Steve Leuck, PharmD, has been practicing both hospital and community pharmacy for over 30 years.  He founded AudibleRx, in 2011, which provides Consumer Medication Information in an easy-to-listen audible format. Increased health literacy means better outcomes.

Steve Leuck, PharmD

It is not uncommon for a patient, following an extensive surgery, to be transferred to an acute recovery unit for their rehabilitation. For instance, when an elderly patient undergoes a hip replacement surgery, it may not be a good idea to send them directly home following the immediate hospital recovery period. 

This particular individual may have coexisting disease states, such as 

 or high blood pressure, that need special attention while they are recovering for 3 or 4 weeks. In addition, the patient may have been started on a blood thinner or a course of antibiotics. 

While in the rehabilitation unit, this patient has multiple medication orders on their chart. These orders include all of the patients previously ordered at-home medications, as well as any new medications ordered to treat the current condition. Regularly, these patients are started on a host of 

 supplements for any dietary deficiencies and to boost their recovery. Additionally, a multitude of ‘as-needed’ orders may cover 3 or 4 different ways to treat 

, nausea and/or vomiting, and constipation. 

Our patient has now been in the acute rehabilitation unit for 3 or 4 weeks and is ready to be discharged back to home. In an effort to maintain continuity of care, the hospitalist working in the recovery unit reviews the list of medications the patient has been on, and electronically sends all of these orders to the patients' pharmacy of choice. 

Now, prior to leaving the facility, the nurse will come into the patients' room to discuss all of the discharge orders. To facilitate this discussion, as well as meet regulatory requirements, all of the discharge instructions and consumer medication information are printed out for the patient to take home.

I have seen patients show up to our out-patient pharmacy with discharge instruction packets of greater than 75 pages. Upon discussion with the patient, we dig into the pages and find the medication administration instructions tucked deep inside the packet. Usually, the discharge medication instruction sheets take up nearly 10 pages. After seeing many of these patients come through our clinic, it is my opinion that even a seasoned health care professional would have a difficult time managing their medications based on this enormous discharge instruction packet.

This process provides an excellent opportunity for pharmacist intervention. In our clinic pharmacy, it is our goal to send patients out with all of the discharge medication instructions consolidated down to a single page Patient Medication Record (PMR). We like to take this opportunity to perform medication reconciliation, assuring that there are no discrepancies between the discharge medication instruction sheet and the prescriptions we are filling for them to pick up and take home.

While at the pharmacy counseling counter with the patient, we describe how we are going to create a PMR for them to use when they are at home. We will briefly recreate the scenario in which they were handed a stack of papers prior to discharge, understanding that this process may have felt a bit overwhelming for them. We will then discuss a plan for taking all of that information about medication dosing and putting it onto a single piece of paper.

In our pharmacy, we have added a section on our prescription label design to accommodate extra information. We have one sticker that lists the prescription number, name of the medication and directions. This sticker is used on our PMR; however, it would also be reasonable to write the information in on the record if a sticker is not available.

More than a year ago, I wrote an article describing our PMR sheet that we use in our store. The article includes a copy of the work sheet for download. Please visit this link and download the form. You will be amazed at the joy patients share when they realize all of their medication instructions will fit on one single page.

Articles

Patients are commonly discharged from acute rehabilitation units with many more medications than they were admitted with. This is an excellent opportunity for pharmacists to perform medication reconcilliation.

Simplify Discharge Education in 2018

The delivery of patient care is changing. It always has, and it always will. As health care providers, we are working amid change from our first day in practice until we retire. As a pharmacist, I must have practiced 25 years before I first heard the term, “

." Now, 5 years later, providing a smooth and efficient transition of care from one setting to the next is the primary focus of many health care institutions.

The transition of care with which pharmacists are concerned is the move from the hospital bed to home. Often, a patient is stabilized on a specific new medication while in the hospital. Traditionally, when a patient is discharged, he or she is prescribed a continuation of the therapy that was started in the hospital. The doctor may electronically send the prescription to the patient’s pharmacy of choice, with the expectation that the patient will stop by the pharmacy, pick up the medication, and continue an uninterrupted cycle of therapy.

