Drug Injury Watch

Medication Mistakes And Pharmacy Errors Continue To Be A Large Problem

Prescription Drugs Wrongly Prescribed Or Improperly Dispensed Are Preventable Adverse Events Which Need To Be Reduced In Number -- And This Can Be Done

(Posted by Tom Lamb at DrugInjuryWatch.com)

In a February 14, 2008 article, "1 in 10 patients gets drug error", Boston Globe reporter Patricia Wen presented some disturbing data from a study which examined adverse events involving prescription errors that occurred in six undisclosed Massachusetts community hospitals:

One in every 10 patients admitted to six Massachusetts community hospitals suffered serious and avoidable medication mistakes, according to a report being released today by two nonprofit groups that are urging all hospitals in the state to install a computerized prescription ordering system.

The report is the first large-scale study of preventable prescription errors in community hospitals, and its author, Dr. David Bates of Brigham and Women's Hospital in Boston, said he was surprised that these mistakes were so frequent in these community hospitals....

The researchers reviewed a total of 4,200 randomly selected patient medical charts at the six community hospitals, covering stays from January 2005 to August 2006. An average of 10.4 percent of patients suffered a preventable "adverse drug event" - defined as a case in which the patient was given a drug even though the medical records noted that the medication could trigger a drug allergy or that the dose given would exacerbate a medical condition. Medication errors were counted only when patients suffered serious reactions, including going into shock or suffering kidney failure. In nearly every instance, the patients remained in the hospital longer to recover from the mistake. Nobody died from any of the mistakes, researchers said.

This February 14 article in the Globe goes on to describe how the computerized prescription ordering system mentioned above works, as well as what types of results its use can produce:

[T]e computerized physician order entry system, which requires doctors to type into a central database every medical order, including prescriptions, diagnostic tests, and blood work. The doctors' orders are matched against the patient's medical history, triggering red flags to prevent problems related to drug allergies, overdoses, and dangerous interactions with other drugs.

Bates said that after this system was put in place at Brigham and Women's Hospital in 1995, preventable medication errors declined by 55 percent over the next two years....

Ms. Wen includes in her article various discussions about how medical insurers, government officials, and healthcare providers, all, would benefit from the computerized system being used at more hospitals in Massachusetts and across the nation.

Turning to another aspect of medication errors, on February 12, 2008 the Indianapolis Star published a lengthy USA Today article, "Too many prescriptions, too few pharmacies", which reported the results of an investigation that USA Today conducted:

The investigation reviewed policies and alleged errors at rivals Walgreens and CVS, the nation's two largest drugstore chains, which fill nearly one-third of all retail prescriptions nationwide. It included a review of scores of lawsuits, as well as pharmacy board disciplinary actions in 10 states and interviews with pharmacists, drug-error victims, their families and attorneys. Some common factors emerged:

• Too many prescriptions, too few pharmacists....
• An emphasis on speed....
• A reliance on technicians....
• Pharmacist incentive awards....
• Counseling gaps....

We learned from this February 2008 USA Today article about prescriptions being improperly filled by pharmacists that, remarkably, the North Carolina Board of Pharmacy is the only state board that requires all major drug errors to be reported to the agency.

The online version of this USA Today article has an interactive graphic component, "How prescriptions are filled and where errors can occur", which gives one a better idea about what goes on behind the counter at your typical chain-store pharmacy.

For anyone interested in the causes and effects of medication errors, both of these February 2008 news reports are well worth your time.

New Book "Medication Errors" Is Subject Of A Good Review In NEJM

This Second Edition Has Detailed, Useful Information For Doctors And Pharmacists

(Posted by Tom Lamb at DrugInjuryWatch.com)

The August 9, 2007 edition of The New England Journal of Medicine (NEJM) has an insightful book review by John P. Burke, M.D., of LDS Hospital in Salt Lake City, UT, which does a very good job of introducing us to a valuable new book, "Medication Errors", second edition, edited by Michael R. Cohen.

As has been reported previously, the Institute of Medicine (IOM) estimates that at least 1.5 million Americans are sickened, injured, or killed each year by medication errors. 

For this new book "Medication Errors", editor Michael R. Cohen -- a pharmacist and the president of the nonprofit Institute for Safe Medication Practices (ISMP), as well as a 2005 recipient of a John D. and Catherine T. MacArthur Foundation "genius grant" -- defines a medication error as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer."

