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Scientia Ricerca is licensed and content of this site is available under a Creative Commons Attribution 4. Journal Menu. Member In. Recommended Journals. Research Article. Marconi Roma. Received: January 17, ; Published: March 11, Objectives: The aim of this study is to examine drug prescription in dental practice, with particular attention to the relevant law provisions.
Materials and Methods: The various aspects of the subject are analyzed, both from a clinical point of view and from a medicolegal one, without neglecting normative standards nor the obligations held by each and every healthcare professional in their dual capacity of prescriber and attending doctor.
Results and Conclusions: This publication discussing the need for dentists to possess an adequate knowledge of drugs and medical substances, of their correct use and of their desirable or undesirable effects, is the result of a determination to make the professional category fully aware of their responsibilities in this field.
The more one knows about drugs and legislative provisions, the fewer pertinent clinical and medicolegal problems will arise. Moreover, this will result in a higher therapeutic effectiveness. The present-day extension of the average life expectancy is also due to a higher and more focused availability of medical substances . However, each medicine may have negative or undesired effects. In Italy drug is the active ingredient.
Medication is the drug that has been transmitted by its specific excipients, in its specific formulations, accompanied by its technical leaflet and approved by the Italian Agency for Drugs AIFA , then sold, prescribed and administered. The same drug can be a component of different medications. This implies great responsibility not only for the producers but also for the end users, whether they are the attending doctor or the prescriber in case the two differ.
As a result many problems can be avoided if drugs and legislative regulations are better known . This is apparently a logical and easily interpreted prerequisite.
Less logical and justified may appear to be the prescription of drugs for the therapy of non-dental diseases. Sometimes, however, these drugs are necessary for the practice of the dentistry profession for example: prescription of a benzodiazepine when in the presence of agitation or anxiety during the phase of pre- and post-intervention or in patients with particular handicaps. On the other hand, if the Italian legislation had not allowed dentists to prescribe, use and administer this kind of drugs, that would have created situations potentially putting at risk two important basic rights protected by the Italian Constitution: individual health and life.
There is a great deal of controversy around this matter, and the positions taken by forensic scientists and experts show widely diverging views. Independently of the type of degree obtained, using, administering and prescribing drugs or medical substances expose dentists to precise responsibilities, both clinical and medicolegal.
Not making use of a product or using it in the wrong way when missing precautionary and evaluative procedures that are correct and validated may lead to unintentional behaviour, even more if damage has been caused and the behavior not only violates the law, but also infringes professional ethics and moral obligations of each doctor.
Anyway, an obligation exists for the doctor to be able to manage the complication. As the matter is so important, each medical professional must keep constantly up to date, in terms of knowledge and analysis, on the most recent scientific acquisitions and clinical evidence.
Furthermore, these elements are widely made known among healthcare professionals by the drugs-surveillance service. This kind of service not only follows a very strict procedure of tests and premarketing validations , but it intervenes during the phases following all those adverse or undesired events that are reported by healthcare professionals.
This reporting is compulsory and regulated by specific laws, but it is also a matter of professional ethics and a moral duty [12,13]. This is very important in order to avoid negative or fatal interferences due either to other substances prescribed to the patient by other doctors or to diseases or conditions that are not strictly connected to dentistry.
Spontaneous reporting of adverse reactions must not be considered as a simple bureaucratic obligation; actually, it constitutes a fundamental, easy and economic instrument—scientifically and culturally valuable-for identifying those alert signals pertaining to the toxicity of medications that are not recognized or recognizable during the pre-registration study M. Magnani, Letter Prot. We can observe an adverse event during a medical operation independently of the existence of a causality link with the operation itself.
