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The first portion of this segment, How To Create and Use A Personal Medication Record, noted that several models of the Personal Medication Record (PMR) are available. Today, the focus is on the means by which one can assess the utility of the actual formats.

In my research for these posts on the PMR, I found far too many PMR candidates to provide even a representative sampling for readers, let alone an exhaustive review. I also discovered, however, that there are a few telltale signals that provide valuable insight into the design of the PMR and its potential fit with the user.

The Pen and Pencil PMR

The example from this category is the AARP-sponsored PMR depicted below (not actual size).¹

Click on graphic to view larger image

Note that the layout is logical, the print is clear, and content is easy to understand. Sufficient room is provided to write the information needed. The box on the first page titled “How to use this Guide” has helpful instructions, especially for those using the form for the first time. The reminder to list all medications is repeated on the second page. All the data cues ask for information that is either essential or of high probable utility. On the first page, “Other Physicians” and “My Medical Conditions” fall into the “not essential but likely useful” category as does the column headed “Start/Stop Dates” on the second page.

My criticisms are limited to a few minor points:

• The user’s phone number. I’m unconvinced of the benefit of including the user’s phone number although I can see the obvious value of an emergency contact. I may be overprotective of my telephone number but I’d prefer not entering any data that is not clearly needed. Were I using this form, I would adapt it by entering, as shown, “See ‘Emergency Contact’” in that space.
• “Last updated” location. I think this is especially important information and worry that it could be missed because it is placed in a box that otherwise has no data entry points. I suggest highlighting it in some manner as a visual cue.
• Page identification. This is a two (or more) page form. My experience is that multi-page forms are prone to separate into the constituent pages and attach themselves to another individual’s file or last month’s page one becomes paired with this month’s revised page 2. Consequently, I suggest that the pages be stapled together and that each page be labeled with the user’s name, the date of the last revision, and its page number. For the first page, only the page number must be added. As indicated, the name, date of last revision, and page number must all be added to the second page.

To be considered as a candidate for your PMR, other formats should at least meet the standard set by the AARP form, the quality of which is thrown into relief when it is compared with less thoughtfully constructed PMRs, such as the one page version shown below.

Click on graphic to view larger image

This Personal Medication Record, one notes, devotes more space to categorizing the type of drug allergies than to listing the medications. Knowing whether one is allergic to anesthesia or allergic to pain medication is, one could argue, more helpful to the doctor than the patient. I’m also not sure “Latex” is a medication or that the distinction among “Aspirin,” “Pain Medication,” and ”
Anti-inflammatory” is either clear or useful. In addition, the space allotted for the medications is insufficient for anyone without calligraphic skills. Finally, there is no “Last updated” cue.

The On-line PMR

When determining which on-line PMR is best for you, there are obvious points, such as a solid privacy policy, a program that works reliably and with reasonable speed when accessed from the computer(s) and internet provider(s) you will commonly use for this purpose, and cost which can easily be determined. Beyond that, however, the individual pros and cons become difficult to track.

Instead of considering such issues individually, I suggest you look at the orientation of the program’s design. My working hypothesis is that On-line PMRs can be divided into two groups: (1) those designed primarily for the benefit of the PMR user and (2) those designed for the convenience of the entity offering the PMR (e.g., a health insurance company).

Note: Typically, it is advantageous a PMR designed for the benefit of the user.

The comparisons that follow will illustrate this idea. PMR #1 is offered to any user at no cost and is apparently supported by product advertising on the same web site albeit not on the PMR itself. PMR #2 is one of those offered by an employer to its employees or byk an insurer to its clients and is available to those eligible at no charge.

The graphic below compares the lists of medication choices users of these two PMRs see on entering “Actos,” a medication used to control diabetes, into the user’s medication list.

Click on graphic to view larger image

The key point is that PMR #1 offers three choices, Actos in the three strengths in which it is sold: Actos 15 mg, Actos 30 mg, and Actos 45 mg., while PMR #2 offers over 50 choices (the screen shot above shows only a portion of the total list) the same medication offered in the same three strengths. Some of the additional choices in PMR #2 arise from some entries featuring the generic name as well as the brand name and some that don’t, but the major factor is that each Actos item is associated with a different NDC code.² My assumption is that the correct NDC is somehow useful to the PMR provider although that seems suspect given that patients do not routinely know NDC numbers and have no way of determining which of the several Actos 30 mg selections one should choose and if, indeed, if makes any difference. At best, it’s confusing.

A similar problem arises if the user wants more information regarding a medication. A strength of on-line PMRs compared to paper and pencil PMRs is the relative ease of obtaining that information. Both PMR #1 and PMR #2 offer buttons that lead to the following screens for Actos:

Click on graphic to view larger image

PMR #1 takes the user to a web site about the medication prepared by the manufacturer. PMR #2 produces a Medline search list. If the PMR were used only by healthcare professionals and knowledgeable patients, I would agree that a Medline search might be the superior offering. Those less familiar with medical terms, however, looking for only basic information such as side-effects, could be overwhelmed, confused, and intimidated by the search list, especially since it preponderantly uses the less common scientific names. One can hardly fault the use of Medline but providing a patient with a single, clear site with the information about side-effects, dosages, etc seems to me the more efficient and effective tactic.

On a related note, PMR #1 offers schedule choices based on time of day (e.g., 7 AM) while PMR #2 offers the Latin abbreviations such as qid, bid, prn, etc. It seems clear which is more easily comprehensible to the naive user. Similarly, PMR #1 provides recognizable graphic representations of the actual pill or capsule, a valuable tool if, for example, the patient is mistakenly given the incorrect medication, or, less dramatically, uses the PMR to make sure the right pill is deposited into the right section of the pillbox; PMR #2 doesn’t offer realistic illustrations.

Perhaps most telling is the view of the total list afforded the PMR user.

Click on graphic to view larger image

The standard view of PMR #1 is the display of all the medications, including name, dose, illustration, and schedule of doses. The standard view of PMR #2 is a similar list of medication names and doses but the schedule for taking those doses is revealed for only one selected medication at a time. Again, PMR #1 offers more utility to the patient.

Also check for other features that may be useful for you. While is a technological trifle, some PMRs offer “wallet sized” PMRs or at least lines for folding large sheets into more manageable sizes.

I find this helpful; others, no doubt, will see it as unnecessary.

As is true of many PMRs, both of these specimens offer refill reminders.

PMR #1 does not have a method within its program of sending the PMR to others or allowing others to access the medication listing. PMR #2, on the other hand, does offer this important feature.

Users can, in fact, allow specified others to access the information on-line and email or fax the PMR to others. Moreover, the access can be limited to certain information, excluding other data, and users can be allowed read-only access or permission to add to the file. That said, the directions for encrypting and decrypting the data are so complex and cumbersome that I was daunted before learning the entire process although I’ve used encrypting software and services on a daily basis for several years. It would require, I believe, significant dedication on the part of any non-geek to actually use the procedure.

The Future

There is an altogether laudable movement to standardize the Personal Medication Record (and the Personal Health Record). When that takes place, this sort of advice will, one hopes, be moot. Given the medical, ethical, and political issues involved, however, reaching that goal in the short term is improbable. In any case a Personal Medication Record is too important to be deferred for a few days, let alone a few months or, more likely, a few years.

So, read about PMRs, make your choices about what is and isn’t important, and try out a form or two to see what fits. Then create your PMR and use it.

Footnotes

1. While the AARP offering is, in my judgment, the best of the lot, its use here should not be considered a recommendation. [back]
2. According to the FDA web site, the NDC is the National Drug Code, a unique 10-digit, 3-segment number assigned to each medication listed under Section 510 of the U.S. Federal Food, Drug, and Cosmetic Act. The number identifies the labeler or vendor, product, and trade package size. The first segment, the labeler code, is assigned by the Food and Drug Administration (FDA). A labeler is any firm that manufactures, repacks or distributes a drug product. The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm. The third segment, the package code identifies package sizes. [back]

The Personal Medication Record - Summary

Although this is the fourth and final AlignMap entry focusing on the Personal Medication Record¹ (PMR) as an important method of decreasing unintentional medication noncompliance (i.e., errors in taking medication),² it summarizes the previous entries and can be read as a stand-alone manual on the practical steps to create and use a PMR.

