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NPTA Takes the Lead in Social Media for Pharmacy

Kristina Michel — Fri, 05 Mar 2010 19:00:00 GMT

Contact: Kristina Michel

Communications Specialist - NPTA

832-426-2685

kmichel@pharmacytechnician.org

FOR IMMEDIATE RELEASE

March 2010

NPTA Takes the Lead in Social Media for Pharmacy

The National Pharmacy Technician Association makes history as the only pharmacy-related professional organization on Facebook to break 10,000 fans

HOUSTON—The National Pharmacy Technician Association (NPTA) has raised the bar for pharmacy organizations as the first pharmacy organization to gain over 10,000 Facebook fans.

NPTA hailed the milestone as a testament to of the organization’s strength and adaptability to the changing needs and information-gathering preferences of pharmacy professionals. The organization’s founder and CEO Mike Johnston, CPhT, attributed the organization’s success to its unique strategy of promoting conversation and communication amongst pharmacy technicians.

“I believe NPTA is unique in the fact that we utilize emerging technologies, such as social media, as a channel to establish genuine relationships and foster authentic conversations,” said Johnston. “We don’t use Facebook simply as a landing page for press releases, as many organizations make the mistake of doing.”

Since its inception in 1999, NPTA has taken the lead in using emerging technologies as a means of connecting pharmacy technicians across the country. The organization’s motivation is fostering conversation and feedback. Content is posted daily on the NPTA Facebook and Twitter pages to bring pharmacy technicians up to date on the latest news and encourage discussion. NPTA also encourages member feedback from surveys, blogs and other online content posted to members. NPTA’s commitment to the support and unity of pharmacy technicians has helped build it into the largest pharmacy technician organization in the United States.

“We view social media as another channel to connect with our constituents – pharmacy technicians – on a direct and personal level,” Johnston said. “We are committed to stay on the leading edge of new and emerging technologies which allow us to achieve our organization’s mission.”

Plans are already in place to push the NPTA social media strategy to the next level. The organization has hired a new communications specialist and is in the process of creating more multimedia content to assist pharmacy technicians with their career development.

About NPTA

The National Pharmacy Technician Association (NPTA), which was founded in 1999, is the largest non-profit trade association for pharmacy technicians in the world. The association represents over 30,000 individuals practicing in a variety of settings, such as retail pharmacy, health-system pharmacy, independent pharmacy, federal pharmacy services, purchasing, education and management. NPTA is the leading provider of accredited continuing education programs for Certified Pharmacy Technicians and offers advanced certifications in Sterile Products and Compounding. The association is committed to advancing the roles of pharmacy technicians to reduce medication errors and advocates for mandatory/standardized technician education, certification and registration. For more information on NPTA, call 888-247-8700 or visit http://www.pharmacytechnician.org.

5-Mar-10 1:00 PM

NPTA Responds to ABC News Report

Kristina Michel — Fri, 05 Mar 2010 16:00:00 GMT

On March 1, 2010, ABC News aired a report on medication errors caused by pharmacy professionals. The network issued a damaging portrayal of pharmacy technicians in practice. The broadcast does pose several critical questions that the pharmacy profession must address.

With the exponential growth in annual prescription dispensing, new drugs, expansion of the OTC selection, and the emergence of advanced technology in the pharmacy, the role of pharmacy technicians has grown dramatically. Add to this the current health care plan that is currently under review and should substantially increase prescription volume to this ever-growing role. The National Pharmacy Technician Association (NPTA) has taken a strong position that in order to practice as pharmacy technicians, individuals should be required to complete a standardized education training program, pass a validated competency-based exam and be registered within their state board of pharmacy.

Everyone agrees that a single medication error is one too many. However, the reality is that mistakes will be made even by the most qualified and educated professionals. NPTA recognizes that mandatory pharmacy technician education will not eliminate all medication errors entirely, but it will significantly reduce the risk. For most states, there is an additional measure that can be taken to ensure patient safety: required and standardized education and training of pharmacy technicians.

The investigative report by ABC News created buzz for the network, but hopefully, this will serve as a wake-up call for the pharmacy profession. Pharmacy technicians are a critical part of the pharmacy team, and for them to be efficient and effective team members, standardized education is necessary. NPTA intends to work with state pharmacy boards, employers, pharmacy associations, accrediting agencies, educators and practitioners, to further discuss the regulation of standardized pharmacy technician training.

NPTA also invites you to comment on this issue.

5-Mar-10 10:00 AM

FDA, NIH Join Forces

Kristina Michel — Wed, 03 Mar 2010 16:00:00 GMT

In hopes of accelerating the approval process of new and emerging medication therapies, the FDA and the National Institutes of Health are officially teaming up for the first time to form a joint leadership council.

