Medication Safety Self Assessment for Community/Ambulatory Pharmacy

General Questions

hat are the benefits of submitting data to ISMP?

The following immense benefits to healthcare consumers and pharmacies only can be achieved if we have the ability to collect and aggregate data on a national level:

• The tool will provide US pharmacies with important baseline information that can be tracked over time. Such data will be useful in advising pharmacies and pharmacists about ongoing system improvements.
• The project will be of great value in gaining consumer confidence. Presently, there is great concern that information is being "hid" from the public. This project can help by allaying these contentions, as the public will be able to see that pharmacies are being proactive in identifying safe practices and will be able to track aggregate progress over time (we intend to enhance the tool and do follow up studies in years to come).
• The project will be of significant assistance to pharmacy managers who seek to identify areas of weakness in comparison to the national experience so that top leadership support can be sought for improvements in these critical areas.
• The project will provide ISMP, the American Pharmaceutical Association (APhA), the National Association of Chain Drug Stores (NACDS), and others with the ability to identify common system weaknesses in US pharmacies and practical system enhancements, including those that are thought to provide the highest leverage for overall error reduction activities.
• ISMP, APhA, NACDS, and others will be able to focus educational efforts and design useful programs to help pharmacies implement high leverage strategies that can positively impact patient safety.

How many team meetings should we schedule and do we need to include managers, pharmacists, and technicians on our team?

From the results of the test pharmacies that already have completed the assessment, our suggestion is to schedule three team meetings of at least one-hour in length. Some of our testing sites have completed the assessment in less time than this and some have run longer than one hour at a scheduled meeting. Including managers, front line staff, technicians, and others who are involved in the medication process is important to get an unbiased and "real" view of your entire system. This will also help if changes are made to enhance your processes. The entire staff and management will understand why changes are being made.

When will the overall aggregate data be available for review?

Should the characteristics contained in the self-assessment be viewed as current standards of practice?

No. ISMP is not a standards setting organization. As such, the self-assessment characteristics represent the ideal and are not purported to represent a minimum standard of practice and should not be considered as such. In fact, some of the self-assessment criteria represent innovative practices and system enhancements that are not widely available in pharmacies today. However, their value in reducing errors is grounded in expert analysis of medication errors, scientific research, or strong evidence of their ability to reduce errors.

Online Data Submission

Note: Several changes have been made to the Demographic Section of the Online Data Submission Form (an additional answer for question number 1 and several drop down boxes have been added). Please read the sections below before you submit data.

Passwords, which are needed for online data submission, are contained in the printed self-assessment booklets. These are available through the corporate offices of many chain pharmacy organizations or may be obtained individually through the American Pharmaceutical Association (APhA) by calling 1-800-878-0729 with reference code A619. There is a $5 fee to cover mailing costs of the booklets.

Yes. It is important that you keep your password in a safe and easily remembered location. The password will allow you or your store to view your results online at any time upon completion of the assessment. This password eventually will allow your store to view the overall summary results of all participating pharmacies. The booklet will allow you to refer back to individual questions once you have submitted your information and received your score. It is also a good idea to keep your printed scores in a safe location in case you lose your password (see next question). Please Note: Passwords are not used to identify pharmacies. The random passwords contained in the booklets are necessary to insure that data may only be entered once and allow you or your store to view your scores at a later time.

If your password is lost, you will not be able to view your scores online. This is why it is important for you to also keep your printed scores in a safe location. ISMP is not able to link passwords or scores with any pharmacy or individual responses.

4) Why does the online data submission form ask for my password before I begin answering questions, while the printed booklet states that the password is needed after questions are entered?

We have changed our procedure for the online submission of the scores so that a password is needed before demographic information and results are entered. This will help prevent stores and individuals from spending time entering data and not having their password available to submit their results.

Once you click on the "Submit to ISMP" button you will NOT be able to change your scores. You will be asked "Are you sure you want to submit" prior to your final submission and your scores entering the database. Once you click "OK" you will not be able to make any changes. You only will be allowed to view your results. If you have not yet submitted your scores you can hit the "Reset Form" button to clear all of your results (see next question). You may go back through the assessment and change individual scores as long as you did not submit the data.

This button allows an individual to "clear" the entire self-assessment, leaving every characteristic blank. You will then need to re-enter every score for every question. You may go back through the assessment and change individual scores as long as you did not submit the data.