The The No-Nonsense Summary that follows is a condensed version of the lengthier discussion that begins with the heading Creating The Optimal Personal Medication Record.

Finally, the continuation of “How To Create and Use A Personal Medication Record”³ will be a description of some of the practical issues I found in creating my own PMR and will illustrate many of the points raised in this discussion.

1. A PMR decreases the risk of medication errors and can provide information that could save your life. Everybody should have one. If you don’t have a PMR, stop what you’re doing, go to the heading, “IA. If you do not have a PMR, make a temporary one - now” (a couple of paragraphs below the collage of PMR forms) and follow those instructions to create a temporary Personal Medication Record.

2. Decide which format suits your permanent, optimal PMR:

A. A pencil and paper form that is simple to use and has fewer privacy risks but is more prone to error and requires more work to update and distribute.

B. A computerized version of the paper and pencil PMR that is not stored on-online so it is easier to revise and less prone to error and has less risk to privacy than internet PMRs but lacks the 24 hours day availability wherever Internet access exists.

C. An on-line PMR that is easy to update, less prone to error, always available, and easy for others to access with your permission, but has inherent privacy risks.

Note: If you cannot add information (e.g., over the counter medications) to a medication list generated by your pharmacy, insurer, healthcare provider, etc., that medication list is not a useful PMR.

3. On-line PMRs offered by employers and insurers carry sufficient risks to privacy and potential problems with portability and access that privately administered PMRs, even if they charge a fee, are, in my judgment, a better choice.

4. Decide which data to enter into your Personal Medication Record based on its utility to you and your healthcare providers, not on the slots and prompts of a form. The core of the PMR is the list of every medicine you take, including prescribed medications, over the counter drugs, herbal remedies, diet supplements, drugs taken “as needed” as well as those taken routinely, and those administered by a nurse or at a clinic (such as I.V. chemotherapy given at the oncologist’s office), with the dose of each, when it is taken, the reason it is taken.

5. Revise your Personal Medication Record immediately if there is any change in the medications you take, regardless of why the change took place. An outdated PMR may not only be inaccurate but also dangerous. Distribute updated PMRs immediately to your personal physician, your pharmacy, and your emergency contact.

6. Use your Personal Medication Record routinely to review your medications before a doctor’s appointment, to order refills, to stock your pillbox, to discuss treatment with your clinicians, …

A Personal Medication Record decreases the risk that you will make a mistake in taking your medication or that healthcare professionals will make a medication error that will result in treatment failure or even harm to you. It can provide essential information in emergencies, especially if you cannot provide that data yourself. Your PMR can also prevent bureaucratic hassles, increase the efficiency of the communication between you and your treatment team, and lessen tensions during doctor visits. That’s why …

IA. If you do not have a PMR, make a temporary one - now
(If you do have a PMR already, go to Step IB)

The Personal Medication Record is such an important healthcare tool that creating a basic, operational version takes precedence over deciding on and completing your optimal PMR.

On an ordinary sheet of paper, write “Medication List” at the top. Then, write the following headings down the left side of the page, followed by the pertinent information:

• Name: your name
• Birth Date: your birth date
• Date: today’s date
• Physician: your primary physician’s name and phone number
• Emergency Contact: your emergency contact’s name, relationship to you, and number
• Medications: each medicine (including prescribed medications, over the counter drugs, herbal remedies, diet supplements, drugs taken as needed as well as those taken routinely, those administered by a nurse or at a clinic, such as I.V. chemotherapy given at the oncologist’s office, etc; if no medications are currently taken, write “I am currently taking no prescribed or over the counter medications, herbal remedies, or dietary supplements.”); the dose of each medicine; when it is taken; the reason it is taken
• Drug Allergies or Reactions: your drug allergies and any bad reactions to drugs you’ve had - if you have no allergies or history of bad reactions, write “None”

Once the list is complete, make at least four copies of the original.

• Keep the original with you at all times (typically, folks carry this in their purses or wallets).
• The first copy goes to your doctor and your medical record at his office. Contact your doctor’s office, tell the office you have just updated and revised your Medications List and would like it placed in your medical record to make sure your doctor has your current and accurate medication information. Ask how to best forward it to them, preferably by fax or email, but otherwise by USPS.
• One copy goes to your emergency contact. Inform your emergency contact that you are sending your Medications List and the importance of keeping it immediately accessible.
• One copy goes to your spouse, parent, adult child, or other close relative or friend.
• Another copy is kept as a back-up in an easy to remember and accessible location. (Mine is in an envelope taped to an inconspicuous spot inside my car.)

Once this is accomplished, go to Step II: Choose a format for your optimal Personal Medication Record.

IB. If you do have a PMR, check that it is up to date, contains at least the essential data, and has been distributed properly

The most basic PMR should contain at least the information listed in Step IA and should be distributed as described there. If your PMR lacks any data or needs to be sent to others, please proceed with that before going on to Step II: Familiarize yourself with the formats available for your optimal Personal Medication Record.

II. Familiarize yourself with the formats available for your optimal Personal Medication Record⁴

There is no standardized PMR today. Any Personal Medication Record, including a list scribbled on the back of an envelope crammed into a wallet, is better than no Personal Medication Record. Because form and content are both important factors, I suggest that you first look at a few of the forms available but not commit to one or another until you have read the next section, II. Enter the data categories you’ve selected, which addresses the content your Personal Medication Record should contain.

Your Personal Medication Record should not only be easy for you to access and use but it should also be easy for your clinicians to access and use. This principle is so fundamental that if your doctor or your healthcare organization offers or actively promotes a particular Personal Medication Record or expresses a preference in response to your query, I suggest you make that PMR your presumptive choice.⁵

Take care, however. Some providers offer access to data that covers only the care they or their clinic perform for the patient and do not allow the patient to enter additional data. If the patient cannot add medications such as those prescribed by others, over the counter medications, herbal remedies, etc and other data such as emergency contact or if there is a problem in making the record accessible to others, the document is inadequate as a Personal Medication Record.⁶

The most important distinctions between Personal Medication Records can be assessed by dividing the formats into four categories: (1) Paper & Pencil PMRs, (2) Healthcare Professional-driven PMRs, (3) Software-driven PMRs that are not stored on-line, and (4) On-line PMRs.

1. Paper & Pencil PMRs
These formats are available from many sources and have the advantage of simplicity. They also carry the greatest risk of errors such as misspellings and illegibility which can lead to serious misunderstandings and are most labor-intensive (thus discouraging updating), and lack a built-in link to information resources. Anyone who has tried to maintain a paper and pencil telephone listing of friends for more than a year or two will understand the logistic problems. Paper & Pencil PMRs should be chosen only when using a computer is, for any reason, impossible or the medications listed are so few in number and so unlikely to change that automating the process would be counterproductive.

2. Healthcare Professional-assisted PMRs
Pharmacies and, less frequently, clinical offices may offer printouts of a patent’s medication list. While this method has the advantages of being automatic and enlisting the efforts of a healthcare professional, the key point is whether the medication list generated includes not only drugs purchased at that pharmacy or prescribed by that doctor but also other, patient-entered information such as those drugs obtained from or prescribed by other sources, non-prescription drugs and herbal remedies, diet supplements, etc. and can be easily updated and redistributed whenever a dose changes or a patient begins taking Vitamin X on the advice of a friend. Myk informal inquiries have indicated that adding data of this sort is, at best, a cumbersome process. Unless you can conveniently add information about mediations prescribed by or obtained from other facilities, I can only recommend this strategy as a last resort for those who might otherwise be unable to organize such a listing.

