Generations of pharmacists had been taught that we are drug experts, and we still are in today’s healthcare systems. But we are also becoming more involved and active in health promotion, health education, disease prevention, and disease management.
	One of the major areas in which we are becoming more involved is diabetes care. Since July 2015, as a clinical pharmacist, I have been a member of an interdisciplinary diabetes team, the DREAM (Diabetes Research Education and Management) Team, at Touro University California College of Osteopathic Medicine in Vallejo.
	Our team takes an interprofessional approach to tackle diabetes our area, from conducting clinical trials and educating healthcare students and practicing clinicians, to leading community outreach efforts in diabetes prevention and providing comprehensive diabetes consultations and clinical care.
	In providing comprehensive diabetes clinical care to patients, I:

Offer medication therapy management focusing on diabetes and cardiovascular risk reduction;

Choose the most clinically sound and appropriate antidiabetic agents with the team;

Offer education on pen devices during the initial visit, discuss a treatment plan for each consultation, titrate medications, and offer insulin pump education and support.

The two diabetologists feel their treatment plans for patients are more complete with a clinical pharmacist on the team. Discussions that lead to treatment plans reflect what the pharmacy profession is trying to achieve: optimizing the safe and effective use of medications.
	Touro University California has created and created a community-based outreach program, Mobile Diabetes Education Center (MOBEC). I serve as program evaluator and have developed a needs assessment and a mechanism to collect, analyze, and interpret data. A registered dietitian and I have been leading efforts to create a series of five-minute, mini-diabetes self-care management modules using the American Association of Diabetes Educators (AADE) 7 Self-Care Behaviors as its backbone.
	Diabetes is not the only area where pharmacists have expanded roles. Other settings of care include:

The acute care setting in hospitals, where clinical pharmacists round with the healthcare team to provide drug recommendations;

Skilled nursing facilities and long-term care facilities, to monitor medication regimens;

Poison control centers, to handle potentially life-threatening medication overdose situations;

Outpatient disease management services settings, where pharmacists work in an interprofessional chronic care model, etc.

Those expansions require additional training and/or education beyond a Doctor of Pharmacy degree, leading to an emphasis on postgraduate education, residency/fellowship training, and board certifications. More pharmacists are now being trained and working in healthcare systems, academic institutions, and governmental entities, which have provided us with opportunities to expand our practice capacity as integral members in healthcare.
	Pharmacy practices include research pharmacists in pharmacy informatics who analyze data and patterns in healthcare systems, and public health pharmacists who help tackle public health issues such as diabetes, smoking cessation, and HIV prevention and treatment.
	The roles of pharmacists in the healthcare sector have changed tremendously with patients’ needs at the heart of our daily practices. One core principle remains constant: It is the pharmacist’s passion and duty to optimize the safe and effective use of medications and improve the health of the society.

Articles

One pharmacist’s thoughts on how and why the practicing pharmacist is becoming a holistic health advocate, as opposed to merely an encyclopedia of pharmaceuticals.

Opinion: Pharmacists Are More Than Just Drug Experts

When the Health Insurance Portability and Accountability Act (HIPAA) of 1996 was first enacted, federal and state governments made little effort to enforce the rules. But in recent years and as related legislation has been passed, more covered entities-including pharmacies-are being held accountable for upholding the act’s requirements.

Pharmacies may be subject to an audit or investigation by the Office for Civil Rights (OCR) that could result in significant fines or corrective actions. Pharmacies that violate HIPAA and expose protected health information (PHI) could open themselves up to a costly lawsuit.

“One thing we have seen over the last three or four years is these investigations have led to multimillion dollar fines,” says Joshua Potter, director of compliance for PRS Pharmacy Services, a pharmacy consulting company. “We’ve also seen patients actually suing covered entities, pharmacies included, when there has been a breach.”

More than ever, pharmacies need to evaluate their policies and procedures, learn how to avoid potential violations, educate pharmacy staff, and implement policies that dictate a course of action if a violation occurs. “The major concern with HIPAA is, in today’s environment, health information is considered highly protected,” says Angelo J. Cifaldi, RPh, an attorney at Wilentz, Goldman and Spitzer P.A., a law firm based in Woodbridge, NJ. “In light of HIPPA and all the responsibilities pharmacists have, they have to be cognizant of everything they do to make sure they are protecting that information.”


	OCR has received more than 186,453 HIPPA complaints since 2003. The office has investigated and resolved 26,152 cases that required corrective actions or changes to privacy practices, and has settled or imposed fines for violations in 55 cases, totaling more than $78 million.

In 2010, Rite Aid Corporation and its 40 affiliated entities agreed to pay $1 million to settle potential HIPAA violations after a joint investigation by the OCR and the Federal Trade Commission found it had been improperly disposing of pill bottle labels that contained health information about patients.

If a suspected violation occurs in a pharmacy, Cifaldi says HHS issues a complaint that the pharmacy must respond to. “The agency is very concerned when they get a complaint, and they exercise it through, so pharmacies better have good policies in place for HIPAA,” he says.

Pharmacies can also be sued if patients believe their health information has been breached. In 2014, an Indiana Court of Appeals upheld a $1.4 million verdict against Walgreens after a pharmacist admitted to viewing the prescription records of her husband’s ex-girlfriend.

Cifaldi says most malpractice insurance policies for pharmacies don’t cover such lawsuits, which means pharmacies often could have to cover the legal expenses themselves.

Many pharmacies may incorrectly believe that simply having a notice of privacy practices (NPP) is sufficient, Potter says. “The notice of privacy practices is really just a document to let the patient know we have things in place to help ensure the privacy of protected health information,” he says. “There needs to be policies and procedures behind that, so just having that notice of privacy practices is not enough.”

For guidance on what the NPP should include, and how it should be provided to patients, visit 

As pharmacies work toward creating effective policies and procedures to protect patient health information, including electronic records, they must first understand when the most common potential violations occur and what they can do to avoid them.