In more detail, from Dr. John Burke's book review in the August 9 NEJM:

This definition includes errors at any stage of medication use and not just during the process of drug administration. Cohen believes that the "five rights" of safe medication use (the right patient, right drug, right time, right dose, and right route of administration) place too much focus on individual performance and overlook the systemic problems that underlie the human errors. He emphasizes that "finding out who was involved is less important than learning what went wrong, how, and why."

According to Dr. Burke, both a new IOM book "Preventing Medication Errors", which he also covers in this NEJM book review, and the second edition of "Medication Errors" call for the elimination of handwritten prescriptions.

As regards this last point, in a June 27,2007 HealthDay article, "Prescription Mistakes: Computerized Ordering Cuts Medication Errors", we learned the substantial benefit obtained by this type of change in prescribing methods:

U.S. hospitals that switched from using doctors' handwritten prescriptions to computerized drug ordering systems had a 66 percent drop in medication errors, say the authors of a review that looked at the results of 12 studies.

The findings are published online in the journal Health Services Research....

Illegible handwriting on prescriptions and transcription mistakes cause as many as 61 percent of medication errors, the experts said....

Currently, only about 9 percent of U.S. hospitals have computerized prescription systems, which can take 12 to 36 months to implement.

Hopefully more doctors and hospitals will move to computerized drug prescription systems in the next few years so as to improve this aspect of drug safety in the U.S. sooner rather than later.

Millions In U.S. Fail To Take Their Medicine Correctly, And The Consequences Can Be Deadly

Medication Non-Adherence In America Is A National Crisis Costing Billions Of Dollars According To An August 2007 Report

(Posted by Tom Lamb at DrugInjuryWatch.com)

Two July 30, 2007 articles by Lauran Neergaard, a reporter who covers health and medical issues for The Associated Press (AP), bring us some important information about prescription medication adherence, or the lack thereof, in the U.S.

The first AP article by Ms. Neergaard, titled "Report: Skipping Doses Could Be Deadly" by The Washington Post, presents these findings from a report to be issued in the first part of August 2007 by the nonprofit National Council on Patient Information and Education:

• Particularly at risk are people whose diseases are initially symptom-free. Although high blood pressure more than triples the risk of heart disease, for example, just 51 percent of patients stick with their prescribed antidote.
• Also at high risk are the elderly, but adherence is a problem for all ages. As few as 30 percent of teenagers correctly take drugs to prevent asthma attacks, for example.
• Poor medication adherence can cost an extra $2,000 a year for each patient in extra doctor visits alone, and it's associated with as many as 40 percent of nursing home admissions, even more costly.
• Add preventable hospitalizations and premature death, and the report estimates that poor medication adherence could be costing the country $177 billion in medical bills and lost productivity.

The second AP article by Ms. Neergaard, titled "Tips to Help Patients Take Meds Properly" by The Baltimore Sun, provides patients with some advice items intended to help them better understand and adhere to their medication prescriptions:

• Before leaving the doctor's office with a new prescription, ask detailed questions including: How and when do I take this? When do I quit? What food, drink, other medicines or activities should I avoid while using this medicine? What is it supposed to do? How do I know if it's working? What are its possible side effects? What do I do if have those?
• Bring to each doctor's appointment a complete list of all prescription and nonprescription medicines you take, so the doctor can check if a planned new drug will interact badly with an existing one. If you use one pharmacy exclusively, the pharmacist can print out a prescription list for you.
• If you have problems understanding the instructions that come with the medicine, ask the pharmacist for help. There may be a simpler brochure, large-print instructions, or translations into languages than English.
• Patients who forget doses could try setting up pill boxes at the beginning of each week with morning, noon and night doses in separate compartments. Technology including "talking" pill boxes that sound an alarm when doses are missed also are under development.

We encourage you to help spread the word about this National Council on Patient Information and Education August 2007 report regarding our significant medication non-adherence problem here in America.

As part of an earlier four-part series on adverse drug reactions, called "ADRs in US", I wrote an article that looked at another aspect of the medication non-adherence problem, namely how the failure of some doctors to provide essential prescription drug information to their patients contributes to this growing problem.

Coincidentally, that particular "ADRs in US" series article is featured -- together with posts from 76 other bloggers -- in the new eBook BlawgWorld 2007 (available as a free download in PDF format), which was released on July 30, 2007.

