To improve prescription drug safety, it is important for hospitals, doctors and consumers (parents, guardians or caregivers) to report serious adverse drug reactions (ADRs) to government regulators of the pharmaceutical industry. No more than 10% of serious ADRs are reported according to the World Health Organization and, in many countries, most of the reports are from pharmaceutical companies.
In the United States, for example, 95% of all 2,191,808 ADRs reported to the Food and Drug Administration (FDA) in 2019 were from the pharmaceutical industry, which is mandated to submit reports to the FDA.
The more reports of serious ADRs the government regulator in any country receives, the more likely it is to direct a pharmaceutical company to do additional testing or revise a drug label, issue a safety warning and, if necessary, recall an unsafe prescription drug.
Health Canada defines a serious ADR as a noxious and unintended response to a drug that occurs at any dose and that:
- Requires in-patient hospitalization or prolongation of existing hospitalization;
- Causes congenital malformation;
- Results in persistent or significant disability or incapacity;
- Is life-threatening; or
- Results in death.
In 2019, the FDA received 173,875 reports of deaths caused by ADRs.
Encourage the hospital in your community to report serious ADRs to the government regulator of the pharmaceutical industry in your country.
In 1998, after analyzing data from hospitals in the United States, researchers concluded that prescription drug-induced deaths in hospitals was an important clinical issue to examine. The data showed, for example, that ADRs was the fourth to sixth leading cause of death in American hospitals in 1994.
If this analysis would have been similar in other countries, and is still valid today, the number of deaths caused by ADRs in hospitals worldwide could be extremely high with Statistics Canada, for example, reporting that 66% of all deaths in Canada in 2014 were in hospitals.
Continuing with Canada as an example; a regulation for Vanessa’s Law went into effect on December 16, 2019, which makes it mandatory for hospitals to report serious ADRs to Health Canada, the government regulator of the pharmaceutical industry, within 30 days of the incident being documented.
Encourage doctors in your community to report serious ADRs to the government regulator of the pharmaceutical industry in your country.
There will, however, be barriers to reporting. According to the World Health Organization, some doctors fear that the acknowledgement of adverse reactions might reflect negatively on their competence or put them at risk of litigation, and some might be reluctant to report adverse reactions because of doubts regarding the causal role of the drug.
Even with these barriers, which is part of the reason why no more than 10% of serious ADRs are reported to government regulators, John Hopkins Medicine published a study in 2016 indicating that medical errors, which includes mistakes involving prescription drugs, was the third leading cause of death in the United States in 2013 behind heart disease and cancer.
Encourage your family and friends to report suspected serious ADRs as a consumer (parent, guardian or caregiver) to the government regulator of the pharmaceutical industry in their country.
Before they submit a government report, it might be helpful for them to get a free RxISK Report which determines how likely it is that an adverse reaction was caused by a drug side effect. Many people think that drug side effects are symptoms of the illness, disease or disorder the drug is supposed to treat. Some people even think they got their prescription just in time because their condition got worse shortly after starting the drug, not being aware that what they experienced might have been an ADR.
RxISK Reports can also be shared with prescribing doctors, who are often not aware of the most serious side effects of a drug, such as death or permanent disability, because of the fraudulent concealment by a pharmaceutical company of negative data from clinical trials or post-marketing studies. In some cases, this deception goes on for decades. A good example is Purdue Pharma, which concealed clinical trial data about how addicting the opioid painkiller OxyContin was to get it approved in the United States by the FDA in 1995, which prevented people from making informed choices about use. By 2019, OxyContin and other opioids had caused hundreds of thousands of overdose deaths worldwide.