A special case of Healthcare Professional-assisted PMRs is the model offered by Medicare. Medicare beneficiaries may be eligible Medication Therapy Management, which specifically includes a Personal Medication Record prepared from Medicare Part D services. Eligibility for these services is explained in Helping Medicare Patients With Part D :
Under Medicare Part D, PDPs are required to have an MTM program for “targeted beneficiaries” who have multiple chronic diseases, multiple medications, and are likely to incur costs above a certain level ($4,000 for 2006). MTM can be offered to all beneficiaries. Non-targeted beneficiaries must pay for MTM out-of-pocket. MTM may include a variety of services (education, special packaging, collaborative drug therapy management, etc.). The best resource to learn more about MTM is http:www.aphanet.org/medicare

While these Personal Medication Records may be handled differently by various pharmacies, the description of the service offered by the National Community Pharmacists Association, directed toward participating pharmacists, is instructive:

CCRx’s Part D MTM program gives you all the tools you need for creating and delivering a state-of-the-art PMR to the patients you serve. Here are a few helpful points for creating an accurate and useful PMR using the Community MTM
(CMTM) platform:

• Information you enter in the “Medications” section of the CMTM application automatically populates the PMR. This includes the “Purpose” field, the “Patient Directions” field, and any additional medications you add to the list.
• Always enter information in the “Patient Directions” field in English, NOT Latin abbreviations. (If you type “TID,” this will appear exactly that way on the patient’s PMR and they won’t understand it).
• As you go through the patient’s medications in the “Medications” field, ask, “Are you still taking this?” If the patient answers no, simply mark “No Longer Taking” and the PMR will automatically update as you go along.
• The PMR also prints a sheet of blank lines for keeping the PMR up-to-date with hand-written entries after the service. New meds get written in and discontinued meds get a line drawn through them with a “no longer taking” note. You can educate the patient how to do this or even offer to do it for them as a value-added service when they come to your pharmacy with their next prescriptions.

After you complete your MTM service and documentation, click the “Documents” icon on the CMTM application. This will allow you view the PMR you’ve created. Review it for accuracy then simply hit the print button and give it to the patient. Remember, the PMR is the centerpiece of the CCRx MTM service.

3. Software-driven PMRs that are not stored on-line
These so-called desktop solutions should have links to medication databases both to access any need information needed and to facilitate data entry by suggesting the medication names and doses. A spell-checker and means of securing data retained on the computer are also important. Many have added features such as automated reminders and alerts when refills are due. In most cases, the software-driven medication records will be part of a larger, more comprehensive Personal Heath Record (PHR), and many software programs will offer the option of on-line storage. Few, if any, software-driven PMRs and PHRs are free; most cost $30-$100. Some software solutions may be offered by a health insurer or an employer free to clients or employees, respectively. If this is the case, users should inquire as to whom has access to the records and what privacy protections are in place. Software-driven PMRs that are not stored on-line are the appropriate choice for those who are (1) able to use computers and (2) wish to protect their healthcare data to the extent possible.

4. On-line PMRs
On-line PMRs have an inherent problem - there is no guarantee that private healthcare data stored on-line can be protected from every possible threat. That said, there is no guarantee that private data of any sort, such as fiscal records, legal information, or romantic emails can be protected from every possible threat - whether that information is transmitted and stored as electronic pulses on-line, sent as a check via snail mail, or handed to a waitress in the form of a credit card. The decision is, then, whether the potential benefits outweigh the risks. And, there are benefits: On-line PMRs are, theoretically, available 24 hours a day, 365 days a year. The well-designed examples are can be easily and readily adapted, revised, corrected, and shared with others by email or fax. Many have links to medication databases, provide graphics of the pill or capsule being taken, and offer refill and medication administration reminders. And, as a final bonus, they tend to be less expensive than software for ones computer and some are offered without charge.

For any on-line PMR offered at by an employer, insurance company, or clinical organization, you should ask (1) if the Personal Medication Record can be continued if you change or drop your insurance with that insurance company, leave that employer, or change healthcare providers, (2) if you can grant others, such as your physician, easy access to records, and (3) if your employer or health insurer can access your healthcare information and use it administratively (e.g., could your employer obtain information about your newly diagnosed serious medical problem and terminate you to avoid future healthcare costs).

My personal recommendation is to opt for a PMR maintained by a for-profit consumer-oriented business or even one subsidized by advertising rather than volunteer data for an insurer’s or employer’s program. The risk of data abuse, however remote, is simply unnecessary. Consequently, On-line PMRs are the first choice for (1) those able to use internet tools and (2) willing to accept the risk to privacy in return for the benefits of on-line processes.

II. Select the data for your PMR and enter that information

The data you choose to enter in your PMR is - and should be - an especially personal choice, a notion reflected in my primary recommendation:

The data fall into two broad groups:

1. Essential Data: The first goal is to assure that most important medication information is included in your PMR and is up to date.⁷

• Name & Birth Date
• Date PMR was last revised
• Primary Physician’s name and phone number
• Emergency Contact’s name, number, and relationship to you
• All medications’ names, dosages, times of doses, and reasons for taking the medication⁸
• Medication allergies and bad reactions

2. Optional Data: Beyond the fundamentals is a seemingly infinite amount of medical information that could, in some circumstances, be helpful. Typically, that help is in the form of familiarizing a clinician with your general health and medication regimen in situations ranging from a routine yearly check-up to a life or death emergency in which you are unconscious or otherwise unable to provide medical information to those treating you. The goal is to provide as much of that information as possible without compromising your privacy beyond those limits you set and without demanding so much ongoing data entry that completing and revising your PMR becomes a burdensome task that is deferred or avoided altogether.

To assist your decision-making, I’ve divided the Optional Data into two subgroups:⁹

Non-essential Information With High Potential Utility and Risk Of Abuse

• Medication issues and precautions (e.g., “Take with food” “Avoid sunlight”)
• Start date of currently used medications
• Stop date of discontinued medications
• Non-medication healthcare supplies (e.g., blood glucose test strips for diabetics, CPAP settings)
• Pharmacist’s name and contact information
• Prescriber name(s) and contact information (in addition to Primary Physician)
• List of all current health problems, whether taking medication for them or not
• Specific notation whether generic or brand name of the medicine is taken
• Date of most recent vaccinations

Optional Information That Incurs Privacy Risks

• Social security number
• Insurance Information (e.g., Company, Group Number, Policy Number)
• Location where medications can be found in home
• Address
• Home phone number
• Cell number
• Date of birth

III. Make and distribute hard copies

Paper copies of your PMR are necessary even if it is available online or in a USB drive or CD you carry.

1. Create and maintain a separate Personal Medication Record for each individual.
2. Carry a current copy of your Personal Medication Record with you at all times
3. Bring extra copies to any healthcare appointment, including pharmacy visits
4. Keep another copy of your PMR in a safe, easy to find place (e.g., in an envelope taped under the dash or seat of your car)
5. Send a copy to your emergency contact. Replace all copies if the medications you take change.

In addition, if your Personal Medication Record is on-line:

1. Arrange for your physician to receive instructions to access your on-line PMR. Check that your physician’s office received them and has actually completed the procedure to assure they can access your PMR
2. Change your password no less often than every three months

IV. When changes occur, update and redistribute your PMR

If there is any change in the medications you take, regardless of why the change took place, immediately revise your Personal Medication Record and change the “Last Revised” date. It is also essential to send an updated copy of your PMR to your primary physician and your pharmacist. Finally, destroy all copies of any previous, now outdated PMRs.

V. Use your Personal Medication Record

Review your PMR before every visit to the clinic. If your understanding of your medication regimen is not identical to the information in your PMR, ask your physician or pharmacist for clarification; prompting questions and facilitating enlightenment is an excellent use of PMRs.

Keep track of and order new refills with your PMR.

If you transfer your medications from the pharmacy’s bottles to a pillbox, use your PMR to fill that container.

Highly Recommended

Of the 20+ specimens from the paper and pencil category I examined,¹⁰ my favorite was My Personal Medication Record, which is AARP-affiliated but can be used by individuals regardless of age. It’s well organized, has prompts for all the essential data and most of the “probably useful” information. At the My Personal Medication Record site, you can (1) download the form in English or Spanish as as a PDF file to complete by hand, (2) download the file as a Microsoft Word document which can be either printed to be filled out by hand or, if you have the Microsoft Word software, completed on your computer, or (3) order the same forms as paper documents by phone at 1-888-OUR-AARP (1-888-687-2277). There is no charge for any of these formats. The AARP deserves accolades for providing, alone of all the Personal Medication Records I checked, a sample of their PMR with a couple of examples filled in and instructions for gleaning the necessary information from the prescription medication labels, which can be found at Sample PMR & Prescription Drug Label Made Easy. Also on the AARP web site is Over-the-Counter Drug Fact Labels, an article which provides analogous instructions for over the counter drug labels.

Information from the American Health Information Management Association about Personal Health Records, most of which include a medication list, can be found at My Personal Health Record. At PHR Search, one can search for programs based on cost (purchase Vs free) and format (Internet service, Software program, Paper-based).