Subpoenas or Other Requests for Information


	When a pharmacy gets a subpoena from a law enforcement agency or court, it can be intimidating, and often a pharmacy owner may be tempted to just hand over their records rather than appear in court, but Cifaldi recommends pharmacies first consult with an attorney.

“When pharmacists just respond to these things on their own and don’t consult their legal counsel, they end up sending more [information] than is required, which always creates an issue,” he says. Before providing information, pharmacies must first make sure the subpoena is enforceable and then determine if they need to seek consent before they release the information.

Potter says most subpoena requests will come from a state court, which means individual state laws determine what a valid subpoena is in that state.

Pharmacists also need to be aware of rules regarding requests for information, such as how quickly they need to provide it. Under federal law, Potter says, if a patient requests their own information, pharmacies have 30 days to provide records and can get an additional 30-day extension if necessary. However, these requests are often also subject to state laws which may have shorter time frames. “There’s all kinds of things that the states also have in place that make HIPAA a little more strict,” he says.


	Allowing spouses to pick up medications for their significant other is a common practice, but in certain situations it can lead to sticky situations. For example, Erica Lindsay, PharmD, MBA, a practicing healthcare attorney in Chicago, had a client whose wife was picking up her prescription at a grocery pharmacy when she was asked if she wanted to pick up her husband’s prescription, too. The woman was unaware her husband had a prescription for Viagra.

Lindsay believes this example was a violation of HIPAA but says it could also be argued that it falls under one of the law’s exemptions.

According to Cifaldi, under the HIPAA rules a spouse has authority to pick up a prescription, unless the patient has given specific instructions that the spouse is not to do so. Pharmacies need to have clear mechanisms in place to track such requests to ensure prescriptions aren’t erroneously handed out.


	Lindsay says pharmacies need to be equally aware of potential HIPAA violations they make while they speak, whether it’s counseling a patient about a sensitive medication within hearing of other patients, a technician loudly announcing the patient’s name and medication name while they ring up the prescription, or providing automatic counseling to a patient who doesn’t want it.

While Lindsay says some attorneys may argue these aren’t true HIPAA violations, they are inappropriate and could open a pharmacy to a potential complaint. Because of potential privacy breaches, she believes a pharmacist should always ask a patient if it’s all right to counsel them before they begin.

“Under HIPAA, if the patient refuses to allow the practitioner to reveal her PHI, that practitioner must stop-not should, must,” Lindsay says.

Using silent methods to communicate information, such as pointing to the drug name on a computer screen or a printout, may improve patient privacy. Other strategies include giving patients a number rather than calling their last name when a prescription is ready.

Experts agree pharmacies also need to engage in regular training and education for employees who come in contact with patient data.


	Electronic PHI, or EPHI, isn’t always something that is stressed as frequently at HIPAA trainings and conference sessions, but it’s equally important and could expose a pharmacy to a potential violation, says Cifaldi.

Potter recommends that pharmacies conduct a risk assessment to identify potential vulnerabilities that may exist in a pharmacy’s technology infrastructure. This includes making sure computers use updated antivirus software and making sure operating systems are current and secure.

Pharmacies need to think about who has access to electronic data and install policies and procedures that dictate its safe use, Potter says. These policies include making sure security software is current-to prevent unwanted data breaches from hackers-and instituting policies that prevent employees from removing electronic devices from the pharmacy.

In one case in New York, Cifaldi says someone took a laptop home from a hospital and lost it. Although the laptop was eventually recovered, it exposed the hospital to unnecessary risk.


	Pharmacies must also consider how they dispose of patient information. For example, computer hard drives and other electronic equipment shouldn’t just be tossed in the trash. They need to be destroyed and the drives erased before they are disposed of. This extends to paperwork and labels that may have patient data, which need to be shredded or destroyed before being placed in the garbage.


	Even with preventative steps, it’s possible a data breach can occur. If a breach does occur, Cifaldi says pharmacies should first contact an attorney.
	“I would highly recommend they consult with a lawyer who has knowledge, because there may be an obligation to report, but how you report could lead to a whole host of problems if you don’t report properly.”

Read more: Incidental Use and Displosure of HIPPA Information

HIPAA violations can result in financial and legal penalities, and the methods of committing a violation continue to grow.

Developing Alternative Communication Strategies Could Avoid HIPAA Violations

Patient visits with physicians are jam-packed with things to discuss and interventions to perform; adult vaccinations can be missed in this process. Pharmacies can fill the gap, but a new report highlights barriers that need to be addressed first.

The study, published in the July issue of Vaccine, reviewed the role of U.S. pharmacies in administering vaccines and what barriers exist to their administration in pharmacies. Nearly 2,000 community pharmacies were studied 2016, and 79.5% reported offering at least one type of vaccine.

Pharmacies most commonly offered influenza vaccine, followed by pneumococcal 13-valent conjugate vaccine, herpes zoster vaccine, and pneumococcal polysaccharide vaccine. Two-thirds of the pharmacies polled also provided vaccination to teens in addition to adults.


	The report revealed several reasons why patients often had to be referred outside the pharmacy for vaccination, including the patient’s insurance not covering pharmacy administration, and patient age not being approved for pharmacy administration.

Brandon J. Patterson, PharmD, PhD, manager of U.S. Health Outcomes and Epidemiology at GSK and coauthor of the study, says the findings highlight the progress that has been made in advancing pharmacy-based immunizations as an additional access point for patients.

Pharmacists play an important role in vaccine education and vaccine recommendations, providing access to immunization services, and administering vaccines, says Patterson and coauthor Philip Buck, PhD, MPH, head of U.S. Health Outcomes and Vaccines at GSK.

The scope of what pharmacies are able to offer varied by pharmacy and location, the report noted, particularly when it came to the maintenance of immunization registries. Insurance policies affecting coverage of vaccines and different rates of copay between pharmacies and physician offices continue to act as barriers, according to Patterson and Buck.

