WHO model website

While health information proliferates on the Internet and e-trade increases worldwide, there is a growing need for health professionals and patients to have access to reliable, independent information on pharmaceutical products. Provision of information, including laws and regulations, helps to maintain public confidence in the work of regulatory authorities and pharmaceutical products in general.

In order to respond to this need, WHO has undertaken to develop a model website for use by drug regulatory authorities wishing to create their own website or improve an existing one. Before development of the project could begin, the most important pieces of information that a drug regulatory authority website should contain were identified in a list of objective, reproducible criteria designed to serve as the gold standard for the analysis. An assessment was then made of the quality of information currently contained on existing websites in different languages and regions and at different levels of sophistication. Those countries having a drug regulatory authority website were identified through a search of the Internet or contacting the national or drug regulatory authority in each country.

In parallel, a bibliographic search was carried out on assessments of health information websites. A set of key criteria was developed relevant to WHO priorities and policies on health information which included different types of drug information. Criteria were identified and a scoring system was devised to weigh content, links, interactivity, accessibility and target user balance (2).

General criteria

User friendliness: First impression and general appearance is most important when accessing a Website. Pages should be designed attractively and entice further exploration; information should be presented logically and clearly enough to be successfully manipulated by the intended users. Information should be easy to find and available in the national and, whenever possible, another widely used language for international users.

Site map: A good map will indicate logical links and organization of the site; it explains how to navigate through pages and indicates where to go and how to get there.

Navigability: This is the characteristic that allows a user to obtain effectively important information. Accessibility, logical organization, and internal search engines are essential.

Speed: The home page and subsequent links (except those from websites outside the control of the regulatory authority) should be displayed within 4 to 5 seconds.

Search: The site should have its own search engine, which also permits a search or hyperlink to other sites.

Update: The website should state the date on which it was created and when last updated. The site is regularly reviewed.

Specific criteria

Mission statement: The mission statement and purpose of the drug regulatory authority is clearly stated and easily accessible. Activities and programmes are described.

Contact information: Contact information with names, addresses, telephone, fax and e-mail should be readily available, complete and up-to-date for each activity. A responsible person or service should be identified to obtain further information.

Organizational structure: The structure of the drug regulatory authority should be available, complete and up-to-date. It allows information on each department to be obtained by selection.

Services: The site offers information related to the drug regulatory authority. The data are clearly organized and easily understood by the users. The site does not contain language which is persuasive, but informative.

News, events and meetings: The site should mention and describe news, events, and planned meetings and has a calendar which is regularly updated.

Safety alerts: Patient and health professionals have easy access to safety alerts by date and product name: information covers recalls, suspensions, revocations, recalls (batch is also mentioned), withdrawals, Dear Dr Letters and labelling changes. The information should be comprehensive, detailed, and chronological.

Adverse drug reactions (pharmacovigilance): The site contains a definition of terms, the procedure for reporting of adverse drug reactions and adverse drug events, how to report on-line, links to useful sites, latest pharmacovigilance reports, etc.

Feedback form: A facility should be available for enabling any user to contact the agency, either to ask questions or to report problems. This feedback form should be complete, easy to download and send back to the regulatory authority.

Regulatory guidance on legislation and regulations: Guidance, including laws, decrees, orders and any legislative and regulatory material related to pharmacy, drug manufacturing, drug registration process, commerce, information on promotion and advertising or e-trade, including the WHO ethical criteria for medicinal drug promotion, should be available.

Instructions for marketing applicants: Information for applicants should be present with a sufficient degree of detail to assist the preparation of registration dossiers, composition of the file, list of documents to file for a first submission, variations, renewal, extension, transfer of marketing authorization. Information on fees, norms, standards and guidance for pharmaceutical production, drug registration and accelerated approval procedures. Information on drug regulation and quality assurance systems, drug regulatory information, guidelines for good clinical practice (GCP) for trials on pharmaceutical products, etc.

Forms which can be downloaded: These should include, among others, a marketing authorization or clinical trial application form, variation application form, and template of summary of product characteristics.

Medicinal products (human/veterinary medicines): This criteria is most important. The website should include:

• The list of drugs authorized in the country, including the generic name, presentations (dosage form and strength), patient information leaflets, summary of product characteristics, labelling, etc.

• A search facility, which permits the user to find items either by brand name, marketing authorization holder, INN/generic name, or therapeutic group.

• The list of cancelled marketing authorizations.