Your information will be submitted to ISMP and placed into a secure database. The computer at ISMP will calculate the overall individual pharmacist or pharmacy score and send the results to the database and return them to the individual entering the data. The length of this process will depend on many factors including, but not limited to, your computer and the connection to the internet. This process should not take more that 1 to 2 minutes but may take longer. You then will be prompted to print the results to have a hard copy of your scores.

8) When reviewing my scores I noticed that many scores were "0" yet I had answered the questions with a "B", "C", or "D". Is this correct?

Each of the characteristics in the assessment was given numerical, weighted scores (see page 5 in the introduction of the self assessment for an explanation of how weights were assigned). Some the characteristics were weighted in a way that results in no numerical score (zero value) unless there is full implementation of the characteristic.

9) How do I score the self-assessment characteristics?

The self-assessment characteristics are scored on a 5-point letter scale with:

• A. There has been no activity to implement this characteristic in the pharmacy or for any patients, prescriptions, drugs, or staff.
• B. This characteristic has been discussed for possible implementation in the pharmacy, but is not implemented at this time
• C. This characteristic has been partially implemented in the pharmacy for some or all patients, prescriptions, drugs, or staff.
• D. This characteristic has been fully implemented in the pharmacy for some patients, prescriptions, drugs, or staff.
• E. This characteristic has been fully implemented in the pharmacy for all patients, prescriptions, drugs, or staff.

For self-assessment characteristics with multiple components, full implementation is evidenced only if all components are present.

For self-assessment characteristics with two distinct elements, each separated with the word, “OR” and labeled (a) and (b), answer either part (a) or (b), but not both.

A few self-assessment characteristics may require evaluation using only column A (no activity) or column E (fully implemented), as partial implementation is not applicable.

Demographic Questions

(See question number 4 below, and the end of this section for specific examples on answering question numbers 2, 3, and 4 in the demographic section)

Yes. You must answer all of the demographic information in order to proceed with the assessment criteria. The only field that is not required is the district number in the category that describes your pharmacy, which appears in the Online Data Submission Form.

Many chain pharmacies have asked ISMP for aggregate summary results of their stores. The results may be used for implementing corporate safety initiatives. Specific stores or individuals are not identifiable. If you are part of a chain of pharmacies, we encourage you to enter the name of your chain pharmacy to ensure accurate statistical data. You can enter the first few letters of your chain and a drop down box will appear with choices. The list of pharmacies was obtained from a national database. If your chain is not listed, select NOT LISTED.

In the online submission form, we have added another box labeled UNSURE. You may use this choice.

In the Online Data Submission Form a drop down box is included for many of the other choices that could be used (hospital owned pharmacy, long term care pharmacy, HMO pharmacy, mail order pharmacy, ambulatory clinic). You would also enter OTHER in question number 3 and then Veterans' Affairs in question number 4.

A full time equivalent represents an individual who works a minimum of 40 hours per week throughout the year excluding holidays and vacation. An individual who works 30 hours a week would be considered 0.75 FTE (30 hours divided by 40 hours) and an individual who works 20 hours per week would be considered 0.5 FTE. If an individual works more than 40 hours per week, he still is considered one FTE.

Definitions used to designate an urban or rural setting are as follows:

Urban: An urban setting is located inside a Metropolitan Statistical Area (MSA), designated by the U.S.Office of Management and Budget, which is a geographically defined, integrated social and economic unit with a population of at least 50,000.

Rural: A rural setting is located outside a Metropolitan Statistical Area (MSA), as designated by the U.S. Office of Management and Budget (see above).

Ambulatory Clinic

Answer OTHER in question number 2, answer OTHER in question number 3 (unless your pharmacy fits in one of the other choices), and select one of the choices given in question number 4 for ownership.

Hospital Owned Retail Pharmacy

Answer OTHER in question number 2, select hospital outpatient pharmacy in question number 3, and answer OTHER in question number 4.

State or Local Government owned pharmacy

Answer OTHER in question number 2, answer OTHER in question number 3 (unless your pharmacy fits in one of the other choices), and answer State or Local Government in question number 4.

HMO owned pharmacy

Answer OTHER in question number 2, select HMO Pharmacy in question number 3, and select either investor owned, for-profit (if this is the type of ownership) or OTHER (nonprofit) in question number 4.

