Advocate

To improve prescription drug safety, it is important for hospitals, doctors and consumers to report 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.

The more ADR reports the government regulator in any country receives, the more likely it is to require a pharmaceutical company to do further testing, issue a safety warning and, if necessary, recall an unsafe prescription drug.

Hospitals

Encourage the hospital in your community to report 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 drug-induced deaths in hospitals was an important clinical issue to examine. The data from 1994, for example, showed that adverse drug reactions was the fourth to sixth leading cause of death in American hospitals.

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, since the regulations for Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act) went into effect on December 16, 2019, it is now 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.

Doctors

Encourage doctors in your community to report ADRs to the government regulator of the pharmaceutical industry in your country.

There will, however, be barriers to reporting for some doctors. According to the World Health Organization, “sometimes healthcare professionals fear that the acknowledgement of adverse reactions may reflect negatively on their competence or put them at risk of litigation. Some are reluctant to report adverse reactions because of doubts regarding the causal role of the drug (although, of course, it is essential that suspected reactions are reported).”

Consumers

Encourage your family and friends to report 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-approval 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 Food and Drug Administration 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.