Section 4

Medication

Is Your Medication Helping or Hurting?

Adapted from adVANCES, the quarterly publication of the Alzheimer's Association of Chicago, Illinois.

It is often assumed that a drug prescribed by a physician is automatically safe. But when medications aren't properly used, serious, even fatal drug interactions can occur.

Individuals over age 65 are at the highest risk for dangerous drug interactions, since they consume 25 percent of prescription and non-prescription drugs. In addition, most have more than one physician or specialist administering care. "Danger occurs when a person is taking more than one prescription drug and is being treated by more than one physician," according to Raymond Woosley, chairman of pharmacology at Georgetown University.

As a person ages, the amount of water in the body decreases, making it difficult to dissolve various medications. Because the medications can't be diluted, their high concentrations can cause severe reactions or stay in the body longer.

People with Alzheimer's disease may be even more at risk, because they may not be able to communicate how a medication is making them feel. Caregivers may also have difficulty distinguishing between a drug reaction and the behavioral symptoms associated with the disease, such as disorientation, hallucinations, and confusion.

"Your physician should review all the medications you are taking at least annually," says Robert Carroll, MD, member of the Alzheimer's Association national board of directors. "This includes prescription and over-the-counter drugs and herbal remedies."

When two drugs are taken together, the effects can be magnified, or in some cases, the drugs cancel each other out. This happens often with even the most common medications. "Antihistamines, pain killers, and ulcer medications all target the central nervous system and can cause excess sleepiness, drowsiness, and confusion when mixed," says Carroll. "These symptoms can often be misinterpreted as worsening dementia."

It is important to be proactive about learning the potential bad interactions that can occur from the drugs you are taking. The best way to protect yourself is to communicate with your physician. Discuss the medications you are taking and any current problems you are experiencing or being treated for by another specialist.

To protect yourself from an adverse reaction:

Keep a list of all drugs you take and regularly discuss them with your physician.
Select a pharmacist who provides comprehensive services. Have all your prescriptions filled there.
Learn about the purpose, actions and side effects of all prescribed drugs.
Learn how to take the drugs, what time of day to take them, and whether they can be taken at the same time as other drugs.
Review the use of over-the-counter drugs with the pharmacist.
Follow the recommended instructions for taking drugs.
Report to your doctor or pharmacist any symptoms that might be related to the use of a drug.

"Protecting a person from adverse drug reactions is a team effort between the patient, caregiver, physician and pharmacist," concludes Carroll.

(From Merck Manual of Medical Information, 1997)

Compiled by the Lincoln/Greater Nebraska Chapter of the Alzheimer's Association, 1999.

Just the Facts and More: Drug Research

To learn more about Alzheimer's disease and to find effective treatments, researchers need caregivers and patients who are willing to participate in research studies and projects. The message is simple: Research is critical in finding ways to prevent, treat, and cure Alzheimer's disease.

There are many different types of research studies. Some projects focus on psychological aspects, caregiver research, or autopsy findings. The information in this paper focuses on drug research. Additional fact sheets will present highlights about other kinds of research.

Many caregivers believe that participation in research projects and studies offers an opportunity to contribute to the future well-being and health of other patients and caregivers, and to fight back against Alzheimer's disease. You can make the most of your participation in a research study or project by following these guidelines:

Understand your motivations.

Review your reasons for participating in the research project. Do you sincerely want to help researchers find a treatment or cure for the disease? Or are you hoping that the patient will improve dramatically by participating in the study? Try not to have unrealistic expectations that the patient will improve greatly or that a cure to the disease will be found while you are participating in the study.

Examine the possibilities.

Many clinical drug trials use two groups for testing. One group receives the drug, and the other receives a placebo, or non-medicated "sugar pill." The participants are not told whether the pill is the active drug or the placebo. It is important to understand this procedure.

Balance risks and benefits.

In a research study, one cannot be sure before doing the study whether or not the drug will be beneficial. Studies in animals are performed before clinical trials to minimize the risk for human subjects. Some patients may show improvements while others will see little or no improvement. In fact, it's possible that some drugs may cause the person's condition to worsen. Careful monitoring is conducted during a drug study to minimize patient harm.

Action Steps

Ask questions.

