Behind the Scenes: The Safety Checks Your Compounded Medication Goes Through
When your doctor prescribes a custom-made medication, it’s natural to wonder about the process and the quality control measures involved. At National Custom Compounding, we take the safety and efficacy of your medication with the utmost seriousness. Our process is regulated and includes several rigorous safety checks, from the initial prescription review to the final quality assurance sign-off, ensuring that what you receive is exactly what was intended by your prescriber.
Here, we provide insight into the layers of verification that take place before a compounded medication leaves our facility.
In this article, we’ll explore:
- The Important First Step: Prescription Review and Risk Assessment
- Ingredient Integrity: Sourcing and Verification
- Precision in the Lab: Technology and Production Checks
- Double Confirmation: The Secondary Pharmacist Review
- Final Quality Assurance and Essential Documentation
The Important First Step: Prescription Review and Risk Assessment
Before any compounding begins, every order undergoes a thorough prescription review and risk assessment. This critical first step is performed by our team of pharmacy assistants and pharmacists and is designed to ensure patient safety and suitability. During this process, we check:
- Suitability: Is the prescribed formulation well-suited for the individual patient?
- Contraindications: Are there any potential safety issues or interactions with other medications the patient may be taking?
- Patient Understanding: Does the patient understand that their product is being compounded and what that involves?
This comprehensive review is key to ensuring the medication will be both safe and effective for you.
Ingredient Integrity: Sourcing and Verification
The quality of a compounded medication starts with the quality of its raw ingredients. We maintain a strict ingredient verification process to ensure the highest standards:
- Quality Sourcing: All raw ingredients are sourced from verified and approved Australian suppliers.
- Supplier Verification: We ensure that all our suppliers adhere to approved and verified practices in Australia, confirming the trust and integrity of the ingredients we use.
By using only verified, high-quality materials, we establish a reliable foundation for every custom preparation.
Precision in the Lab: Technology and Production Checks
Once the prescription is risk-assessed and approved, the compounding process moves into our specialised lab. This stage involves meticulous production checks supported by technology:
- Order Review: Lab technology helps technicians verify the correct order and formulation.
- Product and Weight Verification: Automated systems confirm the right ingredients are selected and the precise weights or measurements are used.
- Photo Verification: Lab technicians perform photo verification throughout the process, confirming that the final product visually matches the expected standard and that all measurements were accurately made.
This combination of technician skill and advanced technology ensures the production stage meets our required high standard of accuracy.
Double Confirmation: The Secondary Pharmacist Review
Even after the production is complete, a second, independent pharmacist check takes place. This double-check system is a fundamental part of our commitment to quality. The second pharmacist reviews everything created to:
- Confirm that the product was made to the highest standard of practice.
- Verify that the final product exactly matches what the patient’s prescriber intended.
This final manual inspection adds an extra layer of human oversight and expertise before the medication is cleared for dispensing.
Final Quality Assurance and Essential Documentation
As a final safeguard, our automated systems check that all procedural and software steps were correctly followed by all personnel involved in the process. This system validation is the final step in the quality assurance and quality control process.
Every single compounded product is attached to a rigorous paper trail, including:
- Formulations
- Standard operating procedures (SOPs)
- Process documentation
This extensive documentation provides an auditable record for every custom-made product, reinforcing our commitment to safety and transparency. This rigorous and multi-layered process is designed to give you, the patient, and your prescriber complete confidence in the quality and accuracy of the medication you receive.
For more information on the standards for compounding pharmacies in Australia, you may refer to the Pharmacy Board of Australia‘s guidelines on compounding of medicines.
Video Transcript
Hi there. Something that we’re really proud of here at National Custom Compounding is the rigor and seriousness of what we do for patients like yourselves, and also your prescribers and healthcare professionals. So the question today is what safety checks happen before a compounded medication leaves the lab? Now by lab we talk about the whole business. We are regulated as a compounding pharmacy in Australia. So the regulations are quite tough, and we do have to operate at a high standard to make sure the medicine we make for yourself is exactly what it should be. So there’s some really key steps that I’ll just talk you through. Now the first step is actually before anything happens, and we would call that a prescription review or a risk assessment. This is done by our team of pharmacy assistants and pharmacists. And basically before anything happens to the order we make sure that it’s well suited for the patient. It’s safe for the patient that the patient doesn’t have any contraindicated medicines, and also to see whether the patient understands that their product is being compounded and what that involves. So it’s quite a big process and it does take a little bit of time. The step after that is more of a lab ingredient process. So we have a verification process that makes sure that all of our ingredients from all of our suppliers are of the highest quality and all come from verified suppliers. So that makes sure that all of the suppliers are acting in a way that is approved and verified in Australia to ensure the ingredients themselves are trusted. The next stage once a product is risk assessed and checked by pharmacists, it then moves into the lab to be made. And there’s a whole lot of technology in our compounding labs that review the order, that review the products, that check the right products are used, check the right weights are made. And ultimately, once the product is finished, all of the photo verification that the lab technicians undergo, make sure that the product looks like the pharmacist expects, and all of the measurements are made accurately. So this ensures that the production stage is done again to the highest standard. Once that’s finished, it then goes into a secondary pharmacist check, which means that everything that’s made is checked a second time by another pharmacist. Again, this is just to ensure that everything is created to the stage that we require. Everything is made to the highest standard and is exactly what the patient expects. And once that final pharmacist check is made, we have some automated systems in our process that also check that all of the software was followed in a correct way by all of the people to ensure that really, the overall quality assurance and quality control process was valid and validated by the time that it was at the end. This leads to the documentation that we do. So we do a range of documents, including formulations, standard operating procedures, processes, that must also be attached to that particular order. So if you can imagine, we’ve got hundreds of individual products being made every day, and all of those products must go through a really rigorous safety and auditing process. So there’s lots of processes, there’s lots of documentation. Ultimately, though, that’s very deliberate because we want to make sure that the patient receiving our product is getting exactly what they’re after, and is exactly as their prescriber intended. So look, hopefully that gives you a bit of insight into our complex process. Hopefully you can trust what we do and how we do it. And if you’ve got any questions, feel free to reach out. We’ll see you soon.
