Monthly Archives: March 2011

Pharmacists offer extra options to compete with mail-order drug firms

The average adult fills about a dozen prescriptions and refills every year; after age 65, they fill more than 30 prescriptions annually. For many people, their local pharmacist may be as familiar as their doctor – and often a lot easier to get time with. Some pharmacists are building on that position, expanding their role from drug dispenser to drug educator and chronic disease coach. By doing so, they may fill a void created by the shortage of primary-care physicians while boosting their business.

Janis McGannon has heart disease, Type 2 diabetes, high blood pressure and high cholesterol. A few months ago she accepted an offer from a nurse at the Bay Street Pharmacy near her home in Sebastian, Fla., to join a new “healthy heart” program at the pharmacy.

At a meeting of the program’s participants, Theresa Tolle, a pharmacist and the owner of Bay Street, gave a talk to about a dozen customers about cholesterol: what it is, how it works and how it can be managed. After everyone was weighed and measured, they received a goody bag that included a pedometer to encourage them to walk 10,000 steps a day.

The next month, the topic was blood pressure. In addition to having their pressures checked and discussing the medications they were taking, participants learned about using light weights and stretchy bands for exercise.

In between monthly meetings, McGannon, 74, logs onto a Web site to record what she’s eating and how much she’s walking. Tolle and the nurse e-mail her regularly to check on her diet or offer tips to keep her on track. Medicare doesn’t cover the $20 monthly fee for the program, but McGannon thinks it’s worth it. “Most of us need to be reminded to do these things, and I’m reminded every day,” she says. “It’s right there on the computer.”

Pharmacists are perfectly positioned to help address the drug “adherence” problem: Research shows that only about half of people take their medications as prescribed. They may fill a prescription but not take the drugs as instructed, for example, or they may discontinue a course of treatment before it’s completed; often, people such as McGannon – who take multiple pills for multiple chronic conditions – simply forget.

Bay Street is one of 50 independent pharmacies offering the heart program nationwide. It and a diabetes management program launched two years ago – available at more than 400 independent pharmacies – were developed by Augusta, Ga., pharmacist David Pope, who is working in partnership with drug wholesaler Cardinal Health. “We’re providing a communication tool to allow pharmacists to step into a coaching role,” says Pope.

In recent years, both independent and chain pharmacies have come under pressure from mail-order pharmacy services, in part because some insurers require that their members get their drugs through the mail. Drug chains and mass-market retailers such as Walmart have fought back with some success, offering $4 generic prescriptions, for example, and 90-day supplies. As for independent pharmacists, “it makes so much sense . . . to offer services beyond just filling prescriptions,” says Steve Lawrence, a senior vice president with Cardinal.

In the past year, Walgreens has rolled out a diabetes education program that provides customers in 10 cities with one-on-one sessions about the drugs they’re taking, how to use a blood glucose meter and other issues. The program is provided through insurers or employers; more than 1,000 people have participated so far, says Colin Watts, chief innovation officer for Walgreens.

In January, CVS Caremark kicked off a program that identifies insured diabetes patients who aren’t getting the drugs they need. The company contacts these patients and invites them to talk with a pharmacist by phone or in person at the store. The company plans similar programs for heart disease, high blood pressure and high cholesterol.

Primary-care physicians are generally supportive of such efforts as long as the pharmacists coordinate care with doctors. “Answering questions about prescription drugs is important,” says Roland Goertz, president of the American Academy of Family Physicians. “But with the time pressures physicians are under, they can only accomplish so much.”

For many patients, pharmacists are the easiest to access and the most trusted medical professional they know. In a Gallup survey released in December, pharmacists ranked third among professions for honesty and ethics. That put them behind nurses (No. 1) but ahead of doctors (No. 5).

When pharmacists reach out to patients, patients may find themselves turning to them for advice and information more frequently. That’s what’s happened in Janis McGannon’s case. Now that she knows Thesesa Tolle and the nurse at Bay State, she calls them or stops by when she has a question about her medication.