Long Term Care pharmacy

Answer OTHER in question number 2 (if this is your primary business), select Long Term Care pharmacy in question number 3, and select the type of ownership in question number 4 (unless you are a nonprofit institution owned pharmacy, in which case select OTHER).

Mail Order Pharmacy

Answer OTHER in question number 2, select mail order pharmacy in question number 3, and select the type of ownership in question number 4 (unless you are a nonprofit institution owned pharmacy, in which case answer OTHER).

Individual Characteristic Questions

This would be defined as updating at least annually patient information before new or refilled prescriptions are dispensed. The actual mailing of a survey is one way to obtain this information. Many pharmacies update demographic and clinical information each time a patient obtains a prescription. They would answer E to this question. Some pharmacies may obtain this information only when a patient is first entered into its database. If patients obtain another prescription more than a year later, they may not be asked for updated information. These pharmacies would answer this question with an A through D depending upon whether the practice is never done or only is done for partial information (e.g., insurance information, allergy check for antibiotics). The important point of this question is that a demographic and clinical history is obtained on all patients at least yearly before prescriptions are dispensed.

The intent of this characteristic is that the pharmacist either asks the patient for up-to-date laboratory values or has easy access to these results before dispensing medications that may require monitoring of laboratory values.

This question addresses the importance of a pharmacist having an up-to-date and comprehensive patient information database. A pharmacist should be aware of a patient with a liver disorder such as cirrhosis when this patient has a prescription for a product with acetaminophen or a medication that is extensively metabolized by the liver. The same is true for medications that may need dose adjustments (e.g., digoxin) in patients with renal disease. The intent of this question is that pharmacists routinely consider medications that may need dosage adjustments and question patients in order to evaluate if a call to the prescriber should be made.

4) Characteristic # 22 - What is a "clinically significant" drug interaction?

Clinically significant drug interactions are those interactions that are considered important from information contained in the drug's package insert, recent literature, or classified in many computer software programs.

A standard format in this question means that the pharmacist is able to read, dispense, and file the prescription directly from his/her computer terminal without having to perform additional "offline" manipulations (e.g., print the prescription and re-enter it into the pharmacy system database).

The "sig code" refers to the instructions that will be printed on the prescription label. For example a sig code for the pharmacist may be "QIDT" and the instruction will print "Take one tablet four times a day". When used, only one standard set of sig codes should be available for all pharmacists to use. These codes also should be reviewed with all staff for error potential, for example having a sig code of "QID" and "QOD" for "four times a day" and "every other day" respectively. These codes could be used in place of one another in error, especially since the "I" and "O" keys on computer keyboards are next to one another.

Various forms of feedback for prescriber education would include: periodic mailings to prescribers that describes unsafe prescription writing practices; presenting a lecture on medication safety at a local prescriber professional meeting; or meeting informally with prescibers to discuss safety issues in medication prescribing.

Medications that may be considered "high alert" drugs are described on page 3 of the self-assessment. "Targeted" high alert medications may include all of these examples or drugs that may be dispensed in your pharmacy that have been associated with known or potential (near miss) medication errors. They also may include medications that you have learned, through review of journals or reports, that may cause serious errors. Aside from notifying all employees of concerns with these medications, physical constraints, such as those listed in this question should be employed.

Proper hand washing would be washing one's hands with soap or a mild detergent and water before and after handling any loose oral solid products. When answering this question you should consider the proximity of hand washing facilities to the area in which medications may be handled or prepared. If a sink is not in close proximity to the dispensing area, then an answer of A through D may be appropriate.

High-risk populations would include: elderly patients who may be receiving numerous different prescription medications; diabetic patients who may need to adjust their dose of medication depending on their blood sugar results or current well being (e.g., infection, flu or cold); pediatric patients; and patients receiving chemotherapy or immunosuppressive medications. "Targeted" high-risk populations may include those listed above or others (e.g., juvenile diabetics, patients over 85 years of age receiving "normal" adult doses, patients recently released from an acute care hospital) that you have decided a pharmacist will speak with the patient or caregiver whenever a new or refill prescription is obtained.

11) What if a question doesn't apply to the services offered or activities in my pharmacy?

If a question doesn't apply to services or activities in your pharmacy, then an answer of E may be appropriate since your pharmacy would not be prone to errors in that circumstance.

Proceed to Survey