The Joint NIH-FDA Leadership Council will be a committee of six of the top scientists from both agencies and co-chaired by Dr. Francis Collins, head of the NIH, and Dr. Peggy Hamburg, head of the FDA. Dr. Collins and Dr. Hamburg were the ones who proposed the creation of the council. The council will work to improve the efficiency and speed of the research and regulatory process of advancing new drugs.

“The first step for many medicines on their way to our pharmacy shelves is a discovery in an NIH-funded laboratory. The last step for all of them is a careful analysis at the FDA,” said HHS Secretary Kathleen Sebelius, who announced the new partnership last week at a press conference in Bethesda, Maryland. “We’re here today because we know we can deliver these treatments faster and safer if these agencies strengthen their partnership, working not just side by side, but also hand in hand.”

The key focus of the new partnership will be to advance and develop testing technologies and other tools federal regulators use to analyze the risks and benefits of drugs being processed for approval. Better technology will help increase the speed and efficiency of the approval process and help pharmaceutical researchers and manufacturers release new drugs to the public faster. The FDA and the NIH also hope that direct collaboration will help drug developers better navigate through the regulatory process. Secretary Sebelius also hopes the partnership will help speed up the advancement of treatments in biomedicine and personalized medicine done through genetic mapping.

“Today, some of our most promising new treatments are based on emerging technologies like cell-based and targeted small molecule therapies,” Sebelius said. “From early in development, basic researchers at NIH should be sharing information about these technologies with scientists at FDA to help them develop standards for safety and effectiveness.”

In addition to the formation of the new joint council, the FDA and the NIH announced that they will collectively be making $6.75 million in grants available over the next three years for research on regulatory science. They are also planning a public meeting in the spring to encourage feedback from all parties involved in the research and development of new medicines and treatments, though an official date has yet to be announced.

3-Mar-10 10:00 AM

Diabetes Med Stinks, Literally

Kristina Michel — Wed, 17 Feb 2010 16:00:00 GMT

A new report in the Annals of Internal Medicine medical journal suggests that a pungent fishy odor may be what’s turning some diabetes patients away from the oral drug metformin.

Metformin, also known as glucophage, is often the first choice of treatment for people with Type 2 diabetes. Nausea and gastrointestinal upset are the side effects most commonly associated with the drug. Researchers at the Medical College of Georgia in Augusta and the University of Georgia College of Pharmacy in Athens suggested that the fishy, dirty socks odor patients have complained about on Internet forums may be contributing to the drug's adverse side effects and is causing some patients to discontinue its use.

The side effects alone have been documented in consumer reports and medical journals. However, no direct correlation currently exists between the smell of metformin and the side effects, and though complaints of the smell are present on Internet messaging boards, they have not been documented in medical journals until now. Allen Pelletier, MD, of the Medical College of Georgia in Augusta and colleagues suggested in the paper that the reason why the smell has gone undocumented for so long is that patients, when complaining to doctors and pharmacists, are not elaborating on the adverse effects of metformin past their physical symptoms.

"Our cases show that the distinctive odor of metformin (independent of other, well-known gastrointestinal adverse effects of the medication) causes patients to stop taking the drug," Pelletier and colleagues wrote. "Patients may report that metformin nauseates them but do not further elaborate or distinguish this as a visceral reaction to the smell of the drug."

The odor is not universally reported by consumers, and the smell may largely depend on where and how the drug is manufactured. For example, in one case reported in the research paper and highlighted in Reuters, a man had been taking brand-name metformin (glucophage, made by Bristol-Myers Squibb) for years before he was switched to an immediate release, generic version. It was not until he switched to the generic version that he noticed the smell and refused to take the drug.

When prescribed appropriately, metformin causes few adverse effects. It is also one of the few anti-diabetic drugs that does not cause hypoglycemia if used alone.

17-Feb-10 10:00 AM

Walgreens Will Buy Duane Reade

Kristina Michel — Wed, 17 Feb 2010 16:00:00 GMT

Walgreens has agreed to buy the New York City retail pharmacy chain Duane Reade in a $1.1 billion deal reached on Wednesday.

In addition to the $623 million Walgreens has agreed to pay, it will also be assuming Duane Reade’s $457 million debt. In a statement to the New York Times, Walgreens chief executive Gregory D. Wasson called the deal a strategic acquisition that would help expand operations in New York.

Walgreens would be acquiring the retail pharmacy chain from Oak Hill Capital Partners, a private equity firm that purchased Duane Reade in 2004. Walgreens has not decided how it will integrate the Duane Reade stores, but it said that the Duane Reade stores will keep their name after the deal closes. The deal is expected to become final on August 31.

