Improve Compliance on the Front End


Applied Clinical Trials

Medication non-compliance or non-adherence to self-administered treatment instructions is a topic that frequently attracts the attention of the news media and the scientific and medical press. There is almost universal acceptance that rates of non-adherence will always be high (rising to 50 percent in some cases). That such non-adherence may lead to unnecessary waste (thus increased healthcare costs) and poor health outcomes (thus reduced quality of life) are justified cases of concern for all healthcare professionals. Many of the articles published however, tend to be superficial; often failing to appreciate all facets while thoughtlessly putting all blame on the patient. It is all too easy to limit the scope of enthusiastic discussions to some well meaning concerns, but without any real understanding of what is wrong and what should be done about it, while at the same time demonising the patient.

There are many potential reasons for non-adherence, including patients’ attitude and behaviour. Rather than looking into the psychological aspects, which appear to be resisting the best efforts of medical professionals, perhaps we should turn our attention to looking for improvements in those areas that can be more easily addressed without having to depend upon unproven theoretical considerations.

The clarity of the dosing instructions, deficiencies in packaging, and also simple forgetfulness on the part of the patient are all elements capable of significant improvement. Furthermore, each patient could also be reminded by their prescribing doctor that it is their personal responsibility to do the best they can in following the medical advice and instructions given to them.

With regard to clarity of instructions, there is sometimes a lack of consistency between what the doctor has told the patient and what the patient’s specialist has said and what the dispensing pharmacist may say. Further confusion may then arise when the patient reads the package information sheet. It is not difficult to appreciate the possibility of confusion developing for the patient who is attempting to assimilate all this information.

Packaging of medicines has hardly changed since the first drugs were pressed into tablets, placed in screw-capped bottles and given to patients. Now just over 100 years later, the usage of blister packs for tablets is a welcome development but may also be a cause of frustration in the case of inappropriate calendar packs as the design may not suit the dose/frequency regime for the particular patient. Unsurprisingly, inappropriate calendar packaging (e.g., two tablets per day when three are prescribed) is a common occurrence leading to much confusion and mistakes.

Pharmaceutical companies spend very large quantities of money on researching and developing their new drugs. However, the development of the finished product in its final container together with unambiguous dosing instructions appear to be influenced by “custom and practice” rather than more intelligent design of packaging that helps the patient to take their medicine in accordance with the dosing instructions.

It may surprise many employed in dispensaries or pharmaceutical companies that patients often find containers difficult to open, for example “child-proof” bottles or problematic blister packs. Not everyone possesses the level of dexterity required to open some of the containers employed and also inappropriately tough foil material on blister packs can lead to broken tablets, especially if the formulation is fragile, thus resulting in frustration and dosage error.  Such problems are easy to understand and should be easy to fix.

Those who think forgetfulness is an early sign of dementia or indicative of a disorganized brain should consider the problems of adherence faced by the patient taking multiple medicines and where the doses and frequencies may be in a constant state of change. Often there is little assistance given to patients in such circumstances. Employment of a calendar-based treatment schedule, showing for all medicines prescribed, when and the quantity to be taken could be of great assistance in such circumstances and if the patient marked each event this would also clearly show which medicines had already been taken.  Alternatively medicine packs could employ a simple tick box design or peel-off stickers which would clearly show each day’s medicines, when they should be taken and also when they have been taken.

While there is realization of the problems caused by non-adherence in clinical practice, less has been said about the impact on clinical research. In the former, wasted financial resources and also deterioration in the patients’ clinical profile with the possibility of the development of medical emergencies are obvious concerns. In the latter, the whole concept of clinical research, which is based on the gathering of evidence-based data to support the safety and efficacy of the drugs being researched, could be challenged if trial medication was not used in accordance with the dosing details of the study protocol. This has worrying implications for the running of new drug development programs where clinical trial volunteers are responsible for their own self-administered trial material.

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