By Jamie Tharp, Pharm.D., pharmacy manager, University of Michigan HomeMed

Rising healthcare costs are triggering insurance companies to consider cost savings opportunities. One targeted area of cost containment is drug expenditures for high dollar specialty infusions. Analyses have shown infusion center therapy administration is 50 percent to 60 percent more costly than the home setting or doctor’s office, as they are able to bill for both drug costs and charge an additional facility administration fee. While many specialty infusion therapies are often safe to administer in low-acuity settings, these site of care changes will require thoughtful considerations to ensure safe and efficacious care of affected patients.

The payers that are currently implementing these changes are Aetna¹, Blue Care Network,^2,3 Priority Health⁴ and United Health Care⁵ with some payers initiating site of care changes as early as July 1, 2016. Therapies that are being targeted are most specialty infusions with an initial focus on IVIG and Remicade.^®

Organizations responding to these site of care changes need to make the following considerations:

·         Patient Safety Considerations

o   Establish criteria for safe use of specialty infusions in alternate sites with less direct access to emergency care (e.g., anaphylaxis kits, access to 911 services, nursing care during infusion and post infusion monitoring period)

o   Establish criteria for patients requiring continuation of services in an infusion center setting (e.g., hypersensitivities, pediatric populations, induction to therapy, etc.)

o   Develop adverse reaction and response to therapy communication pathways

·         Transitions of Care

o   Develop a network of alternate site service providers

§  Assess capacity of infusion pharmacy, visiting nursing agencies and physician office provider partners to accept new workload

§  Assess provider capability to service high complexity therapy administration with prolonged infusions and on-going patient monitoring by a nurse

o   Develop standardized order sets including therapy dosing, administration and monitoring parameters to ensure consistent care across sites of care

Additional considerations include managing patient expectations, as many patients are fond of their infusion center routines and consider their infusions as a time for socialization and networking. As the full impact of the payer initiated site of care changes are realized, the home infusion and home healthcare markets may face initial staffing shortages while trying to accommodate these new complex and time intensive specialty infusions.

What’s next? Depending on your site of practice, you might consider the following steps in response to these payer changes:

• Reach out to referral sources and find out how you may be able to assist in transitioning patients from the infusion center environment to the home or physician office
• Assess your capacity to increase your new referral workload
• Develop staff resources to prepare for new therapies and patient populations
• Contact payers to fully understand policy specifics for the common plans at your pharmacy and work together with your referral sources and payers to establish criteria for identifying appropriate sites of care for different patient populations and co-morbidities.

References:

1. Aetna Inc. Drug Infusion Site of Care Policy. Aetna.com. https://www.aetna.com/health-care-professionals/utilization-management/drug-infusion-site-of-care-policy.html. Accessed December 2016.
2. Blue Cross Blue Shield and Blue Care Network Michigan. Drugs Covered Under the Medical Benefit. BCNSM.com. https://ereferrals.bcbsm.com/bcn/bcn-drugs-medical-benefit.shtml. Accessed December 2016.
3. Anthem Blue Cross Blue Shield. Fast facts: IV sites of care. Anthem.com. https://www11.anthem.com/provider/noapplication/f1/s0/t0/pw_e242033.pdf?refer=ahpprovider&state=wi. Accessed December 2016.
4. Priority Health. Medical policy change for Remicade and IVIG infusions. PriorityHealth.com. http://www.priorityhealth.com/blogs/posts/provider/2016-feb/infusion-sites-of-service. Accessed December. 2016.
5. United Health Care. Specialty Medication Administration – Site of Care Review Guidelines. UnitedHealthcareOnline.com. https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/Medical%20Policies/Medical%20Policies/Specialty_Med_Site_Care_URG.pdf. Accessed December 2016. 