Walgreens currently owns about 7,034 drugstores operating across all 50 states, making it the largest retail drugstore chain in the U.S. Duane Reade, founded in 1960, has 257 stores operating in the New York City metropolitan area. It is known for its high volume, small store layouts in densely populated regions of Manhattan.

17-Feb-10 10:00 AM

Crestor Approved to Fight Heart Disease

Kristina Michel — Wed, 10 Feb 2010 18:00:00 GMT

The FDA has approved the cholesterol medication Crestor for as a preventative measure against heart attack and stroke.

Crestor, typically used to lower cholesterol and produced by AstraZeneca, has now been approved for use in patients who are at risk of heart disease but may not display symptoms. These patients, normally men over age 50 and women over age 60, are at an increased risk of heart disease and stroke due to large amounts of high sensitivity C-reactive protein in their blood.

“Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from Crestor therapy under this approved indication,” said Howard Hutchinson, MD, AstraZeneca’s chief medical officer in the company news release. “This new indication adds to the significant body of evidence physicians use to evaluate Crestor as a treatment option.”

The approval came following the JUPITER trial, a study involving over 8,000 patients with elevated amounts of C-reactive protein. In the study, Crestor helped reduce the risk of heart attack by 54 percent and stroke by 48 percent. The study was also found to reduce the amount of coronary procedures by 46 percent. The results were presented at the American Heart Association meeting in 2008 and published in the New England Journal of Medicine.

Crestor is already approved to lower cholesterol and to help slow the progression of atherosclerosis—a thickening of the artery wall due to the buildup of cholesterol and other fatty materials. Under the expanded guidelines, patients must have both high amounts of C-reactive protein and one additional heart disease risk factor such as hypertension or a family history of premature heart disease.

10-Feb-10 12:00 PM

Dimebon May Help Treat Huntington's

Kristina Michel — Wed, 10 Feb 2010 17:00:00 GMT

A pill being researched for Alzheimer’s disease may also have uses in treating Huntington’s disease, U.S. researchers said Monday.

Dimebon, also known under its generic name latrepirdine, is showing big potential for helping Huntington’s patients improve their thinking, learning and memory skills, according to a report in the Archives of Neurology medical journal. A study involving 91 patients, done by Dr. Karl Kieburtz and colleagues at the University of Rochester in New York and sponsored by the pill’s maker Medivation, showed Dimebon to have an impact on cognition and aging with minimal side effects.

Dimebon has been used as an antihistamine in Russia since 1983. Medivation, a San Francisco-based biopharmaceutical company, had been studying in collaboration with Pfizer the drug’s effectiveness against Alzheimer’s disease.

Medivation and Pfizer are now planning a follow-up trial to confirm the findings of the original study. Reuters reported that Medivation also has plans to begin trials of altered forms of Dimebon to test its effectiveness against other disorders such as Parkinson’s disease, stroke and heart failure.

Huntington’s disease is a genetic brain disorder that slowly diminishes a person’s physical and reasoning skills. Onset typically occurs between the ages of 30 and 50. According to the Huntington’s Disease Society of America, one out of every 10,000 Americans is affected by Huntington’s. Currently, there is no cure for the disease.

10-Feb-10 11:00 AM

Bill Gates Commits $10 billion for Vaccines

Kristina Michel — Wed, 03 Feb 2010 20:00:00 GMT

The Bill & Melinda Gates Foundation has committed over $10 billion to the Global Alliance for Vaccines and Immunisation (GAVI) for the research, development and delivery of vaccines for children in developing countries.

Bill and Melinda Gates made their announcement in a press conference at the Annual Meeting of the World Economic Forum in Davos on January 29. Their goal is to provide vaccines for 90 percent of children in developing countries, which amounts to preventing about 8 million children’s deaths in the next nine years.

"Over the last 10 years, the success of both increased vaccine coverage and getting new vaccines out has been phenomenal," Bill Gates said.

The Gates have been a part of the GAVI alliance from the beginning. They had already donated $4.5 billion for this effort when the GAVI alliance began in 2000. Amazed by the progress in vaccine coverage for children, the Gates decided to more than double their last contribution to over $10 billion. Julian Lob-Levyt, the CEO of the GAVI alliance, was proud of the partnership's progress and personally acknowledged the Gates’ roles.

“GAVI would not have been in existence but for Bill and Melinda,” Lob-Levyt said.

Vaccination rates in developing countries have progressed dramatically over the past 10 years. For example, measles deaths have dropped by more than 74 percent, according to the GAVI alliance 2008 annual report. Melinda Gates said at the press conference that the lag time between the release of vaccines in developed countries and its distribution in developing countries has decreased, and immunization rates that had been declining in the past decade are now on the rise.