The Adverse Drug Reactions And Medication Errors That Require Hospital Care Most Often

Some Lessons Learned From A "Top 10" Drug Errors Session At The American Pharmacists Association 2007 Annual Meeting

(Posted by Tom Lamb at DrugInjuryWatch.com)

The American Pharmacists Association (APhA) Annual Meeting was held in Atlanta, Georgia earlier this year.  A large number of the 7000 attendees took time out of their busy schedules for one of the meeting's most popular sessions, "The Top 10 Adverse Drug Reactions and Medication Errors", which was presented by Matthew Grissinger, RPh, FASCP, a medication safety analyst with the Institute for Safe Medication Practices (ISMP).

As reported in a Medscape.com article by Kathryn L. Hahn, PharmD:

Grissinger first referred to a study that identified the 10 drugs most commonly implicated in adverse events requiring treatment in a hospital emergency department (ED). The study also documented the frequency with which each of the 10 drugs was involved:

1. Insulin (8%);
2. Anticoagulants (6.2%);
3. Amoxicillin (s) (4.3%);
4. Aspirin (2.5%);
5. Trimethoprim-sulfamethoxazole (2.2%);
6. Hydrocodone/acetaminophen (2.2%);
7. Ibuprofen (2.1%);
8. Acetaminophen (1.8%);
9. Cephalexin (1.6%); and
10. Penicillin (1.3%).

According to this May 2007 Medscape.com article, Dr. Grissinger said approximately 40% of these adverse drug events that required a patient to be treated at a hospital emergency room involved unintentional overdoses. 

More generally, so-called "nonadherence issues" were the usual cause for adverse drug events that led to a trip to the hospital; among them were:

• taking incorrect doses;
• taking doses at the wrong times;
• forgetting to take doses; and,
• stopping the medication too soon.

Dr. Grissinger's presentation at the APhA 2007 Annual Meeting also covered the top 10 medications most frequently involved in drug errors.  By definition, drug errors are unintentional acts committed by healthcare providers involving medications.

As many have heard by now, in 1999 the Institute of Medicine (IOM) published a report, "To Err Is Human: Building a Safer Health System", which included their finding that as many as 7000 Americans die from medication errors each year.

From the 2007 Medscape.com article, this is what was learned about medication errors at the Grissinger session:

A somewhat different top 10 list identifies medications that are most commonly misused or mishandled in some way by healthcare professionals. This list is based on information from the United States Pharmacopoeia (USP), which maintains a database of medication errors that are reported anonymously. The figures represent drug errors associated with acute hospital care[5]:

1. Insulin (4% of all medication errors in 2005);
2. Morphine (2.3%);
3. Potassium chloride (2.2%);
4. Albuterol (1.8%);
5. Heparin (1.7%);
6. Vancomycin (1.6%);
7. Cefazolin (1.6%);
8. Acetaminophen (1.6%);
9. Warfarin (1.4%); and
10. Furosemide (1.4%).

Patients who have experienced an adverse drug reaction or a medication error requiring hospital treatment can submit a confidential report to the USP-ISMP Medication Errors Reporting Program (MERP), a voluntary program which is operated by the U.S. Pharmacopeia (USP) in cooperation with the Institute for Safe Medication Practices (ISMP).

More Than One Million Hospitalized Patients Experienced Adverse Drug Reactions (ADRs) In 2004

Findings Of April 2007 AHRQ Report On Side Effects And Other Medication Problems In American Hospitals

(Posted by Tom Lamb at DrugInjuryWatch.com)

A recent online article provided a summary of the findings from the "Adverse Drug Events in U.S. Hospitals, 2004" report issued in April 2007 by the Agency for Healthcare Research and Quality (AHRQ).

According to this online article, entitled "Over 1 Million American Hospital Patients Experience Side Effects And Other Problems With Their Medications":

• In 2004, 1.2 million hospitalized patients experienced an adverse drug reaction (ADR);
• 90 percent of these ADRs were due to a side effect from a medication that was properly administered; and,
• Just 8.6 percent of ADRs among hospitalized patients were because they were given the wrong drug or the wrong dose in the hospital or because they accidentally took an overdose or the wrong drug before entering the hospital.