By Lindsey Ghiringhelli, Pharm.D., BCGP, consultant pharmacist, Pharmerica

Medication regimen reviews following a fall are commonly requested for residents of nursing facilities. About half of all residents in nursing homes fall every year, but increasingly, falls are also the reason for their admission.¹ According to the Centers for Disease Control, one out of five falls leads to a major injury, such as a fracture or head injury.² More than 70,000 patients are hospitalized each year due to falls, and direct medical costs are estimated at $34 billion dollars annually (adjusted for inflation).² Elderly patients are three times as likely to die following a low-level fall compared to those under 70 years of age.³

Medications are just a piece of a much larger picture when it comes to preventing falls or performing root-cause analysis following a fall, and the entire healthcare team should be involved in this process. Other risk factors include gait and balance impairment, neuropathy, advanced age, visual or auditory dysfunction, muscle weakness, acute illness, inflammation, pain, orthostasis, dementia, Parkinson’s Disease, incontinence, environmental hazards, poor footwear and restraints.^{1, 4, 5} As pharmacists, we have unique drug knowledge that helps us identify which medications are most likely to contribute to falls, especially in the elderly. Reducing or eliminating these medications, whenever appropriate, can improve overall safety and quality of life for the patient.^{1, 5} Often times necessary medications can be switched to bedtime administration or parameters added to hold for sedation, hypotension or bradycardia. Working with the prescriber, patient and caregivers will help to weigh the risks and benefits of each medication, identify unnecessary drugs or find opportunities to use lower doses for safer medication therapy.

In beginning a medication regimen review, it is important to gather as much information about the patient and the fall(s) as possible. Consider the circumstances and timing of the fall(s), recent medication changes, lab monitoring, vitals, non-pharmacological interventions, medical history, etc. This information can be used to rule medications in or out based on pharmacokinetics and side effect profiles. Identify high-risk medications such as CNS depressants, drugs that cause dizziness, confusion, blurred vision, syncope, hypotension, orthostasis, hypoglycemia or dehydration. This would include benzodiazepines, sedative/hypnotics, antipsychotics, anticonvulsants, muscle relaxants, antidepressants, antihistamines, anticholinergics, antihypertensives, anti-diabetic agents, anti-arrhythmics, narcotics, ophthalmic products, bowel medications and others. It can sometimes seem that there are more medications with fall potential than those without, which is why a discerning eye and extensive pharmaceutical knowledge is so valuable to the healthcare team.

Additional fall risk may occur when drugs interact to increase serum concentrations. For example, NSAIDs may increase serum concentrations of digoxin, CYP-2C19 inhibitors such as omeprazole can increase concentrations of citalopram and carvedilol, and calcium channel blockers (both dihydropyridines and non-DHPs) can increase serum phenytoin and subsequent risk of toxicities. ⁶ Renal and hepatic dosing guidelines, body weight, chronic conditions and fluid balance changes can also indicate a need to use lower doses. If multiple medication changes are warranted or tapering is needed, recommend a step-wise approach to give the patient time to adjust and the prescriber time to evaluate for any potential consequences of the change. Tools to aid in the medication review process include the Updated Beer’s Criteria⁷ and Screening Tool of Older Person’s Prescriptions (STOPP).⁸ These resources provide detailed definitions for potentially inappropriate drugs and specific conditions which predispose the elderly to adverse drug events.

This review process is useful for evaluating medication-related risk following a fall, but the ultimate goal is to prevent future falls and injuries. Elderly patients who have fallen are two to three times more likely to fall again.² Though you may have ruled out certain high-risk medications as contributing to one particular fall, consider adding closer monitoring, utilizing non-pharmacological therapies, reducing doses or discontinuing these medications, since they may still contribute to a future fall. Talk to your patients, care providers and prescribers about the risks associated with these medications and be a team player to help reduce or discontinue any potentially inappropriate medications and to advocate for safe and appropriate medication use.

References:

1. U.S. Department of Health & Human Services. The Falls Management Program: A Quality Improvement Initiative for Nursing Facilities. Agency for Healthcare Research and Quality website. https://www.ahrq.gov/professionals/systems/long-term-care/resources/injuries/fallspx/fallspxmanapb17.html. Published October 2014. Accessed December 2016.
2. Centers for Disease Control and Prevention. Important Facts about Falls. CDC.gov. https://www.cdc.gov/HomeandRecreationalSafety/Falls/adultfalls.html. Updated September 2016. Accessed January 2017.
3. Konstantinos Spaniolas, Julius D. Cheng, Mark L. Gestring, Ayodele Sangosanya, Nicole A. Stassen, Paul E. Bankey. Ground Level Falls Are Associated With Significant Mortality in Elderly Patients. J Trauma. 2010;69(4):821.
4. Jong M,Van der Elst M, Hartholt K. Drug Related falls in older patients: implicated drugs, consequences, and possible prevention strategies. Ther Adv Drug Saf. 2013;4(4):147-154.
5. Huang AR, Mallet L, et.al. Medication-related falls in the elderly: causative factors and preventive strategies. Drugs Aging. 2012; 29(5):359-76.
6. Lexicomp Online, Hudson, Ohio: Lexi-Comp, Inc.; Date accessed: Jan 9, 2017
7. The American Geriatrics Society. American geriatrics society updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012;60(4):616-31.
8. O’Mahony D, Gallagher P, Ryan C, et al. STOPP & START criteria: A new approach to detecting potentially inappropriate prescribing in old age. Eur Geriatr Med. 1(1):45-51.