“Theresa’s very willing to sit down with you and talk about how to take [a drug] and how it will affect you,” says McGannon. That’s not always the case with doctors, she says: “Sometimes they just gloss over things. They just say, ‘You’ll be fine. Call my office if you have problems.’ ”

Pharmacists want power to change prescriptions

The Ordre des pharmacies du Québec has called on the provincial government to introduce new legislation that would widen the mandate of Quebec’s 7,700 pharmacists.

The Order has requested that Quebec pharmacists be able to make changes to prescriptions without having to send a patient back to the doctor and to diagnose simple health problems and order laboratory tests, among other things.

“Seven days a week, pharmacists in Quebec are forced to send their patients back to the walk-in clinic or emergency room just to get their prescriptions renewed or dosage adjusted,” Diane Lamarre, the Order’s president, said Monday.

With the average wait in emergency rooms running at 17 hours, Lamarre said expanding the role of pharmacists could improve patient care and relieve pressure on the health-care system.

“People ask pharmacists for help and the pharmacists want and can do more, but current legislation prevents them from doing so,” said Lamarre.

Other Canadian provinces already allow pharmacists to prescribe certain drugs, administer vaccines and refill prescriptions.

Parti Québécois health critic Agnes Maltais supported the proposal.

“If pharmacists could do more, we’d help ease the overcrowding of ER wards and above all, we’d help make life easier for thousands of families,” she said.

The proposed series of legislative amendments are now before Quebec’s health department. The Order has asked they be made into law by the end of 2011.

Yves Robert said Monday that the Quebec’s College des médecins has no problem with pharmacists renewing prescriptions for stable patients. It is even open to the idea of extending the existing prescription renewal period from 12 months to 24 months.

But giving pharmacists the goahead to order laboratory tests and resolve health problems, even though minor, is another matter, said Robert, the College’s secretary.

“How medical assessments can be conducted in the neighbourhood pharmacy requires further discussion,” Robert said. “That’s entering into the zone of diagnosis.”

A January 2010 survey by CROP commissioned by the Order found that 92 per cent of respondents believed pharmacists should be able to renew or temporarily extend prescriptions and 91 per cent said they trusted pharmacists to help them deal with simple problems.

A Primer On The Biotech Sector

Biotechnology is one the strangest, scariest, sexiest and most interesting corners of the stock market. In how many other industries are companies striving to literally save lives? Any industry can host a stock that could potentially double, but what other industry can match biotechnology in the sheer number of stocks that could double if their companies’ plans all come to fruition?

On the other hand, in how many other industries do companies burn through hundreds of millions of dollars, often with nothing to show for it? How many other industries rely on scientific arcana that can be challenging to even highly qualified Ph.D.s? And how many other industries sport a warning label that reads “Caution: Poor stock selection may cost you 90% of your initial investment”?

For all those reasons and more, biotechnology is a fascinating industry for investors to explore.

What Is Biotechnology?
In a nutshell, biotechnology is an industry that focuses on novel drug development and clinical research aimed at treating diseases and medical conditions. Biotechnology companies are almost always unprofitable (some suggest that the distinction between “biotech” and “pharmaceutical company” lies in profitability), and many have no real revenue at all.

Biotechnology is also characterized by long development lead times; it can take as much as a decade to get a new drug from test tube to pharmacy shelf. What’s more, there is an overwhelming likelihood of failure, as 85-95% of all prospective new drugs fail to reach approval. Still, for those that succeed, the rewards can be tremendous and “daily doubles” are not unheard of.

The Differences Between Biotech and Pharmaceuticals
There is more than a little gray area between what is “biotech” and what is “pharmaceutical”. Nevertheless, investors should keep a few general points in mind. From a philosophical standpoint, biotechnology is a risk-taking enterprise, while the pharmaceutical industry is about managing and diversifying risk.

As most biotechs have insignificant revenue, to say nothing of income, dividends are exceptionally rare in biotech. In contrast, dividends can comprise a significant part of the expected return from a pharmaceutical stock.

Many biotech companies make no pretense of marketing their own drugs, as they see their expertise being in R&D. By comparison, marketing and sales is the principal strength of many Big Pharma companies. As more and more pharmaceutical companies fire scientists and pull back from basic research, they increasingly become massive marketing machines that need an influx of new products from the biotech world.

