Tuesday 24 January 2023

Types of errors with pharmaceutical labeling and packaging

Image: Ralf Roletschek CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=20717356

Labeling errors arising from the manufacturer of the medicine are a product of poor packing practices. Bad packaging is itself the result of deficiencies in the quality assurance system. Errors with packaging and labeling can have serious consequences, and packaging defects can create problems that may result in drug recalls. Such defects may include breakage, and problems relating to printing or inks, or errors on labels and package inserts (patient information leaflets). The use of GMP and quality control will prevent the release of a defective medicinal product.

By Tim Sandle

Errors with labels can occur from several sources, such as human error, technical errors, errors pertaining to source information and so on. Common errors with labels include labeling the wrong product, spelling or grammatical mistakes, labeling on the wrong side of the package, similar labels on two different products, wrong expiry dates and translation errors. Other errors include incorrect or nonexistent barcodes on packages, and the wrong packaging of products in different packages.

Beyond this, the types of errors that can arise due to labeling issues are varied. Some examples are:

  • Gross Errors – These occur when necessary information is missing from label artwork. This type of error most often occurs when regulatory requirements change but the manufacturer fails to change the package artwork in response to the new guidelines.
  • Context and Meaning Errors – These types of errors occur when information on the label artwork is presented in an unclear or ambiguous way. A context or meaning error could occur if incorrect punctuation is used on the label. 
  •  Content Errors – These occur when there are significant errors in the detailed content of the artwork. The error could be due to the incorrect usage of a symbol on the package label.
  •  Technical Errors – These errors are in functional components of the artwork, including the product barcode.

Furthermore, errors noted by regulators include:

  • Key information, such as the product name, strength, and dosage form, is missing; is expressed in a confusing manner; or is not prominently located and displayed.  A product’s strength or concentration is critically important information for the end user.  If the product strength is not clearly displayed on the container label or is expressed in units of measure that are incongruent with those used in the dosing instructions, the wrong strength can be selected, or the wrong dose administered. Typically, the dose or expression of strength should appear in metric units of measure such as mL, mg, and mcg, rather than apothecary or household measurements (e.g., tsp for teaspoon).
  •     Key information does not appear in the same field of vision (i.e., the information is not readable without having to turn or rotate the container).
  •     Container labels and carton labeling look similar across multiple strengths of the same product or across multiple products within a company’s product line.
  •  Container labels and carton labeling look similar among multiple products from different manufacturers.
  • Container labels and carton labeling are visually cluttered by extraneous text or 107 distracting images and graphics.
  •  Error-prone abbreviations or symbols are used.
  • Text is difficult to read because of font size or style, insufficient color contrast, or other design elements.
  •  Overlapping text is printed on both sides of a clear, transparent, or translucent container label such as those that might be found on syringes, ampules, vials, intravenous bags or low-density polyethylene (LDPE) vials.

Many errors occur due to complexity and it is worthwhile undertaking an exercise that seeks to simply documentation.  Errors can be addressed through reviewing the artwork and label process as an aspect of data integrity. Key to this is developing and creating a data integrity focused culture.

It is important that each producer of medicinal products has written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials. It is also of importance that these written procedures are followed. There should also be regular checks in place with labeling and packaging materials being representatively sampled and examined or tested upon receipt and before use in packaging or labeling of a drug product.

It is not only of importance that such information is accurate and legible, it also needs to be understood. It remains that some instructions and precautions remain unnecessarily complex and are seldom tested for comprehension among consumers to include their feedback in the development process. This is a point that pharmaceutical and healthcare manufacturers should consider.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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