Rx & The Law

Do We Have A Problem?

By Kenneth R. Baker, B.S.Pharm., J.D.
Vice President, General Counsel
Pharmacists Mutual Insurance Company

California, Texas and Florida, three of our most populous states, have each passed regulations or statutes that require a quality assurance program for each hospital and community pharmacy in their states.  While each of these states approach their solution to medication errors slightly differently, they share two basic premises – (1) a mandate that the pharmacy have a plan to reduce pharmacy errors and (2) that failure to do so can result in a penalty.  For most of the pharmacies in these states the deadline is the end of 2001.  Other states, such as West Virginia, are joining in the move to regulate quality. That which has been discussed in pharmacy circles over the last few years as “a good idea” is becoming a legal necessity. 

But, why?  Does pharmacy really commit enough medication errors to require us to formally put a quality program in our pharmacies?  Let’s test our knowledge.  Answer the following questions and then let us decide:  Do we have a problem?

1. First, let us begin with a common understanding of the question:  What is an error? 
   Answer: ________________________.
2. The book entitled “To Err is Human — Building a Better Health System” was a report on the larger problem of medical errors and adverse medical events by the Institute of Medicine.   To whom was the report made and when was it published?
   Answer: ________________________.
3. According to the IOM report preventable adverse events are a leading cause of death in the US.  How many hospital patients die each year in the US from medical errors? 
   Answer:  ________________________.
4. Turning to medication errors, how many deaths are caused each year due to medication errors? 
   Answer:  ________________________.
5. What is the rate (percentage) of major prescription errors in the average ambulatory pharmacy?    
   Answer:  _________ %.
6. How many prescriptions are filled annually in community pharmacies in the United States? 
   Answer:  ________________________.
7. If a pharmacy filled 1000 Rx per week and had an error rate of 0.1%, how many errors would that pharmacy have in one year? 
   Answer:   ______________.
8. Estimate how many errors your pharmacy has in an average week.

Answer How did we do on our quiz?  See if your answers agree with mine.

1. What is an error?  Answer: There are many definitions for an error, but the one I have found most useful in pharmacy is: An error is any failure of quality that reaches the patient.  There are two keys in this definition.  First, an error includes any deviation from what should have happened.  This may be filling the prescription with the wrong drug, what we call a mechanical error, to an intellectual error such as failing to properly counsel or failing to detect a potential allergic reaction. 
2. To whom was the Institute of Medicine report made and when was it published?  Answer:  The Institute of Medicine report, entitled “To Err is Human” was published in December 1999 as a report to the United States Congress.  The publication caused both federal and state governments to examine the need for legislation.
3. How many hospital patients die each year in the US from medical errors?  Answer:   The IOM reported that 44,000 to 98,000 deaths are caused each year by preventable adverse medical events.  This makes these preventable deaths one of the leading causes of death in the US.  This is more than breast cancer, aids or even automobile accidents.  [It is important to note that the question is actually wrong because it says “medical errors”.  Medical errors are included in preventable adverse medical events, but not all medical events are errors. Be aware, you will usually hear it stated in this incorrect manner.  Either way, the answer is sobering.]
4. How many deaths are caused each year due to medication errors?  Answer:   According to a 1993 study cited by the report, medication errors, including those caused by pharmacy staff, nursing staff, medical staff and patients themselves, cause 7000 deaths per year.  While these are not all pharmacy, too many are.
5. What is the rate (percentage) of major prescription errors in the average ambulatory pharmacy?   Answer:   While estimates range from 1⁄2% to 4%, the study I consider best that published in the Journal of the ASHP in November 1994.  That study reported the figure at 1.8%.  These were “major errors” which could have resulted in harm to the patient if not detected.  Many of these errors are actually “near misses”, caught before they reach the patient.  The best estimate of the number of these that reach the patient, based upon preliminary figures from an ongoing study by PMC Quality Commitment, Inc., is approximately 25% of mistakes made.  Assuming both estimates are correct, the number of errors would be 0.4%, or 4 of every 1000 prescriptions.  Absent some ongoing study, most of these are probably never detected. Whichever number we choose, it is alarming.
6. How many prescriptions are filled annually in community pharmacies in the United States?  Answer:   Over three BILLION.
7. If a pharmacy filled 1000 Rx per week and had an error rate of 0.1%, how many errors would that pharmacy have a year?  Answer:   52.  However, no pharmacy is that good.
8. Estimate how many errors your pharmacy has in an average week.  Answer:   In order to make a good estimate, you should ask all pharmacists and technicians to keep track of errors and near misses for one week.  Count the number of ones that actually get to the patient, and those that are caught, but could have reached a patient.  The number will probably alarm you.

No pharmacist or pharmacy technician wants to make an error.  All humans, however make mistakes.  There is no reason to believe that pharmacists or technicians are less prone to human error than doctors or nurses or lawyers or any other professionals.  We should not wait for legislators to force us to develop and implement quality assurance programs for pharmacy.  Proven programs, such as Pharmacy Quality Commitment, exist now. 

Two final questions:  (a) Disregarding the cost of hiring a lawyer and paying a claim, what would be the cost, in money, time and reputation, to your pharmacy of an error that reached one of your patients?  (b) What are we waiting for?
 
This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and insurance companies, and act accordingly.