Archive for August, 2014

When Do Medicines Really Expire?

Tuesday, August 26, 2014 // Uncategorized

From yesterday’s WSJ.

Burning Question

Are Expired Medications OK to Take?

One Expert Explains Why an Out-of-Date Aspirin Might Be Just Fine

By

Heidi Mitchell

Aug. 25, 2014 6:31 p.m. ET

Getty Images

There is a lot of confusion surrounding expiration dates on over-the-counter and prescription drugs. Some people use the stamped date as a loose guideline, others adhere to it strictly, and a few keep their bathroom cabinets stocked with outdated pills indefinitely. One internist, Sharon Bergquist, assistant professor of medicine at Emory University in Atlanta, explains when to get rid of that eye ointment, and why an out-of-date aspirin might be just fine to take.

—Heidi Mitchell

It’s the Law

Since 1979, the Food and Drug Administration has required manufacturers to put expiration dates on prescription and over-the-counter drugs. Most patients don’t know what that date actually means. “It is the final date up to which the manufacturer will guarantee that medicine has full potency,” says Dr. Bergquist. “But that doesn’t mean that is the day that medication will become ineffective or unsafe.”

The expiration date is generally anywhere from 12 to 60 months from the time the product was manufactured, says Dr. Bergquist. She notes the date is conservative and in most cases, the drugs in question haven’t been tested for efficacy or toxicity past that date. Once a pharmacist dispenses a drug to a consumer, he will often put a “beyond use” or “discard after” label on the bottle, which is generally one year from the time he opened the original container. “This is required by 17 states,” says Dr. Bergquist. “But there is very little science behind it. It very well could be that a medication is good for 10 more years.”

A Military Study

At the request of the Department of Defense, the FDA conducted a major study of the shelf-life of common medications.

The study, published in the Journal of Pharmaceutical Sciences in July 2006, looked at the Defense Department’s large stockpile of drugs from 1986 to 2006 and tried to determine if all of the drugs needed to be replaced. The FDA analyzed 122 drugs in 3,005 lots, and studied their stability. “It turned out that 88% of the lots could be extended beyond their expiration date for an average of 66 months—or 5½ years,” says Dr. Bergquist.

Of course, she adds, the military stockpile is generally kept in a climate-controlled, regulated area, “not in a humid cabinet in a bathroom.”

Potency vs. Efficacy

Dr. Bergquist won’t tell her patients outright to use expired drugs. Instead, she breaks it down into two scenarios, she says. “If a person’s life is reliant upon nitroglycerin, an EpiPen or insulin, then he should keep turning over his medications and making sure they are complying with expiry dates.”

But if you have back pain, a cold or a headache, she adds, “and all you have is expired pills at home, in those cases, it’s probably okay if your medicine doesn’t have 100% efficacy.”

She also notes that there haven’t been reported cases of toxicity from expired medications.

Keeping Your Own Stockpile

Some forms of medication have longer shelf-lives than others, notes Dr. Bergquist. Tablets and capsules tend to be most stable, with tablets lasting the longest. Drugs that are kept in liquid suspensions or that need to be refrigerated, go bad relatively quickly and should always be kept up to date.

“Then there are obvious signs: If it has a strong smell; if it is an ointment coming out in crusts and cracks, or if it is crystallized, it should be discarded,” she says. Generally discarding in the trash can is fine, though the FDA prefers controlled substances get flushed down the toilet, she says.

To keep meds lasting at least until their expiration date, store them properly, says Dr. Bergquist. “Don’t leave them in a hot car; keep bottle caps closed tightly, [and] look for places in your home that are dry, cool and away from direct sunlight.”

She recommends storing medicine in clothing drawers, kitchens (not above the stove) and always in their original container.

—Email questions to [email protected]

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A Tale of Two Patients

Monday, August 4, 2014 // Uncategorized

I was struck by this when I read it 10 years ago.  Unfortunately, it is as topical now as it was then.  From The Annals of Internal Medicine.  At the end of the issue they have a section called “On Being a Doctor”.  I think of it as my reward for having weighed through the journal.  I am always humbled by the writing skills of some of my colleagues.

