Monthly Archives: July 2011

Pharmaceutical industry yields to pressure from San Francisco to fund a drug take-back program

Starting as soon as August, San Franciscans will be able to dispose of their unused medicines for free at 16 independent pharmacies and five police stations throughout the city. The pharmaceutical industry is funding the pilot program with $110,000, after facing city plans that threatened to extend producer responsibility to pharmaceuticals. The program has funding for at least 12 to 18 months after which officials hope it will be become permanent. All household medication can be brought to police stations, and participating pharmacies will collect everything else except controlled substances. Disposing of pharmaceuticals has been a chronic problem in San Francisco without a sustainable solution. Currently, no pharmacy accepts unused or expired drugs. For decades, officials told people to simply flush their unused drugs or throw them in the trash. Especially in the past decade, scientists have started to measure the toxic effects of pharmaceuticals in the waterways and groundwater. Continuous exposure to low levels of pharmaceutical residue can threaten wildlife like fish and frogs. Minor residue has been found even in tap water, as Associated Press revealed in 2008 in an investigative report. No comprehensive studies have been published about long-term effects of low levels of pharmaceuticals consumed in drinking water, but officials now advise that no unused pharmaceuticals be disposed down the drain or in the trash. San Francisco supervisor Ross Mirkarimi, who led the negotiations with the pharmaceutical industry to fund the pilot program, said that the scope of the problem with pharmaceutical waste in the Bay Area waterways is not fully known. “What we do know is that our infrastructure is not designed to filter waste,” said Mirkarimi. Most European countries have take-back programs for unused or expired medications. In the United States, the medical waste disposal is primarily regulated at state level. One problem is that a federal law states that only law-enforcement officers may collect controlled substances. Colorado, for example, is piloting a program with eleven take-back boxes around the state and Washtenaw County in Michigan has eleven pharmacies accepting unused medication. Teleosis, a nonprofit organization for greener health care, lists take-back programs nationwide. The pharmaceutical companies have been reluctant to take responsibility for the disposal of their products. When Mirkarimi initiated an ordinance to extend producer responsibility to pharmaceuticals, the companies called for a more “collaborative” approach rather than an ordinance to require them to develop and implement their own collection program. After negotiations, PhRMA, the trade association for pharmaceutical companies, donated $100,000, and Genentech gave $10,000 toward the pilot program. Big chains like Walgreens and Safeway decided not to participate. Mirkarimi said he was neither disappointed nor surprised. “They need to understand what it means to become corporate partners and they’ve got a long way to go,” Mirkarimi said. He said the decision will reflect poorly on the big chains. “I think people will start to ask the obvious question: ‘Why are Safeway and Walgreens not providing this service either free or at very low cost?’” Walgreens said customers can already buy specially designed envelopes for $3.99 to return unused medication for incineration. “We also believe that there are legal risks if we participated in the initiative and that it could violate federal drug enforcement rules regarding the collection of controlled substances,” wrote Walgreens spokesman Robert Elfinger in an email. The pharmacy participates in local take-back events organized by Bay Area law-enforcement organizations. Apart from Walgreens, at least Safeway’s and Kaiser’s pharacies sell similar envelopes. San Francisco residents can pick up these envelopes for free at three locations. This SF Environment initiative will be discontinued when the envelopes run out because they are too expensive ($3.75 each). “The envelopes are really expensive for the city to provide free but we also don’t think that pharmaceutical disposal should be something that people should have to pay for,” said Caitlin Sanders, a Residential Toxics Reduction associate at San Francisco’s Department of the Environment. The pilot program is still in the works. SF Environment does not want to reveal the take-back locations because not all pharmacies have signed the official paperwork. Nine of the city’s 11 districts have independent pharmacies and in each of them at least one pharmacy is participating in the program. SF Environment chose the participating police stations to cover the outlying areas. The program is expected to launch in August. Sanders said she hopes that the pilot is a success and that the companies will renew the funding voluntarily. If not, supervisor Mirkarimi will consider pushing forward with the legislation to extend the producers’ responsibility. “That would depend on how well the pilot program works, what kind of relationship — positive or not — we develop with the pharmaceutical industry, and if federal law evolves by that time,” he said. Having a place to take unused medication does not mean that people actually will do it. Even in countries with effective take-back programs, pharmaceutical waste ends in the wrong place, especially liquid waste that is too often flushed into the sewage system. That’s why about $50,000 of the pilot program funding is going to outreach and education about the program. Mirkarimi has also proposed an ordinance to require all small businesses selling prescription drugs to publicly display materials explaining how to safely and lawfully dispose of unused drugs. The ordinance passed the public safety committee but hasn’t yet been heard in front of the full Board of Supervisors.

Research and Markets: Distribution on the Pharmaceutical Market in Poland 2011 – Development Forecasts for 2011-2013

Distribution on the pharmaceutical market in Poland 2011, development forecasts for 2011 to 2013 was created in order to satisfy increasing client requests for in depth reporting, comprehensive data and professional analysis of this important segment of the pharmaceutical industry in Poland. This new report analyses all major distribution channels, profiles the most influential companies in the sector, and examines in detail the potential effects of legislative changes. It looks at loyalty schemes, parallel imports and the status of current and forecasts trends in the distribution channels. This unique document offers clear and precise data on top achievers in each of the channels – from the biggest wholesalers to the largest pharmacy chains to franchises, purchasing groups and online and hospital providers of pharmaceutical products. Their locations, size, reach and market share are presented along with numbers of customers and outlets. Financial results are highlighted along with strategies for expansion and consolidation in response to current and forecast market conditions. The activities of the sector’s largest wholesalers are scrutinized, and background information about shifts in dominance over recent years is supplied. The geography of Poland is examined in terms of the locations of the greatest numbers of warehouses, pharmacies and degree of chain penetration to reveal concentrations in market activity. Pharmacy chains that operate independently of wholesale distributors appear in an Excel database with complete details on their operations. Pharmaceutical distribution activity extends beyond Poland’s borders via importer and exporter business and increasingly popular online pharmacies. This report is equipped to answer the questions of readers regarding the most extensive parallel imports, their main distributers and permit data for the past year and as forecast into the future. The extent of online activity is also reviewed and accompanied by astute analysis of the effects of current and potential government regulation on this distribution channel, which has experienced worldwide growth in recent years. Key Topics Covered: I. Report methodology II. Executive summary III. Main trends and events in the distribution segment 2009-2013 IV. Wholesale distribution V. Pharmacy distribution VI. Non-pharmacy distribution VII. Online distribution VIII. List of graphs IX. List of tables

Optimizing health-system workflows to meet patient needs

Hospital and health-system pharmacies continue to develop proactive strategies to manage drug shortages and promote patient safety with the support of Pharmacy Technician Certification Board (PTCB) Certified Pharmacy Technicians (CPhTs). Manufacturing issues, including shortages in raw materials and packaging supplies, product discontinuation, limited manufacturing capacity, and pharmaceutical industry consolidation, have led to a significant increase in drug shortages over the last five years. To avoid compromising patient care associated with shortages, hospital and health-system pharmacies have developed proactive strategies to streamline inventory maintenance and utilize key staff, including CPhTs, in pharmacy operations. As part of the supply chain team, many health-system pharmacies utilize CPhTs as the pharmacy purchaser or buyer. In this capacity, CPhTs play a crucial role in assisting the pharmacy team with procurement of medications and managing inventory. “Pharmacy technicians are instrumental in managing inventory and communicating department needs to supervisors,” said Erin Fox, PharmD, Manager, Drug Information Services, University of Utah Hospitals and Clinics. “By working cooperatively within the pharmacy team, they allow the department to better optimize daily workflow output and reprioritize medication distribution activities as patients’ needs change.” Health-system pharmacies may better manage drug shortages by effectively utilizing available technology. Automation has evolved to expand distribution system capabilities and improve safety and efficiency in distribution. Automation pharmacy technicians, responsible for the management of automated dispensing devices such as robots or automated dispensing cabinets, assist with implementation, maintenance, and optimization of these technologies and may be called upon to assist with drug shortage responsibilities. This includes assisting with product distribution, database modification, and the redistribution of product to areas of higher need.

“The accurate and timely distribution of medications to patients is a well-established responsibility in pharmacy practice,” said Melissa Murer Corrigan, RPh, Executive Director and CEO of PTCB. “With the support of CPhTs in purchasing and automation roles, pharmacists may increase their involvement in patient care activities.” In response to recent drug shortages, U.S. Senators Amy Klobuchar (D-MN) and Robert Casey (D-PA), with support of the American Society of Health-System Pharmacists, introduced the Preserving Access to Life-Saving Medications Act (S 296) in February. If enacted, this legislation would provide the U.S. Food and Drug Administration with additional tools to help prevent future drug shortages and require manufacturers to advise FDA when any discontinuance, interruption, or other action may decrease the supply of a drug to a level below the current demand.

Robo-pharmacist readies 350,000 doses perfectly

Your doctor may still be human, but your pharmacist may soon go cybernetic. A robotic drug dispensary system at the University of California, San Francisco is spitting out oral and injected medications for all kinds of patients.

Getting the wrong medication is the greatest risk facing patients under traditional pharmacy systems, according to UCSF Medical Center CEO Mark Laret. But the automated system has prepared some 350,000 doses without a single error, the institution says.

The room-size robots store drugs in dozens of small boxes in a sterile environment. After the 12-hour prescription is received as a digital file, a robot arm finds the correct labeled drug, prepares the proper dose in bar-coded plastic bags on a ring and spits them out into a large bin.

Nurses will begin scanning the bar codes at patient bedsides this year to confirm the doses are correct. Doctors, meanwhile, will begin inputting prescriptions directly into computers next year.

Three of the robots are Robotic IV Automation (RIVA) systems, made by Canada’s Intelligent Hospital Systems. They also prepare hazardous chemotherapy drugs.

Automated pharmacies are increasingly attractive to hospital administrators looking to boost speed and accuracy in drug preparation while reducing labor costs. Other robo-druggists include ForHealth Technologies’ IntelliFill and Swisslog’s PillPick dose packaging and storage system.

Administrators say the robots are freeing pharmacists from the mechanical aspects of their work, allowing them to work with doctors to tailor drugs to individual needs.

That’s all fine and good, but I still think humans have a better bedside manner than machines. I’d even take a holographic image of a human doctor, a la Star Trek Voyager, than a mechanical pill picker. What do you think?

Pharmacists’ challenge to contraception rule heard in court

with discipline if pharmacists refuse to dispense Plan B. Kosirog and Vander Bleek, who owns pharmacies in Morrison, Sycamore and Genoa, have been fighting the rule since.

Kosirog and Vander Bleek said they not only don’t want to stock emergency contraception, they don’t believe they should be forced to help customers obtain it elsewhere. In both their cases, patients can get Plan B from other nearby pharmacies, they said

New rule worse?

The two said they draw a distinction between emergency contraception and regular birth control pills, which Vander Bleek dispenses. Kosirog said he stopped selling birth control pills a month ago so his patients couldn’t try to take more than the prescribed number in order to use them as emergency contraception.

The pharmacists’ lawyer, Mark Rienzi, said a modified version of the state rule, adopted in 2010, expanded its provisions to over-the-counter emergency contraception. The U.S. Food and Drug Administration in 2005 made morning-after pills available without prescriptions to people 17 and older.

The new state rule prohibits pharmacies from citing moral objections for declining to dispense any drug approved by the FDA, Kosirog said. If Illinois ever legalizes physician-assisted suicide, he said, pharmacies would have to hand out those drugs as well.

