July 20, 2007

Is Ulcerative Colitis in Your Life?

If you have Ulcerative Colitis or know someone who has it, read this…. 

 

This shows that it is a good thing to have those ads on TV that talk about Ulcerative Colitis - just as it is good to have the ads about erectile dysfunction - we need to raise awareness about these conditions for those who know nothing about them - and it helps people know they are not alone and there are treatments out there for them.

Ulcerative Colitis (UC) Sufferers Find UC Quite Disruptive to Many Aspects of Daily Life

UC’s Overall Psychological Toll Is Greater Than for Asthma, Rheumatoid Arthritis and Migraines

WAYNE, Pa., May 17 /PRNewswire/ — Nearly three out of four ulcerative colitis (UC) sufferers (73 percent) responding to a new nationwide survey say not feeling well has become a normal part of life. Furthermore, they describe UC as disruptive when it comes to their relationship with a spouse (64 percent), their sexual relations (75 percent) and their emotional state (82 percent).

UC patients "normalize" aspects of their experience to the point that they resign themselves to these burdens. The majority say that there is not much they can do beyond what they are already doing to feel better (70 percent) and they have learned to live with the disruptions that UC causes (83 percent).

"The findings sound an alarm because a diagnosis of UC shouldn’t mean patients are settling for the level of burden reported in this survey for the next 50 or 60 years. UC is a manageable disease with the appropriate therapy," says David Rubin, M.D., a gastroenterologist and assistant professor of medicine at the University of Chicago Medical Center who helped design the surveys.

UC is a chronic autoimmune disease that causes inflammation in the intestine and can lead to symptoms such as severe abdominal pain and cramping, uncontrollable bloody diarrhea several times a day, fatigue and weight loss. It is typically first diagnosed in people between the ages of 15 to 30 and is estimated to affect nearly 700,000 Americans.

The objective of the surveys was to understand how UC affects patients’ lives, including definitions of what’s normal, the threshold for letting the disease disrupt life, and how patients manage their condition. The surveys, titled "UC: NORMAL (New Observations on Remission Management and Lifestyle)" were sponsored by Shire Pharmaceuticals, a specialty biopharmaceutical company which markets UC medications LIALDA(TM) and PENTASA(R) (mesalamines). Please see Important Safety Information included below.

UC patients generally report more stress/depression compared to other diseases

The findings illustrate that UC takes a heavy psychological toll, which is further brought to light when comparing UC patient responses to the survey responses of people with three other chronic health conditions — migraines, rheumatoid arthritis (RA) and asthma, who were also surveyed as part of UC: NORMAL. Eighty-two percent of UC patients said their condition made life more stressful versus 75 percent of migraine patients, 69 percent of RA patients and 46 percent of asthma patients. Furthermore, 62 percent of UC patients reported feeling sometimes or always depressed about having their condition, versus 49 percent of migraine patients, 52 percent of RA patients and 25 percent of asthma patients.

More than four out of five people (84 percent) with UC say they worry about the long-term health effects of having UC, compared to 45 percent of migraine patients, 72 percent of RA patients and 58 percent of asthma patients. Specific worries most commonly mentioned by UC patients were developing colon cancer, having their colon removed, requiring surgery and public fecal incontinence.

Compliance is a challenge

The survey found that 32 percent of UC patients are not currently taking medication to treat their UC. For patients who are taking medications, compliance is an issue. Of those UC patients taking aminosalicylates (5-ASAs), the first-line therapy and most commonly prescribed class of medication for UC, only about half (54 percent) reported that they have taken all of their 5-ASA medications in the past seven days.

Past studies confirm compliance challenges and report that patients who are noncompliant with their prescribed UC medications have a five-fold greater risk of flare-ups than compliant patients. Traditionally, 5-ASA therapies required two to four times daily dosing and up to 6 to 16 pills a day.

"It’s troubling that almost one-third of UC patients are not taking medication because the standard of care is that all patients with a diagnosis of UC should be on medication to maintain control of the condition and reduce the likelihood of relapse," says Dr. Rubin. "The other challenge we need to address is compliance. More convenient dosing regimens such as once-daily dosage formulations may be part of the solution."

