AlignMap

The Personal Medication Record

This post, the fourth and final AlignMap entry focusing on the Personal Medication Record,¹ (PMR) as an important method of decreasing unintentional medication noncompliance (i.e., errors in taking medication),² not only completes the series but also 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.

The No-Nonsense Summary
How To Create and Use A Personal Medication Record

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 Internet access offers.

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  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:

Health care advocates nationwide are increasingly touting the Personal Medication Record (PMR) as a key “empowerment” tool for patients to safely and effectively participate in the management of their own medications.  A complete PMR, which includes a record of all of the patient’s current Rx and OTC medications, allows the patient to easily let each of their doctors know what their other doctors are prescribing and is also crucial for patients when they’re admitted to the hospital, as the admitting staff can instantly know the patient’s complete medication regimen.

• 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.

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:

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 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:

Decide which data to enter into your Personal Medication Record
based on its utility to you and your doctor and other clinicians,
not on the slots and prompts of a form

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.

Resources

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 Resources

• 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.

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.↩
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

   ↩

3. The continuation should be published in the next 2-3 days↩
4. See Choosing The Right Personal Medication Record for a more complete discussion↩
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.↩
6. See also 2. Healthcare Professional-assisted PMR below.↩
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”↩
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.↩
9. This is a simplified adaptation of my original groupings listed in Compiling The Personal Medication Record↩
10. The Paper & Pencil PMR examples were chosen as de facto representatives based on their high ranking on Google↩

[Read more →]

The Personal Medication Record – Part III

[This is the third in a series of AlignMap posts offering pragmatic tips for decreasing unintentional medication noncompliance (i.e., errors in taking medication) with methods now available. It is also the follow-up to The Personal Medication Record - Part I:Everyone Needs A Personal Medication Record and The Personal Medication Record - Part II:Choosing The Right Personal Medication Record.]

1. 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.

2. Enter information. especially personal identifying data, only if it yields a distinct advantage that outweighs the risk of privacy invasion and fraud.

3. 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.

Not Too Much Data, Not Too Little Data, Just The Right Data

Despite the simplicity of the fundamental concept of a Personal Medication Record, which is, after all, at its heart only a gussied up list of the medications you take, the choice of which information is entered into a PMR can is neither obvious or insignificant.

A Personal Medication Record can be significantly diminished in value if certain information is not included, yet if every imaginably useful data point is required, it can become so complex that errors are generated and so burdensome that one avoids using it. Entering still other specific information (as prompted in some formats) puts the PMR’s owner at risk for fraud and other abuse.

The precise content of your PMR may be influenced by multiple factors, such as your heath status, support system, economic situation, relationship with those treating you, etc. Your degree of concern about the privacy of your data and the potential for fraud also play a role in this decision. The important issue is that it is indeed a decision for you to make. That a given PMR form has a space indicated for your Social Security Number, for example, does not mean that you entering that information is a good idea.

Consequently, rather than list a one size fits all protocol, my goal is instead to assist you in deciding which information to include in your PMR. Toward that end, have listed all the data categories from the PMRs I’ve researched in one of four classifications: Essential Personal Medication Record Information, Non-essential Information With High Potential Utility, Non-essential Information With Possible Utility, and Optional Information of Limited Utility That Incurs Privacy Risks.

Group A: The Essential Personal Medication Record Information

• Date of PMR creation and of most recent update
• Patient’s name
• Primary physician’s name and contact information
• Emergency contact information
• Medication* name, strength, and directions for use
• The reason for taking the medication (e.g., “for high blood pressure” “precaution against infection secondary to dental work”)
• Allergies and other medicine-related problems

*Include all medications, including those taken only occasionally, (e.g., medication for pain) or seasonally (e.g., allergy medication), over the counter drugs, vitamins and dietary supplements, herbal medicines, and samples)

Group B: Non-essential Information With High Potential Utility

• 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
• Age (Not birth date)
• List of current medical problems

Group C: Non-essential Information With Possible Utility

• Illustration or description of medication’s appearance
• Specific notation whether generic or brand name of the medicine is taken
• Date of last vaccinations

Group D: Optional Information That Incurs Privacy Risks

• Social security number
• Insurance Information (e.g., Company, Group Number, Policy Number)
• Birth date (Listing age is not a significant privacy risk; birth date is)
• Location where medications can be found in home
• Address
• Home phone number
• Cell number
• Date of birth

Instructions For Use Of Personal Medication Record

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. 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 the now outdated PMR.
5. 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.
6. 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
7. Keep one copy of your PMR with you at all times, another copy in a safe, easy to find place (e.g., in an envelope taped under the dash or seat of your car), and another with your emergency contact. Replace all copies if the medications you take change. These paper copies of your PMR are necessary even if it is available online (in that case, print out copies).