Unfortunately, barriers regularly get in the way of patients receiving medication from the community pharmacy. Most commonly, either the medication is not covered by insurance or the copay for the medication is too expensive for the patient. Depending upon the pharmacy or pharmacist, a phone call may be placed to the hospital that discharged the patient. The trouble is, the person who wrote the order may be off shift or unavailable, and the situation is left unresolved. When this happens, it is common for the patient to leave the pharmacy without medication. 

Medications that fall into this category are usually critical. They most commonly include antiarrhythmic medications, antibiotics, anti-diabetic medications, blood thinners, and a host of other possibilities. Patients may be referred back to their primary-care doctors. However, chances are that the patient may go untreated for many days. Commonly, these patients end up back in the emergency department of the hospital from which they were just discharged.

I practice in an out-patient pharmacy for a mid-sized community hospital. Over the past 2 years, we have begun to address this issue with increased lines of communication between the hospital and pharmacy staff. Throughout the day, we are in regular communication with the care coordination team members and help coordinate “difficult-to-fill” prescriptions. Regularly, the care-coordination team will come by the pharmacy, pick up the discharge prescriptions, and deliver the medications to the patient’s room.

On any given day, we may have up to 5 or 6 patients for whom we process discharge medication orders, totaling between 20 and 30 prescriptions. Throughout this process, we work on the phone with a host of different care-coordination workers, unit nurses, family members, and often the discharging hospital staff member. Our system is thorough, yet fragmented and cumbersome. Often, much more effort goes into completing the entire process than is necessary. 

Ideally, this should be a pharmacy-driven program, with a single technician interfacing with the care-coordination team, the patient, and family members, and the outpatient pharmacy. Unfortunately, in our institution, a pharmacy-driven scenario is not sustainable. Our team of 2 pharmacists and 2 technicians is busy from open to close managing all the functions involved with running a small community pharmacy. We do not have the manpower to interface with all the stakeholders necessary to manage a full-service so-called 

With our staffing and productivity model, we would need to generate an additional 30 prescriptions in a 4-hour timeframe to sustain a 4-hour-per-day meds-to-bed technician. These additional 30 prescriptions per day would be on top of the 20 to 30 discharge orders we are already filling with the help of the care-coordination team. 

Perhaps if the productivity/labor metric was shared between departments, this could be a much more sustainable venture.

I am writing a proposal for the development of a new meds-to-bed technician position in our institution. This position would work 4 hours each day, Monday through Friday. For this to become a sustainable position, we would need to share 1 hour per day from 4 separate departments to make up the 4-hour shift. 

Which departments in the hospital would benefit most if we were able to get patients' prescriptions in their hands prior to walking out the door? These are the departments that will be asked to come up with the hour of shared labor.

The meds-to-bed technician does not necessarily need to be a pharmacy technician. In our institution, we have many capable case managers who may also be adequately trained to manage this position. The meds-to-bed technician would need to have an excellent understanding of all the workings that are involved in the discharge process. This position would also need to understand all that goes into evaluating, processing, filling, and delivering prescription medications. As well as the technical fundamentals, this position would require a self-empowered personality, a strong understanding of hospital navigation, and the proven ability to follow through on task completion.

One individual, rather than a host of different care-coordination team members, would be responsible for managing the flow of discharge prescription orders. 

		Communicating with the discharge planning team about which patients are candidates for the meds-to-bed program

		Assuring that all team members, including the patient’s hospitalist, are aware of the patient’s choice to participate in the meds-to-bed program

		Visiting the patient’s room to explain what to expect, as well as coordinating prescription insurance and payments.

		Alerting the outpatient pharmacy to expect orders and demographic information on specific patients, as well as discussing any insurance or payment issues that need to be resolved.

		Delivering the medications to patient in their rooms, collecting any appropriate payments and signatures, and coordinating a phone or Skype consultation with the pharmacist.

