Reimbursement for Donepezil Available to Eligible Ontario Patients

Donepezil (Aricept), is now being reimbursed to eligible Ontario patients by the Ontario Drug Benefit Program. Donepezil received Health Protection Branch (HPB) approval in August 1997. Until now, however, donepezil has not been reimbursed by any provincial health plan, including Ontario's public drug program which covers senior citizens and those on social assistance. People wanting donepezil have had to pay for it themselves or have it reimbursed by private insurance.

Effective June 1, 1999, eligible ODBP beneficiaries will have the cost of donepezil reimbursed. There are two categories of coverage. Those who have already been on donepezil treatment for more than 60 days, have a confirmed diagnosis of mild to moderate AD and meet the ODBP program criteria will be eligible for reimbursement of donepezil by the ODBP.

Others with a confirmed diagnosis and who meet the ODBP and program criteria but who have never taken donepezil (or have taken it for less than 60 days) will be enrolled in a 12-week trial prescription program, with the medication provided free of charge by Pfizer. The trial prescription program is administered by an independent pharmacy and healthcare company, Caremark Ltd., based in Mississauga, Ontario.

The patient and caregiver also will receive a Pfizer-sponsored program of educational material about AD, including a video, called TriAD and a patient diary. The physician will continue to be supplied with diagnostic and other support tools to help him or her evaluate and track the patient's progress.

At the end of the 12-week trial prescription program, those patients who have benefited from the treatment will be eligible for continuing treatment reimbursed by the Ontario government. All patients receiving reimbursement will be reviewed annually to ensure they are still benefiting from the treatment and thus remain eligible for reimbursement.

The major instrument used to measure eligibility and effectiveness will be the Mini Mental Status Exam (MMSE). A score of 30 represents full cognitive ability; persons with impairment caused by AD score lower and their scores diminish over time as the disease takes its toll on cognitive function.

To be eligible for coverage, persons with mild to moderate AD will have to have and maintain an MMSE score between 10 and 26. A score that drops below 10 is indicative of advanced cognitive impairment of the later stages of AD, for which treatment with donepezil would not be appropriate.

Patients, caregivers or healthcare professionals seeking more information about reimbursement for donepezil can call toll-free to 1-800-510-6141.

Recent Advances in Treatment of H. pylori Peptic Ulcer Disease

Legend:

1. Parietal Cells of stomach lining
2. Mucus
3. Neutralized Acid
4. Drug

Neil Fam, BSc, MSc

Helicobacter pylori was first isolated from human gastric mucosa in 1983. Since that time, recognition of its role as a major etiological agent in the pathogenesis of peptic ulcer disease has revolutionized the approach to diagnosis and treatment of this common condition. Approximately 90% of patients with duodenal ulcers and 80% with gastric ulcers not associated with non-steroidal anti-inflammatory drugs (NSAIDs) are infected with H. pylori.

Novel drug reduced incidence of osteoporotic fracture up to half

In one of the largest late-stage clinical programs ever conducted, the investigational pyridinyl bisphosphonate drug risedronate (Actonel) reduced the incidence of new vertebral fractures by up to 49 percent, and lowered the risk of osteoporosis related non-vertebral fractures by up to 39 percent. The results were presented at the annual meeting of the Endocrine Society.

Professor Richard Eastell, professor of bone metabolism at the University of Sheffield, UK, presented safety data from five clinical studies that enrolled a total of 5,226 post-menopausal women. The proportion of women reporting GI side effects was similar in the risedronate and placebo groups. Currently, risedronate is not available in Canada. For the full article see Nature 1999;397:315-23.

Treating osteoarthritis--when all else fails try viscosupplementation

When pain killers, exercise, and physical therapy have all failed, a medical technology called viscosupplementation can relieve knee pain caused by osteoarthritis. Viscosupplementation does not replace the need for thigh muscle strengthening, or for overweight patients to lose weight. There are currently two products available in Canada, Sodium Hyaluronate (Hyalagan) and Hylan G-F 20 (Synvisc). These products are made of a biopolymer of a synthetic polysaccharide substance called hyaluranan, which is made to possess elasticity and viscosity like that of young, healthy, synovial fluid. They are delivered through a series of injections, all one week apart, and work by adding "padding" to the joint as well as reducing inflammation and improving mobility. Pain relief appears in a few days, progresses over a few weeks, and often lasts several months. One of the concerns about viscosupplementation is that it is relatively expensive, at least more so than NSAIDs and cortisone injections. Unfortunately, most provincial drug plans do not cover viscosupplements, and it is difficult to predict who will gain long-term benefit (e.g. 3-6 months) versus short-term benefits (2-3 weeks) from the products.

Further reading

Adams ME, Atkinson MH, Lussier AJ, Schulz JI, Siminovitch KA, Wade JP, Zummer M. The role of viscosupplementation with hylan G-F 20 (Synvisc) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Osteoarthritis Cartilage 1995;3(4):213-25.