Brent Adams, director of the Illinois Department of Financial and Professional Regulation, said Illinois citizens need access to a variety of medicines sometimes considered controversial, including emergency contraception, psychotropic drugs and drugs to prevent HIV transmission.

A pharmacy owner’s religious beliefs “shouldn’t trump” a patient’s need for legal medicine, Adams said.

Residents fear bank, pharmacy could cause Calverton traffic glut

Calverton residents voiced concern over a proposal to build a bank and pharmacy on Edwards Avenue during a meeting of the Greater Calverton Civic Association Thursday night.

The building proposal comes from a group headed by developer Paul Elliot and the owner of Miller Environmental Group, Jim Miller, who also built the gas station next to the Riverhead Charter School on Route 25 in Calverton. The developers, who filed under the name 1998 Peconic LLC, are seeking a use variance from the Riverhead Town Zoning Board of Appeals because neither a bank nor a pharmacy is permitted under the site’s Industrial C zoning.

They discussed the project at a Feb. 24 ZBA hearing, and the ZBA has yet to rule on the issue.

The plans call for a 13,852-square-foot pharmacy and a 4,092-square-foot bank on the vacant 3.29-acre lot directly south of the shuttered Village Crossroads restaurant on Edwards Avenue. The entrance on Edwards Avenue would be about 500 feet south of the intersection with Route 25.

The pharmacy would not be open 24 hours, as was incorrectly stated at the ZBA meeting.

The two main points of concern raised by some residents who spoke at the civic association meeting were traffic and the fact that the proposal is not permitted by zoning.

“It looks lovely but it’s going against the master plan, which gets me angry,” Kathy Lindstrom said.

Her husband, Hal, reminded the town’s comprehensive master plan was designed to keep retail on major roads like Route 25 or Route 58.

“Once you start getting off those roads, what’s to prevent other uses from coming in that are not permitted in that zoning?”

Ms. Lindstrom also pointed out that the Edwards Avenue/Route 25 intersection was given a grade of F by the state Department of Transportion in terms of traffic flow.

But Mr. Elliott stressed, as he had at the ZBA hearing, that the bank and pharmacy are less intensive uses than those permitted in the Industrial C zone, and that in the past, they have proposed uses that are permitted by the zoning — including a lumberyard and propane storage facility — and those met with opposition.

Chris Tartaglia, an engineer for the applicant, said that banks and pharmacies are not uses that people usually go to as their primary destination, meaning that this traffic would be on the road already, heading somewhere else, and then stopping at the bank or pharmacy along the way.

He said no one is going to come from far away to go to the bank or pharmacy because there would likely be banks and pharmacies near their homes.

Resident Robin Gibbs said pharmacies in Riverhead Town, such as the CVS pharmacies in Wading River and Riverhead, do draw a lot of traffic.

But Mr. Tartaglia said there is a demand for another bank and pharmacy.

“We have tenants interested who are going to invest a lot of money to put a bank and pharmacy here,” he said.

At the ZBA hearing, he said those are the only uses seeking to locate on the property because the property isn’t big enough for many of the permitted uses.

The project also will generate about $120,000 in tax revenue, Mr. Elliott said.

He told a reporter after the meeting that he had expected a mixed reaction to the proposal, but said such feedback is necessarily to be good neighbors.

What is developing as a sort of hamlet center at the intersection already includes a school, post office and the vacant restaurant.

The applicants would not identify potential tenants because no deals have been signed, they said.

Research-Based Pharmaceutical Industry Presentation in Geneva

As one of the 189 nongovernmental organizations (NGOs) in official relations with the World Health Organization (WHO), and in line with WHO principles governing relations with NGOs, representatives of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) will be present to listen to the proceedings of the 64th World Health Assembly (WHA).

The IFPMA will follow with particular interest decisions made by member governments on global health challenges directly involving the research-based pharmaceutical industry, such as pandemic influenza preparedness and fake medical products. The IFPMA will be taking particular note of the outcome of the World Health Assembly’s discussions on the health related Millennium Development Goals (MDGs) and non communicable diseases (NCDs); as both demonstrate the need for global leadership and partnerships. The federation will also be interested in discussions on specific disease areas such as HIV/AIDS, malaria, and cholera.

The World Health Assembly agenda includes a review of the report of the WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness (OEWG/PIP) which scopes out a global system to prepare for future pandemics. Recognizing a shared responsibility to help secure the world against future pandemic influenza outbreaks, the research-based pharmaceutical industry has engaged constructively in the OEWG/PIP process and stands by the collaborative commitments it has made to address this challenge. The Assembly will also consider the report by an external panel to review the “Implementation of the International Health Regulations (2005)” and the response to the 2009 H1N1 pandemic. The findings of the report and its recommendations together with the OEWG report represent an important basis to prepare and fight future pandemics and underscore the essential need for close collaboration between many different stakeholders.

The issue of substandard/spurious/falsely-labelled/falsified/counterfeit medical products is on the WHA agenda. The WHO has a crucial leadership role to play in helping to ensure that medicines everywhere are of high quality, safe and efficacious, and that they are also what they purport to be. The IFPMA supports the global effort to secure high quality medicines, and also hopes there will soon be consensus around priorities on fake medical products. The IFPMA’s “Ten Principles on Counterfeit Medicines” are based on the belief that the production and distribution of deliberately falsified medicines are an important threat to patients’ health and a serious global crime which calls for a global course of action to be taken.

The IFPMA believes this 64th WHA is an important milestone in shaping the global approach that seeks to address the millions of deaths that are caused every year by non communicable diseases — 14 million of which are premature and could be averted or delayed. Given the sheer enormity of the challenge, in particular in low income and emerging countries, the approach needs to involve not only governments but also the private sector, nongovernmental organizations and each of us as individuals. Governments can have a direct impact by introducing or reinforcing fiscal and legislative measures to discourage, for example, the use of tobacco, by imposing restrictions and bans. At the same time, awareness-raising and communications campaigns are a key factor for prevention.

The Assembly will also review the health-related Millennium Development Goals (MDGs). In this area, IFPMA member companies have a strong track record with over 200 long-term partnership programs through which the research-based pharmaceutical industry works to improve health in low and middle income countries and make a tangible contribution to the health related MDGs, tackling HIV/AIDS and other communicable diseases such as cholera, and malaria. At the half way point of the MDGs, in 2007, IFPMA members had made available nearly USD 10 billion dollars’ worth of health assistance for access and capacity building in low and middle income countries, and over 1.3 billion public health interventions. The scale of their efforts is set to continue to achieve the MDGs in 2015. In addition, the IFPMA’s member companies have been supporting the WHO in the fight against neglected tropical diseases through major research and development investments and donations for many years, but more recently there has been a stepping up of the industry’s efforts in response to WHO’s call for help. In 2010 there were five new major donation announcements, and the number of tropical disease-related research and development projects is higher than ever before.

New drug bill could hurt pharmacies, says local pharmacist

A Bass River pharmacist is concerned for his future and those of his counterparts across the province with the passing of new provincial legislation.

Bayside Pharmacy owner Charles Beaver said Friday’s passing of Bill 17 brings a lot of uncertainty to the industry.

The bill is intended to provide fair drug prices for Nova Scotians, but passed before the province and the Pharmacists Association of Nova Scotia had agreed to a new tariff schedule covering items like dispensing fees.

Beaver said the average pharmacy in Nova Scotia would lose $150,000 in the first year of the new bill and $220,000 in subsequent years.

“If nothing is done to address these losses pharmacies will be forced to reduce staff, hours and services,” he wrote in an email to the Truro Daily News. “I expect many sleepless nights in the coming weeks as we are left to wonder how these staggering losses will be recovered.”

The bill includes a cap on the price of generic drugs, compared with the price of equivalent brand drugs. The province says legislation will be phased in during a year to give pharmacies time to adjust.

The price of generic drugs through Pharmacare will be 45 per cent of the price of equivalent brand drugs on July 1, 40 per cent on Jan. 1, 2012 and 35 per cent on July 1, 2012.

Health Minister Maureen MacDonald estimated Nova Scotians would save about $1.6 million, including about $900,000 for seniors, when the 35 per cent cap is in place for a full year.

“The cost of prescription drugs to taxpayers through the Pharmacare programs is also growing at an astounding rate,” MacDonald said in an opinion piece available on our website. “Government spending on drugs through Pharmacare has more than doubled in the past eight years and, last year alone, the total cost was $300 million. This cannot continue unchecked.”

The Pharmacy Association of Nova Scotia repeatedly asked for the bill to be delayed.

“The hurry is the problem,” Beaver told the Truro Daily News. “All we’re asking is work with us, we’re literally begging.”

Beaver anticipates rural communities would be hit first because they have lower volumes. If the price per prescription filled is reduced under the new tariff schedule, the profitability of the stores is at risk.

Colchester North MLA Karen Casey said she and her Liberal caucus exercised every avenue possible to get the governing NDP to delay the bill so the tariff schedule and Bill 17 coincided with each other.

“We all have little pharmacies in rural parts of our constituencies and we’re concerned about their ability to survive,” she said.

“If that drug store (in Bass River) should close, we have a population that has two choices: they can drive to Parrsboro or they can drive to Truro.”

There are some members of the community who do not drive so they would have to find a way to get into town and Casey fears they would not do that because of the inconvenience.

She said the health minister made reference to a list of protected pharmacies across the province, but would not provide the Liberals with a copy of the list or how much money was there to support them.

“It seems like they are withholding information,” Casey told the Truro Daily News yesterday. “I cannot understand why you would ever withhold that because you just get communities anxious and upset, you get pharmacists who don’t know if they’re going to be able to stay open or not.”

Maine drug disclosure rules under fire by GOP majority

Republican lawmakers are moving to repeal state laws requiring drug companies to disclose financial and other information.

The legislators, with the backing of the pharmaceutical industry, say disclosure rules should be left to the federal government, which is moving to set up transparency requirements that are similar to Maine’s.

Democrats, meanwhile, are trying to block the efforts. They and advocates for affordable drugs say Maine’s disclosure laws save millions of dollars a year by keeping costs down and helping to negotiate lower medication prices for MaineCare patients.

The dispute split the Legislature’s Health and Human Services Committee last week, with all eight Republicans supporting two related bills and all five Democrats opposing them.

Debates in the full Legislature have yet to be scheduled, but the bills appear to be following the same track as a controversial health insurance reform bill that divided the two parties before it was passed by the Republican majority in a final vote Monday.

“The general theme this session is to stop making Maine more difficult than other states” for business, said Rep. Meredith Strang Burgess, R-Cumberland, sponsor of the repeal bills. “We certainly want to make sure we’re being smart (about regulation), but at the same time not going too far and letting the free market prevail.”

Rep. Sharon Treat, D-Hallowell, said the disclosure laws – most of which she sponsored – are under attack because they have successfully driven down drug costs.

“The bottom line is that repealing these things is absolutely about improving the bottom line of the drug companies and taking away tools of the government that right now help the state get some of the best rebates in the country and help prevent fraud,” Treat said.

One bill, L.D. 719, would repeal state laws that require drug companies to report to the state wholesale pricing information, amounts spent on drug marketing and the results of clinical trials.

A related bill, L.D. 1116, would repeal a Maine law that says pharmacy benefit managers who negotiate group prices with drug companies must disclose side payments and other financial information.

Maine’s disclosure laws for the drug industry are among the most comprehensive in the nation.

