, the pace with which newer drugs are being introduced in India and worldwide has been increasingly steadily. These drugs come from a tightly regulated pipeline of clinical trials and safety evaluations. The drug, once in the market can then be subjected to a final round of scrutiny by monitoring adverse drug reactions (ADR). Reporting of ADR can facilitate early detection of signals of new, rare and serious ADRs. It also can potentially provide information about the safety and efficacy of the drug in the long run and ultimately safeguards the patients. The specific aims of pharmacovigilance are as follows: • Improve patient safety and care regarding the use of medicines and medical or paramedical therapeutic interventions. • Improve public health and safety regarding the use of medicines • To facilitate the assessment of effectiveness, risks involved and safety of medicines • Encourage safe, rational, effective and cost effective use of medicines • Promote an understanding, training and general awareness about pharmacovigilance and its effective communication to the general public Padma Shri Awardee Dr. K.K Aggarwal - National President, Indian Medical Association (IMA) and , President Heart Care Foundation of India (HCFI) and Dr RN Tandon – Honorary Secretary General IMA in a joint statement said, “In India, pharmacovigilance programs to monitor ADR are operational however, the limitation lies in under- reporting. Adverse drug events (ADEs) result in significant injuries and deaths every year. Estimates suggest that over 50% of all adverse drug reactions treated in hospitals and emergency care are preventable.” Many ADE related injuries, mortalities and incurring hospital costs can be decreased if healthcare institutions strengthen their systems for preventing and detecting ADEs. Research studies have also found that the type and severity of ADE affects length of stay and costs in hospitals. Patients with severe ADEs like arrhythmia, bone-marrow depression, seizures, or bleeding averaged a 20-day hospital stay while those with less severe cases, for 13 days and those with no ADE, only 5 days. Hospital costs for them were much higher as compared to non-ADE patients. Many preventable drug reactions like drug overdoses and internal bleeding associated with the improper use of blood thinners and painkillers are life threatening especially in the elderly. There are many reasons for these reactions and may include poor coordination of care, lack of time and knowledge among health professionals, and lack of patient education. Medication errors are a frequent cause of adverse drug events, the factors that may lead to such errors. Common medication errors that can precipitate adverse drug events include: • Missed dosage • Illegible prescription • Wrong technique • Duplicate therapy • Drug interactions • Equipment failure • Preparation or formulation error • Improper monitoring Both in a clinical setting and at the patient community level, adverse drug reactions can be detected and prevented up to a significant extent resulting in significant healthcare cost reductions, decreased hospital stay and patient mortality reduction. Doctors and patients should be more proactive about reporting adverse drug events. “ADR monitoring and reporting is still inadequate in India; Pharmacovigilance program of India (PvPI) is doing a commendable job. Current adverse drug incident reporting system need to be improved, moreover, strengthening nursing medication and monitoring systems is also required. What is crucial is to create a better environment for healthcare professionals so that they report ADRs without hesitation or fear of punishment or severe repercussions” added Dr KK Aggarwal. The practice of self-medication also needs to be curbed. Lack of knowledge of where, what and how ADRs should be reported also affects reporting. To strengthen existing ADR monitoring programs, awareness needs to be raised amongst the population about the long-term benefits of reporting the side effects of drugs. Government and local medical organizations can take the initiative in form of mass media distribution through newspapers, radio, television and awareness campaigns.

IMA Advisory: Alert on use of sodium valproate in pregnant women

IMA Advisory: Alert on use of sodium valproate in pregnant women These five congenital anomalies could have been saved Dear Colleague Sodium valproate in pregnant women is widely prescribed by the clinicians of many hospitals, which is a matter of great concern as this drug belongs to pregnancy category D (There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.). A total of 5 individual case safety reports have been reported in the NCC-PvPI database. These children born were identified to have congenital anomaly after receiving sodium valproate by their mothers during pregnancy. Kindly DO NOT PRESCRIBE sodium valproate in pregnancy. Report immediately at 9717776514 if such issues are identified with the use of sodium valproate for further actions. Dr KK Aggarwal National President IMA (Contributions from Dr V Kalaiselvan, Principal Scientific Officer, NCC-PvPI, Indian Pharmacopoeia Commission)

IMA issues advisory on the use of Sodium Valproate in pregnant women

IMA issues advisory on the use of Sodium Valproate in pregnant women Considering the multiple adverse effects of using Sodium valproate in pregnant women, IMA issues advisory to its 2.8-lakh members across the nation New Delhi, Jan 02, 2017: Sodium valproate or valproic acid is a prescription drug indicated in cases of Epilepsy to control seizures, bipolar disorder and migraine headaches. Clinical research has shown that sodium valproate can cause serious complications in a developing baby and may lead to multiple congenital disorders. According to the Medicines and Healthcare Products Regulatory Agency (MHRA) taking sodium valproate during pregnancy can cause birth defects (10% of cases) or problems in development and learning as the baby grows up (40% of the cases). WHO has already issued an advisory against the use of the drug in women who are pregnant or who have attained childbearing age. Padma Shri Awardee Dr. K.K Aggarwal, President Heart Care Foundation of India (HCFI) and National President Indian Medical Association (IMA), stated that, “In India, sodium valproate is most commonly used to treat seizures associated with epilepsy. In a minority of cases, it is also prescribed for Bipolar disorders. However, taking sodium valproate during pregnancy can increase the likelihood of developing major and minor birth defects including spina bifida and cleft palate. It can also cause neurodevelopmental defects and learning associated disabilities later in life including memory problems, speech impairment and cognitive decline. Moreover, the drug also carries a high-risk in women who are not pregnant but are of childbearing age.” The IMA-PvPI (Pharmacovigilance program of India) nodal center monitors adverse drug events and spurious drug use throughout the country. It’s database reveals that the drug is still being prescribed in India amongst high- risk patients. “Up to 40% of women who take valproic acid during the course of their pregnancy experience adverse effects. This calls for stringent measures in halting the wrongful prescription of this drug. Moreover, this also calls for stronger warnings on the drug’s information leaflets. IMA’s guidelines for Sodium valproate clearly state that doctors must explain the drugs potential risks to an unborn child while prescribing it to women living with epilepsy”, added Dr. Aggarwal. While prescribing sodium valproate to pregnant women with epilepsy, it is imperative to weigh the benefits and risks of the drug properly before taking clinical decisions. The drug should only be used as a last resort where no alternative is available. Doctors should also talk to their patients about avoiding conception while on the drug