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States Pass Record Number of Laws To Reel In Drug Prices

States Pass Record Number Of Laws To Reel In Drug Prices

“Whether Congress will act this year to address the affordability of prescription drugs — a high priority among voters — remains uncertain. But states aren’t waiting.
So far this year, 33 states have enacted a record 51 laws to address drug prices, affordability and access. That tops the previous record of 45 laws enacted in 28 states set just last year, according to the National Academy for State Health Policy, a nonprofit advocacy group that develops model legislation and promotes such laws.
Among the new measures are those that authorize importing prescription drugs, screen for excessive price increases by drug companies and establish oversight boards to set the prices states will pay for drugs.

“Legislative activity in this area is escalating,” said Trish Riley, NASHP’s executive director. “This year, some states moved to launch programs that directly impact what they and consumers pay for high-cost drugs.”

And more laws could be coming before year’s end. Of the handful of states still in legislative session — including California, Massachusetts, Michigan, New Jersey, Ohio and Pennsylvania — debate continues on dozens of prescription drug bills. In New Jersey alone, some 20 proposed laws are under consideration.

“Both Democrat and Republican leaders have shown a willingness to pursue strong measures that help consumers but also protect state taxpayer dollars,” said Hemi Tewarson, director of the National Governors Association’s health programs.  Riley, Tewarson and others note, however, that states can go only so far in addressing rising drug prices, and that federal legislation would be necessary to have a major impact on the way the marketplace works.

Federal lawmakers are keeping a close eye on the state initiatives, Tewarson said, to gauge where legislative compromise may lie — even as Congress debates more than a dozen bills that target drug costs. Political divisiveness, a packed congressional schedule and a looming election year could stall momentum at the federal level.

The pharmaceutical industry has opposed most — though not all — state bills, said Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, the industry’s main trade group.

“We agree that what consumers now pay for drugs out-of-pocket is a serious problem,” said VanderVeer. “Many states have passed bills that look good on paper but that we don’t believe will save consumers money.”

Limiting Gag Rules For Pharmacists
At least 16 states have enacted 20 laws governing the behavior of pharmacy benefit managers. The so-called PBMs serve as middlemen among drugmakers, insurance companies and pharmacies, largely with pharmaceutical industry support.

Those laws add to the 28 passed in 2018. Most of the new laws ban “gag clauses” that some PBMs impose on pharmacists. The clauses, written into pharmacy contracts, stop pharmacists from discussing with customers whether a drug’s cash price would be lower than its out-of-pocket cost under insurance.

With widespread public outrage over gag clauses pushing states to act, federal lawmakers got the message. In October, Congress passed a federal law banning such clauses in PBM-pharmacy contracts nationwide and under the Medicare Part D prescription drug benefit. The Senate passed it 98-2. Even so, many of this year’s PBM laws contain additional gag clause limitations that go beyond the 2018 federal law.

Importing Cheaper Drugs
Four states — Colorado, Florida, Maine and Vermont — this year have enacted measures to establish programs to import cheaper prescription drugs from Canada and, in Florida’s case, potentially other countries. Six other states are considering such legislation.
Medicines in Canada and other countries are less expensive because those nations negotiate directly with drug makers to set prices.

“This is an area where states once feared to tread,” said Jane Horvath, a consultant who has advised Maryland and Oregon, among other states, on prescription drug policy. “Now both Republicans and Democrats view it as a way to infuse more price competition into the marketplace.”

Hurdles remain, however. A 2003 law allows states to import cheaper drugs from Canada but only if the federal Health and Human Services Department approves a state’s plan and certifies its safety. Between 2004 and 2009, the federal government halted nascent drug import efforts in five states.

Even so, momentum for importation has built in recent years in states and Congress as drug prices have continued to rise. And the Trump administration this summer threw its support behind the idea.

Florida Gov. Ron DeSantis, a Republican and close ally of President Donald Trump’s, signed his state’s measure into law on June 11, claiming he did so after Trump personally promised him the White House would back the initiative.

On July 31, HHS announced an “action plan” to “lay the foundation for safe importation of certain prescription drugs.” The plan includes a process to authorize state initiatives. It also requires formal regulatory review, including establishing Food and Drug Administration safety criteria. That process could take up to two years.