Related: States hope to improve vaccination rates in low-income familes using state registries

“Barriers to vaccination are often due to cost to patients or lack of insurance coverage. Additional strategies are needed to remind patients about the value and importance of vaccinations, especially for vaccines with multiple doses,” Patterson says. “Increasing the use of immunization registries within and accessible across states is also needed to improve the services.”


	Pharmacies can help increase vaccine rates by reinforcing vaccine recommendations to patients and by helping to complete immunization series, say Patterson and Buck. Physicians can help by communicating to pharmacists how they would like to receive documentation of vaccine administrations.

“Ideally, communication between pharmacists and other providers should be a two-way process with physicians providing a referral to the pharmacy and the pharmacy closing the loop documenting and sending confirmation back to the patient’s primary care provider,” Patterson says. “Both groups need to report vaccinations administered to the immunization registry and utilize the registry in assessing patient immunization status.”

Patterson and Buck say they hope the report will motivate additional efforts to address provider and patient barriers that hinder the optimization of the pharmacist’s role in immunization.

This article originally ran in Drug Topics’ sister publication Medical Economics.

New study reveals that immunization registries, communication, and the completion of immunization series can increase pharmacists' role in the immunization process. 

Lack of Insurance and Age Restrictions Among Most Common Barriers to Vaccinations

Simply handing over a sheet of dense safety information or quickly firing off a list of medication instructions isn’t going to be enough for many patients. The National Assessment of Adult Literacy, which was published in 2006-and is the only national data on health literacy skills, according to the CDC-found that only 12% of U.S. adults were proficient in health literacy. The assessment also found that more than one-third of adults would have difficulty with common health tasks, such as following the directions on a prescription drug label.
	No matter how you present patients with information, using simple communication techniques can help them understand the important tips you have for them. Here are a few easy tips to help improve your ability to communicate in plain language.


	For example, when I first began practicing, my director of pharmacy told me he always used the idea of holding his thumb over a firehose and altering its position to explain the concept of high blood pressure and how diuretics work to lower blood pressure. Another example would be comparing how a bacteriostatic antibiotic fights infection to running defense on a football field: You can keep the offensive line (bacteria) at bay, but it doesn’t necessarily make them go away.


	We all have a natural tendency to misunderstand something because we stop listening if we don’t see the value in the topic presented. Would you pay attention to your pharmacist’s instructions on how to take that new green pill if you didn’t know what it was for or how it could help improve your health? It’s much easier to hold a person’s attention and help them grasp concepts once you establish the importance or the need.


	Less is more. If you give the patient too much information at one time, no matter their level of competency, you will lose them and may even confuse them. Focus on illustrating the big concepts and provide important details sparingly based on your assessments of the patient’s level of engagement and understanding.


	Ask yourself, “Would my third-grader understand this concept given my current word choice?” If not, you probably need to scale back and consider using simpler language. Imagine explaining the concept to your neighbor or to one of your friends and apply a similarly casual approach to communicating with your patient. Just make sure you talk to the patient and not at them.


	Whether you are speaking to a patient in English, Spanish, or another language, it’s important to consider how cultural habits and communication may affect a patient’s understanding of your information. It may also alter the information you choose to focus on during your consultation.


	Understand that communicating in plain language does not mean you are dumbing down your speech or your own intellect. In fact, some data show that the higher the level of education, the more likely people are to want to read content in plain language.
	At the end of the day, communication is about human connection.

Only 12% of U.S. adults are proficient in health literacy, but you can help increase understanding through your presentation styles.

Simple Communication Techniques Can Increase Patient Comprehension

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Pharmacy school taught you the art of medicine, now it's time for the art of dealing with your staff.

7 Tips for Becoming a Better Manager

Senior patients have unique needs that require a hands-on approach from pharmacists. Perfecting that approach is becoming even more important, as the number of elderly patients who are cared for by pharmacists grows. An estimated 10,000 people turn 65 every day in this country, and by 2030, 18% of the nation will be at least 65, according to the Pew Research Center.

“When you look at the older adult population, they represent about 15% of the U.S. population, but they consume 39% of prescription medications,” says Chad Worz, PharmD, BCGP, CEO of the American Society of Consultant Pharmacists, an organization focused on advancing senior care pharmacy. “So not only is this population rapidly increasing in numbers, but they are the population that consumes the most medications.”

This translates to a significant opportunity for pharmacists to help patients better manage their medications, and to demonstrate their value as critical members of the healthcare team, Worz says.

“A pharmacist is a great resource for people who are struggling with how many medications they are taking, the cost of the medications they are taking, and the need for an overall manager of those medications.” 

Jeremy Blais, PharmD, district leader in Connecticut for CVS, says previous research suggests that the average senior patient takes between 13 and 19 medications daily-a figure that’s three times the average for younger patients. Blais says patients, especially those who develop ability issues or visual impairments as they get older, have difficulty keeping track.

Steve MacNeill, RPh, owner of Winchester Pharmacy in Winchester, MA, says pharmacists need to take a highly personalized and customized approach for medication management strategies to be effective for each senior patient.

Pharmacists need to fully understand a patient’s living conditions-including issues like whether they are a hoarder, have little outside support, or struggle with memory issues-when designing care plans, he says.

“You have to try to understand where they are coming from first and try to incorporate the program to meet their needs, not telling them how to do it and say you have to follow our process,” he says.

Jeff Kirchner, RPh, CEO of Streu’s Pharmacy Inc., says compliance can be another challenge with this patient population. Most of the elderly population he works closely with believe they are fully adherent; however, they may skip doses from time to time without realizing it.

Senior patients are often also living on a fixed income and may struggle to pay for costly medications, particularly once they’ve reached the doughnut hole, he says.

CVS has developed a program called ScriptPath that analyzes a patient’s medication, including chronic and acute medication, and helps pharmacists develop a prescription schedule for patients.

