For VOLUNTARY reporting of Adverse Drug Reactions by Healthcare Professionals

SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

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Serious Event or Serious Suspected Adverse Reaction-Pharmacovigilance Practice

An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes

• Death
• A life-threatening adverse event
• Inpatient hospitalization, or prolonged of existing hospitalization
• A persistent disability to conduct normal functions
• A congenital anomaly/birth defect

Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious, when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

A Life Threatening Adverse Drug Experience
Any event that occurred due to the use of drug, if it places the patient or the subject at immediate risk of death or if the product or drug is continued it may result in death is described as a life threatening adverse event.
Some of the examples are:

• Hemorrhaging and internal bleeding with rapid drop in blood pressure,
• Loss of consciousness from increase in pressure on the brain etc.

Hospitalization
Any event that occurred due to which the patient/subject is admitted to the hospital for longer than 24 hours or if the stay in the hospital is prolonged due to the adverse event.
Disability
Any event that occurred due to which the patient/subject is unable to conduct normal life functions
Examples are

• Loss of speech,
• Fatigue( if the subject cannot get out of bed at all),
• Loss of memory,
• Paralysis etc

Congenital Anomaly
Exposure to a medical product before conception or during pregnancy results in an adverse outcome in the child is described as congenital anomaly. Thalidomide is the best example of a drug causing congenital anomalies with babies born with deformed arms and legs.

Author- Sirisha Boidapu, Pharmacist, PV Professional

FDA IND Review Team-Different background people working together

The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.

-Project Manager: Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor.
-Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete.
-Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data. 
-Pharmacologist: Reviews preclinical studies.
-Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.
-Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.
-Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Designing Clinical Trials Researchers design clinical trials

Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives.

Then, they decide:-

-Who qualifies to participate (selection criteria)
-How many people will be part of the study
-How long the study will last
-Whether there will be a control group and other ways to limit research bias
-How the drug will be given to patients and at what dosage
-What assessments will be conducted, when, and what data will be collected
-How the data will be reviewed and analyzed Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Key concepts to be considered in expedited reports : Pharmacovigilance Practice

The following list of items are to be included in CIOMS form and submitted to regulatory bodies :

1. Patient details (vitals)
2. Suspected medical product( brand name,batch number, dosage form and strength,dosage regimen, route of administration, international non propiatory name, starting date and time , stopping date and name )
3. Details of the adverse drug reaction (starting date, onset of reaction , stopping date and time and duration of reaction )
4. Details of reporter (name, address, telephone number , profession)
5. Details of the sponsor (source of report, country in which event occurred ,name and address of sponsor , sponsor identification number ).

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Drug Safety Physician / Medical Reviewer Synowledge PV Services India Pvt Ltd

JOB TITLE: Drug Safety Physician/ Senior Drug Safety Physician

LOCATION: Mysore, India

YEARS OF EXPERIENCE: 0-5 years experience in PV

EDUCATION: MBBS/ MD (Any)

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

As a Medical Reviewer

Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
Determine seriousness and relatedness across products as assigned
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
Acquire and maintain knowledge of applicable Global Health Authority regulations
Perform any other drug safety related activities as assigned
Participate in internal and external audits and inspections by clients and health authorities


SPECIALIZED KNOWLEDGE AND SKILLS:

Experience with relevant safety databases and related software applications
Proven experience in customer handling and relationship.
Proven ability to perform task management.
Must have good presentation skills and the ability to give presentations.
Knowledge of the Life Sciences Industry and life cycle of drug.
Relevant product and industry knowledge.
APPLY ONLINE

Opening for Medical Writing for M.pharm/pharm.d Freshers,experienced

 Hiring for freshers -M. Pharm/ Pharm. D at Indegene Lifesystems for Scientific Writing/ Medical Writing.


