Dr Lembit Rägo, Ms Elodie Jambert, Mr Jorg Hetzke
Department of Essential Drugs and Medicines Policy, World Health Organization, Geneva
The WHO Model Web Site is based on the list of criteria used to assess DRA web sites (Figure 1). Different sections should be available through the main headings, as described below.
Figure 1: Model home page
In ‘about us’, the users can find a mission statement, contact information, and location (the DRA address, name of the contact person for general enquiries, a map, how to get there, and the opening hours), as well as information about services, the organizational structure, and a help section with frequently asked questions (FAQs).
News, events, and meetings
There should be a calendar that is regularly updated and transparent, along with news, events, and meetings planned.
Patient and health professionals should have easy access to safety alerts by date and product name: recalls, suspensions, revocations, recall procedures. The information should be comprehensive, detailed, and chronological. Batch size should also be mentioned.
The web site should also contain pharmacovigilance information, with a definition of terms, the procedure to report adverse drug reactions and adverse drug events (on-line, etc.), links to useful sites (for example, the WHO International Drug Monitoring Programme), recent pharmacovigilance reports, etc.
Regulatory guidance, such as laws, decrees, and orders and any legislative and regulatory material related to pharmacy, drug manufacturing, drug registration processes, commerce, information, promotion and advertising, and e-trade should be available.
Medicinal products (human and veterinary)
The list of authorized products - both human and veterinary medicinal products - should be available (Figure 2). A list of marketing authorization revocations, orphan drugs, products under special post-marketing surveillance monitoring, the summary of product characteristics, the patient information leaflets should also be presented on the web site.
Figure 2: Example of information on approved products
There should be a search engine (Figure 3) that permits finding a product by brand name, INN, or marketing authorization holder, among other things.
Figure 3: Example of search engine for authorized products
The kind of information available for a product should include generic name, strength, dosage form, packaging, company, etc. (with more information found by clicking on the generic name).
Statistics about DRA activities, drug consumption, and a country profile should be available (Figure 4).
General information and audience-specific information (for consumers, health professionals, applicants, and manufacturers) should be presented.
Figure 4: Example of web page related to statistics
General information: E-trade
Information and warnings about buying drugs online should be provided to consumers and patients (Figure 5).
General information: Information exchange and discussion groups
Different links should be provided to permit visitors to join electronic discussion groups, such as edrug (http://www.healthnet.org.np/), WHODRA, WHO Mednet, etc.
Audience-specific information: Information for consumers
General information about medicinal products, diseases, and health issues should be made accessible to consumers (Figure 6). Audience-specific information: Information for health professionals
DRAs can provide information for health professionals on safety issues, clinical trials, orphan drugs, medical devices, medicinal products, rational drug use by health professionals, infectious diseases, drugs used in HIV-related infections, etc.
Figure 5: Example of information related to e-trade
Figure 6: Example of general information for consumers
Audience-specific information: Information for applicants
Information for applicants should be presented with a sufficient degree of detail to enable the preparation of application dossiers: composition of the file, fees, document to file for first demand, variations, renewal, extension, transfer of marketing authorization, norms, standards and guidelines for pharmaceuticals, drug registration processes and procedures, and accelerated registration procedures (Figure 7).
Figure 7: Example of information for applicants
Information on drug regulation and quality-assurance systems should also be included, as well as guidelines for good clinical practice for trials on pharmaceutical products, etc.
Audience-specific information: Information on pharmacies
A list of approved wholesalers, distributors, and pharmacies (with addresses, phone numbers, licence status, last inspection date, etc.) should be presented along with information on their activities and volume of business.
Audience-specific information: Information on pharmaceutical companies
Information or statistics on manufacturers in the country should be presented and easily readable: a list of approved manufacturers (name, addresses, contacts, licence status, last inspection date, GMP certificate, etc.). If charts or graphics are included, their quality should be good and should enhance the content rather than distract from it.
A selection of Internet links to other DRA web sites, EMEA, and medical journals should be provided, as well as international links related to medicines, such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), WHO, etc., and European links to such sites as the European Commission, European national agencies, etc.
The site should have its own search engine, that permits searchers either by key words or with an ‘A-Z’ index. It should also permit searches for other sites (Figure 8).
Figure 8: Example of search engine
The documents produced by the DRA should be able to be downloaded and consulted (Figure 9).
Figure 9: Example of publications web page
A site map shows logical lines and the organization of the site. It should clearly show how to navigate through all pages (Figure 10). Users should easily be able to find out where to go and how to get there. The ‘buttons’ or menu items should be labelled using clear language.
Discussion and comments: Review of WHO Model Web Site
The WHO Model Web Site is too detailed. WHO has to define its priorities for the site: i.e., the minimum block of information - the minimum list you need to provide. Suggested minimum content should include information about the DRA itself, information for consumers/patients, and relevant legislation.
Figure 10: Example of a site map
In the discussion, participants proposed diversifying the WHO model into three levels:
1. basic: only information on decisions by the DRA that are their ‘core’ business (registration database, SPCs, PILs, monographs, DRA decisions, etc.);
2. intermediate: useful additional information (drug information, treatment guidelines, prices, addresses, etc.);
3. expanded: information that is ‘nice to have’.
