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.

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.

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)

March 2006 FDA "Patient Safety News" Videos For Doctors Online

Edition Covers Tamiflu, Paxil, Avandia, Amicar and Omacor Name Confusion, and More

The FDA's Patient Safety News (PSN) is a series of monthly video news shows intended primarily for doctors and other health care professionals.  Generally, this series covers significant approvals, recalls, and safety alerts for prescription drugs and medical devices.  Some of the FDA PSN videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences.

Subjects covered in the March 2006 edition of the FDA Patient Safety News include the following:

Tamiflu Approved for Flu Prevention in Children Under 12

FDA Approves First Immune Globulin for Subcutaneous Use

New Information on Paxil and Congenital Malformations

Recall of Vitros Confirmatory Test for Hepatitis B

Suspended Marketing of NeutroSpec

Avandia and Diabetic Macular Edema

Potentially Hazardous Interaction between Avinza and Alcohol

Drug Name Confusion: Amicar and Omacor

New Labeling for Food Allergens

One can find more information about this March 2006 PSN edition and the series in general on the PSN section of the FDA's web site.   

(Posted by: Tom Lamb)

February 2006 FDA "Patient Safety News" Videos For Doctors Online

Edition Covers Alpha-1 Blockers, Amevive, Salagen - Selegiline Name Confusion, and More

The FDA's Patient Safety News (PSN) is a series of monthly video news shows intended primarily for doctors and other health care professionals.  Generally, this series covers significant approvals, recalls, and safety alerts for prescription drugs and medical devices.  Some of the FDA PSN videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences.

Subjects covered in the February 2006 edition of the FDA Patient Safety News include the following:

First Donor Screening Test for West Nile Virus

Preventing Hemolysis with Meridian Hemodialysis Blood Tubing

Bacterial Contamination of Vapotherm Devices

Avoiding Glucose Monitoring Errors in Patients Receiving Other Sugars

Recall of Boston Scientific Vena Cava Filters

Alpha-1 Blockers and Cataract Surgery Procedures

Amevive Contraindicated in HIV Patients

Reporting Adverse Events for Drugs, Devices, Biologics and Dietary Supplements

Drug Name Confusion: Salagen and Selegiline

One can find more information about this February 2006 PSN edition and the series in general on the PSN section of the FDA's web site.   

(Posted by: Tom Lamb)

December 2005 FDA "Patient Safety News" Videos For Doctors Online

Edition Covers Paxil, Strattera, Menactra Meningococcal Vaccine, and More

The FDA's Patient Safety News (PSN) is a series of monthly video news shows intended primarily for doctors and other health care professionals.  Generally, this series covers significant approvals, recalls, and safety alerts for prescription drugs and medical devices.  Some of the FDA PSN videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences.

Subjects covered in the December 2005 edition of the FDA Patient Safety News include the following:

Risk of Suicidality in Children Treated with Strattera

Recall of Enteryx Injections for Gastroesophageal Reflux Disease

Possible Connection between Menactra Meningococcal Vaccine and Guillain-Barre Syndrome

New Caution on Using Paxil During Pregnancy

Preventing Errors with Neuromuscular Blocking Agents

Luer Lock Misconnections can be Deadly

Drug Name Confusion: Toprol - XL, Topamax, Tegretol and Tegretol - XR

One can find more information about this December 2005 PSN edition and the series in general on the PSN section of the FDA's web site.   

(Posted by: Tom Lamb)

Toprol: AstraZeneca and FDA Warn of Medication Errors Due to Similarly Named Drugs

"Dear Doctor" Letter About Reports of Patients Receiving Topamax and Tegretol Rather Than Toprol

In late September 2005 the FDA and AstraZeneca warned of medication errors and pharmacy mistakes involving three brand-name medications: Toprol, Topamax, and Tegretol.

AstraZeneca said it has received reports of medication errors and pharmacy mistakes involving the extended-release version of Toprol, its beta blocker drug used to treat heart failure and hypertension. Apparently, those medication errors occurred when Toprol-XL has been confused with Topamax, a Johnson & Johnson drug used to treat epilepsy and migraines, or Tegretol, a Novartis AG drug used to treat seizures and neuralgia.