Kindly find the job description.
Develop content for various deliverables meeting quality requirements as per client satisfaction metrics, with active guidance from the manager

Responsible to develop content as per the timelines assigned

Responsible to follow the best practices in the department regarding - processes, communication (internal & external), project management, documentation and technical requirements like - language, grammar, stylization, content search, summarizing, data conflicts and referencing

Participate in assigned training programs and work on assignments as per requirement

Participate in cent calls as per project requirements

Compliance to quality, confidentiality and security:

Adhere and follow quality systems, processes and policies

Comply to training and specifications


Education : M.Pharm/ Pharm. D - Freshers

APPLY ONLINE

Pharmacovigilance Medical & Scientific Writer With Crest - Pune

• Identifying and evaluating individual case safety reports (ICSRs) of adverse drug reactions from the published literature
• creating summary content in a range of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing ) to support the drug safety reporting and information requirements of pharma industry clients
• Required background and experience: you will have working experience in the pharmacovigilance/drug safety field and a background in medicine or pharmacy
• Ideal experience would include:
• 
  
• Scanning the literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
• Detailed evaluation of individual case reports e.g. determining seriousness of adverse events, determination of drug causality, subsuming signs and symptoms into clinical diagnoses etc.
• Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities

 APPLY ONLINE

Process Trainer (pharmacovigilance)-Cognizant Mumbai

• Deliver training on the floor - effectiveness measured through Trainer Feedback Score (from Trainees)
• Ensure associates are assigned to process training refreshers based on QA data on associates performance
• Facilitate Process Training Refresher modules effectively measured through Trainer Feedback Score
• Ensure completion of all compliance courses for all associates tagged to the project within timelines
• Willingness to work in rotational shifts
  Only BPharm/MPharm/BDS/BAMS/BHMS candidates need to apply 

APPLY ONLINE 

Drug Discovery Technologies Market 2012-18

Drug discovery technologies play a significant role in the field of pharmaceuticals as they heavily contribute to the introduction of drugs to the market. The application of drug discovery technologies have a significant opportunity in  the launch of drugs for severe diseases such as cancer, cardiovascular diseases, Parkinson’s disease, central nervous system disorders and others. However, the slow growth in the introduction of blockbuster drugs could pose a major threat for the growth of this market.

The major technologies in the drug discovery market are proteomics, genomics, QPCR, DNA and protein microarrays, high-throughput screening, mass spectrometry, laboratory information management systems, microfluidics, gel electrophoresis, chromatography, and protein and nucleic acid isolation.

As the global population ages, there is a growing pressure to keep the healthcare costs under control. Senior citizens are more prone to chronic diseases. It is in the nation’s best interests to keep its population healthy. In addition to this the pressure is paired with the government’s and administration’s responsibility to pay for healthcare. This situation will magnify in intensity if nothing is done to improve the status of treatment and prevention of diseases among the aging population. 

Apart from facing these pressures, the pharmaceutical manufacturers also face an impending surge of expiring patents. This will result in reduced profits of pharma companies. The market players in this field have begun to respond to these factors by restructuring their strategies and bringing innovation in their products thus, improving their productivity and efficiency. Despite these measures, pharmaceutical companies face the fact that drug discovery and development consumes a huge amount of time and money. For instance, drug discovery and development from scratch may take around 15 years and costs about USD 500 million until it is introduced in the market.

Big Data Analytics: The Next Evolution In Drug Development

The drug development process is complex and financially risky. A recent study by The Tufts Center for the Study of Drug Development estimates the cost of developing a new drug at $2.6 billion and suggests that costs of drug development are rising with a compound annual growth rate of 8.5 percent. These rising costs are largely driven by increases in out-of-pocket costs, such as larger clinical trial sizes and higher failure rates for drugs required to demonstrate superiority. Even when considering the efficacy of the 10 highest-grossing approved drugs in the United States, the fact is that for every patient a drug does help, between three and 24 patients fail to show improvement after treatment. Clinicians are typically forced to address this variability in patient outcomes with a trial-and-error approach to intervention, increasing healthcare costs and adding a burden to the patient.

Drug Developers, Providers, And Patients Need A Better Option 

High-throughput technologies are ushering in the era of Big Data in drug development, allowing researchers to assay patients in terms of their genome, epigenome, proteome, metabolome, and microbiome. Precision medicine initiatives are being undertaken to tailor disease treatment by taking into account individual variability in molecular and cellular systems. A biomarker- and technology-driven approach to developing targeted therapies and patient selection strategies has the potential to increase success in the drug development process, decrease cost, and ultimately improve patient outcomes with directed intervention. Read More

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Serious Event or Serious Suspected Adverse Reaction in Pharmacovigilance Practice

An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes :

-Death
-A life-threatening adverse event
-Inpatient hospitalization, or prolonged of existing hospitalization
-A persistent disability to conduct normal functions
-A congenital anomaly/birth defect

Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious, when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Author- Sirisha Boidapu, Pharmacist, PV Professional

Researchers are studying fish which can repair their own hearts.