On Being a Doctor | 1 June 2004

A Tale of Two Patients

Faith T. Fitzgerald, MD

Ann Intern Med. 2004;140(11):929-930. doi:10.7326/0003-4819-140-11-200406010-00017
Text Size: A A A

Requests for Single Reprints: Faith T. Fitzgerald, MD, University of California, Davis, 4150 V Street, Suite 1100, Sacramento, CA 95817.

Late last year, my 87-year-old mother developed diarrhea. I phoned her doctor’s clinic and was answered by a recorded voice that periodically told me, “All of our representatives are busy helping other clients. We appreciate your patience. Your call is important to us. Please hold for our next available representative.” Synthetic music alternated with synthetic messages for 28 minutes before I lost my appreciated patience and hung up. I phoned again later; after a 15-minute hold, in the midst of “Your call is important …,” I was disconnected. I got through on the third try: The first possible appointment was in 2 weeks. I took it. I would cancel my own workday afternoon to take my mother to see her doctor.

The receptionist ignored us when we came into the office at 3 p.m. I stood by her desk, Mom beside me in a wheelchair, while she chatted and joked with the clerk next to her for several minutes. I coughed. Nothing. I coughed more loudly. She glanced in my direction, so I quickly told her we were there for a 3:30 appointment. “Name?” she said. Then, “Registration card?” and “Insurance card?” She stamped a bunch of sheets of paper, then shoved a clipboard covered with a sheaf of documents to be signed toward me. We were directed to sit in the crowded waiting room. When we were settled there, I started to read the forms to Mom, but they were dense and in microprint, and largely unintelligible, so she finally just signed them unread. I carried them back to the clerk, who took them without a word. We waited some more. At 4 p.m. I went back to the desk. I stood in line behind more recently arrived patients and gradually worked my way to the front: “When will my mother be seen?” I asked the clerk.

“Name?” she asked. I told her. “Registration card? Insurance …?”

“We’ve done all that already,” I said.

“Oh!” She shuffled though a pile of stamped papers, found Mom’s, then put them back in the pile.

“Doctor is running behind. He’ll see her as soon as he can,” she said.

“Does he know we’re here?”

“He’ll see her as soon as he can,” she repeated. She sounded annoyed.

“She feels miserable and tired,” I said.

Even as I spoke, the receptionist picked up the ringing telephone and began to talk to the caller, turning her eyes away from me. I stood firm in my spot.

“Hey!” I said. She ignored me. “Hello! I’m still here.”

“Excuse me,” she said to the caller, putting her hand over the receiver. Then to me she said: “I’m on the phone!”

“I know that,” I said. “When will my mother be seen?” It was now 4:15 p.m.

“Doctor will see her as soon as he can,” she said, and resumed her telephone conversation.

I didn’t move. When she hung up the phone, she looked around me to the next person in line behind me. “Name?” she asked him. “Registration card?”

I went back to my mother, who was sitting in her wheelchair holding her head in her hands. “Is the doctor going to see me soon?”

“He’s running behind,” I said.

“Does he know we’re here?”

“I don’t know.”

“I’m really tired,” she said.

“I know.”

“What time is it?”

“4:20.”

“Wasn’t the appointment for 3:30?”

“Yes.”

“Where is he?”

“Busy.”

“I’m really tired,” she said. “And I have to go to the bathroom.”

“I’ll take you.”

“No. The doctor might come and not find us.”

“I’ll tell the receptionist where we are.”

“No. I’m afraid we’ll miss him.”

“Do you want to go home? I can make another appointment.”

“No. I’ll wait.”

She looked up expectantly as each new movement occurred in the waiting room. Periodically, a nurse would come out of the inner office with a sheet of paper and call out a first name. “Bill?” she’d say, and a distinguished elderly man would get up. Then, 15 minutes later, “Harriet?” A woman stirred from her corner. Each time, my mother’s hopes visibly rose with the nurse’s appearance, then fell again, and she slumped back into her wheelchair when the name called was not hers. Finally “Irene?”

I pushed my mother’s wheelchair to the door; I said to the nurse. “My mother is 86 years old and from a time and place that equates respect with titles. Please don’t call her by her first name.”

“Okay,” she said, startled. “What shall I call her, then?”

We were put into a cubicle. Mom’s blood pressure, pulse, and temperature were taken. She was weighed, with great difficulty because of her immobility (I held her up on the small platform of the standing scales), and her body mass index was calculated from a wall chart. We were directed to an examination room that barely accommodated her wheelchair. It was cold. I asked the nurse for a blanket for Mom. She gave me a sheet. “We don’t have any blankets,” she said.

It was 5:30. “Is the doctor coming soon?” my mother asked the nurse.

“He’s running behind,” she said. “He’ll be here as soon as he can.”

“I have to go to the bathroom,” Mom said.

“The doctor may want a urine sample,” she said. “Can you wait?”

“I can wait,” she answered.

“I’ll take you,” I said, and, over her protests, did. On the way to the bathroom, we passed a conference room full of laughing staff. They were having chips, coffee, cake … a party of some sort. We took a long time in the bathroom to get done. Maneuvering Mom in and out of the wheelchair onto the toilet isn’t easy. When we came back to the room, she was frantic. “Did he come? Did we miss him?” Just then, the harried doctor came in. He was apologetic, pleasant, polite, attentive, and thorough. He took a careful history and did a directed physical examination. “Her examination is normal,” he told me, then more loudly to her, “Your exam looks okay, but we should get some tests.”

“Now?” she asked.

“No,” he said. “It’s too late. The clinic lab is closed.”

“When?” she asked.

“We can draw the blood tests tomorrow.”

“What do we do now?” she wanted to know.

“You go home and eat a liquid diet until we know what’s going on.”

“No medicine?” she asked.

“Not until we know what’s going on,” he said.

He turned to me. “I’ll give you a stool cup and urine specimen cup. You can bring them to the lab when you bring her for the blood draw.” It was clear that, though he knew I was a medical school professor and had a clinical, administrative, and teaching schedule of my own, this was quite secondary to the system’s constraints. If we wanted this done, it had to be done this way.

We went home, arriving well after 7 p.m., both exhausted. The next day, after my early morning hospital rounds and rescheduling my non–patient care appointments, I took her to the lab, where a single, haggard phlebotomist faced about 20 patients.

Her diarrhea continued until the study results came back negative, then gradually stopped. “Probably something she ate,” her doctor said when I phoned him with the news.

The bill, when it came 3 months later, was for over $600, mostly paid by Medicare.

Late last year, my 10-year-old boy developed diarrhea. I phoned his doctor’s office, and the receptionist answered within 2 rings of the telephone. I explained the problem, and she said, in a voice of concern: “Oh, goodness. You’d better bring him in. Can you come in about an hour?”

“Sorry,” I said. “I have appointments myself until this afternoon.”

“Well, how about early this evening? Five o’clock? Five-thirty? Or we could see him this weekend.”

“Five-thirty today is good. I’ll get a chance to swing by home and pick him up.”

“See you then. Call if you can’t make it.”

It was a squeeze, but I managed to get away early from work and arrived at the doctor’s office only 10 minutes late. The receptionist looked happy to see me, greeting me by title and last name, and was similarly welcoming to the patient. He was glum and anxious, but she was sympathetic. Within 3 minutes of our arrival, he had been weighed (markedly obese, as before), and we were led into a cheery, warm examination room. Four minutes after that, the doctor came in.

She spoke first to him; “How are you doing?” she asked. Then, as he turned away from her, “You poor guy. You don’t feel well at all, do you?” She ran her hand gently through his hair.

He didn’t answer.

“What’s the problem?” she asked me and smiled sweetly at him. “It seems he’s not up to talking.”

I explained. She quickly, but thoroughly, examined him. He squirmed, uncooperative. She didn’t seem to mind. A stool sample obtained by rectal exam was sent immediately for microscopy. “We’d better check a few labs,” she said. The blood was drawn there and then. By the time she’d finished, the stool report was ready. “No white cells, no blood, no ova or parasites,” she said. “His abdominal exam is normal, but we can get an abdominal radiograph to check for partial obstruction or volvulus if you like.”

“Okay.”

She took him to the radiography suite down the hall and returned in 10 minutes without him, but with his film in hand, showing it to me on the view box: “Negative,” she said. “Perfectly normal. We’re getting a urine sample now,” she said. “Sometimes a urinary tract infection can do this.”

The urine and just-drawn complete blood count results accompanied his return to the examination room 5 minutes later. All was normal. The liver and renal chemistries would take a little longer, and the doctor promised to call me with them in the morning.