Additional Instructions For Use Of On-line Personal Medication Record

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

Next

The next and final Personal Medication Record post is the account of how I chose a PMR for my own use, completed it, and have put it to use, drawing on the information in the first 3 Personal Medication Record posts.

[Read more →]

And Bloggers On John Edwards

Were one to draw the Venn diagram of patient compliance and presidential campaigns, one would anticipate the intersecting portion would be minuscule if it existed at all. Further restricting that intersection to an overlap patient compliance, presidential campaigns, and public controversy certainly, one would think, doom that result to the ignominy of the null set.

Well, as of 2 September 2007, one would be wrong.

That day, presidential candidate, John Edwards elaborated on his healthcare plan to the folks in Tipton Iowa in a speech described in Edwards Backs Mandatory Preventive Care, the AP news story by Amy Lorentzen:

From the lighting of that fuse to explosions of outrage in the conservative blogosphere required only a few hours.

Consider, for example, a Newsalert post published at 7:52 PM the same day the speech was given:

And, just in case the reader doesn’t pick up on the subtle political connotations of “Comrade Edwards,” the post is headed by the following emblem:

How about a few other examples, just for grins?

From the post with my favorite title, Healthcare Part VIII – Drop that Twinkie or I’ll Shoot! at Angry Bear,

And from John Edwards: “you can’t choose not to go to the doctor for 20 years” posted at Althouse, come these passages:

Daystar51 goes beyond lambasting Edwards for promoting “mandatory preventive health care” to speculating on the possible origins of this notion buried in the candidate’s psyche:

An blog/article, dated September 5, 2007, in US News & World Report wields the British healthy practices incentives plan as a blunt instrument to batter the obligatory preventive care Edwards espouses:

Weird Is Relative, writing in What’s the punishment for noncompliance? Endless jury duty?, implies that the Tipton Iowa speech may be fatal to the Edwards candidacy:

It would be difficult to misunderstand the perspective of Not Larry Sabato, who exclaims in John Edwards on Health Care,

In fairness, not every blogger or commenter was bashing Edwards, but pro-Edwards postings are difficult to find. Plunderchat is a one of those few who straightforwardly support the mandatory preventive care, declaring in John Edwards Looking Good on Health Care that

Commentary

1. It turns out that the complete healthcare plan Edwards supports apparently allows folks to opt out of the program if they wish to manage their own healthcare without government mandates. This discovery disappoints me; when I read about the Tipton speech, I envisioned a post about Edwards declaring Patient Compliance “Mission Accomplished.” Then, I would go on to sardonically observe that “the answer to noncompliance was right in front of us – just issue a presidential proclamation that compliance was obligatory. And so on. If folks have the alternative of leaving the system, the obligatory preventive care lacks the extremity of arrogance that would otherwise render this notion an appealing target.

2. Few bloggers noted that we already have a batch of healthcare mandates on the books, including reporting and quarantine of various infectious diseases, undergoing certain vaccinations, obligating parents to follow doctor’s orders re their sick children, lest they be made wards of the state, and, more recently, restrictions on smoking and intake of some foods.

3. I have to wonder if Mr. Edwards and his advisers have considered the difficulty of monitoring, let alone enforcing patient compliance. While checking attendance records to determine who kept and didn’t keep a doctor’s appointment seems simple enough (although distinguishing between appointments missed because of traffic, scheduling snafus, and family emergencies from those missed through noncompliance may require compliance interrogations abetted by bright lights, good copy-bad cop tactics, and polygraphs), medication compliance, for example, is notoriously difficult to determine, and adherence to diet, exercise, and similar non-medication prescriptions is rarely even attempted. Enforcement methods, short of the Pill Police, are relatively easy to come by; e.g., dropping healthcare coverage for noncompliant patients or tying official authorizations such as driver’s licenses to certificates of healthcare compliance would be simple enough, but even a compliance-pusher like me recognizes that this would be a major shift in the patient-clinician relationship as well as in the role of government in this country.

[Read more →]

Source:
Mental Illness Drug Payments Call
BBC News. January 1, 2007

Cash Incentives For Treatment Adherence: Pros and Cons

This is an interesting discussion of the practical aspects of compliance management in day-to-day clinical practice.

