The strongest and best-documented risk factor for drug hypersensitivity (DH) is the history of a previous reaction. Accidental exposures to drugs may lead to severe or even fatal reactions in sensitized patients. Preventable prescription errors are common. They are often due to inadequate medical history or poor risk assessment of recurrence of drug reaction. Proper documentation is essential information for the doctor to make sound therapeutic decision. The European Network on Drug Allergy and Drug Allergy Interest Group of the European Academy of Allergy and Clinical Immunology have formed a task force and developed a drug allergy passport as well as general guidelines of drug allergy documentation. A drug allergy passport, a drug allergy alert card, a certificate, and a discharge letter after medical evaluation are adequate means to document DH in a patient. They are to be handed to the patient who is advised to carry the documentation at all times especially when away from home. A drug allergy passport should at least contain information on the culprit drug(s) including international nonproprietary name, clinical manifestations including severity, diagnostic measures, potential cross-reactivity, alternative drugs to prescribe, and where more detailed information can be obtained from the issuer. It should be given to patients only after full allergy workup. In the future, electronic prescription systems with alert functions will become more common and should include the same information as in paper-based documentation.

• Klíčová slova
• documentation, drug allergy, drug hypersensitivity, education, prevention,
• MeSH
• čipové karty ve zdravotnictví * MeSH
• dokumentace * metody   MeSH
• léková alergie diagnóza   etiologie   prevence a kontrola   MeSH
• lidé MeSH
• průzkumy a dotazníky MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Evropa MeSH

Biopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational drug therapies that is contributing significantly to advancing treatment in multiple disease areas, including inflammatory and autoimmune diseases, genetic deficiencies and cancer. Unfortunately, unwanted immunogenic responses to BPs, in particular those affecting clinical safety or efficacy, remain among the most common negative effects associated with this important class of drugs. To manage and reduce risk of unwanted immunogenicity, diverse communities of clinicians, pharmaceutical industry and academic scientists are involved in: interpretation and management of clinical and biological outcomes of BP immunogenicity, improvement of methods for describing, predicting and mitigating immunogenicity risk and elucidation of underlying causes. Collaboration and alignment of efforts across these communities is made difficult due to lack of agreement on concepts, practices and standardized terms and definitions related to immunogenicity. The Innovative Medicines Initiative (IMI; www.imi-europe.org), ABIRISK consortium [Anti-Biopharmaceutical (BP) Immunization Prediction and Clinical Relevance to Reduce the Risk; www.abirisk.eu] was formed by leading clinicians, academic scientists and EFPIA (European Federation of Pharmaceutical Industries and Associations) members to elucidate underlying causes, improve methods for immunogenicity prediction and mitigation and establish common definitions around terms and concepts related to immunogenicity. These efforts are expected to facilitate broader collaborations and lead to new guidelines for managing immunogenicity. To support alignment, an overview of concepts behind the set of key terms and definitions adopted to date by ABIRISK is provided herein along with a link to access and download the ABIRISK terms and definitions and provide comments (http://www.abirisk.eu/index_t_and_d.asp).

• Klíčová slova
• ABIRISK consortium, anti-drug antibodies, biopharmaceuticals, immunogenicity,
• MeSH
• alergologie a imunologie normy   MeSH
• farmaceutický průmysl organizace a řízení   normy   MeSH
• léková alergie imunologie   prevence a kontrola   MeSH
• léky zkušební škodlivé účinky   normy   terapeutické užití   MeSH
• lidé MeSH
• organizační inovace MeSH
• organizační politika MeSH
• referenční standardy MeSH
• směrnice jako téma normy   MeSH
• terminologie jako téma * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• léky zkušební MeSH

• MeSH
• kočky MeSH
• léková alergie prevence a kontrola   MeSH
• lidé MeSH
• nemoci vnitřního ucha etiologie   MeSH
• poruchy sluchu etiologie   MeSH
• streptomycin škodlivé účinky   MeSH
• vestibulární aparát účinky léků   MeSH
• vestibulární funkční testy MeSH
• zvířata MeSH
• Check Tag
• kočky MeSH
• lidé MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• streptomycin MeSH

• MeSH
• chorobopisy * MeSH
• léková alergie prevence a kontrola   MeSH
• lidé MeSH
• nemoci z povolání prevence a kontrola   MeSH
• zdravotní výchova MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH