Source | FDA Patient Safety News

The U.S. Food & Drug Administration has released a video regarding: “Preventing Patient Deaths from Fentanyl Patches”

The information contained in the video is very informative.  

We’d like to commend the FDA for making this type of valuable information available to the American public.  It not only helps the average consumer but also those people with visual disabilities that must utilize screen readers, etc.  Nice work FDA!

“Preventing Patient Deaths from Fentanyl Patches” — MOVIE LINKS

Click Here to Watch the Video - Windows Media Player

Click Here to Watch the Video - Real Player

A recent report from the Institute for Safe Medication Practices warns about the dangers of misprescribing fentanyl transdermal patches, such as Duragesic. ISMP reminds practitioners that these patches are intended only for patients who are opioid-tolerant, and should not be used for acute pain.

ISMP also pointed out other prescribing errors. In some cases, deaths occurred in patients who were prescribed multiple fentanyl patches, resulting in overdose. In other cases the fentanyl was prescribed in addition to other pain medications, such as oxycodone, or it was prescribed for patients with pre-existing respiratory compromise. ISMP points out that sometimes pharmacists have dispensed these prescriptions without questioning them, and nurses have applied the patches without recognizing the prescribing error.

Here are some of ISMP’s recommendations to help avoid these tragic and preventable errors:

• Prescribe fentanyl patches only for patients who are opioid tolerant, and who have chronic pain that is not well-controlled with shorter-acting analgesics. These patches should not be used for postoperative pain, or for pain that’s short-term or intermittent. Pharmacists should ensure that the patient is opioid-tolerant and suffering from chronic pain before dispensing the drug, and should question the prescriber if this is not the case.
• Set dosing limits. For example, pharmacy computer systems could be set to flash an alert if more than 25 mcg per hour has been prescribed as a first-time dose. Also, in evaluating whether the dose is appropriate, take into account other opiates or analgesics that may have been prescribed.
• Educate practitioners and patients to know the signs of overdose, which include respiratory distress, shallow breathing, fatigue, sleepiness, confusion, dizziness and fainting.
• Prescribing errors are not the only cause of deaths and injuries from fentanyl patches. They also occur when patients mis-use the patches. Sometimes patients and family members do not understand that heat can increase absorption of the drug to dangerous levels. So patients should be told to avoid heating pads, electric blankets or hot baths while the patch is in place, and let their doctors know if they develop a temperature above 102 degrees.
• There have also been cases where children found used patches in the trash and applied them to their own bodies, and died as a result. And so patients should be warned to dispose of the patches by folding them in half and flushing them down the toilet.

ISMP Canada has reported on Fentanyl patch overdoses.  To view the video please click the following link:

http://www.ismp-canada.org/download/CTVFentanylPatchOverdosesContinue2007SEP04.wmv

Source | Institute for Safe Medication Practices

Problem: Despite warnings from the FDA, manufacturers, and various patient safety agencies, fentanyl transdermal patches continue to be prescribed inappropriately to treat acute pain in opiate-naïve patients, sometimes in large doses or in combination with oral or intravenous opiates. Some of these prescribing errors have occurred in hospitals; others have originated in physician offices or ambulatory surgery centers, where well-meaning but misinformed primary care physicians or surgeons have prescribed the drug for opiate-naïve patients under contraindicated circumstances such as acute post-operative pain. Unfortunately, pharmacists have often filled these prescriptions without question, and nurses caring for patients have applied the patches without recognizing the prescribing error. ISMP is deeply troubled by these practices and alarmed by what appears to be a steady stream of reports of adverse events with fentanyl patches—including fatalities—caused by inappropriate prescribing, dispensing, and administration of the drug. The databases to which ISMP has access bear proof of this ongoing safety issue, and numerous case reports have already appeared in previous editions of ISMP newsletters (May 31, 2007; June 29, 2006; May 4, 2006; August 11, 2005; May 20, 2004; September 19, 2001).

As noted two years ago in our August 11, 2005 newsletter (New fentanyl warnings: more needed to protect patients), Ortho-McNeil (Janssen), maker of DURAGESIC (fentanyl transdermal), issued a “Dear Health Professional” letter to bring attention to new boxed warnings in the product label related to improper prescribing (www.fda.gov/medwatch/SAFETY/2005/duragesic_ddl.pdf). Likewise, FDA issued a Public Health Advisory (www.fda.gov/cder/drug/advisory/fentanyl.htm) to alert healthcare providers that deaths and overdoses had occurred in patients using both the brand name product Duragesic and the generic product. Despite these warnings, label changes, and publication of prescribing problems in ISMP newsletters and elsewhere, some practitioners still seem unaware of the dangers with this potent narcotic and the proper prescribing guidelines (see Table 1 at the end of the article). 

In our May 31, 2007 newsletter, we reported that an elderly patient had several fentanyl patches totaling 125 mcg/hour applied to her skin, which caused delirium and led to her transfer to a critical care step-down unit for close observation. In the past few weeks, we received two more reports of prescribing errors—one of which was fatal.

In the first case, the person reporting the event described a post-operative patient with a morphine infusion running immediately after surgery, who was discharged the next day. According to the reporter, a nurse applied a prescribed fentanyl patch, 75 mcg/hour, to the patient’s skin before discharge, and gave the patient three patches to take home as well as a prescription for oxycodone prn every 4-6 hours. Sadly, the patient died within 12 hours of discharge. We were told that the coroner attributed the patient’s death to application of the fentanyl patch. Not only was this patient opiate naïve, and his pain not chronic, he was also being treated for sleep apnea and bronchopneumonia at the time of his surgery. Depending on its severity, existing respiratory compromise is another contra-indication to administering the drug. 

In another event reported this month, an elderly patient was admitted to a hospital after application of a 100 mcg/hour patch to the skin. A family member had called the clinic where the patient had been receiving periodic epidural injections for back pain and asked a nurse to arrange an ambulance for transport for his next visit. This represented a significant change in the patient’s status, so the nurse questioned the family and learned that a fentanyl patch had been prescribed, and that the patient had continued taking PERCOCET 5/325 (oxycodone 5 mg and acetaminophen 325 mg), two tablets, three or four times a day. After calling the patient’s pharmacist to confirm his prescribed medications, the nurse called the family and told them to remove the patch immediately and take the patient to the emergency department (ED). The patient was admitted to the step-down unit. During the call to the patient’s family, the nurse also confirmed that the patient and family had not been counseled when picking up the prescription. They had no awareness of the potency of the drug. Fortunately, this patient did not suffer any permanent adverse consequences. 

Safe Practice Recommendations: The examples of errors described above are closely associated with a knowledge deficit about proper prescribing of fentanyl patches. These examples and others help substantiate the fact that reliance on product labeling and practitioner education alone will not do enough to solve this life-threatening problem. Yes, healthcare practitioners should be educated about safe prescribing, and the potency of fentanyl patches should be stressed. (You can view a free FDA Patient Safety Video [created in cooperation with ISMP] on this subject at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=44#2.) But there will always be those who are unaware of the great risks they take when prescribing fentanyl patches to opiate-naïve patients to treat acute pain. Thus, prescribing guidelines along with checkpoints as described below must be established for this high-alert medication to help avoid the risk of patient harm.       

Create guidelines. Specific prescribing and dispensing guidelines for fentanyl patches that are congruent with the product labeling should be developed and referenced during order entry of the medication in inpatient and outpatient settings. Fentanyl patches should only be used by patients who are opiate-tolerant with chronic pain that is not well controlled with shorter-acting analgesics. Equianalgesic conversion tables should also be included in the guidelines to help prescribers convert patients to an appropriate fentanyl transdermal dose based on preexisting opiate doses the patient has been taking. 

Determine the indication. Pharmacists should determine the indication and ensure that the patient is opiate-tolerant and suffering from chronic pain before dispensing the medication. In inpatient settings, this information may come from the admission data set or nursing staff. In outpatient settings such as community pharmacies, the information must come from the patient profile, the prescriber, or from the patient (or patient’s family) when the prescription is dropped off, ideally, or when providing counseling, if necessary. (See recommendation for mandatory counseling below.) If a new prescription is received for an opiate-naïve patient or the drug is intended to treat short-term pain, intermittent pain, or post-operative pain, the prescriber should be called to question the order. Verification of the indication and any conversations with the prescriber regarding the patient and the prescribed medication should be documented in a consistent place (e.g., pharmacy computer system, progress notes, order form, outpatient prescription).

Set dosing limits. The fentanyl patch should always be prescribed at the lowest dose needed for pain relief. Inpatient and outpatient pharmacy computer systems as well as computerized prescriber order entry systems should be designed to flash an alert on the screen and create a hard stop if more than 25 mcg/hour has been prescribed as a first-time dose. For patients who are admitted to the hospital and using fentanyl patches at home, the dose should be verified during medication reconciliation, and the verified drug list should be sent to the pharmacy. Healthcare providers should remain cautious about orders for a 125 mcg/hour strength because the decimal point has been overlooked at times with orders for 12.5 mcg/hour patches.

Assess concomitant use of opiates. To reduce the risk of an overdose, take into consideration any other opiates pre-scribed for the patient when evaluating the appropriateness of the patient’s dose.  

Limit prescribing privileges. In inpatient settings, consider limiting the prescribing of fentanyl patches to certain categories of prescribers who have been educated about the drug and privileged to prescribe it. Alternatively, orders for patches in doses greater than 25 mcg/hour could be limited to privileged prescribers, or the organization could require a review by a pain management specialist within a specified timeframe. 

Mandatory patient education. Patients who are using a fentanyl patch and their caregivers should be educated about how to use the patch safely. In both inpatient and outpatient settings, this education should be mandatory and scripted for pharmacists and nurses to promote consistent discussions about: indications; potency; dose; safety precautions (e.g., avoid heating pads or hot tubs, remove old patch before application of a new patch); application, removal, and disposal processes; and signs of fentanyl toxicity. The patient package insert (or medication guide if one becomes available) should also be provided to the patient. In outpatient settings, pharmacists should use this counseling opportunity to verify that the patient is opiate-tolerant and being treated for ongoing chronic pain. All patient education should be documented in the patient record.

Know the signs of overdose. Healthcare practitioners who prescribe fentanyl patches, and nurses, patients, and caregivers who place the patches on the skin, should be aware of the signs of fentanyl overdoses, including: respiratory distress; shallow breathing; tiredness, extreme sleepiness, or sedation; inability to think, talk, or walk normally; and feeling faint, dizzy, or confused. If these signs occur, patients (or their caregivers) should seek medical attention immediately. Patients (and caregivers) should also know that they may have a sudden and possibly dangerous rise in their blood level of fentanyl or have a stronger effect from fentanyl if they: use other drugs that affect brain function; drink alcohol; have an increase in body temperature or are exposed to heat; or use other medications that affect how fentanyl is broken down in the body (e.g., ritonavir, ketoconazole). 

ISMP has communicated with Ortho-McNeil and will also be contacting other manufacturers of fentanyl patches to alert them to the latest reports we have received about overdoses in opiate-naïve patients. We learned that Ortho-McNeil, maker of Duragesic, has filed an updated risk management plan for FDA approval that calls for ongoing surveillance to determine the scope of opiate-naïve patients who have been prescribed a fentanyl patch. They have also developed a patient medication guide, which healthcare providers will be required to give to patients, and indicated that the guide would be freely available on its website soon. We suggested that fentanyl transdermal sales forces provide targeted education to physician groups, perhaps standardizing the educational program and making it easily accessible to all healthcare practitioners. As an additional measure, ISMP will continue pursuing a collaborative effort with community pharmacy chains and independent pharmacies to further develop the mandatory education (counseling) process for patients, including scripted topics that detail the information that should be provided and documented.    

Table 1. Excerpts from product labeling for fentanyl transdermal**

Indication
Fentanyl patches should ONLY be used to manage persistent, moderate to severe chronic pain that requires continuous, around-the-clock opiate administration for an extended period of time, and when the pain cannot be managed by other means such as non-steroidal analgesics, opiate combination products, or immediate-release opiates. Transdermal fentanyl should ONLY be used in patients who are already tolerant to opiate therapy, and who require a total daily dose of other opiates at least equivalent to a 25 mcg per hour fentanyl patch. Patients who are considered opiate-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily (or an equianalgesic dose of another opiate).

Initial dose
In selecting an initial dose, attention should be given to 1) the daily dose, potency, and characteristics of the opiate the patient has been taking previously, 2) the reliability of dose conversion guidelines featured in the package insert to predict the potency of the fentanyl dose needed, 3) the degree of opiate tolerance, and 4) the patient’s medical status. Equianalgesic dosing tables are available in the package insert for assistance. Overestimating the dose when converting patients from another opiate can result in a fatal overdose with the first dose.

Dose titration
During the initial patch application, patients should use short-acting analgesics as needed until efficacy with fentanyl is attained. There-after, some patients may still require short-acting analgesics for “breakthrough” pain. The starting doses listed in the equianalgesic tables are conservative to reduce the risk of overdosing patients on the first dose; 50% of patients may require a dose increase. The dose may be titrated upwards on the basis of the average daily use of a supplemental analgesic, but no more frequently than 3 days after the initial dose or every 6 days (after 2 patch applications) thereafter. 

**The information provided is incomplete and should not be relied upon for prescribing. Full prescribing information can be found at: www.duragesic.com/duragesic/shared/pi/duragesic.pdf#zoom=100.

Source | RNWEB

Fentanyl (Duragesic) patches are still being prescribed to opiate-naive patients with insufficient oversight or patient education.

The Institute for Safe Medication Practices has issued a warning regarding ongoing inappropriate prescription of fentanyl (Duragesic) transdermal patches with adverse, sometimes fatal, outcomes. Despite Ortho-McNeil adding a boxed label warning, an FDA advisory, and Institute alerts going back to 2001, fentanyl patches are still being prescribed to opiate-naive patients in excessive doses, in conjunction with other opiates, or without sufficient oversight of titration or patient education. The Institute offers several recommendations to practitioners, including setting up dispensing guidelines and dosing limits, patient education, taking a history of other concurrent opiate use, and teaching users and caregivers the signs of fentanyl overdose.

Institute for Safe Medication Practices. “Ongoing, preventable fatal events with fentanyl transdermal patches are alarming!” 2007. www.ismp.org/newsletters/acutecare/articles/20070628.asp (13 July 2007).

Many doctors are overlooking Food and Drug Administration warnings about delivering the painkiller fentanyl through a skin patch.

In 2005, after the opium-like drug killed a number of patients, the FDA issued a warning that said the painkiller in patch form should be prescribed in low doses and was not be used for patients recovering from surgery, the Los Angeles Times reported Monday.

But since then hundreds of patients have died because healthcare providers have not gotten the message, and prescriptions of the patch did not decrease after the warning was issued.

The problem is even more pressing because a number of other drugs are beginning to be available in patch form, the newspaper said. Though patches can be an easier way to administer drugs, it is more difficult to make sure patients with widely varying body chemistry get the right amount at the right time.

Ortho-McNeil, which makes the brand name form of the drug, called Duragesic, told the Times it would support efforts to make sure the product is used safely.

Source | Globe Life

Fentanyl patches have grown in popularity among chronic pain sufferers despite repeated warnings from health regulators

Ontario’s chief coroner is investigating the deaths of three patients who appear to have overdosed on pain medication that was administered using a stick-on patch. And at least three more deaths in B.C. have been linked to the same drug.

The news is drawing attention to the dangers of fentanyl patches, which have been growing in popularity despite repeated warnings from health regulators that they should not be used indiscriminately.

David U, president and chief executive officer of the Institute for Safe Medication Practices, said the painkiller patch is a good drug and a convenient alternative to the pills, injections and pumps often relied upon by chronic pain sufferers, but fentanyl patches are being widely misused.

“These cases are preventable,” he said of the deaths and the dozens of reports of illness among patients using fentanyl patches in Canada.

“But it’s being given to the wrong type of patient.”

Mr. U, who is a pharmacist by training, said the powerful painkiller - it is about 60 times more potent than morphine on a gram-per-gram basis - should be used only by chronic pain sufferers.

It shouldn’t be prescribed to patients who have not previously taken opioids (opium-based drugs), and the patch should not be prescribed postoperatively.

Mr. U also stressed that only one patch should be used at a time. In many of the deaths recorded, patients had two to three patches, resulting in an overdose. (The patches are virtually invisible on the skin and patients and caregivers can lose track of them.)

The U.S. Food and Drug Administration first issued a warning about fentanyl patches in July, 2005, saying they should be prescribed at the lowest practicable dose, should not be used to treat short-term pain or pain after an operation, and should only be used by patients already on opioid drugs.

The regulator also told physicians that patients prescribed the drugs should be fully advised about safety concerns.

Since then, there have been several more warnings and a growing number of deaths worldwide. There is also a burgeoning concern about other drugs delivered by patch, such as contraceptives and medications for a host of conditions such as attention deficit hyperactivity disorder, Alzheimer’s and Parkinson’s disease.

In Canada, there have been almost 600,000 prescriptions for fentanyl patches in the past year, at a retail value of more than $116-million, according to IMS Health Canada, a private company that tracks prescription drug sales.

The fentanyl transdermal patch, which is sold under three product names in Canada - Duragesic, Ran-Fentanyl and Ratio-Fentanyl - has been on the market since the early 1990s. Use of the patch has doubled over the past four years.

Blondette Burnette of Toronto has lived in chronic pain for more than a decade from injuries suffered in a motor vehicle collision. She said fentanyl patches are the right choice for her.

“I know how to use it properly and safely so that’s the way for me to go,” she said recently as she underwent training at the Wasser Pain Management Centre of Mount Sinai Hospital in Toronto.

Her neurologist, Allan Gordon, stressed that appropriate prescription of the drug, coupled with training of patients, is essential.

“It is a very good drug but it has to be used properly with the right kind of assessment, knowledge and the right kind of education of patients and practitioners,” he said.

“You have to educate, educate, educate.”

Barry McLellan, Ontario’s chief coroner, said his investigation should also help inform health-care professionals and patients alike about the limitations of fentanyl patches.

“If we have any information that will help prevent a death in the future, we want to make sure it’s in the right hands.”

In the meantime, Mr. U said, patients need to be vigilant and not simply accept a more risky drug such as a fentanyl patch just because it is more convenient to take than traditional painkillers.

“This is a high-risk drug. It needs serious precautions.”

Source | The Toronto Sun

By Sarah Green

Rani Jamieson says she was told it was safe to take Tylenol 3 for her pain after giving birth to her son.

Twelve days later, little Tariq was dead.

Jamieson, with her husband Douglas, has filed a class-action lawsuit against drugmakers Janssen-Ortho and Johnson and Johnson, alleging “physicians and consumers should have been formally warned that Tylenol 3 should not be used, under any circumstances, by breastfeeding mothers.”

The lawsuit alleges toxicology tests showed the Toronto newborn, who died just after midnight on April 30, 2005, had toxic levels of codeine and morphine in his blood which Jamieson, 35, ingested from the Tylenol 3s and unknowingly passed on to her son through breastfeeding.

There is no dollar figure attached to the lawsuit and the allegations have not been proven in court.

Jamieson said she scoured pregnancy books and magazines and repeatedly asked her doctors about the safety of taking the medication before and after Tariq was born.

“All these people were telling me it’s safe,” said Jamieson, who has a 17-month-old son and is expecting another son in less than two weeks. “I was also very much ready to bottle feed if I needed to take drugs (after giving birth). I was told it’s still safe to take it.”

Jamieson took the “absolute lowest dose” of the medication, she said — one tablet every six hours. The suit alleged codeine and morphine can lead to lethargy, poor feeding, constipation, irritability, respiratory depression and death in infants,

Codeine itself offers little or no pain relief, but the analgesic effect is produced because the body converts it into morphine, the suit said.

“Infants are most susceptible to the effects of codeine in their systems in the first weeks of their lives,” said Jamieson’s lawyer Joel Rochon.

In a statement, Janssen-Ortho, a subsidiary of Johnson and Johnson, said: “At this time, we have not had the opportunity to review the claim in full. It has not been served on our company. TYLENOL 3 (prescription Tylenol with codeine) is a safe and effective product when used according to the approved prescribing information.”

Tariq was a healthy baby until the day he died, his mom said. The suit alleged that at a regular pediatrician’s appointment just 12 hours before his death, Jamieson noted Tariq’s colour was pale and he had not eaten for several hours. He stopped breathing just a minute or two before paramedics arrived.

Until the toxicology results came in from the coroner’s office six months after Tariq’s death, his parents did not know how their son died, Jamieson said.

The U.S. Food and Drug Administration last month warned nursing mothers who are taking codeine to watch their infants for signs of overdose, calling it a rare, but serious side effect.

Ontario is one of the few jurisdictions in North America to conduct toxicology tests in infant deaths.

Source | The Los Angeles Times

By Ricardo Alonzo-Zaldivar

WASHINGTON — Army Master Sgt. Harold Kinamon entered a military hospital in Ohio for routine respiratory surgery to help him sleep better. The operation, in October 2005, progressed smoothly. He went home with nothing more than a raw throat and a painkiller contained in an adhesive patch on his skin.

That night, Kinamon, 41, died in his sleep — killed by an overdose of the drug delivered through the patch.

What made his death even more tragic was that the dangers of using skin patches to administer the particular painkiller he received, an opiumlike drug called fentanyl, were clearly understood at the time. Only three months earlier, the Food and Drug Administration — responding to a number of similar deaths — had issued a strong warning: Though beneficial under appropriate conditions, fentanyl patches should be used with great caution, and not for postoperative pain relief.

Kinamon’s death reflects more than an individual misfortune. Healthcare providers nationwide are still not getting the message as fentanyl patches continue to be implicated in scores of deaths.

Failure to solve the problem is all the more serious because the use of patches is spreading to other drugs, including other painkillers, contraceptives and medications for children with attention deficit disorder. Moreover, a new generation of high-tech patches is expected to make many more drugs available in patch form.

The benefits of patches have been accompanied by problems, replicating a pattern common to many medical advances: Breakthroughs often come with risks and downsides that may not be fully recognized until later.

Drug safety experts are urging the FDA to reexamine the issue of medicinal patches. One primary problem seems to be how to get the right dose of a drug through a patch for different patients under differing conditions.

Patches are “a neat way of delivering drugs,” but they are not an unalloyed blessing, said Dr. Curt D. Furberg of the Wake Forest University medical school.

The appeal of the patches is clear: They solve a host of problems with more traditional methods of administering medications. Unlike injections, they don’t hurt. Unlike pills, they don’t have to be swallowed. They resolve the common problem of patients not taking drugs in the right amount at the prescribed intervals. And their medicine enters the bloodstream directly, rather than via the stomach.

Those advantages are real, medical experts say, but they are not the whole story.

Sales of Ortho Evra, the first birth-control patch, plunged last year after the FDA cautioned that it exposed women to higher levels of a hormone linked to dangerous blood clots than do oral contraceptives.

With pills, the drug level spikes after consumption, dropping as the time for the next dose approaches. Patches maintain a steadier level, but, over time, this can lead to higher total exposure to the drug. That can cause problems, and the trade-offs are not well understood, experts say.

“What is the corresponding patch level that would be equivalent to oral drugs?” Furberg asked. “People use different formulas and there is disagreement.”

The Daytrana patch for attention deficit disorder recently ran into problems. Opening the patch and getting it to stick was difficult. (The maker says the adhesion problem has been fixed.) And the medication can irritate the skin, causing welts. The FDA is investigating.

The effect of any patch can vary considerably from patient to patient. “Some people may not get enough of the drug, which defeats the purpose of taking it. And some may get too much . . . which is going to hurt some people,” Furberg said.

For instance, heat affects the rate at which the skin absorbs a drug. Sunbathing, a hot shower or exercise can trigger an overdose.

Also, some people have thicker skin, which is more resistant to absorbing a drug. Speed of absorption can vary by a factor of about three, which can complicate finding the right dosage.

Another problem is psychological: Patients and medical professionals have a tendency to see patches as benign devices akin to a bandage. It’s easy to forget the powerful, potentially dangerous drug within.

“Patches are not innocuous,” said Kenneth Sloan, a medicinal chemist at the University of Florida whose research has shown wide variations in how quickly individuals absorb drugs through the skin. “One patch does not fit all.”

That’s why the FDA said in July 2005 that in the case of fentanyl, patches should be prescribed at the lowest practicable dose, should not be used to treat short-term pain or pain after an operation, and should only be used by patients already established on opioid drugs.

Patients and caregivers must be fully informed about safety, the FDA said.

According to Kinamon’s sister Deana, that did not happen in his case. His patch provided the second-highest available dose of fentanyl. And she said she did not recall receiving special instructions about the patch when she picked her older brother up at the hospital. “They didn’t even tell me it was a narcotic,” she said. “They just said, ‘Change it in three days.’ ”

He went in on his day off for surgery to correct his sleep apnea, said his sister. “There’s honor in dying for your country on the battlefield, but there is really no kind of honor associated with that.”

Harold Kinamon’s case is an example of “totally inappropriate prescribing,” according to Larry D. Sasich, pharmacist and professor at the Lake Erie College of Osteopathic Medicine in Pennsylvania.

Kinamon’s hospital, Wright-Patterson Medical Center, declined to comment on his case, citing privacy laws. His doctor also declined an interview. The hospital says it has established safeguards for fentanyl patches since the Defense Department Patient Safety Program issued recommendations last year. (A hospital spokesman said federal law prevented him from discussing what the precautions entailed.)

