“A Pioneer in Patient Medication Education: Still Exploring New Frontiers”





Dr. Dorothy Smith



By Linda R. Bernstein, PharmD

Medscape Pharmacists, 2001

Medscape interviews a leader in pharmacy each month and publishes the interviews on its Internet site. Consumer Health Information Corporation President Dorothy L. Smith, Pharm.D., was the subject of Medscape's interview in August 2001. The following is the transcript of that interview.

Dorothy L. Smith, PharmD, is an author, patient advocate, and expert in patient adherence with medications. Her professional career has been devoted to developing patient information programs and materials for patients, employees, and consumers that give them the information they need to make informed decisions about their healthcare and medication use. She is founder and President of Consumer Health Information Corporation, which develops patient education programs to help bridge the gap between health professionals, pharmaceutical companies, and consumers.

Bernstein: What were your goals and objectives over 20 years ago when you began writing and designing patient education materials? Have they changed over time?

Smith: I always tried to keep my focus on the patient and to develop practical and helpful information that will help patients understand how to take their prescription drugs correctly. If healthcare professionals will use the program, it is extremely important to me that these patient information programs not only be highly effective teaching aids but also save the health professional time. I don't think my goals and objectives have really changed over the past 20 years. What has changed is the sophistication of our programs because of the advances in patient adherence research, drug information technology, and the Internet.

Bernstein: What influenced your decision to take this career path and what hurdles did you face?

Smith: I certainly never intended to end up in publishing or start up a company. I was trained as a hospital pharmacist with a specialty in ambulatory care and drug information. During my residency program, I became concerned that patients were coming to the pharmacy to pick up their prescriptions but were not receiving the information they needed in order to manage their medications correctly in the home.

When I graduated, pharmacists were trained not to counsel patients and to always refer them to their physicians if they asked a question. This just didn't make sense to me. As time went on, I saw patients come back to the pharmacy suffering from needless side effects that they could have managed at home. Many patients did not even know which medication was treating which symptom or did not understand the importance of following dosage instructions. I saw patients hospitalized because they took 2 medications that interacted and caused serious complications. I saw patients stop taking their medications because they did not want to put up with minor annoying side effects that they could have easily managed at home. This [discontinuation of their meds] led to serious complications, and some patients died.

When I saw patients die because they had not been taught how to manage their medications correctly, I decided I had 2 choices: leave pharmacy and go into medicine or stay in pharmacy and try to make a change. I decided to stay in pharmacy and do what I could try to narrow this serious communications gap and try to find a way to provide patients with enough patient information so they could manage their medications safely.

There were no courses in pharmacy on how to counsel patients. So, I read every book on medical interviewing I could find. I went to graduate school and took courses on patient counseling and interviewing from the schools of medicine and nursing. Patients were not used to having a pharmacist counsel them. In fact, one patient thought a "pharmacist" was a "lady farmer" and couldn't understand why he needed to talk about his drugs with me!

The next hurdle was that there were no reference books I could use in my patient interviews that had translated the medical terminology about prescription drugs into common, everyday language. I had to refer to at least 10 different books each time I counseled a patient on a medication to gather the necessary clinical information. Then I had to translate this medical terminology to lay language that patients could understand.

One of the physicians I was working with challenged me to take my crib notes that I had developed for my patients and publish them as a reference book for other doctors and pharmacists to use. That was the start of a 7-year project that ended with the publication of a textbook called Medication Guide for Patient Counseling. It became the first textbook of its kind for pharmacists and physicians.

Across the United States and Canada, physicians and pharmacists told me they needed practical, written sets of "patient-friendly" medication instructions because they lacked the time to translate the professional information into language for their patients. This led to the development of the Patient Advisory Leaflet program that was used in over 9000 community and chain pharmacies in the United States and Canada. Physicians and pharmacists gave the 1-page leaflets to patients when a medication was prescribed or dispensed.

Patients started writing letters to the publisher requesting that these leaflets be printed in a book they could use as a home reference. This led to a series of Family Guides for consumers on medication instructions.

By 1983, I decided to take a chance and founded Consumer Health Information Corporation. The mass paperback, Understanding Prescription Drugs, was published by Simon & Schuster; a Canadian version, Understanding Canadian Prescription Drugs (Key Porter Books), followed. It was surprising to me that approximately 30% of the drugs in the United States and Canada have the same trade name but require different patient instructions. Soon pharmaceutical companies and health professional organizations were calling for assistance in developing programs that would help patients take their medications correctly and increase patient adherence.

Bernstein: What types of decisions are patients making that are having an impact on how effective prescription drugs can be?

Smith: The patient holds the decision-making power once the medication has been dispensed. The physician, nurse, and pharmacist have to rely on the patient to make wise decisions in the home environment.

