Influenza Virus Vaccine

Fuchs, Chris 4

Christopher Fuchs, Pharm.D. Candidate 2015, St. Louis College of Pharmacy

 

There has been a lot of buzz and confusion about the efficacy of influenza vaccines in the last couple of weeks. The Center for Disease Control and Prevention’s (CDC) recent press release has led to many articles claiming that the influenza vaccine will not work and questioning the need for the vaccine. The CDC’s press release stated that early data suggests the 2014-2015 flu season could be more severe and that the vaccine might be less effective. To understand why this year’s influenza vaccine will be less effective, one must understand the influenza virus.

There is no one influenza virus. There are three many type of influenza, type A, B, and C. All influenza viruses belong to the Orthomyxoviridae family. Influenza C rarely causes serious infections in human beings. Influenza A and B more commonly cause infections, with A being the most virulent.

Influenza A is further broken down into different subtypes. The subtypes are based off viral components called hemagglutinin and neuraminidase. Hemagglutinin is a glycoprotein that allows the attachment of the virus to target cells. Neuraminidase is a glycoprotein that allows the viral RNA to enter the target cell. Sixteen hemagglutinin subtypes are known (H1-H16), but only H1, H2, and H3 are known to cause disease in humans. Nine neuraminidase subtypes (N1-N9) are known, but only N1 and N2 are known to cause infections. The two Influenza A viruses in this year’s vaccine are H1N1 and H3N2. Influenza A can be broken down one more time to the specific strain. This involves the site of origin, the isolate number, and year of isolation. So the full names of the two influenza A viruses in this year’s vaccine are A/California/7/2009 (H1N1) and A/Texas/50/2012 (H3N2).

Now that the specific type of Influenza is understood, there are a couple of terms that one must understand: epidemic, pandemic, antigenic drift and antigenic shift. Epidemic is a widespread occurrence of an infectious disease in a community at a particular time. Pandemic is prevalent over a whole country or the world. An example of an epidemic would be a large amount of cases of influenza in a certain city. A pandemic would be a large amount of cases over the entire United States. The CDC is warning that there might be more severe epidemics, but not pandemics.

The other two terms are not as easy to define. Antigenic drift and antigenic shift both involve the influenza virus changing, but to different extents. Antigenic drift are slight mutation of the virus, but the H and N categories stay the same. Antigenic shift is when there is a major change in the virus, either the H or N or both categories change. An antigenic shift is what leads to pandemics. Examples of antigenic shift are the Spanish Influenza outbreak of 1918, the Asian Influenza outbreak of 1957, and the Hong Kong Influenza outbreak of 1968.

With this information, we can now understand what is happening this year. There has been an antigenic drift of the influenza A H3N2 virus. The World Health Organization and CDC release their recommendations for the influenza vaccines usually in February of the year the vaccine is used. This allows pharmaceutical companies time to manufacture the vaccine. Most years this time delay doesn’t affect the vaccine’s effectiveness. But this year the influenza A H2N3 has mutated since the recommendation. This antigenic drift has led to the influenza vaccine becoming less effective. The last time an antigenic drift like this occurred was in the 2007- 2008 flu season. In that flu season the vaccine had an overall efficacy of 37% and an efficacy of 42% against H3N2.

So should a patient still receive the influenza vaccine this year? Yes. Even though the H3N2 virus has mutated, the other viruses appear to have stayed the same. Many patients have a hard time understanding why they need to get a new vaccine every year. As demonstrated above, the influenza virus is constantly changing. Most other diseases with vaccines, such as rubella, measles, mumps, and chickenpox, only require a one or two time vaccination. Those viruses do not mutate or mutate very rarely compared to influenza.

While the vaccine has shown to be less effective this year, it might help prevent future influenza viruses. In 1977 an antigenic shift H1N1 virus emerged, causing a pandemic. The pandemic was more severe for younger patients, those born after 1957. The proposed reason for this was the prevalence of H1N1 from 1918 to 1956. This allowed those born before 1957 to have immunity to the new H1N1 that came about in 1977. The ability for immunization to work years later on a similar but mutated virus is called original antigenic sin.

Understanding the influenza virus is the first step in fighting its spread. Over the course of the flu season approximately 25 to 50 million people will become infected with influenza. Around 200,000 will be hospitalized and around 30,000 will die in the United States. The total cost to the United States healthcare system is more than $40 billion. Hopefully with this information, pharmacists will be able to convince their patients to get the influenza vaccine. While it may not be as effective this year, it is still the best tool we have to fight influenza.

