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Pharma’s SmPC Low Hanging Fruit – SmPC Patient Safety Impact

  • SmPC is a legal document used by healthcare professionals that provides information on the drug including the set dosage and other key information.
  • Even with strict regulation with rigorous guidelines and structure for the information contained in SmPC, too often information has been found incomplete. 
  • Major gaps have been discovered in the information on dosages in different patient subpopulations, mainly regarding adjustments and contraindications.
  • Significant differences have been found between SmPCs of generic and original or ‘brand’ products with the same exact active ingredient compositions.
  • Manual labeling is falling short and patients are paying the price. Pharma companies need to invest in an automatic labeling process to protect patient safety.

What is SmPC (Summary of Product Characteristics)?

SmPC or Summary of Product Characteristics is the legally required document providing essential information on the composition, dosage, interactions, effects, and more imperative details and instructions for any drug or medicine. In Summary of product characteristics (SmPC) – Detecting and Managing Updates in SmPC, we dive deeper into the components of SmPC and the tedious antiquated processes to update them. I highly suggest visiting that page first, to gain a fundamental background on all things SmPC. Here we’re going to look closer at the healthcare professional relationship with SmPC and the patient safety implications that can come from it.

Why is SmPC so Important?

One of the most important roles of the SmPC is to inform healthcare providers. The information contained in the SmPC is critical for pharmacists and physicians to ensure the proper and safe use and distribution of medicine. 

For this to work effectively, the SmPC has to be in a complete, understandable format for quick and easy use for these professionals who are constantly pressed for time and reading hundreds of medical documents.

Physician Readability

Since we know the main purpose of the SmPC is to communicate with healthcare professionals, it’s probably super easy for them to read right? Errrtt. Wrong. 

Studies show physicians actually find most SmPCs lack sufficient information and the ones that don’t, make the information too difficult to find. Many recommendations have been made to improve the readability of this document for physicians, such as increasing the visibility of headings and moving essential information to places it can actually be located by readers, like a key information section at the beginning and placing all related information in one consistent location.

Wasting time searching for information that’s always in different places, and sometimes even missing, is not what we want our physicians depleting their efforts on.

Incomplete Information

Physician readability is the first component in the complicated relationship between patient safety and SmPC. Our healthcare professionals need to be able to read and understand this document to properly use it, but it’s not going to get them very far if the information isn’t there in the first place. Although there is strict regulation with rigorous guidelines and structure for the information contained in SmPC, too often information has been found incomplete. 

Major gaps have been discovered in the information on dosages in different patient subpopulations, e.g. adjustments and contraindications. This information is so crucial to patient safety as it informs doctors what patient subpopulations cannot take certain medication (or need adjustments to dosage to be safe for consumption) due to the harm it could cause to the patient, and even potential death. 

Look we get it, the information that fulfills the SmPC for a particular drug goes through a wild ride from the lab to the hands of the physician. Healthcare providers only see the end of the ride and not the extensive process it took to get all the proper information there. As you can see, the global labeling process involves a complicated and delicate ecosystem with many simultaneously moving parts. 

One reason this information is getting left out is that it’s often the result of endpoint studies done by pharmaceutical companies. These results should be included in study reports and then in the SmPCs. In one study specifically looking at drugs and patients with hepatic impairments, the European Medicine Agency (EMA) published a guideline with recommendations on reporting the pharmaceutical endpoint study for this patient subpopulation. However, even with this governmental recommendation, in 2015-2017 of 51 registered medical products, 15 did not contain the required dosage information specifically for patients with hepatic impairments. For 60% of the drugs evaluated, they found the dosage recommendations and safety information for this subpopulation was unavailable and/or worded ambiguously. Ambiguity has no place in an SmPC. Phrasing like “use with caution” or “not recommended” can be very confusing and leave a very serious health matter open to interpretation. 

To put it in relatable terms, it’s like driving on Main Street after a big storm when the traffic lights are out, all of a sudden the rules of the road are open to interpretation. I think most people can agree that  “open to interpretation” is the last thing we want our healthcare to be. 

Discrepancies between Generic and Original ‘Branded’ Products

The last issue we’ll address here in the relationship trifecta is the inconsistencies found between drugs and medicinal products with the same qualitative and quantitative properties. In simple terms, significant differences have been found between SmPCs of generic and original or ‘brand’ products with the same exact active ingredient compositions. 

How many discrepancies?, and how significant were they?, are probably the next questions to pop into your mind. Well…  when analyzing 31 medicinal products, a 2020 study found that 60% reflected critical differences between the generic and original products. 

Even the EMA states that the content of a generic SmPC should be consistent with the SmPC of the original. It’s obvious the two SmPCs should be consistent because they have the same active ingredient and chemical composure, but this consistency can save lives. Inconsistent information found under the same active ingredient can cause confusion and lead to poor prescribing decisions by medical professionals. While regulation exists in the EU, US, and many counties regarding generics, they are much harder to regulate than their original counterpart. If pharmaceutical companies don’t have automatic labeling systems in place or are not continuously checking their labels with generic and original competitors, (which takes a lot of time) newly reported side effects and safety information will not be updated in sequentially published SmPCs. Unfortunately, that means this key information about potential side effects would not be available to patients or physicians. 

These discrepancies can present as minor implications, but the majority of the time they have been major and potentially life-threatening. One recorded disparity was found involving a generic product for adrenaline. The generic’s SmPC left out contraindications specific for patients with heart defects including ventricular fibrillation and cardiac dilatation. This discrepancy could have been fatal with patients left vulnerable to ventricular arrhythmias or coronary ischemia. 

How can Pharmaceutical Companies Improve this?

Many suggestions have been made to improve the readability of the SmPC to better assist physicians in properly prescribing medication. While this is extremely important for the future of SmPC, the real work to be done is in the pharmaceutical labeling process. As we can see from the dismal information above, there is too much work to be done, too much information and data to be processed, for this process to remain manual. It’s simply not working and innocent patients are unknowingly paying the price. So what can be done? Contact an IT regulatory service provider to find out what automated labeling processes are available to your company. Lucky for you, you’ve already found one! Our technology, ComplianceAuthor™ connects to your existing RIM systems to crawl these repositories, extract text, and gain insight into the data and content. Intelligent insight from the aggregated data is dynamically formatted and passed downstream for omnichannel knowledge flows that comply with client and industry standards. It is then sent to the publishing platform, where it’s transformed into word-based XML-controlled compliant components with tags for downstream transformation, reuse, and formatting. 

With meta-tagging and intelligent insights, our technology can create relationships throughout thousands of repositories and keep all that relevant information in one place. That means all relevant information about a drug including its generic counterparts, studies involving newly reported side effects, and specific patient sub populations are all easily accessible, and easily shareable with health authorities. All updates, including new information received on similar drugs or side effects, are automatically detected which then notifies the pharmaceutical company that an automatic update has taken place, or a manual update is needed to one of the controlled compliant components. This approach makes it simple for pharmaceutical companies to do their part in responsibly updating SmPCs and keeping their patients safe.