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The Omnicare HealthLineSeptember 2016

Focus on Seasonal Influenza 2016-2017- by Allen Lefkovitz

“Annual influenza vaccination is the primary means of preventing influenza and its complications,” according to the Centers for Disease Control and Prevention (CDC). CDC also states that “Complications, hospitalizations, and deaths from seasonal influenza are typically greatest among persons aged ≥ 65 years, children aged <5 years (and particularly those aged <2 years), and persons of any age who have medical conditions that confer increased risk for complications from influenza.” Therefore, since 2010, the Advisory Committee on Immunization Practices (ACIP) has recommend that all persons 6 months or older receive annual influenza vaccination unless otherwise contraindicated.

According to CDC, in the United States:

Between 3,300 to 49,000 seasonal influenza-associated deaths occur each year.

Influenza and pneumonia are the overall eighth leading cause of death.

71-85% of influenza-related deaths occur among those 65 years and older.

54-70% of influenza-related hospitalizations occur among those 65 years and older.

During the 2014-2015 season, only 66% of the elderly were vaccinated.

Both trivalent and quadrivalent influenza vaccines remain available for the 2016-2017 season. Although one new trivalent formulation was approved since last season, two older trivalent formulations have been reformulated this year to be quadrivalent vaccines. This means that more than half of the approved products are now quadrivalent even though the most commonly administered influenza vaccines are trivalent formulations. The various types and the new composition of the vaccines for the 2016-2017 season are shown in the Figure below.

Figure 1 – Types of Influenza Vaccines Available for 2016-2017

TR

IVA

LEN

T

Standard dose, trivalent injection grown in eggs [IIV3] ( e.g., Afluria) - age range varies by specific vaccine HHH

Contains: A/California/7/2009

(H1N1)-like virus+

A/Hong Kong/4801/2014 (H3N2)-like virus

+B/Brisbane/60/2008-like

(Victoria lineage) virus

Standard dose, recombinant, egg-free trivalent injection [RIV3] (i.e., Flublok) - 18 years and older HHH

High-dose (4x) trivalent injection [IIV3] (i.e., Fluzone High-Dose) - 65 years and older HHH

Standard dose, adjuvanted trivalent injection [aIIV3] (i.e., Fluad) - 65 years and older HHH

QU

AD

RIV

ALE

NT

Standard dose, quadrivalent injection [IIV4] (e.g., Fluarix Quadrivalent) - 3 years and older HHH

Contains: Same as Trivalent

Formulation+

B/Phuket/3073/2013-like (Yamagata lineage) virus

Standard dose, intradermal, quadrivalent injection [IIV4] (i.e., Fluzone Intradermal Quadrivalent) - 18 to 64 years

Standard dose, quadrivalent injection grown in cell culture [ccIIV4] (i.e., Flucelvax) - 4 years and older HHH

Standard dose, live attenuated, quadrivalent nasal spray [LAIV4] (i.e., FluMist) - 2-49 years of age

HHH Can be used in individuals 65 years of age and older

The ACIP summary of recommendations and many other helpful influenza resources can be found at: www.cdc.gov/flu/

Inside This Issue1-4 Focus on

Seasonal Influenza 2016-2017

5 The Vaccine Adverse Event Reporting System

6 Clinical Capsule: Antipsychotic Therapy for Parkinson’s Psychosis

6 Regulatory Recap

7 New Drug Adlyxin

7 New Generic Medications

8 HealthLine Quiz

The Omnicare HealthLine 2


New products and changes have occurred since the last influenza season.

• Fluad, a standard dose trivalent vaccine, has an adjuvant (MF59®, a squalene based emulsion) which elicits a greater immune response. It is specifically approved for those 65 years and older.

• Flucelvax Quadrivalent, which replaces the previously available trivalent formulation and is now approved for use in those 4 years and older (previously only available for people 18 to 64 years of age). Also the tip caps and plungers of the prefilled syringes are no longer made with natural rubber latex.

• The only standard dose Fluzone formulation that remains is Fluzone Quadrivalent (Fluzone trivalent has been discontinued).

Since 6 of the 8 types of influenza vaccine are approved for use in the elderly, the question invariably arises as to which product is best. Although ACIP discusses that a clinical study demonstrated a 24.2% greater efficacy with Fluzone High-Dose compared to standard dose Fluzone, the ACIP recommendations repeatedly state “No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended product is otherwise appropriate.” Likewise, the ACIP guidance points out that there have not been any studies yet that compare Fluzone High-Dose to the new adjuvanted Fluad. More specifics about all available products for 2016-2017 are summarized in Table 1 on page 4.

