Kathryn Foxhall is a healthcare journalist based in the Washington, D.C., area.

Kathryn Foxhall

With the move toward coordinated care systems, a "brave new future" will be shifting pharmacists' roles from dispensing to direct clinical practice, says Terry McInnis, MD, MPH, co-leader of the Medication Management Taskforce for the Patient-Centered Primary Care Collaborative. PCPCC is a nonpartisan advocacy group that promotes the Joint Principles of the Patient-Centered Medical Home, a Washington, D.C.-based initiative sponsored by the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association.  

Medication therapy management (MTM) will be key in new systems such as accountable care organizations and patient-centered medical homes, where the goals are to pay attention to the patient, coordinate care, and ensure that the system is helping to control their diseases, she said. 

According to McInnis, with payment reform, quality rather than volume will be emphasized. Lower hospitalization rates will be encouraged; unneeded procedures and duplicative diagnostics will not. 

McInnis, who is president of Blue Thorn, Inc., a healthcare consulting services company, spoke during a recent webinar sponsored by URAC, a nonprofit organization that promotes healthcare quality through accreditation, education, and measurement programs. 

She warned that if pharmacists are only reviewing the drug list and are not aware of patients' clinical conditions, it will be impossible to determine any untreated indications or subtherapeutic dosages, saying, "Some of these other issues are large in terms of drug-related problems in an ambulatory setting."			

Sixty-five percent of pharmacists are currently in dispensing roles, she said, but developments such as robotics and the expanding role of pharmacy technicians could free up a "whole new workforce of community pharmacists" to work in direct patient care. At the same time, McInnis noted, dispensing fees are decreasing. 

The steps to MTM include finding the actual patterns of use, ascertaining where patients are clinically and where they need to be, and then assessing each medication, in that order.  

This requires direct interaction with each patient, she pointed out. Whether a physician or a pharmacist interacts with the patient, an individualized care plan must be developed to achieve treatment goals, she said. "Think about clinical goals of therapy first and then think about the medications needed." 

The model also ensures that the patient "understands, agrees with, and actively participates in the treatment regimens," she said. 

MTM requires follow-up with patients, during which, said McInnis, the practitioner makes sure that changes actually were made. "Just as a physician will require follow-up, the pharmacist has to see the patient again." 

Journal of the American Pharmacists Association

 in 2008, in which Blue Cross/Blue Shield health plan members with hypertension or hyperlipidemia were able to achieve significant clinical improvement and economic outcomes in 2001–2002 with the implementation of MTM. Healthcare Effectiveness Data and Information Set (HEDIS) measures improved in the intervention groups for hypertension (71% vs. 59%) and hyperlipidemia (52% vs. 30%)compared with the control groups. 

Total healthcare costs in 186 patients who received MTM from pharmacists were only $8,197 per member per year compared with $11,965 in the control group. She warned, however, that drug costs may actually increase with MTM. 

McInnis told pharmacists, "You are the medication experts, and I think you are so desperately needed to get this right ... Really, the future is now."			

Asked what it will take for the Centers for Medicare and Medicaid Services to pay pharmacists for this work, McInnis replied, "Pharmacists, as a profession, are going to have to really define what they're doing, what outcomes can be expected, and then, what are the appropriate pay levels for what you're doing. And then, I think, they're going to get the attention of payers and other providers." 

To a great extent, she said, physicians will be paid to help patients reach their clinical goals and reduce expenses, such as hospitalizations and ER visits. If pharmacists can help patients reach such goals, she asserted, "there are not many physicians who won't buy into that." 

"The Patient-Centered Medical Home: Integrating Comprehensive Medication Management to Optimize Patient Outcomes" is a useful resource guide available on the PCPCC website at 

http://www.pcpcc.net/files/medmanagement.pdf

 is a healthcare journalist based in the Washington, D.C. area.

Articles

If the Washington, D.C.-based Patient-Centered Primary Care Collaborative has anything to say about it, MTM will help shift pharmacists' roles from dispensing to direct clinical practice.

MTM opens door to direct patient care

As of midsummer, it was not looking as if the ongoing problem of drug shortages would get much better anytime soon. 

In the spring, the Food and Drug Administration (FDA) had touted the fact that new shortages were cropping up at only half of last year's rate. 

But by late June, new shortages for 2012 were over 80, about the level as the year before. According to FDA figures, ongoing shortages were over 100.  

Threatened shortages actually have been happening faster in the last few months, she added. 

According to FDA, it has stopped more than 150 shortages since last fall. 