Christopher Fuchs
Pharm.D. Candidate 2015
St. Louis College of Pharmacy

 

References

Early Data Suggests Potentially Severe Flu Season. Center for Disease Control and Prevention. http://www.cdc.gov/media/releases/2014/p1204-flu-season.html. Published: December 4, 2014. Accessed: December 10, 2014.

Dolin R. Chapter 187. Influenza. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J. eds. Harrison’s Principles of Internal Medicine, 18e. New York, NY: McGraw-Hill; 2012. http://accesspharmacy.mhmedical.com/content.aspx?bookid=331&Sectionid=40726944. Accessed December 10, 2014.

Brooks GF, Carroll KC, Butel JS, Morse SA, Mietzner TA. Chapter 39. Orthomyxoviruses (Influenza Viruses). In: Brooks GF, Carroll KC, Butel JS, Morse SA, Mietzner TA. eds. Jawetz, Melnick, & Adelberg’s Medical Microbiology, 26e. New York, NY: McGraw-Hill; 2013. http://accesspharmacy.mhmedical.com/content.aspx?bookid=504&Sectionid=40999961. Accessed December 10, 2014.

 

Over-The-Counter Heartburn Medications: Which to Choose?

Fuchs, Chris 5

Christopher Fuchs Pharm.D. Candidate 2015 St. Louis College of Pharmacy

With the holiday season in full swing many patients are eating large portions of rich foods, which may be delicious, but are not what their bodies are accustomed to. This is a perfect storm for heartburn. Patients usually turn to over-the-counter (OTC) medications before going to their physician for the treatment of heartburn.

Heartburn is defined as a burning pain in your chest, just behind your breastbone that can worsen when lying down or bending over.1 If symptoms persist, heartburn may be a sign of a more serious condition called Gastro-Esophageal Reflux Disease (GERD). If a patient is having any of these symptoms they should see a medical professional as soon as possible:

  • Difficulty or pain with swallowing
  • Unexplained weight loss
  • Chest pain
  • Choking
  • Bleeding (vomiting blood or dark-colored stools)

Otherwise, a patient with mild heartburn is a candidate for OTC therapy. As the medication experts, pharmacists are in a great position to help patients choose the best OTC heartburn medication for them.

The three most common classes of acid suppressors will be covered in this article: antacids, histamine receptor 2 antagonists (H2RA), and proton pump inhibitors (PPI). The advantages and disadvantages of each will be discussed.

Antacids

Antacids are inexpensive medications that work for some patients and have the least amount of side effects compared to other acid suppressors. Antacids work by neutralizing gastric acid. With their short duration multiple dosing is usually required. Antacids should not be taken within two hours before or after most other medications due to their effects on absorption.

Generic Name Brand Name Adverse Effect
Calcium Carbonate Tums, Rolaids, Constipation
Magnesium Hydroxide Milk of Magnesia Diarrhea
Aluminum Hydroxide Mag-Al (combination with Magnesium hydroxide) Constipation, Bad Taste

 

Advantages

  • Quick Onset (5-15 minutes)
  • Few side effects
  • Can be taken as needed

Disadvantages

  • Drug interactions with tetracyclines, ferrous sulfate, isoniazid, quinidine, sulfonylureas, and quinolone antibiotics

o   Should not be taken within two hours before or after other medications

  • Short Duration

o   1 to 3 hours of relief maximum

H2RA

H2RAs are usually the preferred agent for prophylactic heartburn treatment. H2RAs work by blocking the histamine H2 receptor on parietal cells; thus, suppressing acid secretion. H2RAs can be used with antacids to combine the antacid’s quicker onset with the H2RA’s longer duration. A good candidate for this therapy option would be a patient that enjoys spicy food, but knowingly gets heartburn after eating it. Taking an H2RA with the meal could prevent this patient’s heartburn.

Generic Name Brand Name Adverse Effect
Famotidine Pepcid AC HeadacheConstipation

Diarrhea

Nausea

Vomiting

Ranitidine Zantac
Nizatidine Axid
Cimetidine Tagamet

 

Advantages

  • Quick Onset: 1-2 hours
  • Duration: ~ 9hours
  • Few drug interactions (excluding cimetidine)
  • Few common adverse effects
  • Can be taken with Antacids
  • Can be taken as needed

Disadvantages

  • Drug interactions with cephalosporin antibiotics, antivirals, and itraconazole
  • Cimetidine inhibits CYP enzymes leading to numerous drug interactions

PPI

Proton Pump Inhibitors are the gold standard for chronic heartburn.3 PPIs work by irreversibly blocking the hydrogen/potassium adenosine triphosphatase enzyme system (proton pump) in parietal cells. This blockade leads to a decrease of hydrogen ion secretion by the parietal cells: therefor, leading to an increase in stomach pH. OTC PPIs should be taken as a two week trial. All PPIs should be taken 30 minutes before breakfast on an empty stomach daily for the two week trial. Since PPIs have a long onset, it is important to remind the patient that it might take a day or two for full effect and to take them every day of the two weeks.

