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by Haley Stenquist, PharmD Candidate Class of 2019
The University of Arizona College of Pharmacy

A new group of generic medications are hitting the prescription drug market in 2019. At ScriptSave, we get a lot of questions about generic medications vs. brand name prescription drugs. “A” rated generics meet the same quality standards as brand name prescription drugs and so they provide the same medical benefits. A drug that is “A” rated by the FDA as a generic equivalent contains identical active ingredients as the brand name drug, the same dosage as the brand name drug, and delivers the same concentrations of drug to the bloodstream within the same amount of time. So what are the differences and what’s coming to a pharmacy near you?

Are Generic Drugs the Same as Brand Name?

Yes, generic drugs are “copies” of the brand name medication that was developed by a company other than the one that originally brought the branded medication to market. Generic drugs are available for a fraction of the price of brand name medications, so consumers are naturally eager for the generics to hit the market. Per the FDA guidelines, a generic drug application must first display the following parameters:

  • The generic drug is “pharmaceutically equivalent” to the brand
  • The manufacturer is capable of making the drug correctly
  • The manufacturer is capable of making the drug consistently
  • The “active ingredient” is the same as that of the brand
  • The right amount of the active ingredient gets to the place in the body where it has effect
  • The “inactive” ingredients of the drug are safe
  • The drug does not break down over time
  • The container in which the drug will be shipped and sold is appropriate
  • The label is the same as the brand-name drug’s label
  • Relevant patents or legal exclusivities are expired2

How Long Does It Take for a Drug to Become Generic?

After an application for a patent of a new drug is filed with the United States, it is granted patent exclusivity for 20 years.  The path to generic drugs coming to market was made cheaper, easier, and faster after the introduction of the Drug Price Competition and Patent-Term Restoration Act of 1984 or known as the Hatch-Waxman Act. This allowed companies to submit an abbreviated new drug application (ANDA). About one year before the expiration of the patent drug, companies that are wanting to manufacture the generic drug will submit the ANDA to the FDA. Generally, after that patent has expired and the ANDA is approved, a generic counterpart can be introduced into the market.1

First Generic Drug Approvals for 2019

Currently, the FDA has approved 16 first-time generics in 2019 between different manufacturers (each manufacturer must submit their own ANDA). These include:

  • pyridostigmine bromide syrup—Mestinon Syrup
    • Improves muscle strengths in patients with myasthenia gravis
    • Novitium Pharma LLC—03/08/2019
  • levofloxacin ophthalmic solution, 1.5%—Iquix Ophthalmic Solution
    • Treatment of corneal ulcer caused by certain bacteria
    • Micro Labs Limited, India—02/27/2019
  • deferiprone tablets, 500mg—Ferriprox Tablets
    • Treatment of transfusional iron overload due to thalassemia syndromes
    • Taro Pharmaceuticals Industries Limited—02/08/2019
  • sevelamer hydrochloride tablets, 400mg, 800mg—Renagel Tablets
    • Control of serum phosphorus in patient with chronic kidney disease
    • Glenmark Pharmaceuticals Limited—02/08/2019
  • levomilnacipran extended-release capsules, 20mg, 40mg, 80mg, 120mg—Fetzima
    • Treatment of major depressive disorder (MDD)
    • Amneal Pharmaceuticals Company GmbH—02/04/2019
  • acyclovir cream, 5%—Zovirax Cream
    • Treatment of recurrent cold sores in immunocompetent patients over 12 years of age
    • Perrigo UK FINCO Limited Partnership—02/04/2019
  • Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP) 100mcg/50mcg, 250mcg/50mcg, 500mcg/50mcg—Advair Diskus
    • Treatment of asthma in patient over 4 years of age and COPD maintenance (250mcg/50mcg)
    • Mylan Pharmaceuticals Inc.—01/30/2019
  • sirolimus oral solution, 1 mg/mL—Rapamune
    • Prophylaxis of kidney organ rejection in patient over 13 years of age
    • Novitium Pharma LLC—01/28/2019
  • vigabatrin tablets USP, 500mg—Sabril Tablets
    • Treatment of refractory complex partial seizures (CPS) in patients over 10 years of age that have failed multiple alternative treatments
    • Teva Pharmaceuticals USA, Inc.—01/14/2019
  • ingenol mebutate gel, 0.05%, 0.015%—Picato Gel
    • Treatment of topical acne
    • Perrigo UK PINCO Limited Partnership—01/07/2019 (0.015%) and 01/09/2019 (0.05%)
  • lurasidone hydrochloride tablets, 20mg, 40mg, 60mg, 80mg, 120mg—Latuda Tablets
    • Treatment of schizophrenia and depressive episodes associated with bipolar disorder in adults
    • Torrent Pharmaceuticals Limited, Accord Healthcare Inc., Lupin Limited, InvaGen Pharmaceuticals, Inc., Amneal Pharmaceuticals Company GmbH—01/03/20193

Newest Generics of 2019

  • As of 03/12/2019, the FDA approved a new generic of Diovan (valsartan) among the vast recalls from multiple manufacturers, this was granted to Alkem Laboratories Limited.4
  • Lannett announced FDA approval for aspirin and extended-release dipyridamole capsules, 25mg/200mg—Aggrenox Capsules for secondary prevention of stroke and transient ischemic attacks (TIA) on 03/27/2019.5

Forecasted Generics for the Remainder of 2019

The Impact of Generics

It is a long, grueling process for a brand name medication to finally be released to the market as a generic, taking in excess of 20 years. Generic medications are instrumental in helping alleviate the financial burden of prescription medication costs in patients. Each year, the effect continues to grow. In the first quarter 2019, there is already a large impact with new generic medications coming to market. This impact is forecast to continue throughout the year, especially with the possibility of heavy hitters such as Lyrica and Restasis.

References:

  1. “S.1538 – 98th Congress (1983-1984): An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise the Procedures for New Drug Applications, to Amend Title 35, United States Code, to Authorize the Extension of the Patents for Certain Regulated Products, and for Other Purposes.” gov, 24 Sept. 1984, www.congress.gov/bill/98th-congress/senate-bill/01538.
  2. Center for Drug Evaluation and Research. “Generic Drugs – What Is the Approval Process for Generic Drugs?” U S Food and Drug Administration Home Page, Center for Drug Evaluation and Research, www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/genericdrugs/ucm506040.htm .
  3. Center for Drug Evaluation and Research. “First Generic Drug Approvals.” U S Food and Drug Administration Home Page, Center for Drug Evaluation and Research, fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/
    ANDAGenericDrugApprovals/default.htm
    .
  4. Office of the Commissioner. “Press Announcements – FDA Provides Update on Its Ongoing Investigation into ARB Drug Products; Reports on Finding of a New Nitrosamine Impurity in Certain Lots of Losartan and Product Recall.” U S Food and Drug Administration Home Page, Office of the Commissioner, fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632425.htm.
  5. “Generic Drug for Stroke Prevention Granted FDA Approval.” Pharmacy Times, pharmacytimes.com/news/genericdrug-granted-fda-approval.
  6. “Pipeline Report Generic Drugs .” Welldynerx. welldynerx.com/content/uploads/2019/02/Generic-Drugs-Feb-2019-2-12-19.pdf.
  7. “Upcoming Generic Drugs.” Corporate Pharmacy Services, corporatepharmacy.com/page/upcoming_generic_drugs.

 

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by Jamie L. Voigtmann, PharmD Candidate 2019
Saint Louis College of Pharmacy

In 2014, approximately 4 million people in the United States were infected with hepatitis C virus (HCV).1 According to the Centers for Disease Control and Prevention (CDC), acute HCV infections reported in the United States increased approximately 3.5 times from 2010-2016 (from 850 to 2,967 cases).2 The speculated reasons for this massive increase have been due to increased intravenous drug use (IVDU) as well as more specific & sensitive testing.