Strang Burgess, the sponsor of both bills and co-chair of the Health and Human Services Committee, said Maine’s requirements are overly burdensome on business.

“Maine has all these things that are a little more aggressive and confining,” Strang Burgess said. “It becomes a patchwork quilt (of varying rules) if you are a large company operating in different states.”

She said the state will not face any increase in drug prices if the bills pass, largely because the federal government is expected to require similar disclosures in the next year or two. “Other sources of information will be available,” she said.

National disclosure rules are part of the Affordable Care Act, which Maine and other states happen to be trying to repeal in court.

Strang Burgess also said the law requiring pharmacy benefits managers to disclose financial information has driven some group negotiators out of the state and reduced competition, actually making drug prices higher.

Treat, on the other hand, called the suite of proposals a gift to the drug industry, which failed to defeat the disclosure rules years ago in the Legislature and courts.

Treat agreed that the federal government is moving to require some public reporting, but said those rules are not yet in place and will not relieve states of their responsibility to guard against overcharging, kickbacks or fraud.

“Some of it is covered by the feds and some of it isn’t,” she said. “The federal government has not yet collected any data.”

Maine needs to keep requiring companies to disclose their average wholesale prices because the federal government has not yet set up any system for collecting that information, she said. The pricing disclosures help the state save millions of dollars a year in spending by MaineCare.

And the ability to negotiate savings is especially critical at a time when thousands of seniors may lose their drug coverage because of cuts to MaineCare, Treat said.

“As far as I’m concerned, this is being taken away by the majority at the behest of the drug industry so there are no checks and balances. We won’t have the means to go after them that we have right now,” she said. “Maine taxpayers and consumers will be the losers.”

Senator Urges FTC to Examine Link Between Drug Shortages, Pharma Consolidation

A critical shortage of drugs, especially chemotherapy and pain relief medications, is endangering patient safety and costing hospitals an estimated $200 million per year as they scramble to procure substitutes, often at higher prices.

Now Sen. Herb Kohl (D-WI) wants the Federal Trade Commission to examine the impact that consolidation in the pharmaceutical industry may be having on the nation’s drug supply.

Kohl said in a letter to FTC Chairman Jonathan Leibowitz that he was prompted to make the request after fielding numerous complaints from healthcare providers about widespread drugs shortages. Kohl is chairman of the Subcommittee on Antitrust, Competition Policy and Consumer Rights, which oversees the FTC.

“As you know, pharmaceutical industry consolidation in recent years has left fewer manufacturers for both branded and generic drugs,” Kohl said in his letter. “There have been at least nine major pharmaceutical mergers since 2000, most of them valued at over $40 billion each. Just two years ago, in 2009, for example, there were three major mergers – the $68 billion Pfizer/Wyeth merger, the $ 41 billion Merck/Schering Plough merger, and the $47 billion Roche/Genetech merger. And just a few weeks ago, two of the leading generic drug companies, Teva and Cephalon, announced their intention to merge, a transaction valued at $7.5 billion. The impact of this consolidation may be having a serious effect on the availability of prescription drugs.”

Roslyne Schulman, director for Policy Development at the American Hospital Association, told HealthLeaders Media that healthcare providers have been dealing with drug shortages for years, but that the problem has grown considerably in the last year or so. “It’s a huge and growing issue. As the Senator mentioned, the number of shortages is unprecedented and it’s affecting the ability of hospitals to provide care. They sometimes don’t find out about a shortage until they try to place an order and they’re told there is a backlog, with no idea when the shortage will be resolved,” she says.

Schulman says the biggest shortages are linked to “the old standby generic drugs, many of them are what are referred to as sterile injectable drugs.” Those are the biggest issue with regard to shortages now. A couple of generic manufacturers have been working with this coalition. They have been part of the discussion, looking at potential solutions.

Karl Uhlendorf, the deputy vice president of the Pharmaceutical Research and Manufacturers of America, said in a statement that “myriad factors contribute to drug shortages, including natural disasters; shifts in clinical practices; wholesaler and pharmacy inventory practices; raw material shortages; changes in hospital and pharmacy contractual relationships with suppliers and wholesalers; adherence to distribution protocols mandated by the Food and Drug Administration; individual company decisions to discontinue specific medicines; manufacturing challenges and consolidations.

“Regardless of the cause, in order to provide patients with uninterrupted access to medicines it is important for all of us who provide life-saving medications to work collaboratively to minimize unexpected disruptions in the supply of vital medicines,” Uhlendorf said.

Schulman said the AHA supports Senate bill (S.296) , which would strengthen FDA oversight of the nation’s drug supply. The bill requires drug manufacturers to notify FDA at least six months in advance of a planned discontinuation or interruption to the drug supply, with penalties in place for noncompliance; requires the FDA to post on its Web site information about drug shortages and to distribute that information to providers and patients’ advocacy groups so they can plan ahead; and requires FDA to develop criteria to identify drugs that are vulnerable to shortages, and plan for ways to mitigate or prevent the shortage.

Government action, however, may not be enough.

“It’s going to be a combination of industry actions, regulatory change, and some legislative change,” Schulman says. “I don’t think FDA has the authority it needs to mitigate these issues.”

Bill targeting pill mills rattle pharmacists

The Legislature’s passage in May of a bill targeting South Florida’s booming “pill mill” industry has local pharmacists very nervous, but also breathing a sigh of relief.

In its original form, House Bill 7095 would have imposed severe restrictions on any pharmacy or doctor dispensing addictive Schedule II and III drugs such as oxycodone, hydrocodone and morphine.

What had local pharmacists really worried was language stating that only “publicly traded” drug store chains in Florida that had “more than $100 million in taxable assets” would be granted the right under state law to dispense those Schedule II and III narcotics.

Had the bill passed in that form, it would have severely impacted, or even closed down, many local independent pharmacies, and put a lot of people out of work.

But that language was removed, much to the relief of independent pharmacy owners statewide.

As passed by the House and Senate in final form, House Bill 7095 does require all 4,000-plus pharmacies in Florida — regardless of size — to go through a new and very stringent repermitting process by July 1, 2012.

And that is a big concern for pharmacists like Kim Cadenhead, owner of Kim’s Family Pharmacy in Cantonment.

“We hope this new legislation requiring stricter background checks will help accomplish the goal of shutting down pill mills,” Cadenhead said.

But what worries Cadenhead and others is that the self-imposed regulations set by pharmacists are largely null and void. House Bill 7095 effectively takes those standards and puts them entirely in the hands of legislators.

Despite those concerns, Florida Pharmacy Association Executive Director Michael Jackson said the repermitting standards will go a long way toward eliminating many of the bad actors operating the state’s pill mills.

“The intent of the legislation, I believe, is to further define who can own and operate a pharmacy in Florida,” Jackson said. “And it’s also to make sure those who do own a pharmacy permit are not convicted felons. Under the old law, felons could own pharmacies.”

Cadenhead doubts state health officials have the manpower to conduct background checks and process more than 4,000 new permits within a year.

And Jackson, too, is concerned about the July 2012 deadline.

“Until the Department of Health writes and issues those new regulations, pharmacy owners won’t know what they have to do to get their new permits,” he said.

For now, pharmacies remain in the dark, their futures uncertain; bitter medicine for those who have always followed the very laws pill mill operators are abusing.

Officials looks into new prescription plan that could save Fall River $450K

A new prescription drug benefits business model, launched less than a year ago in New Jersey, would save the city a guaranteed $400,000 to $450,000. And, according to the company head and city officials advocating the program, it could deliver more than $1 million in annual savings, particularly if school employees join the plan.

The concept is to recoup available rebates and repackaging profits on drugs, currently being kept by many pharmacies, that produce variations in the average wholesale price, said Gary Sekulski, founder of Prescription Corporation of America, based in Denville, N.J.

Sekulski is set to present what he called a unique savings model to the City Council’s Committee on Finance on Tuesday night at 6 at Government Center at the urging of Councilors Eric Poulin and Raymond Mitchell.

They initiated a resolution the council passed this month to hear Sekulski’s company, local pharmacists and selected union officials discuss the potential savings.

Poulin, Mitchell and Sekulski were joined by local pharmacists Thomas Cory of Standard My Neighborhood Pharmacy and Thomas Pasternak of Walsh Pharmacy in making their arguments to The Herald News editorial board last week.

The city spent $11.2 million on prescription drugs, Sekulski said, for its approximately 5,000 employees and retirees in 2010.

“The industry can assign different bar code billing to the same product,” Poulin said, “and the city’s been paying these bills without question for years.”

ADVOCATING FOR CHANGE
Poulin said he’s been advocating a change from the way the city’s been covering the cost of prescriptions under its self-insured plan for more than a year — sometimes meeting resistance, he said.

Sekulski, who said he’s worked in the insurance industry since 1982 and specializes in cost containment, said high profits and discrepancies are the result of more than 60 pharmacy benefit management companies that fill mail-order prescriptions and work as intermediaries between insurers and pharmacies.

He presented a repackaging spreadsheet from “dataRX” Nov. 8, showing a couple dozen pricing examples of 40 milligrams of Nexium, a drug used to provide heartburn relief from acid reflux.

Sekulski’s pricing list varied widely — up to double the price and more — for 30 repackaged pills from the Astra Zeneca brand name.

Poulin said the analysis they received showed, for example, large cost discrepancies between the same drug and quantity for a worker’s compensation claim versus a standard purchase.

“I don’t know how the heck this has gone on for so long without anybody knowing about it. It does beg the question,” Mitchell admitted.

At one point, Sekulski said the “PBM” companies, handling the wholesaling from the manufacturer “can keep 30 to 45 percent” of the cost. The PBMs “can bill a client — the city — higher than pharmacies are billed,” he said. He did not present detailed data to back that up.

HOW IT WORKS
He, along with the two councilors and the two local pharmacists, told The Herald News that Sekulski would form “a partnership” with the local independent pharmacies. Prescription Corporation of America would offer comparable or better mail-order services than those currently available to the city’s employees and retirees.

One thing Poulin and Mitchell stressed was that city participants in the prescription plan would retain the option to continue buying drug prescriptions the same way they have been — by mail order, or at drug-store chains or independent pharmacies.

The city could stand to save more if local pharmacies handled the scripts than a chain drug store, transferring the shared business to Sekulski.

“I will not do a chain as a model,” Sekulski said, “because I can’t disrupt their business model.”

Sekulski said a chain drug store can work out its repackaging of drugs with the manufacturer to benefit its profits.

‘MAJOR SAVINGS FOR THE CITY’
Employee co-payments would remain the same, he and city officials said.

There would not, therefore, be a need to negotiate changes with the unions, Poulin said. However, the city could add “incentives” for participants to purchase prescriptions at independent pharmacies, which would offer lower drug prices to the city.

“It looked like a major savings for the city,” said Officer Michael Perreira, police union president, who — along with Lt. Michael Coogan, head of the firefighters union — met recently with Poulin and Mitchell about the proposal.

“We both agreed we’d be very interested in hearing what they have to say,” Perreira said. Coogan, also a member of the city Insurance Advisory Committee, could not be reached for comment.

A PLAN PROVED SUCCESSFUL
Sekulski said he spent two years researching his model before launching last July. He said there are 11 municipalities, counties and school districts in this program, all in New Jersey.

He named Middlesex County as one self-insured client. He said they spent $18 million on drugs for plan participants — about $7 million more than Fall River — and his company guaranteed a $500,000 savings.

“It looks like they’ll save over $1 million,” he said.