“We think the stage is set for extraordinary progress,” Melinda Gates said. “We think the stage is set to significantly step up coverage.”

The GAVI alliance has big plans for vaccine progress in the next ten years. They plan to increase vaccine distribution for the rotovirus and pneumococcal disease, they are contributing to research and development of a malaria vaccine, and they hope to see the elimination of polio over the next decade.

3-Feb-10 2:00 PM

New Rules for Mental Health Meds

Kristina Michel — Wed, 03 Feb 2010 20:00:00 GMT

The departments of Health and Human Services, Labor and the Treasury jointly released new rules they hope will make mental health and substance abuse medications more accessible to patients.

The new rules require employer health plans to offer the same level of coverage for mental health and substance abuse treatment medications as they would for other medications. Employers with less than 50 workers employed are exempt from the new rules. The rules are the result of the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPAEA), which was passed in 2008.

According to the Reuters article, 150 million Americans are enrolled in company health plans. The joint-department released statement hailed the new law as a crucial step towards equality for consumers enrolled in company health plans.

“Today’s rules will bring needed relief to families faced with meeting the cost of obtaining mental health and substance abuse services,” said U.S. Secretary of Labor Hilda L. Solis. “The benefits will give these Americans access to greatly needed medical treatment, which will better allow them to participate fully in society. That’s not just sound policy, it’s the right thing to do.”

The new rules will become law as early as July 1 of this year. Until then, HHS and the departments of Labor and Treasury are encouraging interested parties to comment on the new rules. Interested parties can make comments on www.regulations.gov. The HHS news release has more information.

3-Feb-10 2:00 PM

FDA Warns of Counterfeit Alli

Kristina Michel — Wed, 27 Jan 2010 18:00:00 GMT

The FDA has issued a warning that a circulating counterfeit version of GlaxoSmithKline’s over-the-counter diet pills Alli may contain the controlled substance sibutramine.

The warning concerns counterfeits of the diet pill Alli 60 mg capsules (120 count refill kit). In a press release issued last week, the FDA warned that preliminary results from tests done by GlaxoSmithKline, maker of Alli, found that the counterfeit pills contain sibutramine in place of the product’s active ingredient orlistat.

Sibutramine, also known as Meridia, is an appetite suppressant used to treat obesity. If improperly used without the advice of a licensed physician and pharmacist, it may lead to gastrointestinal problems, heart failure, renal failure and even death. Sibutramine can also interact in a harmful way with other medications.

Consumers began reporting the counterfeit product last year. So far, the counterfeit Alli has only been sold online, and neither the FDA nor GlaxoSmithKline has found evidence or heard reports that it is being sold through retail stores or any other means. The counterfeit Alli appears similar to the genuine product but with the following key differences:

The outer cardboard packaging on the counterfeit Alli is missing a Lot code.
The expiration date on the counterfeit includes the month, day and year; a real Alli expiration date only contains the month and year.
The counterfeit is packaged in a plastic bottle with a slightly taller and wider cap with coarser ribbing than the genuine product.
The counterfeit has a plain foil inner safety seal under the plastic cap without any printed words; an authentic Alli seal is printed with the words “SEALED for YOUR PROTECTION.”
Counterfeit capsules are larger than the genuine Alli and contain a white powder. Genuine Alli capsules contain small white pellets.

Picture-by-picture comparisons of the real Alli and the counterfeit Alli are available on the FDA website and GlaxoSmithKline’s official consumer information page for Alli, MyAlli.com.

So far consumers who have taken the counterfeit product are reporting stronger versions of the gastrointestinal-related side effects associated with authentic Alli. Consumers should only purchase Alli from reputable stores or their branded online stores, GlaxoSmithKline said. If you feel that you may have purchased the counterfeit product, please contact the FDA Office of Criminal Investigations (OCI) at 800-551-3989, or go online to the OCI Web site. If, for any reason, you feel you may have taken the counterfeit product, contact your local pharmacist or your personal physician immediately.

Pharmacists, pharmacy technicians and other health care professionals are advised to be alert and to report any suspicious products or customer complaints to the FDA's MedWatch Program at 1-800-FDA-1088.

27-Jan-10 12:00 PM

Brown's Win in Massachusetts Senate Race Causes Worry about Health Care Bill

Kristina Michel — Wed, 20 Jan 2010 21:00:00 GMT

In an upset for Democrats, Republican candidate Scott Brown won the late Senator Ted Kennedy’s seat today in a close election, robbing Senate Democrats the 60th vote it needs to ensure passage of the health care reform bill.