My Medication Schedle is included in the “highly recommended” category primarily because it is a free on-line service (the site also sells medication-related supplies) that generates a usable medication list and has a few bells and whistles (e.g., refill reminders) but is not designed as an online medication list to be accessed by others, such as personal physicians. Because on-line PMR’s offered by providers (e.g., Kaiser-Permanente), insurers, and employers are available only to individuals affiliated with those organizations, those who wish to get a feel for how the on-line process takes place can do so here at no cost.

Other Reources
Other paper and pencil format examples include the Athens Regional Medical Center Personal Medication Record from the Athens Regional Medical Center, Athens, Georgia, My Medicine List developed by the American Society of Health-System Pharmacists, the Universal Medication Form, from the University of Louisville Hospital, the Seniorr Navigator Personal Medication Record from Virginia’s Resource for Health and Aging, and the Park Nicollet Personal Medication Record.

Examples of companies selling encrypted USB keys for storing medical data include CapMed’s HealthKey and MedInfoChip.

WebMD Health Manager is an online service that organizes ones health information for a monthly fee.

Followme.com offers, for a yearly fee, both online and paper-based ways to manage medical records.

Footnotes

1. ”Personal Medication Record” is the quasi-official name for a document with the important information about the medicines you take. Instead of “How To Create and Use A Personal Medication Record,” the title could have been “How To Create and Use A List Of Your Drugs,” “How To Make A Medication List,” “How To Make A List Of Medicines,” etc. [back]
2. The previous posts in this series follow:
   1. Everyone Needs A Personal Medication Record
   2. Choosing The Right Personal Medication Record
   3. Compiling The Personal Medication Record

   [back]

3. The continuation should be published in the next 2-3 days [back]
4. See Choosing The Right Personal Medication Record for a more complete discussion [back]
5. By “presumptive choice,” I mean the referenced PMR should be your choice unless you find a distinct disadvantage with the clinician-preferred program or another offering is clearly superior. [back]
6. See also 2. Healthcare Professional-assisted PMR below. [back]
7. More complete instructions for entering this information is available under the heading “IA. If you do not have a PMR, make a temporary one - now” [back]
8. Take care to spell medication names exactly as they are listed on their labels (many different medications have similar names) and and list their dosages and the frequency with which they taken accurately. If you cannot do so or if you are unsure, bring all your medications, including over the counter drugs, herbs, and vitamins with you to the doctor or pharmacist to receive help in completing the list. [back]
9. This is a simplified adaptation of my original groupings listed in Compiling The Personal Medication Record [back]
10. The Paper & Pencil PMR examples were chosen as de facto representatives based on their high ranking on Google [back]

The AlignMap Clinic Evolves Into EnrichMap

This Welcome To The AlignMap Clinic page was a temporary expedient while we worked through the clinical, technical, and legal issues of forming an organization to promote and support the use of the Emap Profile, a survey tool (previously accessible through this page where it was known as “The EnrichMap HealthCare Orientation Survey”) that identifies the likely responses to treatment recommendations based on a patient’s inherent compliance tendencies.

EnrichMap, as an organization, will initially focus on proactively managing adherence to treatment regimen in clinical trials by identifying, prior to enrollment in the study, groups of patients based on their behavioral patterns pertinent to compliance and providing pragmatic, group-specific strategies to minimize unnecessary treatment failures caused by noncompliance and, in turn, reduce the consequent morbidity and mortality, research confoundments, delays, and financial waste.

More information, including links to the current Emap Profile Survey, can now be found at EnrichMap.com.

AlignMap SiteSearch can search for terms from either or both of two locations:

1. The AlignMap.com Website and Blog
2. The AlignMap In Cites Tumblelog

To go …

• To search boxes, scroll down
• Back to the previous page, use browser’s “Back” key or click Go Back
• To the AlignMap Website’s front page, click AlignMap Website
• To the AlignMap Blog’s ’s front page, click AlignMap Blog
• To the AlignMap In Cites tumblelog’s front page, click AlignMap In Cites

Search: AlignMap Website & Blog

Search: AlignMap Web In Cites Tumblelog

Search: BOTH AlignMap Website & Blog AND AlignMap Web In Cites Tumblelog

AlignMap SiteSearch Operational Information

Because the AlignMap SiteSearch search engine is Google-dependent, only those pages of the AlignMap website and blog and the AlignMap In Cites Tumblelog that are indexed by Google show up in the search results. As it turns out, Google does index the overwhelming majority of pages at AlignMap.com although some may be missing and some recently published posts may not be immediately indexed. Because AlignMap In Cites is, at the date of this writing, of recent origin, a lower proportion of its pages is indexed by Google.

Alternative Search Mechanisms

AlignMap.com website and blog are built on Wordpress architecture, and Wordpress Search is available under “Search Options” at the top of every sidebar on every web page on the site. Wordpress Search is less familiar to many users than is Google and has the annoying trait of producing entire post or page that contains the search term rather than the easier to manage links Google provides, but is a solid, competent search mechanism.

AlignMap In Cites can be searched by java-powered Tumblr Search via the labeled box at the end of the introduction that begins each page. That search function is especially fast and, unlike Google will search every post on the site (Google only returns results on posts it indexes and, at this time at least, it does not index every post). The limitation of this mechanism is that, as far as I can determine, it can search only for a continuous string; e.g., entering “patient compliance” will find all instances of “patient compliance” as a single term but will not find posts with both “patient” and “compliance” if those words are separated - such as “The patient was in the compliance study.”

The Ads

The AlignMap SiteSearch Results page also shows context-related ads placed by Google in exchange for use of the Google search technology. Other than use of the search process, AlignMap and AlignMap In Cites receive no compensation from the ads.

#1. It’s “I Before E”
And It’s Alignment Before Empowerment

The empowerment of patients has the potential to improve treatment adherence and healthcare in general but only if that empowerment is accomplished in the context of a therapeutic alliance with the goals and values of patients, clinicians, and the system though which care is provided in alignment.

The empowerment of patients without such alignment endangers rather than enhances healthcare on both the individual and systemic level.

For example, members of a jazz band may discover hitherto untapped power and evocativeness from a composition when they are empowered to improvise and take responsibility for their performance rather than play as automatons. On the other hand, fourth graders in a beginners orchestra may have implicitly agreed to play from the same sheet music and follow the lead of the same conductor, but it requires only a few moments of observation to grasp that such nascent musicians, however desirous they may be to please the audience or how enthusiastically they approach the task at hand, lack the maturity of temperament and conceptual capacity necessary to operate independently without an ensuing cacophony.

Senge’s warning, although written about business administration, is equally valid in this situation,

#2. Love Is Not Enough: Neither Are Good Intentions

If I Only Had a Brain
~ Wizard of Oz

A desire to cooperate on the part of all those involved in a given case — patients, clinicians, and healthcare administration — is a good starting point, but effective implementation of treatment requires knowledge and skills as well as motivation. Further, healthcare situations are dynamic; all parties involved must continuously update their ability to cooperate. The best healthcare will occur when patients, clinicians, and healthcare administrators learn fast and apply what they learn most expeditiously. Accelerating this process is a key responsibility of healthcare professionals.

#3. A Desire For Health & Motivation To Comply With Treatment
Are Not Identical

Let all men, if they can manage it, contrive to be healthy!
~ Thomas Carlyle


Even patients who desperately want to be healthy can vary remarkably in their willingness and capacity to adhere to the prescribed treatment.

It is a mistake to assume that patients will necessarily follow treatment instructions because they want to get well or because they are fearful of the negative outcome of their disorders, even if those consequences are catastrophic.

The goal is to help the patient connect his or her desire for health, as defined by the patient, with a course of treatment that is most likely to be beneficial, also as defined by the patient.

#4. Oneupsmanship Or Compliance-Enhancement: Choose One

More often than not, the first clinician to see the patient for a given ailment is actually providing a second opinion. It is the rare patient who does not arrive at a doctor’s appointment without forming an idea about what his or her symptoms portend. The source of the patient’s self-diagnosis may have been the New England Journal of Medicine, the Miracle_Snake_Oil.com web site, the 90-second personal health feature (inevitably called “To Your Health”) produced as a school project by the local TV station’s 19 year old intern, the overheard fragment of a conversation between two psychiatrists at a party, or my Aunt Hazel from Broken Arrow, Oklahoma. Even if the ideas are inaccurate — make that especially if the ideas are inaccurate — the failure to ask about and listen to these ideas is dangerous. That the clinician renders the correct diagnosis when he interrupts the patient’s prolonged account of recurrent dizziness, fluctuating appetite, and intermittent left knee pain does not insure the patient’s agreement, respect, gratitude, or compliance.

