DRUG PORPHYRINOGENICITY MONOGRAPHS IN THE DRUG DATABASE FOR ACUTE PORPHYRIA
Erik Pomp *, Stig Thunell § and Atle Brun *
*Norwegian Porphyria Centre, Haukeland University Hospital, Bergen, Norway, §Porphyria Centre Sweden, Huddinge University Hospital, Stockholm, Sweden
The drug database for acute porphyria (as presented at this conference by the same authors) has been developed as a practical clinical tool to which can be used as an aid in prescribing problems for patients suffering from acute porphyrias. Establishing prescribing guidance for patients with acute porphyria is a very difficult task. All relevant information needs to be collected and evaluated in a systematic way. Porphyrinologists need a comprehensive source which provides insight in the evidence supporting prescribing guidance. This information can be found in The Drug Database for Acute Porphyria in documents called drug porphyrinogenicity monographs.
Each monograph contains a porphyrinogenicity classification (Porphyrinogenic - Probably porphyrinogenic - Possibly porphyrinogenic - Probably not porphyrinogenic - Not porphyrinogenic), as well as a rationale for the given classification and other background information. The following headings form the outline of a monograph: Substance - ATC code - Risk class - Rationale for risk classification - Most recent revision - Therapeutic use – Metabolism – Pharmacokinetics - Extent of hepatic exposure - Clinical observations - Porphyria drug lists – References.
To gather data, bibliographic searches are performed (standard literature searches include boolean combinations of the drug and an array of predefined elements). Several commercial drug databases are consulted. Summaries of product characteristics from drug manufacturers are consulted as well. Personal communications from porphyrinologists are of major importance, and these are therefore incorporated in the monographs. Available prescribing guidance concerning acute porphyries from other sources is referenced.