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Your medicine may come with a new side effect: financial pain. Prescription-drug spending grew 12.2% in 2014—five times as fast as the year before—according to the Centers for Medicare & Medicaid Services. And the sickest Americans bear the biggest burden. Some 43% of those in fair or poor health say it’s somewhat or very difficult to afford their medications, and 37% say they’ve skipped out on filling a prescription because of cost...What has changed? Generic drugs, long an affordable alternative to name-brand medicines, have become part of the problem. The average price of the 50 most popular generic drugs increased 373% between 2010 and 2014...One culprit is consolidation: After a decade of mergers, three big companies now control 40% of the generics market...Weaker competition means drug companies can charge your insurer more. Meanwhile, pricey new miracle drugs—like hepatitis C treatment Sovaldi are also a key factor forcing up overall medication costs...Fortunately, there are plenty of ways for you to save. By making strategic changes in the medications you take (with your doctor’s okay, of course), the places you buy them, and the insurance plan you elect, you may be able to shave 40% or more off your total prescription-drug costs this year. Here are the steps you need to take.

1. Substitute generics for name brands.
2. Combine pills—or split them.
3. Check the formulary for your insurer’s favorites.
4. Jump through your insurer’s hoops.
5. Ask your plan to make an exception.
6. Use mail-order options.
7. Use a preferred drugstore.
8. Beware of online pharmacy scams.
9. Check your insurer’s formulary lists.
10. Check for tricky deductibles.
11. Price out Medicare options.
12. Clip coupons.
13. Ask for help.

The reputation of the pharmaceutical industry continues to plummet. A day doesn’t go by without seeing at least one negative news story about... drug pricing...stories about how unaffordable drugs are or about how a family has gone into bankruptcy as a result of paying for a lifesaving medication...millions of dollars paid in fines by companies for the illegal detailing of drugs... Companies continue to be dogged by accusations of hiding clinical data...Direct-to-consumer ads are also a lightning rod...It’s not a happy time for the industry...The industry’s trade association, the Pharmaceutical Research and Manufacturers of America is charged with representing the industry on a host of issues, including improving its reputation...Well, PhRMA has a new leader, Mr. Stephen J. Ubl... he couldn’t have picked a more difficult time to assume the mantel of industry spokesperson. If there is one issue...it is that the pharmaceutical industry needs to be reined in, particularly with respect to drug prices. There couldn’t be a bigger bullseye on the pharmaceutical industry...Mr. Ubl has the opportunity to change the tone of the current pricing debate as well as the other issues that impact the pharmaceutical industry’s reputation...Hopefully, he can start to turn the tide and begin to bring the industry back to the esteem that it enjoyed twenty years ago.

Amid ongoing safety concerns over compounding pharmacies, a new analysis finds state oversight is a spotty patchwork of regulations, raising questions about the ability to protect the public health.

• Only about half of the states require compounding pharmacies that make sterile medicines, which are injected or infused into the body, to fully comply with recognized quality standards.
• 60 percent of the states do not require compounding pharmacies to report serious adverse events and reactions related to sterile compounding...
• 16 states reported they do not track compounding pharmacy activity at all.
• 28 states allow traditional compounding pharmacies as opposed to those that make large amounts of medicines for hospitals to provide drugs without prescriptions for individual patients. This practice conflicts with??federal law.
• nine states do not plan on taking any action, such as requiring compounders to register with the FDA or disciplining these businesses.
• 53 percent of the states conduct annual routine inspections for in-state pharmacies that perform sterile compounding.
• any issues discovered during an inspection, 79 percent of the states requires a written response from the pharmacy describing how the issues were addressed,
• 67 percent also need an additional on-site inspection to verify compliance.
• one-third of the states do not perform on-site follow-up inspections to verify needed changes.
• Most of the states...have the authority to issue cease-and-desist orders, but 70 percent also said they were unable to mandate a recall of compounded drugs or were unsure of their explicit authority.

Independent pharmacy owners face significant business challenges in a market dominated by large retail pharmacy chains...research has shown that 83% of all new pharmacies go out of business within an average of 2.5 years...Pharmacy Development Services recently brought independent pharmacy leaders together at its annual conference in Orlando, Florida, to discuss building business strength and solvency...In a keynote session called "How Truly Wealthy Entrepreneurs Secure Big Gains with Their Money," Kevin O’Leary, who’s also known as Mr. Wonderful on ABC’s "Shark Tank," candidly offered no-nonsense advice for independent pharmacy businesses to not only stay afloat, but also reach the next level of success...Specifically, he advised PDS attendees to abide by the following 10 tips that can help strengthen their businesses.

1. Employees are valuable, but they aren’t your friends.
2. Maintain a clear line of command.
3. Be accessible.
4. Delegate, delegate, delegate.
5. Don’t procrastinate.
6. Never pass the buck.
7. Service trumps price.
8. Use technology as a weapon.
9. The boss shouldn’t necessarily make the most money.
10. Business is war.