There are six genotypes of HCV that have been identified; but of these six, only three make up 97% of HCV infections in the United States.1 These three genotypes include Type 1 (both subtypes a & b), Type 2, and Type 3. HCV was initially discovered in 1989 and since then, a search for a cure has become imminent as HCV plays a major role in the development of chronic liver disease, cirrhosis, hepatocellular carcinoma, and commonly ends in the need for liver transplantation.3

Hepatitis Medications Today

Multiple medications have been proven to treat and/or cure of HCV. A cure is defined as a sustained virologic response (SVR) resulting in an undetectable HCV RNA, 12-24 weeks after treatment is completed.1 In the past, a medication called interferons were used to boost the immune system and attack HCV to defend the body; but in the 2017 AASLD/IDSA Guidelines, interferons are no longer recommended in the treatment of HCV.4 Ribavirin has also been used for acute HCV in the past, but now is only indicated for chronic cases of HCV.7 With both interferon and ribavirin, virological response did not often exceed 50%. Since 2014, four once daily HCV medications have been FDA approved for the treatment of acute HCV in naïve patients that exceed a virological response of 90% after 12 weeks of therapy.4

These more novel hepatitis medications consist of multiple drugs with differing modes of action. There are three classes of drugs that are used to treat HCV and they are called direct acting antivirals (DAA) because they directly attack the HCV genome and replication process.4 These three DAA classes include: NS3/4A Protease Inhibitors, NS5A Inhibitors, and NS5B Polymerase Inhibitors (Nucleoside & Non-Nucleoside).4 All of these medications inhibit replication of HCV in the host cell, stopping the life cycle and preventing its transmission to other host cells. Below is a picture that further explains the mechanism of action of each DAA along with each HCV drug and its corresponding DAA class.5

hepatitis c vaccinations - scriptsave wellrx blog imageDirect Acting Antiviral Classes5

  • NS3/4A Protease Inhibitors
    • Boceprevir
    • Telaprevir
    • Simeprevir
    • Asunaprevir
    • Paritaprevir
    • Grazoprevir
    • Glecaprevir
  • NS5A Inhibitors
    • Daclatasvir
    • Ledipasvir
    • Ombitasvir
    • Elbasvir
    • Velpatasvir
    • Pibrentasvir
  • NS5B Polymerase Inhibitors
    • Sofosbuvir
    • Dasabuvir

Comparing Four Novel HCV Medications6

As mentioned previously, there are four HCV medications approved by the FDA that are one pill taken once daily and can result in cure. These medications include Harvoni (ledipasvir/sofosbuvir), Zepatier (elbasvir/grazoprevir), Epclusa (velpatasvir/sofosbuvir), and Mavyret (glecaprevir/pibrentasvir). Harvoni was approved by the FDA in 2014, Zepatier and Epclusa in 2016, and finally Mavyret in 2017. This is relevant because the two more recent drugs, Epclusa and Mavyret, treat all 6 genotypes of HCV while Harvoni and Zepatier are both first line therapy for genotypes 1 and 4.7

Unlike their differing genotype coverage, side effects for all four of these medications are quite similar. The most common side effects include headache, fatigue, and nausea and the instances for these side effects are approximately 16%, 13%, and 9%, respectively. Other more severe side effects (anemia, diarrhea, insomnia, and irritability) have been reported with these medications but only in combination with interferon or ribavirin as well as with prolonged therapy between 16-24 weeks.5

Cost of Therapy

According to current HCV Guidelines, Harvoni, Zepatier, and Epclusa require 12 weeks (84 days) of therapy.7 Mavyret can be either 8 weeks (56 days) or 12 weeks of therapy depending on the patient’s baseline liver disease.7 Unfortunately, considering both the high cost of medication as well as the long duration of therapy does not allow all patient’s to receive treatment. Harvoni and Epclusa have generics available for patients, and the Brand Name options of Zepatier and Mavyret are thankfully in the same price range as the other generic options. The cost of one tablet for these medications is as follows:6

  • Harvoni:
    • Brand Name: $1,350
    • Generic: $500
  • Epclusa:
    • Brand Name: $1,050
    • Generic: $350
  • Zepatier:
    • Brand Name: $300
  • Mavyret:
    • Brand Name: $200

Because these medications are very costly, a 12-week drug treatment regimen of therapy ranges from $16,800 to $113,400. This is a problem. Many patient’s simply do not have this amount of money to spend on one prescription. This further leads to controversial discussions because as mentioned earlier, HCV plays a major role in the development of chronic liver disease, cirrhosis, hepatocellular carcinoma, and commonly ends in the need for liver transplantation.3

Fortunately, there are patient assistance programs and copay cards offered by the manufacturers of these medications which allow a minimum cost of $0 with patient assistance programs and a minimum cost of $5 for copay cards per 4-week supply. Harvoni and Epclusa are manufactured by Gilead Sciences, Zepatier is manufactured by Merck, and Mavyret is manufactured by AbbVie.

Patient assistance programs require paperwork completed by the patient as well as the prescribing physician. Copay cards only work for Brand Name medications and most commonly require private insurance as a primary payor (not government funded insurances such as Tricare, Medicare, or Medicaid). For more information, check out these websites:

If you need help affording other prescription medications, visit www.WellRx.com. Many prices are lower than insurance copay costs!

References

  1. Kohli A, Shaffer A, Sherman A, Kottilil S. Treatment of hepatitis C: a systematic review. JAMA. 2014;312(6):631-640.
  2. Centers for Disease Control and Prevention. Surveillance for viral hepatitis – united states, 2016. https://www.cdc.gov/hepatitis/statistics/2016surveillance/commentary.htm. Accessed on February 13, 2019.
  3. Chen SL, Morgan TR. The natural history of hepatitis c virus (hcv) infection. Int J Med Sci. 2006;3(2):47-52.
  4. Geddawy A, Ibrahim YF, Elbahie NM, Ibrahim MA. Direct acting anti-hepatitis c virus drugs: clinical pharmacology and future direction. J Transl Int Med. 2017;5(1): 8–17.
  5. Dugum M, O’Shea R. Hepatitis c virus: here comes all-oral treatment. Clev Clin J Med. 2014;81(3):159-172.
  6. HCV Treatments: Harvoni, Zepatier, Epclusa, & Mavyret. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: http://online.lexi.com. February 13, 2019.
  7. Recommendations for testing, managing, and treating hepatitis c. Joint panel from the American Association of the Study of Liver Disease and the Infectious Diseases Society of America. https://www.hcvguidelines.org. Accessed February 13, 2019.

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by Cindy Cho, PharmD Candidate Class of 2019,
The University of Arizona College of Pharmacy

When most people think of a diet that leads to poor diabetes control, they may think of a diet high in carbs and sugar. While those types of food do impact your blood sugars, consuming too many saturated fats can be an enemy against diabetes control,too. This is because a hallmark of pre-diabetes, type 2 diabetes, and worsening type 2 diabetes is insulin resistance.

Saturated Fat and Insulin Resistance

First, what is insulin? Insulin is a hormone produced by your pancreas to control your blood sugar levels. Insulin helps move the sugar from the blood into your cells for storage and energy. In other words, insulin is the key that unlocks the door of our muscle cells to let sugars in. Insulin resistance in the state of your body where insulin is not responding properly to move the sugar into the cells, which causes a rise in blood sugars as a result. The pathophysiology of insulin resistance is somewhat convoluted, but what is known is that saturated fat plays a role. It has been known since 1927 that increased consumption of fat delays the process of blood sugars going into the cells, which means that sugars hang around longer in the bloodstream.1 The results of both animal and human studies also show that a high intake of saturated fat is associated with insulin resistance and development of type 2 diabetes.2 This is because an uncontrolled state of insulin resistance leads to a higher risk of getting type 2 diabetes. People are also at higher risk of insulin resistance if they are overweight or obese.

Not All Fats are Bad

Contrary to the connotation of the word, not all fats are unhealthy. Two main sources of fat that we will focus on are saturated and unsaturated fats. Saturated fats are found commonly in animal products, such as red meats and dairy products. On the other hand, unsaturated fats come from mainly plant based sources and consists of foods like olive oil, nuts, and avocados. Studies have shown that in people with diabetes, saturated fats cause insulin resistance whereas unsaturated fats can improve insulin sensitivity.3 Because of this, the consumption of vegetables fats is favored in place of animal fats and processed grains.3 Not only are plant based foods lower in saturated fats, they are generally lower in calories and jam-packed with nutrients and fiber to nourish the body.

Ways to Improve Insulin Resistance

Lifestyle changes, particularly diet, address ones of the root causes of type 2 diabetes: insulin resistance. Following a plant-based diet can be a solution since animal products can contain a high amount of saturated fat. A plant-based diet generally includes legumes, whole grain, fruits, vegetables, and nuts, and discourages most animal products and refined foods.4 The Adventist 2 study, which included about 89,000 people extended across 50 years, demonstrated a substantial decrease in diabetes incidence in those who ate a vegetarian diet. The study also suggested that those who eat meat once or more days a week have significantly higher rates of diabetes.5 Plant-based diets also have been shown to work better in reducing blood sugars, body weight, and cardiovascular risk compared to diets that include animal-based products.6

Plant-based eating patterns, such as the DASH diet, healthy Mediterranean, and healthy vegetarian diets, have been shown to be associated with better health and lower risk for disease according to nutritional epidemiology, randomized controlled intervention trials, and most literature.7 These diets are also appropriate for the vast majority of people. Furthermore, exercise, with or without weight loss, helps improve insulin sensitivity so your body can use the insulin it naturally produces better.8 That in turn can mean lower doses of your diabetes medications, or even coming off the diabetes medications altogether, which can lower your costs on how much you spend on diabetes care. It is shown that after adjusting for population age and sex differences, the average medical expenses for people living with diabetes were about 2.3 times high than people who do not have diabetes.9

Dangers of Uncontrolled Blood Sugars

Controlling blood sugars is important because the longer a high amount of glucose is in the bloodstream, the more damage it can cause to your blood vessels, nerves, and tissues. Therefore, it is very important to have your doctors check your feet, eyes, and kidneys at least yearly if you have diabetes. People with uncontrolled blood sugars are also at higher risk for cardiovascular complications like heart attacks and strokes and are more prone to infections.10 Plant-based diets have demonstrated improvements in blood sugar control, which can possibly reduce or prevent the incidence of long-term complications of type 2 diabetes.

What You Can Do

Talk to your doctor or dietitian about eating more plant-based foods. It may also be easier to think of changes to what you eat as a lifestyle choice instead of as a diet. Small changes to the foods you consume can make a big impact on your health in the long run. Eating healthier doesn’t mean it has to be more expensive either. Shopping for produce in season, or even visiting your local 99 cent store that carries groceries can be helpful methods to save you money and keep you healthy too. You don’t have to be vegan to experience the benefits of a plant-based diet either. Any steps you take to adding more plant-based foods onto your plate can improve your blood sugars.5

Key Takeaways

To summarize, striving to increase the amount of plant-based foods you eat, minimize consumption of animal-based foods, increase your physical activity, along with taking your diabetes medications regularly, can make a positive impact on your blood sugars and overall health!

References:

  1. Dietary Factors That Influence The Dextrose Tolerance Test, J. Shirley Sweeney MD, Archives of Internal Medicine, December 1927
  2. ARIC Study Investigators; Plasma fatty acid composition and incidence of diabetes in middle-aged adults: the Atherosclerosis Risk in Communities (ARIC) Study, The American Journal of Clinical Nutrition, Volume 78, Issue 1, 1 July 2003, Pages 91–98, https://doi.org/10.1093/ajcn/78.1.91
  3. Rachek, L. (2014). Progress in Molecular Biology and Translational Science (pp. 267-292). Elsevier.
  4. McMacken M, Shah S. A plant-based diet for the prevention and treatment of type 2 diabetes. J Geriatr Cardiol. 2017;14(5):342-354.
  5. Tonstad, S., Stewart, K., Oda, K., Batech, M., Herring, R., & Fraser, G. (2013). Vegetarian diets and incidence of diabetes in the Adventist Health Study-2. Nutrition, Metabolism and Cardiovascular Diseases,23(4), 292-299. doi:10.1016/j.numecd.2011.07.004
  6. Trapp, Caroline B., and Neal D. Barnard. “Usefulness of Vegetarian and Vegan Diets for Treating Type 2 Diabetes.” Current Diabetes Reports, vol. 10, no. 2, 2010, pp. 152–158., doi:10.1007/s11892-010-0093-7.
  7. Laddu, D., & Hauser, M. (2019). Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. Progress In Cardiovascular Diseases, 62(1), 9-14. doi: 10.1016/j.pcad.2018.12.004
  8. Duncan GE, Perri MG, Theriaque DW, Hutson AD, Eckel RH, Stacpoole PW: Exercise training, without weight loss, increases insulin sensitivity and postheparin plasma lipase activity in previously sedentary adults. Diabetes Care 26:557–562, 2003
  9. Economic Costs of Diabetes in the U.S. in 2017. (2018). Diabetes Care, 41(5), 917-928. doi: 10.2337/dci18-0007
  10. American Diabetes Association. 2019 Standards of Medical Care in Diabetes. http://care.diabetesjournals.org/content/42/Supplement_1. Published December 17, 2018. Accessed December 17, 2018.

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by Cindy Cho, PharmD Candidate Class of 2019,
The University of Arizona College of Pharmacy

In short, no. You cannot get pneumonia from the pneumonia vaccine. With all of the news coverage about vaccines, it is important to equip yourself with the knowledge on what vaccines are, how they work, and why they don’t cause disease, so you can make an informed decision on your health.

What is a vaccine?

A vaccine is a substance that contains very small amounts of weakened or dead germs to stimulate your body to produce immunity against certain diseases. Before the invention of vaccinations, the only way a person’s body can gain immunity to certain diseases is to (hopefully) survive an infection from the germ that causes the disease. For example, if a person gets pneumonia, an infection of the lung, from a certain germ and survives, their body will remember that specific germ if it were to come across it again. By remembering the germ, the body can protect itself and fight off the infection more efficiently to prevent sickness in the future. Vaccines provide a similar immune system response to help the body create immune system cells to remember disease-causing germs to protect your body, but the best part is that vaccines don’t come with the risks of getting the actual disease or its associated complications. Some vaccines can provide protection against multiple types of germs that cause the same disease to better protect against epidemics.1

What are pneumonia vaccines?

Now that you understand how vaccines work, let’s talk about the pneumonia vaccines! There are two pneumonia vaccines intended for use in the United States by the Food and Drug Administration (FDA), which includes the pneumococcal conjugate vaccine (PCV13 or Prevnar 13) and the pneumococcal polysaccharide vaccine (PPSV23 or Pneumovax 23).2 Both of these pneumonia vaccines contain inactivated, or dead, germs. Because these vaccines contain dead germs, they cannot replicate in the body or cause disease.1 The differences between the two pneumonia vaccines are shown below:

  • Prevnar 13: this is a conjugated vaccine, which means it contains a protein that is joined to a part of dead bacteria to improve the protection the vaccine provides. Doctors give this vaccine to children at 2, 4, 6, and 12 through 15 months old. Young children need multiple doses of this vaccine to boost their protection since their immune system is not yet mature. Adults who need this vaccine only get a single dose. The vaccine has 13 in its name because it helps protect against 13 types of pneumococcal bacteria that most commonly causes serious infections in children and adults.2
  • Pneumovax 23:  this is a polysaccharide vaccine, which means it is made to look like the surface of certain bacteria in order to help the body build protection against that germ. Doctors give a single dose of this vaccine to people who need it. CDC recommends one or two additional doses for people with certain chronic medical conditions. The vaccine has 23 in its name because it helps protect against serious infections caused by 23 types of pneumococcal bacteria.2

 So, who needs the pneumonia vaccines?

