Will requiring CQI by law actually reduce errors?

The goal is admirable. While we will never eliminate medication errors in pharmacy, we must continue to reduce them to the smallest number possible. By passing laws requiring pharmacies to have a continuous quality improvement (CQI) program, the states believe they have taken an important step along this path. Merely passing laws, however, will do nothing.

Unwrap the book

Show proof

The board also needs to ask what makes the system one of continuous improvement. There must be a way of discovering mistakes and preventing them in the future. This requires a method of monitoring, using statistics, charts, and graphs that give real proof that the pharmacy's program is working. The board needs to say to the pharmacy, "Show me your evidence of success."

In order to provide proof of CQI, the pharmacy's program should incorporate monitoring and statistical process controls (SPC). A monitoring program using statistics allows a pharmacy to calculate its success and correct its mistakes.

Monitoring and SPC means recording not just errors that reach a patient, but all mistakes, including those often referred to as near-misses. When each mistake made in the pharmacy workflow is discovered and then recorded, corrections can be made to the process before errors reach a patient. To record and measure errors only is to look only at the tip of the iceberg. Underneath the tip lie all the mistakes, of which most - but not all - are usually caught. These mistakes (near-misses) make up the true story of how the workflow actually functions. The goal of a good quality system is not only to reduce the number of errors that reach a patient, but to reduce the mistakes/near-misses that lead to errors. Without a mistake earlier in the workflow, there will be no error.

Statistics show success

The board of pharmacy's role is the same as that of every pharmacist, to protect the public. It should not take a law or a board regulation to tell pharmacies they need to implement CQI systems to safeguard patients from pharmacy mistakes. If the board passes a regulation, however, the board needs to know that the programs are being used and they are working.

It is counterproductive for inspectors to say, "Show me every error you have made and that you fixed all of them." This will eventually lead to mistakes being covered up and some errors not being reported.

It is better if the pharmacy board inspector can ask for statistical proof showing that the system is improving. If a CQI system with SPC is made a part of a workflow and the staff is trained to use it, improvement will be inevitable. Statistics will show success. Collecting only errors records only failures.

For a discussion of statistical process controls, see Quality & Safety in Pharmacy Practice, Warholak, T.L. and Nau, D.P., editors, chapter 8, Statistical Process Control by Maczygemba, L.R. and Holdford, D.A.

These articles are not intended as legal advice and should not be used as such. When a legal question arises, the pharmacist should consult with an attorney familiar with pharmacy law in his or her state.

Ken Baker is a pharmacist and an attorney consulting in the areas of pharmacy error reduction, communication, and risk management. Mr. Baker is an attorney of counsel with the Arizona law firm of Renaud Cook Drury Mesaros, PA. Contact him by e-mail at ken@kenbakerconsulting.com.