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.
Daniel R. Hoffman, Ph.D.
Last week the US Justice Department filed suit against Novartis that essentially accuses the company of bribing physicians with lavish dinners, trips and speaking fees so they would prescribe the company's drugs. The suit alleges, "In many instances Novartis made payments to doctors for purported speaker programs that either did not occur at all or that had few or no attendees." While Novartis considers these programs as continuing education sessions for physicians, the prosecutors claim "thousands of programs were held all over the country at which few or no slides were shown and the doctors who participated spent little or no time discussing the drug at issue." In other words, there was not even a pretense at medical education.
In fact, the suit contends that "Many speaker programs were also held in circumstances in which it would have been virtually impossible for any presentation to be made, such as on fishing trips off the Florida coast. Other Novartis events were held at Hooters restaurants."
Michael R. Cohen, R.Ph.
It’s not uncommon for us to hear from consumers who’ve been given the wrong medication at their pharmacy. Sometimes patients can be given incorrect information about a drug they’re taking. 
Last week we heard from someone whose father was on multiple medications for blood pressure and diabetes. He had an old prescription in his medicine cabinet for glipizide, which is used to help control high blood sugar. At the time the prescription was filled, the patient’s doctor didn’t include the reason for the medication with the original prescription directions. So, to avoid confusion with other medications, the patient had asked his pharmacist to write on the prescription container what the medicine was for.
Rather than retyping the label the pharmacist took a pen and wrote right on the label. By accident though, instead of writing “for blood sugar,” the pharmacist wrote “for blood pressure.”
Daniel R. Hoffman, Ph.D.
Some weeks it seems as if random events can inadvertently array themselves to reveal the pharmaceutical industry's fundamentals the way a stormy sea provides a glimpse of the ocean floor. This was just such a week.
In one story that appeared within the last few days, a large consultancy reinforced the point (see here) some of us have been making for a few years. Pharma companies must show customers how their products address total disease costs, not how their drugs compare to current standards and competitors. The consultants found that physicians and ACOs have little confidence pharmas will provide this kind of essential evidence.
Around the same time another industry supplier stated a point that's also been made here. Pharma no longer enjoys the advantage of an "information asymmetry" over its customers. In fact the industry does not even own the most data or superior knowledge about the drugs that it brings to market. Moreover, the clinical trial data that pharma does use as the principal content in its efforts to persuade customers, "will be an increasingly small portion of all the data that is being evaluated about medication choices for patients." That is because technology is making so much more new data available to customers in areas such as claims, clinical studies and use, and behavior. The large stakeholders such as payers and providers have incentives to use these other data sources to optimize their choices (see here).
My husband said he experienced pain in his penis when he ejaculated the other night during sex. What are some possible explanations? When should he go see a doctor about it?
Scott W. Asroff MD, FACS, is an urologist at Lourdes Medical Center of Burlington County.
The prostate gland and seminal vesicles are involved with the production of semen, the fluid which helps to transport sperm. Ejaculation is the result of muscular contractions which sends the sperm from the testicles to the urethra where it is eliminated from the body via the penis.
Therefore, any condition that causes inflammation or an infection of these structures may result in painful ejaculation. The causes of painful ejaculation may be in the testicles, prostate or the urethra - the tubular structure which urine and semen travel through exiting the penis. There are various types of inflammation and bacterial or viral infections that can occur and treatment typically includes a trial of antibiotics, fluids, and rest.
Michael R. Cohen, R.Ph.
When you think of Walgreens or CVS you probably have a drugstore in mind. But more and more, as people seek easier and less costly access to pressing health care needs than a hospital emergency department, people are visiting chain pharmacy locations for their in-store medical clinics. This is only going to grow given doctor shortages, especially as 30 million newly insured Americans begin to benefit from the Affordable Care Act.
When my wife got sick recently while we were out of state on vacation, we decided to stop by one of Walgreens “Take Care” in-store clinics. The experience led to some interesting observations.
First, I have to say the clinic was a great convenience compared to an experience we’d had just hours before when we went to a nearby hospital emergency room. My wife, who is a registered nurse, had an infection and the antibiotic her personal physician had prescribed wasn’t working. She called him and he recommended that she see someone in the city we were in. So we went to the hospital ER and, after waiting for an hour and a half sitting next to people coughing and sneezing, and still not being seen, we decided to leave. ER staff warned us that she’d be charged since we already signed in and she had her temperature taken along with blood pressure and weight. I got the bill in the mail recently. It was over $600! They did give us a $300 non-insured patient discount. We are insured but they hadn’t asked us for her card before being seen. I’ve since called the hospital to give them our insurance information so we’ll have to see what the final charge is.
- 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
