Each year, there are multiple alerts from regulatory agencies regarding wrongly-labelled medicines. The term “labelling”, includes the physical label on primary and secondary packaging, the insert or leaflet accompanying the product packaging, the published prescribing information (PI) and the summary of product characteristics (SmPC).
Labelling errors are often identified by pharmaceutical companies, either during routine quality examination of finished product or in response to customer quality complaints. The regulatory agency alerts are usually prompted by self-notification from the marketing authorisation holder.
The impact, or risk, from these labelling errors can vary; some are cosmetic, while others can result in the wrong dosage or wrong product being administered. The direct result of such labelling errors are compounded by reputational damage (in terms of public trust and regulatory confidence in the company’s quality management system) and additional corrective/preventative costs to the manufacturer.
The labelling errors themselves can include:
- the wrong strength being printed on the primary or secondary packaging (product label or product container respectively);
- the prescribing information or patient information leaflet omitting text required by the core summary of product characteristics (SPC), possibly due to a delay in implementing a revision of the core SPC;
- the wrong medicine being shown on the labelling;
- additional and/or erroneous information included in the text;
- inconsistent or contradictory information in the different labelling components of a single product.
Public notifications of such labelling errors are factual and focus on corrective actions relating to affected product lots. The unspoken question is “how did this happen”? There can be many reasons why the answer is not openly acknowledged, though it is surely a hot-topic for conversations around the water-cooler in most companies.
Underneath the simple answer that the error was not identified before product was released to the market, there are several potential root causes. The most straightforward cause is a mix-up during the packing operation of a particular product lot. Although this is a frustrating “own-goal” which highlights a gap in the quality management system, it is relatively easy to correct and prevent in the future. The cause of error becomes more complex when it is embedded in the labelling itself, and some of these are considered below.
- Proximity to the text drafting can play a big part; author and checker(s) both make assumptions about the validity of source content or about the detail exercised by other reviewers.
- Pressure to finalise; labelling is usually the final stage of a long regulatory approval process and the expectation for rapid completion, coupled with a “good-enough” culture (to avoid reinvention of the wheel and last-minute pedantic changes), can work against accurate proof-reading and late revision requests.
- Using previous or similar documents as the template; the “Save As” efficiencies to avoid reinventing the wheel, or to ensure continuity of the house style, can allow the original information to be perpetuated, when it should be revised or deleted. This is more likely when the individuals performing these tasks are goal-oriented but far-removed from the context, the meaning, or the basic arithmetic, which underpins the content.
- Printer’s errors; these may similarly arise from use of a previous template which was then checked by readers at the procurement stage who lack sufficient knowledge of content. There are additional challenges when the proof for a three-dimensional object (such as a carton) is presented for checking, because the two-dimensional plate requires particular spacial skills to confirm that all printed elements are oriented correctly.
Queen’s House Consulting can offer independent proof-reading checks for new or revised medicinal labelling. While recognising that the originating company will have the best expertise in that field, our fresh and detached view can identify inconsistencies which may have slipped through in-house review at the end of a lengthy regulatory process. We can also flag those elements which may need particular confirmation by the in-house experts. If you would like to benefit from these services, please contact Queen’s House Consulting to discuss your particular needs.
