Table 12-1 reviews common terms associated with the quality assurance process that you may hear in your pharmacy. Keep in mind that the voluntary accreditation processes through The Joint Commission and other organizations discussed in Chapter 3, Pharmacy Law and Regulation, are part of pharmacy’s efforts to continually improve the quality of pharmacy care.
Principles of Quality Assurance and Control
Imagine that you own a factory that makes toy balls. Inside each ball is a small doll, but the balls are sealed inside plastic wrapping when they come off the conveyor belt. Because children want to be able to pick out the ball with the correct doll inside, it is critically important that the package labeling match the contents of the ball. However, to check if the packaging has been matched correctly with the ball and its contents, you would have to open the package—thereby destroying the marketable product. How would you ensure the quality of the manufacturing process in this situation?
You could take several approaches. Various checks could be put into the manufacturing process. Quality assurance of this process would start with only having the correct packaging and dolls present on the manufacturing line during production. Employees would double-check one another when the packaging, balls, and dolls are placed into the machine that combines them. Then, as a final check, a small percentage of the finished packages would be opened and checked to make sure they are correct. If any incorrect dolls or packages were found, then more packages would be opened to see if the problem was widespread. If more incorrect products were found, then the entire batch of products might be opened and repackaged correctly.
These are the precise elements used in many pharmacies as means of quality assurance. If you review Chapter 5, Processing Prescriptions and Medication Orders, and think about all the things that could go wrong at each step, you will have a good idea of the task confronting anyone seeking to ensure quality in the pharmacy. Errors in this process can occur in all pharmacy settings—with oral medications in the community, long-term care, and hospital pharmacy; with injectable medications in the hospital or home care pharmacy; and with compounded prescriptions in any pharmacy.
However, there is an important difference between oral and injectable or compounded medications. With an oral medication in a prescription vial, you can check the color and markings on tablets and capsules to see if the correct drug was picked, and you can count the number of tablets. Thus, every prescription for oral medications you prepare can be checked by a pharmacist for accuracy. But with injectable or compounded products, visual inspection is usually impossible. Most injectable products are clear and colorless, regardless of how much drug was put in the solution. Compounded creams and ointments are usually the color and consistency of the base product, regardless of whether too little or too much of the proper amount was incorporated. To ensure quality for most injectable and compounded products, pharmacists must use similar techniques to those used in the toy factory, such as employing double checks and carefully organizing inventory.
Importance of Training
The basis of any quality assurance system is proper personnel training. For technicians who work in community pharmacies or unit-dose areas of hospitals and long-term care pharmacies, proper quality assurance training ensures that technicians are familiar with the drugs they prepare and that they understand pharmacy procedures. In the admixture room of the hospital, home care, or long-term care pharmacy, technicians must be familiar with the drugs as well as the principles of aseptic technique and sterile product preparation. For compounding, knowledge of the drug properties, available equipment, and correct techniques is required to obtain a high quality product. All subsequent parts of the quality assurance process rest on a knowledgeable worker performing tasks in which he or she is competent.
Quality Control of Solid Oral Dosage Forms
For solid oral medications, the pharmacist will generally check every prescription or medication order processed by technicians. The pharmacist may ask you to keep out the container that you obtained the medication from to make sure it is the correct product. As shown in Figure 12-1, the pharmacist will check the directions on the prescription label against the original physician’s order.
Here, a pharmacist checks the work of a technician before dispensing a prescription.
Most computer systems now can display a scanned image of the prescription on the screen or use bar code technology to electronically double-check the prescription or medication order as it moves through the dispensing process. These systems may also have a picture of the correct tablet or capsule on the screen for the pharmacist to check against the product inside the vial. In some high-tech pharmacies such as mail service centers and very high-volume operations, computer systems use a small camera to electronically check the product inside the vial to make sure it matches the image stored in its files. The pharmacist will also look at any auxiliary labels that were placed on the bottle. If everything is correct, the pharmacist dispenses (or authorizes dispensing of) the prescription to the patient and provides any needed counseling about proper use of the medication.
In hospitals where solid oral dosage forms are placed into patient carts, a similar checking process is used. Because nurses check the medications again before giving them to patients, a few states allow technicians to check other technicians on cart fills, thereby freeing up the pharmacists’ time for other activities. Most larger hospitals now have robotic devices that do most of the cart fills, and the barcoding process used with robots ensures virtually 100% accuracy. No checks of the robot are generally done, but caution is required to be sure that the robot’s bins were filled with the correct product.1
Quality Control of Sterile and Nonsterile Compounded Products
As with procedures for preparing compounds, Chapters <795> and <797> of the United States Pharmacopeia (USP) provide standards for quality control procedures required for compounding nonsterile and sterile preparations, respectively (Tables 12-2 and 12-3).2–4 In addition to specific elements of quality control listed in these tables, the standard operating procedures detailed by USP and described further in Chapters 9 and 10 of this textbook also provide an element of quality control—such as the requirement for personal protective equipment (PPE) when compounding with hazardous drugs.
In intravenous admixture and compounding areas, standard procedures will most likely call for you to have nothing in the laminar-flow hood or preparation area except those items you are using to prepare the specific product. Pharmacists will check prescriptions individually, but the appearance of the product is not as helpful as with solid oral dosage forms. Rather, the pharmacist may ask you to keep all injectable product vials—empty or not—for inspection, generally with the syringe pulled back to the amount you put into the admixture. For certain types of admixtures—such as chemotherapy, total parenteral nutrition (TPN), and heparin—another technician or the pharmacist must check all calculations to be sure they are correct. Similar processes are used to check compounded prescriptions, including retaining all bulk containers and indicating how much of each ingredient you used.
| Table 12-2 |