Great question! Pneumonia disproportionately affects the young, the elderly, and the immunocompromised, so the CDC recommends these vulnerable patient populations to receive the pneumonia vaccines.3 The CDC created an immunization schedule that outlines when the two pneumonia vaccines should be received.

CDC recommends vaccination with the pneumococcal conjugate vaccine (PCV13 or Prevnar 13®) for:2

  • All children younger than 2 years old
  • All adults 65 years or older
  • People 2 through 64 years old with certain medical conditions*

CDC recommends vaccination with the pneumococcal polysaccharide vaccine (PPSV23 or Pneumovax23®) for:2

  • All adults 65 years or older
  • People 2 through 64 years old with certain medical conditions*
  • Adults 19 through 64 years old who smoke cigarettes

*Certain medical conditions such as: chronic heart disease, lung disease, liver disease, diabetes, HIV, or certain cancers warrant some adults to receive the pneumonia vaccines before the age of 65.4

What are the side effects of the pneumonia vaccines?

Reactions to the pneumonia vaccine can occur, such as cold-like symptoms, but it is important to realize that those are adverse reactions to the vaccine and not pneumonia itself. Talk to your doctor if you have allergies to any ingredients in vaccines. Below are common adverse reactions to the pneumonia vaccines:

Mild side effects reported with Prevnar 13 can include:2

  • Reactions where the shot was given
    • Redness
    • Swelling
    • Pain or tenderness
  • Fever
  • Loss of appetite
  • Fussiness (irritability)
  • Feeling tired
  • Headache
  • Chills

Mild side effects reported with Pneumovax23 can include:2

  • Reactions where the shot was given
    • Redness
    • Pain
  • Fever
  • Muscle aches

Why are the pneumonia vaccines important?

Vaccines, like the pneumonia vaccines, can prevent or decrease the severity of diseases. Unfortunately, around 50,000 people die from pneumonia in the United States each year.3 It is passed along through airborne droplets, such as from a cough or sneeze, so it is a highly contagious infection.2 It is crucial to receive the pneumococcal vaccine to not only protect yourself but to protect your loved ones around you. Especially if you have a breathing condition like asthma or COPD, it is important to have the pneumonia vaccines to prevent respiratory infections that can potentially make your breathing worse. Talk to your provider or local pharmacy if you are due for your pneumonia vaccine today.

References:

  1. Principles of Vaccination. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/pubs/pinkbook/prinvac.html. Published September 8, 2015. Accessed February 14, 2019.
  2. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/vpd/pneumo/public/index.html. Published December 6, 2017. Accessed February 14, 2019.
  3. Top 20 Pneumonia Facts (2018). American Thoracic Society.  https://www.thoracic.org/patients/patient-resources/resources/top-pneumonia-facts.pdf. Accessed February 14, 2019.
  4. Recommended Adult Immunization Schedule for ages 19 years or older, United States, 2019. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html#note-pneumo. Published January 2019. Accessed February 14, 2019.

 


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by Jamie L. Voigtmann, PharmD Candidate 2019
Saint Louis College of Pharmacy

There are many aspects in life that can decrease prescription fill rates. This in turn causes medication non-adherence, where patients are unable to take their medications regularly as prescribed by a physician. It’s a common and costly problem across America.

What Prevents Patients from Filling Prescriptions?

Barriers to medication adherence include lifestyle preferences, fear or uncertainty about the effectiveness of new medications or adverse reactions, The complexity of instructions and or drug regimens, personal beliefs, and insufficient funds also come into play.1 Patients who have insufficient funds to pay for medications include, not only decreased socioeconomic status, but also all patients that qualify as low-income based on age, gender, race, location, and family size. Patients who have financial restrictions will commonly delay prescription refills, as well as subsequent copays, by splitting pills, taking pills every other day, or even discontinuing medications on their own. This is because many chronic conditions require multiple medications for treatment and many medications are expensive even with insurance.1

The Low-Income Populations Includes Elderly Patients

As mentioned previously, low-income patients not only include race, location, and family size, but also age. As patients become ≥ 65 years old they are most likely dependent on Medicare for health insurance coverage, since it is offered through the government. Elderly patients who experience decreased prescription fill rates have been associated with having increased out-of-pocket costs with prescription medication coverage, lower net worth, and lower household incomes.2 This is important to consider because as patients age their health often declines, indicating more need for medications. It is also imperative to think about this aspect as many Baby Boomers fall into this category, increasing the number of patients sharing Medicare benefits.

Which Types of Medications Do Low-Income Patients Struggle To Get?

A common misconception is that patients with low-income only have trouble affording newer novelty medications, such as HIV, Hepatitis C, and oncology medications. With these types of medications, many patients including the middle and upper economic classes struggle to pay for the medications due to the outstanding drug cost dictated by the manufacturers. Low-income patients also struggle with common health conditions such as asthma, diabetes, and high cholesterol. Patients who are in a lower socioeconomic class experience significantly less control over their asthma and commonly experience increased exacerbations compared to patients who belong to a higher economic class.3

When considering Type-2 Diabetes Mellitus, patients with high-incomes had increased compliance to treatment regimens including diet, exercise, and medications.4 The high-income patient’s also checked their A1c more often and were associated with higher self-care ability.4 Finally considering cholesterol medications, a recent study showed that low-income patients were willing to give up their cholesterol medications if a copay was present because the benefits are not commonly felt unlike insulin for diabetes or lisinopril for increased blood pressure.5

Low-Income vs. High-Income Prescriptions

It is interesting to realize what types of medications low-income patients are filling at the pharmacy, compared to high-income patients. According to The New York Times, high-income patients receive more cosmetic medications to treat baldness, erectile dysfunction, wrinkles, and eyelashes.6 These patients were also more likely to purchase medications to treat mental health.6 They also had more prescriptions for birth control pills due to a consistent prescription from a regular doctor.6 Medications that are more commonly received by low-income patients include HIV and Hepatitis C, most likely due to lack of education in transmission and poor access to healthcare.6

Lowering Overall Drug Costs

Overall, the relationship between income and prescription fill rates at the pharmacy is much more complicated than low-income patients having decreased prescription adherence.6 Different patients are more likely to develop certain diseases or illnesses that would increase healthcare costs. Patients also differ on when they seek medical attention, resulting in a significant cost even before a physician writes a prescription.6 Regardless of income, it’s important to treat patients with as few medications as possible while still treating chronic conditions to help lower overall drug costs for all patients.

References:

  1. Mishra SI, Gioia D, Childress S, Barnet B, Webster RL. Adherence to medication regimens among low-income patients with multiple comorbid chronic conditions. Health Soc Work. 2011; 36(4): 249–258.
  2. Zivin K, Ratliff S, Heisler MM, Langa KM, Piette JD. Factors influencing cost-related nonadherence to medication in older adults: a conceptually based approach. Value Health. 2010; 13(4): 338-45.
  3. Bacon SL, Bouchard A, Loucks EB, Lavoie KL. Individual-level socioeconomic status is associated with worse asthma morbidity in patients with asthma. Respir Res. 2009; 10: 125.
  4. Habib F, Durrany AM. Effect of age and socio-economic status on compliance among type 2 diabetic patients. Curre Res Diabetes & Obes J. 2018; 7(3): 555714.
  5. Watanabe JH, Kazerooni R, Bounthavong M. Association of copayment with likelihood and level of adherence in new users of statins: a retrospective cohort study. J Manag Care Pharm. 2014; 20(1): 43–50.
  6. Quealy K, Sanger-Katz M. The prescription drugs that rich people buy. The New York Times. February 7, 2019. https://www.nytimes.com/2019/02/07/upshot/income-strong-predictor-drug-purchases-serious-diseases.html. Accessed March 9, 2019.

