Hospital Pharmacist
2007;14:55-57
February 2007

American Society of Health-system Pharmacists

Pharmacy intervention improves medicine adherence in the elderly

The Federal Study of Adherence to Medications in the Elderly (FAME) is a prospective, randomised controlled trial designed to address the problem of medication adherence in the elderly. The study, supported by the American Society of Health-System Pharmacists Research Foundation, was described by Jeannie Lee, clinical pharmacist, Walter Reed Army Medical Center, Washington, DC, the principal investigator.

There are numerous barriers to medication adherence in the elderly and there are no effective measures that are known to make a sustained improvement, she said. The purpose of the FAME study was to test the impact of a comprehensive clinical pharmacy programme on blood pressure and cholesterol measurements in the elderly.

The pharmacy intervention involved tailoring medication regimens to ensure that they were simple, preparation of individualised educational material (including an up-to-date medicines list), a customised blister-pack of medicines and regular follow-up.

The study involved a six-month observational phase (Phase 1), during which all participants received customised pharmacy care, followed by a six-month phase (Phase 2) during which participants were randomised into a control (usual care) group and a group that continued to receive customised pharmacy care. Patients over the age of 65 years who were taking four or more regular medicines and were living independently were included in the study. Baseline adherence, blood pressure and LDL cholesterol were measured. In Phase 1, the primary endpoint was change in adherence and the secondary endpoints were blood pressure and LDL cholesterol levels. In Phase 2 the endpoint was adherence.

A total of 200 patients were enrolled in the study and 159 were eventually randomised, 76 to usual care and 83 to the pharmaceutical intervention.

During Phase 1, adherence rose from 61.2 per cent to 96.9 per cent. Dr Lee commented that this was impressive because 36 per cent of patients took medicines at least three times a day and the mean number of medicines per patient was nine. There were also significant improvements in blood pressure and LDL cholesterol levels.

At the end of Phase 2 adherence in the usual care group had fallen back to 69.1 per cent but, in the pharmacy intervention group, it had remained at about 95 per cent. The mean systolic blood pressure in the pharmacy intervention group was significantly lower than in the usual care group, but there were no changes in LDL cholesterol levels.

Poor medication adherence has been described as “America’s other drug problem”. The effects of education on adherence are transient and regular follow-up is essential if the effects are to be sustained, Dr Lee said. In this study, the convenience of the hospital-produced blister packs was pivotal in its success. Teamwork — the coordinated efforts of physicians, pharmacists and patients — also played an important role, she added.

Dr Lee emphasised that this study concerned only military veterans who experienced no financial barriers in obtaining their medicines. She also noted that the blister packing process was highly labour intensive.

Poor reporting of paediatric trial formulations

Clinical pharmacists should make sure that the formulations used in clinical trials are properly documented in reports, according to Richard Leff, programme director, paediatric pharmacology research and development centre, Dallas.

There is currently a paucity of information on drug formulation in reports of paediatric clinical trials, as reported in a recent issue of Paediatrics (2005;116:559). Dr Leff explained that this decreases investigators ability to reproduce results and increases the risk of type two errors (eg, false negative results) and the risk of incorrect dose information. This raises questions about the published findings and their application to paediatric practice.

Furthermore, highly cited journals seem to permit the publication of inadequate formulation information in reports of paediatric trials, Dr Leff said.

Although paediatric clinicians commonly resort to the preparation and administration of unlicensed formulations by manipulating the adult dosage forms, advances in formulation chemistry and paediatric study design will help facilitate future product development. However, investigational pharmacists should clearly document the materials used and compounding procedures followed to ensure reproducibility, Dr Leff said.

In the past the investigators used to focus on the “three Rs” — the right drug, right dose and the right patient. However, we should now be thinking in terms of “five Rs” — the right drug, right formulation, right dose, right delivery and the right patient.

Dr Leff concluded by saying that the responsibility for product development is shared by industry, regulatory bodies, health professionals and society.

Pharmacist-led bone clinic benefits patients

Pharmacists are well placed to make a big difference to patients with or at risk of developing osteoporosis, according to Mary-Beth Elliott, associate professor and vice-chair, pharmacy practice division, School of Pharmacy, University of Wisconsin, Madison.

Some community pharmacies are already involved in osteoporosis screening, she noted. A recent survey of 11 pharmacies in Wisconsin showed that pharmacists from two of these pharmacies had each screened more than 2,000 patients, although the majority had screened fewer than this. All pharmacists used some form of peripheral bone density measurement technique, and a variety of instruments were used. Some charged for the service, some operated a walk-in service and others used appointments.

Several pharmacists reported that the screening clinics increased patients’ awareness of the role of the pharmacist and was professionally satisfying. Drawbacks included the time that it took, the absence of a follow-up strategy to monitor outcomes and the difficulty of explaining false negative and false positive test results, explained Professor Elliott.

Bone mineral density

An important question was whether peripheral bone mineral density (BMD) measurements were useful and whether they could detect people at risk of osteoporotic fractures, said Professor Elliott. Research conducted in a group of nuns showed that there was a good correlation between lumbar spine BMD and calcaneal (heel bone) BMD. Similar patterns have been observed for femur and hip bones. Moreover, age also increases the risk of fracture.

Professor Elliott was responsible for setting up an osteoporosis clinic, staffed by pharmacists, in a veterans’ administration hospital. She is able to prescribe bisphosphonates and order tests such as dual X-ray absorptiometry tests (DXAs). Some years ago she was asked to have a medical resident rotating through the clinic and now medical residents, together with pharmacy students, routinely interview patients before Professor Elliott sees them.