 

Generic Name Brand Name Adverse Effect
Omeprazole Prilosec OTC HeadacheAbdominal pain

Diarrhea

Flatulence

Nausea

Vomiting

Lansoprazole Prevacid 24HR
Esomeprazole Nexium OTC

 

Advantages

  • Long Duration: ~ 24 hours
  • Taken once a day
  • Best results
  • Few drug interactions

Disadvantages

  • Doesn’t work as needed
  • Long Onset: takes 1 to 2 days for full effect
  • More side effects than others

All acid suppressors should not be used for more than two weeks. If a patient’s heartburn returns after use of acid suppressors for two weeks, they should seek medical help as soon as possible. Heartburn that lasts longer than two weeks can be a sign of a serious underlying disease. Mild heartburn can be easily treated with OTC medications. It is important to encourage patients to utilize their pharmacists. Pharmacists can play a key role in helping a patient select the correct acid suppressor for his or her heartburn. Using OTC products will also help the patient avoid unnecessary doctor or urgent care visits. As the holidays continue with all of the turkey, Christmas ham, and pie, it is important to talk to patients about heartburn and encourage them to take action with OTC products.

Christopher Fuchs
Pharm.D. Candidate 2015
St. Louis College of Pharmacy

References

  1. Disease and Condition Heartburn. Mayo Clinic. http://www.mayoclinic.org/diseases-conditions/heartburn/basics/definition/con-20019545.Updated: August 7, 2014. Accessed December 3, 2014.
  2. Lexicomp Online®, Lexi-Drugs® , Hudson, Ohio: Lexi-Comp, Inc.; December 3, 2014.
  3. Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013;108(3):308-28.

5 HIPAA Violations You Might Not Know About

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Reprinted with permission from PBA’s Elements magazine

Despite your best efforts at compliance, your pharmacy might be violating the Health Insurance Portability & Accountability Act (HIPAA). And you might not even know it.

You’ve likely either partnered with a company that provides compliance support for pharmacies or spent hours carefully crafting policies to minimize your risk of a HIPAA violation. After that work, your biggest—and most costly—liability is violating the regulation in a way you didn’t even know was possible.

Here are some examples of HIPAA violations that others have unknowingly committed. Take a look and learn from their mistakes so that you can protect your pharmacy.

1. Employers can be liable for their employees’ violations, despite proper policies

Recently, Walgreens was fined $1.4 million after a pharmacist in Indiana violated HIPAA regulations by reviewing the prescription health records of a woman who previously dated her husband. Despite the company’s strict privacy policies, and the employee admitting she knowingly violated her employer’s rules, the company was still fined. While currently under appeal, the Indy Star reported that this decision is significant because it’s the first time a health care provider is being held liable for a HIPAA violation committed by an employee.

2. Your trash can get you into trouble

In 2009, CVS Pharmacy, now known as CVS Health, was fined $2.25 million after local media discovered that the pharmacy’s trash violated HIPAA regulations. A reporter revealed that the pharmacy’s employees were disposing of old prescription drug bottles with labels containing protected health information still intact. The bottles included patient and pharmacy order information, and they were found in unsecured dumpsters. The pharmacy agreed to pay the fine and also implemented a detailed Corrective Action Plan to ensure that it properly disposed of protected health information in the future.

3. Your digital data is compromised

In one New York hospital, a security breach made it possible for some patients’ health information to be found through a simple search on the Internet. The hospital’s firewall was deactivated, which allowed anyone to view the private health information of deceased patients. In a settlement with the Department of Health and Human Services (HHS,) the hospital paid a $4.8 million fine. As cloud storage and digital data storage become more common, the opportunity for your data to be accidentally compromised by an uploading error or unsecure connection is greater than ever.

4. Design flaws can result in privacy concerns

A study conducted by Change to Win Retail Initiatives found that the layout of some Walgreens’ pharmacies was contributing to possible HIPAA violations. Walgreens implemented “Well Experience,” a new model that moved the pharmacist’s desk in front of the counter in hopes of making pharmacists more accessible. In 80 percent of locations that adopted this model, the study found patient information, like personal medical histories, easily visible to customers. And in nearly half of the stores visited, prescription medication was left unattended within reach of customers.

