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Appendix C: PATIENT PACKET

Medication Education

Form

C–1    Naltrexone Information Sheet: Patient Version

C–2    Acamprosate Information Sheet: Patient Version

C–3    Medication Instructions Summary

C–4    Quick Reference Medication Information Grid

C–5    Patient Instructions for Managing Side Effects

C–6    Sample Medical Emergency Card

Alcohol Education/Mutual-Support Groups

C–7    Name and Location of AA Pamphlet Relevant to Pharmacotherapy

C–8    Listing of Local Mutual-Support Groups

 

Form C–1

Naltrexone Information Sheet: Patient Version1

 

(1 Adapted from Rounsaville, B.J.; O’Malley, S., and O’Connor, P. “Guidelines for the Use of Naltrexone in the Treatment of Alcoholism.” New Haven, CT: APT Foundation, 1995. Reproduced with the permission of DuPont Pharma. )

  1. What is naltrexone, and how does it work?

  2. Naltrexone is a medication that blocks the effects of drugs known as opiates, or narcotics (a class that includes morphine, heroin, or codeine). It competes with these drugs for opioid receptors in the brain. Originally used to treat dependence on opiate drugs, it now has also been approved by the U.S. Food and Drug Administration (FDA) as treatment for alcohol dependence. If you are dependent on opiate drugs, such as heroin or morphine, you must stop your drug use at least 7 days prior to starting naltrexone. Some people should not take naltrexone, such as those suffering from chronic pain who rely on opioid painkillers or people with liver failure or acute hepatitis. Although the precise mechanism of action for naltrexone’s effect is unknown, reports from successfully treated patients suggest the following three kinds of effects:

    1. Naltrexone can reduce your urge or desire to drink.
    2. Naltrexone helps you remain abstinent.
    3. Naltrexone can interfere with your desire to continue drinking more if you slip and have a drink.

    In most clinical trials evaluating the effectiveness of naltrexone, subjects who received naltrexone were significantly more successful in remaining abstinent and in avoiding relapse than were those receiving an inactive placebo pill.

  3. Is it possible to become addicted to naltrexone?

  4. No. Naltrexone is not habit forming or a drug of abuse. It does not cause users to become physically or psychologically dependent.

  5. What are the side effects of naltrexone?

  6. In a large open-label safety study on naltrexone, conducted by Dupont Pharma in 570 individuals with alcoholism, the most common side effects affected only a small minority of people; they included the following:

    • Nausea (10 percent of participants)
    • Headache (7 percent of participants)
    • Depression (5 to 7 percent of participants)
    • Dizziness (4 percent of participants)
    • Fatigue (4 percent of participants)
    • Insomnia (3 percent of participants)
    • Anxiety (2 percent of participants)
    • Sleepiness (2 percent of participants).

    These side effects were usually mild and of short duration. The side effects, predominantly nausea, have been severe enough to cause 5 to 10 percent of people starting it to stop the medication. Patients usually report that they are largely unaware of being on naltrexone. Naltrexone usually has no psychological effects, and users do not feel either “high” or “down.” Naltrexone can have toxic effects on the liver. You will receive blood tests of liver function prior to the onset of treatment and regularly during treatment to determine if you should take it at all, if you should stop taking it, or if you experience the relatively rare side effect of liver toxicity. You should report any side effects to your medical clinician.

  7. What will happen if I drink alcohol while taking naltrexone?

  8. Naltrexone does not reduce the effects of alcohol that impair coordination and judgment. Naltrexone may reduce your feeling of intoxication and the desire to drink more, but it will not cause a severe physical response to drinking.

  9. Is it all right to take other medications with naltrexone?

  10. You should carry a card (Form C–6) explaining that you may be on naltrexone, which instructs medical staff on pain management. Naltrexone does not reduce the effectiveness of local and general anesthesia used with surgery. However, it does block pain relief from opiate medications. Many pain medications that are not opiates are available. If you are having elective surgery, you should stop taking naltrexone at least 72 hours beforehand.

    The major active effect of naltrexone is on opiate (narcotic) drugs, which is one class of drugs used primarily to treat pain but is also found in some prescription cough preparations. Naltrexone will block the effect of normal doses of this type of drug. There are many nonnarcotic pain relievers you can use while on naltrexone.

    Otherwise, naltrexone is likely to have little impact on other medications you may commonly use such as antibiotics, nonopioid painkillers (e.g., aspirin, acetaminophen/ Tylenol®, ibuprofen/Motrin®/Advil®), and allergy medications. You should inform your medical clinician of the medication you are currently taking so that possible interactions can be evaluated.