Brown won the Massachusetts seat over favored Democrat Martha Coakley by 52 percent of the vote. The win comes at a time when Democrats are struggling to merge the House and Senate versions into one bill before the 2010 election season builds momentum.

Though deferring on some key controversial issues like abortion coverage and a public health option, in the area of pharmacy, both versions of the health care reform bill are very similar. Both bills call for better coverage of prescription drugs, expansion of the biotech drug market, the elimination of the Medicare coverage D “doughnut hole,” and financial incentives to improve medication therapy management (MTM) for patients who take multiple prescriptions.

The American Pharmacists Association, the Pharmaceutical Research and Manufacturers of America, and the American Medical Association have all made statements on both versions of the healthcare reform bill.

Among other things, the APhA supports both bills’ efforts to eliminate the Medicare Part D coverage gap, but they recommend adding language in the bill that calls for the Secretary of Health and Human Services to consider the financial impact the current provisions would have on pharmacists and pharmacies. The APhA also supports the provisions in the bills for a MTM grant program and for financial incentives that would improve the current Medicare Part D MTM programs. A full statement of the APhA’s stance on the healthcare reform bills is available on its web site.

PhRMA strongly supports provisions to eliminate the Medicare D coverage gap. In fact, it negotiated a deal with the White House to contribute $80 billion to help cover Medicare prescription drug costs until the part D coverage gap is eliminated. PhRMA President and CEO Bill Tauzin is also a strong supporter of provisions in both bills that would increase funding and expand the biotech drug market. Tauzin has a personal interest in the development of biotechs as biosimilar treatments saved him from cancer.

“It’s the future of medicine,” he said in an interview on CNBC last year. “If we don’t have a system that encourages it…we’re going to lose something extraordinarily valuable.”

Though the AMA believes that both bills make tremendous strides towards increasing access to high-quality care while reducing healthcare costs, it has released letters and statements over concerns about Medicare. The AMA has called for the elimination of the Medicare sustainable growth rate and any provisions in the bill that would give power to an independent commission such as the Independent Payment Advisory Board to mandate payment cuts for physicians.

Full statements on the APhA, PhRMA and the AMA’s positions on health care reform are available on their respective web sites.

President Obama has urged Democrats in Congress to refrain from trying to jam through a healthcare reform bill and to wait until Senator elect Brown is sworn in before moving forward. The President called Brown upon news of his victory to congratulate him.

20-Jan-10 3:00 PM

Second Earthquake Strikes Haiti

Kristina Michel — Wed, 20 Jan 2010 19:00:00 GMT

The relief efforts in Haiti suffered a setback today when a powerful magnitude 5.9 aftershock struck the already-traumatized country and sent terrified survivors fleeing to the streets.

The quake struck this morning about 35 miles from the capital city Port-Au-Prince, interrupting rescue and relief efforts struggling to help the region recover from the devastation of the first magnitude 7.0 quake that struck January 12.

Seven buildings have collapsed in Petit-Grove, a seaside town closest to the epicenter of the quake, according to Mike Morton of the U.N. Disaster Assessment and Coordination agency, the Houston Chronicle reported. So far, there are no reports of people crushed or trapped as a result of the second quake.

The quake comes at a time when relief is starting to pour into Haiti. According to the American Pharmacists Association, over 700 pharmacists volunteered to help with the relief efforts in Haiti. So many pharmacists reached out to assist in Haiti that the APhA had to ask pharmacists to stop volunteering until further notice. Pharmaceutical companies have donated $20 million in medicines, medical supplies and cash.

"The vital role of PhRMA companies and their employees in the global community is clearly defined by such catastrophic situations,” said Billy Tauzin, President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) in a PhRMA-issued release. “It's our civic responsibility to provide health care professionals the tools they need to help save lives, and we're proud to take part in this effort, which will lead to the eventual recovery of Haiti.”

Personnel from the Department of Health and Human Services have treated over 1800 patients since their deployment in Haiti last week. US troops landed in Haiti on Tuesday with food and supplies. The American Red Cross reported on its Twitter page that its $10 text for Haiti donation program has raised over $21 million.

Presidents George W. Bush and Bill Clinton have also started a relief fund, and the celebrity telethon "Hope for Haiti Now" is scheduled to air Friday night on ABC, CBS, NBC, FOX, CNN, BET, The CW, HBO, MTV, VH1 and CMT.

20-Jan-10 1:00 PM

New PT Registration Requirements in Florida

Kristina Michel — Fri, 15 Jan 2010 18:00:00 GMT

Florida’s new law requiring all pharmacy technicians to be registered with the Florida State Board of Pharmacy is now in effect.