There are 3 critical decisions made by the patient:

  1. The patient decides whether or not to fill the initial prescription.
  2. The patient decides whether or not to refill the prescription.
  3. The patient decides how and when to take the medicine and what to do if they think they are developing a side effect.

Bernstein: What are the important features to look for in evaluating the quality of patient education materials?

Smith: Obviously, the most important thing is that the information must be 100% clinically accurate and translated into language that the average consumer can understand.

Consumers also need "practical"patient information that means something to them. Rather than giving the person a long list of potential side effects, people need to know the early warning signs of these side effects and how to recognize them before they become severe. This takes clinical expertise as well as skill in anticipating the most common questions that patients ask regarding these side effects.

The next step is to recognize the problems that patients will have during the prescribed treatment and to develop practical strategies that will help them overcome these barriers. Sometimes, it will be a problem related to the dosage schedule. It may be a problem integrating the medicine into their daily lifestyle. Other times, it will be a problem relating to side effects. Many of these problems can be anticipated in advance so that the patient can be prepared to handle them if they occur. In addition, every person is different and will need individual questions answered by their physician and pharmacist.

Last but not least is the design and layout. Patient information materials can contain wonderful information, but if they are not easy to read and "patient-friendly," they will be less effective. There are certain colors that should be used to help motivate patients and there are other colors that should not be used because they could make it difficult for people with poor eyesight to read.

We spend a great deal of time integrating the content with the design of thepatient information. Complicated medical illustrations are translated into graphics that clearly and simply send the right message. It is certainly true in patient education that a picture can be worth a thousand words!

Since the patient is the one who will be making critical decisions about when and how to take their medications at home, it is essential that they receivepatient information that will provide them with straightforward and easy-to-understand information. And patients need to store this information at home so that if they start developing any symptoms they think might be related to their medicines, they can reread it and call their doctor or pharmacist.

Before any program is submitted to a client, we review it very critically to make sure that it is based on proven patient education principles from start to finish.

Bernstein: How big of a problem is medical literacy in this country? Are average patients able to read the currently available patient package inserts and labels?

Smith: Many people in this country need patient information that is written at least at the Grade 6 level. There are many other people who need the information translated to the Grade 4 level. Since it is very difficult to translate medical terminology to this level, there are many health information Internet sites out there as well as printed materials that are written at a higher readability level. In fact, if you open a magazine and read some of the ads for prescription drugs, you will find that many of them are even written at the Grade 10 or Grade 12 level. Thus, fewer people are going to be able to understand these materials.

But it's a far greater problem than readability... patients must be able to "understand" the information. For example, "red meat" is a word at the Grade 4 level, but many people do not understand it. If told to avoid red meats on a low-cholesterol diet, many people think it is okay to eat steaks and hamburgers because the meat is not red once it is cooked! Information must be written so that people can understand it.

In addition, I don't think we should be expecting the consumer to be medically literate. Health professionals have gone to schools and studied medical terminology for years. It's not fair to expect a consumer to be able to understand health information that is written at a level that requires an understanding of medicine. I shall always remember a professor telling me that one of the true tests of a professional is to be able to simplify his/her professional knowledge so that other people can understand the message. I always encourage my students to put themselves in the shoes of the patient and imagine what it would be like for them to try to understand the procedure manual for the operational system of a computer network system.

Bernstein: What other factors contribute to medication misadventures?

Smith: I believe that an even greater problem than medical literacy is the number of patients who are suffering because they do not know how to manage their medications correctly. In fact, hundreds of thousands of people are ending up with severe medical complications and some are even dying every year because they are not making wise decisions when taking their prescription medicines.

When people make unwise decisions about taking their prescription medicines, they can run into serious problems. Not only does the medicine not have a chance to work correctly, but the person's condition can worsen as a result. For example, if someone has high blood pressure and has no symptoms, it is very tempting to consider stopping the medicine. Over time, the person's blood pressure would not be controlled and the person may end up having a stroke or developing congestive heart failure, kidney problems, etc. It would have been much better to keep the blood pressure under control so that these serious medical problems could possibly have been prevented.

Home medication errors made by patients cost them dearly in terms of quality of life as well as healthcare costs. These errors also cost our healthcare system significant dollars that could have been saved. Studies have shown that it is costing our country more than $180 billion a year to treat the complications of medication errors made by patients -- and that does not include the employer costs when employees miss work.[1] This is twice the figure it would cost to purchase all the drugs in the country!

It doesn't make sense that we are spending more on treating the complications of prescription drug therapy than we are to purchase the medicines initially. Other studies have shown that when patients are taught how to manage their medicines correctly, these costs can be cut in half.

Bernstein: How would you improve upon the currently available patient medication materials provided through drug and database companies?