5. Mishandling files can lead to fines

One health care office was fined for a HIPAA violation due to its filing system. The office had placed large red stickers with the word “AIDS” on the outside of patients’ files. The labels were not only visible to the office staff, but also to all the other patients in the waiting room. Another company was fined after CBS News discovered copies of patients’ medical files in the memory of a copy machine. The company had leased the copier and returned it without erasing its memory. The company agreed to pay $1,215,780 in a settlement with HHS.

Low Dose Aspirin: Who needs it?

Christopher Fuchs Pharm.D. Candidate 2015 St. Louis College of Pharmacy

Christopher Fuchs
Pharm.D. Candidate 2015
St. Louis College of Pharmacy

This is a common scenario: A patient comes into the pharmacy wondering if he or she should start taking a daily aspirin. They have a friend or family member that takes it and suggested they should too. How should a pharmacist respond to this question? One simple and correct answer would be to have the patient talk about aspirin use with his or her physician. However, as pharmacists we are able to tell patients and physicians the most up-to-date recommendations and backgrounds on medications.

Currently low dose 81 mg aspirin is recommended as both primary and secondary prevention of cardiovascular disease. Primary prevention is when aspirin is used to prevent a cardiovascular event in a patient with no history of cardiovascular events. For secondary prevention is when aspirin is used to prevent a subsequent cardiovascular event in a patient who has already had one. For secondary prevention, the 2013 ACCF/AHA Guideline recommends low doses of aspirin for the Management of ST-Elevation Myocardial Infarction in post-STEMI patients.2 It is also recommended for secondary prevention of stroke by Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.3

Aspirin for secondary prevention is widely recommended, but the use of aspirin for primary cardiovascular prevention is less clear. The U.S. Preventive Services Task Force recommends low dose aspirin use in two scenarios based on age and 10-year myocardial infarctions (MI) or 10-year stroke risk1:

  • Men age 45 to 79-years-old for prevention of myocardial infarctions (MI)
  • Women Age 55 to 79-years-old for prevention of ischemic stroke
Aspirin’s benefit outweighs risk in patients:
Age 10-year MI Risk
(men)
Age 10-year Stroke Risk
(women)
45-59 ≥ 4 % 55-59 ≥ 3 %
60-69 ≥ 9 % 60-69 ≥ 8 %
70-79 ≥ 12 % 70-79 ≥ 11 %

 

The Task Force’s recommendations were published in 2009.

There are many other modifiable factors that play a role in cardiovascular disease (CVD). Blood pressure, smoking status, and cholesterol level are all major factors in determining the risk of having a cardiovascular event. Once a patient has his or her hypertension and/or hyperlipidemia controlled, the benefit versus risk for aspirin might have changed. It is important for clinicians to reassess aspirin use on a regular basis. It is an important part of patient care to make sure the patient’s therapies are appropriate and indicated. If the risk of a medication outweighs the benefit, it should not be recommended.

New trials have recently come out that show the risk of adverse effects is greater than the risk reduction for stroke and/or MI. The recent Japanese Primary Prevention Project, which looked at the use of aspirin at 100 mg versus placebo in 14,464 patients, did not find a significant difference between aspirin and placebo in the combined primary endpoint of cardiovascular death, nonfatal stroke, and/or nonfatal MI (p=0.54).4 Aspirin patients were twice as likely to have a duodenal ulcer and three times as likely to have a gastrointestinal (GI) bleed.4

The U.S. Food and Drug Administration (FDA) released a statement in May 2014, recommending against the use of aspirin for primary prevention. The Center for Disease Control and Prevention’s (CDC) Million Hearts Campaign agrees with the FDA’s statement. The FDA states:

“There are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain, in situations where the benefit of aspirin for primary prevention has not been established.”

As pharmacists we are viewed as the medications experts by both patients and physicians. It is our duty to explain the risks and benefits of medications to our patients and educate them on the common adverse effects. An educated patient is frequently one that can actively participate in their own care and a healthier patient. When communicating with physicians, we should be using the latest guidelines and/or recommendations about therapies. Currently, the use of aspirin for primary cardiovascular disease prophylaxis is controversial and not universally agreed upon. Hopefully, in coming months the U.S. Preventative Services Task Force will update its recommendations to address the FDA’s newest statement.