Cases of osteoporosis are not always straightforward, Professor Elliott said. For example, post-menopausal osteoporosis might reasonably be suspected in a 78-year-old woman, but when the patient is male it is important to look for secondary causes. Commonly-seen secondary causes include long- term corticosteroid treatment (eg, after transplants or in pulmonary disease), malabsorption due to Crohn’s disease or coeliac disease, androgen deprivation therapy for prostate cancer and heavy alcohol or tobacco use.

A further problem is the quality of the DXA scan — for example, the presence of osteophytes can spuriously raise the BMD.

Turning to treatment, Professor Elliott said that pharmacists should always ask patients how well they can swallow tablets. More than 50 per cent of patients over 65 years old have some degree of pre-existing dysphagia and are therefore at risk of oesophageal damage if given oral bisphosphonates. She sees many patients receiving alendronate who undergo regular oesophageal dilations. Clearly, these patients are unable to swallow properly and should be given intravenous treatment.

Chronic kidney disease and bone metabolism is a complex topic and Professor Elliott recommended that practitioners should follow the National Kidney Foundation “KDOQI” guidelines and the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines that will shortly be published.

Patients’ progress can be monitored using serial DXAs but discrepant results may be seen if different machines are used or if different measurements made (eg, total hip or just the neck of the femur).

If the BMD is not increasing in spite of bisphosphonate treatment, then the use of teriparatide, an anabolic agent that is effective in preventing fractures, should be considered.

Finally, Professor Elliott pointed out that there are many opportunities to identify people who are at risk and pharmacists should be aware of these. Typical situations include patients who do not understand their risks of osteoporosis, those who do not receive enough calcium and vitamin D, vulnerable patients who are not tested for osteoporosis, those taking gonadotrophin-releasing hormone agonists or prednisone and those who are not evaluated even after a fracture.

Improving nurse communication with pharmacy

Installing an electronic messaging system to enable nursing staff to send messages directly to the pharmacy has improved communication and helped minimise pharmacy staff interruptions.

Jeff Chalmers, pharmacy informatics specialist at the Cleveland Clinic, Cleveland, Ohio, described the one-way messaging system that has been installed at the clinic in an attempt to find an easy and quick way for nurses to communicate with pharmacy staff. When the nurse logs on to a patient’s medication record he or she can click on any item and a dialogue box will pop up. The nurse can then enter a request or a message next to the item, and send it to the pharmacy. In the pharmacy, the message will pop up when the pharmacist clicks on the item to dispense it, so the pharmacist can modify the order or respond as appropriate.

Dr Chalmers explained that there was a concern that although this system would reduce the number of phone calls, pharmacy staff may instead be inundated with electronic messages. Therefore, during the pilot phase, a 30-day sample of messages sent from a 70-bed unit was reviewed. Over the 30-day period the pharmacy received 425 messages from nursing staff. Putting this into context, Dr Chalmers explained that almost 10,000 orders were placed over this period.

The main reason for sending a message (in 43 per cent of cases) was a request to change the time of administration. Other reasons included a missing dose (12 per cent) or wrong frequency (6 per cent). The average number of messages sent per day was 14, with an average response time (until the message was read) of just over one hour.

Dr Chalmers said that overall the system has been successful in terms of minimising non-urgent interruptions to pharmacy staff.

Emergency planning update and initiatives

One of the most recent initiatives in the US Strategic National Stockpile is the establishment of Federal Medical Stations (FMS), Susan Gorman, associate director for science at the division of Strategic National Stockpile, Centres for Disease Control and Prevention, Atlanta, told attendees.

An FMS can be considered to be similar to a mobile hospital, providing an inpatient setting where hospital capacity has been exceeded. However, they are not equipped for acute care. They are used to provide medical supplies and shelter when catastrophic events have occurred, and can also be used in situations where quarantine is needed.

Each FMS holds a three-day supply of medicines and can house up to 250 non-acute care patients. They are designed to be set up in an existing facility, ie, a building that can provide the necessary support including an electricity supply and communication links. Each FMS is delivered by four trailers within 48 hours of a request. An installation team comprising two to four people from the Strategic National Stockpile are trained to set up the FMS, but they will be staffed by people from the local area. National disaster teams will be on hand, but additional staffing needs to be considered.

An FMS consists of three modules. The basic support module will contain 50 beds, administrative supplies, first aid, basic medical supplies and the food service. The treatment module contains medical and surgical supplies and and the pharmacy module contains enough drugs for 250 people for three days. The items to be stocked will be ordered when the type of disaster is known.

There has been some “real” experience in using FMS, Dr Gorman explained, since they were deployed for hurricanes Katrina (35,00 beds) and Rita (2,000 beds). “Everything went pretty well for deployment but the FMS concept was so new people did not really realise that we had it, and so it was not well integrated into the plans for the community,” she said.

There are a number of criteria that must be met for an FMS to be deployed in a particular facility. The facility must have adequate security or law enforcement, secure storage, large floor space, toilets, showers and kitchens, wireless connectivity and climate control.

Dr Gorman went on to describe other new or ongoing initiatives in the SNS. These include radiation countermeasures, such as the RADPACK. Similar to the CHEMPACK (Hospital Pharmacist 2006;13:23 (PDF 100K)), the RADPACK would be forward deployed and would contain all the materials needed in the event of a radiation attack.

Dr Gorman said that other programmes currently being updated by the SNS include the influenza preparedness programme, which aims to make sure that at least 25 per cent of US citizens are covered with antiviral treatment regimens, and the Cities Readiness Initiative (CRI).

The CRI programme aims to help cities increase their capacity to deliver medicines and medical supplies during a large-scale public health emergency. It is expanding and to date 72 cities and surrounding suburbs are enrolled in the programme. They are currently looking for innovative ways to deliver prophylaxis to the public to avoid the need for people to gather at dispensing points. Ideas include employing the services of the US postal service, Dr Gorman said.