Meanwhile, in Congress, the House Committee on Oversight and Government Reform, with its Republican leadership, issued a report in June blasting FDA for being too strenuous in its regulation of manufacturers, particularly since Commissioner Margaret Hamburg has taken office. FDA responded that the agency and the companies themselves are finding glass shards, metal, fiber, bacteria, and fungus in vials.  

The Utah center's Fox commented that just counting the MedWatch reports of adverse events directly related to product quality gives an indication of what the country is facing. "That's why it's taking a long time to fix. It's because we have some pretty severe quality issues," she said. 

In terms of trends taking place over past years, shortages have increased since 2006, expanding 3.8 times since then, according to the Utah center. They increased by about 27% in 2010 and again in 2011, the center's figures indicate. 

A number of people are trying to figure out why issues with manufacturing are increasing now.  

FDA said through a spokesperson recently that it is "a complex problem that is largely the result of inelasticity of manufacturing capability, market forces causing reduced prices, and firms' inadequate investment in manufacturing quality."			

A report issued last fall by the Assistant Secretary of Planning and Evaluation of the Department of Health and Human Services (HHS) said that shortages appear to be greatly due to an expansion in scope and volume of medications produced, because expanded capacity will take several years to build. 

The expansion of products, contended the HHS report, is due to a rise in the overall volume of chemotherapy drugs used and to an unusually large number of drugs coming off patent and thus being available for the generics industry to produce.  

The House committee report pointed out that the Medicare Modernization Act (MMA) has dramatically lowered the prices that Medicare pays for some generic injectables, motivating manufacturers to change the medications they produce. 

In addition, the report noted, group purchasing organizations (GPO) have emerged to help hospital and clinic networks buy drugs at lower prices. That results, it said, in markets that have only a few manufacturers making each product. 

Largely because of reimbursement under MMA and the GPO contracting, the committee report said, "Individual generic injectable drugs are being produced by at most three companies."			

Lower reimbursement and the switching of product lines may also result in some of the quality issues FDA said it is seeing in plants, several observers said. 

What has staved off even higher levels of ongoing shortages is that drugmakers are reporting potential shortages much more often and FDA is using various tactics to prevent them from becoming reality.

Generic drug shortages show no signs of abating

Republicans in the House of Representatives have published a report blaming the current increase in drug shortages mostly on FDA under the current administrator. 

The House Committee on Oversight and Government Reform, chaired by Rep. Darrell Issa (R-CA), states in the 

, FDA’s Contribution to the Drug Shortage Crisis, released Friday, “The drug shortage crisis that took off in 2010 began shortly after Margaret Hamburg became FDA commissioner. Since this time, the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs.” 

The report argues that warning letters from the agency have essentially caused manufacturers to shut down a number of manufacturing lines. “While many of the facilities were older and the upgrade to certain facilities was desirable, the simultaneous, large-scale shutdown of manufacturing lines at most major domestic producers of generic injectable drugs has plunged America into a public health crisis,” the report states. 

Although over-aggressive FDA enforcement is the primary issue, the committee report says, other factors in the shortages include group-purchasing organizations contributing to “both inflexible prices in the market for generic injectable drugs and growing market concentration.” Further, it contends the Medicare Modernization’s Act changes in pricing have cut the reimbursement for older, generic medications administered in non-hospital settings. 

An e-mail response provided by FDA spokesperson Karen Riley says the increase in drug shortages, “is a complex problem that is largely the result of inelasticity of manufacturing capability, market forces causing reduced prices, and firms’ inadequate investment in manufacturing quality.” 

The FDA statement argues that although the agency did send warning letters, all the companies that stopped producing drugs did so voluntarily after determining that continued production would endanger patients. 

Asserting that the agency considers the risks of a shortage versus the risk of poor quality or unsafe product in any enforcement action, the FDA statement says, “Manufacturing problems that prompted potential shortage situations have included particulate matter (glass shards, metal, fiber, other materials) in the vials, which can cause severe consequences if injected intravenously; and bacterial or endotoxin contamination, which can cause infection or a shock like syndrome, and other serious defects.” 

In response to the committee’s accusation about a sudden increase in warning letters, the FDA statement says that of the 1,720 warning letters the committee cited for fiscal year 2011, 1,040 were tobacco warning letters, resulting from its new authority from Congress over tobacco at the retail level. 

Republicans in the House of Representatives have published a report blaming the current increase in drug shortages mostly on FDA under the current administrator.

Report blames FDA for drug shortage crisis; FDA defends its enforcement actions

The National Institute for Occupational Safety and Health (NIOSH) may recommend that healthcare workers, including pharmacists and pharmacist technicians, be transferred away from positions where they handle hazardous drugs if the workers are trying to conceive, are pregnant, and/or breastfeeding. 