 


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hypothyroidism - dr. checking patient - scriptsave wellrx blog

by Jamie Voigtmann, PharmD Candidate

Your body has a number of glands, but the thyroid gland is the small gland at the base of your neck that makes hormones to regulate your metabolism. This impacts your body’s metabolic rate (how you burn calories) as well as heart and digestive function, mood, and more. But what happens if something impacts the thyroid?

How Does the Thyroid Work?

First, the hypothalamus releases TRH which activates the pituitary to release TSH.1 This in turns activates the thyroid to produce and release T4 and T3 into the body but at an approximately 14:1 ratio, with T4 being 14 and T3 being 1.2 Then T4 and T3 bind to proteins and travel to other tissues in the body. There, the T4 will be changed to T3 by removing one molecule iodine.1 This is important because T3 is the active thyroid hormone unlike T4, which is inactive; T3 allows the body to control metabolism, temperature, and heart rate.1 Finally, the T4 and T3 in the body cause a negative feedback loop to the hypothalamus and pituitary. This can make the hypothalamus and the pituitary produce more hormones when T4 and T3 are low or produce less hormones when T4 and T3 are high.1

thyroid process - diagram - scriptsave wellrx blog image

What are the Causes and Symptoms of Hypothyroidism?

Hypothyroidism is most commonly caused by an autoimmune disorder which is when the body’s immune system attacks its own tissues rather than infections. Because of this, the autoimmune disorder causes a decreased amount of T4 and T3 being made.3 Other causes, although unlikely, include a low amount of iodine through diet, removal of the thyroid, radiation therapy for cancer treatment, and certain drugs (amiodarone, lithium, iodine, and rifampicin). Signs and symptoms of hypothyroidism are commonly dry skin, sensitivity to the cold, constipation, poor memory, fatigue, weight gain, puffiness around the eyes, and a slowed heart rate. These signs and symptoms are highly suggestive of hypothyroidism, but alone cannot diagnose this condition. Diagnostic measures most commonly include high TSH levels and low T4 levels.

What are the Treatment Options?

Synthetic T4 Replacement

The most common T4 replacement medication is levothyroxine, and it is recommended as the first treatment option for hypothyroidism.2 Although it is not the active form (T3), it can be made into T3 in the body’s tissues and is generally well-tolerated by many patients. Benefits of levothyroxine include normalizing thyroid function, once daily dosing, few side effects, low cost, and safety in pregnancy.2 But one thing that is very important and specific about levothyroxine is how it is taken. Levothyroxine must be taken on an empty stomach so that it can be appropriately absorbed by the body.3 This is easiest to accomplish in the morning right after waking up, at least 30 minutes before eating breakfast; but, it is possible to take levothyroxine before bedtime as long as it is 4 hours after eating.2 Levothyroxine must also be taken separately (approximately 4 hours before or after) from products such as calcium, iron, and antacids that contain aluminum or magnesium in order to optimize its absorption and efficacy.3 These products are commonly in the form of vitamins or supplements, as well as Tums, Mylanta, Milk of Magnesia, Alka-Seltzer, Maalox, and Rolaids.

Synthetic T3 Replacement

Hypothyroidism therapy also can consist of liothyronine, which is the active form of thyroid hormone: T3. Liothyronine has some disadvantages for the treatment of hypothyroidism when compared to levothyroxine. Currently it is only approved for once daily dosing, but this does not mimic the true release pattern of T3 from the thyroid.4 One small, randomized study showed an improvement in weight loss and decreased lipid profile compared to levothyroxine, but only if liothyronine was taken three times daily.4 Because of this, liothyronine is not currently recommended over levothyroxine because it’s once daily dosing does not provide better results.2 But, it is possible an extended-release formulation of liothyronine can prove to be clinically beneficial in the future.2 Overall, liothyronine has some disadvantages for the treatment of hypothyroidism when compared to levothyroxine such as unknown dosing schedule for best effect and increased cost.

Synthetic Combination Therapy

Some medications used to treat hypothyroidism have a mixture of T4 and T3. Unfortunately, there are many differing studies with different T4:T3 ratios and have unclear results.3 But, many of these clinical trials do not show benefit of T4 and T3 over T4 alone (levothyroxine).2 It has been reported that few patients taking levothyroxine alone still experienced signs and symptoms of hypothyroidism, although their TSH level was corrected to its normal value; and it has been discussed that these patients could potentially benefit from combination T4 and T3 therapy, but evidence is limited.2,3 Overall, levothyroxine remains the standard of care when treating hypothyroidism, with combination therapy of T4 and T3 only being considered after a patient tries levothyroxine and it does not work effectively.2

Natural Desiccated Therapy

This type of hypothyroid medication is also a combination of T4 and T3 but instead of being synthetic (made from chemicals), it is naturally obtained. This is because it is derived from thyroids of animals, particularly domesticated pigs.2,5 The common name of this type of medication is Armour Thyroid.5 The T4:T3 ratio is always 4:1, unlike the natural body’s ratio of 14:1.2 This can lead to an increased level of T3 at once and can result in adverse effects including increased heart rate and anxiety.2 But, there was one minor study completed that reported results of patients preferring desiccated therapy over levothyroxine due to decreased symptoms of hypothyroidism.5 Because this study was small, did not use appropriate questionnaires, and did not assess safety, it does not warrant its use over levothyroxine for hypothyroidism.2 Natural desiccated therapy falls into the same category of combination therapy . It should only be considered for patients who have tried levothyroxine and did not correct his/her thyroid function.2

References

  1. Yen PM. Physiological and molecular basis of thyroid hormone action. Physiol Rev. 2001; 81(3): 1097-1142.
  2. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the american thyroid association task force on thyroid hormone replacement. Thyroid. 2014; 24(12): 1670–1751.
  3. Chakera AJ, Pearce SHS, Vaidya B. Treatment for primary hypothyroidism: current approaches and future possibilities. Drug Des Devel Ther. 2012; 6: 1–11.
  4. Celi FS, Zemskova M, Linderman JD, et al. The pharmacodynamic equivalence of levothyroxine and liothyronine. a randomized, double blind, cross-over study in thyroidectomized patients. Clin Endocrinol (Oxf). 2010; 72(5): 709–715.
  5. Hoang TD, Olsen CH, Mai VQ, Clyde PW, Shakir MK. Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism: a randomized, double-blind, crossover study. J Clin Endocrinol Metab. 2013; 98(5): 1982-1990.
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ScriptSave WellRx app pill refill reminders - blog image

by Dan Johnson, RPh and PharmD,
Vice President of Network Strategy, ScriptSave

The risk for medication interactions dramatically increases as patients take multiple drugs. ScriptSave’s own Dr. Dan Johnson recently had an article published on the Living Better 50 website on steps you can take to protect yourself from dangerous drug interactions.

*****

More than 2 million patients are hospitalized every year after they inadvertently mix their prescription drugs, while another 100,000 die annually. And the statistics get worse with age. The chance of an adverse drug reaction for people over 50 jumps 33 percent versus younger people.

Even over-the-counter medications and supplements can incite dangerous health risks.For example, patients with high blood pressure should avoid taking cough medicines with decongestants and should consult their pharmacist on the best options to seek relief from cold and flu symptoms. Patients taking prescriptions for depression, chest pain, ADHD, gout, arthritis and other common ailments can frequently be at more risk for dangerous reactions if they don’t keep track of their prescription regimen.

How Can Patients Protect Themselves From Drug Interactions?