Every hospital has a vested interest in helping patients achieve the best possible outcome. One way of helping discharged patients stay discharged is to assure that they have their difficult-to-fill prescriptions in their hands when they leave the hospital. But doing this has proven elusive. 

In my opinion, if all the involved departments came together to share the productivity of the increased workload, a sustainable meds-to-bed program could be developed. This program, managed on a daily basis by a meds-to-bed technician, would provide such a valuable service, we would wonder how we ever managed without it.

West L. Ambulatory pharmacy as the hub of transitional care. Knowledgedriven, AmerisourceBergen.

knowledgedriven.com/articles/health-systems/ambulatory-pharmacy-as-the-hub-of-transitional-care.aspx#.WgkO61tSyUk

Published October 31, 2017. Accessed November 26, 2017.

Is there a way to maintain these services in a cost-effective way so that all stakeholders benefit?

How Sustainable Are 'Meds-to-Beds' Programs?

Imagine, for a moment, you are at the pharmacy counter with the pharmacist counseling you about your discharge medications. You have recently been discharged from the hospital with a newly-diagnosed irregular heartbeat. 

This is a big deal. While you were in the hospital you were started on a blood thinning medication to help keep your blood from clotting. Your undiagnosed high blood pressure was also stabilized with the addition of 2 separate blood pressure medications. While you were there, the hospitalist also started you on a medication to help decrease your cholesterol levels. In addition, you were prescribed some medication to help decrease your level of anxiety.

While at the pharmacy counter, the pharmacist is very thorough with the consultation. You have ample time to ask questions and discuss any concerns you may have about your medications. The pharmacist hands you a hefty stack of leaflets, letting you know it would be a good idea to read through all of the medication information to make sure you completely understand your therapy. 

As you are leaving, you feel relatively confident about the interaction and understand you may phone the pharmacist back at any time if you have questions about your therapy.

You make it home, sit down in your easy chair and begin to unpack your prescription bag. First, you pull out the booklet of pharmacy leaflets and begin to shuffle through them. The first page is blank, the second page is blank.  You continue through all 15 pages and they are all blank.

Your anxiety is beginning to flare and you remembered that one of the medications prescribed for you is to help decrease anxiety. You reach into your bag and begin pulling out the prescription bottles. Much to your surprise, the bottles are not labeled. You have 5 prescription bottles, all with medications filled in them, and not one of them has a label. How will you know how to take your medication?

This is what it must feel like to be blind or challenged with vision. Labels are on the bottles; however, you cannot read them. It is difficult to imagine how an elderly patient, living on their own, with some level of visual impairment, can manage their medications without some help. 

In 2012, the President of the United States signed into law the FDA Safety and Innovation Act (s.3187), requiring pharmacies to provide accessible prescription drug labeling for the blind, low vision and seniors. Under Section 904 of the Act, the US Access Board, comprised of representatives of the visually impaired community as well as large pharmaceutical companies, were tasked to determine the best practices for accessible prescription drug container labels. In developing the best practices, the Access Board confirmed the use of braille, auditory means and enhanced visual means.

The completed best practices guidelines were published in July, 2013. Their goal was to create and publish best practices guidelines for accessible prescription drug container labels, including guidance to pharmacies on how to provide accessible prescription drug container labels to patients with visual impairments to enable them to manage their medications independently and privately, and have the confidence that they are taking their medications safely, securely, and as prescribed.

Currently, 2 different companies are in the business of providing label reader options for the visually impaired. Each has a different mechanism for providing the prescription label information to the visually impaired; however, they utilize differing technologies. 

 offers a Digital Audio Label that is 2 inches tall by 1 inch wide and adheres to the prescription bottle. With a push of its button, the user hears a clear audio description of the prescription label information using text to speech software.

 uses a solution where a tiny microchip is embedded in the label. When the prescription bottle is held over a ScripTalk reader, you simply press a button on the reader device and you hear a text to speech voice of all the information on the label.

