Provision of safety-related information on pharmaceuticals and tasks associated with them ("BESI"): toxicological part

Status:

completed 12/2013

Aims:

Several million people in Germany's health services work with pharmaceuticals. However, the German Medicinal Products Act (AMG) makes no provision for mandatory marking of pharmaceuticals with the usual hazard symbols under the legislation governing dangerous substances. Workers in nursing care, doctors' surgeries, pharmacies, etc. often have little knowledge of the health risks associated with contact with these substances. The aim of the "BESI" project launched by the German Social Accident Insurance Institution for the health and welfare services was to obtain and evaluate safety-related information on pharmaceuticals and the associated tasks in order for specific protective measures to be defined from the resulting data. Within this project, the IFA was asked to gather information on the toxicological assessment of this group of substances, in particular regarding their carcinogenic, mutagenic, reprotoxic/teratogenic and sensitising properties.

Activities/Methods:

With reference to the example of anti-infective agents, relevant toxicological information was gathered, in particular from the following sources: safety data sheets of the European Directorate for the Quality of Medicines & HealthCare (EDQM); prescribing information for the proprietary medicinal products containing these active agents, European Public Assessment Reports (EPARs); the relevant data from the US Food and Drug Administration (FDA); and the Toxicology Data Network (TOXNET) of the United States National Library of Medicine (NLM). The data were evaluated by a group of experts comprising pharmacologists, toxicologists and prevention experts. The objective was to assign the active agents under consideration to three hazard categories according to clearly defined criteria.

Results:

The information (in many cases limited) that could be used for OSH purposes on the toxicological properties of pharmaceuticals was compiled for 93 lead substances from the category of anti-infective agents and described in "agent dossiers". Each agent was classified within the system below according to criteria defined in the project support group, primarily on the basis of carcinogenic, mutagenic or reprotoxic (CMR), sensitising or other harmful properties:

S: Sensitising substances

1: Toxic or highly toxic substances and substances with known CMR properties

2: Substances suspected of having CMR properties

3: Substances harmful to health without CMR properties, including irritative or caustic substances and substances for which sufficient grounds for a higher classification do not exist

The study found that over 50% of the anti-infective agents evaluated had to be classified in the BESI "S" category owing to their potentially sensitising properties. 28% of the 93 lead substances are active agents with known CMR properties and/or with toxic and very toxic properties stated on the safety data sheets (BESI Category 1).

This completes the assessment in the BESI project of the toxicological properties of the selected lead substances. In a second module, for which the Institute of Occupational, Social and Environmental Medicine of the University of Mainz assumed responsibility, the actual exposure to the active agents at the workplace was studied. At the end of the project as a whole, the toxicological assessments and the exposure data obtained are to be merged, and a uniform marking system proposed that will be coupled to a specific catalogue of protective measures.

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