  1. Ideally, patients should go to the same pharmacist and discuss any other prescriptions they may be taking. This conversation should include over-the-counter and supplements – in addition to any medications.
  2. Be aware of how common household foods can impact medications. People who take Lipitor or Zocor with grapefruit juice may experience muscle pain and other side effects.
  3. As we age, our bodies metabolize drugs slower and at different rates. Because of this, patients should monitor any reactions to any new or existing drugs.
  4. There are many user friendly, free mobile apps that keep track of a patient’s regimen – alerting them to potential dangerous interactions. ScriptSave WellRx has a new “Virtual Medicine Cabinet” that warns patients of hazardous drug interactions. It also sends reminders when patients need to take their next pill, or need a refill.

Read the full story on living50better.com.

 

————–Addendum (13 Mar, 2019)————–

…and check out what Dr Max Gomez had to say on CBS News, including an interview with ScriptSave’s Dr Dan Johnson.

 

 


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probiotics - yogurt image - scriptsave wellrx blog

by Terra Leon, PharmD Candidate 2019

Bacteria in food might not sound like a good thing, but probiotics are good bacteria that mimic the natural bacteria you have in your gut. The bacteria that naturally occurs in the gut supports proper gastrointestinal health and digestion. Different strains of probiotics can also support other functions in the body such as reduce vaginal infections, prevent autoimmune disease, reduce urinary tract infection rate, and ease skin ailments2.

Sources of Probiotics

Probiotics can be taken in several ways. As supplements, much like vitamins, or in dairy products, like yogurt, cheese, lactobacillus milk or kefir.

When choosing a dairy product like yogurt for your intake of probiotics it is important to choose a yogurt that has “Live and Active Cultures” on the product label. This statement means that the yogurt has at least 100 million active cultures per gram of yogurt1.  If you choose to use supplementation in the form of a capsule you should try and choose a product with a strain of probiotic that aids in the reason you are taking it. To start, most patients use a probiotic supplement that has both species of Bifidobacterium and Lactobacillus because these species are most commonly found in the gastrointestinal tract and aid in digestive health1. A commonly prescribed probiotic is VSL #3. Ask your doctor or pharmacist if this could be right for you.

What are Antibiotics

Antibiotics are widely used when a patient has a bacterial infection in the body. They work by inhibiting growth and replication of the bad bacteria that has infected your body. Different antibiotics target different bad or foreign bacteria in your body. Some even have a wide spectrum of activity and can wipe out the bad bacteria and the beneficial.

Purpose of Combined Use

When a patient receives a new antibiotic from their doctor, they are often told at the pharmacy that this medication has the potential to cause stomach upset or diarrhea for up to a month after use. The reason this happens is the antibiotic taken for an infection is powerful enough to kill off most bacteria in the body during the period it is being consumed. This includes the normal flora in your gut which helps with digestion and stool formation. Taking a probiotic with the species Bifidobacterium and/or Lactobacillus can greatly help reduce the likelihood of prolonged diarrhea and stomach pain. Once the antibiotic is consumed it will wipe out the bacteria in your stomach (good and bad) so taking a probiotic to help replace the good digestive bacteria can help reduce stomach upset. When using probiotics with antibiotics it is important to separate the two by 2 hours to ensure the antibiotic doesn’t wipe out the probiotic you just consumed. Using probiotics during antibiotic treatment and up to 3-7 days after antibiotic treatment can reduce the likelihood of stomach upset5. Always check with your doctor or pharmacist to ensure the use of probiotics is appropriate.

Risk vs Benefit

Probiotics are great in aiding in digestive health and preventing unwanted disorders. However, for those who are immunocompromised the risk can out weigh the benefit. Since the majority of probiotics work in the digestive tract side effects like gas and bloating are a possibility. Patients who have a compromised immune system, have certain bowel problems or are severely ill need to consult their doctor before starting a probiotic. Pregnant women and young children need to consult their doctor before starting probiotics.

Common Species/Strains of Probiotics Available

Species

  • Bifidobacteria (B.): commonly used in food and supplements to support your immune system, decrease growth of harmful bacteria in gut, and help breakdown lactose into nutrients2.
  • Lactobacillus (L.): produces lactase to breakdown lactose and produce lactic acid. Lactic acid helps reduce the amount of harmful bacteria and can fuel the body’s absorption of minerals2. This species of bacteria is commonly found in the mouth, vagina and small intestines.

Strains

  • animalis: helpful in supporting digestion, supporting immune health and fighting food borne bacteria2.
  • breve: works in the digestive tract and vagina to reduce yeast and ferments sugars to help your body absorb the nutrients2.
  • lactis: improves digestion, lower cholesterol and enhances immunity and fights tumor growth3.
  • longum: found in the GI tract and aids in the breakdown of carbohydrates and has antioxidant properties2.
  • acidophilus: found in the small intestines and the vagina. Helps to improves blood pressure and cholesterol, fights off bacterial/viral/fungal infections, aid in digestion and even reduce allergy severity3.
  • reuteri: found in the mouth and intestines. It helps fight off gingivitis by reducing oral bacteria that causes tooth decay and can help re-establish the pH of the vagina and aid in the digestive system2,3.
  • rhamnosus gg: boost immune system, reduce allergies and inflammation and can aid in digestive support by decreasing constipation, leaky gut symptoms and IBS symptoms3.
  • plantarum: can improve your overall health by improving your digestion and immunity. This strain of probiotic has a growing temperature that is very close to our body temperature allowing it to thrive3.
  • gasseri: found in the digestive and vaginal tract. This strain can assist with weight loss by possibly suppressing dietary fat absorption in the small intestines and in turn inhibiting calorie intake4.
  • casei: improves immunity, allergies (pollen), digestion (fights diarrhea) and can improve cholesterol levels3.
  • brevis: can reduce mouth ulcers and periodontal disease. This strain has also been seen to reduce urinary oxalate levels (kidney stones) and decrease H. pylori colonization3.
  • salivarius: found in the colon, vagina, small intestines and mouth. This strain can improve dental health, immunity and digestion3.

Resources:

  1. “What are probiotics?” Mayo Clinic. 14 Apr. 2017. Mayo Foundation for Medical Education and Research. 23 Jan. 2019 <https://www.mayoclinic.org/what-are-probiotics/art-20232589>.
  2. “6 Most Common Types of Probiotics.” Healthline. Healthline Media. 23 Jan. 2019 <https://www.healthline.com/health/types-of-probiotics#benefits>.
  3. Jerkunica, Evan. “About Top 15 Most Researched Probiotic Strains.” Lactobacillus plantarum Benefits & Side Effects – Probiotics.org. 2014. 23 Jan. 2019 <http://probiotics.org/strains/>.
  4. Leech, Joe. “Probiotics and Weight Loss Review: Microscopic Miracle or Mirage?” DIET vs DISEASE. 17 Dec. 2018. 23 Jan. 2019 <https://www.dietvsdisease.org/probiotics-and-weight-loss-review/>.
  5. Sherman, Max. “Probiotics and Microflora.” U.S. Pharmacist – The Leading Journal in Pharmacy. 17 Dec. 2009. 23 Jan. 2019 <https://www.uspharmacist.com/article/probiotics-and-microflora>.

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2019 opioid guidelines - scriptsave wellrx blog image

by Katie Tam, PharmD Candidate,
University of Arizona College of Pharmacy

In October 2017, Acting Health and Human Services (HHS) Secretary Eric D. Hargan issued a statement declaring a nationwide public health emergency regarding the opioid crisis.1 The opioid epidemic in America has become a top priority in efforts to prevent opioid overuse.

Opioids are a drug class that includes heroin, oxycodone, hydrocodone, codeine, morphine, fentanyl, and many other prescription pain relievers. These medications can carry serious risks, like addiction, overdose, and even death.

