Editorial: Standard Operating Procedures, Part 1
Standard Operating Procedures (SOPs) are rapidly becoming a part of daily pharmacy practice, especially in a compounding pharmacy. Is this a good trend or just another paperwork task that we must perform?
SOPs are written documents that detail how a task is to be conducted. If one goes to a fast food chain in different parts of the country, the menu is almost the same and the food tastes almost the same. How is this done? Through the use of standardized procedures and products. SOPs can also help ensure quality uniform practices and preparations within a pharmacy.
In the past, SOPs may not have been necessary in a one-pharmacist operation that was compounding only a couple of prescriptions per day. However, in today's world, where many prescriptions are compounded, the need for uniformity in quality is apparent. Also, quality dictates that medication errors be eliminated or at least minimized.
If a compounding pharmacist must be absent from work and a relief pharmacist fills in, where is the assurance that there will be consistency and uniformity in the performance of the relief pharmacist? As new pharmacists and technicians in your facility are trained, how can the training be done efficiently and accurately? The answer is well-designed and well-implemented SOPs.
Most routine operations and tasks in a pharmacy should be covered by SOPs. Who should write them? Generally, it is best if the person doing the task writes the SOPs, which then should be reviewed and revised, if necessary, by the pharmacist-in-charge, manager, or owner. They should be implemented and reviewed at least annually by the individuals involved.
SOPs are not necessarily written for any governmental agency or organization; they are of most value to the pharmacy staff. They are also a great defense in case something goes wrong and/or there is an adverse event involving litigation, etc. Properly written, implemented, and reviewed SOPs and associated documentation are an excellent defense if the need arises.
Where can SOPs be obtained? First, they can be written-by you and your staff. However, that is a long, tedious process. Second, they can be purchased from several sources. The International Journal of Pharmaceutical Compounding's subscription website, www.CompoundingToday.com, has over 300 SOPs that can be downloaded in MicroSoft Word format, tailored or individualized to your specific pharmacy, and printed using the name of your facility, etc. It is necessary to be sure that they are critically read and modified to match exactly what is being done in your facility. It can be potentially dangerous to have an SOP on file that is not followed or implemented exactly as written.
Next week, we will briefly discuss how to write SOPs and what they should contain.
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief
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