This schedule uses redesigned prescription labels with bright, color-coded instructions that clearly indicate when the medications should be taken.

“The way we designed it, people can actually line their bottles up in their medicine cabinet by time (of dose),” Blais says, adding that the program helps pharmacists set time aside to have more in-depth conversations with patients.
	MacNeill uses weekly Omnicell blister cards to help improve medication management for his patients.

“It’s fully customizable, so I can have a patient who takes their meds at 7 a.m., 10 a.m., and noon time, and then a bedtime dose,” he says. “We can put them all on the same card.”

The packaging helps highlight compliance issues and allows for the pharmacist to work closely with a doctor to address any compliance issues that may occur.

For instance, if a patient always forgets to take their 5 p.m. medication, the pharmacist could work with the doctor to discuss changing the dose and having the patient take the medication at 8 p.m. with her other medications instead.

MacNeill says the compliance packaging is hugely successful, with about 85% of patients using the service and an average of 10 new patients a week adding it. Although it’s labor intensive for the pharmacist, he believes it’s a valuable addition.

Related: Pharmacist tINtervention Helps Elderly Patients

Kirchner, who also offers blister packaging, saying it helps promote a pharmacy’s value not only to the caregiver, who may not have to spend time each week preparing medications, but to nurses or staff at assisted-living or long-term care centers.

Reducing the number of trips a patient or caregiver needs to take into the pharmacy, whether it’s through a medication synchronization program or compliance program, is also beneficial for those juggling multiple prescriptions.

A Walgreens spokesperson says their patients can take advantage of prescription refill reminders that can be delivered to a cell phone or email address. Walgreens also provides easy-open caps to patients who need them due to arthritis or other joint conditions.

“We also offer our prescription labels in large print to make it easier for patients to read and adhere to vital prescription information such as directions and warnings,” the spokesman says.

Kirchner says pharmacists should conduct a comprehensive medication review to determine what medications a patient is taking and which medications they have been prescribed.

“I think in general, when you are starting to deal with people who are older, there’s a little resistance to change. There’s just a lot of anxiety around change, and I think you need to understand that as a pharmacist. Sometimes it’s going to take more than a couple touches to get somebody to do something. It’s probably going to take more time than you think in terms of conversation,” he says.

Conducting a comprehensive medication review also opens the door for a longer conversation between the pharmacist and patient to learn more about their current habits, lifestyle factors, and level of retention that can help pharmacists better prepare a treatment plan.

It also might bring to light whether the patient is struggling to pay for medication, so that the pharmacists can intervene and try to find programs to help with drug costs or reach out to physicians to suggest lower cost options.

To gain an accurate sense of a patient’s understanding regarding medications and current habits, it’s important for pharmacists to ask probing questions such as what kind of side effects a patient is experiencing, how often they take the medication, when they take their medication, and even how long they’ve been on a drug regimen, says Blais.

Pharmacists need to become the quarterback of complex drug regimens, managing multiple prescriptions and multiple providers to be one central hub where a patient or caregiver can come for complete and clear guidance about their treatment plan.

“That really is what sets our profession apart from a pill dispensary,” Blais says “At the end of the day what makes pharmacists special is they are the front lines of healthcare, nobody in the healthcare system sees a patient more than a pharmacist.”

Recognize senior challenges to develop better pharmacy strategy and counseling services. 

Methods for Elderly Medication Management 

The closest exposure most pharmacists have to medical marijuana products in their day-to-day practice is likely to be with cannabinoids, such as dronabinol (Marinol, Syndros, THC) or the newly approved cannabidiol (CBD; Purified CBD, Epidiolex), according to William Kirchain, PharmD, CDE, Wilbur and Mildred Robichaux Endowed Professor at Xavier University of Louisiana College of Pharmacy. True medical marijuana, he says, refers to herbal products, which are sold through either marijuana dispensaries or specialty permitted marijuana pharmacies.

CBD and tetrahydrocannabinol (THC) are two natural compounds found in Cannabis, the marijuana plant. CBD does not cause the “high”; that comes from THC, which is the primary psychoactive component of marijuana.

While pharmacists must counsel patients thoroughly when they dispence Epidiolex or Marinol, all pharmacists should also be discussing medical and recreational use of marijuana with all their patients because marijuana can interact poorly with certain prescription medications and over-the-counter medications.

Studies indicate that more Americans are trying marijuana for recreational use and medicinal purposes as laws surrounding marijuana use have become more liberal. At press time, 31 states, and Washington, DC, allow comprehensive public medical marijuana and cannabis programs. Of those, nine have approved marijuana for recreational use.

Each state has its own laws about how patients can access medical marijuana.

Related: No Matter the Law, Pharmaciists Need to Know About Cannabis

In a controversial move, back in June 2018, Oklahoma voters voted to made it legal to use, sell, and grow marijuana for medicinal purposes in a referendum  (State Question 788). The referendum passed despite pushback from conservative politicians and law enforcement groups.

Estimates of past-year marijuana use has increased for middle-aged and older adults, according to a study published in Drug and Alcohol Dependence. The analysis comes from data gathered in the National Survey on Drug Use and Health from 2015 and 2016. About 9% of U.S. adults between ages 50 and 64 used marijuana in the previous year, according to survey results. About 3% of people over 65 used the drug in that time period.
	In the 2016 study, almost one-quarter of Americans over age 65 who had used marijuana in the previous year said they received permission from their physicians. A January 2017 research overview published by the National Academies of Science, Engineering, and Medicine, showed that a still small but growing number of studies suggest that marijuana may be helpful in treating pain, nausea, and spasticity.

Medical marijuana can be marketed and sold in a variety of forms, as the properties of THC and CBD are used to produce a desired therapeutic response, Scott Tomerlin, PharmD, APhA spokesperson. Some of the latest trends in medical marijuana include the use of CBD oil in a variety of topical and oral preparations, he says.