The two industries also stand apart when it comes to valuation and business evaluation. Models and valuation derived from cash flow are quite relevant in assessing pharmaceutical stocks; while many analysts gamely attempt to construct discounted cash flow models for early-stage biotechs, the reality is that success is often quite binary (“drug works” or “drug doesn’t work”).

Beware the Gatekeeper
As the regulatory body that approves new drugs for the U.S. market, as well as permitting human clinical trials, the Food and Drug Administration (FDA) is the ultimate gatekeeper to every biotech’s success. The FDA requires that all companies establish (to its satisfaction) that a potential new drug is safe and efficacious for its stated purpose.

Investors need to understand the FDA process and requirements. In order to get FDA approval, biotechs must establish a sufficient body of information that the drug is safe and effective and this is generally done through a series of at least three clinical trials (Phase One, Phase Two and Phase Three).

If these trials meet their goals of safety and efficacy (and these goals are typically made in consultation with the FDA), the company will file a formal request for approval called a New Drug Application (NDA). Upon receipt of a completed application (and a hefty filing fee), the FDA assigns a so-called PDUFA date – a date by which the agency will issue a decision on the application. The FDA then reviews the application and may convene a special panel of experts called an advisory committee. These committees review the application and issue an opinion as to whether the FDA should, or should not, approve the drug based on the information that is currently available.

The FDA then evaluates the panel’s responses and makes its decision. The FDA will either grant approval and allow the company to market the drug or it will issue a complete response letter (CRL). A CRL is tantamount to a rejection, though it does highlight the FDA’s concerns and allows the company to collect more data and reapply later.

Biotech investors also cannot overlook the importance of understanding the FDA’s “mood” at any given point in time. When the FDA is in a conservative posture, safety and clean data becomes paramount and equivocal drugs often are rejected. When the FDA is in a more liberal posture, some of these rules are not applied as rigorously and drugs with a somewhat dicier risk-benefit profile often make it to market, particularly those drugs meant for diseases with few other treatment options.

What Biotech Investors Need to Know
When considering a potential biotechnology investment, there are several additional factors to keep in mind:

Pipeline
A biotech’s pipeline is everything, and it is the source of the company’s presumed and projected value. Generally speaking, investors should try to focus their attention on companies with multiple Phase 2 programs (that is, multiple drugs in Phase 2 testing, not a single drug in multiple Phase 2 studies). It is true that single-product biotechs can be big winners when they succeed, but the reverse is also true – they can suffer crushing losses if that one and only product candidate fails.

Not all diseases are equally valuable
Some diseases are huge potential markets, but have ample competition and strict expectations for safety or performance. For instance, while cancer and arthritis are major diseases with multibillion dollar potential, there are numerous drugs already approved and available – if new drugs do not offer something novel (better efficacy, fewer side-effects, etc.), they may not even get approved, let alone find a large market.

On the other hand, less-common diseases can represent bigger opportunities than people realize. So called “orphan drugs” target diseases that affect fewer than 200,000 people, but consider that getting just 20,000 users of a drug costing $50,000 a year (not a bad price for a life-saving drug) means a billion-dollar revenue opportunity. What’s more, companies developing orphan drugs are given some additional assistance in the form of market exclusivity and less stringent trial enrollment targets.

As a result, almost any disease target can pay off with the right drug. Few people had even thought of restless leg syndrome as a disease, but drugs sold for this syndrome have done well. Likewise, there is a drug on the market with the sole stated purpose of making eyelashes grow longer, which shows that one can never completely dismiss an idea.

That said, investors should be careful with companies looking to crack certain diseases. Countless companies have tried and failed miserably to develop effective drugs for sepsis, Alzheimer’s and obesity. While there will eventually be successes here, and the rewards will be great, there will likely be devastating failures as well, and the odds are not in the investor’s favor.
Corporate philosophy
Investors also need to understand the objectives and goals of company management. Many biotechs intend to develop their drugs only so far on their own and then basically trade them to a larger drug company in exchange for upfront cash and future royalties. Other companies, though, keep the marketing rights to themselves and build out their own sales force. Ultimately, these seem to be the companies that build the most value for shareholders, but it’s a riskier path.