We suppose that there is a causality link between drug and event. In this concept expanded so much that it came to include harmful and undesired effects due both to a medication used in accordance with the indications as per the commerce introduction authorization, and to the exposure to such medications for professional reasons [, ]. AE and ADR do not constitute medical mistakes, unless previous recognition and highlighting of the problem are known Bollettino di Informazione sui Farmaci, or BIF-Drug Information Bulletin, containing notes sent by the drugs-surveillance service as well as other sources of specific updated information.
Some Historical Data The benefits associated with the administration of medical substances or of substances viewed as curative have been known since ancient times, as well as their possible inefficacy or even noxious effects.
In the International Committee for the Safety of Drugs considered it worthwhile to monitor the safety of substances on the market and develop strategies to reduce the risks and increase the benefits connected to their use, also through the spreading of information on a large scale . The boundary Between Clinical Practice and Experimental Use of Medicines Drugs and substances cannot and must not be used if their use and launch on the market are not authorized.
Only a few experimental clinical projects are allowed, and they are monitored in accordance with the current regulations Ministerial Decree of July 15 th , In Italy this experimentation is regulated by very strict norms that safeguard and protect people voluntarily accepting to undergo a specific programme.
These substances are used with different aims and dosage or on different kinds of populations than those usually known they are used not in accordance with the authorizations given by the Ministry of Health or with the terms specified in the list issued by the Single Commission for Drugs.
In these cases the suggested dosage is not respected, and the contraindications listed in the Summary of Product Characteristics RCP are not considered . It is not a matter of a systematic use of these medicines. It is an occasional use of substances about which there is clear information of efficacy and usefulness scientific proofs, guidelines.
Those substances are launched on the market with different clinical indications. Their use cannot leave out the existence of such facts, as well as correct and precise information given to the patient, followed by their consent.
A typical example, in dentistry, is the use of metronidazole in paradontology for infections supported by anaerobic bacteria that cannot be otherwise controlled. The Italian National Health Service SSN distributes that medicine only to female subjects, and only as regards other therapeutic indications. The Court of Cassation declared, with sentence No. The act of prescribing implies diagnostic evaluations carefully arrived at [28,29].
This act results in a therapeutic prescription filled in and signed by a doctor or a dentist by hand or by means of an electronic device. The prescription must be written in an indelible, clear and legible way, possibly without corrections.
The corrections, when present, should be countersigned. This document involves taking on an important responsibility on more than one level: professional, disciplinary-deontological, conventional, civil and penal. This is true for both the prescriber doctor or dentist and the pharmacist the person who provides the drugs. The medical prescription has the essential function of reducing the risk connected to the use of drugs for health safeguard .
It is also a tool for controlling the public spending whenever the drugs are to be paid by the National Health Service SSN . It is a written document with its own formal requisites , through which it is possible to prescribe drugs that are recognized as effective and useful, in accordance with the ministerial and State dispositions. The directions regarding the pharmaceutical form, the formulation and the dosage of the substance are not compulsory on the prescription.
But it is highly advisable to give them, and it is also a sign of accuracy. In the absence of specific directions, the pharmacist has to provide the medicine at the lower dosage. It is highly recommended to clearly indicate any reference to pediatric or adult formulation in order to avoid any situation that can cause negative events. The responsibility for a possible negative reaction in respect of this substitution, however, falls back into the person writing the prescription.
This means that if the doctor has a justified reason or if he knows something about the possibility of negative or adverse reactions for example allergies to excipients , he would be obliged to point out the non-replaceability of the product.
On the contrary the sentence of the Court of Cassation No. Professional Updating and Relevant Rules Professionals in the healthcare field have the duty to keep themselves up-to-date with respect to the recent medical-scientific discoveries Legislative Decree No.
This is true for drugs prescription as well. In case of a proven damage caused by a mistaken conduct, the doctor will have to demonstrate the non-involvement of his own behaviour for each causal hypothesis of offense. Moreover he will be responsible for personal harm or for unintentional homicide in case of death. But this autonomy and self-determination are limited by precise national and community regulations, by the specific authorizations of the products, the guidelines, the recommendations and the rules regulating clinical experimentation.