Other findings from this April 2007 AHRQ report, which is part of its Healthcare Cost and Utilization Project (HCUP), and published in its Statistical Brief #29:

• Average total hospital costs for patients who experienced drug side effects or other ADRs were $2500 more than for patients who did not experience any drug side effects or other ADRs  ($10,100 compared with $7,600);
• Corticosteroids, blood thinners, and anti-cancer drugs were the top three types of drugs involved in these hospital ADRs, and those events which involved drug side effects were mostly due to side effects from properly administered medications;
• As for those hospitalized patients who suffered side effects from properly administered drugs, they tended to be older (average age: 64 years old) than patients who suffered from side effects related to wrongly administered medication (average age: 47 years old); and,
• Nearly 60 percent of the hospitalized patients in America who experienced an ADR during 2004 were women.

Healthcare providers and patients who are interested in these findings about ADRs in American hospitals may also want to take a look at the "List of High-Alert Medications", which is put out by the Institute for Safe Medication Practices (ISMP).

According to this ISMP document:

High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error.  Although mistakes may or may not be more common with these drugs, the consequences of an error with these medications are clearly more devastating to patients.

Lastly, healthcare providers and patients are encouraged to report actual as well as potential medication errors to the Medication Errors Reporting Program (MERP).  Such reports can be made online at http://www.ismp.org or by calling 1-800-FAIL-SAFE.

List Of Internet Sites That Provide Medication Information And Drug Interaction Checkers

Patients Should Use These Free Self-help Resources In Addition To Telling Doctor About All Current Drugs And Supplements

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the February 27, 2007 edition of the Washington Post staff writer January W. Payne compiled a list of free internet sites which patients can use to research newly prescribed drugs and to check for possible dangerous drug interactions.

There are actually two lists of internet medical sites in this Post article, the first is "Medication Information" and the second is "Drug Interaction Checkers".

Of course, as pointed out in the prelude to these two lists, a patient should let their doctors and pharmacist know about every prescription drug as well as any and all dietary supplements -- vitamins, minerals, herbs -- they are currently using when there is any talk about a new medication being added to their drug therapy regimen.

To be clear, the internet resources compiled in this February 27 Post article are meant to supplement, not replace, the patient's discussion with their doctors and pharmacist.

In an era where patients seem to be prescribed more and more drugs by their several different doctors, self-help as regards potentially fatal drug interactions is vital.

Health Canada's MedEffect Now Offers Online Reporting Of Adverse Drug Reactions

Objective Is To Increase Percentage Of ADRs That Get Reported To Regulators

In October 2006 Health Canada announced that its MedEffect web site is now able to accept online reports of suspected adverse drug reactions (ADRs) for those prescription medications marketed in Canada.  This announcement was published in the Canadian Adverse Reaction Newsletter, Volume 16, Issue 4, released in October 2006.

Before this electronic upgrade and practical improvement, doctors or patients who wanted to report serious side effects due to use of a prescription drug had to call in, fax, or mail a paper ADR report form to Health Canada.

According to Health Canada, the new MedEffect online reporting system generates a file that can be printed and stored electronically by the person submitting an ADR report online. As with the earlier methods of reporting ADRs to Health Canada, any and all information regarding the identity of a subject patient as well as the person making the ADR report to the MedEffect program will be kept strictly confidential.

According to Health Canada's October 2006 Canadian Adverse Reaction Newsletter:

Underreporting of [adverse drug reactions] is a well-known global issue. International studies have estimated that only 1%-10% of all [ADRs] are reported. Health professionals have identified barriers to reporting that relate to the inconvenience and lack of user-friendliness of reporting.

A link to Health Canada's MedEffect web site can be found in the sidebar, under the heading Resources.

(Posted by: Tom Lamb)

Some Recommendations To Reduce Serious Adverse Drug Reactions In The U.S. (Part of Series: ADRs in US)

Part Three: Medication Errors Can Be Reduced By Better Prescribing Methods

In our first part of this series, we looked at the extent of serious adverse drug reactions (ADRs) in the U.S., and in the second part we considered how those could be reduced by better monitoring of emerging drug-safety issues. In this third part, we will see how the number of serious ADRs resulting from medication errors might be reduced by better prescribing methods.

In July 2006 the National Academy of Sciences' Institute of Medicine (IOM) issued a report that reminded us just how many people are harmed by medication errors.  Marc Kaufman, of the Washington Post, gave us an idea of the magnitude this problem in his July 21, 2006 article about the IOM report:

At least 1.5 million Americans are sickened, injured or killed each year by errors in prescribing, dispensing and taking medications....  Mistakes in giving drugs are so prevalent in hospitals that, on average, a patient will be subjected to a medication error each day he or she occupies a hospital bed....  The report found errors to be not only harmful and widespread, but very costly as well. The extra expense of treating drug-related injuries occurring in hospitals alone was estimated conservatively to be $3.5 billion a year.

