Generic Prescription Drug Info

The American Society of Health-System Pharmacists (ASHP) has published a new statement outlining appropriate criteria for a proposed intermediate category of medications that would be available from pharmacists in outpatient settings without a prescription. Drug products appropriatefor this intermediate category would have proven public healthbenefits and should be identified by processes that include the inputand advice of experts, such as pharmacists, physicians, andother licensed health care professionals. Medications in this category would only be available to patients after an assessment by and consultation with the pharmacist.

The ASHP Statement on the Criteria for an Intermediate Category of Drug Products appears in the March 1, 2009, issue of the American Journal of Health-System Pharmacy.

The statement recommends criteria to ensure the category would contain safe and effective medications with proven public health benefits, such as drug therapies for hypertension and osteoporosis. ASHP advises pharmacies to adopt standardized processes, adhere to quality measures, and report adverse-drug events. The statement also suggests the Food and Drug Administration (FDA) evaluate those events to ensure patient safety.

ASHP, which has long proposed the creation of an intermediate category, believes pharmacist oversight of and collaboration with patients using medications in the category is essential. “An intermediate category of drug products would increase patientaccess to and benefit from medications that would otherwisebe available only by prescription,” said ASHP President Kevin J. Colgan, M.A., FASHP. “Choosing appropriate drug products for an intermediate category-inconjunction with patient assessment,counseling, and monitoring by a pharmacist-would improve public healthwithout compromising patient safety.”

In testimony to the FDA, ASHP voiced support for the creation of an intermediate category. The Society also told the agency that pharmacists should receive appropriate payment for the services they provide to patients using medications in the category.

The statement recommends additional criteria for the intermediate category, including:

- Medications should meet many of the criteria for reclassifying prescription drugs to nonprescription status,
- Pharmacists should offer laboratory monitoring for patients,
- Patient therapy should include information on needed lifestyle changes, and
- Patient medical records should include care provided by pharmacists.

Three University of Queensland researchers have received separate grants aimed at improving the practice of community pharmacy and customer health, through better use of medicines.

The School of Pharmacy researchers will receive grants totalling close to $200,000. These are the first grants to be funded by The Pharmacists Board of Queensland.

Dr Lisa Nissen and Mr Greg Kyle will receive $149,927 over three years, to assess the commercial influences on community pharmacists’ recommendations and any impact on professional practice or patients’ use of medicines.

“Most published research on prescribing influences focuses on doctors,” Mr Kyle said.

“This study will investigate whether commercial activities, such as promotional tools and preferred supplier agreements, might influence the products that community pharmacists recommend to consumers.

“The results will indicate whether strategies are necessary to respond to any influences that might be identified.”

The role of pharmacists in the correct use of medications is the focus of a $29,810 grant for Mr Neil Cottrell. With Dr Nissen and Ms Gina Gujral, he will investigate medication adherence in people who have had a heart attack and now take a number of medications.

“In this study a community pharmacist will regularly review and discuss medication issues with people who have had a heart attack. It is hoped that this type of regular review encourages improved use of medicines and increases the likelihood of a person taking their medicine,” Mr Cottrell said.

Dr Therese Kairuz will use her grant of almost $20,000 to explore “health literacy”, how well consumers comprehend health information.

“Although health information may be delivered in pharmacies, there is a wealth of anecdotal evidence surrounding consumers’ misapplication of this information. This has significant implications for appropriate use of medicines and health services,” Dr Kairuz said.

Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt released the following statement today on a new report from AARP examining the high prices of various specialty products and the need for generic biologics to lower costs for consumers.

PCMA represents the nation’s pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use of electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 200-plus million Americans.

“This study is the latest sign of momentum surrounding biogenerics as an important health reform issue. The President’s budget also included a provision that would create a regulatory pathway to approve generic biologics as a way to save billions of dollars for both the public and private sector.

“For over a quarter century, generic medicines have increased access and affordability for consumers, employers, labor unions, government agencies, and others. However, expensive biologics have not faced generic competition, straining public and private payers’ ability to provide affordable drug benefits for these necessary and often life-changing products.

“Generic competition lowers costs because it gives patients the power to choose and gives manufacturers an incentive to reduce prices. We need legislation which allows generics to compete with biologics in the same way they already do with conventional drugs.”

