2 min read
Ever wondered about the drug labels and what goes into creating the content for it? Of course it serves the purpose of providing information about the ingredients, usage and what the medication is used for but how do health authorities standardize the content structure for it? The answer is SPL (Structured Product Labelling) and SPM (Structured Product Monograph). While the two names might sound similar, they serve different purposes in the world of medicine.
SPL provides clear and concise information directly on medication labels. This information empowers patients and healthcare professionals to make informed decisions about their medication use. They usually contain product name and strength, indications, dosage and instructions, warning and precautions and adverse reactions. It follows the HL7 (Health Level 7) International standards for formatting products and drug information.
SPM is specific format used in the pharmaceutical industry for electronically submitting comprehensive drug to regulatory bodies primarily Health Canada. Their content is more in-depth and usually includes chemistry and manufacturing information, pharmacology (how the drug interacts with the body), toxicology (potential safety risks), clinical trial data, (results of studies on humans) and non-clinical studies (studies on animals or in a lab setting).
While both provide details about the product, follow the HL7 standards and submitted in XML format, they both serves distinctly different purposes:
Focus
SPL focus on the concise and clear information of the product label and provide relevant details for patients and doctors and medical workers.
- Product name and strength
- Indications (what the drug is used for)
- Dosage and administration instructions
- Warnings and precautions
- Adverse reactions
Whereas SPM focuses on comprehensive and in-depth document for regulatory review and contain extensive scientific data of the drug.
- Chemistry and manufacturing information
- Pharmacology (how the drug interacts with the body)
- Toxicology (potential safety risks)
- Clinical trial data (results of studies on humans)
- Non-clinical studies (studies on animals or in a lab setting)
Technical Aspect
While both use the XML format, the codes used for both are vastly different.
SPL uses specific codes that are unique for product and labeller combination which is the FDA refer as the National Drug Code. On the other hand, SPM uses codes by the Health Canada which is used in the Drug Identification Number System. The codes are typically eight characters long and consist of a series of numbers, letters, and symbols.
Language
SPL just has one language mandated which is English whereas SPM which is mainly used in Canada, has English as well as French mandated. That means that not only are the submitted documents are in French and English, the content of the label and code used to define the products will be in French and English.
Analogy
SPL consist of concise information which is easy to understand for the general public. More like a consumer pamphlet or brochure for a quick review of the product.
SPM is like a technical manual for the experts or the engineers. It dives into the intricate workings, components and safety considerations of the product.
Conclusion
In essence, SPL and SPM aim to ensure safe and effective use of medication. Understanding both of them can make regulatory submissions less complicated and efficient. If you are interested in exploring SPL-SPM, Freyr offers a one-stop solutions for your SPL-SPM needs.
