Standardized Pharmaceutical Compounding: The Key to Creating Quality Preparations Every Time

Standardized Pharmaceutical Compounding: The Key to Creating Quality Preparations Every Time

i-med-bottleWhen it comes to pharmaceutical compounding, many like to think there’s only one way of doing things. We want to believe that all employees working in our pharmacy operate by the same procedure. It’s a nice thought, right? The sad truth is this probably isn’t the case.

What’s more likely is that if you ask two employees to explain how they prepare a specialty compound, you’ll receive two similar, but different answers. Contrary to popular belief, there’s usually more than one right way to do things. That’s great for the final result, because it means you can still yield quality preparations. The problem is that  your results aren’t uniform, and those slight variances can lead to inefficiency. By establishing a standardized procedure for compounding within your pharmacy, you can ensure a quality preparation is made every time.

The Advantages of Having a Standardized Procedure

The ultimate goal of any standardized procedure is to minimize errors. Not only is this for the benefit of our patients, it also helps protect your bottom line in notable ways.

  • Eliminates wasted materials and labor

Sometimes we must rework a formulation to ensure a quality preparation. There’s absolutely nothing wrong with this, as it must be done to make sure that patients receive appropriate treatment. But correcting a less-than-ideal preparation also results in lost time on the compounder’s part and excess use of possibly expensive ingredients. With a standardized procedure, you can create a quality preparation correctly the first time.

  • Guarantees regulatory compliance

When the Compounding Quality Act was passed in 2013, it gave the FDA more regulatory oversight of drug compounding pharmacies. Having clearly established procedures for routine tasks, like hand washing, to more patient-oriented ones, like accurate record keeping, demonstrates your pharmacy’s commitment to quality assurance. With these standards in place, you have more control over your pharmacy’s ability to meet federal and state requirements for drug preparations.

How to Establish Standardized Procedures in Your Pharmacy

Your pharmacy likely already has established procedures when it comes to preparations. Everyone working within your pharmacy probably intends to follow it to the letter. We all know what happens next. Expectations don’t always meet reality.

Chances are your standard operating protocols (SOPs) are kept in a thick binder. Consider this: How often do you pull that binder off the shelf? Is it collecting dust? If you have a question, what are you more likely to do: flip through a binder to find the answer or ask a fellow co-worker? While well-meaning, this is often how deviations from established procedures begin.

Here are steps your pharmacy can take to prevent this from happening.

  • Identify the differences between written procedures and reality

It seems basic, but this is crucial in standardizing pharmaceutical compounding. If everyone in your pharmacy prepares a transdermal migraine treatment differently, you have no overall control over the final product. It shouldn’t be difficult to learn of any variations. Pharmacists are notoriously honest, and as preparations reflect ability and experience, you’ll find that those in your pharmacy want the best outcome.

  • Determine the best method

In an ideal world, the written procedure you keep in your SOP binder is the best one. Unfortunately, this may not always be the case. Protocols are tweaked and streamlined all the time. What’s important is that everyone is aware of any improvements and changes. As pharmacists, we can’t rely on word-of-mouth. Human memory is faulty, and we may forget to take note of important steps. Those missing steps can result in costly mistakes.

  • Create a flow chart

Flow charts are great tools when it comes to communicating how a process is done. Breaking down your written SOPs into a simple flow chart can ensure standardized compounding among your pharmacy’s workers. It can be drawn on a whiteboard or printed on a poster, which anyone can easily reference when a question arises. Studies have also shown that flow charts improve people’s decision-making skills in a pharmaceutical setting, which is an added bonus.

Standardized compounding offers many benefits. Not only does it improve efficiency by minimizing errors, it aids compliance with new regulatory acts. Implementing SOPs doesn’t have to be difficult. Simple solutions like moving procedures from a rarely-referenced binder to highly visible flow charts and posters ensures that workers in your pharmacy have clear communication regarding standards, thus being more likely to adhere to them. By doing so, you can help ensure that your preparations are of uniform quality, contributing both to the satisfaction of your patients and the efficient maintenance of your pharmacy’s resources.

Along with establishing standardized practices for your pharmacy, you’ll need the best ingredients for your compounded preparations. Pharmaceutica North America would like to be the supplier of high quality products for your pharmaceutical compounding needs. Contact us today to learn more.


Go Deeper: Compounding for Topical and Transdermal Drug Delivery


Quality Assurance for the Custom Compounding Pharmacy: A Checklist for Success


Sorry, the comment form is closed at this time.