Leah E. Perry is a healthcare writer based in the Atlanta area.

Leah E. Perry

One of the best-known drugs going generic this year is the cholesterol-lowering drug Lipitor (atorvastatin), which brought in an estimated $5.3 billion in U.S. sales in 2010. The cost of Lipitor is expected to drop from an average cost of $228 per prescription to $46 per prescription in its generic form. It is slated to go generic in November.  

Zyprexa (olanzapine), Eli Lilly's top-selling drug, prescribed for the treatment of schizophrenia and bipolar disorder, is expected to drop from $747 per prescription to $149, once it goes generic in October. 

The following is a partial list of other notable blockbusters that either have already gone off patent or are in the pipeline and expected to do so by the end of 2014:  

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As a flurry of blockbuster drugs lose their 20-year patent protection, the market is splitting wide open as drugmakers offer competing generic versions.

Floodgates open

In an effort to improve technology and security in its pharmacy operations, Ashtabula County Medical Center in Ohio recently began using QuadraMed's Pharmacy Integrated Medication Management (IMM) system. 

The IMM system provides real-time wireless and point-of-care medication scanning. It also allows nurses to verify a patient's identity, validate medications against active orders, and document medication administration online. The technology is designed to reduce medication errors and improve overall patient care. 

A key selling point for Ashtabula was "definitely the integration piece," according to Wendy Nagy, RPh, a staff pharmacist and clinical coordinator at Ashtabula. IMM "has the nursing component along with the electronic medication administration record (MAR), physician order entry, and an electronic medical record," she said. The facility is hoping to implement all the components eventually, providing a single fully integrated solution.  Ashtabula went live with the pharmacy component in May, replacing a much older Cerner system. So far, the biggest advantage Nagy has experienced is reduced paper in the pharmacy. "There is definitely less paper involved and less duplicate stickers. We are able to record electronically who checks the identifications," she said. "Our goal is to eventually go to bar-code medicine and online MARs." 

Once fully implemented, the unified database will provide seamless medication management and close the loop from order entry to medication administration. Nursing and pharmacy staff will gain instant access to patient status records and clinical information, which will further assist in reducing medication administration errors and streamlining workflow. 

Ashtabula is the first pharmacy to implement the system since QuadraMed purchased it from Misys in 2007. Once the purchase was complete, QuadraMed immediately began working on product enhancements. At that time, October 2007, Ashtabula was already in the beginning stages of implementation. The implementation team then worked for another eight months to get the facility ready to meet its live deadline. 

"Because the system is a total pharmacy system, the pharmacists played a pivotal primary role in the whole process, because they are the gatekeepers for the medication dispensing process and for patient safety," Carol Boehmer, QuadraMed's manager of client services and Ashtabula's IMM project manager, said.  

"The entire implementation was accomplished by the director of pharmacy, the pharmacists, and pharmacy techs. Vendor and hospital had to work together to meet the Ohio State Board of Pharmacy IT requirements - some of the strictest in the nation. Many of the requirements were new and unfamiliar to the staff. Among the mandates was a requirement for a specific sign-on to identify the staff member entering the orders and performing the key strokes.  

To meet that criterion, QuadraMed collaborated with a third-party vendor (Maxim Integrated Products), which manufactures plastic keys, called iButtons, that enhance system security.   This security measure ensures that the person interacting with the application and entering the orders is the person to whom the unique log-on and password have been assigned. If the key is removed from the computer without proper log-on or log-off procedures, the application shuts down immediately.  

Although a fairly smooth implementation was accomplished, there were some challenges along the way, particularly working with a small IT department and a pharmacy staff that had to continue with daily operational responsibilities while performing a major IT system overhaul.  

An Ohio hospital automates its pharmacy with an integrated medication management database.

Medication management goes electronic at an Ohio hospital pharmacy

These predictions were made by Accredo Health Group VP of Health Outcomes Solutions Richard Faris, Ph.D., R.Ph., in August at the National Association of Chain Drug Stores Pharmacy and Technology conference in Boston. Accredo is a specialty pharmacy services provider based in Memphis. Faris' comments and similar market forecasts have been the catalyst for community pharmacies to start reaching beyond their comfortable borders to grab a share of the growing specialty pharmacy market. 

More and more, community pharmacies are facing either joining a specialty pharmacy network or being shut out of access to many drugs considered specialty meds with restricted distribution. Bruce Roberts, R.Ph., executive VP and CEO of the National Community Pharmacists Association in Alexandria, Va., for one, is not pleased about the present state of specialty pharmacy as it relates to community pharmacists.  

Specialty players started out of the independent marketplace, Roberts continued. "Independents saw this as an opportunity to address the needs of specialty drugs, which are centered around clinical issues, billing issues, and the ability to gather outcomes information with regard to the use of these drugs. The independents did a great job managing these drugs and building these companies, but were eventually bought out by regional companies and then inevitably by the PBMs. 