Family nurse practitioners need to be more aware of the commercial pressures they face as a result of their increased involvement in prescribing, according to a survey published in the March issue of the UK-based Journal of Advanced Nursing.

“Our detailed study of 84 family nurse practitioners (FNPs) showed low awareness of how marketing by pharmaceutical companies affects clinical decisions and creates conflicts of interest” says Dr Nancy Crigger, from William Jewell College, Missouri, USA.

“However they were clear that some marketing activities, promotional items and gifts were less ethical and acceptable than others. For example, gifts that benefited patients and conferences were more acceptable than resort seminars and office equipment.”

Dr Crigger, herself a qualified FNP, adds: “The influence of marketing on physician prescribing has been widely researched and this indicates that the more involved physicians are in marketing, the less likely they are to recognise when their clinical judgement has been compromised.

“Our study suggests that the same is now happening to FNPs who have been given greater responsibility for prescribing some types of medication.”

Key findings from the survey included:

- 5% admitted that pharmaceutical reps influenced their prescribing and 26% said they did not, with the vast majority answering sometimes. However they said that other FNP colleagues (18%) and physicians (25%) were more likely to be influenced than them.

- 41% said they were not influenced by drug company marketing, but 17% said they were. 44% believed their prescribing was positively influenced by marketing rather than negatively, with 10% saying it wasn’t.

- Two-thirds said that promotional items did not influence their prescribing, with just 1% saying it did. 14% said that pharmaceutical representatives may cross ethical boundaries by giving FNPs gifts, but 42% said they did not.

- Nurses were more in favour of education gifts and those that benefited patients. The majority said that educational gifts were ethical and appropriate (49%) and that non-education gifts were not (47%). 51% agreed with gifts that benefited patients and 52% opposed gifts that did not benefit patients.

- 45% said it was not acceptable or ethical to accept inexpensive gifts but 15% said it was. 59% disagreed with expensive gifts but 7% felt they were acceptable and ethical.

- Nurses felt more comfortable attending sponsored events such as lunches and dinners (48%), trips (45%) and conferences (65%), but resort seminars (32%) and happy hour events (21%) were deemed less ethical.

- 50% felt that events organised by drug companies were more educational than promotional, but 15% disagreed.

- 62% of respondents accepted samples, 50% educational items, 41% office supplies and 30% office equipment.

- 41% said that their advanced practice training covered conflicts of interest when it came to drug marketing and 34% said it did not.

The FNPs who completed the 22-item questionnaire were chosen at random from a list of licensed nurses provided by the Missouri State Board of Nursing. 42% of the 200 nurses who were approached responded. Their ages ranged from 25 to 69 (average 47) and they had been in practice for one to 33 years (average 9.4). The majority (82%) were female and 60% served rural populations.

“Our study suggests that pharmaceutical marketing is widespread among FNPs and that FNPs fail to recognise how they are being influenced by this practice and that greater involvement in marketing may reduce their critical assessment of such practices” says Dr Crigger.

“It points to the need for all FNPs to evaluate their personal attitudes and practices concerning the ethical appropriateness of accepting gifts, meals, educational programmes and trips from pharmaceutical companies.

“We believe that prescription decision making should be based on the best interests of patients and on maintaining the trust of the patients and the public.

“Further research is needed to determine the impact of pharmaceutical marketing, but until then we believe that FNPs should avoid situations that could create a conflict of interest.”

A doctoral thesis presented at the Sahlgrenska Academy, University of Gothenburg, Sweden, shows that it is possible to describe and quantify the relationships between dose, concentration and effectiveness of several drugs against HIV/AIDS and malaria. The method may allow improved treatment and fewer undesired effects for patients with these diseases.

Registered pharmacist Daniel Röshammar has in his thesis studied the optimal use of certain pharmaceutical substances that are used to combat HIV/AIDS and malaria. He has analysed, among other things, data from 121 healthy volunteers from Uganda using a mathematical model known as a pharmacometric model. The study showed that both sex and genetic differences between individuals influence the way in which the body metabolises efavirenz, which is part of some anti-HIV/AIDS drugs. Other studies have focussed on 74 people from Zimbabwe with HIV/AIDS, and showed that a reduction in the daily dose of efavirenz from 600 mg to 400 mg can reduce the risk of undesired effects in those affected who have a genetically conditioned poorer ability to catabolise the substance.