Hundreds of thousands of people in the UK are living with debilitating heart failure. They can’t regenerate their damaged hearts. But zebrafish can. If part of their heart is damaged they can repair it in a matter of weeks, just like we are able to mend a broken bone.  That’s why our Mending Broken Hearts Appeal is funding researchers to find out what their secret is.

Because zebrafish are transparent early in their life cycle, it’s easy for researchers to see their hearts and blood vessels grow. Their hearts begin to develop after just 12 hours, and they reach adult size – about 3cm long – in about three months, so they can provide quick research results. Read More

Biological similarity of humans and other animals

Although humans and animals (technically “non-human animals”) may look different, at a physiological and anatomical level they are remarkably similar. Animals, from mice to monkeys, have the same organs (heart, lungs, brain etc.) and organ systems (respiratory, cardiovascular, nervous systems etc.) which perform the same functions in pretty much the same way. The similarity means that nearly 90% of the veterinary medicines that are used to treat animals are the same as, or very similar to, those developed to treat human patients. There are minor differences, but these are far outweighed by the similarities. The differences can give important clues about diseases and how they might be treated – for instance, if we knew why the mouse with muscular dystrophy suffers less muscle wasting than human patients, this might lead to a treatment for this debilitating and fatal disorder. Read More

More investment to characterize animal models can boost the ability of preclinical work to predict drug effects in humans

Mice take the blame for one of the most uncomfortable truths in translational research. Even after animal studies suggest that a treatment will be safe and effective, more than 80% of potential therapeutics fail when tested in people. Animal models of disease are frequently condemned as poor predictors of whether an experimental drug can become an effective treatment. Often, though, the real reason is that the preclinical experiments were not rigorously designed. 

The series of clinical trials for a potential therapy can cost hundreds of millions of dollars. The human costs are even greater: patients with progressive terminal illnesses may have just one shot at an unproven but promising treatment. Clinical trials typically require patients to commit to year or more of treatment, during which they are precluded from pursuing other experimental options. Launching a clinical trial without the backing of robust animal data keeps patients out of tests for therapies that may have a better chance of success.Read More

Frequency of adverse drug reactions

Frequency of adverse drug reactions

Whenever possible, an estimate of frequency should be provided, expressed in standard category of frequency. It is always difficult to estimate incidence on the basis of spontaneous reports, owing to the uncertainty inherent in estimating the denominator and degree of under-reporting. However, whenever possible, an estimate of frequency should be provided and in a standard form.
The following standard categories of frequency are recommended:

Very common
> 1/10 (> 10%)
Common (frequent)
> 1/100 and < 1/10 (> 1% and < 10%)
Uncommon (infrequent)
> 1/1,000 and < 1/100 (> 0.1% and < 1 %)
Rare
> 1/10,000 and < 1,000 (> 0.01% and < 0.1%)
Very rare
< 1/10,000 (< 0.01%)

Current status of clinical research in India

 

Clinical research has grown exponentially over the past decade in India because of cost advantage, treatment naïve patient, qualified doctors conversant in English etc. India was the second most preferred country to conduct clinical trials outside the US in 2009. However, recent years have witnessed a decline in number of trials in India (529 in 2010; 253 in 2012). The number of drugs entering the Indian markets had been gradually reducing even before the current slump in clinical research activity (270 in 2008;140 in 2011; 44 in 2012 and 25 in 2013). This necessitates a relook on the strategy so as to optimise clinical research in Indian context. The problems and possibilities around the clinical research arena can be broadly grouped as capacity building issues and ethico – regulatory ones.

Read More

Regulators and patients driving demand for Phase IV studies, says Quintiles

Full spectrum CROs are well-positioned to service the growing demand for late-stage observational trials driven by regulatory and patient pressure, says Quintiles.

Read More

Omega (Ω)

A measure of disproportionate reporting for drug-drug-ADR triplets in ICSR databases, designed to highlight potential signals of drug-drug interactions. Just like the more established disproportionality measures for drug-ADR pairs, Ω is based on a contrast between the observed and expected number of reports. A positive Ω indicates higher reporting than expected.

Rechallenge

The point at which a drug is again given to a patient after its previous withdrawal.