"These reports include instances where Toprol-XL was incorrectly administered to patients instead of Topamax, Tegretol, or Tegretol-XR, and vice-versa, some of them leading to adverse events," AstraZeneca said in a September 2005 "Dear Doctor" letter.  AstraZeneca also issued a "Dear Pharmacist" letter at the same time given that some of the errors were due to drug-dispensing mistakes.

According to an AstraZeneca spokesman, Jim Minnick, the drug company was still reviewing reports of medication errors where patients received Topamax or Tegretol rather than Toprol, but so far it appears that the number of reported adverse events have been "very rare."  The FDA did not comment on the AstraZeneca statement about the number of reports of incorrect prescriptions written involving the three drugs nor the number of patients who suffered an adverse event because of the mistakes in dispensing Toprol, Tegretol, and Topomax.

In has been reported, however, that there were some cases where the patient was hospitalized because of the Toprol-Topamax-Tegretol medication errors. Most of those patients who had been hospitalized suffered from a worsening of the underlying condition that was not treated properly as a result of their having received the incorrect medication. In their Dear Doctor letter and Dear Pharmacist letter, AstraZeneca has acknowledged that there were reports of recurrence of seizures, return of hallucinations, recurrence of hypertension, and at least one suicide attempt.

AstraZeneca believes that most of these medication errors were the result of verbal and written prescriptions being incorrectly interpreted or incorrectly filled because of the similarity of the three drug names and because some of the drugs share overlapping strengths.

On their web site, the FDA has an article entitled "Drug Name Confusion: Preventing Medication Errors".  Among some of the steps patients can take to reduce the likelihood of drug-name medication errors are:

• Know the name and strength of prescribed drugs before leaving the doctor's office
• Insist that the doctor include the purpose of the medication on the prescription
• Ensure that a refill is, in fact, what it should be
• Tell your doctor of any medical history changes

(Posted by: Tom Lamb)

Pharmacists in Florida Must Warn Patients About Certain Drug Risks

Appellate Court Imposes New Legal Duty on Florida Pharmacists

In early June 2005 a Florida appellate court ruled that a Florida pharmacist can be held legally liable for failing to warn patients about certain risks associated with their use of prescription drugs, even if the pharmacist is filling a doctor's prescriptions.  This is the first time that a Florida state court has imposed such a legal duty on pharmacists dispensing drugs in Florida.

The patient in this case, a 46-year-old waitress, died from an overdose of prescription drugs. In the time leading up to her death, the patient had been taking six prescription drugs, including the powerful painkillers OxyContin and Percocet, as well as the anti-anxiety drug diazepam. These drugs are generally known to be harmful if taken together, and some of these drugs are highly addictive with long-term, repeated use.

Earlier in the proceedings for this lawsuit, the trial judge ruled that under Florida law a pharmacist is not liable for this type of patient overdose situation if the pharmacist is properly filling a doctor's prescriptions as written. A Florida appeals court, however, reversed that decision in this June 2005 ruling.

As the foundation for its decision, the 4th District Court of Appeals for Florida noted that pharmacists already must have "general knowledge" of the prescription drugs they dispense as well as the side effects risks those drugs present. Building upon this, Judge Mark E. Polen wrote for the Florida court: "Thus a strong policy basis already exists supporting a pharmacist's duty to warn customers of the risks inherent in filling repeated and unreasonable prescriptions with potentially fatal consequences."

In more detail, the 4th District Court of Appeals for Florida observed that its decision in this new case conflicts with rulings issued previously by two other Florida appeals courts in earlier cases with similar facts. This Florida appellate court, however, cited recent cases in Pennsylvania, Arizona, Nevada, Missouri, and Tennessee wherein state courts have found that pharmacists have a legal duty to warn patients, doctors, or both about the possible serious side effect risks which can arise with either using prescription drugs repeatedly over a lengthy period or time, or using prescription drugs in certain combinations.

The attorney for one of the pharmacies named as a defendant in the underlying lawsuit said that this June 2005 appellate court decision would be appealed to the Florida Supreme Court in the near future.

(Posted by: Tom Lamb)