Quality Compounding

Dear Trusted Customer,

Compounding pharmacies all over Australia have had a real wake-up with the recent media awareness of dubious operations in our industry. They claimed to offer high-quality products, but what does “high quality” truly mean and why is it significant? If most compounding pharmacies are claiming that they have the highest quality products, how can a consumer differentiate true quality from baseline industry standards?

Achieving high-quality compounded products requires adherence to a strict, consistent and repeatable process. Quality assurance programs will differ between compounding pharmacies, but I believe the best quality assurance programs focus on the following main areas: Relationships, quality ingredients, personnel and team training, premium equipment, internal and external quality assurance testing, dedicated quality assurance personnel and third-party accreditation. Understanding these areas can provide a better understanding of the concept of quality in the compounding industry and reveal the determining factors of quality in a compounded product. The medicine that your Formulae Compounding Pharmacy takes seriously and with pride, as you the customer are our priority. Our Personalised medicines need to be safe, effective, and trusted by our patients and doctors, that’s the relationship that we treasure and value always.

QUALITY = TRUST 

Relationships 

Our Formulae Compounding pharmacists value relationships with all our patients and referring doctors and allied health practitioners. We see this relationship involving open communication, mutual respect and collaboration. Our mission is to ensure patients understand their medication and potential side effects with CMI ( Consumer Medication Information) we text this to all new clients. We also offer guidance on lifestyle changes and preventive measures. In return patients trust our team, they adhere to medication plans and feel empowered to ask questions. We receive many requests every day post the global pandemic with continuing medication shortages, sometimes we are not able to because of the risks involved. This conversation and decision is taken seriously.

QUALITY = EFFECTIVENESS

Quality Ingredients

Compounding pharmacies purchase their ingredients from a handful of regional and national pharmaceutical chemical wholesalers in Australia. Before a wholesaler sells their chemicals to a compounder, they test their chemicals for potency, impurities, and dozens of other chemical characteristics. Suppose the chemicals pass the wholesaler’s internal testing standards as well as industry quality standards set by an organization such as the TGA. In that case, they will release the chemical for sale to compounding pharmacies. We check all ingredients to ensure they are safe , free of impurities and have the chemical composition legally specified.

Premium Equipment

Compounding pharmacies utilize a wide range of tools and equipment to assist technicians during different stages of the compounding process. Items in this category range from handheld devices like electric mortars and pestles, spatulas, hand mixers, and specialised scales up to gravitational mixers and automated powder blenders such as EMP and MAZZ. The most specialised are sterile units, purposefully built for demand. These have elaborate air filtration, humid and temperature control isolated rooms. Most of these pieces of equipment and rooms are high-use items that must be replaced and calibrated often. Our Compounding pharmacies use a reputable third-party company to come on-site to perform calibration activities at least twice a year. Validation that all patients should request.

QUALITY = SAFETY

Personnel Training

The act of compounding, which is the physical assembly of a compounded product, is largely performed by licensed pharmacists and pharmacy technicians. Formal education and training for compounding-related skills is continuously happening and all team members enrol in external independent training regularly. Our Compounding pharmacies also rely on our internal training programs to make sure their technicians possess adequate knowledge and skills to safely and consistently make compounded products. A robust employee training program requires the existence of an up-to-date training manual, a dedicated training team, verbal and physical demonstration of learned skills, standardized observational assessments, and a director-level manager responsible for monitoring the consistency and success of the program itself.

A company providing ongoing training and retraining is just as important as providing a new hire with a dedicated training period. At a minimum, existing employees should be required to re-demonstrate their compounding skills by way of a standardised, graded, observational exam twice a year.

Internal and External Quality Assurance Testing

After compounding is complete, a series of internal quality assurance testing methods should be executed to ensure that the compounded product meets or exceeds quality standards. The testing methods that can be performed have varying levels of intricacy and unfortunately, cannot be utilized for every dosage form that a compounding pharmacy makes. However small batches allow, sample testing to ensure processes and procedures are congruent with quality.

In addition to internal quality assurance testing, compounding pharmacies should also utilize third-party laboratories to verify the potency sterility (when applicable) and stability of their compounded products. These tests are expensive and as a result, are hidden costs that often patients aren’t aware of.

Dedicated Quality Assurance Personnel

Every compounding pharmacy that stands behind the quality of its products must dedicate an individual, or preferably a team, toward maintaining and monitoring the effectiveness of its quality assurance program. Routine product testing and regular sit-down meetings must be carried out. Quality assurance within compounding pharmacies is an evolving field that requires constant attention. There are always ways to improve product quality, even with companies that have well-established, time-tested quality assurance programs. Each Formulae pharmacy has a dedicated QMS personnel, and weekly meetings with risk management tools to allow for continual learning and improving standards.

Third-Party Accreditation

Third-party private sector organisations, such as the Pharmacy Compounding Accreditation Board (PCAB), provide accreditation services for compounding pharmacies and many other industries. Organisations such as PCAB require applicants to adhere to a long list of policies and procedures before accreditation is granted. Typically speaking, third-party accreditors have more detailed, more stringent guidelines compared to state and federal regulators. Third-party accreditation is expensive but is a great way to ensure that a compounding pharmacy’s operations are exceeding what is minimally required. Consumers can advocate for themselves by choosing to do business with compounding pharmacies that have either achieved or are actively working toward achieving third-party accreditation.

At Formulae Compounding Pharmacies we have our internal accreditation process that follows a PCAB structure, by all Australian state and federal expectations.

A compounding pharmacy’s product quality is very much influenced by its internal processes and quality assurance procedures. A solid quality assurance program should include a special focus on the ingredients that go into the relationship with the patient’s needs and requirements, personnel training, the correct use and maintenance of equipment, internal and external quality assurance testing, appointing dedicated quality assurance personnel, and seeking third-party accreditation. Compounding pharmacies come in all shapes and sizes, all with their processes and procedures. Formulae pharmacies aim to exceed baseline industry standards with advanced internal and external processes and procedures to provide its customers with the very best compounded products and customer service. It is this that stands us apart from and gains your trust in our compounded medicine.

Please allow this opportunity to open up the conversation and build a better relationship with your Compounding Pharmacist and your Formulae Team. We look for feedback and questions to build better systems hello@formulae.com.au

Regards Mary-Louise Condon
BPharm ABAAHP GAICD

About the Author

Mary-Louise Condon BPharm ABAAHP, one of the most respected compounding pharmacists in Queensland, is known for providing excellent customer service, exceptional product consistency and reliability, and patient education. Having worked in the industry for 30 years, starting as a pharmacist and now specialises in Anti-ageing Lifestyle Medicine ( A4M)