The issues are basic:

• Noncompliance is a common problem in psychiatric practices; 20-50% of these patients are believed to be non-adherent to prescribed medication
• Paying people with severe mental illnesses to take medication may encourage some to stick to their drug regime
• There are practical and ethical concerns about using cash payments to enhance compliance

Commentary

While the clinical study is interesting, the BBC story is more provocative, and its issues may well be more significant than the research findings in determining if the strategy of financially rewarding patients for adherence is put into practice.

The quote from Marjorie Wallace, of the charity Sane, exemplifies the resistance to this tactic:

Even the chief author of the study, Dr Dirk Claassen, indicated that such measures, if used at all, would be applied to a limited group: “Financial incentives might be a treatment option for a high-risk group of non-adherent patients with whom all other interventions to achieve adherence have failed.”

While the use of loaded terminology such as “bribes” triggers a multitude of negative connotations, especially when the patients bear psychiatric diagnoses, the same basic considerations are the essence of the ethical struggle over any compliance enhancement schemes.

It seems intuitively apparent, for example, that the approval of an authority figure can be as powerful or more powerful than a cash payment. Are the urgings of the doctors as unacceptable as monetary reinforcements? What if the urgings come from friends and family? How about reminders to take medication or a physician’s listing of research indicating the effectiveness of a medications? Is there any difference in promoting compliance with psychiatric medications and adherence to treatment for HIV disorders? If paying patients to take an anti-psychotic unethical, should states rescind laws legally forcing resistant patients to take drugs to treat tuberculosis? For that matter, should the government be allowed to enforce regulations requiring childhood vaccinations or restricting the use of tobacco or serving of certain foods?

Indeed, one school of bioethics maintains that any reinforcement, encouragement, or even commendation of treatment adherence is the equivalent of coercion on the part of the clinician, some holding that even subtleties as seemingly innocuous as a physician’s tone of voice, however benign his or her intent, represent intimidation of the client.

For clinicians such as myself, however, the notion of simply laying out various treatment options, including no treatment at all, in a value-neutral manner without indicating my recommendation is unpalatable and smacks of shirking ones duties.

The precedent that comes to mind is the battle between physicians and the antivivisectionists in the early 20th century.¹

My guess is that most clinicians charged with the care of patients make many decisions every day that involve parsing such ethical dilemmas with the well-being of a human being in the balance. For that reason, if no other, I believe that an automatic dismissal of material inducements, one of the few compliance enhancements strategies shown to routinely be effective, is counter to the best interests of patients and deserves further consideration.

1. E.g., William Osler performed vivisection to study typhoid and tapeworm in pigs and testified against antivivisection legislation in government hearings in the U.S. and England↩

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Pertussis Outbreak in an Amish Community—Kent County, Delaware, September 2004–February 2005 From the Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report 2006;55:817-821. JAMA Vol. 296 No. 16, October 25, 2006. 1960-1964.

Noncompliance With Pertussis Vaccination

While the theological tenets of the Amish permit vaccination, the CDC continues to document low coverage for routine childhood vaccinations in many Amish communities. In this case, 345 cases of pertussis occurred, mostly in preschool children, during a September 2004–February 2005 outbreak in such a group in Delaware.

After the initial cases were reported, “control measures and active surveillance for additional cases were instituted, including enhanced contact investigation and outreach and special community pertussis clinics at Amish schools.” Laboratory confirmation of the diagnosis was also obtained.

In addition, a self-administered survey and interviews with volunteer households were used to obtain data re vaccinations. Pertinent results follow:

In an editorial note, the CDC points out that “among the diseases for which universal childhood vaccination is recommended in the United States, only pertussis has had an overall increase in reported cases since 1980, increasing from 1,730 cases in 1980 to 25,827 cases in 2004.” In the outbreak afflicting this Amish community, the younger children (1-5 year old) were overrepresented, accounting for 41% of all cases, a rate congruent with that seen throughout the US prior to the availability of vaccination.

Commentary

The too-often repeated sequence of inadequate community adherence to vaccination schedules followed by outbreaks of preventable disease is one more reminder of the importance of the need to actively promote compliance enhancement to prevent as well as treat disorders.

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EU Urged To Vaccinate Girls Against Cervical Cancer Reuters October 5, 2006

An editorial in Lancet recommends that member states of the European Union mandate the vaccination of 11-12 year old girls against the human papillomavirus (HPV), a major cause of cervical cancer. Cervical cancer is diagnosed in 470,000 women each year and is the cause of death in 230,000.

