PharmacovigilanceinClinicalDentistry SC
PharmacovigilanceinClinicalDentistry SC
PharmacovigilanceinClinicalDentistry SC
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Gabriel Rodrigues
Manipal Academy of Higher Education
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Developments in dental pharmacotherapeutics require dentists discusses the rationale for pharmacovigilance in dental practice
to constantly update their knowledge of new drugs, drug safety, using specific methods and reviews the pros and cons of adverse
and therapeutic trends. Recent incidents of bisphosphonate- drug reporting among dental practitioners.
associated poor healing, spontaneous intraoral ulceration, and Received: April 27, 2010
bone necrosis in the oral and maxillofacial region stress the need Accepted: June 21, 2010
for vigilant spontaneous reporting of adverse events. This article
P
harmacovigilance refers to the pharmacovigilance activities ADRs are encountered in routine
science of activities related throughout the organization, and dental practice and how many of
to the detection, assessment, by encouraging participation in the those remain unreported due to a
understanding, and prevention WHO Program for International lack of understanding among den-
of adverse effects or any possible Drug Monitoring. The WHO’s tists concerning pharmacovigilance.
drug-related problems.1 Recently, Uppsala Monitoring Centre manages
the scope of pharmacovigilance has an international database of adverse Drug safety in the dental
been widened to include herbals, drug reactions (ADRs) received from scenario
traditional and complementary med- member countries’ national pharma- Virtually all drugs have the potential
icines, blood and biological prod- covigilance programs.2 to cause adverse oral reactions; the
ucts, medical devices, and vaccines. table includes a list of drugs that
Pharmacovigilance seeks specifically Pharmacovigilance for commonly cause various adverse oro-
to improve patient care and safety dentists facial reactions, enabling dentists to
related to medicine and all medical Dentists prescribe a wide range be vigilant in reporting any adverse
and paramedical interventions; to of drugs in their routine clinical reactions to these drugs.5,6 While
improve public health and safety practice; these most commonly most dentists likely are familiar with
in relation to the use of medicines; include antibiotics, analgesics, ADRs caused by drugs that they pre-
to contribute to the assessment of anti-inflammatories, and antipyret- scribe (such as antibiotics, analgesics,
benefit, harm, effectiveness, and risk ics.3 Drug safety in dentistry is and anti-inflammatories), they also
of medicines, thus encouraging their an equally important parameter, need to be aware of the other drugs
safe, rational, and more effective compared to the profession’s medi- that can cause oral reactions that
(including cost-effective) use; and to cal counterparts. A 2005 report of require dental intervention.
promote understanding, education, bisphosphonate-associated osteone-
and clinical training in pharmacovig- crosis of the jaws (ONJ) highlighted Postmarketing surveillance in
ilance and effective communication the importance of promoting drug dental therapeutics
to the public. safety. The dentists’ timely reporting The wider range of therapeutic
Drug safety constitutes the cor- of this adverse reaction prompted options from different classes of
nerstone of modern therapeutics. the FDA and the manufacturer drugs allows dental practitioners to
The Medicines Team of the World (Novartis) to make labeling changes provide therapeutic interventions
Health Organization (WHO) to reflect the possible risk of that previously were unimaginable.
aims to determine the safety of ONJ with bisphosphonates.4 This Dentists are responsible for under-
medicines by ensuring a reliable and incident shows the effectiveness of standing the relative benefits and
timely exchange of information on pharmacovigilance; however, it also risks of available therapies and must
drug safety issues, by promoting raises the issue of how frequently voluntarily report any unexpected
Board of directors
Organizational level
1. Create liaisons with health
ministry, pharmaceutical Dental board
industries
2. Build a robust pharmacovigi-
lance system
3. Make ADR reporting mandatory
4. Conduct periodic inspections
5. Promote research in ADRs Pharmacy and
Patient safety Medication safety therapeutic
committee team in dentistry committee
Institutional level
1. Build medication safety team
2. Increase awareness of drug
safety (newsletters, meetings)
3. Emphasize pharmacovigilance
at the undergraduate and
postgraduate level Clinical Clinical
Individual dentists
pharmacologists pharmacists
Individual level
1. Train in pharmacovigilance
2. Build liaisons with other health
care professionals in medication elderly patient with renal failure preventing and managing adverse
safety promotion would have a different pharmacoki- reactions and should be accurate,
netic profile than a younger, healthy balanced, open, understandable,
patient and therefore would require and targeted.9
adjustments to dose and duration
of treatment to avoid an ADR Building an effective
performed by a clinical pharmacist. from accumulation of medication.9 pharmacovigilance system
The assessment includes reviewing Life-threatening ADRs require in dentistry
the strength of the evidence that prompt intervention, whereas Chart 1 presents the three-tier
indicates a possible drug-related milder ones (such as nausea) can be approach that can be used to build
ADR as well as considering other considered during the next routine a proactive pharmacovigilance
immediately available evidence that labeling revision. system in dentistry. A strong
might help to support or oppose Currently, ADR management regulatory framework with dental
a hypothesis. The resultant action relies heavily on statistical evalu- organizational support is important
will depend on several factors, ation of signals and mathematical for introducing and implementing a
including the seriousness, frequency, quantification of risk of patients robust pharmacovigilance program
and preventability of the ADR, the with ADRs. Pharmacogenetics at a national level. Dental schools
nature of the disease for which the can play a specific role in targeting can collaborate and integrate organi-
patient is being treated, the benefits the risk of occurrence of ADRs in zational approaches to patient safety
of treatment, and the availability of patient populations with diverse through the initiation of a medical
alternative treatments. ethnic backgrounds through safety team at an institutional level
Dose and duration of treatment genetic mapping. Risk communica- (Chart 2). A medication safety team
can be important. For example, an tion plays an important role in can be a stand-alone entity that