Dennis Burton, VP of specialty pharmacy services at SpecialtyScripts Pharmacy, Fall River, Mass., also believes PBMs are funneling much of the specialty pharmacy business to their own operations. He lists six dominant PBM-controlled specialty pharmacies: Aetna, Cigna, Anthem's PrecisionRx, Medco, Express Scripts, and Caremark. 

Some believe it's not too late for community pharmacies to get into this field, which is growing by leaps and bounds.

Specialty Pharmacy: Don't miss the boat

Currently in development for retail pharmacies is the Community Specialty Pharmacy Network (CSPN), based in Philadelphia. The proposed 100-store network is designed to serve as a resource and support system to assist community pharmacies in expanding and building on their specialty pharmacy business. 

But for many of Gellis' colleagues across the country, the process of providing specialty pharmacy services is something new-and very different from the specialty pharmacy environment of a few years ago. The root of this surge of interest in specialty pharmacy by community pharmacists is threefold: a trend by payers looking to diversify, the opportunity to provide specialty services to small pharmacy benefit managers that don't have mail order or specialty pharmacy, and big changes in reimbursement.  

However, what has been a springboard to action for some community pharmacies has been an obstacle for others. The reimbursement environment has proven to be a bit dicey for independent pharmacists looking to segue into specialty pharmacy, said sources who spoke to 

"The biggest obstacle [independent pharmacists] have is on the reimbursement side," said Dean Erhardt, a partner in and general manager of biotechnology services for the pharmaceutical consulting firm VCG & Associates, St. Louis. "What has been going on in the specialty pharmacy and PBM world in the past few years is that the contracting at the payer level goes to PBM mail order or specialty pharmacy mail order and away from retail pharmacy," he explained. He and other VCG consultants worked with NACDS in developing the specialty pharmacy white paper. "So, the first thing the retailer has to do is get back in the game by having a relationship with both the payer community and the manufacturing community." 

According to Erhardt, manufacturers can help independents identify the services they should make available for therapies at the payer level. "What we hear when we talk to payers is not that they are opposed to retail, but that when they're talking about how to set up a distribution program, retail is not even at the table," he noted. 

Community pharmacies have been bypassed because specialty pharmacies have gone to the payers and allowed them to access these very specialized medications at a better price, Erhardt continued. 

Independent pharmacist John Musil, Pharm.D., of Phoenix, agreed with Erhardt's view of the current landscape but added that it is often difficult for independents to break into existing networks and acquire a share of the specialty pharmaceutical business. "A lot of independent pharmacies have trouble developing good manufacturer relations," he said. "It's been an issue for pharmacists to communicate well because they see manufacturers as evil, when, in fact, they can be their best friend."  

An increasing number of community pharmacies are venturing into the specialty pharmacy arena. Despite what some industry experts describe as a fragmented marketplace, community pharmacy leaders say they are poised to take on and develop this segment of the industry and keep specialty drugs in their settings.

Is specialty pharmacy a field for you?

Recent years have seen dramatic growth in the specialty pharmacy market, a segment of the industry addressing the needs of patients with chronic illnesses such as cancer and HIV. Sales of specialty medications-though expensive, often injectable, and typically requiring more patient education-have trended upward at more than 25% annually for the past five years. Industry experts forecast annual increases of more than 30% through the rest of this decade, according to Armada Health Care, a specialty pharmacy group purchasing organization in Short Hills, N.J. 

Are manufacturers ready to acknowledge this growing trend and all of its accompanying changes? And, like the chains, clinics, and mail-order pharmacies before them, are they ready to view specialty pharmacies as a new class of trade and grant them discounts as a result?  

Specialty pharmacy can be arduous territory for manufacturers. Research and development of specialty medications are costly for manufacturers, and the end-products serve only a small portion of the patient population. Specialty medications are estimated to cost $10,000 to $250,000 per patient per year. Because this specialty niche is meeting increasing market demands, drug manufacturers are very much embracing specialty pharmacy, claims Larry Irene, R.Ph., CEO of Armada. 

Specialty pharmacies are poised for explosive growth. "Most of the leading drug manufacturers today are beginning to employ specialty pharmacy representatives or create such departments within their infrastructures," said Irene. "Clearly, specialty pharmacy is gaining exposure."  

One reason for the increased exposure may be that specialty pharmacies are managing the high costs of these meds with techniques such as pharmacy network management strategies. Coupled with mounting pressure on health insurers to keep costs down, specialty pharmacies are gaining wider acceptance among manufacturers, patients, and providers. 