“Other products that have gained popularity over recent years have included the use of hemp seed oil as well as the use of products containing CBD for veterinary use. E-cigarettes and other products which allow CBD to be inhaled in a vapor form, otherwise known as ‘vaping,’ are becoming increasingly popular on the marketplace as well,” he says.

There are more than 40 compounds in common CBD oils and extracts, and these products may vary in potency by a substantial amount even batch to batch. Some states allow use of “low THC, high CBD” products for medical reasons in limited situations. 

Marijuana is metabolized through the liver, primarily through the CYP450 enzyme system, specifically 2C9, and 3A4 pathways, according to Deborah A. Pasko, PharmD, MHA, senior director for Medication Safety and Quality with ASHP.

“Drugs that undergo these same metabolic pathways are at risk of having a drug-drug interaction with marijuana. If the non-THC drug is an inducer it will lower concentrations of THC. If the non-THC drug is an inhibitor then it will elevate concentrations of THC,” Pasko says.

Knowing if a patient is being treated with medical marijuana establishes the opportunity for pharmacists to identify any potential drug interactions, especially if the patient may present with adverse effects that could be attributed to any recent changes in medication or over the counter use,” says Tomerlin. “It is always a good plan for the pharmacist to be fully equipped with as much information that is necessary to provide optimal patient care.”

Shital Mars, CEO of Progressive Care Inc., a healthcare and technology company with services that include medication therapy management, prescription pharmaceuticals, and compounded medications, says marijuana is generally well-tolerated in patients with mild to moderate risks of serious adverse side effects and/or dependence.

However, marijuana does have some notable drug interactions to consider before use. They include:

Just because there is a drug interaction, however, does not mean that the two substances cannot be used in combination, Mars says. With drug interactions, “it’s important that the doctor and pharmacist monitor harmful side effects or therapy inefficiencies. In many cases with the medications listed above, medical marijuana acts on the enzymes that either inhibit or induce the metabolic rate of the medication, meaning that interaction with medical marijuana can either increase the potency and effectiveness of the medication or decrease it.”

Kirchain says pharmacists should be aware of adverse reactions associated with marijuana use. These include: central nervous system depression, worsening of depression and other psychiatric illnesses, weight gain, and xerostomia.

Read More: Making the Case for Regulated Marijuana

There can be interactions with contaminates of marijuana products. “Smoked products may increase the risk of respiratory illness, and there have been reports of food-borne illness such as salmonella,” Kirchain says.

Other serious but rare adverse events associated with marijuana use include cannabis hyperemisis syndrome, characterized by recurrent nausea, vomiting, and crampy abdominal pain; cannabis-associated arteritis; and Takotsubo cardiomyopathy (also known as Takotsubo syndrome), a serious condition that includes sudden onset cardiovascular symptoms,” says Kirchain.

Smoking is the most common method of consumption of marijuana, but eating food products that contain marijuana (known as edibles) is quickly becoming a popular way to consume the drug. Although still illegal under federal and many state statutes, food products containing marijuana or marijuana extracts are currently common in states that either permit or that have declined to prosecute medical or recreational marijuana, according to the DEA.
	“The differences of these products vary considerably based upon who and how the end product is manufactured,” Pasko says. “Marijuana scientists can alter the potency depending upon the section of the plant that is used, and also the total dose of THC in the compound.”
	The marketplace for edible and smoked medical marijuana products is continuing to expand, with a plethora of options for patients to consider for use, according to Tomerlin. “Edible marijuana products may have the potential to be more potent than inhalable versions, but these products and the concentrations of THC and CBD can vary widely,” he says.
	Smoked/vaped products will produce a more immediate effect on the body because the route through the lungs provides direct access to the blood, Mars says. “However, these effects should generally wear off much quicker than edible products and produce a less-intense psychologic effect even though the absorption of cannabinoids is higher than in edible products.”
	Edibles take longer to achieve an effect because of the route through the gastrointestinal tract, according to Mars.
	“Generally speaking, the issue is less that the person may die from ingesting too much through an edible, but rather they will be more impaired and may feel ill and experience nausea, vomiting, diarrhea, headaches, dizziness, etc.,” she says. “Pharmacists and physicians should be on the lookout for these side effects so that they can counsel their patients on how to avoid or handle them safely.”
	Beyond the inhalable or edible route, topical preparations such as creams containing CBD oil, as well as other products-including lip balms and aromatic incense wicks to name a few-are readily available, according to Tomerlin.

Epidiolex is first FDA-approved drug comprised of an active ingredient derived from marijuana. It was approved in June 2018 for treatment of two rare severe forms of pediatric epilepsy.
	The DEA gave a Schedule 5 classification to the antiseizure drug, the classification with the lowest degree of restriction, indicating the DEA believes it has a low potential for abuse.
	Epidiolex is a purified CBD oil extract, says Kirchain.

Read More: What Pharmacists Need to Know About Epidiolex


	Pharmacists should use the same approach with THC that they would counseling for any other medication, including discussing risks associated with impairment, toxicities, and long-term side effects, Pasko says.

When counseling patients who are using medical or recreational marijuana, pharmacists should also:

Tell patients that it should not be used by pregnant women or women who are breastfeeding.

Warn patients about the use of marijuana, medical or otherwise, in minors.

 “In some cases, medical marijuana has been prescribed to children with certain nervous system conditions,” Mars says. “In children, it is important to use medical marijuana with proper supervision and medical professional follow up. Used without such controls can subject a child to risk of psychotic and cognitive impairment conditions later in life.”

Be wary of promises that are too good to be true.

 “It’s not magic,” Mars says. “There are many places that talk about the medicinal benefits or marijuana; however, one should be wary of promises that are too good to be true. Marijuana does have medicinal benefits that are now being confirmed through controlled clinical trials, but it should not be used a cure-all or catch-all for any condition a patient may have.”

Keep a complete medication profile for patients including all OTC, herbal, illicit, and prescription medications.

