The power of Total Quality Management

December 10, 2015

Even in the best of circumstances, mistakes happen. CQI can keep them from becoming medication errors that reach the patients.

Ken BakerThe first directive of the Pharmacists’ Code of Ethics reads: “A pharmacist respects the covenantal relationship between the patient and pharmacist.”1 A covenant is generally defined as an agreement. Common synonyms for covenant are contract, commitment, guarantee, pledge, and promise.2

See also: The ethics of a "Just Culture"

Ethically, if not legally speaking, pharmacists and their patients enter into what lawyers call a unilateral contract - an act by a patient balanced by a promise by the pharmacist. As the APhA website explains it, “... a pharmacist has moral obligations in response to the gift of trust received from society. In return for this gift, a pharmacist promises to help individuals achieve optimum benefit from their medications …”1

If the pharmacist is to optimize patient benefits of prescription drugs dispensed, the primary obligation must be to fill the prescription correctly. The promise is perhaps best stated as “First, do no harm.”

Continuous Quality Improvement

Almost every pharmacy, whether hospital or community, today has introduced a continuous quality improvement plan into its pharmacy practice workflow. In order for these tools to be effective, we must make sure the CQI program in place is used faithfully and completely.

This means that during busy times when the prescriptions are stacked up and nurses and patients are waiting, pharmacists and pharmacy technicians will resist the temptation to speed up the process by skipping steps. We ensure this by training and instilling quality habits as part of the workflow.

Error audits

We also do it by auditing. Auditing is quality control. No CQI system is complete without monitoring for quality. One form of quality control is checking each prescription several time during the filling process to stop “near misses” from becoming errors that reach a patient. It also includes a vigorous system of reporting of error incidents followed by appropriate root-cause analysis. A root-cause analysis allows the pharmacy staff to correct the mistakes that led to the error, which should reduce the risk of this error happening again.

See also: Pharmacy CQI: Monthly Rx safety audits

It is not enough, however, to study errors that reach a patient. It is equally - perhaps more -important that we monitor our system to discover all mistakes that enter into the workflow that could, if not caught, reach the patient and result in an error and possible injury to a patient.

In most pharmacies with a CQI system, more than 10 mistakes occur for each error that reaches a patient. The most effective way of eliminating errors is to reduce the mistakes that can lead to the errors. Without mistakes there are no errors.


Total Quality Management

In the 1940s and 1950s, Edwards Deming developed a system of Total Quality Management that is used throughout industry in the United States and the world; it forms the basis of every CQI program used in pharmacy today.

Deming’s approach teaches quality by statistical monitoring.3 In pharmacy, this is best used through recording each mistake in addition to each error.

Collectively, errors and mistakes are referred to as Quality Related Events or QRE. In a pharmacy filling 500 prescriptions a day, this information pertaining to all QREs should take no more than 15 minutes a day to capture and enter into a database for later analysis and display.4

For each month, every pharmacist and every technician should know:

  • How many QREs do we make?

  • How many of our mistakes become errors?

  • Did we improve this month over last month and last year by having less QREs as a percentage of prescriptions filled?

Each of these can be charted and displayed to the staff. A chart like the one accompanying this article should be posted in each pharmacy.5

This way pharmacy staff can know it is improving and that quality is important to the pharmacy.

1. I refer to the APhA Code of Ethics because it appears to be the code accepted by most pharmacist associations and pharmacists. See Accessed November 1, 2015.

2. Google definition available at Accessed November 1, 2015.

3. See Accessed November 1, 2015.

4. National Alliance of State Pharmacy Associations, Pharmacist Quality Commitment CQI system. Accessed November 1, 2015.

5. Baker, Kenneth R. Medication Safety – Dispensing Drugs Without Error. Delmar, Cengage Learning (2013).