#5. “Complianceadherenceconcordance” Just Doesn’t Scan;
Let’s Call It Compliance Until Something Better Comes Along

Now look, Colonel Bat Guano – If that is really your name
~ from Dr. Strangelove

They certainly give very strange names to diseases
~ Plato

And to compliance
~ Showalter

Even though I’m a doctor, I just can’t go along with “medical compliance” as an ideal term for whatever it is we’re talking about. I’ve also had it with “patient compliance.” “Cooperation” doesn’t quite work with me. And while “adherence” has its adherents, it does not seem something I could stick with. As for “concordance,” which carries the official sanction of the Royal Pharmaceutical Society of Great Britain, it just doesn’t lend itself to puns.

Pragmatically, whatever distinctions once may have existed between the connotations of “compliance” and “adherence” have likely been washed out by the pervasive use of these and their congeners as synonyms in the preponderance of the medical literature. The argument can legitimately be made that such semantic quibbles may now produce more distraction than insight into the clinician-patient relationship. Lacking compelling advantages favoring the use of any of the suggested terms and the institutionalized encoding of “medical compliance,” “patient compliance,” and “medication compliance” into the medical literature and databases, it makes sense — until something better comes along — to continue using this familiar phrase to designate the healthcare behaviors of individuals responding to medical recommendations and, unless specified otherwise, assume that “adherence,” “compliance,” and “concordance” refer to the same phenomenon.

My own hunch is that eventually, the issue of compliance/adherence will be properly subsumed by a focus on treatment implementation and execution.

For what it’s worth, my preference is to get behind “alignment” under the premise is that we are striving not so much to persuade, coerce, or trick patients into doing what their doctors prescribe as to align clinicians, patients, payers, and anyone else involved in healthcare so that everyone is working in concert. An easy example of alignment’s advantages is the case in which a patient does not adhere to the prescribed treatment plan but does communicate that decision and his or her reasons to the clinicians. That is not “compliance” (at least by a strict definition), but it seems different from and exponentially preferable to the case in which the patient not only does not follow the treatment plan but also misleads the clinician into thinking he or she is doing so. Assuming the patient was not just perversely turning down all options, he or she and the clinicians could be in “alignment” although the patient is not in “compliance.” The other important connotation is that “alignment” obviates the assumption, essential to “compliance,” that patients are either obedient or disobedient to the dictates of the clinician; rather, “alignment” allows for a less one-sided involvement of the clinicians and patients. Nonetheless, “alignment,” used in this sense, would not be recognized by the medical community.

For more on the issue of nomenclature, see:
Running Patient Compliance Up The Flagpole
The New, Improved Patient Compliance

#6. There is no universal antidote for noncompliance

AKA The Universal Truth About Universal Panaceas


It’s the rare coach of a team sport who even claims to treat all his or her players the same; teachers acknowledge the need to individualize education as much as possible; and, perhaps most telling, marketers espouse as their ultimate goal a sales message personalized for a specific potential customer. Yet, the medical literature dealing with patient compliance often expresses perplexity, frustration, and, on occasion, amazement that a given intervention (whether that intervention is patient education, cues & reminders, free medical services, easy access to services… ) improves compliance among some but not all patients.

That different patients react in different ways to healthcare recommendations and compliance-enhancing efforts is a concept that hardly rises to the level of a profundity but must, it seems, be evangelized.

#7. “Better patient education” is the answer — but only if the question is “What is the only response made to correct noncompliance in 90+% of cases?”

This is a specific case of Mencken’s observation,

There is no indication that patient education is uniformly the appropriate corrective reaction to noncompliance; there is evidence that patient education, regardless of how well structured the teaching process and how motivated the client, is unsuccessful in achieving compliance in a significant portion of cases.

More information does not necessarily result in more compliance. It is a difficult intuitive leap, for example, to concur with the bureaucratic a priori rationale that providing a patient a three-page listing of a medication’s adverse effects (instead of a one-page list of a subset of those adverse effects) will result in that patient taking the medication more faithfully.

Educating the patient without first determining if education will solve the problem for that patient in that situation is no more rational than automatically prescribing antibiotics to every patient complaining of coughing and a sore throat.

#8. Compliance Enhancement Can Be A Win-Win-Win Game

While there may be, despite the unremitting efforts of pharmaceutical detail reps, no free lunch, compliance enhancement may be the source of that equally elusive goal, the Win-Win outcome. In fact, compliance enhancement may be the sole example, other than casino and lottery ads, of the Win-Win-Win game.

Looking Out For #1, #2, and #3

Improved compliance tends to result in happier

• Clinicians: who can count on treatment plans being implemented as written
• Administrators: who savor the lower costs
• Patients: who avoid unnecessary delays in recovery, relapses & side-effects

#9. Once You’ve Seen One Noncompliant Patient,
You’ve Seen One Noncompliant Patient

The extent to and manner in which Patient X, in a specific set of circumstances,² adheres to a prescribed treatment can be extrapolated and generalized to accurately characterize — the extent to and manner in which Patient X, in that specific set of circumstances, adheres to that prescribed treatment.

Compliance is the result of a complex collection of cognitive, emotional, physiological, and cultural factors, some of which are obvious, others which are subtle, and many of which may be in conflict. Compliance not only varies from patient to patient but the same patient may respond differently to the demands of different treatment regimens and in response to various disorders. Further, Patient X’s compliance behavior vis-à-vis the same disorder and treatment may vary under different circumstances; patient X’s adherence to the same treatment for the same disorder may, for example, be different at ages 5, 15, 35, 55, and 85.

Past compliance behavior for a specific patient may be somewhat predictive of that patient’s future compliance, but the power and reliability of such predictions are not impressive even if the circumstances are similar. Generalizing beyond a specific patient to a group of patients has proven a sucker’s bet for clinicians.

#10. Complacency about compliance leads to treatment failure

If you know that 75% or more of your patients follow your treatment recommendations, one of the following explanations holds:

1. You are charismatic, empathic, and knowledgeable — and incredibly lucky. If enough poker players try drawing to an inside straight enough times, someone — somewhere — sometime — does eventually end up with that hand. So, sure, it’s possible that 75% of your patients are compliant. If you’re this lucky, however, let’s you and me go buy some lottery tickets.
2. You are incredibly charismatic, empathic, and knowledgeable but are no luckier than the rest of us schmucks. You also sustain a charmingly naive confidence in human nature despite evidence to the contrary, tend to invest heavily in Franklin Mint commemorative plates depicting the official fungus of each state, continue to expect the check that (you have been assured) is in the mail, and believe for every drop of rain that falls, a flower grows.

Footnotes

1. Yeah, I know — Dave’s Top Ten Lists are a lot funnier but just see how much they improve adherence to scheduled clinical appointments. And, we acknowledge that the content of the original Top Ten (AKA The Ten Commandments) has not required any patches, let alone major revisions, in the past few thousand years (although we would submit that since the first set of tablets crashed — literally — the current revision is arguably the 1.1 version). Our product is just more — uh — flexible. [back]
2. E.g., the severity of Patient A’s disorder, the side-effects of any medication, the doctor’s empathy, etc. [back]

Disclaimer

The use of information from the AlignMap site or from materials referenced on the AlignMap site is at the user’s own risk.

The content on the AlignMap site is informational only. It is not intended to and should not be considered medical advice. Further, no doctor-patient relationship is formed. AlignMap does not guarantee the accuracy, usefulness, timeliness, or safety of the content. Users should always seek the advice of physicians or other qualified health providers with any questions regarding a medical condition. This site is not a substitute for professional medical advice, diagnosis, or treatment.

Viewers should not disregard professional medical advice or delay in seeking it because of information on the AlignMap site.

The AlignMap web site is provided only on an “as is” basis. AlignMap disclaims all responsibility for any loss, injury, claim, liability, or damage of any kind resulting from, arising out of, or any way related to any errors in or omissions from this Web site and the content, including but not limited to technical inaccuracies and typographical errors.