Bridging the physician/patient gap

Patients are also normalizing their experiences with flare-ups, a serious worsening of UC symptoms. UC patients reported an average of eight flare-ups per year. Four out of five (81 percent) of those surveyed say they consider the number of flare-ups they experience to be "normal" for their condition. On the other hand, in a survey of gastroenterologists also done as part of UC: NORMAL, physicians reported that a "typical" number of flare-ups per year on average is three among all patients (2 flare-ups if condition is mild; 4 if condition is moderate; 5 if condition is severe).

UC patients admit that they do not report all of their flare-ups to their physicians, making it difficult for physicians to understand the impact of UC on their patients’ lives. One-third (34 percent) said they are sometimes reluctant to tell their doctor about flare-ups.

"If patients are experiencing multiple flare-ups a year, they should feel empowered to talk to their physicians openly about their disease and ask if their current therapy is appropriate for them," says Dr. Rubin. "As physicians, we need to ask questions to encourage patients to be forthcoming and open with us about the challenges they face and the concerns they have."

As a company committed to educating patients and working with physicians, Shire is developing a program that will launch this fall and is designed to help foster increased discussion between physicians and patients about UC and its management.

Low public awareness

Further confounding the challenges for UC patients, their disease is relatively unknown among the general public. According to UC: NORMAL’s survey of a cross section of the general public, 74 percent of Americans have either never heard of UC or have heard of it but know little about it, even though UC’s prevalence approaches the numbers for HIV/AIDS and Parkinson’s in the United States.

More than two-thirds of UC patients report that having UC is embarrassing to them (70 percent) and that they are reluctant to tell people about their condition (66 percent). With low public awareness and this hesitation to talk openly about their UC, feeling isolated is a risk for UC patients.

"This survey highlights the need to raise awareness and engage the public in a discussion about UC," says Richard Geswell, president, Crohn’s and Colitis Foundation of America (CCFA). "There’s a scarcity of data relating to patient experience and opinions of UC and its treatment, so I hope these findings will help bring this disease to the forefront and assist the ulcerative colitis community in identifying areas to focus our efforts."

"Like many other chronic diseases, there’s no medical cure for ulcerative colitis, but with better management of quality of life issues, improved patient communication and by getting patients on effective therapies, we can help patients live more normal, fulfilling and productive lives," concludes Dr. Rubin. "I hope the survey will spark a national dialogue about UC. I know I’ll use it as a conversation starter in my practice."

The surveys were conducted by Richard Day Research and included a total of 1,975 people: 451 UC patients, 300 gastroenterologists, 309 RA patients, 305 asthma patients, 305 migraine patients and 305 adults from the general U.S. population who may have chronic health conditions. All patient surveys and the general public survey were fielded through an online panel that closely reflects the U.S. adult population overall. Physicians were recruited from a list of all board certified gastroenterologists in the U.S. Assuming no sample bias, the margin of error for the sample of 451 UC patients is +/- 5 percent; assuming no sample bias, the margin of error for a sample of 300 (the other surveys) is +/- 6 percent.

For more information about the survey, visit http://www.ucnormal.com/. For more information on ulcerative colitis, visit http://www.managinguc.com/.

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July 14, 2007

Do You Take Your Medicines As Prescribed?

 Another clip from Medical News Today about the number of pills and Daily Adherence to medication. Although it focuses on certain conditions, the issue is applicable to everyone and every condition. Compliance (adherence to instructions) is such a big factor in health success that we all (doctors and patients alike) must pay attention to what will improve a person’s ability to follow the advice/instructions:

New Study Suggests Number Of Pills Not A Factor When It Comes To Daily Adherence To Medication

There is no correlation between the daily number of pills a patient is prescribed to take and how well a patient will adhere to a dosing regimen, suggests a new study presented recently at the 19th Annual Meeting of the Academy of Managed Care Pharmacy (AMCP) held in San Diego (April 11-14). The large-scale study looked at patients taking a variety of high blood pressure medicines, specifically calcium channel blockers (CCBs), and provides more supportive evidence that adherence to prescribed medication is influenced by a multitude of factors. The study specifically examined dosing regimen to see if there was a relationship between that factor and adherence in patients with a co-payment of at least $20.

More on Do You Take Your Medicines As Prescribed?