What must continue to occur in this market is more structure and organization, which, Irene claims, his company is helping to bring about. "Bringing structure to the current disorganization within this industry is how manufacturers will develop strategies for a specific trade class," he explained. "Naturally, manufacturers will follow a strategic plan laid out for them. Traditionally, consider hospitals, home health care, long-term care, and all the other trade classes associated with managed care; the contracting has always followed."  

Bonelli is already seeing a willingness on the part of manufacturers to grant discounted contracts in recognition of specialty pharmacy's unique services-not merely market share gains but also enhanced patient compliance and persistence, patient education, and physician interaction. "Large, established pharma companies, as well as emerging biotech firms, have already executed contractual agreements [with specialty pharmacies]," contributing to enhanced efficacy, improved clinical outcomes and economic efficiencies, and reduced adverse reactions. 

One strategy Armada is pursuing is education. Manufacturers need "a clear understanding of what they are getting into," said Irene. Without that, he added, the contracting process could become frustrating and create some pushback. Once the market is clearly defined and manufacturers determine they are going to be in that market, strategies will evolve and incentives will follow. 

Last month in Atlanta, Armada sponsored its second annual Specialty Pharmacy Summit, bringing together more than 100 of the nation's specialty pharmacies, manufacturers, and wholesalers. Through such educational venues, Irene hopes to build a strong networking community within the specialty pharmacy segment. "By forging stronger lines of communication and establishing defined guidelines, these stakeholders will help steer the future of specialty pharmacy as it continues to evolve." 

THE AUTHOR is a writer based in Atlanta. 

Recent years have seen dramatic growth in the specialty pharmacy market, a segment of the industry addressing the needs of patients with chronic illnesses such as cancer and HIV. Sales of specialty medications-though expensive, often injectable, and typically requiring more patient education-have trended upward at more than 25% annually for the past five years. Industry experts forecast annual increases of more than 30% through the rest of this decade, according to Armada Health Care, a specialty pharmacy group purchasing organization in Short Hills, N.J.

Specialty pharmacy: A new class of trade?

Because only some states now require hospitals to report their healthcare-associated infection (HAI) rates, while others don't, the Centers for Disease Control & Prevention is considering helping states develop policies to obtain this information. Lending support to this initiative is consumer demand for the public disclosure of HAI data. 			

At present, sparse data are available on how hospitals are performing relative to controlling their HAIs, despite the fact that mortality resulting from nosocomial infections is the most frequently used quality indicator for infectious diseases. This is according to a draft document on reporting HAIs crafted by the Healthcare Infection Control Practices Advisory Committee (HICPAC), the infection control advisory panel to CDC. 

HICPAC has issued a draft guideline designed to help health systems develop and implement reporting systems. It also describes how such systems could reduce or prevent HAIs and what effect, if any, they would have on improving healthcare performance using clinical process measures or outcome measures.  

The committee met in October in Atlanta to discuss further steps to refine the proposed guideline. "This document provides an opportunity for the epidemiologists HICPAC represents to work with legislators and create an informed approach to the problem so that whatever is done is meaningful," said Jane Siegel, M.D., professor of pediatrics at Southwestern Medical Center in Dallas, chair of the infection control committee at Children's Medical Center and the former co-chair of HICPAC.  

Arguing that all states should make their HAI data available to the public is Consumers Union, publisher of 

. "There is a danger here, but we feel something can be done about HAIs," Lisa McGiffert, campaign director of 

									http://stophospitalinfections.org/

, a national initiative to stop hospital infections and an arm of Consumers Union, told HICPAC committee members. "We've talked to hospitals and they believe it, too. So you should go into this with that in mind-that you can have an impact on moving this forward." 

Currently four states-Florida, Illinois, Missouri, and Pennsylvania-have enacted or are considering legislation to publicly disclose HAI rates. Legislative efforts are under way in other states to create public reporting systems for HAIs. 

Already the reporting system in Pennsylvania has come under scrutiny in that state, which just began requiring hospitals to report four types of HAIs-the top four recommended by CDC-in January to the Pennsylvania Health Care Cost Containment Council (PHC4). Controversy erupted after the release of just the first-quarter data. The HAI information, which became available in September, revealed 2,300 HAIs, according to the 

. But Pennsylvania hospitals billed insurers for almost 57,000 infections, spawning charges of noncompliance and gross underreporting.  

However, in a letter to the editor, Carolyn Scanlan, president and CEO of the Hospital & Healthsystem Association of Pennsylvania, blasted the article, stating that "to say that the number of infections reported for a single quarter is an underreport is totally misleading. The system is still in its infancy, and we should resist the urge to characterize or criticize preliminary data or the motives of those collecting and submitting the data." 

Because only some states now require hospitals to report their healthcare-associated infection (HAI) rates, while others don't, the Centers for Disease Control & Prevention is considering helping states develop policies to obtain this information. Lending support to this initiative is consumer demand for the public disclosure of HAI data.