 “Medication management services should be conducted when dispensing any medication,” Pasko says. “There should be a discussion about any other medication that they may be taking that could interact with the medical marijuana.” 

Pharmacists should prepare to advise patient consumption methods and THC drug interactions as use and manufacturing models continue to grow and legalize.

Prescription Counseling Equally Applicable to THC Products

At the Shoshone Pharmacy in Shoshone, ID, a patient arrives to pick up his prescription. The technician asks him to wait, explaining that the pharmacist would like to discuss potential drug interactions with him. The patient is ushered into a private room where he sits across from a 20 inch video screen. Before long, the pharmacist, who is at another pharmacy, appears on the screen, and the discussion commences.

Telepharmacy scenarios, like that take place regularly at Shoshone Pharmacy, and are becoming more common at chain, retail, and health-system pharmacies nationwide.

Currently, 23 states allow telepharmacy, though requirements vary, according to the National Association of Boards of Pharmacy. Several other states have telepharmacy pilot programs in place.

“Telepharmacy can help bring back pharmacy services to areas that are underserved, such as rural areas,” says Lisa Schwartz, PharmD, senior director, professional affairs, NCPA.

In fact, the first state laws surrounding telepharmacy started with a pilot program in North Dakota in 2001. The program brought pharmacy services to 80,000 citizens in medically underserved, remote, and rural communities. Following the success of the pilot program, the North Dakota Board of Pharmacy established permanent rules in 2003 that allowed telepharmacy to be practiced on a broader scale.

In Idaho, the Shoshone pharmacy operates as a satellite pharmacy to R&R Pharmacy in Jerome, ID, about 18 miles away. Shoshone serves a community of 1,500 people who were previously without pharmacy services. While a community of only 1,500 wouldn’t justify a fully-staffed pharmacy, the staffing by technicians, along with the videoconferencing, ensures that those in the community are not deprived of pharmacy care.
	How it Works
	The pharmacy is set up like a regular pharmacy, but is staffed by technicians, explains Jason Reading, PharmD, owner of the two pharmacies. Prescription orders are transmitted to the pharmacist at the main pharmacy for verification. “We have a good system of checks and balances in place,” says Reading. “Setting up a remote pharmacy makes sense from a business standpoint, from a pharmacy professional standpoint, and from a patient care standpoint.”

From a business standpoint, a satellite location can bring a pharmacy up to capacity in terms of filling prescriptions. “If a pharmacy has the capacity to fill 300 scripts a day, but is only filling 200 based on patient volume, why not get paid for the additional 100 scripts?” he says. From a professional standpoint, a pharmacy staffed by technicians frees the pharmacist to perform clinical interventions.

In addition to Shoshone Pharmacy, Reading recently opened a small satellite pharmacy at North Canyon Medical Center in Gooding, ID, about 26 miles from Jerome. It operates mainly as a discharge pharmacy, but provides other services to the community, such as immunizations. As a further reach toward the provision of patient care, Reading recently placed a pharmacist on site at a local medical clinic with physicians, which would not have been possible had the remote pharmacies not been staffed by technicians.
	In the Chains
	In chain pharmacies, CVS Health has innovated by allowing patients to consult with a healthcare provider via a mobile device through the CVS App. The MinuteClinic Video Visits are geared to patients ages two and older who use the app seeking treatment and advice for a minor illness, minor injury, or a skin condition, according to the company.

After completing a health questionnaire through the app, patients are matched to a board-certified community-based healthcare provider in their state, who reviews the questionnaire and proceeds with the video-enabled visit via the patient’s smartphone. When relevant, the physicians call prescriptions into the patient’s pharmacy or refer patients to providers in their community. The program, which has been in place since August, has recently expanded.
	Hospital Telepharmacy
	Videoconferencing can be a powerful tool in a discharge setting, says Brian Roberts, CEO of PipelineRx, a San Francisco-based provider of cloud-based telepharmacy services, primarily in the hospital setting. In addition to allowing pharmacists to consult with patients, videoconferences may take place between nurses and pharmacists, and physicians and pharmacists. Videconferencing may also be arranged with pharmacists once a patient is home, helping to ensure continuity of care, he says.

“While some health system pharmacists may find outsourcing to be threatening, it is empowering,” Roberts says. Rather than eliminate pharmacists, pharmacists are deployed to other areas of the hospital. “Pharmacists are able to work at the top of their game,” he says.

In the inpatient setting, telepharmacy usually involves order entry from a remote site, generally during the hours when the regular pharmacists aren’t on duty. Delta County Memorial Hospital, in Delta, CO, a 50-bed rural hospital, has 24/7 pharmacy coverage since pharmacists from PipelineRx process orders overnight. “We’re able to offer outstanding seamless care when the pharmacy staff is not able to be physically present,” says Philip Neary, PharmD, a clinical pharmacist at the facility.

The remote pharmacists also perform services such as pharmacokinetics, renal assessments, therapeutic interchanges, and IV to oral changes. The overnight pharmacists also check for duplication of therapies, do medication reconciliations, check for patient allergies, and evaluate laboratory results. The PipelineRx platform allows the hospital to collect data, perform clinical interventions, and track cost-savings, says Neary. “These are all activities we might not have been able to justify at a smaller facility.”
	In a similar scenario, at Memorial Hospital of Salem County in Salem, NJ, telepharmacists take over when the inpatient pharmacy closes at 10:30 pm., says Jon Margolin, MS, director of pharmacy at the facility. In addition, the telepharmacists answer questions from nurses and other practitioners. “Basically, the remote pharmacists mimic what we do during the day,” says Margolin. “The screening they do allows us to catch more errors in real time. This is huge.”

