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Practicalities

 Editorial  A drug is more than just an active substance mixed with excipients. There is more to consider than its pharmacological properties or its economic success. A drug is also a physical product that is part of the patient's daily life. And its packaging components, such as its box, the blister packs, bottle, vial or syringe, and the patient leaflet, are an integral part of this.

For nurses, who handle and use all these components, the packaging sometimes helps to administer the drug. Nurses also identify the drug by the information printed on the box or the label on the container. For pharmacists, the box provides useful information and is an aid to dialogue with patients or their carers, for explaining treatments, specifying dosing regimens, and warning patients about certain risks. Once opened, the box may contain additional items intended to help take or administer the drug correctly. For doctors, although the drug is rarely physically present during the consultation, being familiar with a drug's packaging is important in order to prescribe it accurately and to avoid any ambiguity concerning the dose and administration details.

For pharmaceutical companies, packaging is a design and manufacturing issue. Well-designed packaging is a crucial aspect of medication safety. For example, the product may require an accurate measuring or dosing device, or a system to prevent needlestick injuries or to protect children from accidental poisoning, and the information on the box and labels must be clear and well-organised.

And before granting marketing authorisation, drug regulatory agencies must make sure that sufficient attention has been paid to developing a product that is safe and convenient, by requiring that samples of the packaging items be provided as part of the application.

In summary, a drug's harm-benefit balance cannot be evaluated without examining the actual physical components that make up its packaging. It is a mistake to underestimate the practicalities of medication use, because poorly designed packaging can make life difficult for patients, their relatives and health professionals, and can even expose them to danger. This is why, for so many years, Prescrire has endeavoured to obtain, examine and provide as much information as possible about drug packaging, why we attribute Packaging Awards every year, and why we publish an annual review of the packaging analysed over the course of the previous year (see "Annual review of drug packaging" Prescrire Int n° 251 > Pdf, free).

©Prescrire 1 September 2023

Source: "Practicalities" Prescrire International 2023; 32 (251): 199. Free.

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