Keep in mind, too, that it is not necessarily an all-or-nothing decision. Biotech companies can choose to co-promote a drug with a larger partner, and may opt to do so as a way of building an internal sales force without completely sacrificing the cash flow that can come from royalties.
Capital structure and financing options
Biotechs burn through money. That’s just a basic fact. It’s also a basic fact of life that clinical trials cost a great deal of money (always at least tens of millions of dollars and often hundreds of millions). Investors, then, should strive to find companies that are well-funded for their near-term clinical needs.

In essence, it’s always good to let other investors take the dilution, but that is admittedly not always an option. Companies will often wait to raise money until they have good news to announce and can sell shares at the higher post-announcement prices. Waiting too long exposes investors to the risk of missing those “good news pops” that make up most of the gains in biotech investing.

The Bottom Line
A full how-to covering biotech investing could easily run into tens of thousands of words, but hopefully this is a good start for many investors new to the world of biotechnology. Make no mistake, biotech investing is a very risky endeavor and failures will outnumber successes. That said, with patience, research and attention to detail, it is entirely possible for investors to find the winners that will more than pay for the occasional losers.

FDA Panel Says Home Gene Tests Need MD Input

Certain types of genetic tests that are available for at-home use without a prescription should not be used without the involvement of a physician or genetic specialist, an FDA advisory panel recommended.

So-called direct-to-consumer (DTC) genetic tests can provide information ranging from a whether a person is lactose intolerant, at risk of developing Alzheimer’s disease, or likely to respond to a certain type of drug. After taking a quick blood or saliva sample in the privacy of one’s own home, the test is mailed to a laboratory for interpretation and the person is later sent his or her results.

But some of those results — for example, a person’s likelihood of developing heart disease — are of limited utility without the involvement of a physician, agreed members of the FDA’s Molecular and Clinical Genetics Advisory Panel, which wrapped up a two-day meeting on DTC testing on Wednesday afternoon.

“I want any test that has a high predictor that a person will get a disease, I want that filtered through a physician,” said panelist Valerie Ng, MD, PhD, a pathologist at the University of San Fransisco in Oakland, Calif.

The panel wasn’t clear on whether that would mean a physician would have to order the test, or if a physician would have to interpret the test, or both. That will ultimately be up the FDA to decide. The agency — which may decide to make certain tests that are currently DTC available by prescription only — isn’t required to follow the advice of its advisory committees, but it often does.

Physician involvement is not nearly as important for nutrogenetic tests that tell a person how their body processes a certain type of food, or for other less-serious genetic information, such as whether the person has thick earwax, the panel decided.

Following the hearing, Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics, told reporters that certain types of tests, such as nutrogenetic tests, might be appropriate for at-home use as long as the companies make truthful claims.

Other tests, such as carrier screening tests — which show whether a person is a genetic carrier of a condition and therefore has a risk of passing it on to their children — may eventually require doctor involvement.

“We’re not going to be able to take one approach to all types of tests,” Gutierrez said. “Some may not require a doctor at all and some might require that a qualified health professional be involved, and some might involve the doctor to order the test.”

“Most of the committee agrees that physician involvement is necessary,” panel chairman John Waterson, MD, PhD, a geneticist at Children’s Hospital and Research Center in Oakland, Calif., told MedPage Today after the meeting.

The popularity of DTC tests increased exponentially following the completion of the Human Genome Project. Last year, the FDA informed companies selling the do-it-yourself genetic tests that they weren’t in compliance with FDA regulations. That move led pharmacy giant Walgreens to shelve plans to stock a genome mapping kit. Some companies dropped out of the DTC game, and others have been working with the FDA to comply.

Genetic testing companies believe it is an individual’s right to have full access to their health information, while others who testified at the meeting felt that having too much medical information can be harmful, particularly if the information is incorrect, or if there’s not much a person could do with the information.

Jeremy Gruber, president of the Council for Responsible Genetics, a nonprofit organization founded to stimulate public debate on the social and ethical impacts of genetic technologies, said he thinks the FDA should better regulate DTC genetic testing companies in order to mitigate the harm that could be caused by the tests.