Margolin hopes telepharmacy will allow the hospital’s pharmacists to expand the services they provide. “It is our goal for pharmacists to be more involved in inpatient counseling, discharge counseling, and be able to go on rounds and respond to hospital emergency codes with other members of the healthcare team,” he says. 
	Pushing Back on Telepharmacy
	Convincing directors of pharmacy in hospital settings to use telepharmacy can be a challenge, says Roberts. “They tend to have more of an entrepreneurial approach. They want the pharmacy to grow bigger with the hiring of more staff, but bigger is not necessarily better.”

There is resistance in the retail setting, as well, says Reading. “There are those who say we’re killing the profession by staffing the pharmacies with technicians, but the concept lets pharmacists expand their capabilities,” he says.

Patient resistance can also be a barrier to telepharmacy. While patients don’t seem to mind talking to pharmacists via a video screen, they do sometimes get upset if they must wait, Reading says. “They don’t see the inside of the pharmacy where the pharmacist is; they just see the video screen so it’s easy to assume the pharmacist is sitting there with his feet up,” he explains. “The technicians need to be careful how they talk to the patient when they bring them into the video room.”

Reimbursement for telepharmacy services, and lack of it in many cases, is another barrier. Currently, many of the telehealth payment models involving pharmacists have been implanted in managed care organizations such as Kaiser Permanente.

As the private sector shifts away from fee-for-service in favor of value-based care, there is likely to be increased interest from insurance payers to explore telehealth models, according to the study, “Pharmacists providing care in the outpatient setting through telemedicine models: a narrative review,” published in Pharmacy Practice in 2017.

Legislation is another impediment to telepharmacy. “Since the telepharmacy concept is still in its early growth stages, in many cases, the legislation is not keeping up with the technology,” says Neary.

Roberts agrees. “Our pharmacists are licensed in multiple states and work across multiple sites,” he says. “We need to comply with individual state regulations, some of which are more stringent.” Some states, for example, require that a call center be set up; others require that prescriptions be saved for seven years.  

On the health system side, telepharmacy is still an underpenetrated market, so has plenty of room to grow, says Roberts. Currently, it is in about 20% of U.S. hospitals, he says.

Down the road, he sees the technologies expanding to nursing homes, psychiatric facilities surgery centers, and hospital outpatient pharmacies. The technology will also be used more across the individual hospitals in a system. “Orders may be shared across a hospital with a blend of services and technology,” Roberts says. “Telepharmacy is here to stay.” 

Kathleen Gannon Longo is a contributing editor.

Adoption of video conferencing technologies improve dispersal and communication to patients and healthcare professionals alike.

Telepharmacy Business Model Allows Satellite Operation and Increased Patient Convenience

A new campaign that has the support of several pharmacy organizations will educate consumers about the value of pharmacists.
	The American Association of Colleges of Pharmacy (AACP), which represents the 143 accredited schools of pharmacy, recently launched the Pharmacists for Healthier Lives public awareness campaign.

“This is a critical time for healthcare in the United States. People are concerned about access, coverage, and medication management. Pharmacists play a vital role on the healthcare team, and yet most people are not aware of all they do to promote healthier, better lives. We need to change this,” Maureen Thielemans, AACP’s director of communications, tells Drug Topics.
	Most people are familiar with their local community pharmacist, but are unaware that many pharmacists hold doctorates and are important members of a patient’s healthcare team, Lucinda Maine, PhD, RPh, executive vice president and CEO of AACP, says in a statement. “They work in a variety of settings such as hospitals and clinics, and make tremendous contributions in the advancement of medicine.”

ASHP, the Academy of Managed Care Pharmacy, the Accreditation Council for Pharmacy Education, the National Alliance of State Pharmacy Associations, the Georgia Pharmacy Association, and PrescribeWellness, are partnering with AACP.
	While groups like NCPA and APhA are not yet involved, “as the campaign builds, we anticipate that other pharmacy and related organizations will join the coalition,” says Thielemans. The campaign will last several years.

Partner organizations have access to an online toolkit of key messages and branding resources to use in personal and professional communications. The general public can also engage with Pharmacists for Healthier Lives on its Facebook page and through the campaign’s website. AACP is encouraging the use of the hashtag, #Indispensable to promote the campaign on social media.

Pharmacists for Healthier Lives will also be supported with earned media outreach nationally and in key markets. “Next year, we anticipate exploring additional media outlets to include online, transit, print, and broadcast,” Thielemans says.

A new partnership between Walgreens and Kroger could mean Kroger will eventually sell its pharmacy business to Walgreens, according to an analyst.

The two massive retail chains recently announced that customers in 13 initial stores in northern Kentucky can order Kroger grocery items online and pick up orders at participating Walgreens locations. Plus, Kroger’s Our Brands grocery items will be available at participating Walgreens locations. “The diversified shopping assortment will complement Walgreens products and services across health and wellness, pharmacy and beauty,” according to the companies.

Edward Kelly, retail analyst for Wells Fargo, believes the partnership will have various effects. “Opportunity for future collaboration could include the cross-selling of each company’s leading own brands, sourcing agreements, supply chain efficiency, proprietary preferred/restrictive pharmacy networks, or possibly even the sale of [Kroger’s] pharmacy business to [Walgreens],” Kelly says in a research note he provided to Drug Topics. “We recommend investors pay careful attention to the evolution of this partnership and other potential avenues of value creation.”

Kelly believes an in-store pharmacy arrangement, similar to Target and CVS Pharmacy’s partnership, is likely for Walgreens and Kroger. “Pharmacy is particularly tough for anyone other than the key scale players as preferred/limited networks are becoming more prevalent, the generic cycle has slowed, reimbursement rates are getting squeezed, and more complex specialty pharmacy is the growth driver,” Kelly wrote. “The front-end of the drugstore is also challenged given its lack of differentiation and poor value proposition. Now that we know [Kroger] and [Walgreens] have been talking, it’s obvious to us that future collaboration is possible.”

Jim Cohn, a spokesperson for Walgreens, however, tells Drug Topics that the current partnership has “no impact to pharmacy,” In addition, a partnership such as Target and CVS’ arrangement “is not a part of the pilot project, and our plans at this time are … to continue to listen to customer feedback in the coming months, while also gathering learning and insights to help determine any future steps.”

