Drug Injury Watch

Beware The Potential Dangers Of Free Drug Samples

Some Ways That Free Drug Samples Can Harm Patients

(Posted by Tom Lamb at DrugInjuryWatch.com)

PLoS Medicine-- which is a peer-reviewed open-access journal published by the Public Library of Science -- published an essay by Susan Chimonas and Jerome P. Kassirer in May 2009 called "No More Free Drug Samples?" which provides a fresh perspective on a well-established practice in doctors office across the U.S.

This essay starts with the ideas that many of us may have about this practice:

Everybody likes something free, and free prescription drug samples are no exception. Patients love to receive them, and doctors feel good about handing them out. The practice of providing free drug samples is based on the tacit assumption that “sampling” does much more good than harm.

Chimonas and Kassirer go on from there to deconstruct these preconceptions, working at various levels:

In this essay, we question the assumption that good trumps harm when prescription drugs are provided free to practicing doctors. We argue that “sampling” is not effective in improving drug access for the indigent, does not promote rational drug use, and raises the cost of care.

I want to focus on the drug-safety aspect of this free drug samples issue. 

In their May 2009 PLos Medicine essay, Chimonas and Kassirer make these points in support of their contention that samples can have "negative consequences" when it comes to patient-health:

• In drugstores, pharmacists often identify potentially harmful drug interactions, intercept inadvertent medication errors, and offer a patient-friendly printout of instructions. In doctors' offices, however, detailed patient education regarding sample use rarely occurs, and when it does, it usually lacks information about drug interactions or instructions on how the drug should be taken. [footnote omitted]

• Moreover, if distribution is inadequately documented in patients' records, some people who receive samples in doctors' offices may not be notified or told to discontinue the medication in the event of a product recall or the emergence of new drug complications.

• The samples that drug representatives offer are almost never time-worn and well-tested drugs, nearly never generics, and usually comprise the newest agents on the market. As such, they expose patients to risks not yet identified in clinical trials. The experience with Vioxx is a case in point.

Chimonas and Kassirer discuss in this insightful essay, also, several other concerns they have with the seemingly "generous" practice of doctors dispensing free drug samples to patients.  It total, the authors conclude that:

The tradition of physicians dispensing samples has many serious disadvantages and is as anachronistic as bloodletting and high colonic irrigations. As the profession begins to slowly extract itself from the influential grip of industry, it must also deal with the undue influence of free samples.

If this topic interests you, "No More Free Drug Samples?" is a relatively short essay that is worth reading when you have an opportunity.

Drug Interaction Prevention Is An Ongoing Process For Doctors And Patients

An Introduction Using Examples And Facts Relevant To Avoiding Drug-Drug Interaction Risks

(Posted by Tom Lamb at DrugInjuryWatch.com)

Patients who require multiple prescription drugs at one time, i.e., concomitant use, are sometimes placed at risk for developing drug-drug interactions (DDIs), where one drug alters the effect of another drug. In turn, drug-drug interactions can lead to decreased therapeutic benefit or efficacy, adverse effects of varying degrees, or even patient death.

To further complicate this type of situation, non-prescription medications and herbal preparations or supplements can contribute to the potential for developing DDIs.

The following examples and facts are intended to help doctors and patients avoid drug interactions and their potentially serious, even fatal, consequences.  They are taken from an educational article, "Managing Drug-Drug Interaction Risks" (free site registration required), which is intended for physicians, pharmacists, nurse practitioners, physician assistants, nurses, and other healthcare workers -- but the information therein could be helpful to patients and their families.

• DDIs contribute to patient morbidity and may cause emergency department visits, hospitalizations, and re-admissions.Examples of patient morbidity caused by DDIs include gastrointestinal (GI) bleeding, renal dysfunction, electrolyte imbalance, hypertension, hypotension, bradycardia, arrhythmia, drug toxicity, and decreased drug effect.
• Examples from the literature of mortality associated with DDIs include ciprofloxacin in fatal seizures, moclobemide-clomipramine overdose in fatal serotonin syndrome,and fatal outcome from a warfarin and nonsteroidal anti-inflammatory drug (NSAID) interaction.
• [T]he risk for DDIs increases significantly after 44 years of age and is greatest for patients over 74 years of age. The need for multiple medications often arises with advancing age that may further the risk for DDIs.
• Patients taking 2 medications had a 13% risk while patients taking 5 medications had a 38% risk for DDIs. Patients taking 7 or more medications had an 82% risk of developing adverse drug interactions.
• Other patient-related risks for DDIs... include very young age, female sex, genetics, decreased organ function, use of a medication having a narrow therapeutic range (eg, warfarin, digoxin, and cyclosporine), major organ impairment, metabolic or endocrine risk conditions (eg, hypothyroidism, hypoproteinemia), and acute medical issues (eg, dehydration).