The Herald News was awaiting a requested list of his clients and contacts on Friday.

City Administrator Shawn Cadime said he participated in talks with Sekulski, Poulin, Human Resources Director Madelyn Coelho, the local pharmacists and the city’s longtime insurance consultant, Group Benefits Strategies in Auburn, represented by Ginger Hastings.

“What we’re trying to do is find any kind of savings we can in health care,” Cadime said, noting significant yearly increases in costs.

Cadime said when they met in April “they gave a great presentation. It seems worthwhile to look at,” he said, “if the city can save even $300,000 to $400,000.”

Responding enthusiastically, he said, “Anytime anybody’s guaranteeing money it’s really hard to pass up. (But) We need to ensure we’re not missing any details.”

He said they were awaiting additional information from GBS’ Hastings. “We’d be the first in Massachusetts,” he added.

A MORE CAUTIOUS APPROACH
Mayor Will Flanagan took a more cautious approach while stating that Cadime and his staff had the financial details.

“This is one of those cost-saving measures we’re looking at right now,” Flanagan said.

He said it “may not be included” for the upcoming budget starting July 1, “but it may be implemented this year or early next year before the close of the books for fiscal year 2012.”

“We’re still going through the detailed process. We’re doing some more research,” said Coelho, who’s coordinated the information. “We should know a lot more in a week or so.”

IRONING OUT DETAILS
She said the question of changing the mail-order user from Express Scripts and whether a change would need to go out to bid needs to be determined.
According to Sekulsi, and based upon preliminary data, he said, “We will guarantee someplace between $400,000 and $450,000.” He said typical rebates the self-insured municipalities could receive for buying in quantity had not been passed along to Fall River, according to information given to him.

Because costs to clients for school employees are put in the cheapest wholesale classification with hospitals, inclusion of the School Department could increase the guaranteed amount to a range of $1 million to $1.3 million, he said.

When asked how he made his money, Sekulski said his commission would be “from 50 to 70 percent” for any additional savings above the guaranteed amount listed in the contract with the city.

That would mean he’d pocket that percentage above the $400,000 or what he guaranteed.

Poulin said the city’s insurance consultant, GBS, was slow providing necessary data and gave an incomplete year-to-year comparison of expenses for this new company to draft a specific financial contract.

The head of GBS, Jack Sherry, whose company consultants on health care costs to 190 municipalities and school districts, said he’d try to reach Hastings to return a call about their position on Sekulski’s proposal. None was immediately received Friday.

Cory said he became familiar with Sekulski’s fledgling company during a pharmaceutical conference. He predicted that if the city accepts the model, the five local pharmacies in the city “would have 90 percent of the former mail-order business.”

Pasternak said the increased business would also likely mean more jobs for city residents as the local pharmacies expand their staff to meet the added demand.

Drug industry: Nation aims for role as global pharmacy

India’s commerce ministry is aiming to carve out a role for the nation as the world’s pharmacy.

Once known for making low-cost copycat drugs for its price-sensitive domestic market, India’s pharmaceutical industry has emerged as a global force, supplying low-cost, quality off-patent medication.

It increasingly sends drugs to western markets such as the US as well as to developing economies.

India’s pharmaceutical exports grew robustly during the financial crisis and were estimated at $10.3bn in 2010-11, up more than 10 per cent on the previous year and nearly double the level of five years earlier, the commerce ministry says.

But in a fragmented global generics market currently estimated at $85bn a year, India’s government, and its pharmaceutical companies, believe there is plenty of room to grow, especially as numerous blockbuster drug patents expire in the next few years.

India aims to increase drug exports to $25bn by 2013-14, aided by pressure on fiscally strained developed countries to cut healthcare costs.

“Developing countries are facing fiscal problems, and wherever public health is a major charge on the national exchequer, solutions will have to be found,” India’s commerce ministry wrote in a recent strategy paper. “An integral piece … will be increasing reliance on high-quality generics, instead of patented or brand-name drugs. This is an opportunity we cannot miss.”

Once focused mainly on the domestic market, Indian companies have become adept at filing applications to sell their low-cost generics in western markets – almost immediately after they go off patent, or by challenging the patent.

New Delhi-based Ranbaxy, bought by Japan’s Daiichi Sankyo in 2008, expects to get six months of US sales exclusivity – a privileged granted to the first generics company successfully to challenge a drug patent – for its version of Pfizer’s blockbuster cholesterol-lowering drug Lipitor.

Ranbaxy’s performance in the past year has benefited from six month exclusivity periods for generic versions of GlaxoSmithKline’s anti-herpes medicine Valtrex, and a generic version of Eisai’s Aricept for Alzheimer’s disease.

“There is well-oiled machinery that cranks out these applications to sell drugs,” says an India-based investor in the pharmaceutical industry.

India has more than 100 pharmaceutical manufacturing facilities approved by the US Federal Drug Administration – more than any country outside the US.

Many of these companies have warehouses in Malta, where they ready generic supplies for shipment to the EU when drugs go off-patent there.

Indian drug companies are also looking to emerging markets, such as Russia, Latin America and the Middle East.

Bino Pathiparampil, an equity analyst with Mumbai-based India Infoline Capital, says: “They are making big gains [in such territories], although from a very low base.”

Multinationals such as Merck, Abbott Laboratories, Sanofi-Aventis, and GlaxoSmithKline – once bitterly resentful of Indian copycats – now see the country as an increasingly important part of their global supply chain.

Recently, India has seen a series of takeovers of locally owned drug companies by pharmaceutical companies.

Multinationals are also forging manufacturing, sales, marketing and research tie-ups with local companies. One such is Merck’s partnership with Gujarat-based Sun Pharma to develop, make and sell branded generic drugs to emerging markets.

“Big pharma players are more open to work with emerging market players,” says Vasant Kumar, president of Scriplogix, a New York-based consultancy. “They need to keep costs under control, and emerging markets are becoming more important in their portfolio.”

However, India has yet to establish itself as a base for innovative pharmaceutical research.

Local research firms such as Jubilant, TCG, the Tata Group’s Advinus, and Dr Reddy’s Aurigene, are promoting themselves as partners to do contract work for big companies seeking to reduce costs.

But the business is held back by concerns about intellectual property rights and companies’ reluctance to outsource such a crucial function.

“Leakage is rampant,” says the industry investor, who adds that companies looking to outsource “don’t want to take a chance”.

Some Indian companies say they have a few promising molecules in development. But research spending by most Indian drug companies is a pittance, the highest levels being between 5 and 10 per cent of sales – insignificant compared with large multinationals.

OxyContin prescriptions by Ontario MDs vary greatly, study finds

Some doctors are writing significantly more prescriptions for such powerful painkillers as OxyContin than their colleagues, a new study suggests — a practice some are blaming on the influence of pharmaceutical companies.

A new study highlights the issue of opioid-related deaths, which have surged in recent years to the point where they are now considered more common in North America than deaths from HIV. The report, which looks at data from 2006, was published in this month’s issue of Canadian Family Physician.

It found Ontario’s most frequent opioid-prescribing family doctors wrote 55 times more prescriptions for the narcotics than physicians who prescribed the drugs the least.

Those doctors handing out the most prescriptions had the highest numbers of patient deaths linked to the drugs, according to researchers at St. Michael’s Hospital and the Institute for Clinical Evaluative Sciences, both in Toronto.

“We know that the drugs are useful in particular patient populations, and we also know that they’re potentially very dangerous,” said the study’s lead author, Dr. Irfan Dhalla, who called the variation in prescription rates striking.

“The drugs need to be used and prescribed with great care.”

A 2009 report by the College of Physicians and Surgeons of Ontario found that opioid-related deaths in Ontario increased 49 per cent between 2002 and 2006.

Deaths linked to oxycodone — the active ingredient in OxyContin, also known as Hillbilly Heroin — shot up 240 per cent between the same years.

Dhalla is calling for better education of physicians when it comes to appropriately handing out the drugs.

“I think education needs to occur at all levels,” he said. “Medical students don’t receive enough education about these issues, and until recently at many universities, the education was being delivered — at least in part — by people who have ties to the pharmaceutical industry and were presenting information that was potentially biased.”

St. Michael’s physician Dr. Philip Berger pointed to pressure from the pharmaceutical industry as a reason for the spike in prescriptions.

“It is important to recognize that one reason opioids are prescribed so often is that the pharmaceutical industry has marketed these drugs very aggressively,” Berger said in a statement.

He later told Postmedia News that pharmaceutical companies’ “unethical and unbelievably aggressive marketing” practices are unfairly influencing Ontario’s overstressed family physicians.

“With that nudge and push from the pharmaceutical companies, they may be more eager to just prescribe a drug without exploring other methods of relieving pain,” he said. “They make it appear that it’s normal to prescribe medications in situations where they should not be.”

The University of Toronto revised the curriculum for one of its pain-management courses in 2010 after a 371-page pain-management book funded and copyrighted by Purdue Pharma, the manufacturer of OxyContin, was distributed to students in the course.

From 2002 to 2006 the course was funded in part by donations from drug companies — a practice the U of T curtailed in 2007.

Purdue Pharma, the manufacturer of OxyContin, could not be reached Tuesday for comment.

The study looked at prescription records for Ontarians aged 15 to 64 who qualified for provincial drug coverage.

In 2006, 166 of the 408 people in the province whose deaths were linked to opioid use received at least one prescription for the drugs in the 12 months prior to their death.

Of that group, 102 received their final prescription before death from a family physician.

Sixty-two per cent of patients who died while in the care of a family physician had a doctor who was among the group of most frequently prescribing physicians.

According to the Ontario government, between 1991 and 2009 the number of prescriptions for oxycodone skyrocketed 900 per cent.

The drug is about 1.5 to two times more powerful than morphine.

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The Ontario government responded in November 2010 with the Narcotics Safety and Awareness Act, which will allow the Ministry of Health to monitor the prescription of opioids and stop addicts from obtaining drugs from multiple doctors at the same time.

A spokesman for the Ministry of Health said the department is currently developing plans to work with the health-care sector to educate doctors on appropriate prescribing methods as part of its narcotics strategy. There is no timeline for the launch of the education program.

Prescribed pain by Corporate America

During the ultimate scene of betrayal in the movie Wall Street, a young stockbroker named Bud Fox learns that his idol, the golden-calf worshipping Gordon Gekko, has not only lied to him but left his father’s company exposed to the whims and hunger of the wolves of Wall Street. In a climactic moment, Fox asks Gekko, “how much is enough? How many yachts can you water ski behind?”

Even though this film was mid-1980s fare, one can once again repeat that old refrain, the more things change the more they stay the same. Perhaps not for the actor who played Bud Fox, Charlie Sheen, who should share Natalie Portman’s Oscar for real-time transformation into the Black Swan.

But for the rest of us, who have watched as greed has become the foundational structure upon which much of our modern economy is built, it is often difficult to see how we might close the Pandora’s Box and return to saner times. You know, back when being Donald Trump wasn’t considered an asset in a hair-club-for-men commercial, much less a race to be President of the United States.

There is nowhere this greed is more pervasive than among those companies responsible for the health of roughly 300 million of Americans – Big Pharma. You know, the guys who got a better sweetheart deal from George Bush’s Medicare prescription drug benefit than Ana Nicole Smith did from that old rich guy.

Later, re-importation from Canada and bulk negotiation for Medicare prescription drugs were written out of any Obama healthcare plan, even though each was at the heart of Democratic Party campaign promises in 2006 and 2008.