By Cynthia Peitzsch, R.Ph., consultant pharmacist

The Food and Drug Administration (FDA) announced in August 2016 new labeling that warns against the concurrent use of opioids and benzodiazepines. The widespread use of this combination, and the resulting increase in the number and severity of overdoses has prompted the addition of a black box warning. Previous warnings have included the use of other central nervous system depressant medications with opioid or benzodiazepines, but these new warnings target this specific combination. FDA records from 2004-2011 indicate overdose deaths have tripled from opioid /benodiazepine combination. The Centers for Disease Control and Prevention (CDC) reports that during the same time period, there was a 41 percent increase in patients receiving both medications.

The FDA Safety Announcement stated, “A U.S. Food and Drug Administration (FDA) review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, we are adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines.”

They continued the statement with, “Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.”

Additional Information for Healthcare Professionals from the FDA:

• Reserve concomitant prescribing of opioid analgesics with benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
• Avoid use of prescription opioid cough medications in patients on benzodiazepines or other CNS depressants.
• If the decision is made to concomitantly prescribe a benzodiazepine or other CNS depressant for an indication other than epilepsy with an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response.
• If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid, and titrate based on clinical response.
• Monitor patients closely for respiratory depression and sedation.
• Advise both patients and caregivers about the risks of respiratory depression and sedation if opioids are used with benzodiazepines, alcohol, or other CNS depressants (including illicit or recreational drugs).
• Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the opioid and benzodiazepine or other CNS depressant have been determined.
• Screen patients for risk of substance-use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants, including alcohol and illicit or recreational drugs.
• Encourage patients to read the Medication Guides or patient information leaflets that come with their filled prescription(s).
• Report adverse events involving opioids, benzodiazepines, or other medicines to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.

Reference

1. U.S. Food and Drug Administration. Drug Safety Communications. FDA.gov. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM518672.pdf. Accessed January 2017. 

By Linda Branoff, C.Ph.T.

Have you been feeling depressed, tired and achy lately? Do you have bone pain and muscle weakness? Are you getting a lot of infections? These signs may indicate you should get your vitamin D level checked. Recent research has shown that a low level of vitamin D has been associated with several health issues. Even without symptoms, you could be at risk.

Vitamin D deficiency has been linked to cancer, depression, cardiovascular disease, chronic kidney disease, diabetes and severe asthma in children. It is essential for strong bones, and it helps the body use calcium from your diet. vitamin D production is also helpful in protecting older adults from osteoporosis. Cell growth, neuromuscular and immune function and reduction of inflammation are affected as well.

Here are just a few things that can contribute to a vitamin D deficiency:

1.       Limited exposure to sunlight - vitamin D is known as “the sunshine vitamin” because it is produced in the body from exposure to sunlight. If you don't spend much time in the sun or are always careful to cover your skin (sunscreen inhibits vitamin D production), you may be experiencing a deficiency.

2.       Not consuming recommended levels of vitamin D – It occurs naturally in a few food sources such as certain fish, fish liver oil and egg yolks. It is contained in fortified dairy and grain products, such as milk, cereal, yogurt and orange juice. Cheese also contains smaller amounts of Vitamin D.

