Some normal drawbacks can only be observed after a medicine has been taken by many people. Everyone should participate
Allergic skin reactions, such as erythema and urticaria, and vascular type, such as hypotension, tachycardia up to anaphylactic shock. Abdominal pain. Balance disorders. Nausea and diarrhea. Liver damage. Bleeding. The list of adverse effects resulting from the single or chronic use of a long-lasting medicine. They can be serious, not serious, known, i.e. those reported on the package insert, or involving a patient for the first time. Among these also falls the lack of effectiveness of the drug (which could cause disease progression).
Abuse or improper use
In all cases in which there is a suspicion of an adverse reaction, linked to the abuse of the drug or improper intake, in order to improve the safety of the molecule after placing on the market required to health professionals and citizens of submit a report electronically to the Italian Medicines Agency (Aifa). The agency in turn transmits it to the European database (Eudravigilance), which collects notifications from all national regulatory agencies and manufacturing companies. This does not mean that the drug is actually causing the side effect observed or that its use is dangerous. For example, in older people suffering from multiple pathologies, who take at least five different drugs a day, problems could develop deriving from their interaction (including loss of efficacy). important Always contact your doctor if you have any suspicious symptoms, perhaps to reshape the dosage, for the possible suspension or replacement of a medicine, and never to take other medicines on their own initiative than those already prescribed. Alessandro Politi, secretary of the Italian Society of General Medicine for the province of Milan.
What to report
The suspected adverse reaction must be reported as promptly as possible. Just connect to the Vigifarmaco.it portal (edited by Aifa) and fill in the online form (different for citizens and health personnel) with personal data, height, weight, description of the disorder, specialty of the drug (selected from the list of Aifa drug database). Alternatively you can download the report form from the Agency website and send it by fax or email to the Pharmacovigilance manager of the region to which they belong (contacts are on the Aifa website) or to the manufacturer. Doctors and other health professionals are required to send the report to the contact person for pharmacovigilance of the structure to which they belong within 2 days, or 36 hours in the case of biological drugs (vaccines included).
Valuable information
Continuous monitoring of the side effects of life-saving drugs. estimated that patients with adverse reactions are 1 in 10, like those in the hospital, which double and more in the elderly. While hospitalizations due to adverse reactions are about 1 in 20 says Ugo Moretti, Professor of Pharmacology at the University of Verona and member of the Support and Coordination Secretariat of the Aifa Pharmacovigilance Office. The level of tolerability of adverse reactions it depends on the therapeutic context and on the risk-benefit ratio, explains Moretti, who is also responsible for the Veneto Regional Pharmacovigilance Center. Six benefits are superior, even essential for survival of the patient and to defeat the disease, such as cancer, side and adverse effects, for example immunosuppression in the cancer patient, are considered acceptable.
Gesture of social responsibility
Make a timely report a gesture of social responsibility. The number of cards sent in 2019 had reached 65.097, which dropped to 421,699 in 2020 following the pandemic, but in 2021 it reached 128,699, of which 100 thousand reports related to Covid vaccines reports the pharmacologist the pharmacologist. Based on the inherence, frequency and severity of the problem recorded, Aifa, and at the European level the EMA (European Medicines Agency), if necessary they evaluate changes in the use and marketing bans of the medicinal product.
Natural products
Natural products they are not in themselves a guarantee of safety. You may encounter problems, even serious ones, after taking food supplements, vitamins, probiotics, herbal products, herbal teas, homeopathic medicines, galenic preparations, preparations of the Chinese or Ayurvedic tradition. The competent authorities therefore invite you to send a report to the Higher Institute of Health through the institutional portal Vigierbe.it. People often push themselves to use these products in the belief that they are harmless. But not so, especially if you are following another therapy, they can interfere by reducing its effectiveness, warns the expert. Impossible to completely prevent the possibility of adverse reactions from drugs or natural products. You can to reduce the risk. The first rule is to take drugs only if they are really needed, following medical advice. The same goes for supplements and infusions, reminds Moretti. Monitoring a drug’s risk profile lasts forever. The evaluation of possible harmful effects cannot be exhausted in the clinical trial phase, before the molecule enters the market, explains Moretti. Tests generally exclude children, the elderly, and women of childbearing age. They are performed for a limited time and on a small sample compared to the variety and actual number of people who will take the drug for many years.
Interactions
Drug interaction could in turn lead to adverse effects, in particular in the over 65s in polytherapy. The estimate of elderly patients who are exposed to potential interactions varies between 35 and 60% – specifies the pharmacologist -, but the percentage of these subjects suffering from clinically significant reactions caused by interactions drops to 5-15%. A situation that warns general practitioners, the first reference for the health of citizens. Some frequent combinations have contraindications. Politi, a general practitioner in Milan, gives some examples: Anti-inflammatories associated with anticoagulant and antiplatelet drugs increase the risk of bleeding. Antidepressants affect the metabolism of other molecules. The gastroprotector, used too casually, together with medicines for diabetes or for the thyroid gland can trigger skin reactions. Dizziness and falls can give her a mix of diuretics and sedatives. Massimo Di Maio, national secretary of the Italian Association of Medical Oncology, raises the issue in the fight against cancer: The patient must report everything he takes to the doctor, including supplements and herbal products. Pump inhibitors, by altering stomach acid, and antihypertensives, for example, affect the absorption of anticancer drugs taken by mouth.
The Deprescription Clinic
Correct the therapies, reviewing the dosages and the frequency of the control tests and, if necessary, removing the old ones that are now useless, with the aim of eliminating or reducing the toxic effects caused by the interaction between drugs. The first Deprescription clinic and therapeutic reconciliation born in 2019 in the Casa della salute di Torre Pellice, inside the ASL Torino 3, aimed at patients over 65 who have been prescribed at least 5 different molecules per day. In the first 10 months of activity – reports Simonetta Miozzo, at the head of the project – we took care of 127 people, an average of 78 years and ten molecules to be taken every day. We removed about 3 drugs per patient from the therapies. The advice offered by the clinic comes prescribed by prescription from the respective general practitioner. there is also a family nurse who educates on correct drug adherence.
November 27, 2021 (change November 27, 2021 | 22:18)
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