Adverse Drug Reactions - Read the package leaflet!!!

By Dr. Marcus Zulian Teixeira – http://www.homeozulian.med.br

Adverse Drug Reactions (ADRs) contribute to a substantial increase in patient morbidity and mortality, as well as increasing healthcare costs.

Many ADRs are avoidable with proper prescription and monitoring, because they often occur as an extension of the drug's mechanism of action (adverse/side effects) or as known drug interactions.

Patients at greater risk of ADRs include those at the extremes of age (children and the elderly), those with multiple comorbidities (diseases), those taking several drugs (polypharmacy) and those admitted to intensive care units or experiencing care transitions.

Unfortunately, clinical trials evaluating the efficacy and safety of drugs are generally carried out on adults without many comorbidities, and little is known about the pharmacokinetics and pharmacodynamics (metabolism, excretion, adverse events, interactions, etc.) of these drugs when used on children and the elderly, the most susceptible and fragile age groups.

As the risk of ADRs becomes greater as the number of drugs increases, it is imperative that prescribers are vigilant about the “cascade of prescriptions” (polypharmacy) and take steps to discontinue drugs that have the potential to be more harmful than beneficial, avoiding causing iatrogenesis in their patients.

Therefore, numerous articles (see below for some examples) warn of the importance of knowing about ADRs, both by patients and health professionals, contrary to the contempt observed in the medical community for these events.

By prioritizing a single desired therapeutic effect, the countless other adverse/collateral effects of modern drugs, which can alter internal homeostasis and cause other diseases and/or comorbidities when used chronically, are overlooked.

As common examples, chronic use of oral hypoglycemic agents (type 2 diabetes) can cause hypoglycemia (weakness, fainting and falls), cardiovascular disease (high blood pressure, for example) and kidney disease (kidney failure, for example). Non-steroidal anti-inflammatory drugs (aspirin, diclofenac, ibuprofen, naproxen, etc.) can cause gastroduodenal ulcers, kidney and liver failure, as well as increasing the risk of cardiovascular accidents (acute myocardial infarction and stroke). Antihistamines, a common component of “sleeping pills” and “antiallergics”, in addition to rebound insomnia, can cause daytime drowsiness, mental confusion and thickening of secretions, causing chronic respiratory problems. Antacids and proton pump inhibitors (omeprazole, pantoprazole, etc.), used indiscriminately to treat chronic heartburn and gastric discomfort, can cause diarrhea/constipation, malabsorption, bone fractures, magnesium deficiency (seizures), among other problems.

As Prof. Dr. Anthony Wong, Medical Director of the Center for Toxicological Assistance at HCFMUSP, points out in an excellent article published in the journal Being a Doctor of CREMESP (When medicines are poisons), “the excessive prescription of drugs by doctors needs to be reviewed” so that we can reduce ADRs.

In addition to this “exaggerated medical prescription”, which should be reviewed regularly to adapt it to the patient's needs and time of life, the self-medication, The abuse of over-the-counter (OTC) medicines further aggravates the situation and can lead to poisoning, addiction (tolerance) and serious adverse events (liver failure, rebound effect, etc.).

Unfortunately, when asked about the possible adverse/side effects of the medicines described in the package leaflets, it is common to hear fellow doctors tell their patients: “don't read the package leaflet, because if you do you won't be taking any medication”.

How can you “not read the package leaflet” when it provides a (partial) idea of the adverse/side effects that patients may experience from using various drugs? How can we not enlighten them about these possible iatrogenic effects resulting from the inappropriate and abusive use of modern drugs? With rare exceptions, in which impressionable patients can be influenced by reading, knowledge of these adverse reactions is what allows for a minimum of safety throughout therapy, especially in the treatment of chronic diseases and with the indiscriminate use of drugs seen today.

Acting in line with the Hippocratic maxim primum non nocere (“first, do no harm”), also known as the “principle of non-maleficence” in bioethics, doctors have an obligation to avoid risks, damages and costs to patients, reducing the overuse of medicines and the unnecessary indication of tests, procedures and surgeries.

Bibliographical references

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