Medicines in older people
Older people use more medicines than the rest of the population, yet medicines are seldom tested in them or designed for their needs, and they receive less and lower-quality treatment than younger people. The gap has several causes, from ageism and missing clinical data to polypharmacy, and closing it is shared work between industry, regulators, prescribers, pharmacists and patients.
An ageing population
Owing to declining birth rates and increased longevity, the global population is ageing: in 2000 one person in nine was 60 or over, and by 2050 the figure was expected to rise to one in five. The ageing has had, and will continue to have, a large impact on healthcare.
The ageing of the Baby Boomer generation and the general rise in life expectancy continue to expand the proportion of adults aged 65 or over, globally and in the United States. In recent decades medical advances have made 100-year birthdays almost commonplace. In 2019 about 50 million people aged 65 or over lived in the United States, more than 15% of the population against 10% in 1970, and the number was predicted to nearly double to 95 million by 2060, a quarter of the population. Japan's older population was already a quarter of the total, up from 7% in 1970, and Germany's was 21%, up from 13% in 1970. In 2013, 10,000 people in the United States were turning 65 every day.
Older people are in general the highest users of medicines and take more medicines than the rest of the population, and in 2017 Eurostat expected them to make up almost a third of all Europeans by 2050. Yet medicines are rarely developed or packaged to take their specific needs into account.
Unequal treatment
Inequalities remain in older people's access to treatment: although the need for healthcare services increases with age, older people, especially those aged 75 and over, receive less frequent interventions and less and lower-quality treatment than younger people. They also receive less expensive treatment than younger people for the same illness. Some studies indicate that prescriptions of recently introduced, non-substitutable medicines tend to be proportionally lower in the younger part of the oldest age groups. Diagnostic procedures are often used less intensively in older people than in younger adults, mammography being an example, partly because it has not been adequately tested in older women.
Older people are less likely to be prescribed relevant medications and to receive target doses of them. For example, several country-specific studies have shown them less likely to receive antihypertensives, and prescriptions of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers and anticoagulants declined sharply in the 75-to-85 age group. Some studies have also shown them less likely to receive statins, angiotensin-converting enzyme inhibitors and calcium channel blockers. In general, older women with breast cancer received less treatment than younger women. Treatment of older people has also been shown to be symptom-based rather than diagnosis-based.
Causes of inadequate or inappropriate treatment
Many factors contribute to inadequate or inappropriate drug treatment of older people: ageism, a lack of testing of medicines in older people and of clinical data in them, a lack of proper diagnosis as a basis for treatment, with unclear diagnoses causing hesitancy to start treatment, a lack of concordance and of compliance, and polypharmacy.
Ageism, as defined in 1969, is a type of discrimination that involves prejudice against people on the basis of their age. Like racism and sexism, it involves holding negative stereotypes about people and is difficult to combat. It is not limited to older people: adolescents and children can also be discriminated against because of their age. One author held in 2013 that approval of the proposed 2008 EU directive against age discrimination, which covers not only work and education but also access to goods and services, healthcare and social welfare, would be one step towards improving the situation. In 2013 the proposed directive was being considered by the Council of the EU. In that author's view, approving it would convey that it is not acceptable to deny older people the healthcare they need because of their chronological age, and that the benefit of a treatment must be weighed against its risks for the individual patient, regardless of age. The author also held that, on an individual level, people should react and act when they encounter ageism in any form. In the author's view, it is unacceptable to be denied a treatment, a mobile phone subscription or a bank loan just because of chronological age.
Clinical data in older people are lacking, and in 2013, unlike medicines for children, medicines for older patients had no specific legal requirements governing their development. The European Medicines Agency (EMA) had reacted by preparing a document on quality aspects of medicines for older people. Older people are a heterogeneous population who react to medicines in different ways. Some may have difficulty taking their medicines, such as swallowing tablets, opening packages or reading the patient information leaflet. Many have comorbidities, and physical changes such as renal or hepatic impairment or altered gastrointestinal motility are important when evaluating a medicine's benefit–risk profile. Because many older patients use several medicines at the same time, it is difficult to design clinical trials whose data will not be confounded by polypharmacy. Ethical aspects must also be considered, including how best to obtain informed consent from people with dementia and how to test new medicines in frail individuals.
A lack of proper diagnosis as a basis for treatment contributes to inappropriate treatment of older people. For example, one survey found that one-fifth of patients treated with hypnotics for insomnia were receiving the medication inappropriately, because they had originally asked for it to treat feelings of loneliness that they did not articulate to the prescribing physician.
Concordance is an agreement reached by negotiation between a patient and a healthcare professional that respects the patient's beliefs and wishes about whether, when and how medicines are to be taken. The term and its practical effects have been questioned. Some patients want clear, straightforward advice, while others want to discuss the pros and cons of a treatment. Concordance should nevertheless be sought for patients who show a need for such discussions and want them.
A lack of compliance is very common, and it can be remedied with compliance aids such as tablet dosing boxes, watch alarms and medication reminder charts.
Polypharmacy means that a patient is being treated with many different medicines. In Sweden in 2011, people aged 75 and over were treated with an average of five medicines at the same time, which is regarded as polypharmacy. In the same year 11% of all people aged 75 and over were treated with ten or more medicines at the same time, and 10% were being prescribed medicines that should be avoided in older people. Polypharmacy is known to be the main risk for adverse drug reactions in older people. This might be because the patient has many health problems that require medication. Other contributing factors include multiple prescribers for the same patient, different platforms for maintaining medical records, multiple names for the same medicine, and a lack of consultation time for the patient.
