Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 41

There is also a trend toward reporting from standardized lists of drug names, medical and surgical history, AE codes, laboratory data, and demographic codes. This allows people to document AE cases in a standardized language and format that is easily translated by the computer into any other language. The only area proving resistant to this computerization is the medical narrative, where a case is summarized in prose in a few paragraphs such that the reader can get an understanding of what happened to the patient. Whether a computer-derived narrative (or no narrative at all) will prove to be as useful as a narrative prepared by a safety-trained healthcare professional remains to be seen. Harnessing artificial intelligence and machine learning may facilitate this.

Interestingly, English has become the international language of AE reporting. PSURs and E2B transmissions are written in English. Some countries require translation of some or all sections, but this is becoming less prevalent as short time frames and international harmonization are requiring that English be the language of drug safety — at least for 15-day expedited reporting and periodic reporting. Sometimes AEs occurring in a particular country must be reported to the national health authority in the language of that country rather than or in addition to English.

After the report is received or uploaded to the database in a company’s safety department, it must be logged in and a unique number assigned (either before or after a search for duplicate cases). How this is done depends on whether the case arrives electronically or has to be manually entered into the safety database. A rapid determination must be made by a medical professional to see whether it is an “expedited” or “alert” report that must be sent to the health authorities within 15 calendar days of first arrival. The data must be entered into the database (if not already uploaded), coded, medically reviewed, quality-checked, and dispatched outside the company to the appropriate health authorities, subsidiaries, and business partners, as well as to others inside the company such as clinical research physicians who follow the safety profile of the drug in question. Any horrific AEs that might produce immediate regulatory or public health problems must also be identified and acted on urgently.

From a more general point of view, the wisdom of relying on spontaneous reporting of AEs, and thus trusting the goodwill and timely reporting of the healthcare community and patients, has been seriously questioned in the past few years. As several drugs have been withdrawn from the market or have had urgent labeling changes made following the reports of severe toxicity, the search for a more efficient method of rapidly identifying new safety issues is under way in many quarters. The FDA and EU continue to examine its spontaneous reporting system for efficiency and other health agencies around the world are also examining better mechanisms to capture SAEs.

It is highly likely that electronic healthcare records will in time supplant the spontaneous AE reporting systems now in place. With the electronic tracking of all patients’ encounters with the healthcare system (prescriptions given and filled, doctor visits, hospital stays, complaints and diagnoses recorded in standardized forms, etc.), it is likely that health agencies and possibly companies will be able to “mine” the information using complex search algorithms and artificial intelligence tools to do real-time SAE tracking. Prospective use and epidemiology studies will become feasible. Adding genomic data, health economic information, and other data will transform the drug safety surveillance system. This is not likely to happen soon and there will surely be false starts and dead ends in the quest to obtain drug safety data, but there is little doubt that this will occur to everyone’s (presumed) benefit. Note also that the regulations for the handling and reporting of post-marketing AEs are not static in spite of “harmonization”.