Maybe money can not buy you love – but the halls of Congress have a more Heidi-Fleiss-kind-of ethic to them.

Steve Lendman of RINF.com, in providing a summary of David Sirota’s bestselling book, Hostile Takeover, clarifies:

This industry is one of the most profitable in the country making about 18 cents profit on every dollar of sales; it is aided by government using our tax dollars to fund about one third of all research on new drugs the industry gets at no charge; the industry spends about twice as much on advertising, promotion and administrative costs as they do on R & D to develop new drugs; the prices charged for prescription drugs in the US are inordinately high compared to the rest of the world and are rising at about four times the rate of inflation; these rising costs plus those for most all health services are rising so fast, companies are forcing their employees to pay a greater share of them or are reducing overall health care benefits.

Ever feel like you are the bank and they are Dillinger? If not, you probably should.

I can attest to their greed personally, from working with preeminent plaintiff’s lawyer Ed Blizzard, who has challenged the right of pharmaceutical companies to poison Americans, like it is part of their business model. It is Blizzard who made Vioxx drug-maker Merck pay dearly – to the tune of $4.85 billion – for the scores of Americans who lost mothers, fathers, brothers and sisters, because Vioxx promised to help with arthritis and instead delivered sudden cardiac arrest.

Now, because a lack of any regulation, Americans are being poisoned by hip implants created by Johnson & Johnson subsidiary Depuy Orthopaedics Inc., that are not only not tracked by any regulated registry, but in many cases were never even tested before being put into people’s bodies – so the inside of victims hips could come to resemble a post-Deepwater Horizon Gulf of Mexico.

You can tell they’re confident that their 93,000 recalls, which they had been warned about as early as 2008, but did not do anything to address until 2010, aren’t proof of any wrongdoing. That is probably why Depuy’s President, David Floyd, just resigned.

Even worse, the chromium poisoning that is destroying victims’ bone and muscle is nothing new, in fact, you may remember a town of people who got cancer due to its ill effects from the movie Erin Brockovich. Now, they have Depuy and Johnson & Johnson to thank for this honor.

So one understands we are talking about real people here, one of Blizzard’s clients, 58 year-old construction worker Larry Barnett of Modesto, Illinois, “suffered debilitating pain – he had trouble even walking or standing after receiving the part” and now is “at much greater risk for cancer.” Barnett told reporter Mike Cronin of The Daily, that Depuy’s ASR hip replacement has “screwed up my life for three years.” This man was a hard-working construction worker, who “only wants to get back to work”.

One wonders if any pharmaceutical company had to give up income for three years, which they would do first – hand off the bill to American taxpayers or make Canada to accept re-importation of drugs from the United States for 150 per cent of the price.

As Blizzard has said, “nobody signed up for an oil spill in their body.” They did not sign up for cancer either.

So let me ask the question this time, as Sheen is a bit preoccupied with other matters: When is enough, enough?

India makes strong pitch for pharma exports to China

India made a strong pitch to push exports of its pharmaceuticals to China in a big way asserting that a good opening exists for its USD 21 billion strong pharma industry to make forays into China, if Chinese government cleared hurdles to provide market access.

Indian Ambassador to China, S Jaishankar along with the an Indian pharma delegation, headed by N R Munjal, President, Indian Drug Manufacturers Association, met officials of State Food and Drug Administration (SFDA) and Chinese Ministry of Commerce today and urged them to take steps for faster clearance of licences for Indian products.

Jaishankar said the delegation tried to impress upon Chinese officials that while the Chinese companies trading in Active Pharmaceutical Ingredients (API) were getting clearances in about an year, it is taking three to five years for an Indian companies to clearances in China.

China’s API exports to India touched USD 3.3 billion last year, while Indian drugs struggled to post USD 500 million worth of exports to China, even though Indian companies boasts of USFDA approved facilities, exporting to 170 countries, Jaishankar said.

“We tried to make out a case that like India making use of Chinese machinery to expand its infrastructure, China, too, should take advantage of well placed Indian pharmaceutical industry which can help to make the basic drugs available for far cheaper prices benefiting the Chinese public,” Jaishankar told PTI after meeting the officials.

He said though bilateral trade crossed USD 60 billion last year, it tilted heavily in favour of China with its exports crossing over USD 40 billion.

It would be difficult to continue sustaining bilateral trade on the basis of current trends, he said.

It would be even more difficult if, as expected, some of India’s current major exports actually started to decline, he said, pointing to the decline Indian raw material exports like iron ore and cotton.

“There is an urgent need to change the trade basket and introduce elements where India has proven competence.

Pharmaceuticals readily fit the bill, he said adding for its part India is organising campaigns to create awareness of Indian products IT and Pharmaceuticals.

India is pushing for market access based on the assurances by Chinese Prime Minister Wen Jiabao, to address the trade imbalance, he said, adding an Indian pharma delegation is visiting China for the first time to closely interact with their Chinese counterparts.

He said during today’s interaction, Chinese officials had proposed to a nodal body comprising of SFDA officials and Chief Controller of Drugs of India to interact on the market access issues, which will be seriously considered.

Duphat Conference and Exhibition commences its second day with outstanding participation

Despite the fact the pharmaceutical industry had achieved a tremendous progress in the past years, yet there are lots of pressing issues that are vague due to the lack of data and resource. However, the Duphat conference this year sheds light on these issues of interest in the pharmacology science and tries to present solutions.

Distinguished Speakers from the UAE, Belgium, United Kingdom, Denmark, Australia, Egypt and Japan specializing in Pharmacology, Academics and Research shared their latest expertise and greatly contribute to the pharmacy profession during Duphat conference.

Dr. Ali Al Sayed Director of Pharmaceutical Services Department at the Dubai Health Authority and the conference chairman said “For the second consecutive day, the speakers have discussed many relevant topics including; The pharmacist’s Role in personalised Medicine, the Role of Pharmacists in Individualized Medicine; Evolving Science in Pharmaceutical Practice, Implementation of a Robot for Chemotherapy Preparation, Technology Driven Topical and Systemic Drug Delivery Systems, Pharmacy Practice Governance, Worksite Health and Productivity Management to Name a Few.

Dr. Ali also said that Duphat conference intends to meet the interests of pharmacists from hospitals and community pharmacies, professionals from the pharma-industry, marketing professionals, researchers, academics, scientists, biotech experts, clinicians, students and other healthcare professionals.

The scientific program also included a number of workshops presented by internationally renowned specialists. The second day workshops covered topics such as Monitoring Pharmaceuticals during Storing, Handling, and Transportation by Means of Indicators, Health Risk Appraisal at the Worksite, Medication Safety, and Strategy to Enhance Patients Adherence to Medication.

On the exhibition side, more than 300 regional and international pharmaceutical companies are showing their latest products and researches at the Duphat. The exhibition attracts more and more exhibitors every year due to many attendees interested in this field. Duphat conference and exhibition is expected to attract more than 10,000 visitors and participants this year.

Congratulations Ken Wicks~ 40 years

HART’S Pharmacy owner Mr Ken Wicks has been congratulated by the Pharmacy industry for achieving a feat very few of his colleagues can claim. Ken has provided the local community with 40 years of continuous pharmacy advice and service.

We caught up with Ken recently to gain an insight into what it takes to operate a business and provide a high standard of service for such an extended period.

Gazette: How long did you originally come for?

Ken: The initial contract was for three months with an option to extend if both parties agreed. The series of extensions continued until 1985 when I purchased the business.

Gazette: Where did you live in those early days?

I boarded at the Commercial Hotel among a large group of people and we were spoilt foodwise by the owners, Mr and Mrs McRae.

Gazette: Who were the doctors in 1971?

Dr Keith Beck and Dr Peter Rikard-Bell.

Gazette: Who were on staff in March 1971?

Mary Tarby, Helen Sinclair and Justin Hart. Marion Jordan was the bookkeeper and the owner Andie Hart spent periods of time behind the counter as well.

Gazette: In the past, as well as present, Hart’s Pharmacy has outstanding staff, would you like to comment on this?

Staff is the essential ingredient in a successful business.We have been fortunate over the years to have employed outstanding individuals. At present the combined pharmacy experience of the staff amounts to an astounding 139 years!

Gazette: What is the cornerstone to providing the service you have over the last forty years?

Remembering people’s names and being a good listener when presented with their problems.

Gazette: How has technology affected pharmacy in your forty years?

Dramatically, in the past all prescriptions were hand-written in a large prescription ledger to the present day with full on computerization.

Gazette: No doubt you have seen many changes, are they all for the good of the community?

Pharmacists by nature are very adaptable and the consumer at the end of the day is the winner

Gazette: What process did you have to go through to achieve your qualifications?

Four years at Sydney University followed by one year pre-registration before I could practise as a pharmacist.

Gazette: Can you recount for us some of your most memorable achievements in pharmacy? Achieving positive outcomes when presented with an amazing array of issues over the years.

Gazette:Your longevity and success can be attributed to what?

I enjoy coming to work and pharmacy in the country is practicing what I call “Real Pharmacy”. The positive feedback you receive from people is most gratifying.

Gazette: Hart’s Pharmacy has expanded over the years, has this allowed you to provide a wider range of services?

The Medicare Access Point, the photo kiosk, cosmetics and skin-care and a larger health consulting area are a few of the services we now offer.

Gazette: Hart’s Pharmacy is Quality Care accredited. Do all pharmacies have this accreditation?

No. Hart’s Pharmacy has been accredited for 10 years and the last evaluation in 2010 we achieved 98 per cent.

Gazette: Finally, what has been the most important issue professionally over the forty years?

Establishing and maintaining good relationships with all the doctors in the area. Sadly in some parts of Australia there are doctors who won’t even take a call from a pharmacist. The staff would like to congratulate Ken on such an achievement and furthermore would like to thank Ken for providing such a pleasant work environment. As a long time provider of Alpharpharm generic medicines to the community, Alphapharm would like to congratulate Ken on reaching this milestone and thank him for his support over the past 25 years.

Technology Embracing Pharmacy, Millennium Pharmacy Systems, Welcomes New CIO

Chicago based pharmacy services provider to the long-term care industry, Millennium Pharmacy Systems recently announced the appointment of John Tauber as its chief information officer (CIO). Tauber has been serving the company as interim CIO since the fall of 2010. In a press release, the company announced that the latest appointment is a part of the company’s goal of providing the long-term care industry with the cutting-edge technology-enabled solutions.

Tauber, who has acquired extensive industry experience working in the fields of corporate, turnaround, and growth sectors, will oversee all information technology operations of the company. He will be based at Millennium’s Shared Services location in Cranberry Township, Pennsylvania.

Prior to joining Millennium Pharmacy, Tauber was the CIO for MedImpact Healthcare Systems. There, his role involved delivering IT services for one of the nation’s largest prescription benefits management (PBM) companies.

A dual Bachelor’s degree-holder in computer science and in mathematics he also served as an adjunct professor at the Lake Forest School of Management.

“John (Tauber) has proven his effectiveness and has shown that his goals align with the direction of Millennium. We are very pleased to welcome him to the Millennium family and look forward to his contributions,” Millennium CEO Rich Scardina said in a statement.

“Millennium Pharmacy Systems has been the launching pad for technology into the long-term care pharmacy industry and into many of its customers’ operations. I am pleased to have the opportunity to help continue and enhance the tradition of technology-enabled solutions both internally and externally,” Tauber stated in the release.

