Health and safety: the responsible use of self medication products

Non-prescription medications contain widely used active ingredients and dosages of low toxicity, intended to treat mild, transient ailments that are very common during the change of seasons. These medicines have years of research and large case histories of use behind them, are periodically monitored by the Ministry of Health, and usually do not give rise to complex side effects. Assessment of symptoms, therefore, can be done by the patient, who can adjust intake according to his or her past experience, without monitoring by the treating physician. It is important, however, to avoid prolonged use (generally, 3 to 5 days) and to keep in mind that, in particular situations, these products may have contraindications or interact with other medications, compromising their effectiveness. Responsible use of medications for self-medication involves, first and foremost, correct dosing, compliance with the mode of administration and storage. Information that can be acquired directly from pharmaceutical packaging, which is designed to safeguard the integrity of medicines and provide indispensable indications for safe consumption. In the presence of frail patients or those who are already undergoing therapies, it is essential to consult the doctor before taking.

Difference between non-prescription (SOP) and over-the-counter (OTC) medicines

Medicines that can be purchased without a prescription fall into two categories. SOP (Without a Prescription) medicines, which include products such as Paracetamol and Ibuprofen for children, cannot be displayed to the public because they require interaction with a pharmacist (not coincidentally, they are referred to as board drugs). OTC (Over The Counter) medicines, in contrast, are placed on shelves accessible to consumers and can be purchased independently. Top sellers in Italy in the second half of 2022 include Rinazina nasal spray and Aspirin.

Unlike SOP drugs, OTC drugs can be promoted through commercials in different media (radio, TV, newspapers, Internet), subject to evaluation and approval by a commission of experts established by the Ministry of Health.

To be approved, the commercial must follow certain parameters:

• make explicit the advertising nature of the message;
• promote a rational use of the product and present it in an objective manner;
• report, in addition to the name of the drug, the active ingredient it contains;
• urge the patient to carefully read the directions on the package and package insert;
• avoid making it appear unnecessary to consult the doctor;
• avoid implying that the drug is free of side effects;
• avoid addressing the message to children;
• avoid using images that depict alterations of the human body caused by disease;
• avoid comparisons with other medicines.

Encouraging responsible use of medicines: pharmaceutical packaging

Unlike deductible medicines, self-medication products are not reimbursed by the National Health Service and their cost is fully covered by the patient. The packaging, therefore, must have a stamp on it stating “Non-prescription drug.” To encourage responsible use of medicines, patients are advised to take certain precautions:

• ask the treating physician or pharmacist if the product may interact with any therapies already underway;
• store the medicine at the recommended temperature, observing the expiration date;
• read the directions on the package insert carefully;
• strictly adhere to the recommended intake, timing and doses;
• consult your doctor if the symptom persists or undesirable effects appear.

Safely designed and regulatory-compliant pharmaceutical packaging must be simple and functional so that the patient can use the product independently. The outer packaging must clearly and legibly display information to allow traceability, identification and proper use of the medicine: name, composition (active ingredient and excipients), therapeutic indications, pharmaceutical form (drops, capsules, tablets, etc.) dosage, expiration date, lot number. The package insert should, in addition, specify precautions for use, contraindications, possible side effects, storage and administration methods, special warnings, and any interactions with other medicines.