Christopher Fuchs
Pharm.D. Candidate 2015
St. Louis College of Pharmacy

 

References:

  1. Aspirin for the Prevention of Cardiovascular Disease: Preventive Medication. U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf/uspsasmi.htm. Published March 2009. Accessed November 25, 2014.
  2. O’Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61(4):e78-e140. doi:10.1016/j.jacc.2012.11.019.
  3. Lansberg MG, O’Donnell MJ, Khatri P, et al. Antithrombotic and thrombolytic therapy for ischemic stroke. Chest.2012;141(2_suppl):e601S-e636S. doi:10.1378/chest.11-2302.
  4. Ikeda Y, Shimada K, Teramoto T, et al. Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Japanese Patients 60 Years or Older With Atherosclerotic Risk Factors: A Randomized Clinical Trial. JAMA. 2014;

New Pneumococcal Immunization Recommendations in Elderly Patients

Christopher Fuchs Pharm.D. Candidate 2015 Saint Louis College of Pharmacy

Christopher Fuchs
Pharm.D. Candidate 2015
Saint Louis College of Pharmacy

Pneumonia is the leading cause of infectious mortality in both children and adults. Pneumonia’s mortality ranges from 30% to 40%1, 2. With such a high mortality, one of the best options is to prevent the patient from ever getting pneumonia through immunization. As pharmacists, immunizing patients against pneumonia is a great opportunity for us to prevent a serious and life threatening infection.

Pneumonia is caused by several bacteria, viruses, and fungi. The most common bacterial pathogens include S. pneumoniae, M. pneumoniaeLegionella speciesC. pneumoniaeH. influenzae, P. aeruginosaAcinetobacter species, and methicillin-resistant Staphylococcus aureus (MRSA). S. pneumoniae is the most common pathogen and is the causative infection in 75% of pneumonia cases3. The influenza virus is the most common viral pathogen3.

There are currently two pneumonia vaccines on the market, 13-valent pneumococcal conjugate vaccine (PCV13, Brand name: Prevnar 13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23, Brand Name: Pneumovax23). PCV13 contains 13 serotypes of S. pneumoniae, specifically the 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F serotypes4. PPSV23 contains 23 serotypes of S. pneumoniae, specifically the 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F5. Both vaccines are easily accessible and have been proven to prevent pneumonia infections.

The Center for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) have recently updated their guidelines on the use of PCV13 and PPSV23 in patients > 65 years old. The update is a result of the outcomes in the Community Acquired Pneumonia Immunization Trial in Adults (CAPiTA). The CAPiTA trial is a randomized, double-blind clinical trial with 84,496 participants’ age > 65 years old, which took place in the Netherlands. PCV13 was found to be 45.56% (p = <0.001) effective at preventing the first episode of vaccine-type community acquired pneumonia.

The old recommendations said to give PPSV23 to patients > 65 years old with no mention of PCV13. The new recommendations are broken down between vaccine-naïve patients and patients who have received PPSV23 already.

  • In vaccine-naïve patients > 65 years old: patients should receive one dose of PCV13 then a dose of PPSV23 six to twelve months later. The minimal time between pneumonia vaccines is 8 weeks6.
  • In patients previously vaccinated with PPSV23 > 65 years old: patients should receive one dose of PCV13 if they have not already received it. The dose of PCV13 should be given greater than or equal to one year since last PPSV23. If an additional dose of PPSV23 is indicated it should be six to twelve months from last PCV13 and greater than or equal to five years since last PPSV236.

These new recommendations will be in effect until 2018. In 2018, the ACIP will reevaluate the use of PCV13 in patients > 65 years old. The ACIP and CDC recommendations for other age groups and immunocompromised patients remain the same.

For more information about immunizations and current vaccine recommendations please take advantage of the MPA’s immunization webpage (available at https://www.morx.com/immunizations). On this page, MPA members can find information about immunization schedules, the latest immunization recommendations, specific information about the influenza vaccination, and information about National Immunization Awareness Month (NIAM).

Christopher Fuchs
Pharm.D. Candidate 2015
Saint Louis College of Pharmacy

References

  1. Nseir S, Mathieu D. Antibiotic treatment for severe community-acquired pneumonia: Beyond antimicrobial susceptibility. Crit Care Med 2012;40(8):2500–2502.
  2. Bradley JS, Byington CL, Shah SS, et al. The management of community-acquired pneumonia in infants and children older than 3 months of age: Clinical practice guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. Clin Infect Dis 2011;53(7): e25–e76.
  3. Blackford MG, Glover ML, Reed MD. Chapter 85. Lower Respiratory Tract Infections. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L.eds. Pharmacotherapy: A Pathophysiologic Approach, 9eNew York, NY: McGraw-Hill; 2014. http://accesspharmacy.mhmedical.com/content.aspx?bookid=689&Sectionid=45310531. Accessed November 17, 2014.
  4. Prenvar 13 Package Insert, Pifzer
  5. Pneumovac23 Package Insert, Merck
  6. Tomczyk S, Bennett NM, Stoecker C, et al. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014;63(37):822-5.