3.       Chronic kidney disease- kidneys cannot convert vitamin D to its active form

4.       Obesity or gastric bypass surgery - Being obese does not affect skin's ability to synthesize vitamin D, but greater amounts of subcutaneous fat seize more of the vitamin and alter its release into circulation. Obese individuals who have undergone gastric bypass surgery may become vitamin D deficient over time without a sufficient intake from food or supplements, since part of the upper small intestine where vitamin D is absorbed is bypassed and vitamin D released into the serum from fat stores may not compensate over time

The most accurate way to measure how much vitamin D is in your body is the 25-hydroxy vitamin D blood test. A level of 20 nanograms/milliliter to 50 ng/mL is considered adequate for healthy people. A level less than 12 ng/mL indicates vitamin D deficiency.

Treatment for vitamin D deficiency involves getting more vitamin D through diet and supplements. Although there is no consensus on vitamin D levels required for optimal health, and it likely differs depending on age and health conditions, a concentration of less than 20 nanograms per milliliter is generally considered inadequate and requires treatment.

Guidelines from the Institute of Medicine increased the recommended dietary allowance (RDA) of vitamin D to 600 international units (IU) for everyone ages 1-70, and raised it to 800 IU for adults older than age 70 to optimize bone health. The safe upper limit was also raised to 4,000 IU. Doctors may prescribe more than 4,000 IU to correct a vitamin D deficiency.

Vitamin D toxicity can cause anorexia, weight loss, polyuria and heart arrhythmias. More seriously, it can also raise blood levels of calcium which leads to vascular and tissue calcification, with subsequent damage to the heart, blood vessels and kidneys.

References:

1. WebMD. Vitamin D Deficiency. Webmd.com. http://www.webmd.com/diet/guide/vitamin-d-deficiency#2. Updated May 2016. Accessed December 2016.
2. U.S. Department of Health and Human Services. Vitamin D: A Fact Sheet for Professionals. National Institutes of Health website. https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/. Updated February 2016. Accessed December 2016. 

I started in the pharmacy technician practice after going away to college for a year. I moved back home and was looking for a job while I finished going to school. I answered a job posting for cashier at a pharmacy. Shortly after starting I was promoted to manager with keys and alarm code. I then started helping out in the pharmacy and was given the technician training manual by a pharmacist I worked for as a Christmas gift, and he said to study and take the exam. So I did, and I was certified in 1999. I then started the career I hadn't even considered before. Previous to becoming a pharmacy technician, I had been working as waitress at my father’s restaurant the previous year before starting school. At the time, I was thinking of pursuing a career in social work before I started in the pharmacy. 

Before I took the technician certification exam I had completed two years of general studies in college. In the end, I could not continue classes because the responsibilities increased at my job, and I did not have the schedule flexibility to fit in classes before online became an option. Ultimately it was Rodney Sharp, R.Ph. who bought me the technician training manual and encouraged me to study and take the exam. I accepted his challenge, and have not looked back since.

I have worked at Fox Hills Medi-Mart since 1991, and I have moved from cashier through every job within the company, learning how to do each one so I could fill in and help when necessary. It was, and still is, a great feeling when the owners said they felt comfortable taking a short vacation knowing I was at the store and able to keep it running properly in their absence. Currently I work in the pharmacy that provides retail and long-term care services. I enjoy the relations that I have been able to form with our retail customers. I have been lucky to watch many children grow up and become their own person. I also manage the long-term care accounts and have been able to form many relationships with the nurses and staff at each facility. I very much enjoy when I get to go out to the facilities and interact directly with the staff and patients.

I became involved in Michigan Pharmacists Association (MPA) and MSPT after I received my certification. I was sent a letter from MPA congratulating me on my certification and a copy of the Michigan Pharmacist journal and a complimentary membership, which I thought was a very nice gesture. After reading the journal and speaking with my co-workers who were current members, I joined. Membership is a very good way to keep up with the industry and to learn what is going on in the government both state and federal. Membership also provides you with continuing education (CE) opportunities which every technician needs now that we are fully licensed professionals. The opportunities for networking and meeting great people are wonderful. My involvement with MSPT started when an email was sent to MPA members looking for nominations for the MSPT Executive Committee. Ralph Heuerman, R.Ph. sent in my name and encouraged me to try something different. I decided to run, and with great excitement and surprise I was elected to the committee and have enjoyed every moment spent doing our various activities, and I was honored to serve as the 2015 MSPT President.

Currently I live in Waterford and have a son. Outside of work I enjoy bowling, crafting and spending time with my family.