The European Commission last week licensed the first HPV vaccine (Gardasil) for use in children aged 9–15 years and women aged 16–26 years. The vaccine has already been used in the United States in girls as young as nine and women up to the age of 26.

The Lancet editorial also noted growing support for vaccinating boys as well as girls but held off this recommendation pending more data from clinical trials.

Commentary

Compulsory vaccination is interesting arena for patient compliance. This nexus of government and medicine highlights the inherent conflict between private freedoms and the public good. Consequently, competent medical advice should be a necessary but not sufficient element in a political entity’s decision to demand any medical procedure, including preventive ones such as vaccination. Lancet’s endorsement of the cervical cancer vaccination certainly qualifies as competent medical advice. How the countries making up the European Union react to this recommendation by a medical source that is medically reputable and publicly prestigious but unendorsed by any government.

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Outbreak of Measles In 2005 Shows Risk Of Refusing Vaccines
William Bulkeley Wall Street Journal August 3, 2006; Page D6

Implications of a 2005 measles outbreak in Indiana for sustained elimination of measles in the United States., Parker AA, Staggs W. et al. N Engl J Med. 2006 Aug 3;355(5):447-55
____________________

A Centers for Disease Control and Prevention study demonstrates the link between 34 new cases in one Indiana community in 2005, the largest such outbreak in nine years,¹ with a single set of parishioners, 10% of whom were estimated to have refused vaccination because of media reports that associated vaccines with autism.² Of the 34 cases, 33 came from this community and most came from four households.

Commentary

That this outbreak occurred despite the fact that measles vaccinations coverage in Indiana were 92 percent for preschoolers and 98 percent for sixth graders points out the significance of even a small fraction of noncompliant individuals in public health matters.

Footnotes

1. By way of comparison, there were 27 cases throughout the U.S. in 2004; 56 in 2003; 44 in 2002; 116 in 2001 and 86 in 2000.↩
2. Measles vaccinations in the U.S. don’t contain thimerasol, a form of mercury that has raised most of the vaccination concerns.↩

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Vaccine guidelines growing more complex
Mike Stobbe, Associated Press Sun Jul 30, 12:25 PM ET
______________________

The key quote comes from Dr. Anne Schuchat, the Director of the National Immunization Program,

Indeed, the number of recommended vaccines is expected to increase from 12 to 13, albeit only for girls (the 13th is a vaccine against cervical cancer).

Merely tracking the immunization histories of children and adolescents has become a complex logistical undertaking for parents, clinicians, and government. Understanding even the rudiments of the scientific underpinnings and the clinical ramifications of the vaccines may already have grown too difficult a task for the majority of the public.

And, an inevitable result of treatment processes becoming more complicated is the increased risk that patients will not be able to comply with those treatments..

Adherence to the recommended vaccine schedule is also threatened by other issues:

• The cost of all recommended vaccines has increased from $100 to $1250 in the past 20 years [tag]cost[/tag]
• Because immunized people may still be susceptible to outbreaks of disease, booster shots are more frequently recommended
• Specific vaccines experience sporadic shortages
• Changes in official vaccination recommendations change unpredictably and are often not systematically or effectively communicated to the public

Commentary

Compliance isn’t possible unless a treatment plan is understood.

Paradoxically, an advance in healthcare, the development of new, effective vaccines, renders adherence to these preventive programs increasingly difficult and unlikely. It may well be that the next significant quantum improvement in public health will be the result not of yet another vaccine but a solution to the information management conundrum, such as a centralized, electronic health information system.

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Well-Intentioned Food Police May Create Havoc With Children’s Diets
By Harriet Brown

This essay in the May 30, 2006 New York Times raises concerns about the extent to which schools intervene in the lives of their students in hopes of improving health.

In the past, such efforts have included discrete and intermittent interventions (e.g., vaccinations and immunizations, either provided by or required by the schools), ongoing programs integrated into the school structure (exercise programs and health education), and auxiliary programs that had an impact on the students’ general health (e.g., hot lunches). Today, these elements seem to be accepted by all except religious sects that disallow certain medical measures, some conservative political groups alarmed by the intrusiveness of government, and a few others with concerns about the safety of specific medical procedures.

Ms Brown’s essay addresses the currently popular battle on obesity which is being carried out in the schools, by local initiatives and via legislation, such as the Child Nutrition Promotion and School Lunch Protection Act now before Congress, which would, in effect, set standards on food served at school cafeterias and vending machines.