Highlights from the CDC and the 2016-2017 ACIP Recommendations

• As it takes 2 weeks to develop necessary antibodies, ACIP clarified their recommendation about timing of vaccination by stating “Health care providers should offer vaccination by the end of October, if possible.” ACIP still encourages vaccine administration “be offered as long as influenza viruses are circulating and unexpired vaccine is available.”

• Influenza vaccination should not be delayed in order to procure any specific vaccination if an appropriate, alternative vaccination is already available.

• In June 2016 ACIP made an interim recommendation that live attenuated influenza vaccine (LAIV4) (the “nasal flu vaccine”) NOT be used during the 2016-2017 season. Although still FDA approved and available, recent data on LAIV4 that were reviewed by ACIP indicated no significant effectiveness. This follows ACIP recommending LAIV4 over inactivated influenza vaccine (IIV) for children during the 2014-2015 season, and rescinding that preference for the 2015-2016 season.

• For all children aged 6 months to 8 years, 2 doses of the 2016-2017 vaccine should be administered (at least 4 weeks apart) UNLESS they have received 2 or more doses during any previous season (these 2 doses did not need to be during the same or even consecutive seasons).

• Recommendations for persons with egg allergy were extensively modified (see Allergic Reactions and Influenza Vaccination on page 3)

• Adequate supplies are anticipated for the upcoming season, but higher risk individuals who especially should be targeted for receiving vaccination in the event of limited supplies include:

Everyone 6 months through 5 years or 50 years of age or older

Residents of nursing homes and other

long-term care facilities

Those with chronic pulmonary (e.g., asthma) or cardiovascular*, renal,

hepatic, neurological, hematologic, or metabolic disorders (e.g., diabetes)

Persons who are immunosuppressed

(e.g., due to medication, HIV infection)

Women who are or will be pregnant during the

influenza season

Persons 18 years and younger who receive

long-term aspirin therapy

American Indians / Alaskan natives

Persons who are extremely obese (BMI greater than or equal to 40)

Healthcare personnel who have contact with patients

Household contacts (including children) and

caregivers of persons with medical conditions that put them at higher risk

*Chronic cardiovascular disorders excludes

isolated hypertension



Allergic Reactions and Influenza VaccinationSevere allergic reactions to vaccines are considered “very rare” (< 1.5 cases per 1 million doses), but are most commonly associated with an allergy to eggs, certain antibiotics (e.g., neomycin, gentamicin), gelatin, or latex. CDC generally suggests that if a person reports history of a severe allergy (e.g., anaphylaxis) to any substance contained in a vaccine, an alternative vaccine that does not contain that substance should be considered instead of complete avoidance of vaccination. However, a previous severe allergic reaction to influenza vaccine, regardless of the component suspected of being responsible for the reaction, is a contraindication to future receipt of the vaccine.

Except for the trivalent, recombinant influenza vaccine (RIV3) and the cell culture-based inactivated influenza vaccine (ccIIV4), all influenza vaccines are prepared by growing viruses in embryonated chicken eggs; however, even ccIIV4 contains a very small amount of total egg protein, such that only Flublok is completely egg-free.

For several years, ACIP has provided specific guidance on which influenza may or may not be used by persons with various types of egg allergies. Based upon continued assessment of vaccine safety data, ACIP has modified their previous recommendation that egg-allergic recipients should be observed for 30 minutes after vaccination. Instead, everyone vaccinated (regardless of allergies) should be monitored for 15 minutes after vaccination.

Additionally, anyone with a history of severe allergic reaction to eggs (i.e., more than hives) now may receive any recommended and age appropriate influenza vaccine, but they should be vaccinated only in an inpatient or outpatient medical setting under the supervision of a healthcare provider who is able to recognize and manage severe allergic conditions.

Influenza Vaccination and Long-Term Care With the heightened awareness around antibiotic stewardship in long-term care (LTC), a comprehensive immunization program is an important strategy.