“Many HIV/AIDS patients are treated with efavirenz, and they should be genetically tested using a blood test before deciding on a dose. This is particularly important in Africa, where the fraction of patients with a poorer catabolic ability is greater than it is elsewhere”, says Daniel Röshammar.

Repeated measurements of the drug concentrations and virus levels in 239 previously untreated Scandinavian patients with HIV/AIDS allowed a similar model to be used in order to study the antiretroviral effects of anti-HIV/AIDS drugs. Calculations showed that treatment in which efavirenz was combined with other pharmaceutical substances was more effective than two other frequently used combination treatments.

“It may be possible in the future to use the model to predict when the treatment will lose its effectiveness for an individual patient, and explain why”, says Daniel Röshammar.

Further work involved using a model to describe how the catabolism of the anti-malarial drug artemisinin increases and the concentration of the drug decreases when patients take this drug. When artemisinin was given to 97 patients in Vietnam without other drugs, approximately 37% of them were affected by recrudescent malaria. The model showed that this could not be explained solely by low drug concentrations. Another anti-malarial drug, piperaquine, may be a suitable partner for artemisinin in the treatment of malaria. An investigation of 12 Vietnamese study subjects, however, allowed scientists to estimate that the levels of piperaquine that remain in the body are too low to be effective, and this increases the risk that the malaria parasite will develop resistance.

“Research shows that pharmacometric models can be adapted to patient data in order to understand the relationships between drug concentration, effectiveness and the progress of disease, while at the same time taking into consideration differences between patients such as, for example, weight, age, sex, genetic factors, other diseases and other drugs. We expect that these tools will be important in the fight against HIV/AIDS and malaria”, says Daniel Röshammar.

Source: Ulrika Lundin
University of Gothenburg

Sens. Byron Dorgan (D-N.D.), John McCain (R-Ariz.) and Olympia Snowe (R-Maine) on Wednesday introduced a bill (S 525) that would allow the reimportation of lower-cost prescription drugs from other nations, Bloomberg reports. The lawmakers said that the legislation would save the U.S. $50 billion, which includes $10 billion in savings for the U.S. government, over the next 10 years. According to a statement from the lawmakers, the legislation would “bring consumers immediate relief and will ultimately force the pharmaceutical industry to lower drug prices in the U.S.” Julia Wanzco, a spokesperson for Snowe, said, “We do expect this to pass” in part because President Obama in his fiscal year 2010 budget proposal announced a “strong interest in implementing this policy.”

The Pharmaceutical Research and Manufacturers of America opposes the legislation because of safety concerns. In a statement, Ken Johnson, senior vice president at PhRMA, said, “The worldwide counterfeit threat is knocking at America’s door and will soon be greeted if prescription drug importation moves forward,” adding, “Interest in prescription drug importation is waning in part due to the millions of seniors accessing medicines and saving money through the Medicare prescription drug program and consumer weariness in the aftermath of recalled tainted foreign products” (Randall, Bloomberg, 3/4).

CDC last week sent out letters to several chain pharmacies that offer no-cost prescription antibiotics to low-income consumers urging them to promote responsible use of antibiotics, the New York Times reports. According to the Times, the agency is concerned that the no-cost drugs could promote the wrong message and might worsen the problem of drug resistance.

Pharmacies that are offering no-cost antibiotics to low-income consumers include Giant Food Stores, Meijer, Publix, ShopRite, Stop & Shop and Wegmans Food Markets. According to the Times, “The generic antibiotics included in the free programs are relatively inexpensive compared to other drugs, in part because they typically are used for limited periods and are not refilled.” The Times reports that pharmacies have adopted the programs “to promote customer loyalty and compete for the business of major retailers.”

Lauri Hicks, medical director for CDC’s Get Smart Program, said, “If a patient believes that they can get an antibiotic quite easily or for free, then it may increase the pressure on health care providers to prescribe it” (Parker-Pope, New York Times, 3/5). Anne Gershon, president of the Infectious Diseases Society of America, said, “We don’t want to give the public the idea that we can just use (antibiotics) whenever we want. Free drugs can give that impression” (LaMendola, South Florida Sun-Sentinel, 3/4). She said, “If you give antibiotics away, it sort of implies that we should use them rather freely,” adding, “Giving away antibiotics could lead to stockpiling of drugs. We need to control antibiotic use very carefully, because more and more bacteria are becoming resistant to antibiotics.”