    Because the liver breaks down naltrexone, other medications that can affect liver function may affect the dose of naltrexone.

  11. What will happen if I become pregnant while taking naltrexone?

  12. If you have the biological potential to have a child, you should be using an effective method of birth control while taking naltrexone. However, if you miss a menstrual period, report this to your medical clinician at once and take a pregnancy test. If you become pregnant, you will discontinue the medication. Your medical clinician should continue to ask about your health throughout your pregnancy and also about the health of your baby after delivery.

  13. Should I take naltrexone with a meal?

  14. There is no information that taking naltrexone with or without meals makes any difference in effect.

  15. What happens if I stop taking naltrexone suddenly?

  16. Naltrexone does not cause physical dependence, and you can stop taking it at any time without experiencing withdrawal symptoms.

  17. If I take naltrexone, does it mean that I don’t need other treatment for alcohol dependence?

  18. No. Research studies have shown that naltrexone was most effective when it was combined with treatment from professionals and/or mutual-support groups.

  19. What is the relationship of naltrexone to AA and other mutual-support groups?

  20. There is no contradiction between participating in support groups and taking naltrexone. In fact, one multisite study showed that naltrexone-taking subjects who attended mutual-support groups, such as AA, had better outcomes. It is most likely to be effective for you if your goal is to stop drinking altogether. If other mutual-support group members caution against taking any medications, you should refer them to the pamphlet “The AA Member—Medications and Other Drugs,” which explicitly states that AA members should not “play doctor” and advise others on medication provided by legitimate, informed medical practitioners or treatment programs.

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Form C–2

Acamprosate Information Sheet: Patient Version2

(2Adapted from Mason, B.J., and Goodman, A.M. Brief Intervention and Medication Compliance Procedures—Therapist’s Manual, 1997. http://www.alcohol-free.com. )

  1. What is acamprosate, and how does it work?

  2. Acamprosate is a new, investigative medication for treatment of alcohol dependence already approved in several European countries and currently being studied in clinical trials in the United States. It is thought to reduce the urge for alcohol by working directly on certain neurotransmitters in the brain (chemicals that transmit information between nerve cells) whose balance has been disturbed because of regular, heavy drinking. Although acamprosate can only be used in the United States with permission of the U.S. Food and Drug Administration, it has been available in Europe since 1989 and has recently been approved for marketing by prescription in more than 12 European countries, including Belgium, France, Germany, Ireland, Italy, the Netherlands, Spain, Switzerland, and the United Kingdom. It is estimated that more than 1 million patients have been treated with acamprosate since it became available.

  3. Is acamprosate addictive?

  4. No. Acamprosate is not habit forming or a drug of abuse. It does not cause users to become physically or psychologically dependent.

  5. What are the side effects of acamprosate?

  6. Like virtually all medications, acamprosate can cause side effects, but these are usually minor and go away as patients continue to take the medication. In European controlled clinical trials, the only types of symptoms that were consistently more common in subjects taking acamprosate than in subjects taking placebo (a sugar pill) were stomach symptoms. These were usually mild, tended to occur when subjects first started taking the medication, and consisted primarily of loose bowel movements or mild diarrhea. Some subjects also had changes in their sex drive—sometimes this was increased and sometimes decreased, but there was no definite pattern. As with many drugs, sometimes people on acamprosate develop skin rashes or itching. In earlier studies, subjects on acamprosate and those on placebo both experienced equal amounts of this type of symptom. You should tell your medical clinician of any side effects.

  7. What will happen if I drink alcohol while taking acamprosate?

  8. Acamprosate does not change the way the body metabolizes (breaks down) alcohol, so acamprosate will not make you feel sick if you drink (i.e., it does not work like Antabuse). And there is no evidence of an added effect of alcohol if you drink while taking acamprosate.

  9. Is it possible to take other medications with acamprosate?

  10. Because acamprosate is eliminated exclusively by the kidneys, drugs that may be toxic to the kidneys, such as aminoglycoside antibiotics (gentamycin and amikacin), should be avoided. Inform your medical clinician of whatever medication you are currently taking so that possible interactions can be evaluated.

  11. What will happen if I become pregnant while taking acamprosate?

  12. If you have the biological potential to have a child, you should be using an effective method of birth control while taking acamprosate. However, if you miss a menstrual period, report this to your medical clinician at once and take a pregnancy test. If you become pregnant, you will discontinue the medication. Your medical clinician should continue to ask about your health throughout your pregnancy and also about the health of your baby after delivery. Even though acamprosate should not be used during pregnancy, animal studies have not shown any ill effects on either the course of pregnancy or on the offspring, nor is there any evidence from animal studies that acamprosate causes birth defects.