AlignMap does not warrant or present that the information available on or through the site will be correct, accurate, timely, or otherwise reliable. AlignMap may make improvements or changes to the web site at any time.

Other Web Pages

The AlignMap site may reference or link to other web pages. AlignMap does not monitor or take responsibility for other web sites and web pages, which are the sole responsibility of their owners and creators. Their positions and opinions do not represent those of AlignMap.

Limitations of Liability

When you access this website, you agree that the AlignMap is not liable for any loss or injury caused in procuring, compiling, or delivering the information gained from the site. In no event will AlignMap be liable to you or anyone else for any action taken by you on the basis of such information or for any incidental, consequential, special, or similar damages.

Allan Showalter, Director
AlignMap Consulting Services
7716 Crystal Springs Road
Crystal Lake, IL 60012

Phone: 815 459 3201

AlignMap Patient Compliance Archive At Furl.net

I have selected and saved a list of web sites at Furl.net that deal with compliance. These can be accessed at

Once on site,

• Enter a search term or filter by topic in order to find articles of interest, then click the “Look” button.
• Use your browser’s back button to return to AlignMap.com.

AlignMap In Cites

AlignMap In Cites is a tumblelog I use as an augmentation to the AlignMap web site and weblog. (For more information, see AlignMap In Cites - More Content, Less Delay) This is a listing of briefly annotated links to items pertinent to patient compliance and can be found at

AlignMap focuses on aligning patients, clinicians, and other stakeholders with their healthcare systems to improve the proportion of successfully implemented treatment plans and, consequently, increase clinical effectiveness and efficiency, decrease costs and improve outcomes.

AlignMap services to healthcare organizations include consultation, training, and program development in these areas
• Patient Compliance
• Patient-Clinician Relationships & Communications
• Organizational Restructuring

About: Allan Showalter, Director

Contact AlignMap

About Allan Showalter, MD & AlignMap

The Short Version
I’m a psychiatrist with a long-time interest in what is commonly called patient compliance (more about that label later). AlignMap is my consultancy dedicated to helping healthcare professionals and organizations and their clients prevent the unnecessary morbidity and mortality, needless treatment failures, excessive costs, and demoralization of clinicians that result from noncompliance through strategies that focus on the effective implementation of the best workable treatment plan for each specific patient.

Background
Since entering clinical practice, I’ve been curious about patient compliance. Why do some patients adhere to healthcare recommendations while others don’t and still others sometimes do and sometimes don’t? Why do some patients agree to take a medication but then never fill the prescription? Why do some faithfully show up at appointments to report that they never missed a pill, always follow their diabetic diet, or have completed their routine blood tests when it is all too obvious that they have been noncompliant? My experiences are not, of course, unusual; indeed, every clinician has observed similar phenomena. Nonetheless, I found the topic and its tangents intriguing, especially when my reading revealed that this problem had produced many thoughtful journal articles and books and no small volume of pontification, but precious little in the way of useful answers.

I now believe that current efforts to enhance compliance are, if not doomed, then at best restricted to isolated successes with unacceptably small benefits compared to the costs of the complex, labor-intensive programs that are most likely to be effective.

The problem is that “medical compliance” is little more than a name (a name, incidentally, that is almost unanimously held in contempt but is almost universally the terminology of use if not of choice) in search of a phenomenon. Other than calculating a purely mathematical compliance rate that measures the number of times a patient, for example, took a medication compared to the number of times that patient should have taken that medication, the meaning of medication compliance (or patient compliance or treatment adherence or … ) is so unclear that it is not only confusing but also dangerous.

I am now convinced that the focus should be shifted from compliance to the goal of optimal treatment implementation. This web site is an elaboration and discussion of this idea.

A Vision for Tomorrow: Systemic Alignment

The Nature Of The Problem Previously Known As Noncompliance

The inability to efficiently improve medical compliance, especially at a time when healthcare costs for many industries have become a major cost of doing business, is costly and frustrating. (A recent McKinsey Quarterly observed that, “In a few years, the average Fortune 500 company may be spending as much on health benefits as it earns in profits.”)

Widely misunderstood, medical noncompliance is a problem more ideological than pathological. Its complexity belies our obsessive drive to find a panacea for it. Indeed, Medical Noncompliance is ultimately no more than a label we’ve assigned to an extraordinarily wide and varied category of non-optimal behaviors patients exhibit in response to their clinicians’ treatment recommendations.

Consideration of this predicament, while disheartening, does provide useful insights for future efforts:

1. Noncompliance is not a phenomenon limited to the arena of medicine. There is little evidence that compliance with medical instructions is inherently distinct from compliance with laws, advertising campaigns, safety requirements, or recommendations from other professionals. Thus contributions from anthropology, social sciences, and psychology, especially research in decision-making, the diffusion of new ideas, marketing research, game theory, and general systems theory, can be profitably applied to this problem.
2. Similarly, although the term Medical Noncompliance implies that the fundamental issues center on the disease, the treatment, and the medical environment, the heart of the problem seems to be an individual, intrapsychic matter rather than a universal effect of the medical condition. To address compliance then, we need to assess compliance-pertinent personality factors at work in an individual patient.
3. While most efforts to improve Medical Compliance have focused on the final stages of the medical event (e.g., taking a pill, arriving on time at a rehabilitation appointment, eating foods appropriate to a given diet, etc.), it may well be that the proactive problem-solving needs to occur much earlier, in the course of shaping a treatment plan for a particular patient and in the working relationship between clinician and patient.

Guidelines

1. Each discrete behavior encompassed by noncompliance may
   • present in an infinite range of severity
   • result from any of a multitude of causes
   • have an impact on the prescribed treatment that varies from trivial to catastrophic.

   However tempting and intellectually appealing the idea of a one-size-fits-all solution may, no single technology or tactic can offer a panacea. Instead, a rational approach to improving medical compliance must take into account the diversity of noncompliant behaviors by utilizing multiple approaches and personalizing these efforts.

2. The methodology must be integrated into the local healthcare system, automatically implementing mechanisms to detect and address noncompliance. In the absence of such a methodology, clinicians often overlook noncompliance and its impact on treatment outcomes.
3. The time and skills necessary to execute the compliance-enhancement strategy must meet the demands of feasibility. For more than a decade, healthcare professionals have been required to perform more and more clinical tasks in less time. Any plan that obliges the physician to wedge yet another time-consuming procedure into the patient visit is doomed, as is any system that requires nearly psychic capacities for insight or the bedside manner of a Marcus Welby.
4. The system must be self-monitoring and self-correcting. In the absence of an evidence-proven methodology, it is essential that the success or failure of any tactic be assessed and the entire system adjusted if that is indicated by the results.

Good Patients, Bad Patients, Economic Man, & Other Nonexistent Species

1. Compliance models & programs beg the question of how real patients in real clinical situations decide to follow – or not follow – a specific treatment

2. Compliance models & programs assume a rational patient, which is no more realistic than the rational man assumption of discounted economic theories

3. The implicit requirement that patients behave rationally leads to the clinically & ethically flawed classification of patients, vis-à-vis compliance, as “Good Patients” “Bad Patients” and “Pitiful Patients”

The Myth Of The Rational Patient

The consensus view gleaned from research and clinical experience toward these theories and programs can be summarized in a Lincolnesque aphorism:

And, as it turns it, none work with most of the patients most of the time. It is especially discouraging that, even when potentially helpful methodologies are available, we are unable to predict which patients will respond to which methods.

The problem with the hypothetical models of compliance and compliance programs is that they beg the question of how real patients in real clinical situations decide to follow – or not follow – a specific treatment. The orthodox medical perspective that patients first make a careful analysis of the benefits and risks of each course of action and then choose the alternative with the best ratios of pros (anticipated health benefits) to cons (fiscal and non-fiscal costs associated with compliance, including side-effects, discomfort from feelings re use of medication, reluctance to accept the sick role, … ).

This kind of assumption leads to researchers developing mathematical representations of the patient’s decision-making process; for example, one paper conveniently condenses the “probability of noncompliance” to

and the patient’s calculation of the pros and cons of compliance to

That such formulas appear to be gibberish to those of us who struggled with pre-med calculus does not, of course, necessarily rule out their capacity to generate insight into medical compliance. On the other hand, the idea that such mathematical equation directly reflects an individual’s decision-making triggers, at least in me, a severe case of cognitive dissonance.