The U.S. Department of Health and Human Services (HHS) reported that more than 42,000 people died from overdoses involving opioids and estimated 40% of opioid overdose deaths involved a prescription opioid.2

New Medicare Part D Opioid Overutilization Policies

To help you use prescription opioid pain medications more safely, the Centers for Medicare and Medicaid Services (CMS) has recently introduced new regulations in the Medicare part D prescription drug program. Using recommendations made by Centers for Disease Control and Prevention (CDC) on prescribing opioids for pain, CMS developed new safety measures. Here are some key points that are crucial to understand:

  1. New Opioid Users: Your Medicare drug plan and pharmacist will do safety reviews of your opioid pain medications when you fill a prescription. If you are a new opioid user, you may be limited to a 7 day supply or less. The hope is to reduce the risk of longer-term opioid misuse through closer management of opioid naïve patients.2 This policy will affect Medicare patients who have not filled an opioid prescription within the past 60 days and will prevent pharmacies from filling a new opioid prescription exceeding a 7 days supply.2
  2. Limited Opioid Amount: During the safety review, your pharmacist will also look for potentially unsafe opioid amounts and drug-drug interactions that may increase your risk of overdose. If your pharmacist decides that your total opioid prescription dose is not safe, the plan may limit your coverage of these drugs. This alert will identify patients that may benefit from closer monitoring and care coordination and encourage doctors to educate patients about opioid overdose risk and prevention.3
  3. High-Risk Opioid Users: This new regulation allows Medicare drug plans to implement a drug management program (DMP) that limits access to opioids and benzodiazepines (used for anxiety and sleep) for patients at high risk of opioid abuse.3 High risk patients will need to obtain their opioids from specified doctors or pharmacies. Before Medicare places you in a DMP, it will notify you by letter. The goal of this program is to identify potential at-risk patients and provide better care coordination for safer use of opioids and benzodiazepines.3

Opioid Policy Exclusions

The new opioid regulations do not apply to patients with cancer, those who get hospice, palliative, or end-of-life care, or who live in a long-term care facility. Also, patients who use the medication-assisted treatment (MAT) program will not be impacted by these new policy changes.2

About 115 patients die every day from an opioid overdose. Because opioid addiction is driving this epidemic, the hope is that these new regulations will reduce the negative impacts of the epidemic on Americans.4 If you suffer from severe or long-term pain, talk with your doctor about all your pain treatment options including whether taking an opioid is appropriate for you. There may be other ways to manage your pain with less risks.

Resources:

  1. HHS Acting Secretary Declares Public Health Emergency to Address National Opioid Crisis https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html
  2. A Prescriber’s Guide to the New Medicare Part D Opioid Overutilization Polices for 2019. Centers for Medicare and Medicaid Services. https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/RxUtilization.html. Accessed January 20, 2019.
  3. CY 2019 Final Call letter. Centers for Medicare and Medicaid Services. https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf. Accessed January 20, 2019.
  4. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep. 2016;65:1-49, available at http://dx.doi.org/10.15585/mmwr.rr6501e1.

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nocturnal cramps - scriptsave wellrx blog image

by Katie Tam, PharmD Candidate
Class of 2019, University of Arizona

Do you wake up in the middle of the night feeling as if your lower legs are paralyzed and cramped? Do your lower leg muscles feel as if they are hard to the touch and tight? If you experience these symptoms, you may have nocturnal leg cramps.

What are Nocturnal Leg Cramps?

Nocturnal leg cramps (leg cramps at night), also called Charley horses, are involuntary contractions or spasms of the muscles in the legs that usually occur during the night. These leg cramps often involve the posterior calf muscles, but can also involve the feet or thigh muscles. Because the muscles are tightened and knotted, nocturnal leg cramps are extremely painful sensation. Symptoms of straining, tightening, cramping, and knotting may last up to 10 minutes per episode.1 Since leg cramps can last for a while, the patient may experience muscle tenderness and soreness for up to a day after symptoms are gone. Nocturnal leg cramps are more common in women and in adults over the age of 50.1 Laboratory evaluation and specialized testing are usually not necessary to confirm diagnosis.

Are Nocturnal Leg Cramps the Same as Restless Leg Syndrome? 

In a word, no. Nocturnal leg cramps are not the same as RLS (Restless Leg Syndrome).

Nocturnal Leg Cramps Restless Leg Syndrome
Usually occurs at night or at rest Usually occurs at night or at rest
Cause pain and cramping Cause discomfort and crawling sensation
Stretching the muscle relieves pain Moving the legs relieves discomfort

Causes of Nocturnal Leg Cramps

The exact cause of nocturnal leg cramps is often unknown. However, there are several factors that may increase your risk of leg cramps:

  • Sedentary lifestyle
  • Over-exertion of the muscles from exercise
  • Standing for long periods of time
  • Improper sitting position, like crossing your legs1

The following medical conditions are also known to cause nocturnal leg cramps:

  • Pregnancy
  • Endocrine disorders (diabetes, hypothyroidism)
  • Structural issues (flat feet, spinal stenosis)
  • Neurodegenerative disorders (Parkinson’s disease)
  • Neuromuscular disorders (myopathy, peripheral neuropathy)
  • Medications (diuretics, intravenous iron sucrose, raloxifene, statins, naproxen, conjugated estrogens, beta agonists)
  • Dehydration/electrolyte imbalances2

Management and Treatment of Leg Cramps

  1. Stretch: The best method to relive pain and cramps is to stretch the affected muscle and hold the stretch for one minute.
  2. Exercise: Walking around sends a signal to the muscle that it needs to relax after contracting, which will help ease the leg muscle.
  3. Massage: Kneading, rubbing, and massaging the affected muscle can also relieve the cramps.
  4. Apply heat: Other methods that have shown some benefit include taking warm baths and showers, and applying a hot towel or pad to the affected area to relax the tight muscles.2
  5. Over the counter medications: No current medications have shown safe and effective results in patients with nocturnal leg cramps. However, calcium channel blockers (diltiazem), vitamin B12 complex, carisoprodol (Soma) have some good evidence and may be considered in some patients.3 Magnesium have some benefit in pregnant patients and mixed results in non-pregnant patients with leg cramps. No evidence supports the use of nonsteroidal anti-inflammatory drugs (naproxen), potassium, or calcium.3

Prevention and Self-Care Strategies:

  1. Hydration: Drink lots of water and fluids every day to keep your body hydrated and help your muscles contract and relax more. Men should drink 15.5 cups (3.7 liters) of fluids and women should drink 11.5 cups (2.7 liters) of fluids a day.
  2. Stretch before bed: If you experience nocturnal leg cramps, stretch your calf muscles for a few minutes before bed.
  3. Doing light exercise: Walking around your neighborhood or house before bedtime may help prevent leg cramps at night.
  4. Wearing comfortable shoes: Wearing shoes that support your feet can help prevent leg spasms.
  5. Untucking the covers: Loosening the bed covers at the foot of the bed will give your legs more space to move and prevent cramps.1

The next time you experience nocturnal leg cramps, identify the cause. Then, try one of the treatment methods to relieve your leg cramps. After resolving your leg cramps, use the self-care strategies to help prevent future leg cramps. However, if your leg cramps persist for long periods of time and occur every day, talk to your physician to determine whether or not you have leg cramps or other alternative medications that are appropriate.

Resources:

  1. Leg Cramps at Night. https://my.clevelandclinic.org/health/diseases/14170-leg-cramps-at-night. Accessed January 10, 2019.
  2. American Academy of Family Physicians. Nocturnal Leg Cramps. Accessed January 10, 2019.
  3. Abdulla AJ, Jones PW, Pearce VR. Leg cramps in the elderly: prevalence, drug and disease associations. Int J Clin Pract. 1999;53(7):494–496.