Two big problems remain: In the weeks since the announcement, the Canadian government has opposed any plan that would rely solely on Canada as a source of imported drugs. The pharmaceutical industry also opposes the plan.

Creating Drug Affordability Boards

Maryland and Maine enacted laws this year that establish state agencies to review the costs of drugs and take action against those whose price increases exceed a certain threshold.
New Jersey and Massachusetts are debating similar legislation this year.

Maryland’s law establishes a five-member board to review the list prices and costs of drugs purchased by the state and Maryland’s county and local governments. The board will probe drugs that increase in price by $3,000 or more per year and new medicines that enter the market costing $30,000 or more per year or over the course of treatment.

If approved by future legislation, upper payment limits on drugs with excessive price increases or annual costs would take effect in January 2022. “My constituents have signaled loud and clear that bringing drug prices down is one of their top priorities,” said state Sen. Katherine Klausmeier, a Democrat representing Baltimore, who sponsored the legislation.

Maine’s law also establishes a five-member board. Beginning in 2021, the board will set annual spending targets for drugs purchased by the state and local governments.

Increasing Price Transparency
This year, four states — Colorado, Oregon, Texas and Washington — became the latest to enact laws requiring drug companies to provide information to states and consumers on the list prices of drugs and planned price increases.

The majority of states now have such transparency laws, and most post the data on public websites. The details vary, but all states with such laws seek to identify drugs with price increases above 10% or more a year, and drugs with price increases above set dollar values.

Oregon’s new law, for example, requires manufacturers to notify the state 60 days in advance of any planned increase of 10% or more in the price of brand-name drugs, and any 25% or greater increase in the price of generic drugs.

“That 60-days’ notice was very important to us,” said Rep. Andrea Salinas, chair of the Oregon House’s health committee, who represents Lake Oswego. “It gives doctors and patients advance notice and a chance to adjust and consider what to do.”

Finding Gluten-Free Nutrition, Dietary Supplements, and Medications

Non-celiac gluten intolerance and celiac disease are becoming more common. Celiac disease is a chronic autoimmune disorder caused by a genetic intolerance to gluten. Non-celiac gluten intolerance is diagnosed in people who do not have celiac disease, but have intestinal or extra-intestinal symptoms related to ingestion of gluten-containing grains.

Both conditions are treated by avoiding gluten containing foods. Finding ‘gluten free’ nutrition is becoming easier to do, but eliminating gluten from one’s diet can be a complex and time-consuming process.

Gluten is the protein component of wheat (e.g., including spelt, kamut, semolina, and triticale), barley (e.g., including malt), and rye. When a person with celiac disease or non-celiac intolerance ingests gluten, specifically the antigenic gluten constituent called gliadin, it can cause intestinal inflammation, diarrhea, abdominal pain, bloating, weight loss, fatigue, and iron deficiency anemia. Food malabsorption and nutritional deficiencies result.

Over time, these conditions can cause liver disease, defective gallbladder emptying, and osteoporosis. Celiac disease may be a reversible cause of osteoporosis. Adherence to a gluten-free diet is one way to help suffers minimize overall symptoms and to maintain maximal bone mineral density.

For perspective, oats are considered a type of gluten grain, but do not have the antigen that other gluten grains above do. Thus, oats do not induce an immune reaction in the small intestine of people with celiac disease. However, many commercial oat products are contaminated with wheat, barley, or rye and it’s important to carefully read their labels. Look for products that are certified to contain less than 20 ppm of gluten (FDA’s ‘gluten free’ definition).

Consumption of as little as 10 mg-50 mg gluten daily can lead to a clinical relapse in people with these conditions. Celiac disease may increase the risk of developing some types of cancer (e.g., T cell lymphoma and intestinal adenocarcinoma) if gluten restrictions are not maintained or gluten intake is only partly restricted.

It is important to find out where gluten resides in foods. This means not only reading food labels on products you purchase for home but also on foods you consume from fast food establishments and restaurant dining. Soups, sausages, and ice cream may contain hidden amounts of gluten as fillers. Talk with your grocer and restaurant owners before you consume questionable food items.

Watch out for the gluten content in herbs, other dietary supplements, and medications.