General changes suggested for the WHO Model Web Site
• Delete ‘services’ from the main menu and move under ‘contacts/about us’.
• Separate news from events and meetings.
• Contact information should include information on external contacts to related agencies (such as anti-poison services) and medical institutes in addition to internal contact information.
• Guidance should be provided on where and how to find reliable information.
• Information should be grouped by interest (patients and consumers, business and healthcare professionals), and by level (e.g., with different colours).
• The heading ‘safety alerts’ is too long. ‘Alerts’ should be removed from the heading so that it says ‘safety’ only.
• Complaints - what should be done about complaints?
• Publications - everything the authority publishes should be on the web site, regardless of whether it must be paid for or is free.
• Medicinal products should be replaced by ‘authorized products’. For the countries that have WHO’s Model System for Computer-assisted Drug Registration (SIAMED), the list of authorized products should be directly linked to SIAMED. Information about immunological products should be provided (allergy, etc.). The definition of terms for ‘drugs’ or ‘medicines’ should be discussed and should be clear to everybody. Advice on veterinary drugs should also be presented.
• A good site map is essential. Entry points for the different users should be easily accessible, with shortcuts by major needs or target groups (consumers, healthcare professionals, businesses).
• ‘Regulatory guidance’ should be replaced by ‘laws and regulations’ and should contain legal documents, etc., as well as the legal framework on which DRA activities are based and the procedures for decision making.
• The entire supply system should be described. The drug supply system should have links.
• For a quality web site, you need qualified staff and sufficient resources: Denmark’s DRA has one IT person and one coordinator who runs the site; in addition, all staff prepare and provide technical information.
• The idea of a customizable site was suggested: i.e., a site that could be configured for basic, intermediate, and advanced users. One can think of a personalization system where a person logs on by identifying her/himself as belonging to a user group. The Swedish Pharma Industry uses interactive identification, for example. The Swedish industry site asks the user to choose an interface for one of the following: regulator, patient, health provider, or ‘general’ user.
• The date of creation and last update must be mentioned.
• Rapid upgrading is essential.
• Information can be categorized by how often it should be updated: immediately, quarterly, and once a year.
Information for consumers
• The health issues contained too much information.
• Legislation is also important to consumers.
• Links to sources of reliable information and other institutions could be provided (e.g., to WHO’s disease-oriented pages).
The mission statement
Simply stating the mission is not enough. The plenum suggested a minimum set of information on the DRA, which should include the following:
• Who we are. What we produce and provide. What the web site contains.
• A list of contact information showing what the DRA is doing, with a description of its activities (e.g., what the DRA is responsible for and what it is not responsible for). The prime lines of responsibility, duties of the authority; comments on basic responsibilities.
• DRAs should state clearly what they want to show on the web site: only information exclusively available to the DRA, with links to originators/holders of other information.
• Rational therapy information should be provided (i.e., how to use the medicines).
• List of registered drugs.
• Changes in drug status: e.g., when a drug changes from prescription to OTC, etc.
Any site should be based on a documented quality-assurance system. There was a discussion on quality labels for Internet web sites dealing with medicines, as proposed by the Nordic Council on Medicines; a further label is now being implemented by IFPMA.
A web site will only be successful if:
• It is based on a functional regulatory body with clearly structured information;
• It knows its audience;
• It routinely maintains its data;
• It has dedicated support staff.
A site should be presented in its national language and English.
• Specific consumer information is missing.
• Treatment guidelines and disease information are missing.
• Links to psychotropic drugs are missing.
• Basic WHO information, such as a WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, is missing.
• The model web site can be used to add a link to SIAMED (which is one advantage of a computerized registration process), and it could also be packaged with WHO reference/guidelines information on health and medicines.
• Other items that could be included:
• a glossary;
• address lists for pharmacies, with opening hours;
• drug side effects;
• poison information, first aid;
• training courses for chronic diseases;
• clear identification of medicines registered, and those marketed.
MCC was asked whether it would be willing to test the new ‘model web site’. The ‘new’ MCC web site could initially be hosted on WHO’s computers, and it is likely that WHO/EDM IT staff could assist in the development. For example, patient organizations were invited to test the Swedish industry site, which is also designed for use by disabled persons. Usability testing should be carried out, including usability by handicapped people.
The US Food and Drug Administration (FDA) keeps a list of DRA web sites (http://www.fda.gov/oia/agencies.htm). MCC should inform the FDA about its web site as it is not yet listed.
Sites must be based on a documented quality-assurance system. The points to consider are quality assurance, internal guidelines, etc. The European Union has developed guidelines on quality criteria for health-related web sites . As the volume of information increases, mechanisms for controlling the quality of this information are required. A content-quality group looks at information posted.
A specially designed contact point for problems (such as counterfeit drugs, problem drugs, and unregistered products) would be useful. A panel could eventually be used for managing feedback.