Consumers will soon find it easier to use over-the-counter medicines, as a US Food and Drug Administration regulation comes into force to provide new, easy-to-under-stand labelling on non prescription drugs. These are the drugs that Americans use most, and the regulation is seen as a critical step towards preventing tens of thousands of unnecessary hospitalisations caused by their misuse each year.

A standardised format means that labels clearly show a drug’s ingredients, dose and warnings. It also helps consumers to understand information about a drug’s benefits and risks as well as its proper use.

The labelling, headed “Drug Facts”, makes it easier for consumers to identify active ingredients, which will be listed at the top, followed by uses, warnings, directions and inactive ingredients. The rule sets minimum type sizes and other graphic features for the standardised format but there are options for modifying this for various package sizes and shapes.

What is different?

Standardised, easy-to-follow format

The regulation requires labels to list ingredients in the same place on every product, and explain which ingredients are used to treat specific symptoms.

Critical information about the drug product

The regulation requires clear presentation of a drug’s ingredients, dose and warnings, making it easier for consumers to: understand essential information about the medication’s expected effectiveness and associated risks, determine appropriate dosage for children and adults, and compare the content of different products.

Making labels easier to understand is one obvious way to make drug consumption safer (U.S. Food and Drug Administration)

Increase in size of the label type so that it can be read easily

The regulation specifies the minimum type size for labels.

Allowance for modified format for small packages

The regulation allows packages that are too small to use the standardised label to use a modified version that includes the most essential information.

Informing the public

A public education campaign developed by the Food and Drug Administration is helping consumers to understand the new labels’ benefits. Print and radio public service announcements, consumer brochures and posters have all been used in the campaign. Working in partnership with national health and professional organizations, the Food and Drug Administration has successfully disseminated its message across a wide range of education networks.

The new label, which applies to all 100,000 over-the-counter drugs and drug cosmetics, began to appear on some products in spring 1999, and will be on the majority of products within two years. Within the next six years all over-the-counter drugs in the USA will have the new labelling.

Seminar promotes independent drug bulletins in CEE and NIS

Cooperation was top OF THE agenda as the Latvian drug bulletin CITO! hosted the first International Society of Drug Bulletins’ Regional Seminar for the Countries of Central and Eastern Europe and the Newly Independent States, held in Riga in January 1999. Over the last few years many new bulletins have been started in the region in response to the lack of practical, high quality, comparative drug information. Encouraging cooperation between them to improve standards has become one of the Society’s priorities.

Thirty-four participants from Armenia, Bosnia and Herzegovina, Croatia, the Czech Republic, Estonia, France, Kazakhstan, Kyrgyzstan, Latvia, Moldova, Poland, Slovenia, Tajikistan, the Netherlands, and the United Kingdom attended the seminar. Discussions centred on ways to strengthen the regional network of drug bulletins, and to improve the quality of drug information by promoting the essential drugs concept and rational use of drugs.

General policy issues were addressed in plenary sessions, and smaller practical training workshops focused on the skills needed to start or to improve a drug bulletin. Topics included: how to develop an editorial policy, how to improve readability, reaching target audiences, collaboration with other stakeholders, independence and financial sustainability, and access to reliable sources of scientific information.

After their discussions, participants decided to forward the seminar report to their ministries of health with a letter requesting support for independent drug information.