Medication-related harm
Harm arising from the use of medicines remains a leading cause of preventable patient harm, particularly in older adults taking several medicines. Older adults are particularly vulnerable to it through several interrelated factors, including multimorbidity, polypharmacy, age-related changes in pharmacokinetics and pharmacodynamics, and difficulty with adherence. The WHO identifies older patients and those taking multiple medications as being at greatest risk.
Involving older patients in regular medication reviews helps reduce polypharmacy and improves adherence. In one case, a woman in her seventies was admitted after a fall, and a common sleeping tablet she had been taking for months was a key contributor to it. A structured review found that the tablet was no longer appropriate and carried a high risk of falls, and deprescribing it while discussing safer alternatives with her reduced her risk of harm and improved her overall treatment plan.
Responsibility for improving treatment
The responsibility for improving the treatment of older people with medicines lies with the pharmaceutical industry and, in Europe, the EMA and national regulatory agencies, as well as prescribers, dispensing pharmacists and patients themselves. Clinical trial and health economic data are needed to assure the effective and safe treatment of older people. Medicines need to be not only clinically effective but also cost effective, bearing in mind the increasing number of older people needing medical treatment.
The pharmaceutical industry has an important role, in that all medicines, old and new, should be tested in the age groups in which they will be prescribed. The overall cost of medicines is increasing, and as more expensive new medicines enter the market, both the economic and the clinical value of medications need to be documented. To help older patients, comprehensive patient information leaflets should be produced in large print, and advertising should follow the codes of ethics set out by the WHO and by national rules. During a medicine's life cycle, its benefit–risk ratio in older patients should be re-evaluated.
The EMA is responsible in Europe for following the development of emerging medicines through clinical trials and through the ongoing evaluation of licensed medicines, which includes evaluating whether a medicine can be used safely and effectively in the patient groups to which it is expected to be prescribed, older people among them. In 2013 it had developed a geriatric medicines strategy and established an expert group for the evaluation of medicines for older people, the Advisory Group on Geriatrics. Through this group it intended to ensure that medicines used by geriatric patients are of high quality and appropriately researched and evaluated throughout their life cycles. It was also working to improve the availability of information on the use of medicines in older people through product information and European public assessment reports, so as to assist informed prescribing. It also interacted with stakeholders through the Patients and Consumers Working Party, and it was responsible for the pharmacovigilance programme, which includes reporting adverse reactions and medication errors.
On 1 August 2017 the EMA invited public comments, by 31 January 2018, on a reflection paper on how medicine developers can better address the needs of older people who take medicines. Some older people face difficulty opening boxes or bottles, reading instructions, and swallowing or breaking tablets and capsules, which can result in medicines not being taken as intended, in medication errors and ultimately in a reduced quality of life. The reflection paper describes aspects that developers may consider when designing medicines for older people, such as the route of administration and dosage form, dosing frequency, excipients, container closure systems, devices and technologies, and the user instructions in the product information. For example, where there is evidence that older people find it difficult to break a tablet by hand, companies may improve the tablet's breakability or consider alternative approaches such as small tablets in a dose dispenser, and they may consider redesigning containers so that older patients can open them easily without assistance. Comments were particularly invited on the accuracy of tablet breaking, the administration of medicines through feeding tubes, and multiple compliance aids and multiple drug dispensing systems, containers that clearly state the day or the moment at which a medicine is to be taken. The EMA said that, depending on the outcome of the consultation, the content of the reflection paper might be developed further into regulatory or scientific guidance.
Prescribers must base their prescribing on knowledge of the causes of the patient's health problems, the benefit–risk profile of the medicine and the other medicines the patient is prescribed. To avoid errors, one physician should be responsible for the patient's medication and should coordinate prescriptions given by other physicians. The physician needs the time to inform the patient about the diagnosis and to discuss the medication with them. The physician should then assess the patient's reactions to treatment, evaluate them and, if necessary, adapt the therapy, which is known as therapeutic auditing.
Pharmacists are responsible for checking that the correct medicine is delivered. They should signal the prescriber when medicines not to be used by older people have been prescribed and when interactions might occur, and they should allow the patient time to ask questions.
Patients questioning their medicines
In Sweden a project started in 1999 developed into the "Master your drugs" campaign, run by the two major organisations for older people, the National Pensioners' Organisation and the Swedish Association for Senior Citizens, which together have some 700,000 members. Seminars and study circles about medicines are organised for the members, in which they are shown how to weigh benefits and risks.
The members are given a list of questions to ask their doctor, including:
- Why are you prescribing this medicine for me?
- For how long should I take it?
- What are the most common adverse effects?
- Can I use it together with other medicines and herbal products that I take?
- Is it good for me to take this medicine, bearing in mind how old I am?
- Has this medicine been tested in older people?
The members are also given a list of medicines contraindicated in older people, and if prescribed any of them, they are recommended to ask their doctor: "The information on the list I have here says it is contraindicated in older people. Why are you prescribing it for me?" The campaign was originally funded by the two organisations, and the Swedish government later took over its financing. In 2013 the programme was being assessed on an ongoing basis, with results to be presented in 2015.
Unmet needs
In 2013 effective medicines were lacking in some indications, such as rare diseases, Alzheimer's and Parkinson's disease and osteoporosis, and new antibiotics were needed for infectious diseases in which bacterial resistance had become a problem. These issues present challenges for the pharmaceutical industry. Preventive medicine also needs re-evaluation. The lack of effective health economic evaluation is a problem that must be addressed to allow changes to current practice to be monitored. Data on the number needed to treat to save one life are needed for different age groups. Whether it is right to treat large populations with medicines that may cause adverse effects in order to save one life is a question that is difficult to answer.