Smith: This is a very difficult question to answer because there is such wide diversity among the various patient medication materials.

I would encourage the companies to test their wording to make sure that patients will be able to understand it and to make sure that the information is practical. Every precaution needs to be taken to remove any chance of patient misinterpretation, so that the patient is not harmed.

After the basic content is developed, I would recommend that they integrate behavior modification techniques in order to help convince the patient to follow the instructions. It is the patients who have the power in this whole process, and if they are not convinced that the information is important, they will not take the drug correctly!

There are many patient education techniques that can be applied to different diseases, drugs, and patient populations. The key is to select the best techniques so that they meet the needs of the people to whom you are giving the information.

Bernstein: How would you describe the "perfect" patient-pharmacist encounter? Obviously just handing the patient a piece of paper with instructions is not enough. What are the other components of patient education that need to occur to optimize patient understanding?

Smith: I certainly agree that just handing the patient a piece of paper with instructions will never be enough. Written instructions should only be used as reminder sheets because it is impossible for a person to remember everything he or she is told about how to take the prescribed medicine. They do serve a very useful purpose, though, and people should re-read these sheets as they continue through a course of therapy.

Far more important than the written instructions is the personalized information that the patient should receive from the pharmacist. I believe that every person needs a "family pharmacist" whom he or she can trust.

This pharmacist will keep a confidential record of all the medications and counsel the patient every time a prescription is dispensed. At the initial prescription stage, the pharmacist will take a drug history and help plan a dosage schedule that will "work" with the person's lifestyle and work schedule. Helpful advice about how to manage minor and commonly occurring side effects will be discussed, and the pharmacist will also teach the patient the early warning signs and appropriate actions for more serious adverse effects. At each refill visit, the pharmacist will counsel the patient and learn whether the patient has been having any problems remembering to take the medication or whether he or she has experienced any symptoms that might be related to adverse effects.

Bernstein: You are a board member of the National Council on Patient Information and Education. How does this organization work to improve medication communication between patients and healthcare providers?

Smith: The National Council on Patient Information and Education (NCPIE) is a coalition of nearly 200 healthcare organizations representing healthcare providers, consumers, university professors, and business groups that develop patient information. It was formed almost 20 years ago and is committed to safer, more effective medicine use through better communication. The organization has been very active in getting the message out that consumers need to ask questions about their medicines so they know how to take them correctly. NCPIE holds a conference every 2 years to bring together all these members.

The organization encourages consumers to learn about their medications before they start taking them and to do the following:

  1. Ask questions about instructions for use, precautions, and side effects whenever a new medicine is prescribed.
  2. Share information with doctors, pharmacists, nurses, and other healthcare professionals about other prescription and OTC medicines they are taking.
  3. Read carefully any written information that comes with the medicine, and save it for future reference.

(See www.talkaboutrx.org.)

Bernstein: What are the limitations of currently available patient medication education resources? Do you have any data on recent studies of the quality of medical databases?

Smith: The first problem is keeping the information up-to-date. We are currently conducting a study and looking at the quality of several sources of patient medication instructions on the Internet and are finding that the databases vary significantly with regard to content and how up-to-date they are.

Bernstein: What are pharmaceutical companies doing to educate patients about their products?

Smith: More and more pharmaceutical companies are starting to develop well-designed written patient information sheets in language the layperson can understand. The government does not normally require a pharmaceutical company to develop these instruction sheets, so most of the companies that are developing them are doing so voluntarily. These medication sheets are reviewed thoroughly by the US Food and Drug Administration (FDA) to make sure that the information is completely accurate and that both the risks and the benefits are presented. Many companies are also posting the patient package insert (PPI) on their Web site for consumers to read. There will usually be a date at the bottom of these instructions so you can tell when it was last updated. The pharmaceutical company is required to update its patient instructions whenever there is a pertinent change in the drug labeling.

Pharmaceutical companies are also realizing that patient adherence and patient retention are linked. They are starting to see the importance of developing a patient-adherence strategy for the specific medication rather than just developing a variety of different types of patient education materials.

Bernstein: What is your company's approach to designing patient medication education materials?

Smith: We try to educate people about their medications and try to anticipate all the problems that the patient might encounter by looking at it from the patient's point of view.

Since health professionals in their practice settings use many of our programs, it is also critical that we look at the problems in hospitals, clinics, and pharmacies from the health professional's point of view. Then we stand back and identify the barriers that health professionals encounter every day in their practices. This is when our years of experience in clinical practice come into the picture. Health professionals need programs that will help them teach the patient in a minimum amount of time.

