Rozalina Asenova Kulaksazova
Specialized Drug Information Department, Bulgarian Drug Agency, Bulgaria

The web site of the Bulgarian Drug Agency (BDA; www.bda.bg), was produced in 1998 by the team of the Information Technologies Department and funded by BDA’s budget. Access is free and the information from the site can be downloaded. The home page (Figure 1) contains the main menu, a picture of the BDA building and its address with the ‘hot line’ telephone number. The content is organized in two languages, indicated by Bulgarian and English flags on the upper right corner of the home page. An animated banner below the flags in the upper right corner of the page focuses the attention of visitors on ‘hot topics’ for discussion, the current one being the mutual recognition facilitating procedure. The main menu has links to specific sections, as described below.

Figure 1: BDA home page

About us

This provides a link to the page that presents the BDA as the government body responsible for regulating the pharmaceutical sector in Bulgaria and for ensuring the quality, efficacy, and safety of the medicinal products sold in the country.

Scope of activities

The page behind this link describes trends and the main activities within the Agency.

Functions

Under functions, the tasks entrusted to the Agency and its social responsibilities are described, thus making the services offered by the Agency known to the general public.

BDA structure

This page shows BDA’s hierarchical structure, encompassing the Agency and its interrelated components, such as directorates and departments.

Documents of main importance

This is shown in Figure 2. It is the ‘legislative’ link giving access to basic regulations related to pharmaceuticals.

Figure 2: Documents of main importance

Six regulations are on-line, two of which have been translated into English. Three other documents concerning the marketing authorization procedure and fees payable for the expert work carried out by the Agency are also available in English. The Agency’s approved standard operating procedure is currently being set up in Bulgarian. This page is updated on a regular basis.

Marketing authorization

This link has sublinks to the medicinal products with marketing authorization granted during the previous quarter of the current year, the list of medicinal products with suspended marketing authorization, in vitro diagnostic medical devices, and the register of drug stores.

It also provides a register of all the medicinal products with effective marketing authorization, as well as a register of licensed wholesalers, in both Bulgarian and English.

Medicinal products can be searched by (Figure 3):

• trade name;
• international nonproprietary name (INN);
• ATC code;
• manufacturer.

Figure 3: Search criteria

The separate columns can be arranged in alphabetic order. Information for every medicinal product presented on the site includes the items mentioned above plus the pharmaceutical dosage.

The same link presents information on wholesalers. The search can be done in alphabetical order by the type of license they have obtained (full or partial). This information is updated on a weekly basis.

Medical devices

This link gives visitors access to the register of medical devices authorized in Bulgaria. The search can be performed by ATC code or class.

GCP (good clinical practice)

This topic deals with the main documents related to the regulation and notification form and the list of ethics committees with authorized standard operating procedures, in both Bulgarian and English. The page is updated on a regular basis.

Market analysis

Here one can find a pharmaceutical market review, based on statistical data that are updated on an annual basis.

OTC

The main menu also provides access to the list of over-the-counter (OTC) drugs by (1) OTC medicinal products and (2) OTC medical devices, updated on a quarterly basis.

Postapproval control

This information - on recalled medicinal products - is available only in Bulgarian. It contains the product trade name, manufacturer’s name, batch number, and grounds for recall for all medicinal products that have been recalled. The page is updated on a regular basis.

Pharmacovigilance

This page provides a description of the reporting system for adverse drug reactions and is available only in Bulgarian. It is updated on a regular basis.

News and meetings

This information is updated on a regular basis.

Analysis of BDA’s web site

From the information on BDA’s web site, the following conclusions can be drawn:

1. The information provided can be classified according to content.

• Administrative: About us, Scope of activities, Functions, Marketing authorization links.
• Legislative: Documents of main importance, GCP.
• Statistical: Market analysis.
• Methodological: Pharmacovigilance, News.
• Information on medicinal products: Marketing authorization, OTC, Postapproval control.

2. The frequency of updating information is one of the basic classification criteria for the information provided on the BDA web site.

• Information updated on a regular basis: administrative and legislative information.
• Information updated on a weekly basis: information on medicinal products.
• Information updated on a quarterly basis: information on medicinal products.
• Information updated on an annual basis: statistical information.

3. The information can also be classified according to the language in which it is available.

• only in Bulgarian;
• in both Bulgarian and English.

The information provided is mainly addressed to specialists working in the pharmaceutical sector and to healthcare professionals.

The tracking system provides statistics on visitors to the web site.

• The average number of daily visitors is 44.

• The average number of weekly visitors is 263 (the highest = 441).

• Visitors from different countries in Europe, North America, Asia, and Australia have visited the web site.

• Over a 65-day period, the highest number of visitors (1100) was from Bulgaria, followed by the United Kingdom (37), and Australia (29).

Discussion and comments

Who is the audience? Consumers/patients, healthcare professionals and professionals in business

How and what information can consumers find on a DRA web site? DRAs put in pieces of information aimed at specific audiences.

The minimum information a DRA web site should contain:

• all registered drugs;
• reference sources;
• all elements required for making an informed decision;
• quality control;
• important adverse drug effects.

Information provides value for money, and drug information is only 1% of the total cost of regulation.