• Information on orphan drugs.

• Products under special postmarketing surveillance.

Approved manufacturers: Information on manufacturers in the country should be presented and easily readable. A list of approved manufacturers - name, address, contact, licence status, last inspection date, etc should be available. Charts or graphics should enhance information rather than distract from it.

Import and export: Statistics on import and export, guidance for importers, exporters, and the WHO type certificate, should be presented and easily readable.

Approved wholesalers, distributors, pharmacies: A list of approved wholesalers, distributors, pharmacies with information on activities and volume of business should be presented.

Basic statistics on drug consumption: The site should offer information covering:

• Global consumption data.
• Quantity of packages sold in pharmacies.
• Consumption at hospitals.
• Data on OTC sales.
• Quantity of drugs produced, etc.

Basic statistics on country profile: The site should contain information such as the pharmaceutical market size.

Basic statistics on drug regulatory authority activities: The number of new drug applications received, pending applications, time taken to process applications, positive or negative decisions, applications withdrawn, inspections of pharmacies, wholesalers, manufacturing sites, etc.

Links: Hyperlinks to other pages and sites should be:

• Worthwhile and appropriate for the intended audience.
• Clearly labelled and serve an easily identifiable purpose.
• Of added value to the Website.
• Current and operating efficiently.
• Grouped in some type of logical order.

Links related to medical journal Websites, national drug regulatory authorities, and international links should be accessible.

Publications:

• Sources of information cited should be reliable, pertinent and identified.
• Publications should be downloadable with a bibliographic list of references which is current.

The publications page should contain, for example, the annual report, quarterly report, cumulative list of recalls, safety alerts, and other decisions that restrict use of medicinal products. Guidance materials, latest list of approved products, latest list of approved manufacturers, wholesalers, importers, distributors, medical journals, newsletter and periodicals, etc.

Conclusions

Very few drug regulatory authorities offer their information resources via a website to an Internet audience. Indeed, many drug regulatory authorities do not have a website, and those that have one seem to have either a very small amount of information, or a vast amount of information which is difficult to access. Most websites do not post independent drug information, and very few provide access to drug marketing authorizations or approved drug information. The quality of health information provided is very heterogeneous and could benefit from improvement.

Without drug information, health-care providers and consumers may be uncertain as to which drugs are approved for treating conditions, which drugs meet national regulations and which drugs may be imported. For consumers, problems are exacerbated by the growth in pharmaceutical e-trade, which is unregulated. Ensuring rational use of drugs and efficient drug supply in this situation becomes even more difficult. At the same time, lack of drug information can suggest that drug regulatory authorities are not “transparent” enough, ultimately leading to poor trust in the quality and legitimacy of their work.

Drug regulatory authorities should provide reliable drug information for consumers/patients, health professionals, public and private sector organizations (hospitals, manufacturers, importers etc.), making it more available and easily accessible. The Internet is a powerful information tool that has proved to be a source of valuable, good quality information on approved drugs, treatments and medical products available on different national markets.

Future activities

The criteria set out in this article were developed by WHO and presented to drug regulatory officials and representatives of nongovernmental organizations as part of the work towards creation of a WHO model website. It is intended that the model website will be pre-configured with WHO Guidelines and working data, with the minimum set of information to be defined that is related to the core functions of a drug regulatory authority, as far as confidentiality rules and data security allow.

As part of the project, WHO will assist a selected number of interested countries in establishing a Website based on the WHO model. At a future stage, the model Websites will be validated through a panel of users from different stakeholders.

The benefits that drug regulatory authorities will gain from the model Website initiative will contribute to:

• Increasing the transparency of their own activities.

• Improving collaboration between drug regulatory authorities, health professionals and academics.

• Improving the public health impact of drug regulatory work.

• Facilitating networking between drug regulatory authorities to solve drug regulation problems.

• Offering reliable and unbiased drug information to guide Internet users.

Additionally, increased availability of drug regulatory information will combat substandard and counterfeit drugs by enabling verification of product registration status in countries and alert drug regulators and health care providers to regulatory action in other countries.

References

1. WHO Drug Information, 13(3): 163 (2000).

2. http://www.who.int/medicines/library/qsm/who-edm-qsm-99-4/who-edm-qsm-99-4.htm

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6. Net scoring: criteria to assess the quality of health Internet information. Centrale santé. http://www.churouen.fr/netscoring/netscoringeng.html

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