The IOM report found that some of the more common medication errors involved:

• doctors writing prescriptions that could interact dangerously with other drugs a patient is taking;
• nurses putting the wrong intravenous drug in an IV drip; and,
• pharmacists dispensing the right pill but at the wrong dosage level.

This July 2006 IOM report, "Preventing Medication Errors", was written for the Centers for Medicare and Medicaid Services.  It had two primary aims, to estimate the incidence of medication errors and to identify the best preventive strategies to prevent and reduce those error.

In the recommendations part of their report, the experts serving on this IOM committee reiterated what many observers had noted previously, that many medication errors could be avoided if there were better prescribing methods by doctors.  Specifically, the report included these four recommendations:

1. All prescriptions should be written electronically by 2010.
2. Doctors should improve communication with patients about how to take drugs safely and about potential risks.
3. Doctors should use electronic decision-support tools to write prescriptions.
4. Doctors should regularly review all medications with patients and other physicians involved in a patient's care.

The IOM committee members said the extent of the medication errors problem requires immediate action, and noted that at least a quarter of the injuries caused by medication errors could be prevented by taking steps like those recommended in its report.

In the final part of this ADRs in US series we will look at how the failure of some doctors to provide essential prescription drug information to their patients is part of the problem.

(Posted by: Tom Lamb)

Extent Of Serious Adverse Drug Reactions In The U.S. (Part of Series: ADRs in US)

Part One: An Introduction To This All Too Common Problem

The World Health Organization defines adverse drug reactions (ADRs), also known as adverse drug events (ADEs), in this manner:

A response to a drug that is noxious and unintended and occurs at doses normally used for man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiologic function.

Essentially, therefore, the concept of adverse drug reactions includes all responses involving prescription drugs that cause a patient some harmful side effect, or puts them at risk of such harm.

In connection with its MedWatch reporting system, the FDA has more narrowly defined "serious adverse drug reaction" as a medical event caused by a prescription drug which resulted in a patient's death, hospitalization, or disability, or has caused a congenital abnormality, a life-threatening event, or a required intervention to prevent permanent damage. 

Unfortunately, these serious adverse drug reactions are all too common in the U.S.  It has been estimated that over 770,000 Americans are hospitalized each year due to their adverse drug reactions.  In turn, the hospital expenses to treat those patients are estimated to be between $1.56 billion and $5.6 billion annually.

For many people the extent of serious adverse drug reactions (ADRs) in the U.S. was first brought to their attention in 1999, when the National Academy of Sciences' Institute of Medicine issued a report entitled To Err Is Human: Building a Safer Health System.

In the next part of this ADRs in US series, we will consider how some of these serious adverse drug reactions might be prevented.

(Posted by: Tom Lamb)

Drug Errors Occur At All Points In Medication Process

Implementation Of Monitoring Programs Can Reduce And Prevent Mistakes
 

In June 2006 the medical journal Quality & Safety in Healthcare published an article, "Computer based medication error reporting: insights and implications", that demonstrated drug errors can and do occur at all points in the medication process.

Medical researchers, led by Marlene Miller and Christoph Lehmann, analyzed 19 months of data from a voluntary medication error reporting system in use at the Johns Hopkins Children's Center from 2001 to 2004.

As regards where the drug error occurred during the medication process, they found:

• 30% were prescribing errors;
• 24% were dispensing errors;
• 41% were administration errors; and,
• 6% were documentation errors.

Analyzing their data by drug type, the researchers observed:

• 17% of the errors occurred with antibiotics or anti-virals;
• 15% with pain relievers and sedatives;
• 11% with nutritional supplements;
• 8% with gastrointestinal medications; and,
• 7% with cardiovascular medications.

A June 26, 2006 UPI news article provided some perspective from one of the authors, Dr. Lehmann, who said: "Error reporting is only as good as the actual changes that are made as a result of it."  The UPI article went on to report:

"In response to those findings, [the Johns Hopkins Children's Center] has created several programs to reduce and prevent such errors, including a computerized ordering tool for pediatric chemotherapy, an online infusion calculator for IV infusions, and an online total parenteral nutrition calculator for premature babies."

Significantly, this team of medical researchers led by Dr. Miller and Dr. Lehman determined that half of all medication errors at the Johns Hopkins facility during the study period occurred in children under six-years of age.

(Posted by: Tom Lamb)