Online access to up to date info is needed for both HC professionals and patients
Dear Sirs,
I believe that correct, up to date information about medicines is urgently needed for both general public and health care professionals. Such a database should be created and managed by a single highly trusted body, such as the MHRA.
Online access to SPCs / PILs can be different for HCPs and for general public, but the information people get about medicines should be as correct and consistent as possible.
kind regards
Veronika
Why the contribution is important
1) Current situation is, that information in SPCs / PILs is very inconsistent and very often seriously out of date. Different MAHs have very different information included in their SPCs / PILs. This is very confusing for both HCPs and patients and seriously undermines trust in pharmaceutical industry in general. Missing and misleading information in SPCs / PILs has serious impact on public health.
2) Process of SPC / PIL update in many companies is currently slow and complicated, and many, especially generic, MAHs take advantage of this situation.
3) Generic products still can bring significant new safety information, due to large number of patients exposed to active ingredients. Low frequency signals, use in special populations, and long term effects can only be discovered in large populations, and not in clinical trials with limited number of subjects. Proper and consistent data collection across the industry is essential.
4) Screening for new safety signals should be based on evidence and evaluation of all events in a single central database, using a single method and conducted by highly trained personnel. In my opinion, appropriate methods for signal detection should be coordinated with other goverment bodies, and generally should be consistent with those used in defense industry. From my experience, it is next to impossible to evaluate correctly a signal from a small number of cases, or in a situation when data entry is conducted in an inconsistent way.
5) Different MAHs use several databases, which are in many cases impossible to validate (Excel spreadsheets). Incompatibility of databases used by different companies results in repeated data entry, especially after merges and re-organizations. Too "creative" workflow adopted by some MAHs for case processing only adds to duplication / multiplication of data, and makes proper signal detection extremely difficult.
6) In my opinion, scientific literature should be reviewed centrally by a single team of experts. This simple measure would allow MAHs to use their resources much more efficiently. Multiplication of cases originating from literature only adds to workload and does not provide any additional value.
7) From my point of view, SPC / PIL updates should be managed centrally, and should not provide too much space for "creativity".
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