How better labels and package inserts could help people increase their adherence to therapies
By Jerome Reinstein, Director-General, World Self-Medication Industry (WSMI)
The literature on adherence to therapy has concentrated on specific therapies. There is at least one area, however, which is applicable to adherence to all therapies: improving the usability of medicine labels and package inserts. Along with all the specific interventions to improve adherence to therapy, the use of written information for the patient, which has been proven to result in appropriate behaviour with the medicine, is one that needs additional research and the application of what is already known about medicine information design.
WHO has stated on a number of occasions that about half of medicines are not used according to best practice. One of the reasons for this is that labels and leaflets are often not as useable as they should be. Currently, labelling regulations are content-based. That is to say, regulators in individual countries or the European Union decide on what should be on a label and what should be in a leaflet. Sometimes, the regulations even state that the information should be "in consumer-understandable language". However, no regulations currently require testing of labels and leaflets to determine their performance in real-life use. That is to say the labels and leaflets are not tested by members of the public to determine whether an acceptable standard of performance has been reached. One exception to this is in Australia where Consumer Medicines Information is performance-tested and where the contents of labels and leaflets are in the process of being regulated on a performance-test basis.
There are universal principles for producing usable medicines information, but in practice they are not followed by regulatory authorities. Information design principles can be used to produce labels that can be shown to be usable by people. The steps required are:
- Scoping - defining the problem to be solved.
- Bench-marking - setting performance requirements for the design.
- Prototype development - using the best writing and layout skills to develop a prototype.
- Testing and refinement - changing the prototype to meet performance requirements (this process may have to be repeated several times in iterative testing to reach the agreed standard).
- Specification and production - implementing the design for production and distribution.
- Monitoring - measuring the design's performance in use.
The application of these principles is not obvious and must be taught as a discipline. However, the principles can be learned in a short time and can then be applied and tested in any cultural environment, even in environments in which many people are illiterate, where communication agents such as children or village elders can be used to transmit the information on medicines.
How the pharmaceutical industry can help in enhancing adherence to long-term therapies
By H. Bale, Director-General, International Federation of Pharmaceutical Manufacturers Associations (IFPMA).
Medicines won't work if you don't take them. Even the best treatment plan will fail if it isn't followed. The most obvious consequence of nonadherence is that a person's illness may not be relieved or cured.
According to an estimate from the Office of the United States Inspector General, every year nonadherence to drug treatment results in 125 000 deaths from cardiovascular diseases such as heart attack and stroke. In addition, up to 23% of admissions to nursing homes, 10% of hospital admissions, many visits to doctors, many diagnostic tests and many unnecessary treatments could be avoided if people took their drugs as directed.
Unfortunately, people often don't take their medicines as prescribed. This nonadherence has serious and wide-reaching outcomes, ranging from the extra cost to whoever pays for the wasted medicines and additional treatment, to the cost to patients who will suffer avoidable illness and in serious cases, even death. For example, missed doses of a glaucoma drug can lead to damage to the optic nerve and blindness; missed doses of a heart drug may lead to an erratic heart rhythm and cardiac arrest; missed doses of a high blood-pressure drug can lead to stroke; and failure to take prescribed doses of an antibiotic can cause an infection to flare up again and can lead to the emergence of drug-resistant bacteria.
Studies of patient behaviour show that some 50% of medicines are not taken as prescribed. There are many reasons for this, and among the many reasons that patients give for not adhering to a treatment plan, forgetfulness is the most common. A key question is: why do people forget? The psychological mechanism of denial is often a reason, and sometimes something about the treatment may greatly concern the patient, resulting in a repression of the desire to follow the prescribed treatment. Illness in itself is a concern, and having to take medication is a constant reminder that you're ill. Other reasons for not adhering to a treatment plan include the cost of treatment, inconvenience and possible adverse effects.