On February 25...upon conclusion of the...criminal case...United States v. Vascular Solutions, Inc...Judge Lamberth charged the jury...The case involves allegations that...a medical device company and its president, engaged in an unlawful off-label marketing campaign. The government’s superseding indictment alleged that the defendants engaged in a criminal conspiracy to violate the Federal Food, Drug, and Cosmetic Act, and committed four counts of selling misbranded medical devices...After deliberating for one day, the jury came back with a verdict of "not guilty" on all counts for both the company and its CEO...FDA’s ability to restrict speech that is truthful and not misleading is limited...FDA has long stated that the dissemination of information about unapproved uses can be important for medical professionals, and so long as the information is distributed according to certain guidelines...promotional speech itself would not be evidence of misbranding so long as the speech was solely truthful and not misleading. This position is consistent with a growing trend among courts to find that truthful and not misleading promotional materials may be distributed by a company without violating the misbranding provisions of the FDC Act...given the growing willingness of companies to challenge FDA’s regulation of off-label promotion, their success in doing so, and court decisions indicating...an unapproved use does not violate the misbranding provisions...DOJ and FDA must carefully consider how to proceed in bringing charges of off-label promotion.

Nearly 50 students visited 31 congressional offices on Capitol Hill earlier this month as part of ASHP’s Student Advocate Training & Legislative Day. The two-day conference, also known as SSHPTakesDC, gives student pharmacists hands-on experience in how to directly affect public policy...the students made the case for provider status legislation, the Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592 and S.314), by emphasizing how the pharmacy school curriculum and postgraduate residency training prepare future practitioners to be patient care providers...“I feel like we had a good impact,” said Winston Johnson, a third-year student at Palm Beach Atlantic University in West Palm Beach...Conference attendees also met with Rep. Earl “Buddy” Carter, the only pharmacist serving in Congress. Carter praised the students for their foray into advocacy and encouraged them to stay engaged in the political process. “Politics are important to our profession,” he noted...It’s so inspiring to see these ASHP student leaders in action, and it is clear after seeing their poise, passion, and professionalism during their visit to Capitol Hill that the future of the profession of pharmacy is going to be in very good hands...

City and health directors from across the country are urging the Food and Drug Administration to adopt new labels to "explicitly warn about a dangerous combination of medications" that have been fueling the nation’s prescription drug overdose epidemic over the years...Available online, the petition, which has been signed by academics, researchers and physicians, requests that the FDA amend black box warnings on all opioid analgesic and benzodiazepine class medications...to require medication guides that specifically warn patients of concurrently using both drug classes...We believe that this black box warning is a critical first step in raising awareness around the danger of co-prescribing these medications…The warning educates doctors so that they can provide the highest quality of care to patients...

Imagine new medicines that effectively fight cancer, but may result in fewer side effects thanks to more accurate targeting of tumor cells. Today, PhRMA released a new video that highlights these promising new therapies called antibody drug conjugates, or ADCs...represent a continuing shift in the cancer treatment landscape toward personalized medicines that more accurately attack specific targets fueling cancer cell growth while leaving more healthy cells unharmed...You can think of them as smart bombs, basically. Precision weapons against cancer...which may provide patients the same level of benefits of standard chemotherapy without some of the side effects that often accompany such treatments...

As the pharmacy landscape shifts and evolves, pharmacists across the country continue to work toward a common and crucial goal: gaining legislative recognition as health care providers...Gaining provider status is a complex and multifaceted objective, but at its heart is the exclusion of pharmacists from the Social Security Act. Exclusion of pharmacists from the SSA prevents many state and private health care plans from compensating pharmacists for patient care services...the omission of pharmacists from the SSA also creates barriers for Medicare beneficiaries who seek to utilize these services in outpatient settings...While provider status efforts are crucial to the pharmacy profession, they’re equally important to patients...Gaining ground in the states...a number of state laws passed in 2015 have given advocates much to celebrate.

• North Dakota Governor Jack Dalrymple signed into law 4 bills that expanded the role of pharmacists in the Peace Garden State and recognized them as health care providers...
• ...Washington Governor Jay Inslee’s signing of SB 5557...The first bill in the country to require the inclusion of pharmacists in health insurance provider networks...amends the state’s Every Category of Health Care Providers law, which obliges commercial health plans to include every category of health care provider within an individual’s participating provider network.
• ...Oregon governor Kate Brown signed HB 2028 into law...bill permits pharmacists to receive reimbursement for performing clinical pharmacy services, enabling them to more fully use their skills and knowledge to treat patients.
• ...the federal arena...federal recognition remains the primary goal for many proponents of provider status...a proposed bill has given advocates hope that such a victory is well within reach...the Pharmacy and Medically Underserved Areas Enhancement Act would amend the SSA to cover pharmacists’ services under Medicare Part B, but only if these services are provided in areas of the country that the Health Resources Services Administration defines as medically underserved areas...The bill is awaiting approval...

Pharmacy students are the future of the profession and...they will be the ones most impacted by provider status...Earning legislative recognition as health care providers will ensure that the next generation of pharmacists is able to treat patients to the full extent of their knowledge and abilities...

Ritzman Pharmacy and Northeast Ohio Medical Center’s ‘Pharmacy of the Future" collaboration is about to be open to the public. The Ritzman Pharmacy at NEOMED’s grand opening will take place March 7 at the...Education and Wellness Center...The new pharmacy is driven by an interest in creating a pharmacy experience that takes a holistic approach to wellness where the pharmacist is at the center of a patient’s care. It will offer fitness facility membership, primary care services, medication management and physical therapy in addition to standard pharmacy services...I am proud to be at the forefront of this effort to promote community-oriented, whole-person health. The pharmacy experience can be so much more than an errand to check off a list...