Tips For Patient-Centric Adherence Packaging Cheat Sheet (DRAFT) by [deleted]

Patient adherence packaging can signif­icantly improve patient adherence - but ONLY if patients use it correctly. This requires that patients understand the adherence usage instru­ctions and are motivated to follow these instru­ctions. Not only does this require that the patient instru­ctions are easy to understand and follow but that the patient "­buy­s-i­n" on the personal advantages available with the patient adherence packaging.

1. Tip #1 Make sure patients understand "­how­" and "­why­" patient adherence packaging can help make taking medica­tions easier for them

In spite of all the advances being made in patient adherence packaging, many patients are still not using the packaging correctly. Many patients do not understand the purpose of compliance packaging. Perhaps this could be one of the reasons that they are removing all the medica­tions at once.

Health profes­sionals need to know how to counsel patients when the initial compliance package is dispensed. Patients will be more inclined to use the patient adherence packaging if they understand how the compliance packaging can help them remember to take a medication at the right time and check if they have already taken a dose. This is a major advantage over medica­tions dispensed in a standard prescr­iption vial.

2. Tip #2 Make it easy for patients to understand how to take the "­fir­st" dose

If you can step back and try to pretend you are a patient using a compliance package for the first time, it might be easier to understand why so many people are having problems.

How would you know how to open the compliance package and remove the dose if you could not understand the instru­ctions on the package? I believe this is a critical problem many patients are currently facing. Instru­ctions must be written in language people can unders­tand. In addition, these instru­ctions need to be available in one place on the package, preferably with the first dose. Sometimes the instru­ctions on how to use the package are separated on both the front and back of the package so the patient has to try to "­piece the inform­ation togeth­er".

Sometimes dosage instru­ctions are included at the bottom of the panel because that is where there is available blank space. This may look good from a design layout but it makes it very difficult for patients to unders­tand. When inform­ation is split and not near the doses being discussed, it actually can cause confusion and lead to patient non adherence - exactly the opposite goal of patient adherence packaging.

Make it easy for the patient to understand how to take the first dose and keep all the patient inform­ation in one place, preferably with the approp­riate doses to aid patient compre­hen­sion.

3. Tip #3 Use white space so that it maximally impacts patient compre­hen­sion.

White space is at a premium due to FDA required inform­ation but it can be every effective if used optimally for patient instru­ctions. Follow patient education guidelines to make sure the message will be understood by patients but also use design techniques that lead the patient through the package and its message so it is maximally effective. In some instances, illust­rations may be more effective than the words.

4. Tip #4 Provide patient instru­ctions for use in a logical order

When patient instru­ctions are separated and not in a logical order of use, patient compre­hension falls and patient adherence will fall. It is essential that the inform­ation provided on how to use the adherence packaging and the medication are clear and in a logical order of use.The package will be even more successful when the ideas are organized in the order that your audience will use them.

For instance, if a dose is titrated or requires special dosage inform­ation, place this inform­ation next to the specific dose. This will increase patient adherence. Do not place specific dosage inform­ation in any area that is blank, just because there happens to be space available. This is currently happening with several patient adherence packages and is confusing patients. Instru­ctions are easier to follow if they are near the dose being discussed and the instru­ctions include logical steps or timing sequence.

5. Tip #5 Make sure the instru­ctions are a Grade 6 reading level

Several healthcare agencies have recomm­ended patient education materials not be higher than a sixth grade level when commun­icating with the general US popula­tion. There are many methods of testing the readab­ility of your patient inform­ation including the Flesch­/Fl­esc­h-K­incaid readab­ility test available in some word processing progra­ms.Make sure patients do not give up because they cannot understand the instru­ctions. All the patient instru­ctions must be clear, unders­tan­dable and reinforced with approp­riate design.

Tip #6 Graphic illust­rations must be self-e­xpl­anatory and not contradict written inform­ation

A good illust­ration can be very effective. However, the illust­ration must not be confusing to patients in any way or this can decrease patient adherence. Always ask "How can this illust­ration be misint­erp­ret­ed?­" and then keep working on it so that the illust­ration is completely clear and instru­cti­onal.

Tip #7 Use a font patients can easily read and colors that increase health literacy

Often the branding colors used as the background are too dark for even a black font to show through. The result is that a patient (even without visual problems) will have problems just reading the inform­ation. The reverse is common, too. White wording on a pale color is also difficult to read.

Color is very important and can improve patient recall. Some colors can be motiva­tional and help improve patient adherence. However, some color combin­ations should not be used for medica­tions to treat certain diseases. For example, patients with diabetes who have undergone laser treatment for retino­pathy have difficulty distin­gui­shing between blue and green. If you are developing packaging for a diabetes medica­tion, caution should be used in printing blue and green together on the packaging. Never use yellow on a white background for packaging that will be dispensed to older adults because as a person ages, their vision "­yel­low­s" and they will have difficulty distin­gui­shing between yellow and white.

Tip #8 Reinforce the FDA-ap­proved patient labeling for the medica­tion.

It is important to use the same patient wording approved by FDA for the patient labeling on the patient adherence packaging. Also reinforce the same admini­str­ation steps. This will help prevent patient confusion because they are receiving the same wording or "main steps" on the patient adherence package as on the patient labeling.

Whenever possible, attach the patient labeling to the patient adherence packaging so that it is readily available to the patient for reference and more inform­ation.

Tip #9 The patient adherence packaging should follow the patient adherence strategy developed for the medica­tion, regardless of whether it is a clinical trial or a product launch.

A patient adherence strategy should be developed for every medication before it goes through a clinical trial and before it is launched. The patient adherence strategy will vary with each product. The clinical trial protocol should clarify how many doses of a medication can be missed without a signif­icant clinical effect and this should be tied to the definition of patient adherence for every clinical trial. Patient adherence packaging can be an effective component of this adherence strategy.

Tip #10 Provide health care profes­sionals with demos they can use in patient counse­ling.

Pharma­cists can be extremely effective partners with patient adherence packagers because they are the last health profes­sional to counsel a patient before the patient assumes full respon­sib­ility for the use of the product. Pharma­cists need demons­tration products they can use so that the patient leaves the pharmacy fully informed on how to remove a dose and how to use the patient adherence packaging optimally.