A consideration of an analogous situation is helpful. The rational patient who populates theoretic models of compliance is closely related to the “economic man” who once inhabited economic theory, behaving exclusively on the basis of perfect understanding of perfect data used in a perfectly logical and reasonable manner to optimally satisfy his self-interest.

In fact, if a purebred economic man ever existed, it was in a land far away and a time long ago. At best, the economic man is an oversimplified ideal, useful in generating theory but inadequate to account for real life behavior. Instead, most economists, all stock brokers, used car dealers, eBay merchants, and anyone making a living in retailing, advertising, or marketing have long recognized that emotions, cultural beliefs, self-concept, altruism, personality factors, social mores, and other forces, albeit often disguised as rational determinations, are significant influences when an individual selects a brand of cereal or chooses a spouse or adheres to a doctor’s recommendations.

While few economists would intentionally base their recommendations and predictions on the concept of the economic man, most clinicians and researchers, however, still seem to subscribe to the notion of a universe of healthcare populated by logical patients, who, even in the midst of the incapacity and distress caused by their disorder, operate exclusively on the basis of intellectual and rational processes to choose and execute their treatments.

Two indictments of the “economic man” model statements by economists are equally applicable to healthcare:

Ernest Partridge:
Clearly, “economic man” and “the perfect market” are severely truncated accounts of human nature and society, and thus very poor foundations for public policy-making, for practical politics, and for just provision for future generations. … And intelligent men and women will wonder how it was possible that anyone could ever have believed such nonsense.

Colin Camerer and George Loewenstein:
The Platonic metaphor of the mind as a charioteer driving twin horses of reason and emotion is on the right track—except that cognition is a smart pony, and emotion a big elephant.

A particularly malignant outcome of the rational patient model is the casual but all too real grouping of patients into Good Patients (i.e., those who follow their prescribed course of treatment and get better), Bad Patients (i.e., those who do not follow their prescribed course of treatment although they are capable of understanding the doctor’s advice, apparently because they are spitefully oppositional), and Pitiful Patients (i.e., those not bright enough to understand the wisdom of the treatment plan or not functional enough to execute that plan).

This de facto classification can cause clinically and ethically flawed practices. For example, the fear that nonadherence to the anti-HIV medication cocktails causing the development of treatment-resistant HIV strains combined with the notion of bad or pitiful patients (who are noncompliant in either case) has sometimes led to recommendations that these drugs be withheld in certain cases, usually designated by the presence of race, ethnicity, socio-economic class, or history of substance abuse, factors believed – inaccurately – to be predictive of poor compliance.

Replacing the idea of a patient who is perfectly rational with a more realistic hypothesis that accounts for other, non-intellectual influences is an essential step toward understanding compliance management.

PDF Download
The State Of The Art Section, which includes The Verdict, Current Models, Current Programs, and Patient Behavior subsections and all citations is available in PDF format for download at ~State Of The Art~


Next
A No-Nonsense Approach

Current Patient Compliance Programs

1. There are multitudes of programs & devices designed to enhance compliance

2. Most of these programs & devices are never scientifically tested

3. For the overwhelming majority of these devices & single-premise programs, there is little evidence of effective compliance enhancement for more than a small fraction of the patient population

4. The programs that show the most promise for effective compliance enhancement are typically multifaceted, well-staffed and resource-rich

Overview of Current Compliance Program Design

While a relatively limited number of theoretical models of compliance has been accepted by consensus, and expositions, reviews, and critiques of each are readily available, programs and interventions promoting adherence are ambiguously defined, often operate in obscurity or are initiated with fanfare and surreptitiously terminated, and typically do not meet the standards for scientific investigation, even when they are described and catalogued as research. Peterson’s meta-analysis of trials of interventions to improve medication adherence, in fact, found that only 61 of 484 pertinent studies met minimal inclusion criteria as randomized, controlled trials with at least 10 subjects per intervention group.

Interventions may require complex and extensive staffing and monitoring logistics, consist of no more than a printed sheet of information, or call for the equipment ranging from a give-away plastic pill box with compartments for each day of the week to wristwatch alarms to timed medication dispensers to internet connected devices that alert the patient that a dose is due, electronically documents that the medication was dispensed, provides informational prompts to the patient, and warns if a dose is missed or taken at the wrong time.¹ Other compliance enhancement interventions include but are assuredly not limited to

• One on one counseling provided by a pharmacist, nurse, educator, or physician
• Educational videos, brochures, and tapes presented to individuals or groups
• Court mandated and monitored treatment
• Promotions of self-reliance and self-efficacy
• Improved patient-clinician communications
• Directly observed therapy (e.g., treatment for Tuberculosis)
• Mechanical or electronic reminders with visual or auditory cues
• Adherence programs provided by a pharmaceutical manufacturer and often limited to a single medication
• Automated or personal phone calls or email
• Disease management programs
• Celebrity endorsements
• Public Service Announcements in broadcast media or publications
• Simplification or alteration of regimes
• Assistance to increase accessibility (e.g., increased clinic hours, transportation, home services, etc)

This diversity and the large number interventions precludes an exhaustive critique of each. Some generalizations are, however, possible:

• As is the case for the theoretical models, many of these interventions depend on a cogent, rational patient
• A large proportion of the interventions are based on the notion that noncompliance is the result of a lack of understanding and is best addressed by education. Research findings and clinical experience, however, indicate that education, even when successful, is often insufficient to correct noncompliance.
• Similarly, many interventions are reminders, designed to combat forgetfulness, inattention, and absent-mindedness. Even when these are significant problems, reminders are no panacea.
• Perhaps the strategy receiving most attention is reorganizing the clinician-patient relationship such that the patient’s role is more assertive, collaborative, and proactive. This has proved a difficult for both clinicians and patients, and the results are not universally positive.

Next: Patient Behavior: Good Patients, Bad Patients, Economic Man, & Other Nonexistent Species

PDF Download
The State Of The Art Section, which includes The Verdict, Current Models, Current Programs, and Patient Behavior subsections and all citations is available in PDF format for download at ~State Of The Art~

Footnotes

1. Links to many such devices can be found in the AlignMap FURL Archive under the Category, Enhancement Of Compliance. [back]

Overview of Current Compliance Models

1. Current Compliance Models implicitly require patients to behave rationally for the models to operate properly

2. The requirement that patients behave rationally severely restricts the clinical utility of these models and theories

Theoretical Health Behavior Models And Patient Compliance

Several hypothetical models of healthcare compliance have been developed which are appealingly straightforward, logical, and internally consistent. Moreover, they seem to provide genuine insight into certain features of patients’ responses to healthcare recommendations. Yet, as already noted, their impact on routine clinical care has been negligible. This ineffectiveness, I propose, is secondary to an element common to all of these models: each of these hypothetical constructs postulates a patient who functions solely and invariably in a logical manner. Without such an individual, the models, however elegant, will not operate properly.

Three of the most influential models, The Health Belief Model, The Transtheoretical Model, and Learning Theory, provide illuminating examples of this notion.¹

The Health Belief Model, is predicated on the ability of a rational individual to consciously weigh the advantages and disadvantages of a given behavior holds that the extent to which an individual will follow a healthcare recommendation is a function of his set of beliefs regarding that recommendation. According to this model, a patient will adhere to a treatment regimen if he believes the health problem being treated is significant, the prescribed treatment is likely help, and he (the patient) is able to implement the recommended course of action. The most common intervention based on this model is a discussion between the patient and the clinician of the pros and cons of undertaking the recommended behavior, followed by the patient’s decision regarding treatment.

The Transtheoretical Model’s starting point is the assumption that health behavioral changes are the result of a logical process, which is divided into five stages:

1. Precontemplation:
   The individual has yet to consider a change possible or needed
2. Contemplation:
   The individual grasps the problem and considers change
3. Preparation:
   The individual plans to act on the change within the ensuing month
4. Action:
   Contemplation and preparation are transformed into actual changes
5. Maintenance:
   The goal becomes sustaining behavioral change and resisting relapse

Learning Theory promotes an analogous methodology of breaking down complex healthcare-pertinent behavioral changes into small steps that can be sequentially established (learned) and reinforced.