Routine monitoring for hyponatremia not justified for patients on SSRIs

Selective serotonin reuptake inhibitor (SSRI) antidepressants are gaining popularity for treating depression. Increasing reports of hyponatremia led New Zealand researchers to investigate the incidence, time course and risk factors complicating treatment with fluoxetine (Prozac) or paroxetine (Paxil). Wilkinson and colleagues found that the incidence of hyponatremia was 4.7 per 1000 people treated per year for fluoxetine and 6.3/1000 people treated for paroxetine. Both older age (70 and over) and low body weight were identified as risk factors. Given the above incidence rates, researchers concluded that routine monitoring for hyponatremia was unjustifiable. If monitoring were deemed necessary, they recommend it be done 3 to 4 weeks after initiation of treatment. They also recommend keeping a closer eye on older people with a low body weight (e.g. body mass index (BMI) < 20) who are taking SSRIs.

Source: Wilkinson TJ, Begg EJ, Winter AC, Sainsbury R. Incidence and risk factors for hyponatraemia following treatment with fluoxetine or paroxetine in elderly people. British Journal of Pharmacology 47(2):211-217.

Chronic Pain Management: Older People Need Better Access to Opioid Analgesics

Cox-2 Inhibitors Offer Hope to Arthritis Sufferers

Anna Liachenko, BSc, MSc

Despite potentially serious side effects, non-steroidal anti-inflammatory drugs (NSAIDs) are currently one of the very few options available for alleviating chronic pain and inflammation. Over the past 30 years, scientists searched for safer NSAIDs and managed to create the 20 different drugs and 40 dosing options currently available in Canada. While some of the newer drugs turned out to be safer than others, their design was based largely on trial-and-error. A recent major breakthrough in the understanding of the molecular mechanisms of NSAID action allowed researchers to methodically design a new class of NSAIDs. These new drugs, the Cox-2 Inhibitors or C-2SIs, are not only comparable to the older NSAIDs in efficacy but are also (at least in theory) devoid of some of the most serious side effects. One of these drugs, celecoxib (Celebrex) has just become available in the US and Canada. Another, rofecoxib (Vioxx) is under review by the Food and Drug Administration (FDA) in the US and the Health Protection Branch (HPB) in Canada. Moreover, increased safety of some of the previously approved NSAIDs is now thought to be attributed to the same molecular mechanism. Newly arriving NSAIDs as well as the best NSAID options currently available in Canada are discussed below.

Treatment of Heart Disease in the Elderly: Prescribing Practices Show Under-use of Medications

Lilia Malkin, BSc

Heart disease is a major cause of morbidity and mortality in the geriatric population. According to Health Canada, myocardial infarction (MI) and ischemic heart disease (IHD) accounted for over one-third of deaths in men and women aged 65 and older in 1995, once again firmly establishing coronary artery disease (CAD) as the leading cause of mortality in Canada. In Ontario, 23 percent of patients die within one year of experiencing MI and one-third of congestive heart failure (CHF) patients succumb within one year of being hospitalized for CHF. Importantly, as Dr. David Naylor, co-editor of the 1999 Institute for Clinical Evaluative Sciences (ICES) Cardiovascular Atlas points out, the Canadian demographic profile is shifting toward a larger geriatric population, potentially greatly increasing the number of Canadians vulnerable to heart disease. Therefore, it is imperative that both primary and secondary prevention methods be used as extensively as possible to reduce the morbidity and mortality due to CAD.

Try Combining Donepezil and Vitamin E for Alzheimer’s

Extracts from the leaves of the Ginko biloba tree and Vitamin E are just two of the therapies being investigated for the treatment of Alzheimer's Disease

Neil Fam, BSc, MSc

Alzheimer's Disease (AD) is a chronic neurodegenerative disorder characterized clinically by a gradual onset of progressive memory loss with deterioration in patients' social and occupational function. Changes in mood, behaviour and perception are also problematic aspects of the disease. Neuropathologically, AD is associated with the formation of amyloid plaques and neurofibrillary tangles, with impaired synaptic function and neuronal cell death. In particular, patients with AD suffer the loss of cholinergic, noradrenergic and dopaminergic neurons. Loss of acetylcholine neurotransmission in brain areas involved in learning and memory is thought to underlie many of the cognitive symptoms of AD. This concept forms the basis of current therapeutic strategies which aim to increase available acetylcholine levels in the brain by inhibition of acetylcholinesterase.

Understanding Pharmacokinetic Changes is Imperative

Rhonda Witte, BSc

It is one thing to know how the body changes with age, but it is another to understand the effects of these changes on the body. Decreased kidney size? A smaller liver? They may sound like minor changes, but it is crucial to understand the significance of such age-related changes in terms of selecting appropriate drug therapy. Geriatric clinical pharmacology is not a large part of the general practice of medicine but with an increasing elderly population, greater knowledge in this area is required.¹ What must be kept in mind is that it is not just about what drugs should be prescribed to the elderly--it is about the right drugs that should be prescribed to a geriatric patient on an individual basis.

Pharmacokinetics

Fundamental to geriatric medicine is the understanding of age-related changes in pharmacokinetics. Such changes have profound impacts upon drug usage in the elderly population. When ignored, severe complications and even death can result from pharmacotherapy. What makes the situation even more complicated is that pharmacokinetic changes vary with the individual. Therefore, each patient must be treated with a highly individualized approach² and one patient's situation cannot set the standard for other patients to follow.

Pharmacokinetics refers to time-dependent changes of drug concentration and their metabolites in the body, or more simply, what the body does to a drug.