The use of medications in pregnancy and lactation presents a challenge to all health care providers. Human data about medical product safety in pregnancy at the time of market approval are limited or absent. – Pregnant women are usually actively excluded from clinical trials. – Women who become pregnant during clinical trials are discontinued but followed. • Consequently, almost all clinically relevant human data are collected post-approval. Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal, and infant risk–benefit considerations. This is especially true with the long-standing pregnancy risk categories A, B, C, D, and X, which make risk–benefit ratio assessment difficult. To address the need for updated risk categories, FDA published a final rule entitled which is known simply as the “Pregnancy and Lactation Labeling Rule” (PLLR), in December 2014.The PLLR became effective on June 30, 2015. • Important goal of the PLLR conversion process is to have accurate and up-to-date labeling recommendations which reflect the post-approval experience. Labeling for over-the-counter (OTC) medicines will not change; OTC drug products are not affected by the final rule. #pharmacovigilance #drugsafety #patientsafety
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#Thalidomide catastrophe changed the course of medical history, driving many significant developments that has been established in throughout off the world. This tragedy was a turning point for the pharmacovigilance system. In 1968, WHO Program for International Drug Monitoring (PIDM) was launched. In 1978, Uppsala Monitoring Centre (UMC) was established as a WHO Collaborating Centre for International Drug Monitoring to manage the technical and scientific aspects of the program. As in other parts of the world, when many medical scientists started rational use of medicine and monitoring ADRs in the late 1960s, many eminent pharmacologists of India also started studying ADRs and trying to understand the concept of Pharmacovigilance. The journey of #pharmacovigilance in India was initiated through a national seminar about pharmacovigilance that was organized under the auspices of Indian Pharmacological Society (IPS) during the Silver Jubilee Celebrations program at Maulana Azad Medical College, New Delhi from 21-22 October 1983 and since than the pharmacovigilance system spread their wings in the entire nation to enhance their efforts in #drugsafety and #patientsafety.
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Bijender Sangwan reposted this
Yet another contaminated batch from Indian pharma manufacturer has been found to contain unacceptable amounts of diethylene glycol and ethylene glycol. WHO has issued an alert regarding this alarming situation. This time its Iraq. It’s high time that CDSCO implements tighter guidlines to put an end to this and stricter actions need to be taken. One batch of COLD OUT ~- paracetamol and chlorpheniramine combination syrups used to treat symptoms of the common cold and allergy - manufactured by Fourrts India for Dabilife Pharma Private Limited has been reported to the World Health Organization (by a third party) as substandard or contaminated. • The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants. • The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%," it said, adding that to date, the stated manufacturer and the marketer have not provided guarantees te WHO en the safety and quality of the product. Ethylene glycol and diethylene glycol are toxic alcohols with a slightly sweet taste. • Contamination of cough syrups with these glycols can occur, especially in products containing paracetamol. • In addition to its use in antifreeze, ethylene glycol is used as an ingredient in hydraulic fluids, printing inks, and paint solvents and diethylene glycol is used in the commercial preparation of antifreeze, brake fluid, cigarettes, and some dyes.
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Pharmacovigilance in Pregnancy. Teratogenic agents may affect development of the embryo and fetus and upon exposure by a pregnant woman can cause birth defects, fetal loss or abnormal growth and development. Congenital Malformations (Birth Defects) *Congenital anomaly (synonym in U.S: Birth Defect): Morphological, functional and/or biochemical development disturbance in the embryo or fetus, whether detected at birth or not. The term congenital anomaly is broad and includes congenital abnormalities, foetopathies, genetic diseases with early onset, mental retardation etc. *Congenital abnormality: A consequence of error of morphogenesis i.e. structural morphological defect, grossly or microscopically present at birth, whether detected at birth or not. *Congenital Malformation: A morphological defect of an organ, part of an organ or larger region of the body resulting from an intrinsically abnormal developmental process. #pharmacovigilance #drugsafety #patientsafety
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By looking at one of the worst pharmaceutical catastrophes in history, from which many difficult lessons were learnt. #Thalidomide was the biggest man-made medical disaster ever. More than 10,000 children were born with a range of severe and debilitating malformations condition called #phocomelia ( condition causes the upper or lower limbs of the child to be underdeveloped or missing and it can affect one or multiple limbs) along with an unknown number of fetal deaths. Because of #teratogenic (ability to disturb the growth and development of an embryo or fetus) effect of thalidomide. This catastrophe was the turning point for the pharmacovigilance system. A series of significant changes was occurred after this event. We can consider this to be one of the first recorded examples of how rare adverse events could be evaluated by using the collected knowledge and pooled information and data of the global community. #phamacovigilance #patientsafety #drugsafety
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The history of #pharmacovigilance started 175 years ago. On the 29th of January 1848, 15-yr-old girl Hennah Greener, from Winlaton, England. Sadly died on receiving the chloroform anesthetic for the removal of a toenail. The cause of death was possibly an episode of ventricular fibrillation. In 1893 this report subsequently published in The Lancet. Resulting in the first trigger for the reporting of Spontaneous reports for suspected adverse drug reactions. After that a series of events happened by following one of the major event #thalidomide tragedy that was a turning point for the pharmacovigilance system. 1968: The WHO started the Programme for International Drug Monitoring. From the starting day the Pharmacovigilance till now it's continuously developing. #pharmacovigilance #patientsafety #drugsafety
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Exploring the World of #pharmacovigilance. Are you passionate about ensuring the safety of pharmaceutical products and want to make positive impact on public health? Join me on a journey through the dynamic era of Pharmacovigilance- is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. In this series of posts, we will dive deep into the concept of pharmacovigilance and regulatory guidelines. Stay tuned for more updates, insights and discussions about pharmacovigilance. #pharmacovigilance & Ensuring the #drugsafety #patientsafety
