Michael R. Cohen, R.Ph.
We often receive reports from people who took the wrong medicine or the wrong dose because of mix-ups with products that looked similar. Sometimes people rely on the appearance of tablets, capsules, or packages to identify their medicines, instead of reading the labels carefully. 
Look at these eye drop containers - three completely different medications. With the small print and similar cap colors, pharmacists, doctors and nurses would be hard pressed to tell them apart and their patients can also easily pick up the wrong item. Yet, using the wrong bottle could cause unexpected effects.
The FDA and manufacturers could do a much better job when drugs are approved by assuring product appearance is better differentiated. But there are lessons for patients and health professionals too. Most people know that reading the label is important, but human nature sometimes leads us to make assumptions and take shortcuts.
Daniel R. Hoffman, Ph.D.
Approximately half the drugs now in clinical development involve an approach known as targeted therapy. Last week's posting discussed some of the problems associated with that strategy. These include increasing the risks of drug development, price gouging, fostering a blind-leading-the-blind phenomenon, and a reluctance by pharmas developing these targeted therapies to enter collaborative "cocktailing" agreements (i.e., using drugs from two or more companies to create the most effective regimen).
In these and other ways, pharma has deliberately handicapped its drug development efforts by sacrificing it to finance's short-term demands. The pattern leads many observers to the reasonable assumption that it will be quite some time until the industry can regularly launch new drugs capable of substantially advancing the respective standards of care. That's too bad for pharma because the growing refusal by public and private payers to cover premium-priced drugs that are only marginally better than cheaper generics has doomed the industry's business model.
This idea that new drugs launched during the last several years are mainly me-too's and so-what's recently received objective corroboration. Last week the journal Health Affairs published an analysis that reviewed hundreds of clinical trial results from the 1970's through the 2000's. Although trial results represent a biased indicator of drug quality, given what researchers now know about the tendency of pharmas to publish mainly the results that favor their products, if one assumes this bias has remained fairly constant over the decades, the findings are quite informative.
Marie McCullough
For the third consecutive year, Children’s Hospital of Philadelphia has landed in the top spot on U.S. News & World Report’s annual “honor roll” of best pediatric hospitals in the nation.
In addition to the overall honor roll ranking, U.S. News evaluates children’s hospitals in 10 specialty areas. For 2013-14, CHOP ranked among the top four hospitals in all 10 specialties, with pulmonology and urology rated the best.
The neighboring Hospital of the University of Pennsylvania made the adult honor roll, placing 15th in the United States overall, with national rankings in 13 out of 16 specialties.
Daniel R. Hoffman, Ph.D.
Recently a knowledgeable pharma veteran lamented the fact that the industry has not widely adopted what he considers a particularly useful approach to drug development.
One company "had it right," he wrote, "when their research model was to study particular pathways and find drugs to affect various receptors and proteins that would account for unique differences among patients. Unfortunately they abandoned that model and decided to go after blockbusters and easier targets."
The approach that he was extolling is known as "targeted therapy." While it has not been widely adopted as the cornerstone of pharma's drug development, it has acquired that status at Novartis under Mark Fishman and his group in Cambridge, Mass. Others in the industry consider this strategy for drug development an example of academic medicine run wild.
Daniel R. Hoffman, Ph.D.
Does the private control of drug development and health care in general bestow better health and prosperity on Americans? For people in the C-suites, their bluestocking shareholders and some others, it undoubtedly does. For most Americans, it doesn't appear to work so well.
Earlier this year the US National Research Council and Institute of Medicine issued a report (see here) that compared the health status of Americans to fifteen other affluent, democratic countries. These include Australia, Canada, France, Italy, most of the Nordic countries, Spain, and the UK.
Echoing the findings of many previous studies, the Council found that despite spending the highest per capita amount on health care, Americans don't live as long. In fact, compared to people in the other democratic countries, people here are the least likely to reach the age of 50. Throughout the course of their lives, Americans suffer poorer health from birth all the way to age 75.
Michael R. Cohen, R.Ph.
You may find it hard to believe, but FDA has no say in how many over-the-counter drugs are named. That’s a
great help to companies who want to market their drugs but it’s a problem for those of us concerned about drug safety.
OTC users sometimes fall victim to a potentially dangerous situation that exists with many “over-the-counter drugs” (ones sold on grocery store or pharmacy shelves without a prescription). It’s a problem that the public is largely unaware of, and it has led to confusion and medication errors made by consumers.
Here’s the issue. I’m sure that you’ve noticed that companies often use the same trusted brand name for an entire line of products, even if the ingredients in each product are completely different. That happens with soap suds and deodorants but with OTC drugs people sometimes use the wrong medicine – to their detriment. So watch out if you’re searching store shelves for Benadryl, Claritin or Zyrtec Eye Drops, Triaminic, Sudafed, Betadine, Surfak, Kaopectate, or AZO. What is in these products may not be what you expect.
Daniel R. Hoffman, Ph.D.
