Adverse Drug Reactions in the Oral Cavity
Knowledge of oral drug side effects is lacking, partly due to dentists' low reporting rates. Common side effects include dry mouth, pain, and blistering. To enhance patient care and increase awareness, it's crucial for dental care to report suspected cases.
Table of contents
This article is based on an original article in Swedish which can be found here
The recomendations in this article are based on Swedish recommendations and guidelines
BACKGROUND
Knowledge about oral drug side effects is insufficient. This is partly due to the lack of reporting found side effects by dentists. It is important for both dentists and physicians to understand when a reaction in the oral cavity is related to a drug, so that appropriate measures can be taken. It is especially important that serious side effects are reported, for the benefit of future patients. In this article, drug side effects in the oral cavity are defined. It also describes how to report a drug side effect.
What is a drug side effect
A drug side effect is defined by the WHO (World Health Organization) as a harmful and unintended reaction that occurs with normal use of a drug for the treatment of, prophylaxis against, or diagnosis of diseases, or for modification of physiological function.
Within the European pharmaceutical collaboration, a side effect is defined as "a harmful and unintended reaction to a drug" (EU Directive 2010/84 and LVFS 2012:14). A serious side effect is specifically defined as a side effect that leads to death, is life-threatening, requires hospitalization or prolongs hospitalization, leads to persistent or severe activity limitation or disability, or consists of a congenital malformation or defect. In Sweden, reported side effects are collected by the Medical Products Agency. This is in turn linked to a common database within the EU, which is connected to the global side effect work within the WHO.
An oral drug side effect can take many different forms. All drugs, including herbal medicines, have side effects. Even a normal dose of a drug can for specific individuals become too high and cause side effects. This can be due to genetic variations, the condition of kidney and liver (which are responsible for breakdown and excretion) or due to interactions with other drugs.
The age of the patient also playes a role in the risk of side effects. In children, different drug reactions can sometimes be observed compared to adults. This is because children differ in terms of body constitution, organ function, and the development of the immune system. In the elderly, side effects are more frequently observed. This is due to the fact of a slower elimination of drugs, which can lead accumulation of the drug. The older person has an altered relation of muscle mass and fat, which affects the drugs distribution volume. Polypharmacy, which also increases the risk of interactions, is more commonly seen in the elderly population.
How to report a drug side effect in Sweden
According to LVFS 2012:14 § 19, all healthcare practicioners, must report suspected drug side effects to the Medical Products Agency.
- It is sufficient to have a suspicion of a drug side effect for one to be obligated to make a report. The Swedish Medicines Agency thereafter determines whether the side effect exists or not.
- The dental practicioner should repport all suspected oral side effects that are observed. Not only side effects from the own given treatment, but all suspected drug related oral side effects. Many drugs can cause side effects in the oral cavity.
When to report a side effect, use the form developed by the Medical Products Agency. This can be found on the Medical Products Agency's website. It is also linked via FASS website, Stockholm County Council's Janusinfo, several pharmaceutical committee websites, on various healthcare provider websites or below in this article. Reports should mainly be submitted electronically.
- The form is filled out with the information available, who is reporting, and who the patient is.
- A brief description of the reaction itself.
- Information about the suspected drug (dosage, duration of treatment, etc.).
- Information about any other medications.
- Attach a photo (if applicable) of the reaction.
- The form is sent electronically.
All information is treated with full confidentiality. If necessary, the Medical Products Agency will obtain additional information from the healthcare provider. It is particularly important to report unusual side effects and side effects from new drugs. The latter are usually included on the EU's list of drugs subject to "enhanced monitoring." This is marked with a black triangle ▼ in the package leaflet. Older drugs can also sometimes be subject to enhanced monitoring.
It is important to understand that, as a dental practioner, you do not need to have an established drug reaction side effect. When faced with a suspected, or established drug side effect, you report to the Medical Product Agency. The assessment is thereafter made by them.