“We believe that everyone should have access to their genome and allowed to sequence it if they choose,” said Gruber. However, he added, “We must acknowledge that DTC testing can cause as much harm as good.”

Many people argue that knowing genetic predisposition to a certain disease — particularly one for which there is no treatment, such as Alzheimer’s — adds no value and only serves to increase anxiety.

However, that finding was disputed in a recent study published in the New England Journal of Medicine that found users of the at-home genetic tests did not have increased anxiety after their results were revealed.

“The bottom line from actual studies, is that when people attempt to learn something, they are not upset by what they learn, even when the news is bad,” said Mary Pendergast, a lawyer, industry consultant, and former FDA deputy commissioner. “Everyone’s lives have trials and tribulations. We can handle it.”

>The panelists — about half of of whom were medical doctors — also questioned whether average consumers are sophisticated enough to understand their genome screening results, which is part of the reason a physician could be helpful. (However, most physicians aren’t trained geneticists, so they can’t be expected to be able to accurately interpret the results either, a few committee members pointed out.)

But representatives from the companies that make the tests disagreed with the unsophisticated consumer argument and argued that people deserve to be able to have unfettered access their genetic information.

Pendergast — who delivered sharply worded testimony during the public hearing that elicited scattered applause from the audience — accused the panel, and doctors in general, of being “paternalistic.”

“The medical profession has objected every time the FDA has tried to give tests directly to consumers,” she said, providing home pregnancy tests as an example. “It’s, frankly, medical paternalism — the FDA trying to keep medical products from consumers ‘for their own good.'”

The panel also heard from witnesses who referenced a 2010 undercover investigation by the Government Accountability Office (GAO), which revealed that home genetic tests often provide incomplete or misleading information to consumers. For the GAO investigation, investigators purchased 10 tests each from four different direct-to-consumer genetic testing companies — 23andMe, deCode Genetics, Pathway Genomics, and Navigenics — and the interpretation of the results differed according to which company analyzed the results.

How to maximize workers’ compensation prescription drug savings and ensure the highest level of care

While the overall number of workers’ compensation claims has decreased over the past few years, insurance industry studies show medical treatment costs are continuing to grow at an alarming rate with prescription drugs being one of the major contributors.

The impact, however, isn’t solely driven by the price of the drugs, but instead, in large measure, it has been due to the increased utilization — more drugs are being prescribed, more frequently, and for longer periods of time. In many cases there are more appropriate and cost-effective treatment alternatives — but, in order to better manage this process, more focus and expertise is required than what is provided in most Pharmacy Benefit Management (PBM) programs, especially when comparing workers’ compensation benefits to group health.

“One of the major challenges workers’ compensation insurance programs encounter with controlling medication costs is ensuring injured workers are being prescribed the most effective and appropriate drugs to treat an injury or work-related illness,” says Daryl Corr, president of Healthesystems. “Since the complexity of injuries and patient medication tolerances can vary so significantly, combined with the challenge of widescale use of pain medications, treatments can’t be a one-size-fits-all approach. Therefore, it’s critical to incorporate more clinically focused strategies to ensure prescription drug treatments are being managed appropriately, especially in the most complex cases.”

Smart Business spoke with Corr about the uniqueness of workers’ compensation prescription benefits and how clinically focused tools are impacting medication costs and the quality of care.

How can a clinical services program help reduce the costs associated with complex workers’ comp pharmacy claims?

At the most basic level, a clinical services program helps customers design and maintain the pharmacy program’s medication plan (formulary) around the specific prescription medications or classes used to treat workers’ comp related injuries. These rules can help determine whether a drug requires a prior authorization before dispensing.

However, on a more targeted level, a successful clinical services program can have a big impact when focused on the most complex workers’ comp cases. These complex cases may represent a small percentage of an insurance payer’s injured worker patient population, but they have a tendency to drive most of the cost. In a lot of situations, this goes well beyond the typical 80/20 business rule axiom. For many insurance payers, less than 10 percent of the claimants receiving prescription drugs are driving over 70 to 80 percent of their overall drug treatment costs.