In the U.S., with our aging population and an ever-increasing use of prescription medications, it seems safe to say that the more one knows about the how to avoid possible drug-drug interactions, the better.

If you are aware of any additional guidance or resources regarding how to avoid drug interactions, please let us know by submitting a Comment, below.

Adverse Drug Reactions Lead To Significant Number Of ER Visits Each Year

New Canadian Study Highlights Link Between Some Medications And Serious Health Problems

(Posted by Tom Lamb at DrugInjuryWatch.com)

A June 3, 2008 article, "More than 1 in 9 ER visits medication-related", in The Globe and Mail reported the highlights of a study published in June 2008 by the Canadian Medical Association Journal which concerned 1,017 patients who presented at the Vancouver General Hospital emergency room (ER) during a 12-week period back in 2006.

The team of researchers who conducted this study were led by Peter Zed, an associate professor at Dalhousie University and the clinical coordinator in emergency medicine at Capital Health in Halifax.

From the June 3 Globe and Mail news article we get these study-findings about adverse drug reactions (ADRs) in Canada:

• 12 per cent, or more than 1 in 9, of all emergency room visits were medication-related, ranging from patients who did not take their medication as prescribed to those who had a bad reaction to a drug;

• adverse drug reactions accounted for nearly 40 per cent of those visits, making them the most common medication-related problem that landed patients in the emergency room;

• 60 per cent of those visits were unpreventable - meaning that patients experienced problems after taking the medication as directed;

• many of the adverse drug reactions in the study involved patients who experienced bleeding complications, rashes or other issues that required hospitalization in some cases; 

• non-adherence - when patients don't take medication as directed - was responsible for about 30 per cent of medication-related emergency room visits;

• some patients may be on several different kinds of medication, which can greatly increase the risk of drug-related health problems;

• the most common drug categories associated with problems were antimicrobial agents, which include antibiotics, painkillers containing opioids and anti-psychotic drugs; and,

• over all, about 75 per cent of the medication-related problems documented in the study were considered moderate, 10 per cent severe and about 15 per cent mild. Some of the most common issues were pain, delusion, paranoia and hallucinations, as well as vomiting and other gastrointestinal problems.

In 2006 we ran a four-part series on adverse drug reactions (ADRs) in the U.S., which started with this post, "Extent Of Serious Adverse Drug Reactions In The U.S. (Part of Series: ADRs in US)".

To reiterate what I said in my prior post, we encourage doctors and patients, both, to submit MedWatchreports about ADRs to the agency when appropriate.

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.

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 Common But Severe Drug Interactions Involving Coumadin (Warfarin)

Beware Of "G" Herbs and Supplements: Garlic, Ginseng, Ginkgo Biloba, and Ginger

In April 2006 Douglas S. Paauw, M.D., a University of Washington medical investigator, spoke at an American College of Physicians meeting about adverse events associated with Coumadin (warfarin) therapy which are caused by drug interactions.

As explained in an April 9, 2006 MedPage Today article by Peggy Peck:

Adverse events associated with Coumadin therapy continue to be a leading cause of hospitalizations for drug-related adverse events, and many times the problem can be traced to those herbs and supplements, he said. Dr. Paauw ran through those and other hazards during a session titled, "Ten Common Prescribing Errors: Drug Interactions and Side Effects."

Starting with the herbs and supplements, Dr. Paauw had an easy-to-remember bit of advice: be particularly careful with herbs and supplements beginning with the letter "G".  Garlic, ginger, and gingko biloba, all increase the anticoagulation of Coumadin (warfarin).  Meanwhile, ginseng decreases the anticoagulation of Coumadin (warfarin).

According to the April 9, 2006 MedPage Today article, Dr. Paauw told the audience of doctors that "the most severe Coumadin adverse events are often traced to Bactrim aka Septra (TMP/sulfa), a frequently prescribed antibiotic in elderly patients who are also the most likely users of Coumadin."

During his presentation, Dr. Paauw listed several other prescription drugs that are likely to interact with Coumadin, including these:

• erythromycin,
• amiodarone,
• Diflucan (fluconazole),
• Nizoral (keotoconazole),
• Sporanox (itraconazole), and
• mentronidazole.

Dr. Paauw also mentioned that the use of Prilosec (omeprazole) or Tylenol (acetaminophen) while using Coumadin at the same time can affect a patient's INR.

As pointed out in the MedPage Today article, Dr. Paauw's presentation emphasized these two lessons concerning drug safety:

1. Patients need to know that herbs, supplements, and vitamins can react with prescription drugs: and,
2. Patients should, on a regular basis, tell their doctor(s) about all prescription and non-prescription drugs that they are using in order to reduce the risk of adverse events caused by drug interactions.

(Posted by: Tom Lamb)