NIOSH recently called for comments and information for a Current Intelligence Bulletin it intends to publish on "alternative duty" and other forms of administrative controls for such situations. 

The category of "trying to conceive" would include males. 

However, the agency cites evidence that some hazardous drugs have caused adverse reproductive outcomes in healthcare workers: "For example, nurses and pharmacists exposed to hazardous drugs at their worksite reported an increase in adverse reproductive events including spontaneous abortions, stillbirths, and congenital malformations when compared with unexposed healthcare workers." 

				Noting that many drugs classified as hazardous are used to treat such illnesses as cancer or HIV, NIOSH also said in 2004, "The numbers and types of work environments containing antineoplastic drugs are expanding as these agents are used increasingly for nonmalignant rheumatologic and immunologic diseases." 			

The current announcement is calling for information on the trends in production and use of hazardous drugs in the past 10 years, the procedures that present potential exposure, the industries or occupations in which exposures occur, guidelines and recommendations on alternative duty or temporary assignment policies. and other information. 

According to Thomas Connor, PhD, a lead NIOSH official on the effort, the call for information is one of several actions flowing from the 2004 NIOSH Alert warning about healthcare worker exposure to drugs that might cause skin rashes, infertility, miscarriage, birth defects, and possibly leukemia and other cancers. That alert, hammered out over four years with input from numerous stakeholder groups, recommended a list of steps to limit exposure, including the use of personal protective equipment and the use of ventilated cabinets for drug preparation. It also included a list of drugs it said should be handled as hazardous and urged that each organization create its own list of drugs considered hazardous.  

Connor noted that over the last two decades healthcare workers have begun using protective equipment. On the other hand, a recent study he conducted in three hospitals found results similar to those from a study he made a decade ago: The majority of the wipe samples contained at least one drug.  

				If the environment is contaminated, said Connor, "We assume that workers are also getting exposure."			

After public comments are gathered, NIOSH is likely to draft a document that will also go out for public comment, said Connor. He estimated that it may take two years to finish a final bulletin. 

Connor said that an actual regulation flowing from these guidelines is not currently being considered. He said he knows only anecdotally of lawsuits related to the issue. 

In addition to the call for information on reproductive health, NIOSH is in the process of modifying the 2004 list of drugs it cites as hazardous, for reproductive and other reasons, in the healthcare workplace. Connor says that from this point forward that revision is expected to be done every two years or sooner. 

The call for information on reproductive effects was published in the Federal Register on September 16 and comments were due to the agency 60 days after that date. 

Kathryn Foxhall is a healthcare journalist in the Washington, D.C., area.

The National Institute for Occupational Safety and Health (NIOSH) may recommend that healthcare workers, including pharmacists and pharmacy technicians, be transferred from positions where they handle hazardous drugs if the workers are trying to conceive, are pregnant, and/or breastfeeding.

NIOSH on reproductive effects of hazardous drugs

With stakes so high, Congress is working to create a more direct pathway for the Food and Drug Administration (FDA) to approve "biosimilars," the generic or "follow-on" versions of biologics. Two very different proposals are now before the legislature. 

Making follow-on versions of biologics will be far more difficult than making generic versions of traditional drugs. CRS noted, "typical pharmaceutical products consist of small molecules, on the order of dozens of atoms, that may be readily characterized and reproduced through well-understood chemical processes. In contrast, biologics are often made up of millions of atoms, feature a more complex structure than traditional pharmaceuticals, and are manufactured from living cells through biological processes." 

Advocates say it's hard to know whether Congress can reach a deal this year. On the one hand, there are still big differences between the bill supported by the biologics industry and the one supported by the generics industry and some patient advocates. In addition, Congress has other big issues on its plate, including energy overhaul and healthcare reform. 

On the other hand, according to lobbyists on both sides, members of Congress are talking about grafting a biosimilars bill onto the healthcare reform bill, which Democrats and the President vow to move this year. In addition, the Obama administration supports the biosimilars legislation and has put it into its budget projections; the economy is providing more pressure to save money with biosimilars; and Rep. Henry Waxman (D-Calif.), a major advocate for the more generics-friendly proposals, has moved into the powerful position of chair of the House Energy and Commerce Committee, a key committee for healthcare. 

Katie Huffard, executive director of the Coalition for a Competitive Pharmaceutical Market (CCPM), said there are signs the issue will heat up soon in Congress, and legislators have been asked to set aside major chunks of time for it. In addition, she said, the last Congress has already educated many key players on the issues. Beyond that, Huffard and others say, pressure is building, because the European Union is moving ahead with a biosimilars pathway passed several years ago and several biosimilars are already approved. 