Within their “Core Elements for Antibiotic Stewardship in Nursing Homes” program, CDC included a Fact Sheet for residents and families entitled “Top 10 Infection Prevention Questions to Ask a Nursing Home’s

Leaders”. Question #4 of the Fact Sheet asks “Is the flu vaccine mandatory for all staff working in this nursing home?” Additionally on this subject CDC reminds residents and families that “The nursing home

should also know what percentage of residents received the flu vaccine during the last flu season.”

ACIP continues to recommend that all health-care facilities offer free and convenient access to influenza vaccination for all healthcare professionals (HCP), including night, weekend, and temporary staff, with particular emphasis on workers who provide direct care for persons at high risk for influenza-related complications. Although conclusive supporting data are not available for all of the following, strategies to help protect older individuals in LTC include:

Vaccination of all employees

with any potential patient contact

Frequent hand washing

Masks Nasal Swabsfor early detection

Restricting Accessof visitors or employees

with symptoms of influenza-like illness

Despite the many efforts to encourage annual influenza immunizations to employees in LTC, the residents we serve remain at significant risk. During the 2014-2015 season, CDC says influenza vaccine coverage of all healthcare professionals (HCP) continued to increase to 77.3%; however, LTC HCP remain as having the lowest coverage rate, at only 63.9% (only slightly higher than 63% in 2013-2014).

To support increasing this rate, CDC has developed a toolkit specifically for long-term care which is available for free at: www.cdc.gov/flu/toolkit/long-term-care/. Likewise, the ACIP summary of recommendations and many other helpful influenza resources can be found at: http://www.cdc.gov/flu/.



Table 1 – Influenza Vaccine Formulations Available for the 2016-2017 Season

Trade Name Manufacturer Contains Mercury? Recommended Age Group

Trivalent, Inactivated Influenza Vaccine (IIV3)

Afluria® Seqirus Only in MDV ≥ 9 years¥

Fluvirin® Seqirus Yesδ ≥ 4 years

Fluzone® High-Dose Sanofi Pasteur No ≥ 65 years

Trivalent, Inactivated Influenza Vaccine (aIIV3) with Adjuvant (MF-59®)

Fluad™ Seqirus Noδ ≥ 65 years

Trivalent, Recombinant Influenza Vaccine (RIV3)

Flublok® Protein Sciences No ≥ 18 years

Quadrivalent, Inactivated Influenza Vaccine (IIV4)

Afluria® Quadrivalent Seqirus Only in MDV ≥ 18 years

Fluarix® Quadrivalent GlaxoSmithKline No ≥ 3 years

FluLaval® Quadrivalent ID Biomedical Only in MDV ≥ 3 years

Fluzone® Quadrivalent Sanofi Pasteur Only in MDV ≥ 3 years*

Fluzone® Intradermal Quadrivalent

Sanofi Pasteur No 18-64 years

Quadrivalent, Cell Culture-based Inactivated Influenza Vaccine (ccIIV4)

Flucelvax® Quadrivalent Seqirus No ≥ 4 years

Quadrivalent, Live Attenuated Influenza Vaccine (LAIV4) Intranasal†

FluMist® Quadrivalent MedImmune No 2-49 years

MDV = Multiple-dose vials¥ Afluria is FDA approved for those ≥ 5 years, but ACIP recommends limiting use to those 9 years or older. Afluria may

also be given using a jet injector for patients 18 to 64 years* The multiple-dose vials are approved for ≥ 6 months, but single-dose 0.5 mL vials and syringes are only approved for

≥ 36 months. A smaller 0.25 mL prefilled syringe is available for use in children 6 to 35 monthsδ Prefilled syringes have a tip cap that may contain natural rubber latex† ACIP’s interim recommendation is that LAIV4 not be used during the 2016-2017 season.



Medication Safety by Carrie Allen

The Vaccine Adverse Event Reporting System As a reminder, adverse events related to vaccines are monitored by the Vaccine Adverse Event Reporting System (VAERS). This is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States.