Before making a decision to get involved in a research study, make sure you get satisfactory answers to the following questions:

Purpose of Research
- What is the purpose of this study? Why is it being done? What do the researchers hope to find?
- How will the study be conducted? Who will participate? Where will it be conducted? Over what span of time will the study be conducted? Keep in mind that some studies continue for as long as five years.
Drugs, Dosage and Effect
- What kind of drug might the patient be given? How large is the dosage and what are the risks involved in taking this dosage?
- How will the drug be given? How will you be involved as a caregiver? What are the other responsibilities that the family might be asked to assume? For example, will you be asked to keep a daily diary? And how often will you be expected to bring the patient to the research site? Who will be your contact person?
- What are the potential side effects of the drug? How might the patient's behavior change as a result of taking the drug? To what extent could the patient's condition become worse?
Requirements
- What kind of consent form will the patient be asked to sign? Keep in mind that a family member may be asked to sign for the patient. If you have questions or do not understand the form, you might want to talk with the researcher. Don't hesitate to discuss your questions with the patient's personal physician.
Costs
- What is the cost of participating in the study - both in time and money? To what extent will travel, lodging, and meal expenses be covered by the research project? How will expenses be reimbursed?
Researchers
- What are the credentials of the researchers? Have they conducted similar studies?
- Do you feel that the researchers are people you can work with easily? Do they answer your questions and give the information you request?
Information and Follow-up
- What kind of reports or information will you receive about the completed research? Will there be follow-up procedures required.

Directions in Research for Alzheimer Treatments

Throughout the United States and worldwide, dozens of medications for those suffering with Alzheimer's disease are being tested in clinical trials. Current drug treatments focus on producing temporary improvements in cognitive impairment. Long term strategies being developed now will attempt to slow the progression of the disease.

The Food and Drug Administration (FDA), in conjunction with the Alzheimer's Association and other professional groups is working to ensure the development of drugs that are effective and safe for the person with Alzheimer's disease. The FDA has appropriately high standards for judging whether the benefits of a medicine likely outweigh its possible risks.

The process involved in drug development, from first identifying the medication in the laboratory to the end stage of introduction into the marketplace, is a slow and expensive procedure. Costs have been estimated between $115 to $150 million to move a drug from the pre-clinical phase to availability to the public. The research funding efforts of the Alzheimer's Association have contributed to the process of developing new drugs.

Human Testing (Clinical Trials)

There are three phases of human testing, each involving larger numbers of people than the one before.

Phase I: These tests involve about 30 normal, usually healthy volunteers to determine the drug's safety profile in the body. Aspects of the drug's action are also studied (How is the drug absorbed? How does it pass through the body? What is the effect of the drug, and how long does it last? What is a safe dosage range?). This process takes about one year.

Phase II: This phase consists of controlled studies in approximately 100 to 300 volunteer patients (people with the disease) to assess the drug's effectiveness. Simultaneous animal and human studies continue to determine if the medicine is safe. This period of clinical testing takes about two years.

Phase III: Here the testing moves to larger numbers of volunteer patients, usually 1,000 to 3,000 in clinics and hospitals. Physicians give the medicine, and patients are monitored to determine the effect of medication on the disease and to identify adverse reactions. Phase III clinical studies last about three years.

New Drug Application (NDA): Following the successful completion of all three phases of clinical trials, the company sponsor must file an application. The report must contain all the scientific information that the sponsor has gathered. The average review of the application by the FDA (Food and Drug Administration) takes two to three years.

Approval: Once the NDA (new drug application) is approved, the medicine becomes available for your doctor to prescribe. The company must continue to submit periodic reports to the FDA, including any cases of adverse reactions, and appropriate quality control records. For some medicines, the FDA requires additional studies to evaluate long-term effects.

Resources

One of the best places to turn for additional help is the Alzheimer's Association. The Alzheimer's Association has more than 83 Chapters and 1,600 support groups nationwide, where family members of people with Alzheimer's disease or a related disorder share their experiences, provide each other with emotional support, hear practical suggestions and learn to rebuild their lives.

The primary resource for this fact sheet was Peter Whitehouse, MD, Ph.D., University Hospitals of Cleveland, Alzheimer Center, Cleveland, Ohio.

Compiled by the Lincoln/Greater Nebraska Chapter of the Alzheimer's Association, 1999.

Other Resources include:

Alzheimer's Association and Pharmaceutical Manufacturers Association. "Alzheimer's Medicines in Development." Washington, D.C., November, 1989.
George J. Ana. (1989). "The Rights of Patients: The Basic ACLU Guide to Patient Rights." Carbondale, Illinois: Southern Illinois University Press.
Nancy L. Mace and Peter V. Rabins, MD. (1991). "The 36-Hour Day." Baltimore: The Johns Hopkins University Press.

Just the Facts and More: Medication

As a caregiver you need to understand the use of medications, and be alert to possible over-medication and to adverse reactions to drug combinations. No medications prevent or cure Alzheimer's disease, but physicians rely on several drugs to manage delusions and hallucinations, depression, agitation, or sleeplessness.