The new policy, which went into effect on January 1, requires that anyone who wants to work as a pharmacy technician in Florida must be registered with the State Board of Pharmacy. Currently registered pharmacy technicians or new registration applicants must submit proof of completion of one of three requirements.

Completion of a board-approved pharmacy technician training program,
Completion of 1,500 hours of pharmacy technician work experience under the supervision of a licensed pharmacist, or
Certification from an agency accredited by the Pharmacy Technician Certification Board, the Institute for the Certification of Pharmacy Technicians, or any other agency accredited by the National Commission for Certifying Agencies.

These new requirements are the result of Section 465.014, a new law that passed back in 2008 with the help of advocacy efforts on the part of the Florida Society of Health-System Pharmacists and the Florida Pharmacy Association. The PTCB hailed it as a progressive step towards increasing patient safety for consumers. According to the PTCB press release issued in 2008, the new law stands to affect over 40,000 pharmacy technicians working in Florida.

Pharmacy technicians registered before 2010 have until December 31 to complete one of the three listed requirements. Otherwise, they will have to re-register in 2011. Along with completion of one of the three new requirements, registration applicants must fill out an application, pay a $105 fee and submit proof of a board-approved pharmacy technician training program.

For more information on the new registration requirements or to answer any questions, please contact the Florida State Board of Pharmacy, or consult their web site.

15-Jan-10 12:00 PM

Tylenol Recall Expanded to More OTC Products

Kristina Michel — Fri, 15 Jan 2010 16:00:00 GMT

McNeil Consumer Healthcare Products expanded its recall of Tylenol products to include Motrin, Rolaids, Benadryl and more over-the-counter products today.

In December, McNeil had recalled certain lots of Tylenol Arthritis due to a moldy smell that made some consumers sick. McNeil, a subsidiary of Johnson & Johnson, has again expanded the recall to include more Tylenol products like geltabs, rapid release, and extended relief pills as well as Motrin IB, regular and extra strength Rolaids antacids, and Benadryl allergy tablets.

The odor’s source comes from a chemical called 2,4,6-tribromoanisole that can manifest itself in wood pallets that transport packaging materials. Somehow, the chemical found its way into certain packages of Tylenol Arthritis, causing the smell. As a precaution, McNeil is expanding the recall to other product lots that may have been contaminated by the chemical.

The company still has no idea how the chemical came into contact with the packaging materials. In addition to investigating the issue, McNeil has stopped shipping their products on the wood pallets in question and has issued an order requiring suppliers to discontinue the use of wood pallets.

A full list of products included in the recall is available on McNeil's Product Recall Information site. For instructions on how to return products listed in the recall or dispose of them, call 1-888-222-6036. Consumers who have medical questions or feel they may have been affected by any of the recalled products should consult with their doctor or contact the FDA MedWatch Program.

15-Jan-10 10:00 AM

FDA Launches New Site "FDA Basics"

Kristina Michel — Wed, 13 Jan 2010 15:00:00 GMT

The FDA began the first phase of its Transparency Initiative yesterday with the launch of FDA Basics, a new page that helps users better understand the workings of the agency.

NPTA was invited to a teleconference on the launch of FDA Basics. FDA Principal Deputy Commissioner Dr. Joshua Sharfstein outlined the format of FDA Basics in a live online presentation and took questions from the invited media. The page is designed to be an information resource site to help the public better understand what the agency does and how it does it. Sharfstein, the head of the Transparency Task Force, said FDA Basics specifically came from comments and suggestions from the FDA Transparency Initiative blog.

“We got over 900 different ideas and comments,” said Sharfstein. “The level of engagement from all sectors that are involved with the FDA has been impressive.”

The site is formatted in separate pages highlighting each office of the FDA and the products for which it is responsible with answers to frequently asked questions about that office, video interviews with agency leaders, and short videos explaining agency activities. If consumers have more information or want to make suggestions on how to improve the site, question and ratings sections are available.

“I think this is a step towards making the FDA a more open and transparent agency,” said Sharfstein.

The new site marks the first of three phases in the FDA’s Transparency Initiative, a plan started back in June by FDA Commissioner Dr. Margaret Hamburg in response to the Obama Administration’s commitment to develop strong support of the Department of Health and Human Services. The FDA went directly to consumer groups, the companies it regulates and special interest groups for suggestions on how to make the agency more transparent and understandable to the public. The agency hosted two meetings in August and November, and it started a blog to hear comments and suggestions directly from the people.

“I think that it’s been a very participatory process,” said Sharfstein. “We appreciate everyone who contributed and we’re really looking forward to having this up as a resource for the public and moving on to the next step.”