In Los Angeles County and Florida, similar deaths continue to occur, statistics show. The L.A. County coroner’s office investigated 32 accidental deaths related to fentanyl in 2006, the same number as in 2005, the year the FDA issued its warning. Florida authorities reported 126 accidental deaths related to fentanyl in 2006, a rate one expert in the state described as “steady.”

Ortho-McNeil, which manufactures Duragesic, the brand-name form of the fentanyl patch, says stronger safety measures are needed. “Philosophically, we would support any new efforts that would strengthen safety and ensure this product is used appropriately,” said spokesman Greg Panico.

Whereas the opioid patch was intended for cancer patients and others with unrelenting pain, Ortho Evra, the birth-control patch, was designed for active younger women.

Kristen Britt, 28, a veterinary nurse from Stockton, said she thought the patch would fit her lifestyle. “I was looking to find something easy and safe,” she said. “To put one on and not have to change it for a week, I liked that a lot.”

Seven months after she started using the patch in 2005, she felt a pain in her right leg. At first, she said, she thought it was muscle strain, but the pain grew worse.

“One day, I couldn’t walk anymore,” she said. “I was literally screaming in pain.” Doctors found a blood clot. For months she had to take blood-thinning medications, which have risks of their own.

Soon after Britt’s experience, the FDA issued a new warning for Ortho Evra, saying the patch exposed women to about 60% more estrogen than did a typical birth-control pill. Estrogen is known to increase the risk of blood clots, which can cause strokes and other complications.

The maker of Ortho Evra says the patch has not been conclusively linked to a higher blood-clot risk.

Now Britt is at higher risk of blood clots, especially if she becomes pregnant. She is suing the company. Her attorney, Lori E. Andrus of San Francisco, says about 1,900 plaintiffs have filed federal suits and hundreds more cases are in state courts.

The president of the Institute for Safe Medication Practices, Michael R. Cohen, said: “Patches are convenient, and patients do like them, but there are reasons to examine the whole patch issue.”

So far, the FDA is sticking with the status quo. “FDA reviews patch products, like any other products, on a case-by-case basis for safety and effectiveness,” said Susan M. Cruzan, a spokeswoman.

But critics say that in the case of fentanyl, the FDA has been ineffective. Fentanyl patch sales grew 10% the year after the warning, with more than 4.7 million prescriptions written, according to Verispan, a market analysis firm.

Said Furberg: “The purpose of the [warning] was to cut back on prescriptions, so it’s a failure.”

The family of a Florida man has won a $5.5 million wrongful death verdict against two subsidiaries of pharmaceutical giant Johnson & Johnson in the nation’s first federal trial involving a patch form of the narcotic painkiller fentanyl.

The 2-man, 6-woman jury deliberated for 11 hours over two days before returning their verdict earlier today in the U.S. District Court for the Southern District of Florida.

Janssen Pharmaceutica Products, LP, and ALZA Corp. were sued by the family of 28-year-old Adam Hendelson following his death on Dec. 17, 2003. Both companies are subsidiaries of New Brunswick, N.J.-based Johnson & Johnson.

Mr. Hendelson suffered chronic hip pain as a result of an automobile accident, and wore a Duragesic (R) patch on his right arm. Duragesic is the brand name of a transdermal patch that contains a gel form of the drug fentanyl, an opium-like substance that is up to 100 times stronger than morphine.

“In essence, the jury found that Adam Hendelson did not have to die,” said the attorney for the Hendelson family. “The facts and the evidence clearly showed that Janssen and ALZA knew that problems with the Duragesic patches could hurt or kill someone, and in Adam’s case, that’s exactly what happened.”

Janssen and ALZA both manufacture and sell Duragesic patches, which accounted for $1.5 billion in total sales in 2005. In June 2005, more than a year after Mr. Hendelson’s death, the defendants issued new health warnings regarding the use of Duragesic.

Source | FDA

DURAGESIC® (fentanyl transdermal system CII) Recall Notice Product Photos

Janssen Pharmaceutica Products, L.P., recalled one lot of DURAGESIC® (fentanyl transdermal system CII) 75 mcg per hour patches, control number 0327192. No other dosage strengths and lot numbers were affected. A control number is listed on every DURAGESIC® 75 mcg per hour on every patch carton and patch pouch. See the photos below for the location of the control number and dosage strength.

Photo of DURAGESIC 75 mcg/hr product carton