In other news, MedImpact Healthcare Systems, Inc. has been awarded Pharmacy Benefit Management accreditation from URAC, a Washington, DC-based health care accrediting organization that establishes quality standards for the health care industry. The announcement was made at the company’s annual client conference.

Healthcare Solutions Adds Industry Expert to P&T Committee

Healthcare Solutions, the parent company of pharmacy benefit manager Cypress Care, today announced it has added healthcare industry expert Sanford M. Silverman, MD, to its pharmacy and therapeutics (P&T) committee. The addition of Dr. Silverman further strengthens the company’s P&T committee, which serves as an advisory board to provide recommendations on the selection and use of medications to treat workers’ compensation and auto claimants.

Healthcare Solutions’ P&T committee reviews medication safety issues, proper drug utilization trends, drug recalls, new generic introductions, changes in FDA drug indications and drug misadventures that have occurred in the most recent quarter. The committee also focuses on emerging issues, including legislative updates and best practice pain treatment protocols prevalent in the workers’ compensation and auto markets.

Dr. Silverman has been practicing medicine for over 20 years and is in private practice as the medical director and CEO of Comprehensive Pain Medicine in Pompano Beach, Florida. He is board certified in anesthesiology with added qualifications in pain management from the American Board of Anesthesiology and a Diplomate in Pain Medicine from the American Board of Pain Medicine. He is also a Diplomate in Addiction Medicine from the American Board of Addiction Medicine. His practice consists of interventional and medical treatment of chronic pain, opioid addiction and treating complex chronic pain with hyperalgesia.

“We are very pleased to add Dr. Silverman to our P&T committee,” said Jim Andrews, R.Ph, senior vice president of pharmacy services for Healthcare Solutions. “He brings a wealth of pain management expertise to the committee and will be a valuable advisor in the development of policies regarding the evaluation, selection, and therapeutic use of drugs and related services for our customers.”

Healthcare Solutions P&T committee is chaired by Chip Robison, Pharm.D, director of clinical pharmacy services for Healthcare Solutions. Dr. Robison is a member of the Work Loss Data Institute (WLDI) Official Disability Guidelines Editorial Advisory Board and actively participates in providing pharmacy guidance to the committee. Under Dr. Robison’s leadership, the P&T committee recently developed customized, claim age-specific formulary design as well as formulary enhancements to assist non-subscriber customers. He also serves as clinical preceptor for pharmacist interns with the Academy of Managed Care Pharmacy, The University of Georgia and Mercer University. The P&T committee continues to monitor the impact of the Food and Drug Administration’s risk evaluation and mitigation strategies (REMS), as well as the state-specific adoption of the Official Disability Guidelines.

HCPC Expands Annual Event to Drive Pharma Collaboration

The nagging problem of patient adherence to their medicines will be addressed in a novel way at a May event that seeks to bring pharmaceutical industry stakeholders together to review the latest research and collaborate on strategies to improve patient adherence. With RxAdherence 2011, the Healthcare Compliance Packaging Council seeks to foster greater collaboration between marketers and packagers to build a compliance-packaging strategy into the product development and launch process.

For the last 18 years, the Healthcare Compliance Packaging Council (HCPC) has explored the scope of the problem and potential packaging solutions at its annual National Symposium on Patient Compliance. Now HCPC is expanding its lineup of speakers and invited attendees to include pharmaceutical marketing professionals and others involved in pharmaceutical development, branding, and market analysis.

Speakers at the conference will include Vernon Schabert, principal, IMS Health Economics and Outcomes Research, who will review current adherence interventions; Rebecca Burkholder, JD, VP of health policy, National Consumers League, who will explain NCL’s national multi-media campaign; and Tom Hubbard, senior program director, the National Network for Health Innovation, who will look at the current state of adherence programs in the context of ongoing health care reform initiatives.

Data from cases in which packaging has played a role in medication adherence will also be shared. Ted Lithgow, Ph.D., chief science officer, MWV Healthcare, will present just-released peer-reviewed pharmacoepidemiological research analyzing pharmacy claims data. Another presentation, by Kamal Jethwani M.D., lead research Scientist, Center for Connected Health, will review a six-month study on the use of an electronic compliance reminder by patients taking an antihypertensive medication.

Industry peers will come together for a panel discussion in the afternoon on how consumer research, brand marketing, and well-developed compliance prompting packaging brought together early in the process can increase patient refill rate and patient adherence. Featured panelists include Christine Coyne, product director, Endo Pharmaceuticals; Diane Krusko, cardiovascular marketing director, Pfizer; Sander Flaum, CEO, Flaum Partners; Jay Carter, AbelsonTaylor; Justin Schroeder, director, marketing & business development, Anderson Packaging Inc.; and Ted Lithgow, Ph.D., chief science officer, MWV Healthcare. The discussion will be moderated by Christiane Truelove, editor-in-chief, Med Ad News, and Daphne Allen, editor, Pharmaceutical & Medical Packaging News. Both brands are published by UBM Canon.

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Continuing a long-standing tradition, Walter Berghahn, executive director, HCPC, will present HCPC’s Compliance Package of the Year Awards Presentation during lunch. (For more details on the competition, visit www.hcpconline.org.)

The event is sponsored by UBM Canon: Pharmaceutical & Medical Packaging News, Med Ad News, PharmaLive.com, and Pharmalot.

About UBM Canon

UBM Canon, the leading B-to-B media company dedicated exclusively to the global $3.0 trillion advanced manufacturing sector, helps support the flow of information, commerce and innovation in such sophisticated segments as medical devices and pharmaceutical development. UBM Canon also addresses cutting-edge developments in broader areas of advanced engineering design and manufacturing, and manufacturing processes and packaging.

Managed Health Care Associates, Inc. (MHA) Released Results of Fourth Annual Independent Long Term Care Member Study with Highlights of Specialty Pharmaceutical Product Utilization

Managed Health Care Associates, Inc. (MHA), a leading health care service company focused on alternate site health care providers, announced the completion of its fourth annual Independent Long Term Care Member Study, the results of which were released at the 2011 MHA Long Term Care Business Summit, March 17, 2011 in Las Vegas, Nevada.

This study was first introduced in 2008 to provide MHA members and other industry stakeholders with additional insight into the operations of independent long term care pharmacies nationwide. Report findings represent participant data in demographic, financial and technology categories as well as by number of residents serviced and geographic region.

New to the 2011 LTC member survey is an analysis highlighting the growing utilization of specialty pharmaceutical products in the long term care setting. These results indicate double digit growth in prescription product utilization of specialty medications used to treat Multiple Sclerosis (MS) and Inflammatory Conditions over a comparative time period of 2009 vs. 2010. The data also demonstrates that long term care pharmacies are increasingly providing specialty pharmaceuticals to seniors across the continuum of care.

“We are pleased to have expanded the scope of this year’s study with dispensing data participation from nearly 900 independent LTC pharmacies nationwide as well as added report topics including Specialty Pharmacy,” stated Michelle Templin, Vice President of Long Term Care. “Our members recognize MHA’s commitment to the LTC industry and to the success of their respective pharmacy operations. And, as the market leader in LTC Pharmacy, we know what it takes to deliver a very meaningful LTC research report.”

MHA members who attended the Business Summit were given a complimentary copy of the Independent Long Term Care Member Study. Members not in attendance will receive a copy of the study directly through their Account Management team. Other interested parties may request copies by contacting MHA’s marketing department.

About MHA

Managed Health Care Associates, Inc. (MHA) is a leading health care service company that offers a growing portfolio of services and solutions to support the diverse and complex needs of the alternate site health care provider. MHA provides expertise in Group Purchasing, Managed Care and Payer Contracting, Reimbursement Management, Specialty Pharmacy Solutions, Pharmaceutical Data Analytics, Clinical Pharmacy Software and Legislative Advocacy. Through the delivery of innovative and targeted health care services and solutions, MHA helps members increase operational efficiency, maximize business growth and provide optimum care for patients.

NCPDP Releases Enhancements to Its Telecommunication, Manufacturer Rebate and Formulary and Benefit Standards

The National Council for Prescription Drug Programs (NCPDP), the leading not-for-profit pharmacy standards development organization, announced today the availability of enhancements to its Telecommunication, Manufacturer Rebate and Formulary and Benefit Standards. Every year billions of pharmacy claims are formatted using NCPDP Standards, the core framework on which the pharmacy industry operates. NCPDP’s Standards provide a uniform format and layout for electronic communication of pharmacy-related data to automate and improve real-time transmission, accuracy, processing and exchange of data. The development of new standards and enhancements to existing standards are conducted using the organization’s collaborative and consensus-building process.

Telecommunication Standard
The Telecommunication Standard defines the record layout for real-time prescription claim transactions, billing pharmacy transactions, certifying eligibility and prescription drug benefits,communicating detailed information defining reimbursement or denial of compensation with explanations, and concurrent drug use review. Enhancements available in the Telecommunication Standard Implementation Guide Version D.6 include:
New field for Controlled Substance Reporting to indicate the prescription was dispensed for use on something other than human.
A means for the pharmacy to submit Section 340B status subsequent to providing the prescription service.

Manufacturer Rebate Standard
The Manufacturer Rebate Standard provides a standardized format for the electronic submission of product utilization, plan membership, formulary information, market definitions, and reconciliation from Pharmacy Management Organizations (PMOs) to Pharmaceutical Industry Contracting Organizations (PICOs).The Manufacturer Rebate Utilization, Plan, Formulary, Market Basket, and Reconciliation Flat File Standard Implementation Guide Version Ø5.ØØ includes editorial corrections to the standard and the removal of fields not in use.

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Formulary and Benefit Standard
The Formulary and Benefit Standard provides a standard means for pharmacy benefit payers (including health plans and pharmacy benefit managers) to communicate formulary and benefit information to prescribers via technology vendor systems. Enhancements available in the Formulary and Benefit Standard Implementation Guide Version 3.Ø include:
New field for co-pay specific messaging
Removal of outdated or not used data elements and values
Provides clarity as to the ability for payers to send multiple Quantity Limits (QLS), Text Messages (TMS) and/or Resource Links (RLS)
Consistent support of RxNorm codes
Provides clarity to Formulary Status values

About NCPDP
Founded in 1977, NCPDP is a not-for-profit, ANSI-accredited, Standards Development Organization with over 1,600 members representing virtually every sector of the pharmacy services industry. Our diverse membership provides leadership and healthcare business solutions through education and standards, created using the consensus building process. NCPDP has been named in federal legislation, including HIPAA, MMA, and HITECH. NCPDP members have created standards such as the Telecommunication Standard and Batch Standard, the SCRIPT Standard for e-Prescribing, the Manufacturers Rebate Standard and more to improve communication within the pharmacy industry. Our data services include the NCPDP Provider Identification Number, a unique identifier of over 75,000 pharmacies, and HCIdea, “The Prescriber Identity Solution.” NCPDP’s RxReconn™ is a legislative tracking product for real-time monitoring of pharmacy-related state and national legislative and regulatory activity.

BioScrip Receives URAC Accreditation in Specialty and Mail Service Pharmacy

BioScrip, Inc. (NASDAQ: BIOS) announced today that it has been awarded specialty pharmacy and mail service pharmacy accreditation from URAC, a Washington, D.C.-based health care accrediting organization that establishes quality standards for the health care industry.

Specialty pharmacy and mail service pharmacy offers comprehensive oversight of the distribution, clinical management, and reimbursement of oral, injectable, and IV drug products for chronic conditions. Specialty pharmaceuticals represent the fastest growing segment of drug spending due to new product approvals, high unit costs, and increasing use.