So, focusing more attention on this narrow group of claims maximizes the opportunity to significantly reduce drug spend. However, it requires a lot more expertise and commitment from the PBM to achieve the best results. You need a highly skilled and knowledgeable staff of PharmD clinicians focused on examining individual cases, analyzing drug therapies and identifying alternate treatment options — subsequently interacting with prescribing physicians and claims professionals to educate them about more appropriate alternatives when they are available. This approach focuses on the claims where the largest dollars are being spent in order to maximize the potential savings impact.

What is the best way for a PBM to integrate clinical services into a pharmacy program?

The most successful clinical tools are highly integrated into a PBM’s overall pharmacy program. There are critical pharmacy program functions necessary to make this happen, namely powerful technology and proactive communications. Incorporating powerful technology takes pharmacy management to the next level by proactively identifying problematic prescription trends through systems edits and evidence-based medical guidelines. A proactive communication process is key, especially when it comes to interactions between the PBM, the prescribing physician and the insurer’s claims professional.

A PBM’s team of PharmD professionals needs to actively interact with physicians to provide education and insight into the specifics about the prescribed drugs and the injuries they are treating. Depending on a physician’s specialty, they may have limited knowledge about the effectiveness of a particular drug or alternatives available — or, frequently a physician may not be aware of all medications being prescribed to an injured worker if they are being treated by multiple physicians. Clinical education and outreach is imperative and must occur quickly in order to be most effective.

Are these targeted clinical services applied universally to all workers’ comp claims?

Not necessarily. Usually, these types of services are focused on the most complex claims. All clients and their individual claims are unique — just like each diagnosis is unique to each injured worker. In addition, rules and regulations differ from state to state and may affect how or if you can interact with physicians, or whether there are specific mandated treatment guidelines in place. A PBM must be aware of these rules and work with customers to ensure everyone maintains compliance. With these added issues, it becomes even more crucial for a PBM to take a proactive role in educating its clients about what is occurring in the market as it relates to applying best treatment guidelines and clinical best practices.

There is also a need to proactively monitor the pharmaceutical industry to identify new drugs that are entering the market, which may have an impact on a workers’ comp pharmacy program. The key is to help clients make the right decisions by factoring both treatment effectiveness and cost. It isn’t solely driven by the price of one pill. It’s about applying the right treatment to achieve the optimal outcome, which typically means lower costs over the life of the claim.

Buyouts skew Indian drug industry

Tie-ups between Indian drug companies and multinational pharmaceutical firms, which initially received a lot of media attention, have proven to be more beneficial for big pharma than for Indian companies, according to a recent study.

The study authors found that co-operation between multinational pharmaceutical companies and Indian manufacturers had not boosted the R & D capacity of Indian pharmaceutical businesses.

They also found that there had not been any significant transfer of technology from developed countries.

In the report, Médicins Sans Frontières (MSF), a medical non-governmental organisation, describes India as the pharmacy of the developing world.

MSF relies on Indian companies to supply 80% of all generic HIV drugs it distributes abroad.

It is not the first time that Indian officials have begun to suspect that such co-operation between drug companies is ultimately not beneficial for Indians.

When a foreign firm buys an Indian drug company, that firm inheirits the intellectual property of the foreign company.

But quite often, the same Indian companies have already benefited from patent waivers on research done by Indian technical institutes, or from Indian tax incentives.

In essence, multinational firms are benefiting from previous investments of Indian taxpayers’ money when they buy Indian drug companies.

Last year, the Indian commerce ministry said some analysts were concerned that foreign companies would steer Indian companies away from the Indian market, weakening competition and ultimately opening up a new price range for more expensive drugs, thus driving up prices overall.

The researchers found that clinical research organisations in India failed to raise their technological standards after being integrated with high-grossing pharmaceutical firms.

They found that most of the drug discovery efforts of such firms were aimed at Western markets.

While some Indian drug companies have also acquired foreign firms in the mean while, foreign firms have also bought Indian companies.

Study author Dinesh Abrol, of the National Institute of Science, Technology and Development Studies (NISTADS), said that buying domestic Indian companies would give multinational companies fewer challenges over proprietary technology.

He said that the buyouts would ultimately lead to decreased manufacturing capacity for Indian-made generic drugs.