Both of the above products provide an excellent way for those challenged with vision to listen to the important information on the prescription label. The next question is how do these individuals access the important Consumer Medication Information handed out in the form of pharmacy leaflets with their medications.

 provides a solution where individuals may listen to the consumer medication information of their specific prescription. These sessions are designed specifically for listening and the consumer may pause, rewind, or fast forward at any time. After listening to a session, a consumer will have a clear idea of what they do and don't know about their medications and be in a much better position to take educated questions back to their own health care provider.

If you or someone you care for is challenged with vision, take a look at these 3 options, they might just be what you are looking for.  Ask your pharmacy and other health care providers if they would consider offering these accessibility services.

Best Practices for Making Prescription Drug Container Label Information Accessible 

to Persons Who are Blind or Visually-Impaired or Who are Elderly.

https://www.access-board.gov/guidelines-and-standards/health-care/about-prescription-drug-container-labels/working-group-recommendations

. Published July 10, 2013. Accessed October 8, 2017. 

Imagine you are blind. How do you tell one prescription bottle from the next?  

Accessible Prescription Information

I recently received a request from a pharmacy technician who fills in at our store now and again. He is in nursing school, and in his pharmacology class they were tasked with coming up with useful ways to teach seniors 

 and help them increase their understanding of their medications. He asked me if I had any specific tools I use with senior patients to fulfill these specific needs.

This just happens to be one of my favorite topics, and yes, I do have some favorite tools. Of course, each scenario has its own specific needs. However, with a little thought, I came up with my top 5 or 6 criteria in each section.

		It is super important to help people decrease the number of times they take pills each day. Most seniors tell me that they spread out taking their pills to 6 or 7 times per day (before and after each meal, bedtime, nap time, or a multitude of other specific situations.) Whenever possible, I like to help them decrease the number of dosing times to 3 per day at most, though sometimes, it must be 4, and other times, we can get it down to 2. We take some time to look at everything and discuss what can be given together. Often, seniors mistakenly think that they can't take one pill with another. In this situation, simple education goes a long way toward ensuring medication adherence.

, and help them fill it out. Make sure that patients understand how to use this record.

		Help the senior pick out a useable pill box. Show them all the options, let them choose the one they want, and make sure that they know how to use it. I will even ask them to bring it in and show me what it looks like when it is filled up.

		Make sure that they fully understand what to do if they miss a dose.

		Most importantly, make sure that the senior understands that they shouldn't guess with their medications. If they have a question, encourage them to call their pharmacist or doctor. Quite often, seniors feel as if they don't want to bother their pharmacist with questions. They need to know and understand that we work for them and are a resource.

Helping seniors understand their medications:

		Before beginning a discussion, evaluate the patient and understand any specific barriers to counseling that they may have, such as a lack of education, specific religious beliefs, language skills, social concerns, eyesight problems, speech issues, stigmas, or any other concerns. The pharmacist's counseling will change for each patient as different barriers are uncovered. There is no one-size-fits-all counseling method. Each patient gets his or her own custom-built counseling session.

		At the basic level, senior patients should have a one-word answer to why they are taking each medication, ie, "what is it for?" When I am counseling patients, while preparing their personal medication records, I write the indication on the record, next to the medication. At this point, I have the senior patient match up the indication to the medication name.

		As we are completing the personal medication record, I have patients explain how they take their medications and show them how that fits onto the record. Next, it is important that they can verbalize what they do if they miss a dose.  

		Ask patients if they know what to look for to tell whether a medication is working. This can be a great teachable moment to discuss how their disease states are improving or not.

		Finally, based on the barriers discussed, figure out how much more information you think the patient can handle. Tell them about a couple of the most significant adverse effects, and let them know what they should do if they experience these. Then ask them what adverse effects they will look for and what they will do about them if they occur.

This is a lot of information to take in, but it is extremely important to keep It simple. Pharmacists must understand patients' specific barriers, provide information, and then have them teach it back.

What tools should pharmacists use to help older people maintain adherence and understand their medications?

Tips for Helping Seniors with Their Medications

Since 1982, the National Council on Patient Information and Education (NCPIE) has led a grassroots movement to help patients better understand their medications. 