While the article focuses on the wisdom of taking such actions based on unproven or oversimplified correlations between obesity and specific disease states, the ethical issues of using public authority, in this case the schools and legislation affecting schools, to intervene in the lives of individuals in hopes of improving health are even messier. Reading news stories, for example, of Arkansas Governor Mike Huckabee’s personal 100 pound weight loss and his consequent enthusiasm for enacting regulations to halt obesity causes one to wonder about the justification for those who are in positions of power pushing their own passions, however well-intended, onto others. Motives are even less clear in other situations since coming out in favor of improved school nutrition would seem a particularly safe, politically advantageous position.

Similar ethical conflicts (e.g., physicians advising Vs. coercing patients to follow a medication regimen) are not, of course, unusual in the field of medical compliance, but the school arena does merit special attention given that children are affected and the reasoning behind these decisions is unclear.

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The AlignMap Vision: Alignment Of All Healthcare Stakeholders

The No-Nonsense Summary
Healthcare Alignment

1. Infuse the principles of the Engagement Model into every aspect of the organization

2. Focus on implementing the best workable treatment plan for the patient rather than the patient’s compliance with an ideal treatment plan

3. Alignment of all stakeholders starts with explicit conversations between those stakeholders

The Engagement Model: An Expectation Of Patient Involvement

Implementing the best workable treatment plan for the patient requires the participation of the client.

While simplistic and so integral to to our Western notion of healthcare that stating this axiom explicitly seems a declaration of the obvious, the difficulty of implementing this principle is a major factor in the phenomenon of noncompliance.

In recent years, an increasing number of organizations invested in or providing healthcare (most pertinently, disease management programs) have realized that offering clients the option of participating in a health-enhancement program, regardless of how alluringly the invitation is offered, automatically excludes not only those who decide not to participate but also that significant fraction of the population who are not opposed to the plan but do not join because of passivity, social inhibitions, procrastination, lack of awareness, and other reasons that have little to do with the real or perceived value of the program.

Because such individuals are not opposed to the proposed program, they are likely among those who could most benefit from special protocols and activities that help them manage or prevent medical disorders.

Instead of expecting patients to self-enroll, the engagement model calls for the identification of all patients within a population who fit the criteria for the specific program, their automatic enrollment, and, only then, the extension of an opportunity to opt out of the program.

Disease management programs report participation of 90-95% of the population with the engagement model, compared to typical participation rates of 10-30% typical when patients are required to self-enroll.¹

Even in the worst case scenario (i.e., everyone except those who would have signed up for the program on their own opts out), as many patients are reached, albeit at greater cost, as in the self-enrollment model. And, the self-enrollment model is not without its own problems; I have, for example, been antagonized by repeated and increasingly aggressive computer-generated written notifications from my health plan administrator, urging me to opt in to a special program for diabetics that I have decided would not provide an acceptable benefit/cost ratio in my case.

Using The Engagement Model To Create A Culture Of Cooperation

A key AlignMap percept is extending the Engagement Model beyond the purpose of driving participation in a specific program to infusing its principles throughout the entire healthcare system to create an environment in which cooperation is the expectation (making the offer of an opportunity to opt out all the more important).

The pragmatic significance of this concept for a specific clinical practice or healthcare organization is straightforward:

Strategies for Aligning Patient and Clinician

1. Cease Firing At The Wrong Targets
Just Say No To Snipe Hunts & Compliance Showdowns

The snipe hunt is a traditional practical joke in the Ozarks where I was raised. The victim is indoctrinated to the lore of snipe hunting, taught a special snipe call, and assigned the job of catcher, i.e., holding a gunnysack, while everyone else serves as beaters, driving the snipe toward the catcher. The snipe hunt takes place at night in the middle of a thicket or, preferably, a swamp. The “snipe” in “snipe hunt,” however, is a hoax; the beaters disperse to the local bar to wait for the victim, who is left in the dark holding the bag, to realize he’s been duped.

Similarly, the single-minded pursuit of improved compliance is typically unsuccessful because, as discussed here, the compliance being sought, the massive information published about it and the equipment sold to manage it notwithstanding, is, for pragmatic purposes, nonexistent. Consequently, even though the problem is noncompliance, the answer is not simply “fix the noncompliance.”