Studies have shown that patients are more likely to be motivated to take their medicines correctly as prescribed when they:
- understand and accept the diagnosis;
- agree with the treatment proposed; and
- have been able to address and discuss seriously their concerns about the specific medicines.
Ways to improve adherence. Dr Joanne Shaw, director of the Medicines Partnership project (UK), points out that being part of the decision-making process involved in buying a home, household goods or a new car is obvious to most people, but this may not be as obvious when getting treatment for their illness. It has been shown that people normally adhere better to their prescribed treatment if they have a good relationship with their prescribing doctor. One reason for this is that when people participate in their health care planning, they also assume responsibility for it and are therefore more likely to stay with the plan. Getting clear explanations in a language they understand and understanding the rationale for the treatment also help to increase adherence.
A further important issue identified by the Medicines Partnership project, is that people are more likely to adhere if they believe that their doctor, nurse, physician assistant or pharmacist cares whether or not they stick with the plan. Studies show that people who receive explanations from a concerned doctor are more satisfied with the help they receive and like the doctor more; the more they like the doctor, the better they follow a treatment plan. Written instructions help people to avoid mistakes caused by poor recall of what the doctor said.
Creating a two-way relationship between patient and doctor can start with an information exchange. By asking questions, a patient can come to terms with the severity of his or her illness and intelligently weigh the advantages and disadvantages of a treatment plan. Misunderstandings can often be clarified simply by talking to an informed professional. Good communication also ensures that all caregivers can understand plans prescribed by other health care practitioners.
Patients who take responsibility for helping to monitor the good and bad effects of their treatment and discussing concerns with health care practitioners are likely have better results from a treatment plan. They should inform the doctor, pharmacist or nurse about unwanted or unexpected effects before adjusting or stopping the treatment on their own. A patient often has good reasons for not following a plan, and a doctor can make an appropriate adjustment after a frank discussion of the problem.
Patients may also form support groups for people suffering from similar conditions. Often the fact that there are other patients trying to cope with the same problems can be helpful, and the patient support groups can provide suggestions for coping with problems, building on the experiences of other patients.
Reasons for not adhering to a treatment plan. It is also important to try to understand the reasons for not adhering to a prescribed treatment. The patient could be misunderstanding or misinterpreting the instructions. Forgetting to take a medication is common, and experiencing adverse effects may be perceived as worse than the disease itself, especially if the disease is asymptomatic - the treatment of high blood pressure is a classic example of this. What may be represented as "misunderstanding or misinterpreting or forgetting", could be the expression of underlying beliefs and priorities about medicines in general, and the patient's regimen in particular. Denying the diagnosis and the illness, and not believing that the medicine will help are other factors. Patients may also fear adverse effects or becoming dependent on the drug (which may lead the patient to take a "medication holiday"). Sometimes patients may believe mistakenly - that the disease has been sufficiently treated, as is often the case when people take antibiotics for an infection, and the symptoms disappear before all the bacteria are eradicated. Other factors may be worries about the costs, or the patient experiences problems, for example, difficulty swallowing tablets, opening the medicine container, or following a cumbersome treatment plan.
For older people adherence may be a particular challenge, as they are often taking several drugs concurrently, making it harder for them to remember when to take each of them. It is also not unlikely that they could experience an adverse drug interaction. Doctors should take care to obtain information about all the drugs a person is taking, not only prescription medications, but also over-the-counter preparations.
A role for industry. The main role of the pharmaceutical industry is to develop safe and efficacious treatments. The development of drugs with few side-effects and easy or easier administration would promote adherence. Because medicines are for patients and their optimal use, the industry's role should go beyond the traditional one of bringing the medicines to the market. Industry also has a necessary role in helping to inform patients about their products. This should be in such a way that broader and increased knowledge and understanding can support the patient's relation to, and dialogue with, the prescribing doctor and the other health professionals involved, such as nurses and pharmacists, in following the prescribed treatment to achieve the best outcome for both the patient and the health care system.