The NCPIE is a nonprofit organization comprising various members, including patient advocates, health professionals, public health organizations, schools of pharmacy, pharmaceutical manufacturers, and government officials. 

These members develop programs aimed at helping consumers make educated decisions about their health and about the prescription and OTC medications that they take. The NCPIE's programs are also aimed at health care professionals. 

The NCPIE's content is unique in that it always provides actionable tips aimed at increasing communication.

Development of information for consumers focuses on a general understanding of medication safety and the importance of engaging health care providers in conversations about health and medications.

Information for health care professionals focuses on effective ways of providing material to consumers and engaging consumers in effective education discussions.  

The NCPIE is involved in the following medication awareness campaigns, all of which offer valuable resources for both consumers and health care professionals:

: This campaign has occurred every October for the past 31 years. During the month, the NCPIE encourages both health care professionals and consumers to understand how better medicine communication may promote improved medicine use and health outcomes. Over the years, this program has increased its focus to help consumers understand their expected health outcomes, possible medication adverse effects, and the benefits and potential risks of therapy.

: This message is simple but vitally important. In this campaign, the NCPIE encourages patients and health care providers to discuss medications before prescriptions are filled. Discussions must include an understanding of medication adverse effects, how to avoid adverse drug reactions, the importance of following the medication regimen, and how a medication can improve a condition. The Talk Before You Take website has excellent tools for health care providers to use with patients.

: Many seniors take 3 or more medications each day, and 4 of 5 seniors take at least 1 daily. For this campaign, the NCPIE offers a number of actionable tools aimed at avoiding medicine mishaps, managing adverse effects, and improving knowledge about medication use.

: The NCPIE has partnered with the Boy Scouts of America to develop the SCOUTStrong Be MedWise program. This campaign is an interactive way to educate youth about the importance of safely and responsibly using medications. The SCOUTStrong website offers 4 interactive lessons about medication, covering topics, such as what is medicine, using medicine safely, and understanding drug labels.

: This real-life recovery tool is designed for both consumers and health care professionals who are either seeking recovery resources or need help talking to others who are seeking resources. This site has tools that help discuss prevention, treatment, and referral for 

In addition to those 5 flagship campaigns, the NCPIE collaborates with other organizations and actively participates in the following programs.  

		National Recovery Month Planning Partners

		Prescriptions for a Healthy America: A Partnership for Advancing 

		Script Your Future National Medication Adherence Awareness Campaign

		The Acetaminophen Awareness Coalition—Know Your Dose Campaign

		The Medicine Abuse Project by the Partnership at DrugFree.org.

		The National Coordinating Council on Medication Error Reporting and Prevention

		The CDC PROTECT & PROTECT-Rx Initiatives: Advancing Children's Medication Safety

		Protecting Access to Pain Relief Coalition 

for information about all these campaigns and programs and more. In addition, becoming a member of the NCPIE is an excellent way to support healthy medication use.

1. National Council on Patient Information and Education. Talk about your medicines month: 2016: polypharmacy-America's other drug problem. 

http://www.bemedwise.org/talk-about-your-medicines-month/2016

. Published October 2016. Accessed August 24, 2017.

2. National Council on Patient Information and Education. Talk before you take. 

3. National Council on Patient Information and Education. Must for seniors: toolkits for older adults. 

http://www.bemedwise.org/health-education-resources/older-adults

4. National Council on Patient Information and Education. SCOUTStrong. 

http://www.scouting.org/scoutsource/BSAFit/MedWise_Award.aspx

5. National Council on Patient Information and Education. Recovery opens doors. 

6. National Council on Patient Information and Education. Be medwise. 

http://www.bemedwise.org/national-council-on-patient-information-and-education/about-us

Here is the 411 on this organization, which offers programs to help consumers better understand their medications.

What is the National Council on Patient Information and Education?

The FDA has a well-founded belief that states: “People are able to make better decisions about their health care and better use of the prescription medications available to them when they are well informed about the medications they take. Access to useful written information about prescription medications is important to ensuring appropriate use of these products.”