The primary objectives of VAERS are to: Detect new, unusual, or rare vaccine adverse events

Monitor increases in known adverse events

Identify potential patient risk factors for particular types of adverse events

Identify vaccine lots with increased numbers or types of reported adverse events

Assess the safety of newly licensed vaccines

VAERS helps to identify any important new safety concerns and helps ensure that the benefits of vaccines continue to outweigh the risks. For example, VAERS detected reports for an unusually high amount of intussusception (GI obstruction in which one segment of the bowel becomes enfolded within another segment) after the RotaShield rotavirus vaccine in 1999. Epidemiologic studies confirmed an increased risk, and these data contributed to the product’s removal from the US market. Newer rotavirus vaccines have been developed since this time that are safer, and have a low risk for intussusception. In another instance, VAERS determined that there may be a potential for a small increase in risk for Guillain-Barre’ syndrome (GBS) after receipt of the meningococcal conjugate vaccine, Menactra. As a result of this finding and further testing, the Warnings and Precautions section of the prescribing information now states that “persons previously diagnosed with GBS may be at increased risk of GBS following receipt of Menactra vaccine. The decision to give Menactra vaccine should take into account the potential benefits and risks”.

Approximately 30,000 VAERS reports are filed each year. About 85-90% of the reports describe mild side effects such as fever, arm soreness, and crying or mild irritability. The remaining reports are classified as serious, which means that the adverse event resulted in permanent disability, hospitalization, life-threatening illness, or death. While these problems happen after vaccination, they are rarely caused by the vaccine.

VAERS encourages reporting of any adverse event that occurs after the administration of any vaccine, even if you are unsure whether a vaccine caused them.

The National Childhood Vaccine Injury Act requires health care providers to report:

• Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine.

• Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccination.

You can report a vaccine-related adverse event to VAERS by:

Filling out an online form at https://vaers.hhs.gov/esub/index

Faxing a form to: (877) 721-0366

Mailing a form to: VAERS, PO Box 1100 Rockville, MD 20849 [pre-addressed postage-paid report forms can be received by calling the VAERS Information Line at (800) 822-7967]



The Clinical Capsule by Kori Hauersperger

Antipsychotic Therapy for Parkinson’s Disease (PD) PsychosisHallucinations and delusions may occur as part of the disease process, or in 5-10% of cases, as a side effect of PD medications. PD medications that can worsen or cause psychosis include amantadine, dopamine agonists (e.g., ropinirole), and levodopa/carbidopa. While seeking to avoid functional impairment as well as adverse effects, a reduction in dose or elimination of these medications should be considered. Past therapies for PD psychosis have included antipsychotics that worsen PD functioning (e.g., Zyprexa, Haldol). The antipsychotics below have been shown to improve psychosis while generally retaining PD control.

Medication* Initial dosing Notes

pimavanserin(Nuplazid)†

• Two 17 mg tablets (34 mg) once daily• No titration needed

• ONLY drug that is FDA-approved for the treatment of PD psychosis

• May take up to two weeks for effectiveness• Not recommended for patients with severe renal

impairment (i.e., CrCl < 30 mL/min)

quetiapine(Seroquel)†

25 mg once daily Safe, but inconsistent efficacy data

clozapine(Clozaril, Fazaclo)†

12.5 mg once or twice daily Highly effective, but requires frequent monitoring of the absolute neutrophil count (ANC) due to rare, life-threatening neutropenia

*Drug interactions with these drugs may decrease efficacy, require a reduced dose, and/or increase the risk for heart arrhythmias.

† All antipsychotics have a boxed warning related to increased mortality in elderly patients with dementia-related psychosis

Regulatory Recap: Revised State Operations Manual Appendix PP: Guidance to Surveyors of Long Term Care Facilities - by Carrie Allen

In June, CMS updated the State Operations Manual (SOM) Appendix PP: Guidance to Surveyors of Long Term Care Facilities https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf These updates include changes regarding psychosocial harm from the Survey and Certification memo (S&C: 16-15-NH) issued earlier this year as well as substantial changes to F329: Unnecessary Drugs.

While some of the specificity of the content regarding F329 was removed from the text (e.g., certain tables of medications), it is important to realize that this will not diminish scrutiny related to the judicious and appropriate use of medications in nursing home residents. The changes were made in an effort to increase ease of use for surveyors, not to diminish the importance of monitoring the appropriateness of use of medications previously listed in Appendix PP. In fact, since the 2014 Office of the Inspector General report on Adverse Events in Skilled Nursing Facilities (https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf), regulatory focus on medication use has become more comprehensive, whereby medication use is assessed in the context of: its effect in combination with other medications, prescribing cascades, appropriate monitoring, and care planning. Please ask your consultant pharmacist for clarification on processes at your facility related to the changes to Appendix PP and F329. In addition, a memo was released in June by Omnicare summarizing many of these changes – please ask your consultant pharmacist if you need a copy.