In fact, a direct assault on noncompliance is often counterproductive because of its potential for divisiveness. Given the nature of the patient-clinician relationship, the clinician is, by default, responsible for evaluating the quality of patient’s execution of the treatment. If compliance is the goal, how can the clinician even address adherence to treatment with the patient without implicitly blaming the client for treatment problems? When intoned in a compliance is good for you fashion, for example, healthcare recommendations can seem sanctimonious and condescending while a more vigorous, enthusiastic presentation is likely to come across as a attempt to “sell” or even bully the patient, Even using a neutral tone can make the clinician seem detached rather than caring. And if there has been no clinical progress or the patient’s condition has worsened, it requires a special skill to ask the appropriate question of patient – if he or she has actually followed the prescribed treatment plan since the last visit – without evoking the perception of an accusation.

Compliance-driven healthcare offers clinicians only two choices: (1) ignore noncompliance or (2) adjudge patients as compliant (“good patients”) or noncompliant (“bad patients”). The former alternative entirely precludes improvement while the second leads to either nihilistic inaction (“what can I do if the patient won’t cooperate”) or to the clinician-patient interactions featuring pleas, demands, arguments, and ultimatums, none of which are likely to increase adherence or support the patient’s overall alliance with his healthcare professional.

2. Aim Beyond Compliance At The Real Target

Ultimately, the purpose of any patient-clinician interaction is to provide the patient with the best healthcare possible; that’s the goal.

It’s a primary AlignMap percept, in fact, that a first step in achieving optimal healthcare efficacy is the adoption of this operational principle:

Pragmatically, the shared goal of implementing the best workable treatment plan for the patient aligns patient and clinician in a joint effort to achieve a goal that is fundamental, identifiable, and important to both parties. It affords, in fact, the purpose (or, for the more philosophically inclined, the telos) of any healthcare intervention on whatever scale. In this scheme, compliance is relegated to a secondary, more appropriate role as a useful statistical measure rather than the end-point of the patient-clinician dynamic.

Further, the aligned patient and clinician are mutually and interdependently empowered as a function of this goal.

The patient is explicitly (and pragmatically) authorized the final arbiter of the treatment plan. To implement the best workable treatment plan for the patient, after all, only declares openly what has always been true, albeit acknowledged only tacitly if at all: the real treatment plan is the treatment plan the patient carries out. The patient’s involvement also directly increases the likelihood of the patient executing the agreed-upon course of treatment. Implicit in the notion of implementing the best workable treatment plan for the patient is the expectation that the patient understands and is capable of carrying out the components of that plan. There is also a growing collection of evidence demonstrating that patients who select their own course of treatment (from a clinician-approved menu of potentially beneficial treatments) are more likely to follow that regimen and have better outcomes than those who are offered only one treatment choice.

The clinician, as the healthcare expert, is responsible for not only informing the patient of the pros and cons of appropriate courses of treatment but also advocating those courses of treatment with the greatest chance of success for the specific patient. Further, the clinician is obligated to refuse to prescribe a patient-requested treatment if its risk exceeds its potential value because, applying the “first, do no harm” heuristic, the best workable treatment plan for the patient may be, quite literally, no treatment at all.

3. Pull The Trigger: Putting Alignment Into Practice

Refocusing on implementing the best workable treatment plan for the patient as the primary clinical goal requires a shift in perspective for clinician with its attendant cognitive and attitudinal adjustments. These shifts must then be orchestrated to play out in clinical practice.

The starting point in systematically realigning a practice is to consciously aim at this new target. Clinicians must talk overtly and specifically talk with patients about the objective of alignment. The same concepts should be published in materials provided clients, clinical and business staff must be familiarized with the notion, and issues at staff meetings must be considered in light of this goal. It must become the practice’s mantra. Such conversations facilitate the role changes of both clinicians and patients necessitated when the shared goal of interaction becomes to implement the best workable treatment plan for the patient.

The training of personnel, the interviewing techniques used in patient visits, the formation and integration of healthcare-enhancement programs, the patient education tactics, and the myriad of other specifics involved in this approach are beyond the scope of this Section.

1. Given that disease management companies use high enrollment rates in their marketing and may even benefit directly by charging fees based on the number of patients enrolled, one may question these numbers and, perhaps more significantly, the extent and quality of participation when patients are automatically enrolled. Nonetheless, this phenomenon certainly correlates with clinical experience, and there are objective measures of participation (e.g., the rate of hemoglobin A1c levels completed for diabetic patients) that support the claimed advantage of the engagement model.↩
2. Including but not limited to scheduling, screenings, vaccination programs, specific promotions, treatment, and patient education↩

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