Once we have identified the barriers faced by every person in the team (including the patient), we develop a patient adherence strategy that will help overcome these barriers at each stage of the prescription drug therapy. We develop Personal Progress Logs for patients that help them identify the things that can trigger their migraines or allergies, etc. This is the creative and fun part of the process. It's applying everything in medicine and pharmacy to a creative program that will help patients receive the most benefit from their medications.

It is absolutely essential that we stay up-to-date with all the research on patient adherence, behavior modification, the Transtheoretical Model of Change, national policy issues, and new regulations that have an impact on the legality of wording that is used. It is exciting to work on medications while they are still in the research stages and to develop programs in different languages for medicines all over the world.

Bernstein: What projects or goals do you have in mind for the future?

Smith: I have found my work with the pharmaceutical companies to be a very professionally rewarding experience. Pharmaceutical companies have realized that they need high-quality patient education materials in order for patients to respond effectively to their medications.

More and more companies are realizing that it is in their best interests to develop an FDA-approved patient package insert. We now have several years of experience perfecting our procedures and working with companies throughout the FDA regulatory review process. We will definitely be expanding in this area. The development of a wide variety of patient education/adherence programs will always be a major emphasis. We have learned through the years how to develop programs (ranging from DTC collateral materials to refill adherence programs) that meet the needs of both health professionals and their patients. The numbers rise if the written materials are reinforced appropriately during personalized patient interviews.

I hope that I can get back to updating some of the books I have written for consumers and develop a newspaper column with practical information. I believe that there is a real need for practical information and I have always enjoyed working directly with consumers and the media. We are working on developing an electronic patient medication database based on my previous books as well as a series of publications for children and caregivers. I am committed to working with the national organizations on patient safety issues so that consumers become better informed and take their medications more safely. Hopefully, our academic training programs will continue to expand and we can get more students interested in this area as a future career.

Bernstein: What can the pharmacist do to improve the quality of their patient medication communications given the many obstacles they face?

Smith: Since time is the major restriction that pharmacists face in their daily practices, the key is the best use of that time. Pharmacists need to delegate as many of the noncognitive tasks as possible to their assistants so they are freed up to spend more time with patients and monitoring their therapies.

The healthcare practitioner needs to use strong patient communication techniques so that patients can understand the information they are being given. Second, the healthcare practitioner must be able to convince and motivate the patient to follow the instructions. After all, it is the patient who will decide whether or not to follow the advice. Finally, the patient must trust the healthcare practitioner. As soon as the patient trusts the healthcare provider, the patient relationship becomes strong and your patient becomes one of your strongest allies.

Bernstein: Describe how you are trying to train the next generation of pharmacists to be sensitive to patient education communication issues. How can other pharmacists do the same?

Smith: Teaching remains important to me. Even though we are a small company, I am committed to helping pharmacy students pursue their interests in patient education.

A few years ago we started a Specialized Clerkship in Drug Information/Patient Education. Depending on the specific university, the senior students spend 1-2 months with us and are involved in a wide variety of program development and national policy issues. The program has expanded, and we are currently affiliated with about 30 schools of pharmacy across the United States.

Three years ago, we started a Summer Internship Program for undergraduate pharmacy students who have a keen interest in patient education, medical writing, and student leadership. All of our students participate in actual projects the company is working on. They also write an article for their hometown newspaper. My hope is that some of these students will decide to pursue a career in patient education and help improve the home management of medications by patients.


Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: Updating the cost-of-illness model. J Am Pharm Assoc. 2001;41:192-199. Available at: http://www.medscape.com/ APhA/JAPhA/2001/v41.n02/ jap4102.02.erns/jap4102.02.erns-01.phpl.

Linda R. Bernstein, PharmD, is President of Vita Media Corporation, San Francisco, California. She is a pharmacist, educator, media producer, writer, and on-air talent specializing in the development of innovative educational programs for health professionals and consumers. Email: vitamed@altavista.com.

About Consumer Health Information Corporation

Consumer Health Information Corporation was founded by Dorothy L. Smith, Pharm.D, an internationally recognized clinical pharmacist with expertise in patient adherence and patient education. The mission of Consumer Health Information Corporation is to help patients learn how to manage their diseases and prescribed treatments safely and wisely. The company has developed more than 4000 evidence-based patient education programs for medications, medical devices, disease management and Phase III clinical trials worldwide.  A respected clinical and educational source, Consumer Health Information Corporation has won major national and international awards for excellence in patient and consumer education programs that have significantly increased patient adherence. Dr. Smith is the author of more than 130 professional articles, 23 books and has delivered more than 150 professional and scholarly addresses.

Copyright 2012 Consumer Health Information Corporation. All rights reserved.

Contact Us for a link to the published article.  









Consumer Health Information Corporation  

Experts in Patient Education and Adherence Since 1983
8300 Greensboro Drive, Suite 1220
McLean, Virginia 22102

[constantcontactapi formid="1"]