By this time, he looked better. I noticed that they had cut his nails, which had been a little long, while he’d been in the radiography suite. I was given dietary instructions by his physician. “No further therapy was warranted,” the doctor said, and we left. The visit, exam, labs, radiograph, pedicure, and advice had taken 30 minutes and cost $175. He was hungry again that night, and his doctor phoned me first thing next morning to ask how he was doing and to give me his lab results—all normal.

“Probably something he ate,” the veterinarian said. “You know how dogs are, and Igor is particularly dedicated to eating anything he can get his muzzle around.” She laughed. “But if it happens again, just call us.”

Faith T. Fitzgerald, MD

University of California, Davis; Sacramento, CA 95817

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Don’t Worry about Ebola, Worry About Chikungunya

Saturday, August 2, 2014 // Uncategorized

There is a lot in the news about the outbreak of Ebola in West Africa and concern that treating infected healthcare workers in the US might cause it to spread here.  That’s not going to happen, but there is another African virus that has spread to the Caribbean and has now been reported being transmitted in Florida.  This is Chikungunya.  It’s like a replay of West Nile Virus, though this infection tends to be less severe.  It can become widespread since it can be spread by mosquitoes which are present in the U.S.

Chikungunya Spreads Through the Caribbean Stephen G. Baum, MD reviewing Fischer M and Staples JE. MMWR Morb Mortal Wkly Rep 2014 Jun 6. Stephen G. Baum, MD Local transmission of chikungunya virus has now been identified in 17 countries or territories in the Caribbean and South America. Stephen G. Baum, MDChikungunya virus — an alphavirus — and the illness it causes have long been recognized in countries in Africa, Asia, Europe, and the Indian and Pacific oceans. Before December 2013, when locally spread infection was reported from Saint Martin, cases in the Western Hemisphere all involved travelers returning from endemic regions. Since that time, local transmission is known to have occurred in 17 countries or territories in the Caribbean and South America. As of May 30, 2014, 103,018 suspected and 4406 laboratory-confirmed cases have been reported from that area — more than 95% of them in the Dominican Republic, Martinique, Guadeloupe, Haiti, and Saint Martin.Infection is spread mainly by Aedes aegypti and Aedes albopictus mosquitoes, both of which transmit dengue virus as well. These vectors are prevalent in the Caribbean but also exist in the continental U.S. (NEJM JW Infect Dis Apr 10 2014). Humans are the primary amplifying host. Most infected individuals develop symptomatic disease typified by acute onset of fever and symmetrical polyarthralgia; joint pain may be debilitating and long-lasting. There is neither a vaccine nor a specific therapy. – See more at: http://www.jwatch.org/na34937/2014/06/11/chikungunya-spreads-through-caribbean#sthash.pw1VhwYr.dpuf

2 in Florida Said to Catch Fever Found in Tropics

By JULY 17, 2014 New York Times

Doctors have been warning that Chikungunya fever, a tropical disease that causes severe joint pain, would soon reach the continental United States. Now it has done so, federal and state officials said Thursday.

The first domestically acquired cases were found in two Florida residents, one from the Miami area and one from Palm Beach, according to the state’s Health Department. Neither had traveled to countries where the mosquito-borne disease is endemic. One case has been confirmed by the Centers for Disease Control and Prevention; the second has not.

While seldom fatal, the Chikungunya virus (pronounced CHIK-en-goon-ya) causes high fever and sometimes a rash in addition to joint pain. Its name, from the Makonde language of East Africa, refers to people walking “bent up” with pain. In about 20 percent of patients, the pain can last a year or more.

The disease has been widespread in the tropics for centuries, but until 50 years ago it was confused with dengue fever, which kills far more people.

Dengue has been transmitted inside Texas along the Mexican border a few times since 1980. In 2009, it temporarily established itself in Key West, Fla., setting off a large mosquito-control effort.

Last year, Chikungunya cases were found for the first time on a Caribbean island, St. Martin. The virus quickly established itself in Puerto Rico. Until Thursday, all the 232 cases detected in the continental United States were in people who had returned from endemic areas.

On Wednesday, two researchers at the National Institutes of Health published an article titled “Chikungunya at the Door — Déjà Vu All Over Again?” in The New England Journal of Medicine predicting that local transmission was imminent. The first case was confirmed by the C.D.C. about 24 hours later.

Dr. Anthony S. Fauci, one of the authors, called it an “amazing coincidence.”

 

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