This new concept is an opportunity to test and learn, as the companies determine how to best work together to further elevate their customer offering, Stefano Pessina, executive vice chairman and CEO of Walgreens Boots Alliance, said in a joint statement from the companies. “We continue to evolve our offerings to meet the changing needs of our customers and provide a more differentiated shopping experience.”

Opioid abuse prevention legislation, signed into law by President Donald Trump, is being praised by pharmacist organizations.

Both NCPA and NACDS say they are pleased with the passage of the SUPPORT for Patients and Communities Act (HR 6) by the House of Representatives and its companion Senate bill that was also passed. The legislation was signed into law on October 24.

Requires electronic prescribing for Schedule II through V controlled substances prescriptions covered under Medicare Part D starting January 1, 2021. In addition, the use of electronic prior authorization for covered Part D drugs will be required starting January 1, 2021, Ronna Hauser, PharmD, vice president of pharmacy policy and regulatory affairs at NCPA, tells Drug Topics.

“These requirements may change some pharmacy work flow aspects,” Hauser says. In addition, pharmacists may see Medicare Part D lock-in programs grow, as lock-in provisions for Medicare patients that are at-risk for opioid abuse will be required by 2022, and will be an option for plans starting January 1, 2019, according to Hauser.

The Medicare Part D provision “maintained provisions to exempt long-term care patients in nursing facilities and to ensure that patients’ choice of pharmacy is respected,” NCPA says in a statement.

Provides federal grants to states to assist drug disposal authorized collectors with the cost to purchase, install, and maintain drug take-back kiosks; the cost to dispose of collected unwanted prescription drugs; and the cost to train staff in operating the kiosks with the goal of improving take-back programs and participation in the states, NACDS says in a statement.

Enhances eligibility for the Medicare Part D Medication Therapy Management program to include at-risk beneficiaries.

Requires federal agencies to develop and distribute materials to train pharmacists on the circumstances in which they are allowed by law to decline to fill a prescription for a controlled substance, NCPA says. These circumstances may include the suspicion of fraud, forgery, or other forms of modification.

“Pharmacists will soon have access to HHS materials/training that can be a resource to determine when to decline to fill a controlled substance prescription,” Hauser says.

Strengthens prescription drug monitoring programs. The legislation takes “important technical steps to facilitate a collaborative and interconnected system that provides meaningful prescribing information to healthcare providers that can help prevent fraud, waste, and abuse,” NACDS says.

Social media sites often lead consumers to websites that sell prescription drugs illegally, according to a new report.

During a recent four-week study, the National Association of Boards of Pharmacy (NABP) performed keyword searches on multiple social media sites and easily found posts leading to websites selling commonly counterfeited and/or abused medications. Keywords and terms used included “Viagra,” “ciprofloxacin” (Cipro), and “Xanax for sale online.”

On Pinterest, for example, NABP found 66 posts promoting sale of medications; 38% provided links to websites selling prescription medicines illegally. Similar keyword searches on Instagram, Facebook, Twitter, Reddit, and eBay garnered similar results.

Characteristics of these sites include selling products not FDA approved, not requiring a prescription, and selling controlled substances.

“This review of social media sites was a subset of NABP’s ongoing study of online drug sellers, which has found that 95% of websites selling prescription drugs online are doing so illegally,” says NABP in a statement.

Twitter and Snapchat require that advertisers of pharmacies and pharmacy products be verified by NABP. Pinterest executives say they are taking steps to further reduce the number of illicit “pins” that slip through their filters, according to NABP.

“As Americans’ reliance on social media platforms for news and information has grown in recent years, it is expected that the prevalence of rogue online pharmacies in these spaces will also increase. The goal is for social media companies to take steps and use available resources to screen and monitor their platforms for harmful content linking to illegally operating websites,” NABP says.

Small Doses: November News

Independent community pharmacies are operating under what may appear to be perfect storm conditions. Squeezed by rising drug costs, declining reimbursement rates, and increasing competition, they’re battling choppy seas in search of new and diverse revenue streams.

But there is a ray of sunshine. As the healthcare system shifts to value-based payments, the role of the pharmacist as a dispenser of prescriptions is evolving to one of total healthcare provider.

It’s a logical extension of what pharmacists already do, and an opportunity they need to take advantage of, says Patrick Devereux, PharmD, RPh, president of Family Medical Services (FMS) Pharmacy in Bessemer, AL.

“The pharmacies that are going to be sustainable in business-and this applies to chains and independents-are the ones that embrace a model of clinical services to improve patient outcomes and not solely rely on dispensing,” he says. 

For Devereux and many other community pharmacists, adding diabetes education to the clinical services they offer to patients is a particularly compelling option.

One-and-a-half million Americans are diagnosed with diabetes every year, according to the American Diabetes Association (ADA), and 30.3 million are already living with it, either knowingly (23.1 million) or unknowingly (7.2 million). Another 84.1 million Americans have a diagnosis of prediabetes. That’s roughly 116 million potential candidates for either diabetes self-management education and support (DSMES) or a diabetes prevention program (DPP).

Translating those statistics into dollars and cents is an eye opener. Earlier this year the ADA announced that diabetes is now the most costly chronic illness in the country, with expenses totaling $327 billion in 2017. Medical expenses for people with diagnosed diabetes average $16,752 per year, with $9,601 of that directly attributed to the condition itself.

“The data indicate one of every four healthcare dollars is incurred by someone with diagnosed diabetes, and one of every seven healthcare dollars is spent directly treating diabetes and its complications,” the ADA says.

Drug Topics spoke to several community pharmacists  about their diabetes education programs and how they can be a revenue stream. Here’s their advice for other pharmacists.

Drug Topics November 2018

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Telepharmacy Business Model Allows Satellite Operation and Increased Patient Convenience

Small Doses: November News

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