Last year, CDC sent similar letters to major retailers that were promoting low-cost drug programs, urging them to educate customers about drug resistance (New York Times, 3/5).

Antibiotics Not for Flu, CDC Warns
The new round of CDC warnings come as some pharmacies offering no-cost antibiotics have linked the offers to the cold and flu season, neither of which should be treated with antibiotics. Neil Fishman, chair of an antimicrobial resistance work group for IDSA and an infectious disease specialist at the University of Pennsylvania, said, “Most of the infections during cold and flu season … are due to viruses and not the result of bacteria, so antibiotics don’t work,” adding, “This is exactly the time we don’t want to encourage antibiotic use” (New York Times, 3/5).

Hicks said, “A number of the chains were advertising free antibiotics as a solution to cold and flu season. Of course we know antibiotics don’t work for colds and flu,” adding, “Perpetuating that idea is not helpful. We have been trying to combat that myth and they are not helping with those words” (South Florida Sun-Sentinel, 3/4). IDSA said the pharmacies would be providing a more important public service if they offered no-cost flu shots (New York Times, 3/5).

The NPA has told the DH Review of prescription charges for people with long term conditions that removing prescription charges would improve access to medicines for patients and decrease the administrative burden on community pharmacies. Pharmacists experience severe pressures on their time and any release of time could be used to enhance patient care.

The NPA expressed the view that extending prescription charge exemption to people with long term conditions should not be contingent on savings to the drugs budget. The NPA recommends investment in concordance schemes as a better way of achieving value from drug budgets.

Stephen Fishwick, NPA Head of External Relations, comments: “The NPA’s starting point is that medicines are a vital component of treatment for many people with long term conditions so we would support any changes that remove unnecessary impediments to accessing medicines.”

Two researchers from the Dartmouth Institute for Health Policy and Clinical Practice on Friday plan to push an FDA advisory panel to adopt a “drug fact box” labeling system for print prescription drug advertisements that quantifies the benefits and risks of taking a drug, the New York Times reports. The fact boxes would be similar in concept to nutrition fact panels on food packaging. The advisory committee will be examining ways to best provide consumers with accurate data.

Federal law requires that drug advertisements include a brief summary about the possible side effects of a medication and about risks for certain people who should not take the drug. However, “ads are not required to — and seldom do — spell out how well a drug works or how often volunteers in clinical studies had side effects,” according to the Times. Critics contend that the current method of “risk communication” is misleading because ads do not include effectiveness statistics. Critics say that current ads could influence people to seek prescriptions for drugs that have limited benefit, or that the lack of details about side effects could lead people to avoid highly effective drugs if they overestimate the risk.

Steven Woloshin, a general internist and researcher at the institute, and Lisa Schwartz, also of the institute, plan to present findings from two randomized studies showing that most people presented with comparative risk and benefit information through the fact boxes were able to identify which drug was more effective between two drugs. The studies were published last week in the Annals of Internal Medicine. Woloshin and Schwartz will urge the panel to require the fact boxes to appear on printed material such as magazine advertisements, as well as on FDA’s Web site. Woloshin, said, “We thought, if you could do it for Cocoa Krispies or Diet Coke, why couldn’t you do it for Lunesta or other drugs?” (Singer, New York Times, 2/26).

The Colorado Senate on Tuesday gave preliminary approval to a bill (SB 132) that would repeal a program created to provide low-income state residents access to affordable prescription drugs, the Denver Post reports. When the Colorado Cares Rx Program was created in 2007, supporters believed it could help more than 250,000 state residents. The state partnered with RxOutreach, the not-for-profit arm of a mail-order pharmacy, to operate the program.

However, when it was rolled out in 2008, Colorado Cares “came under immediate criticism,” according to the Post. A Post analysis found that many of the drugs available through the program were available for lower prices at chain pharmacies. About 40 people enrolled in the program, according to state Sen. Betty Boyd (D), who sponsored the bill that would repeal the initiative.

Under the measure, the Colorado Department of Health Care Policy and Financing would post information about affordable drugs on a Web site (Ingold, Denver Post, 2/25). The bill also cuts the number of employees for the program from four full-time workers to one part-time worker, who will answer residents’ questions about lower- or no-cost drugs. Much of the money allocated for the program was never spent, according to Boyd (Bartels, Rocky Mountain News, 2/25). Eliminating the program would save the state about $3.9 million annually (Denver Post, 2/25).