Gluten-Free Foods
Consuming foods certified to be ‘gluten free’ will help keep the daily gluten total to under 50 mg and not cause symptoms for most people with celiac disease. Gluten-free grains include rice, millet, corn, quinoa, sorghum, and buckwheat. For more information, visit http://glutenfreecooking.about.com/od/gettingstarted/a/hiddengluten.htm
or http://www.glutenfreeliving.com/nutrition/ingredients.

Gluten-Free Herbs and Other Dietary Supplements
It would be impossible to find information about the gluten content in over 60,000 products on the worldwide market. One can contact dietary supplement manufacturers directly for more information on gluten content before taking any of these products, including vitamins.

Gluten-Free Medications
Over-the-counter and prescription medications may contain gluten in the list of inactive ingredients. For example, sweeteners used in medications may be hidden sources of gluten. Some manufacturers cannot guarantee their medications are gluten-free because the suppliers of raw materials can not do so, making it even more difficult for consumers to figure out what is safe to take and what is not.

A great resource for determining the overall ingredient content in medications, including whether or not gluten is present, can be found online at www.glutenfreedrugs.com .

Another online medication reference comes from the National Institutes of Health at www.dailymed.nlm.nih.gov. Go to the site, type in the generic name of the medication you want to review, then scroll down to the name of the manufacturer of that particular product, then click on ‘description.’ Scroll down to the inactive ingredients and look for gluten.

A third way to find more information about your medication’s gluten content is to call the medication manufacturer directly. Be sure to have the medication’s lot number available when you call.

Finally, click on https://www.ncbi.nlm.nih.gov/pubmed/?term=Gluten+content+of+the+top+200+medications+of+2009%3A+a+follow+up+to+the+influence+of+gluten+on+a+patient%E2%80%99s+medication+choices for “Gluten content of the top 200 medications: follow up to the influence of gluten on a patient’s medication choices” by AR King in Hosp Pharm 2013:48:736-43.

By Cathy Rosenbaum PharmD MBA RPh CHC

Grapefruit Interactions with Medication

Certain prescription and/or OTC medications and dietary supplements may negatively interact with grapefruit juice, grapefruit, Seville oranges, pomelos, and tangelos due to chemicals in the fruits.

Fruit chemicals are thought to block enzymes in the body that metabolize medication in the small intestine, thereby causing the medication to hang around longer than expected. Interestingly, these fruits may also interfere with transporters in the body, causing medication to be less well absorbed into the bloodstream, and may reduce medication or supplement effects. Sound confusing? It’s complicated.

Product classes involved in unwanted interactions include, but are not limited to:

-Antihistamines (e.g., Allegra)
-Antianxiety
-Antihypertensives
-Cholesterol-lowering ‘statins’
-Corticosteroids for Crohn’s disease and ulcerative colitis
Dietary supplements

Only some of the medications and supplements in each of the categories can be affected by the fruit/juices. Every person may react differently based on the amount of fruit they consume, the medication or supplement type/dose taken, and the individual’s natural ‘enzyme levels.’

Don’t worry, but do get educated about how and when to properly take your medications and supplements to be safe. Enjoy healthy nutrition. Talk with your pharmacist about what’s best for you!

Beyond Use Dates on Prescription/OTC Medications & Dietary Supplements

Expiration dates on OTC & prescription medications and dietary supplements typically fall between 12 – 60 months after product production. Pharmaceutical manufacturers are required by law to establish these dates but do not have to study product stability and potency beyond those dates.

A recent study published in JAMA Internal Medicine using eight medications containing 15 active ingredients demonstrated product potency for decades beyond the original expiration dates. Another study in the military concluded the same results for 100 medications after 15 years.

The U. S. government has a Shelf Life Extension Program to extend dates on federal stockpiles for the military. But this is the exception to the rule in a special population to save the government money in repurchasing.

The bottom line for consumers is this – > follow the product manufacturer’s established expiration date stamped on the OTC bottle or prescription vial. Follow these same guidelines for your dietary supplements as well.

Keep all of these products in a cool, dry, dark place in your home.

Polypharmacy Is Not Jolly!

