6. Spontaneous/voluntary Adverse event reporting:

Although drugs are passed through a series of trials to establish their efficacy and safety in human beings before they get marketing approval, not all the adverse effects caused by a drug can be detected in clinical trials, especially uncommon ones and those appear on long-term administration of that drug because clinical trial results are limited by strict inclusion criteria; relatively small sample size and short study period. Hence, it becomes necessary to have a system that keeps strict vigilance over and is able to disclose such type of adverse drug reaction(s) (ADRs) after marketing approval of drugs. Spontaneous reporting is one of the most widely utilized methods of pharmacovigilance. 

A spontaneous report is a direct communication of adverse event information by healthcare professionals or consumers to a company, regulatory authority or other organization (e.g. WHO, Regional Centers, Poison Control Center). 

Any one can experience side effects or events after taking medicine if we report that event we can prevent future occurrences. 

How do we report adverse events: 

1. Direct reporting to Regulatory Authority: 

One can report an AE to the FDA MedWatch and, in Canada to Adverse event reporting system(https://hpr-rps.hres.ca/static/content/form-formule.php?lang=en), in the UK to the “Yellow Card Scheme”, in Australia blue card (https://www.bluecard.qld.gov.au), “ADR reporting (Red) form” and “VigiFlow” (software provided by the WHO) in India. 

2. Reporting to Pharmaceutical companies: We can even report events directly to manufacturer of product by sending emails/fax or by telephone (details are available in google), some companies have call centres to collect adverse events.

3. Social Media reporting: Nowadays social media sites have reached the mainstream. Have you ever complained about an unpleasant health issue (maybe a strange ache or sudden difficulty sleeping) on your Facebook page? Ever tweeted a picture of a swollen or discolored part of your body? Even if you haven’t, you almost certainly have seen others in your social media network do so. 80% of internet users have looked online for health information in the past year. 16% have specifically gone looking online for people who might share their same health concerns. That’s why the pharma world can no longer ignore social media sites as places to find vital data on adverse events (AEs).

Minimal information required for reporting:

• Reporter information
• Patient demography
• Medical history
• Suspect drug and other drugs
• Events experienced and impact on daily life
• Physician inputs. 

What happens when we report the adverse events to Regulatory authority or manufacturer: 

PV team collect the reported events and perform below assessments: 

• Analyse seriousness of the event 
• Assess the reason for event occurrence
• Understanding if it is new event or already known information
• Writing summary in medical format 
• Submitting information to regulatory authority

Once Regulatory authority (ex: FDA, EMA, etc..) receive reports they will see the risk that drug is creating and take necessary actions like below: 

1. Labeling change 
2. “Dear Health Care Professional”  letter 
3. Risk management plan/program

Targeted Education and Outreach

Reminder Systems

Fail-Safe Systems

4.Product withdrawal

Below are few examples where drugs were withdrawn from market and this has happened because of spontaneous reporting:

Accutane (Isotretinoin): This drug is used for acne and was withdrawn from market due to increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendencies. This drug has been on market for 27 years. 

Bextra (Valdecoxib): This is NSAID (pain relief) medication and was withdrawn from market due to serious cardiovascular adverse events (like death, MI, stroke); increased risk of serious skin reactions (like toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme); gastrointestinal bleeding. This drug has been on market for 3.3 years. 

Cylert (premolin): This is a central nervous system stimulant to treat ADHD/ADD and was withdrawn from market due to liver toxicity. This drug has been on market for 30 years.

Darvon and Darvocet (Propoxyphene): This is Opioid pain reliever and was withdrawn from market due to serious toxicity to the heart; and over 2,110 deaths reported due to this product. This drug has been on market for 55 years. 

DES (Diethylstibestrol): This is used as synthetic estrogen to prevent miscarriage, premature labor, and other pregnancy complications. This drug was withdrawn from market due to clear cell adenocarcinoma (cancer of the cervix and vagina), birth defects, and other developmental abnormalities in children born to women who took the drug while pregnant; increased risk of breast cancer, higher risk of death from breast cancer; risk of cancer in children of mothers taking the drug including raised risk of breast cancer after age 40; increased risk of fertility and pregnancy complications, early menopause, testicular abnormalities; potential risks for third generation children (the grandchildren of women who took the drug) but they are unclear as studies are just beginning. This drug has been on market for 31 years.

If you have not yet reported any event that you/friend/relative/colleague have experienced after taking any medicine then please start doing it. It is important and our responsibility to keep the medicines that we are taking are safe enough for us and for our next generations.