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June 25, 2007

Preventing Medication Errors

The Institute of Medicine (IOM) published findings in 1999 on the quality of healthcare in America. That report, "To Err Is Human: Building a Safer Health System," concluded that as many as 7000 Americans die from medication errors each year.[1] In July 2006, the IOM released a new report, "Preventing Medication Errors," stating that the frequency of medication errors and related injuries was still a serious concern.[2]

A common question that arises is: "What drugs are most often involved in medication errors?" Matthew Grissinger, RPh, FASCP, is a medication safety analyst with ISMP, the nation’s oldest voluntary drug error reporting program, located in Huntingdon, Pennsylvania. His session on "The Top 10 Adverse Drug Reactions and Medication Errors" drew an audience that filled the meeting hall.[3]

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).[4] 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%).

Unintentional overdoses made up 40% of these ED visits, representing the most prevalent mechanism of injury by far. Other mechanisms included side effects and allergic reactions. Some of the drugs on this list are especially common (eg, hydrocodone and amoxicillin), so the sheer volume of prescriptions written is a major factor.

The elderly also play a key role in this issue, as they account for 34% of all written prescriptions. The average number of prescriptions for an elderly person in the United States in 2000 was 28.5 per year. That number is estimated to reach 38.5 by the year 2010. Almost a quarter million seniors are hospitalized every year due to reactions between prescription and over-the-counter (OTC) medications.

Common misuses that lead to adverse drug events are taking incorrect doses, taking doses at the wrong times, forgetting to take doses, or stopping the medication too soon (all nonadherence issues). An example of commonly misused medications can be seen with arthritis therapies. Seventy million Americans suffer from arthritis and joint pain, which translates into 30 million people taking nonsteroidal anti-inflammatory drugs, either prescription or OTC. Misuse of these drugs leads to 103,000 hospitalizations and 16,000 deaths per year. Unnecessary use of nonsteroidal anti-inflammatory drugs also increases avoidable side effects, such as dyspepsia, peptic ulcer, and gastrointestinal bleeding.

Another high-volume prescription class is the antibiotics. This group represents significant inappropriate prescribing: Twenty-three million antibiotic prescriptions are written for colds, bronchitis, and upper respiratory infections each year, Grissinger said, despite the fact that antibiotics don’t kill viruses.

Top 10 Medications Involved in Drug Errors

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%).

Hospitals and healthcare systems use the USP database to track medication errors and identify trends. Drug errors are defined as unintentional acts committed by healthcare providers involving medications. Grissinger noted that comparable data are unavailable for outpatient care.

The number 1 error-prone medication is insulin. In fact, a 1998 ISMP study found that 11% of all serious medication errors involve insulin misadministration.[6] Errors include mixing up products with similar packaging (look-alike products); confusing generic listings on computer databases; similarity in names (eg, Humalog and Humulin); and most importantly, confusing the abbreviation "u" for units with the number 0. ISMP reports that these errors have been occurring for over 30 years.

The second drug on this list is morphine, which can be extrapolated to include all opioids, Grissinger said. Similar names for some of these drugs often cause confusion, such as:

  • Avinza and Evista;
  • Morphine and hydromorphone;
  • Oxycontin and MS Contin;
  • Hydrocodone and oxycodone; and
  • Oxycodone and codeine.

In the community pharmacy, these drugs often are stacked close together in a locked area, and many have similar packaging, making it easy to grab the wrong one when dispensing. Another common mistake is mixing up oxycodone with oxycodone ER (extended release), especially in handheld device order entry.

Morphine oral solutions cause many problems because of the multiple concentrations that are available, all stored close to each other. For example, it would be easy to confuse "mL" with "mg"; using 5 mL of morphine 20 mg/mL (100 mg) instead of the prescribed 5 mg (0.25 mL) would lead to overdosing the patient. Alternatively, an intended dose of 1 mL of morphine 20 mg/mL (20 mg) might be given as 1 mL of 10 mg/5 mL (2 mg), thus underdosing the patient. Grissinger also reported a case in which Avinza (morphine ER caps) 30 mg was misinterpreted and dispensed as "qid" (4 times daily) instead of "qd" (once daily), causing a near-fatal overdose.

Acetaminophen is another drug on the error list that causes many problems. It is available in many different strengths, and various measuring devices are available for dispensing it. In addition, it is found in many combination medications, both prescription and OTC. Prescription labels of combination products with acetaminophen can be very confusing for the patient. For example, hydrocodone 10/650 has 650 mg of acetaminophen, but many patients would not know how to interpret that.