NEW Drug by Dave Pregizer

Adlyxin® Injection

Brand Name (Generic Name) Adlyxin [ad-LIX-In]; (lixisenatide) [lix-i-SEN-a-tide]

How Supplied 50 mcg/mL (10 mcg/dose) and 100 mcg/mL (20 mcg/dose) in 3 mL prefilled pens.

Therapeutic Class Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist

Approved Indication An adjunct to diet and exercise for the treatment of adults with type 2 diabetes.

Usual Dosing Initiate at 10 mcg subcutaneously once daily for 14 days. On Day 15, increase to 20 mcg subcutaneously once daily. Administer within one hour before the first meal of the day.

Common Drug Interactions Adlyxin delays gastric emptying. Drugs for which a delay in effect is undesirable should be administered one hour before Adlyxin (e.g., antibiotics, acetaminophen). Administer oral contraceptives at least 1 hour before or 11 hours after Adlyxin. Risk of hypoglycemia with concomitant sulfonylurea or basal insulin (e.g., Lantus) use.

Most Common Side Effects Nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia.

Miscellaneous Inject subcutaneously in the abdomen, thigh or upper arm.

Website http://products.sanofi.us/adlyxin/adlyxin.pdf

NEW Generic Medications

Generic Name Brand Name Date Generic Available

Mesalamine 800 mg Delayed-Release Tablet Asacol® HD Tablet DR 8/9/16



HealthLine Quiz- by Steve Law

1. Between 71% and 85% of influenza-related hospitalizations occur in those 65 years and older:a. True b. False

2. Which type of influenza vaccine is NOT recommended for older patients (65 years or older)?a. Afluria Trivalentb. Fluad Adjuvanted Trivalentc. Flublok Recombinant Trivalentd. Fluzone Intradermal Quadrivalent

3. Which statement from the CDC and 2016-2017 ACIP recommendations is FALSE?a. Everyone vaccinated (regardless of allergies)

should be monitored for 15 minutes after vaccination.

b. Individuals should be offered influenza vaccination by the end of October, if possible.

c. Targeting healthcare personnel for receiving the influenza vaccine should only be in the event of limited supplies.

d. The live attenuated influenza vaccine is not recommended for use during the 2016-2017 influenza season.

4. Individuals with an egg allergy (e.g., hives) should only receive the egg-free vaccine, Flublok. a. True b. False

5. A primary objective of the Vaccine Adverse Event Reporting System (VAERS) is to detect new, unusual, or rare adverse events: a. True b. False

6. Quetiapine (Seroquel) is FDA-approved to treat Parkinson’s Disease psychosis:a. True b. False

7. Which is FALSE concerning the new medication: Adlyxin™ Injection?a. It is a Glucagon-Like Peptide-1 (GLP-1)

receptor Agonista. It may delay gastric emptyinga. It should be administered once daily within

one hour before the first meal of the daya. The starting dose is inject 20 mcg

subcutaneously once a day

*Please note, the HealthLine Quiz is designed to help readers retain information that is relevant to their care setting. It is not an approved source of continuing education credits for healthcare professionals.

Editorial BoardAllen L. Lefkovitz, PharmD, CGP, FASCP – Senior Editor

Carrie Allen, PharmD, CGP, BCPS, BCPP, CCHP – Assistant Editor

Kori Hauersperger, PharmD

Steve Law, PharmD, CGP

Terry O’Shea, PharmD, CGP, FASCP

David Pregizer, RPh

Yamini D. Shah, PharmD

Barbara J. Zarowitz, PharmD, FCCP, BCPS, FCCM, CGP, FASCP

Contributing Authors for This IssueAllen L. Lefkovitz, PharmD, CGP, FASCP

Director - Clinical Pharmacy Education and Drug Data, CVS Health

Carrie Allen, PharmD, CGP, BCPS, BCPP, CCHP

Clinical Pharmacist, CVS Health

Kori Hauersperger, PharmD

OSC2OR Clinical and Drug Information Analyst, CVS Health

David Pregizer, RPh,

Consultant Pharmacist, HCR-Manorcare

Steve Law, PharmD, CGP

Clinical Services Manager for Indiana; Omnicare Pharmacies in Indiana

Answers to the HealthLine Quiz: 1) B 2) D 3) C 4) B 5) A 6) B 7) D

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