The second phase, which the FDA hopes to launch by the end of February, will delve deeper into the workings of the FDA with more information on what the agency does in the interest of protecting consumers. The third phase is aimed at promoting transparency between the FDA and the industries it regulates. The agency hopes to launch its third phase two months after the start of the second phase.

13-Jan-10 9:00 AM

New Seasonal Flu Vaccine for Elderly

Kristina Michel — Tue, 29 Dec 2009 22:00:00 GMT

The FDA announced its approval last week of Fluzone High-Dose, the first ever seasonal flu vaccine licensed for use on people 65 years and older in the United States.

Fluzone High-Dose, produced by Sanofi Pasteur, is intended for use on the elderly to combat the seasonal flu. Fluzone High-Dose uses a higher dose to induce a stronger immune response in seniors, said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research, in an FDA-issued release. It contains four times as much antigen as standard flu vaccines. The FDA gave it accelerated approval as a product designed to prevent serious or life-threatening disease.

Seniors are at highest risk for complications of seasonal flu, which often result in hospitalization and death if unchecked. Though they are at the highest risk for influenza-related complications, seniors respond the weakest to the traditional seasonal flu vaccine because of their weaker immune systems.

Fluzone High-Dose will be available for consumers by the 2010-11 flu season as an injection shot. Because of the vaccine's higher potency, the FDA reported that mild side effects were more frequent compared with Sanofi's standard-strength Fluzone vaccine. Side-effects included pain, injection-site redness and swelling, headache, muscle ache and fever. As standard for any seasonal flu vaccine, patients who are sensitive to egg products or who have had life-threatening reactions to prior flu shots should not be vaccinated with Fluzone High-Dose, the FDA said.

Fluzone High-Dose is designed to combat only the seasonal flu, not the H1N1 strain. In spite of seniors 65 years and older being at highest risk for complications associated with the seasonal flu, the same group has proven not nearly as vulnerable to the H1N1 strain, so much so that the CDC does not include seniors among the high priority groups to receive the H1N1 vaccine first.

29-Dec-09 4:00 PM

Tylenol Arthritis Recall

Kristina Michel — Tue, 29 Dec 2009 20:00:00 GMT

McNeil Consumer Healthcare announced that it has expanded its voluntary recall of Tylenol Arthritis Pain Caplet 100-count bottles, with the distinctive red EZ-OPEN CAP, to all available lots.

The move is an expansion of the original recall of five lots back in November. The recall was issued amid consumer complaints of a moldy odor coming from the bottle that induced nausea, stomach pain, vomiting, and diarrhea. As of last week, the company has extended the recall to all available lots of Tylenol Arthritis as a precaution.

The source of the smell comes from a chemical known as 2,4,6-tribromoanisole, a chemical used to treat wooden pallets to transport and store packaging materials. As of now, officials are still unsure how the chemical came into contact specifically with the Tylenol Arthritis 100-count bottles. As a precaution, they have halted the release of the 100-count Tylenol Arthritis bottles until January 2010 as they work to move production to a new facility. In a release issued by the FDA, health officials say that the adverse effects of the chemical are temporary and non-serious.

Consumers who have purchased the product should contact McNeil immediately at 1-888-222-6036 for instructions on a refund or replacement. Officials are advising consumers who feel they may have been affected by the recalled lot to consult their primary care physician. Consumers may also report their concerns to the FDA MedWatch website. A full list of the recalled lots is available on the Tylenol web site.

McNeil Consumer Healthcare is a division of McNeil-PPC, Inc., a subsidiary of Johnson & Johnson. The company markets over-the-counter and prescription pharmaceuticals including the complete lines of Tylenol and Motrin IB (ibuprofen) products for adults and children.

29-Dec-09 2:00 PM

800,000 Doses of H1N1 Vaccine Recalled

Kristina Michel — Wed, 16 Dec 2009 16:00:00 GMT

Sanofi Pasteur issued a voluntary recall of about 800,000 doses of the H1N1 pediatric vaccine due to a decrease in potency last week.

The recall affects four lots of pre-filled syringes for children ages 10 and younger that were issued across the US earlier this fall. The problem was detected last week during a routine stability test of the vaccine after the lots had been shipped. The company, the CDC, and the FDA have stressed that parents should not worry if their children received the recalled vaccine and should continue their children’s two-dose immunization series if not already completed.

Tests performed on the affected vaccines before they were shipped indicated they were fine. Weeks after the vaccines were issued, their potency levels had dropped only 12 percent below the government standard. Most of the vaccines have already been used, and officials with the CDC and the FDA say they believe the potency is still high enough to protect children from H1N1.