Recognizing that consumers were not receiving adequate written information about their medications, in 1979 the FDA approved regulation 44 FR 40016, which stated that patients would receive written information with each medication. By 1980, the FDA had finalized this regulation with the intent that manufacturers of medications would develop and distribute FDA-approved patient medication information.

In 1982 this regulation was revoked by the FDA (47 FR 39147) with the assurance that the development of patient medication information would be met by private sector providers. The theory was that independent developers within the health care world would create a more innovative and effective product without regulation.

Over the next 15 years, the FDA continued to monitor the patient medication information development and distribution process. The FDA found that the distribution of written information had slightly increased; however, the content was highly variable and its usefulness was inconsistent.

By 1995 the FDA felt it was time to intervene once again with the intent of increasing distribution and consistency of the written patient medication information. Regulation 60 FR 44182 was adopted, which was enacted into Public Law 104-180 in 1996. The following were defined in this new public law:

		By the year 2000, 75% of people receiving new prescriptions would receive useful written patient information with their prescriptions.

		By 2006, 95% of people receiving new prescriptions would receive useful written patient information with their prescriptions.

		Require manufacturers to prepare and distribute medication guides for a limited number of prescription drug products that posed a serious and significant health concern.

		The proposed rule defined that criteria for usefulness would be developed so that written information may be evaluated with regards to the target goals.

Interestingly, as long as the private sector met these goals, the FDA was prohibited from any further regulation regarding content or format of the patient medication information. 

With criteria for usefulness in mind, a steering committee was enlisted, consisting of health care professionals, consumer organizations, voluntary health agencies, pharmaceutical manufacturers, prescription drug wholesalers, drug information database companies, CMI developers, as well as others. From this committee, a report was written titled: 

Action Plan for the Provision of Useful Prescription Medicine Information.

Over the following 6 years the FDA contracted with the National Association of the Boards of Pharmacy (NABP) to assess the effectiveness of the Action Plan provisions. The results of the NABP assessment determined that, by 2002, distribution of written information to patients had increased to nearly 89% of all new prescriptions; however, the usefulness of this information was highly variable. Less than 50% of the written information met criteria to be considered "useful."

Following the 2002 review of distribution and usefulness, the advisory committee recommended that the FDA once again take a more active role in the Consumer Medication Information process. Sometime in the early 2000’s, the terminology changed from Patient Medication Information to Consumer Medication Information, or CMI. 

The FDA was asked to provide some guidance and clarification regarding the interpretation and implementation of the Action Plan. The guidance provided should describe processes needed to evaluate and develop CMI while also ensuring that all CMI is considered useful based on the criteria developed by the Action Plan.

The FDA notes that CMI, which adheres to the original Action Plan, will be considered useful when:

		Information in generalized CMI about the use of or indication for use of the drug is consistent with the most recent version of the manufacturer’s professional labeling or package insert (PI) (see 21 CFR 201.56 and 201.57).

		It includes the components suggested in the Action Plan and substantially conforms to the formatting suggestions made in the Action Plan, specifically:		

				Sufficiently specific and comprehensive

				Presented in an understandable and legible format that is readily comprehensible to consumers

This description of useful CMI is just the tip of the iceberg. Much more information on what constitutes "useful" may be found at the Guidance Document for Useful Written Consumer Medication Informaiton.

 The FDA makes clear that this guidance document is only intended to assist private vendors in developing CMI. Neither the FDA or drug manufacturers review or approve CMI. This guidance is recommended to maintain a level of continuity with the CMI that is provided to consumers.

This guidance document does not maintain a legally enforceable protocol. This should be looked upon as recommendations, suggestions and guidance. If a vendor has an alternative approach to the development of CMI, they are encouraged to contact the appropriate FDA staff to discuss it with them.

1.  US Department of Health and Human Services, FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER).  Guidance Document for Useful Written Consumer Medication Informaiton. FDA web site. July 2006. Accessed Aug. 6, 2017 at:  

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080602.pdf

Is CMI meant to help patients engage in educated discussions about their therapy or just meet the regulatory requirements of the facility providing it to the patient?