Compounding Extemporaneous Pharmaceutical Preparations

By Francis Okeke, PharmD

June 13, 2022

Can Pharmacy Management Systems Help in Pharmaceutical Compounding?

Compounding extemporaneous pharmaceutical preparations is a process that is unavoidable in many pharmacies. Hospital pharmacies must ensure medication is available in the required dosage for convenient use. Sometimes this preparation extends to other medical consumables; sterile and non-sterile.

Community pharmacies also share this burden and must often carry out extemporaneous preparations for efficient medication administration. Therefore pharmacists, pharmacy managers, and other staff need to look out for the processes involved in these preparations. Good manufacturing practices (GMP) guides help to ensure these preparations are carried out under the best conditions.

This article explores how leveraging a pharmacy management system can help get the best outcomes from these compounding processes.

How can a Pharmacy Management System help in Pharmaceutical Compounding?

People

Human resources are a vital part of any pharmaceutical compounding process. Every person involved in the production process must understand the significance of their role in the production process. Good manufacturing practices (GMP) standards have specified guidelines for all personnel in the manufacturing process to follow. These guidelines ensure that the quality of products at the end of every production process meets the highest standards.

Leveraging a pharmacy management system can help improve the efficiency of the personnel processes involved in pharmaceutical compounding. With a pharmacy management system, all roles are clearly defined, and every person involved in the compounding processes knows what to do at every point in the production process.

A fundamental requirement of GMP standards is that personnel must have clear roles. A Pharmacy management software can help itemize specific staff roles and share these roles with concerned staff per time. This makes their participation in the compounding process clear and straightforward. Staff involved in the production process should understand the importance of defined processes and procedures in their work.

Processes

An integral part of a good manufacturing process (GMP) is the precise definition of processes. Compounding medicines requires the meticulous adoption of slated processes and documentation of these processes. Deviations from the defined processes can lead to undesired outcomes.

A pharmacy management system can automate the compounding process to ensure optimal compliance with these processes. Automating the processes with pharmacy management software can help improve the overall efficiency of the compounding process, ensuring that the best quality products are produced with optimal resources.

Another integral part of GMP requirements on procedures is the documentation. Documenting these procedures helps monitor the possible effects of any alteration to these procedures on the overall outcome of the compounding process. If the problem with this compounding is significant enough, it could lead to the withdrawal of all the products from that batch.

Also, having the process documented makes it easy to reproduce the process. This is important if people handling the compounding process need to change. Having the procedures spelled out directs other personnel as they step into the role.

Primary Materials

In the compounding of pharmaceutical products, the raw materials used in the process must meet the best standards. Leveraging a pharmacy management system can help achieve this as all standard requirements in the compounding process are clearly defined, and other professionals can easily access these details.

Apart from these, having the primary standards of the raw materials used helps ensure the reproducibility of the compounding process. The required raw materials and product standards are documented with a pharmacy management system and can be easily accessed by anyone who needs to reproduce the pharmaceutical products.

Having these records also helps with audits and other forms of quality assurance checks on the products.

Premises

A core part of good manufacturing processes at any level is the quality of the environment where the product is produced. Understanding the importance of the environment on the product, pharmacists and other relevant staff involved in the compounding process can optimize necessary pharmacy management software to get the best outcomes from their compounding processes.

With pharmacy management software, pharmacists and other personnel involved in the compounding process can document all the relevant metrics of the compounding area per time, ranging from the ventilation patterns to other vital factors that can affect the quality of products from the production process. This can also include water systems, waste disposal protocols, etc.

Overall, it is crucial to have reasonable control of all the critical parts of the production process involved in pharmaceutical compounding. These factors ultimately affect the quality of the overall products from the compounding process.

Good Manufacturing Processes (GMP)

Good manufacturing processes (GMP) define a range of standards for all the parts of pharmaceutical manufacturing that help ensure the reproducibility of baseline quality of products. Trusted health institutions often set these guidelines and help subject all manufacturing processes to a minimum benchmark.

In pharmaceutical manufacturing, there are different GMPs for different classifications of products. For instance, sterile pharmaceutical products have different standards from unsterile pharmaceutical products.

Conclusion

Overall, pharmacy management software can be a handy tool in pharmaceutical compounding. Several processes in pharmaceutical compounding can be automated, and the overall efficiency of the process is improved. However, it is vital to understand the processes involved in compounding and their peculiarities. This helps to choose the best software for your process.


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References

  1. Deng, Y., Lin, A.C., Hingl, J., Huang, G., Altaye, M., Maynard, H., Mayhaus, D., and Penm, J., 2016. Risk factors for iv compounding errors when using an automated workflow management system. American Journal of Health-System Pharmacy, 73(12), pp.887-893.
  2. The Five P's of GMP in Pharmaceutical Careers The Five P's of GMP in Pharmaceutical Careers | TIPT
  3. Pharmaceutical Quality Management System (QMS) Pharmaceutical Quality Management System (QMS) - SimplerQMS
  4. Pharmacy Management System: Benefits, Features, and Providers of Pharmacy Software Pharmacy Management System: Benefits, Features, Providers | AltexSoft
Francis Okeke, PharmD

Francis Okeke is a clinical pharmacist. He is adept at providing clinical and technical information to nurses, patients, and caregivers. He is well equipped with the best approaches and evidence-based practices of administering drugs and therapeutic procedures to patients. He obtained his first degrees at East Tennessee State University and Clemson University and studied further to obtain his Masters of Public Health at the Royal Institute of Health, Nigeria.