“BioScrip is very pleased to have been awarded full accreditation for both specialty pharmacy and mail service pharmacy from URAC,” stated Richard M. Smith, President and Chief Executive Officer of BioScrip. “Going through the process challenged us to find better ways to serve our customers, and it is a constant reminder that our first responsibility is to the patient and the quality of clinical service we provide.”

URAC accreditation is granted to only a select group of organizations that demonstrate a commitment to quality standards. To achieve the accreditation for specialty pharmacy and mail service pharmacy, BioScrip participated in a complex application process which required a comprehensive review of BioScrip customer service and clinical pharmacy processes against a combined 146 quality standards by expert analysts.

“By applying for and receiving URAC accreditation, BioScrip has demonstrated a commitment to quality health care,” said Alan P. Spielman, URAC president and CEO. “Quality health care is crucial to our nation’s welfare and it is important to have organizations that are willing to measure themselves against national standards and undergo rigorous evaluation by an independent accrediting body.”

About BioScrip

BioScrip, Inc. (Nasdaq: BIOS) is a national provider of specialty pharmacy and home care products and services that partners with patients, physicians, hospitals, healthcare payors and pharmaceutical manufacturers to provide clinical management solutions and delivery of cost-effective access to prescription medications. Our services are designed to improve clinical outcomes for chronic and acute healthcare conditions while controlling overall healthcare costs. Bioscrip, Inc. is also nationally accredited with the Accreditation Commission for Health Care, Inc.

About URAC

URAC, an independent, nonprofit organization, is well-known as a leader in promoting health care quality through its accreditation and certification programs. URAC offers a wide range of quality benchmarking programs and services that keep pace with the rapid changes in the health care system, and provide a symbol of excellence for organizations to validate their commitment to quality and accountability. Through its broad-based governance structure and an inclusive standards development process, URAC strives to ensure that all stakeholders are represented in establishing meaningful quality measures for the entire health care industry.

The pharma outsourcing industry in India will grow significantly over the years

Manish Gupta, CEO, Indegene Lifesystems Pvt Ltd discusses the career opportunities that exist in the pharma outsourcing industry

1) How is the pharma outsourcing industry faring currently?
Globally, pharmaceutical companies outsource in two large areas—clinical development and marketing. The marketing outsourcing space is larger and is where specialised agencies operate. Till now, due to the high profitability of the pharmaceutical industry and the lack of unified sourcing strategy for marketing services, this space was very fragmented. However, with the current pressure on the pharmaceutical industry, this space is transforming rapidly. Companies want to drive efficiency and effectiveness in their marketing efforts in developed markets and are looking at expertise for their rapid scale-up from their outsourcing partners in emerging markets. This is an area that we believe holds tremendous opportunities for India and will grow significantly over the next few years.

2) Which are some of the emerging career opportunities within this industry?

The new wave in the area of pharma outsourcing is in the domain of “marketing and commercialisation” services. In fact, the rapid growth of this segment has been riding on the talent available in the country. Professionals in this domain are expected to bring in-depth industry experience and global market knowledge that support a range of services across each phase of the outsourcing lifecycle.

* Medical and pharmacy graduates and postgraduates can explore careers in medical writing, patient adherence programs, and clinical trial analytics. This allows them to explore careers beyond a single clinical specialty, provides them an opportunity to remain at the cutting-edge of medical knowledge, and contributes to healthcare globally.

* Nursing professionals can play a role in managing patients across therapy in patient adherence services and patient counseling and support services.

* Creative and Art graduates can play a role in developing communication and medical illustrations and can leverage their creative and visualization skills.

* Lifescience graduates with management qualification have opportunities in areas of client services, strategy, business development, project, and operation management.

3) What are the skills and qualifications required to excel in this industry?

Apart from professional qualifications in medical and life sciences, professionals are expected to have very strong written and verbal communication skills. They also need to have the ability to work in teams, handle pressures due to tight timelines, and demonstrate passion for continuous learning. Since global outsourcing has now straddled continents, knowledge of additional foreign language is an added advantage.

4) How do you foresee the growth of this industry in the near future?

The opportunities in this industry are tremendous, with the global pharma companies facing severe cost pressures and realising that the viable way to success is exploring innovative ways to meet their existing and emerging business challenges. Global aging, increasing life expectancy, changing disease epidemiology, health awareness, and rise in disposable income in emerging markets will change the way healthcare and pharma business are conducted. Globally, companies are expanding the range of services that they want to outsource. Moving ahead from outsourcing services like manufacturing, clinical trials, and R&D outsourcing, global pharma companies are now seriously considering and outsourcing marketing and commercialisation services.

Portsmouth’s Healthy Living Pharmacies Return to Fratton Park this Saturday

Portsmouth’s Healthy Living Pharmacies are returning to Fratton Park this Saturday.

Seven pharmacy Healthy Living Champions will be at Portsmouth FC’s match against Preston this Saturday, based on board the Pompey bus in the main car park. They will be offering fans a chance to check up on their health and ask any questions about healthy lifestyles or the NHS services on offer in their local pharmacy. The drop in event starts at 1pm and will continue until kick off.

The event follows on from a range of successful community outing for the city’s 15 Healthy Living Pharmacies. In the past month Health Living Champions have set up health stalls at venues including colleges, pubs and churches. The team were last at Fratton Park in February when they spoke to dozens of fans.

“People understand and remember the services they can get in a healthy living pharmacy best when they have conversation about it, even if it is only a few minutes.” said Health Living Champion, Sophie Furmedge from Rowland’s Pharmacy in Fratton Road.

“Pharmacies in Portsmouth are knowledgeable, friendly, able to support people with a whole range of lifestyle changes, and all have a private room. It may be very different from how people remember it. There are Healthy Living Pharmacies open everyday of the week and into the evening so people can come in when they find it most convenient,” Sophie added.

The first Healthy Living Pharmacies were launched by NHS Portsmouth in June last year the project has won national recognition from the health chiefs and the pharmacy industry. Services offered include NHS Stop Smoking support, weight management, emergency contraception, medicine use reviews and alcohol support.

Independent pharmacists gather in Tampa to rally against prescription drug bill

A piece of legislation aimed at combatting Florida’s prescription drug epidemic would burden small businesses and make it harder for independent pharmacies to thrive, according to a group of pharmacists who convened Sunday.

The crowd of more than 150 independent pharmacists turned out Sunday afternoon at the Embassy Suites Hotel near the University of South Florida for a discussion of the bill, which last week passed the House Judiciary Committee.

The bill, filed by Rep. Robert Schenck, R-Spring Hill, aims to allow pharmacies to dispense prescription drugs only if they are part of publicly traded companies, have more than $100 million in taxable assets or have been continuously permitted for 10 years. It also prohibits wholesalers from shipping more than a specified amount of certain drugs to any retail pharmacy.

Organizers of Sunday’s event mobilized quickly to spread word about the legislation, which they say favors big corporations over independent neighborhood pharmacies. Attendees included former Hillsborough County Commissioner Rose Ferlita, who has worked as a pharmacist for more than 40 years. Some came from as far away as Jacksonville to learn more about the bill.

“We feel this is job-killing legislation,” said Leke Alli, owner of Bearss Pharmacy in Tampa and one of the organizers of Sunday’s event. “They’re trying to taint independent pharmacies with pill mills. We believe that pharmacies should be well-regulated, but not to our detriment.”

Leaders of the event stressed the need for pharmacists to contact their legislators to voice opposition and make donations to a political action committee maintained by the Florida Pharmacy Association.

“Failure to get involved in health care policymaking empowers others to determine your future,” said Michael Jackson, executive vice president of the Florida Pharmacy Association. “Our profession and our industry is at risk here.”

Jackson pointed out that tools his organization has to combat regulations affecting independent pharmacists pale in comparison with those available to physician and insurance groups.

“We are working with a slingshot; they are using cruise missiles,” he said.

Some attendees asked when the bill would go for a vote before the House. So far a vote has not been scheduled.

Jackson called the bill “a solution looking for a problem,” saying the proper way to deal with pill mills is to enforce laws already on the books.

UAE Pharmaceutical Market Poised for Astounding Growth

The UAE pharmaceutical market is regarded as the most lucrative market in the Middle Eastern region, growing at a double digit rate for the past few years. Growth can be attributed to a number of factors, such as rapidly escalating population, liberal trade policies, and adaptation of international healthcare standards. These factors will enable the UAE pharmaceutical market to grow at a CAGR of around 17% during 2010 – 2013, says our new research report “UAE Healthcare Sector Forecast to 2012”.

Our extensive research on the UAE pharmaceutical industry has found that, there is a strong preference for branded drugs in the UAE as opposed to generic products. The authorities have responded to this by trying to increase the demand for cheaper generic products through a variety of measures, including tight restrictions on advertising of pharmaceutical products and a ban on direct marketing to the consumer. Further, demand in the OTC medicines market is growing faster than demand for prescription drugs. An increasing number of people are therefore, buying products through pharmacies and investors. Private companies are reacting to this demand trend by rolling out more pharmacy stores.

Our team of experts has segmented the healthcare industry into hospital services market, medical services market, and pharmaceutical market. All these sectors have been further segmented to provide exhaustive knowledge of the industry. Most importantly, regulatory environment prevailing in each of the sector has also been covered in the report.

Our report “UAE Healthcare Sector Forecast to 2012” provides thorough analysis of the various segments of the healthcare industry together with the detail study of the investment opportunities in the country. The report has thoroughly examined current market trends; industrial developments, and competitive landscape to enable clients understand the market structure and its progress in coming years. Due consideration has been given to the possible after effects of recession on the industry. It will help clients to have a proper insight of the current and future outlook of the healthcare industry in the UAE.

Press Release: BioPlus Names New Chief Strategic Officer

BioPlus Specialty Pharmacy (BioPlus), one of the nation’s leading specialty pharmacies, today announced that Russell Gay has been named Chief Strategic Officer. In this position, Gay will provide key leadership for all of the business development at BioPlus, including the strengthening and growth of relationships with the payors, physicians, the pharmaceutical industry, and various industry partners.

“Russell is tasked with developing and diversifying our business. He shares our values, understands the intricacies of the specialty infusion market, and appreciates our unique position of leading measurable outcomes,” says Dr. Stephen Vogt, president and CEO of BioPlus. “Russell’s business experience in the key areas of infusion, home care, and specialty have prepared him well to lead our business development,” he adds.

Gay comes to BioPlus from MedfusionRx, where in his position as vice president he played a significant role in building that company into one of the largest specialty pharmacies in the United States. During the course of his 25 years as a dynamic leader in the healthcare industry, he has testified before Congress and federal regulatory bodies regarding healthcare reform and pharmacy patient issues, as well as serving as the Executive Director of the Independent Specialty Pharmacy Coalition and as a Principal of 2020 ConsultRx LLC.

“I am excited to further the mission of BioPlus, that is, of creating a patient-centric, high-touch service for patients throughout the United States with the goal of improving quality of life in those with chronic diseases,” Gay shares. “Achieving this mission while keeping costs at a level that attracts payors will be a key part of my upcoming work here at BioPlus.”

About BioPlus Specialty Pharmacy

Altamonte Springs, Florida-based BioPlus is a pharmacist-owned national specialty infusion pharmacy company designed to provide high-touch services and specialty pharmaceuticals for patients with chronic diseases such as arthritis, hepatitis C, cancer, and others. BioPlus has served the needs of patients and prescribers of biologic medicines for over 20 years. Licensed in all 50 states, BioPlus is one of the nation’s largest independent specialty pharmacies.