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does tamiflu help - scriptsave wellrx blog post image

by Terra Leon, PharmD Candidate 2019

Tamiflu (oseltamivir) is a prescription medication used in the treatment of influenza in patients 2 weeks and older. It can also be indicated as prophylaxis treatment from the flu and reduce the chances of getting the flu in patients 1 year and older1.

tamiflu package-flu shot image - scriptsave wellrx blog

How does Tamiflu work?

Tamiflu (oseltamivir) is a prodrug, meaning that the drug is metabolized into the active drug after it is administered. Prodrugs are beneficial when the active drug itself has low availability in circulation and is not absorbed well in the stomach. Prodrugs are designed to not only increase the amount active drug in circulation, improve elimination but they also can reduce adverse effects or unintended side effects. Once Tamiflu is metabolized into the active drug, the active drug blocks replication of the virus in the body3. Tamiflu stops the replication process of the influenza virus in your body, it does not cure you of the flu rather it shortens the duration of flu like symptoms in the body by about 1-2 days.

Can everyone use Tamiflu?

Tamiflu (oseltamivir) is recommended in patients for treatment of influenza who are 2 weeks and older and is to be initiated within 48 hours of influenza symptom onset2. Tamiflu may also be prescribed for patients who were exposed to a confirmed flu diagnosis within 48 hours of close contact with the infected individual2. Patients who use Tamiflu >48 hours of symptom onset or exposure may still benefit from the medication, specifically children4. A study was done in children indicating that if Tamiflu was administered within 5 days of symptom onset that overall flu symptoms were reduced by 1 day when compared to placebo4.

Tamiflu side effects

The main side effects patients experience while using Tamiflu are headache, nausea and vomiting3. Please seek medical attention if you have any serious skin and hypersensitivity reaction.

Misconceptions about Tamiflu

Tamiflu will cure me of the flu

Most patients have the misconception that Tamiflu will cure them of the flu, when in reality the medication works by reducing the number of days with flu like symptoms. There is not direct cure for the flu since it is a viral entity, like the common cold. All we can do is treat our symptoms to ease the burden of the virus on the body. The most effective way to protect yourself from the flu is to receive your flu vaccination annually.

Tamiflu is a replacement for the flu shot

Tamiflu or any antiviral medication is not a replacement treatment for the flu vaccine itself. Receiving the flu vaccine is the primary defense to protect yourself from the flu. Antiviral medications are second line when the flu vaccine is not available or contraindicated for the individual4. Most insurance companies will cover the flu vaccine at little to no cost at all where Tamiflu (oseltamivir) can cost anywhere from $50-$135 depending on insurance and quantity needed5. That being said, receiving the flu vaccine protects you from the unwanted flu symptoms as well as the unwanted cost of medication, doctor office visits, and valuable time off work and school.

When I take Tamiflu I cannot get sick

There is no evidence that Tamiflu has any effect on any other illness in the body that does not contain influenza viruses, including bacterial infections. Some bacterial infections can initially present as influenza, it is important to be tested for influenza before starting Tamiflu as the sole treatment2. Always follow up with your doctor if you suspect a secondary bacterial infection in order to be treated appropriately.

Resources:

  1. “Fever, aches, chills. Check your symptoms and learn more about a prescription flu treatment.” Tamiflu.havaswwsfdev.com. 2019. 15 Jan. 2019 <https://www.tamiflu.com/>.
  2. Tamiflu Prescribing Information. 2018. 15 Jan. 2019 <https://www.gene.com/download/pdf/tamiflu_prescribing.pdf>.
  3. “Tamiflu (oseltamivir).” Facts & Comparisons. 15 Jan. 2019 <https://fco.factsandcomparisons.com/lco/action/search?q=tamiflu&t=name&va=>.
  4. “Influenza (Flu).” Centers for Disease Control and Prevention. 22 Nov. 2013. Centers for Disease Control and Prevention. 15 Jan. 2019 <https://www.cdc.gov/flu/news/flu-antiviral-benefits.htm>.
  5. “Tamiflu (oseltamivir).” ScriptSave Wellrx.  Feb 2019 https://www.wellrx.com/prescriptions/tamiflu/

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alternatives toSudafed for HBP patients - allergy image - scriptsave wellrx

by Katie Tam
PharmD Candidate Class of 2019, University of Arizona

It’s allergy season and you can’t breathe the fresh air because your nose is congested and stuffed. You visit the pharmacy and purchase a box of Sudafed. Your pharmacist asks if you have a history of high blood pressure, and you answer “yes.” The pharmacist replies that she does not recommend Sudafed for you, but why?

What you need to know about Pseudoephedrine:

Brands of common over-the counter decongestants that contain pseudoephedrine: Allegra-D, Alka Seltzer Plus Cold Medicine Liqui-Gels, Aleve Cold and Sinus Caplets, Benadryl Allergy and Sinus Tablets, Claritin-D Non-Drowsy 24 Hour Tablets, Robitussin Cold Severe Congestion Capsules, Sudafed 24 Hour Tablets, SudoGest, Wal-phed 12 hour, Suphedrine.2

Indications: nasal congestion, sinus congestion, and Eustachian tube congestion

Adverse side effects of pseudoephedrine:

  • Common: insomnia, nervousness, excitability, dizziness, and anxiety
  • Infrequent: tachycardia (rapid heart beat) or palpitations
  • Rare: dilated pupils, hallucinations, arrythmias (irregular heartbeat), high blood pressure, seizures, inflammation of the large intestine, and severe skin reactions

Contraindications for pseudoephedrine:

  • Diabetes mellitus
  • Cardiovascular disease
  • Severe or uncontrolled high blood pressure
  • Severe coronary artery disease
  • Prostatic hypertrophy
  • Hyperthyroidism
  • Closed angle glaucoma
  • Pregnant women

Pseudoephedrine and High Blood Pressure Interaction

In 2005, a study showed that pseudoephedrine increased systolic blood pressure and heart rate, but had no effect on diastolic blood pressure.1 They also found that higher doses and immediate-release formulations of pseudoephedrine were associated with higher blood pressures.1 In addition, the study revealed that patients with well controlled hypertension had higher systolic and diastolic blood pressures after taking immediate release pseudoephedrine formulations.1

What are safe alternatives to pseudoephedrine in patients with high blood pressure?

There are a few safe and effective alternatives to pseudoephedrine in patients with high blood pressure that can relieve nasal or sinus congestion symptoms. Placing a humidifier in the bedroom keeps moisture in the air, which helps prevent your nasal passages from drying out. Humidifiers can also help break up mucus and soothe inflamed nasal passageways.3 In addition, propping your head up on 2 pillows may help the mucus flow out of your nose and relieve some congestion. Saline sprays are also another safe option that can loosen congestion and improve drainage.3 If a patient with high blood pressure insists on taking a medication that includes pseudoephedrine, their pharmacist or physician will recommend the patient to monitor their blood pressure and take a sustained-release formulation to reduce the risk of increasing blood pressure.3

Next time you have sinus or nasal congestion, ask your physician before using pseudoephedrine if you have high blood pressure. Your local pharmacist can also help manage nasal congestion symptoms, provide valuable information regarding safer alternatives, and ensure optimal drug selection in patients with high blood pressure.

Resources:

  1. Salerno SM, Jackson JL, Berbano EP. Effect of Oral Pseudoephedrine on Blood Pressure and Heart Rate: A Meta-analysis. Arch Intern Med. 2005;165(15):1686–1694. doi:10.1001/archinte.165.15.1686.
  2. Radack  KDeck  CC Are oral decongestants safe in hypertension? an evaluation of the evidence and a framework for assessing clinical trials.  Ann Allergy 1986;56396- 401.
  3. High Blood Pressure and Cold Remedies: Which Are Safe? Mayo Clinic.  https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/expert-answers/high-blood-pressure/faq-20058281. Published January 09, 2019. Accessed January 20, 2019.

 

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