Although these medications may affect specific disease symptoms and assist in managing them, they can also produce side effects such as agitation, dry mouth, drowsiness, problems in walking, tremors, falling, or constipation.

Even though a physician might prescribe a drug for a limited period of time, it can sometimes take up to four weeks for a drug to leave the patient's system after use is discontinued.

Some medications can contribute to the Alzheimer patient's problems and make some symptoms even worse. For example, a person who begins taking drugs for high blood pressure or a heart problem might appear to be more confused than before he began taking the drugs.

So called anti-cholinergic drugs can also block the production of a chemical within the brain called acetylcholine and further alter the patient's memory.

To understand the effects of medications and how to manage their use, consider the following tips:

Action Steps

Get medical advice.

Be cautious about giving any medication - whether it's an over-the-counter or prescription variety.

Begin by asking your physician to review all medications, in order to check for any possible interactions between drugs.
Make sure that every physician involved in the person's care knows about all prescribed medications.
Find out as much as possible about every medication, including its name, purpose, dosage, frequency, and possible side effects. If serious side effects occur, report them immediately to your physician.

Be prudent.

Under no circumstances should you change dosages without first consulting your physician. In addition, avoid the temptation to exaggerate or over-report symptoms in order to persuade your physician to prescribe a new drug or to increase the patient's dosage. Do not share medications with other caregivers or keep medication bottles from old prescriptions.

Rely on your pharmacist for information.

Pharmacists can be another information source. Your local pharmacist can also check for interactions between drugs. Keep in mind that pharmacists can neither prescribe drugs nor alter drug dosages.

Maintain accurate and ongoing records.

Keep a written record of all current medications, including the name of the medication, dosage, and starting date. Carry a copy of this list with you in your wallet or purse at all times. This record will be invaluable in the event of a serious drug interaction or overdose.

Be candid and direct.

In clear, simple language help the individual understand the kinds of medications he is taking and why. In addition, offer clear instructions such as these: "Here's the pill for your high blood pressure. Put it in your mouth and drink some water."

Develop a routine for giving the medication.

Giving medications in a specific way at specific times of the day or evening will help to reduce conflicts. However, if the person refuses to take the medication, stop and try again at a later time.

NEVER assume the individual will take medications on his own. It may be necessary to check to see whether the medicine has been swallowed. At some point in the progression of the disease, you will need to assume responsibility for giving medications.

Stay organized.

Separating pills into a plastic container with small compartments labeled "day" and "evening" or "Monday," "Tuesday," "Wednesday," etc. will help in tracking medications.

Other caregivers find it useful to give medications in individual cups or envelopes, or to keep a calendar and check off each dose as it's taken.

Adapt to the person.

If the person has problems swallowing pills or spits out the pills, you might try crushing the pills and mixing them with applesauce or cottage cheese. Some medications might also be available in liquid form.

Take safety precautions.

Put a lock on the medicine cabinet or place the medications in a locked drawer. If the person spits out pills, make sure these pills aren't picked up and eaten by children or pets.

Avoid leaving the person alone with medication bottles in the room. Be sure to throw out all old medicines.

Be prepared for emergencies.

Research the names and telephone numbers of pharmacies or taxi services that deliver medications. Also find out the names of pharmacies that are open on Sundays and weekends.

Keep the number of your local poison control center or emergency room handy.
If you suspect a medication overdose, call the number before inducing vomiting or taking any other action.

Resources

One of the best places to turn for additional help is the Alzheimer's Association. The Alzheimer's Association has more than 83 Chapters and 1,600 support groups nationwide, where family members of people with Alzheimer's disease or a related disorder share their experiences, provide each other with emotional support, hear practical suggestions and learn to rebuild their lives.

The primary resource for this fact sheet was Peter Whitehouse, MD, Ph.D., University Hospitals of Cleveland, Alzheimer Center, Cleveland, Ohio.

Special thanks to the following Chapters of the Alzheimer's Association: Eastern Massachusetts and South Central Michigan.

Compiled by the Lincoln/Greater Nebraska Chapter of the Alzheimer's Association, 1999.

Other Resources include:

David L. Carroll. "When Your Loved One Has Alzheimer's Disease: A Caregiver's Guide." New York: Harper and Row, 1989.
Howard Gruetzner. "Alzheimer's: A Caregiver's Guide and Sourcebook." New York: John Wiley and Sons, 1988.
Nancy L. Mace and Peter V. Rabins, MD. "The 36-Hour Day." Baltimore: The Johns Hopkins University Press.