If that were to happen, a serious fault would be debited to the doctor in case of damage or complication. Obviously the case of lack of results and positive outcome in view of correct diagnostic and therapeutic evaluations is different.
The use of a medication has to comply with correct and validated directions, dosage and method of administration, things that the doctor has the precise duty to know it is suggested to carefully read the technical sheet of the medicine, in particular with reference to section 4.
This obviously interferes with the relationship between doctor and patient. Rarely do problems arise regarding this problem when healthy and positive effects are seen.
On the contrary, in case of undesired events or of specific damage connected to the substance used, we wonder whether the patient was exhaustively informed about the characteristics of the medicine, about the possibility of undesired effects, etc.
Moreover, if the patient had well understood the implications, we wonder whether he had accepted the risk on the base of what the doctor had told or promised him. The patient has not only to be informed about the possible undesired effects of the medicine, but also about the influence of certain behaviours on the percentage of these effects and on their seriousness a typical example is the hyperplastic gingivitis due to Diphenylhydantoin.
The problem reflects very delicate aspects in the case of administration of drugs for serious and weakening diseases. A typical problem—and a current one—is that of the osteonecrosis of the jaw bones, or of the atypical fractures of the femur  or of the appearance of gastric carcinoma [37,38] following the administration of Biphosphonates in the case of diseases associated with osteoporosis or neoplastic illness .
There are practical, clinical, administrative and medico-legal problems, for dentists, related to therapeutic choices, to prophylactic intervention and to the correct management of any possible complication. Practically, a correct and documented anamnesis collection and the execution of tests, specific verifications in case of doubts, problems and possible complications, are necessary [42,43].
From a juridical point of view a professional is in the right if he or she refuses to administrate or prescribe a medicine for which the medical prescription is compulsory, upon request of a patient, without having any knowledge of the subject—clinical or anamnestic. Drugs constitute a source of responsibility also in the activity of dentists, both for the prescriber and for the person who cannot ignore such prescriptions .
The fact of ignoring the taking or not of pharmacological substances, or the existence of other pathological conditions, constitute a significant element for the acknowledgement of professional fault, in case a careless administration of other drugs or medical substances or certain therapies interferes and generates negative effects. Patients often self-prescribe drugs or substances based on personal evaluations or free interpretations of general notions or advice of friends and acquaintances. The Risks Connected To Biological Elements The consumption of acid tartrate Zolpidem a sleeping pill in association with chamomile tea produces hallucinogenic effects.
Consequently on one hand there is a contraindication to the contemporaneous ingestion of both substances technically wrong behaviour and on the other hand the patient has not been given an adequate piece of information. Doctors and dentists often do not ask patients if they take them, and patients do not tell the professional if they ingest them. That what is natural cannot hurt is a false conviction.
It should be unnecessary to remember that a lot of substances of natural origin are powerful poisons. The centuries-old use of herbs and derivatives more or less purified and mixed up cannot be a synonym of efficacy and safety in itself. It does not have the characteristics of a simple placebo.
It can seriously lead to the risk of interaction with other medicines or phytotherapeutic products . In any case there is a large series of decrees and rules regulating their production, packaging, composition, labelling, advertising, etc. Actually in Italy such normative references are not so compulsory for these products, compared to the monitoring activity carried out on drugs .
Author: Prof. Filippo Bartoccioni
Piazza Girolamo Fabrizio, 6 - - Roma - email: info libreriauniverso. Via Agenore Zeri, 11 - - Roma - email: info libreriauniverso. L'opera si prefigge di essere uno strumento di lavoro utile per permettere al medico di procedere con sicurezza nella somministrazione del farmaco o in una manovra invasiva. ISBN: Titolo: Farmaci e procedure in medicina d' urgenza - Con allegato manuale tascabile. Autori: Tartaglino. Editore: Edizioni Medico Scientifiche.
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