The Indian commerce ministry said that alliances between local and global pharmaceutical companies had also been seen in Brazil, Egypt, and Pakistan.

Drug shortages affecting local hospitals

Drug shortages ranging from anesthetics to emergency room necessities have forced local hospitals to plan ahead and work together to make sure there is enough to go around.

While drug shortages are nothing new, a perfect storm of quality-control issues and manufacturing slowdowns and shutdowns have caused the worst shortages in most pharmacists’ memories. Across the nation, hospitals are having to get creative when it comes to meeting needs – often turning to older drugs to treat patients.

“This is the worst I’ve seen it ever,” said David Rowlands, director of Community Medical Center’s pharmacy. “We’ve had to do a lot of gymnastics, but it has not had any adverse effect on the care we provide.”

Shortages have affected local hospitals both large and small, though none has reported any problems that have affected a hospital’s ability to continue caring for patients.

“We haven’t had to turn anyone away,” said Michele Musheno, director of Moses Taylor’s pharmacy.

The U.S. Food and Drug Administration reported more than 150 drug shortages in the last year. About 60 of those are considered by federal officials to be “medically necessary.”

Five years ago, there were only 55 or so different drugs in short supply, Pennsylvania Medical Society President Ralph Schmeltz, M.D., said.

Amongst the most problematic shortages is propofol, a commonly used anesthetic for surgeries. Several injectable painkillers used for surgeries, trauma patients and those suffering from serious illnesses, as well as certain cancer drugs and medications used to treat heart patients are also in short supply, according to hospital pharmacists around the region.

The reasons for the shortages are myriad, local and national experts said. The FDA has ramped up inspections and cracked down on drug safety, shutting down plants where problems are found.

“The FDA has been under a lot of pressure to make sure drugs are made safely,” Dr. Schmeltz said. “Inspections have found particulate matter in IV drugs, which has caused shutdowns. You can’t inject foreign material into patients.”

Consolidation in the drug industry has resulted in fewer plants making certain drugs, and other plants have stopped production when a drug is no longer profitable.

Propofol, for example, is in short supply because one manufacturer, Teva Pharmaceuticals, decided to stop making it because of a quality issue last year.

Around the same time, propofol manufacturer Hospira also experienced some quality control issues that interrupted production.

The FDA allowed Hospira to begin manufacturing propofol again this summer, but the plant needed time to get production running smoothly before it could begin filling back orders.

Further complicating the drug shortage problem is that there is no way to predict shortages.

“It doesn’t seem like the drug companies are very forthcoming about upcoming shortages,” said Marsha Shaw, the director of Mercy Tyler’s pharmacy, which has also struggled with drug shortages over the past year. “We try to keep a certain inventory of emergency medications on hand, but it is expensive to keep our inventory up.”

Hospital pharmacies around the area are also comparing notes when it comes to what shortages are affecting them, often borrowing or lending certain drugs to make sure every facility has enough.

“We talk to other hospitals and try to have a plan in place,” Ms. Shaw said. “The drug companies allocate a certain amount to each hospital, so we try to plan for what we will have.”

Shortages of premixed drugs that come in syringes to be used in emergency rooms have pharmacists at local hospitals mixing their own, a time-consuming process. Sometimes, drugs that are in short supply can be replaced with other, older drugs, pharmacists said.

“There are other drugs out there that often work just as well,” Ms. Musheno said. “We have to educate doctors and nurses about those changes when we make them” to make sure orders reflect the approved switch.

At Mercy Tyler, pharmacists send weekly memos informing staff of drug shortages and substitutions, Ms. Shaw said. And while there are few problems using substitutions, older drugs could require different dosages or cause different side effects than newer treatments, pharmacists said.

The increasing number of drug shortages has attracted the attention of federal legislators. U.S. Sen. Bob Casey, D-Pa., along with U.S. Sen. Amy Klobuchar, D-Minn., has introduced legislation that would require drug manufacturers to give the FDA notice when an issue arises that might lead to a shortage.

“We’ve had reports about this problem,” Mr. Casey said. “We want to put in place a better structure that will result in fewer crises.”