Clearly, an absolute requirement for each of these theories, as it is for the other compliance models, is an individual who operates in a predominately logical manner. In fact, the intuitively assessed validity of these models correlates precisely with the degree of rationality one assigns to an imaginary patient; a convincing argument can be made that the ideal subject would be a rudimentary artificial intelligence machine – or Star Trek’s Dr. Spock. The implict goal of these theories appears to be assisting individuals who already operate on the basis of logical calculations make those calculations even more logically. That is no small accomplishment, nor is it irrelevant to compliance. It just isn’t enough. The nature and consequences of this logic-dependency are discussed in a later Section, Good Patients, Bad Patients, Economic Man, & Other Nonexistent Species. Before that, however, it is necessary to consider real world applications – the programs and tactics used to enhance compliance.

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The State Of The Art Section, which includes The Verdict, Current Models, Current Programs, and Patient Behavior subsections and all citations is available in PDF format for download at ~State Of The Art~

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Current Program Design


Footnotes

1. Caveat: The descriptions that follow are illustrative rather than complete and are not presented as well-rounded examinations. A more thorough, yet still succinct, summary of all the most important models can be found in Elder’s Theories and Intervention Approaches to Health-Behaviour Change. [back]

The Verdict From Patient Compliance Research

1. The most impressive outcome from decades of research and centuries of clinical experience is a plethora of papers. Clinically useful compliance enhancement interventions? Not so much.

2. The compliance enhancement tactics that seem most effective are also the most complex, least efficient, and least practical.

The labors of compliance researchers have resulted in an impressive number of papers published (a Medline search for “patient compliance” turns up more than 27,000 articles over the past 20 years; and the chart below by Dusing et al indicates the pace of such publications is accelerating), a similarly impressive internet presence established (Google shows about 408,000 hits for “patient compliance”), numerous post-graduate degrees earned, some positive PR generated, and, occasionally, an isolated, situation-specific improvement in compliance rates.

None of this, however, has led to reproducible methodologies that can reliably and enduringly enhance compliance. Nor has a foundation been laid for the progressive growth of knowledge about and ability to manage treatment adherence.

The most damning evidence of the practical ineffectiveness of contemporary compliance enhancement theories and programs is the absence of their influence on day to day clinical practice. My experience as well as that of my colleagues over many years of medical practice in various settings, locations, and specialties is that patient compliance is only rarely a discrete topic in clinical settings or an issue that comes quickly to the minds of most clinicians, even in situations, such as treatment failure, in which noncompliance is a likely, and perhaps, the likely cause. Even fewer clinicians (other than those treating a few special populations, such as HIV infected patients and organ transplant candidates) implement specific interventions with the goal of managing noncompliance.

Still, it is undeniably tricky to prove the absence of an effect on a system as ambiguous, variegated, and unwieldy as American healthcare.

A reasonable proxy, however, is available; the following passages are drawn from medical literature dealing with compliance and not only summarize the findings of the article from which they were excerpted but are also representative of the overwhelming majority of scholarly and clinical reviews on the topic:

Most methods of improving adherence have involved combinations of behavioral interventions and reinforcements in addition to increasing the convenience of care, providing educational information about the patient’s condition and the treatment, and other forms of supervision or attention. Successful methods are complex and labor intensive, and innovative strategies will need to be developed that are practical for routine clinical use.¹

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Several complex strategies, including combinations of more thorough patient instructions and counselling, reminders, close follow-up, supervised self-monitoring, and rewards for success can improve adherence and treatment outcomes. However, these complex strategies for improving adherence with long-term medication prescriptions are not very effective despite the amount of effort and resources they consume.²

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The conundrum of compliance is extremely complex, and as yet whilst there are possible indicators as to some possible understandings and explanations, amongst some patients, in some contexts, with some areas of treatment/advice, these are still rather theoretical. Despite the wealth of research into determinants and management of compliance, few simple conclusions can be drawn.³

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It is unlikely that there will ever be a “cure” for noncompliance. No single, specific strategy that will enhance compliance in all patients—or even in the majority of patients—has been found. Compliance researchers agree that a range of strategies must be used, targeted to the underlying cause or causes of noncompliance and tailored to the needs and circumstances of each individual patient.⁴

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No single approach to improving adherence can be recommended on the basis of the evidence reviewed. Complex interventions may improve adherence and control in difficult patients. Worksite, nurse-led, protocol-guided care may have some advantages over usual care in younger men. Unfortunately, the wide variation in the types of intervention used and the outcomes measured make statistical meta-analysis methods inappropriate.⁵

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The Final Verdict On Patient Compliance

So there it is. After almost 2500 years of pondering, healthcare’s consensus is that compliance problems are complex, and the most promising solutions are also complex, as well as impractical and diverse, with no sure means of determining which interventions are most likely to work for a specific patient. And, few reviewers confidently endorse any specific tactic without extensive hedging.

To understand the problem underlying orthodox notions of patient compliance, it is useful to examine some examples of these theoretical models and programs. That’s next at Overview of Current Compliance Models

PDF Download
The State Of The Art Section, which includes The Verdict, Current Models, Current Programs, and Patient Behavior subsections and all citations is available in PDF format for download at ~State Of The Art~

Footnotes

1. Osterberg L, Blaschke, T. Adherence to Medication. N Engl J Med 2005;353:487-97. [back]
2. Haynes RB, McDonald H, Garg AX, Montague P. Interventions for helping patients to follow prescriptions for medications. (Reprint of a Cochrane review 2003, Issue 4) Update Software Ltd, Summertown Pavilion, Middle Way, Oxford OX2 7LG, UK. 9 [back]
3. Playle J. Concepts of compliance: Understandings and approaches, Br J Fam Plann 2000: 26(4): 213-219. [back]
4. American Pharmacists Association and Pfizer U.S. Pharmaceuticals, Medication Compliance-Adherence-Persistence (CAP) Digest. 2003. pp 7-8. [back]
5. Ebrahim, S. Detection, adherence and control of hypertension for the prevention of stroke: a systematic review. Health Technol Assess 1998; Vol. 2: No. 11 p 25. [back]

Patient Compliance Myths

1. The only absolute criterion for patient noncompliance is that a clinician has made a treatment recommendation to a patient. Once that’s accomplished, it’s a numbers game; as the number of patients receiving the treatment recommendation increases, the likelihood noncompliance will occur approaches certainty, regardless of the treatment, disorder, patient demographics, astrological signs, … .

2. It is essential not to confuse bullet points (information about noncompliance) with silver bullets (panaceas for noncompliance).

3. If a patient’s clinician is well-trained, proficient, & sensitive, his or her accuracy in determining if that patient is compliant or noncompliant with treatment will equal that obtained from flipping a coin.¹

After 20 years of talking about patient compliance with clinicians and civilians, I can report with confidence that the prevailing beliefs about treatment adherence are reasonable, based on common sense, and steadfastly maintained in the face of well documented evidence to the contrary. As H.L. Mencken put it, For every complex problem there is an answer that is clear, simple, and wrong.

Myth #1
Noncompliance Is Unusual Except In Certain Groups

It’s only common sense, for example, that noncompliance occurs only occasionally and even then is primarily a problem of the foolish, the recalcitrant, the poorly educated, the psychologically or intellectually impaired, and the poor. After all, when ones health and sometimes ones life is at stake, why wouldn’t any reasonable, mentally competent person who is aware of the problem and can afford the treatment follow the physician’s advice? Yet, surveys of actual healthcare behavior consistently indicate that significant noncompliance exists throughout healthcare., and, in fact, there are many instances in which noncompliance is routinely more prevalent than compliance; i.e., situations in which compliance is the aberration.

For example, a study² completed in 2000 found that 20% of patients given medication prescriptions never filled their prescriptions, and of those who did fill their prescriptions, 50% did not take the medications as directed; for those keeping score, that means the majority – 70% of all patients – were noncompliant. Multiple studies, in fact, calculate the chances that an individual prescribed medication non-acute disorders will satisfactorily adhere to that treatment plan as no better than even money – approximately 50%. For impressive noncompliance, it’s hard to beat The Nurses’ Health Study, a collection of data describing the healthcare behaviors of 84,129 female nurses, which reported that only 3% of the participants adhered to medical advice on diet and exercise.

To paraphrase Chickenman’s³ catchphrase for patient noncompliance: It’s Everywhere! It’s Everywhere!
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