Polypharmacy Is Not Jolly! By Cathy Rosenbaum PharmD MBA RPh CHC

Hallelujah. The healing paradigm is finally shifting in the U.S. The time is ripe for doctors to rethink how they prescribe medications. Less is more. As a fellow health care professional, I believe medical students should be taught to utilize drugs sparingly, as only one of many, customizable tools in their future healing quivers.

Envision a country where you as the patient could be asked by your doctor to select from a menu of non-invasive, evidence-based holistic healing regimens when needed. That’s right, you would choose! Aromatherapy, guided imagery, spiritual retreats, Yoga, Tai Chi, personality testing, and acupuncture would be covered by insurance or included as part of your total office visit fee. Doctors would collaborate with evidence-based non-traditional medicine practitioners for your good.

Seniors over age 65 years represent 12% of the U.S. population and consume 32% of prescription medications. Many take five or more prescription medications, intentionally combining them with other over-the-counter medications and multi-ingredient dietary supplements. Boomers, we need to collectively push back against that machine.

Everything changes. Our body’s physiologic clock resets as we mature in the life journey. We become more sensitive to the effects of medications. Talk with your doctor about this list of possible options the next time you go to the office.

• Sleep Restoration – drink a cup of chamomile tea, lavender tea, or decaffeinated green tea before bedtime; try a few minutes of slow, deep breathing as you retire to inhale life-giving oxygen and calm you down from the day’s challenges
• Stress/Anxiety – repeat affirming statements about your life blessings (we all have them); read up on the benefits of acupressure
• Weight Loss – eat apples and drink water for snacks; walk around the dining room table and up/down home stairs for ½ hour a day (yes, and let your neighbors see you through the window)
• Arthritis Pain/Inflammation – talk with your doctor about the appropriateness of glucosamine HCL or turmeric dietary supplements instead of a years worth of NSAIDs like Naprosyn and Motrin that can damage the kidney, heart, and stomach
• Viral Colds – eat chicken noodle soap; try zinc lozenges, as directed on the package label, at the first sign of symptoms
• General Health – exude a positive attitude; teach your family to grow, cook, and eat from the Mediterranean diet (e.g., olive oil, colorful fruits and vegetables, moderate wine consumption, nuts); prefer whole (not processed) foods for your nutrition regimen, locally grown in your own organic garden or community supported agriculture farm

New Year’s Resolutions

Consumers:

• Let your feet do the shopping. Choose a primary care physician that thinks out of the box and is open to integrative health principles & practices (see the Academy for Integrative Health and Medicine @ www.aihm.org )
• Don’t expect to get a prescription medication every time you leave the doctor’s office
• Incorporate medicinal herbal spices and teas into your nutritional regimen for health and taste
• Take charge of holistic you in your body mind and spirit
• Get educated on the exciting integrative health and healing paradigm (visit www.NIHseniorhealth.gov, www.babyboomers.com, www.lifereimagined.com)

Physicians:

• Be aware of all medications and dietary supplements your patients are taking; supplements act like drugs and have interactions and side effects that you must acknowledge and manage
• Treat your patient as an equal partner in the decision-making process and consider his/her point of view before prescribing any medication
• Try prescription drug reduction strategies (one medication as opposed to several, lowest dose possible)
• Try drug holidays (e.g., FLEX study with Fosamax for osteoporosis)
• Try evidence-based, alternate drug regimens (e.g., every other day Zocor for high cholesterol)
• Promote healthy nutrition to your patients at every office visit; discuss connection to eating whole foods and a healthy immune system

Pharmacists:

• Explain to your patients the importance of shopping at one pharmacy for all prescription medications
• Get educated on nutrition and dietary supplements,
• Recommend medicinal herbal teas instead of OTC medications whenever appropriate
• Talk consumers out of taking antibiotics for viral infections

Summary
Integrative health and medicine is here to stay. Take a lifelong learning class in your local community. Teach your grandchildren about it as your contribution to the family legacy. Be a part of the health evolution revolution. Happy New Year!

Dr. Rosenbaum has authored and just published, Don’t Sweep It Under the Drug! Integrating Evidence-Based Body Mind & Spiritual Practices into Your Health & Wellness Tool Kit, available on www.Amazon.com. Her book is the Xulon Press Fall 2015 Second Place Winner of the Christian Authors Award, Category: Health.