 In June, Waxman released a letter asking the Obama administration to consider how it can prepare now for the legislation's passage, saying, "The speed of FDA's action will determine how quickly safe and effective generic biologics become available to patients." 

This year in Congress, the biologics industry supports HR 1548, sponsored by Rep. Anna Eshoo (D-Calif.), which would make it more difficult to market biosimilars than would alternative legislation. Among other things, it would give innovative biologic products 12 years of data "exclusivity," the time in which a company may not rely on preclinical, clinical, or other data submitted by another company seeking FDA approval. 

The generics industry and some patient advocate groups support HR 1427, sponsored by Waxman, which would allow exclusivity of five years with three years for certain modifications of products. On the Senate side, Sen. Charles Schumer (D-N.Y.) has introduced S 726, legislation identical to Waxman's. 

It's also expected that Sen. Edward Kennedy (D-Mass.), chair of the Senate Health, Education, Labor and Pensions Committee, will introduce a biosimilars bill. He sponsored the bill that would have provided 12 years of exclusivity; it passed his committee unanimously in 2007. 

The current bills also differ on when a biosimilar would be considered "interchangeable," that is, eligible under state law to be substituted by a pharmacist or an insurer for the original product prescribed by a physician.  

In coming years, nearly half of all newly approved drugs could come from biotechnology. With stakes so high, Congress is working to create a more direct pathway for the FDA to approve "biosimilars", the generic or "follow-on" versions of biologics. Two bills before Congress approach the issues differently.

Biologics bills duke it out in Congress

Research is providing hints about the possible relationship between 

 and various medications, according to studies recently presented in Washington, D.C., at the annual joint meeting of the American Society for Microbiology and the Infectious Disease Society of America.  

 is one of the few conditions presently causing an increased number of deaths over time; it may contribute to as many as 20,000 deaths per year, according to the Centers for Disease Control and Prevention (CDC). 

University of Iowa researchers reported that seasonal peaks in 

 occur mostly in March, following influenza peaks in December, January, and February. They note, "We believe that this relationship exists because of the increased antibiotic use during influenza seasons." 

Christine Hansen and co-authors said that incidence of 

 fell dramatically with the institution of an antimicrobial stewardship effort. In 2004 and 2005, the Shands facility at the University of Florida put use restrictions on a number of antibiotics. During their four-year study, the consumption of ceftriaxone, ticarcillin/clavulanate, ciprofloxacin, gatifloxacin/levofloxacin, and clindamycin significantly decreased. The 

 rate fell from 1.4 to 0.8 cases per 1,000 patient days. The decrease was associated with reduction in the consumption of ticarcillin/clavulanate, gatifloxacin/levofloxacin, and clindamycin. 

According to another paper presented at the Washington meeting, narcotic use may be increasing the severity of some 

 cases. Researchers looked at the records of 21,240 patients at St. Luke's Episcopal Hospital in Houston, of whom 123 developed 

They found that 49.3 percent of patients who did not get 

 had been treated with narcotics and about 51.2 percent of those who did get the disease had not received narcotics. The gaps were much wider between patients with severe 

The researchers, led by A. L. Mora, found that of 

 patients who had not been given narcotics, 40.4 percent had severe cases; of those who had received narcotics, 61.5 percent had severe cases. In addition, the researchers said, 20 percent of 

 patients who had received narcotics had refractory cases, defined as persistent diarrhea after seven days of treatment. Among the 

 patients who did not receive narcotics, only 10 percent of the cases were refractory. Researchers also found that use of narcotics appeared to increase the duration of time between admission and the diagnosis of 

Another clue was offered by researchers associated with the Veterans Administration Connecticut Health Care System. They cautioned that some patients suspected of having 

 may actually have norovirus, even if there is no outbreak of that disease. Tests of stool samples of 73 patients suspected of having 

 showed that 9 had that disease, but 13 had norovirus and 51 had neither. The researchers noted that despite the advent of molecular assays for norovirus, testing for it is still relatively uncommon.  

Also at the meeting, research from the Canadian Nosocomial Surveillance System Program, which can offer some studies not available in the United States, confirmed that severe 

 cases are more likely to be associated with the emerging NAP1/027/BI strain (known as NAP1) and are more likely to occur in the elderly. Of 1,008 

 patients studied, 31 percent were infected with the NAP1 strain. Clifford McDonald, MD, a 

 expert from the CDC, indicated that the epidemic is still increasing, as far as can be determined from hospital discharge data through 2006. There are no regular reporting requirements for 

is a healthcare journalist in the Washington, D.C., area.