All sectors in the health care business face major turning points within the next three years. This means the pharmaceutical industry and other manufacturers, together with providers such as physicians and hospitals, will operate in a different environment by the end of this decade. The important question is just how well each sector is preparing its course corrections to meet the new challenges.
What's behind these enormous changes that will remake health care businesses? Basically they can be summarized with the phrase, "value-based reimbursement." Stated in its simplest terms, value-based reimbursement (VBR) means that the large public and private payers have decided the price they're prepared to pay for any health care product or service will depend upon how much it improves outcomes and reduces overall costs. Although various countries and private payers may differ in their specific methods of applying VBR, a worldwide trend is making it the cornerstone of health care.
The impetus behind VBR lies in the fact that per capita health care costs are rising faster than overall economic growth and the disparity will get worse until some radical changes occur. Health care already accounts for 18% of GDP in this country and it will rise to 20% within the next few years. In a sluggish global economy, the need to devote increasingly larger proportions of a nation's wealth to health care remains simply unacceptable.
Michael R. Cohen, R.Ph.
Occasionally, things go wrong when prescriptions are being prepared at the pharmacy. For example, one person's medicine may be placed into a bag that is labeled with someone else's name. Or a label prepared for a prescription may be mistakenly placed on a bottle containing another person's medicine.
Another reason that a patient might receive a medication intended for another patient is often because the patient was not properly identified before the medication was given. For example, if the pharmacist identifies the patient only by name it can cause a mistake if there is another patient with the same or similar name is listed in their computer system or their prescription bag is also ready for pick-up. Also, patients who are confused or hard of hearing might answer "yes" even if they are called by the wrong name.
One of the most important things you need to do when picking up medicine from the pharmacy is to confirm that what you’ve been handed is actually for you.
Daniel R. Hoffman, Ph.D.
Did anyone in Big Pharma post improved results for the first quarter? Pfizer, Merck, Bristol-Myers Squibb, AstraZeneca, GlaxoSmithKline, Sanofi and Novartis (the last two in their pharmaceutical operations) all generated lower sales this past quarter, compared to the same period last year.
Some companies (such as Roche, Novo Nordisk, and AbbVie) did post gains in their pharma units, but overall it was a dismal quarter for the branded drugs sector.
Throughout the year a number of observers wondered when investors would start to see a major disconnect between the soaring stock prices of Big Cap pharmas, most of which hit 52-week highs many times this past quarter, and some very shaky fundamentals. As it turns out, it may not take all that long.
Michael R. Cohen, R.Ph.
Nearly 1,200 patients in Canada received lower doses of their cancer drugs as a result of poor communication between a compounding pharmacy supplier and several hospitals that utilized the service. The drugs were cyclophosphamide and gemcitabine, used as part of a regimen for breast and lung cancer as well as lymphoma and leukemia. Patients received watered down doses for about a year without anyone realizing there was more saline solution in the bags than stated on the label. Finally, a pharmacy technician at one of the hospitals noticed more fluid in the bags than expected and brought it to the attention of others.
When preparing chemotherapy, cancer drugs are added to ready-to-use intravenous fluid bags from a manufacturer, but the bags typically hold a greater volume of diluent than stated on the label, a situation known as “overfill.” Overfill takes into account that some evaporation might occur from the plastic bags and also that some fluid will be left in IV tubing after injection. Additional fluid is also added to the individual cancer drug vials to make a solution out of the powder inside before adding them to the bag.
About a year ago, the hospitals stopped outsourcing chemotherapy preparation from a pharmacy they’d worked with previously and contracted with a new provider. In this recent incident, the new pharmacy labeled the product differently than in the past. The total amount of drug in the bag was labeled correctly but the final drug concentration listed on the label did not take overfill into account.
- Abington Memorial Hospital
- Agency for Healthcare Research and Quality
- American Medical Association
- Aria Health
- Centers for Disease Control and Prevention
- Centers for Medicare & Medicaid Services
- Consumer Medication Safety site from ISMP
- Cooper University Hospital
- Crozer-Keystone Health System
- ECRI Institute
- Inquirer Health & Science
- Institute for Safe Medication Practices
- Jefferson Health System
- Kaiser Health News
- Kennedy Health System
- Lourdes Health System
- Medical Society of New Jersey
- Mercy Health System
- New Jersey Department of Health and Senior Services
- New Jersey Hospital Association
- NPR.org Shots
- NYTimes.com: Well
- Penn Medicine
- Pennsylvania Department of Health
- Pennsylvania Health Care Cost Containment Council
- Pennsylvania Medical Society
- Pennsylvania Patient Safety Authority
- St. Mary Medical Center
- Temple University Health System
- Tenet Healthcare
- The ACP Advocate Blog by Bob Doherty
- The Chester County Hospital
- The Hospital & Healthsystem Association of Pennsylvania
- U.S. Department of Health and Human Services
- U.S. Food and Drug Administration
- Virtua
- WSJ.com Health