Grissinger reminded the audience that acetaminophen can be toxic, even though it is sold OTC. A recent study showed that acetaminophen-induced liver toxicity accounts for more than 40% of US cases of acute liver failure.[7]

Antibiotics are the next big group of drugs associated with medication errors. As with opioids, the liquid dose concentrations increase the risk for mistakes. Confusion over measurements in "mL" vs "tsp" (teaspoons) can cause a 5-fold overdose or underdose if undetected. In one case, for example, azithromycin suspension was dispensed with directions to take 2.5 tsp daily (equivalent to 12.5 mL) instead of the intended 2.5 mL daily, Grissinger reported. The entire contents of the bottle were administered according to the labeled instructions, and the child developed diarrhea.

Reconstituting antibiotics can also be problematic. Pharmacists have mistakenly reconstituted antibiotic suspensions with alcohol instead of distilled water.

System Errors May Interfere With Individual Efforts

Most healthcare professionals have learned the "5 rights" of safe medication use: the right patient, the right drug, the right time, the right dose, and the right route of administration.

However, in his book Medication Errors, Michael Cohen wrote that these "rights" focus on individual performance and can overlook system errors. Examples of system errors are poor lighting, inadequate staffing, handwritten orders, doses with trailing zeros, and ambiguous drug labels. All of these can prevent healthcare professionals from verifying the 5 rights.[8]

Experts at ISMP have identified 10 key "system" elements that most influence medication use, reported Donna Horn, RPh, DPh, ISMP Director, Patient Safety - Community Pharmacy. Systems factors play a major role in increasing the likelihood that an individual will make an error. Deficiencies in any of these system elements can lead to medication errors[9]:

  1. Patient information (age, weight, allergies, diagnoses, and pregnancy status);
  2. Drug information (up-to-date information readily available);
  3. Communication (collaborative teamwork between all healthcare members and the patient);
  4. Drug labeling, packaging, and nomenclature (limit look-alike and sound-alike drug names, confusing packaging);
  5. Drug standardization, storage, and distribution (restricting access to high-alert drugs);
  6. Medication delivery device acquisition, use, and monitoring;
  7. Environmental factors (poor lighting, cluttered work spaces, noise, interruptions, nonstop activity, and deficient staffing);
  8. Staff competency and education;
  9. Patient education; and
  10. Quality processes and risk management (systems are needed for identifying, reporting, analyzing, and reducing the risk for medication errors with a nonpunitive culture of safety).

When an error occurs, it is tempting to blame individuals, Horn said. A "systems approach," however, looks at the whole system rather than individual errors. For instance, failures in the design or implementation of systems can lead to excessive reliance on memory, lack of standardization, inadequate access to information, and poor work schedules. Thus, with a systems approach, accountability is expanded to include anyone who had any influence over the error, setting the stage for broader solutions.

How Can We Prevent Medication Errors?

Nearly half of all adverse drug events have some form of "preventability," and many do not represent errors of commission but, rather, errors of omission. This implies a failure on the part of someone (pharmacist, physician, patient, or the interactions between these groups) to detect certain factors that most likely led to the adverse event. These factors include:

  1. Failure to detect a disease state contraindication to the drug therapy;
  2. Failure to detect a significant drug interaction;
  3. Failure to detect a significant drug allergy;
  4. Failure to prescribe the correct dose for a specific patient;
  5. Failure to monitor drugs with narrow therapeutic indexes; and
  6. Patient knowledge deficits.

Many of these can be avoided by spending a few minutes counseling the prescriber and/or the patient. Communication is key, Horn said. Barriers to effective communication include illegible handwriting, abbreviations, verbal orders, ambiguous orders, and fax or ePrescribing problems.

When communicating with prescribers, pharmacists should identify the issues clearly and concisely, said Marialice Bennett, RPh, FAPhA, Professor and Pharmacy Director of the University Health Connection at Ohio State University in Columbus, Ohio.[10] She offered these suggestions for such discussions:

  • Outline the specifics of the problem;
  • Keep focused on the patient;
  • Provide possible solutions;
  • Ask for prescriber feedback; and
  • Document the final decision.

Conflict can lead to poor communication, which can hinder the discovery of medication errors, she said. Conflicting opinions about patient care should be handled objectively and professionally. The ISMP recommends that healthcare organizations create a code of conduct that encourages behaviors supportive of team cohesion, staff morale, and sense of self-worth and safety.

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