Drugs’ Cost and Safety Fuel a Fight

After weeks of controversy, federal health officials announced last week that they would not stop pharmacies from making a cheaper alternative to a costly drug given to prevent premature birth. And separately, they investigated the deaths of nine Alabama hospital patients who received a nutritional supplement contaminated with bacteria.

The two events seemed unrelated, but both revolved around a century-old struggle between pharmacists and the government over who is best equipped to safeguard the nation’s drug supply. And both raise questions about what price the country is willing to pay for that protection. It is the drug industry equivalent of the battle between food trucks and restaurants.

The Alabama supplement was made by a so-called compounding pharmacy, a company that makes medicinal concoctions that are not otherwise available, like a liquid form of a drug sold only as a pill. But while the compounds are supposed to be made specially for individuals, some compounding pharmacies operate in a legal gray area, making large batches of medicines and selling them widely.

Even though many patients over the years have died after taking these medicines, the F.D.A. does not subject compounding pharmacies to the strict controls that are routine for drug manufacturers.

The battle over the pregnancy drug, 17P, goes back at least to 2003, when demand soared after a landmark study confirmed its effectiveness in preventing premature births. First approved by the Food and Drug Administration in 1956, it was manufactured by Bristol-Myers Squibb until 2000; now the only makers are compounding pharmacies, which charge $10 to $20 per injection — $200 to $400 for the drug’s 20-week course.

There is no evidence that present supplies of 17P are unsafe, but the F.D.A. is always eager for crucial injectable medicines to be made under consistent and verifiable controls. Applying for manufacturing approval can be expensive, and companies generally go through it only if they can be assured of a high price and exclusive rights.

Since it was decades old, 17P had no patent protection. But a law called the Orphan Drug Act does provide seven years of exclusive sales rights to manufacturers who win F.D.A. approval for drugs that affect fewer than 200,000 people.

On Feb. 3, the F.D.A. approved an application from KV Pharmaceutical, a specialty-drug manufacturer based in St. Louis, and gave the company its exclusive orphan license. KV named the drug Makena. The March of Dimes, which has long been dedicated to preventing premature births (and has received more than $1 million in donations from KV and its partners), cheered the announcement.

Then KV announced that the price for Makena would be $1,500 per injection, or $30,000 for an entire course. And the company sent letters to compounding pharmacies warning that they could run afoul of the F.D.A. if they continued to sell competing versions.

Last week, in the face of protests from outraged obstetricians, women’s advocates and lawmakers, the agency issued a statement asserting that KV’s letters were incorrect and that “at this time and under this unique situation, F.D.A. does not intend to take enforcement action.” On Friday, KV announced that it would slash its price for Makena, to $690 per dose. It defended the price by pointing out that the F.D.A. had insisted it conduct a long and expensive clinical trial.

But the controversy did not end. “This company took advantage of the system,” said Dr. Alan Fleischman, medical director for the March of Dimes.

Mary Dunkle, a spokeswoman for the National Organization for Rare Disorders, said the Makena controversy should not be “used to undermine the Orphan Drug Act, which we consider one of the most important pieces of legislation ever enacted.”

Dr. Janet Woodcock, director of the F.D.A.’s center for drug evaluation and research, said the incentives built into the legislation were crucial for its success. The F.D.A. is still eager for KV to complete its confirmatory clinical trial.

“There is a price that society has to pay for having a quality drugs,” she said. “But that price should be reasonable,” she said.

Guardian Pharmacy LLC Expands Services to Long-Term Care Facilities Solidifying Southeast Footprint

Guardian Pharmacy, LLC, one of the largest institutional pharmacy companies in the U.S., announced that Southern Pharmacy Services of North Carolina has joined the Guardian family. In addition to Southern Pharmacy locations in Pink Hill and Kernersville, Guardian’s expansion includes startup pharmacies in Atlanta, Georgia, and Crestview, Florida.

The combined Guardian entity will include more than 35,000 long-term care patients and 15 pharmacies across eight states. This strategic expansion will boost Guardian’s 2011 revenue well beyond $200 million, more than 30 percent over 2010.

These new locations enable Guardian and its partners to seamlessly serve the needs of specialty patients in assisted living and skilled nursing facilities, behavioral health group homes and other institutions throughout the Southeast.

Fred Burke, CEO and co-founder of Guardian Pharmacy, said: “We’re thrilled to partner with Southern Pharmacy Services’ owners, Chad and Marybeth Terry. The longstanding reputation of their pharmacies and emphasis on clients, employees and community mirrors our core business beliefs.”

Entrepreneurial Business Model is Secret to Success

Founded in 2004, Guardian has enjoyed substantial growth in part due to a unique business model that enables partners to enjoy a significant ownership stake and local autonomy over their pharmacies.

The goal is to build a sustainable business where the entrepreneurs/partners can expand their focus on superior customer service while taking advantage of financial and administrative support from Guardian to accelerate topline growth and improve profitability.

The company partners with industry entrepreneurs who want to start their own business or join Guardian with an established pharmacy.

Southern Pharmacy Partnership is a Win-Win

According to Marybeth Terry of Southern Pharmacy Services, “It was the Guardian business model that attracted us to this relationship. This partnership enables us to focus on what we do best – ensuring that our clients’ and patients’ specialized needs are met with care and consideration. In turn, Guardian provides us with a Corporate Support Center assisting with day-to-day business operations – from payroll to rebate management – and the intensely complex revenue cycle that is so time-consuming.”

Georgia and Florida Pharmacies Round Out Geographic Footprint

Two new startups, Guardian Pharmacy of Atlanta and Guardian Pharmacy of NW Florida, are examples of the company’s commitment to partnering with industry entrepreneurs looking to start their own business.

Robert Dunn, Guardian Pharmacy of NW Florida president, said: “Guardian provides the perfect opportunity to leverage my 12 years of experience in this field, enabling me to run a business without assuming all of the risk.”

Matt Hopp, president of the new Atlanta pharmacy agrees, “It takes an expert team to understand the complexities of the healthcare industry. I was looking for a partner who really understood the market and could reduce my execution risk when building my business.”

Both pharmacies are scheduled to be operational by May.

About Guardian

Guardian Pharmacy, LLC, headquartered in Atlanta, Ga., is one of the nation’s largest institutional pharmacy companies and ranks among Georgia’s fastest growing privately held companies. Guardian’s pharmacies focus on providing outstanding client service and patient care to long-term care facilities including assisted living, skilled nursing, behavioral health group homes and others. Founded in 2004, Guardian has experienced a 46 percent compounded annual growth rate which the company attributes to its unique Local-Autonomy business model. Pharmacy operators participate in local ownership and benefit from Guardian’s extensive experience in high-growth, specialty pharmacies.

The pharma outsourcing industry in India will grow significantly over the years

Manish Gupta, CEO, Indegene Lifesystems Pvt Ltd discusses the career opportunities that exist in the pharma outsourcing industry

1) How is the pharma outsourcing industry faring currently?
Globally, pharmaceutical companies outsource in two large areas—clinical development and marketing. The marketing outsourcing space is larger and is where specialised agencies operate. Till now, due to the high profitability of the pharmaceutical industry and the lack of unified sourcing strategy for marketing services, this space was very fragmented. However, with the current pressure on the pharmaceutical industry, this space is transforming rapidly. Companies want to drive efficiency and effectiveness in their marketing efforts in developed markets and are looking at expertise for their rapid scale-up from their outsourcing partners in emerging markets. This is an area that we believe holds tremendous opportunities for India and will grow significantly over the next few years.

2) Which are some of the emerging career opportunities within this industry?

The new wave in the area of pharma outsourcing is in the domain of “marketing and commercialisation” services. In fact, the rapid growth of this segment has been riding on the talent available in the country. Professionals in this domain are expected to bring in-depth industry experience and global market knowledge that support a range of services across each phase of the outsourcing lifecycle.

* Medical and pharmacy graduates and postgraduates can explore careers in medical writing, patient adherence programs, and clinical trial analytics. This allows them to explore careers beyond a single clinical specialty, provides them an opportunity to remain at the cutting-edge of medical knowledge, and contributes to healthcare globally.

* Nursing professionals can play a role in managing patients across therapy in patient adherence services and patient counseling and support services.

* Creative and Art graduates can play a role in developing communication and medical illustrations and can leverage their creative and visualization skills.

* Lifescience graduates with management qualification have opportunities in areas of client services, strategy, business development, project, and operation management.

3) What are the skills and qualifications required to excel in this industry?

Apart from professional qualifications in medical and life sciences, professionals are expected to have very strong written and verbal communication skills. They also need to have the ability to work in teams, handle pressures due to tight timelines, and demonstrate passion for continuous learning. Since global outsourcing has now straddled continents, knowledge of additional foreign language is an added advantage.

4) How do you foresee the growth of this industry in the near future?

The opportunities in this industry are tremendous, with the global pharma companies facing severe cost pressures and realising that the viable way to success is exploring innovative ways to meet their existing and emerging business challenges. Global aging, increasing life expectancy, changing disease epidemiology, health awareness, and rise in disposable income in emerging markets will change the way healthcare and pharma business are conducted. Globally, companies are expanding the range of services that they want to outsource. Moving ahead from outsourcing services like manufacturing, clinical trials, and R&D outsourcing, global pharma companies are now seriously considering and outsourcing marketing and commercialisation services.

Zatlers discusses cooperation between Latvian and U.S. companies in Chicago

Yesterday, President Valdis Zatlers, during the last day of his official visit to the United States, met with representatives of various U.S. companies to discuss the distribution of Latvian products on the U.S. market as well as U.S. companies’ investments in Latvia, LETA was informed by the president’s press service.

In the morning, Zatlers met with the management of pharmaceutical company “Abbott Laboratories” and invited its representatives to cooperate with Latvian pharmaceutical companies and visit Latvia to become familiar with the pharmaceutical industry in Latvia.

Zatlers also met with the management of the largest drugstore chain in the United States – Walgreens. Walgreens provides access to consumer goods, services and pharmacy in all U.S. states. Both sides discussed the possible sale of Latvian products at Walgreens stores.

Representatives of various Latvian companies – Advaita, Pure Chocolate, Bio2You, Lacu maize, Madara and Wuff it! also participated in the meeting. Zatlers noted that, during his visit to the United States, he has also become a Walgreens client and would like to be able to buy quality and interesting Latvian products in the company’s stores.

The president also met Suzlon Wind Energy CEO Andris Cukurs. The company produces wind generators and related products, and services them throughout the world.

Within the framework of the meeting, Zatlers informed the company’s management about the latest developments in Latvian energy sector, and invited the company to participate in the establishment of wind parks in the Baltic Sea. Representatives of Latvian Association of Wind Energy and “Baltic Wind Park” company also participated in the meeting, and informed the U.S. company about their vision of project.

New business contacts was the main subject of Zatlers’ meeting with Chicago Mayor Richard Daley and Illinois Governor Pat Quinn. Zatlers informed the high ranking officials about the advantages of business environment in Latvia and investment opportunities in Latvia. The U.S. side expressed interest about Latvian ports and energy market.

As reported, on March 27, Zatlers departed on a one-week working visit to the United States. Besides Detroit and Lansing, the president also visited Washington D.C. and Chicago (Illinois).

The aim of the visit primarily was to promote political dialogue between Latvia and the United States.