Sanofi Pasteur, a division of the Sanofi-Aventis Group, said in a CDC-issued release, it is not uncommon for the strength of a vaccine to wane over time. That is why their officials perform stability tests long after their vaccines have been issued. Experts theorized in an article by the Associated Press that the antigen--the vaccine‘s key ingredient--may be sticking to the walls of the syringes.

According to its web site, Sanofi Pasteur is the largest producer of seasonal influenza vaccines in the world. It also has the broadest range of vaccines against 20 infectious diseases.

This is not the first time a company has issued a recall of H1N1 vaccines. In February, Novartis issued a recall of five lots of its H1N1 vaccine. In that instance, the vaccines had been exposed to freezing temperatures. GlaxoSmithKilne also issued a recall of about 170,000 H1N1 vaccines in Canada earlier in November amid reports of serious allergic reactions.

16-Dec-09 10:00 AM

Bayer Recalls Alka-Seltzer Cold Medicine

Kristina Michel — Wed, 09 Dec 2009 21:00:00 GMT

Bayer Consumer Care issued a voluntary recall of a single lot of its Alka-Seltzer Plus liquid cold medicine, affecting some 100,000 packages, on Tuesday.

The problem concerns the Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels combination packages in Lot # 296939L. Bayer Consumer Care, a division of Bayer HealthCare, decided to recall the lot when consumers reported that the information on the underside of the blister package was reversed.

The mistake causes the label for the green Night capsule to appear under some of the blue Day capsules and vice versa. Bayer was concerned that consumers with the reversed labels might accidentally take a Night pill, which induces drowsiness, under the assumption that it was a Day pill.

Company spokeswoman Tricia McKernan attributed the problem to an error in the printing process. During production for the affected lot, the machinery had to be shut down and manually restarted.

"We're retraining our operators and putting corrective actions in place to make sure this never happens again," McKernan said in the Associated Press report.

Bayer has said that the recall only applies to the combination package of the Day and Night cold pills. The recall does not impact any individually packaged Alka-Seltzer Day and Night cold products or Alka-Seltzer effervescent cold relief products that may have been included in the lot.

Consumers who may have purchased the mislabeled product should contact the Consumer Relations Call Center at 1-800-986-3307 for information on how to get a refund and to address any questions or concerns they may have.

9-Dec-09 3:00 PM

Actor Dennis Quaid Supports Pharmacy Tech Initiative

Kristina Michel — Wed, 09 Dec 2009 17:00:00 GMT

Actor Dennis Quaid, who recently created his own family foundation to raise awareness of the dangers of medical error, announced his support of the American Society of Health-System Pharmacists’ Pharmacy Technician Initiative on Tuesday.

The Pharmacy Technician Initiative advocates that every state pass a law requiring pharmacy technicians to pass a pharmacy technician training program and be PTCB certified as prerequisites for state board registration. ASHP hopes the Initiative will improve patient safety and quality of care and build a stronger, more reputable workforce of well-trained pharmacy technicians.

Quaid became involved in improving patient safety following an incident in 2007 that nearly took the lives of his newborn twins. Quaid and his wife took the newborns to Ceders-Sinai Medical Center, where they were supposed to be given antibiotics intravenously to treat a staph infection. The twins were instead given an overdose of the blood thinner Heparin, which nearly caused them to bleed out.

Officials traced the cause of the accident to a pharmacy technician and the nurse in charge of caring for the twins. The pharmacy technician mistakenly put larger-dose bottles of Heparin in the same bin as smaller-dose bottles. The nurse then pulled a larger-dose Heparin bottle from the bin without checking the label.

Following the incident, Quaid found that similar errors happen across the United States, often with fatal consequences. In fact, according to The Quaid Foundation mission statement, every year in the United States, more people die from medical mistakes than from breast cancer, AIDS and car accidents combined.

“A very similar incident killed three infants in Indianapolis a year before that (in 2006),” Quaid said on a TV interview on the Oprah Winfrey Show. “Even after our incident, two other fraternal twins in Texas, in Corpus Christi, died last year because of this.”

Quaid is scheduled to appear as a keynote speaker at ASHP’s Midyear Clinical Meeting on December 12 at the Venetian Hotel in Las Vegas. The Quaid Foundation joins 17 states that have already announced their support and involvement with the Pharmacy Technician Initiative. In addition to setting standards for pharmacy technician licensure, The Quaid Foundation also hopes to improve systems such as barcode medication administration and drug labeling.

Quaid called the incident that nearly took his twins’ lives a sobering experience, and he does not blame the healthcare workers involved in the accident.

“Individually, nurses, doctors and pharmacists are good people,” he said, “but they’re hamstrung by working in a broken system.”

9-Dec-09 11:00 AM