  13. Should I take acamprosate with a meal?

  14. Acamprosate can be taken with food, but food does decrease the amount of medication that the body absorbs. Gastrointestinal symptoms may decrease by taking the medication with food.

  15. Is it all right to crush the pills?

  16. Acamprosate pills should not be crushed because they have an enteric coating. Destroying this coating can lead to a worsening of gastrointestinal side effects.

  17. What happens if I stop taking acamprosate suddenly?

  18. Acamprosate does not cause physiological withdrawal symptoms when it is stopped.

  19. What happens if I miss a dose?

  20. If you miss a dose of acamprosate, do not take it simultaneously with the next scheduled dose; there should be a minimum of 2 hours between doses. If this is not feasible, do not take the skipped dose. Instead, wait until your next scheduled dose, and take only that dose.

  21. If I take acamprosate, does it mean that I don’t need other treatment for alcohol dependence?

  22. No. Research has shown that acamprosate was most effective when it was combined with treatment from professionals and/or mutual-support groups.

  23. What is the relationship of acamprosate to AA and other mutual-support groups?
  24. There is no contradiction between participating in support groups and taking acamprosate. It is most likely to be effective for you if your goal is to stop drinking altogether. If other mutual-support group members caution against taking any medications, you should refer them to the pamphlet “The AA Member—Medications and Other Drugs,” which explicitly states that AA members should not “play doctor” and advise others on medication provided by legitimate, informed medical practitioners or treatment programs.

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Form C–3

Medication Instructions Summary: General Review of Most Frequently Asked Questions

  1. How often should I take the medications?

  2. Take four pills in the morning, two at midday, and two in the evening.

  3. Can I take medications with meals?

  4. Because one of the medications is best taken on an empty stomach to help with absorption of the medication, it is best to take the medications about 1 hour before a meal or 2 hours after a meal. However, if you experience or are concerned about stomach problems, take the medications with meals. Discuss this with the clinician prescribing your medications.

  5. What should I do if I miss a dose? Should I take two doses at once?

  6. No. Do not take a double dose of either medication. Allow at least 2 hours between doses.

  7. If I miss a morning dose, should I take the morning dose or the midday dose at midday?

  8. If you miss the morning pills, take them as soon as you remember. If you remember near the time for the midday dose, take the four morning pills, wait 2 hours, and then take the midday dose. Allow at least 2 hours between doses.

  9. Why are there three extra lines of medication in the blister card for each week?

  10. The blister cards have 10 days worth of medication. This includes doses for 7 days of medication plus a few extras in case you find yourself without medications. For example, if you drop a pill down the sink or are unable to come in for your scheduled session, you may need an extra pill.

  11. What should I do if I lose a dose?

  12. If you lose one or more pills, replace them with medication from the corresponding extra medications. For example, if you needed to replace a lost morning dose, go down the morning columns (the first four columns of pills) on the blister card to find the first line of extra medication (eighth row of pills) and take those pills.

  13. Can I crush, cut, or chew the medications?

  14. No; because one of the pills has a protective coating to reduce stomach problems, it is best to take the pills whole.

  15. What should I do with the blister card?

  16. Return the blister card empty or with unused medications at the next visit. Return it even if you did not take all of the pills that were recommended.

  17. Can I remove the medications from the blister card and take them with me?
  18. It is best to keep the pills in their original packaging until you actually take the dose. Although you will be asked about whether you took your medication at each visit, the blister card is another way to keep track of pill-taking. If you take the pills out of the blister card, you might lose them or not be able to remember if you took those pills. If you absolutely must take the pills out of the blister card, try to remember which pills you removed as well as if you did actually take that dose.

  19. Does it matter where I store the medications?

  20. Do not store the medications in a car because high temperatures affect them.

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Form C–4

Quick Reference Medication Information Grid

How do the medications work? 1. Take away or reduce the desire to drink
2. Help maintain abstinence
3. Reduce the urge to keep drinking if a slip occurs.
Are they addictive? No
Are there any possible side effects? Nausea, loose bowel movements, headache, dizziness, fatigue, insomnia, anxiety, depression, sleepiness, increased or decreased sex drive, skin rashes, and itching
What happens if I drink while taking the medications? 1. Decreased feeling of intoxication
2. Decreased desire to drink more
3. No effect.
What other medications should I avoid while taking the medications? Opioid (narcotic) pain relievers and drugs that are toxic to the kidney (e.g., gentamycin, amikacin).
What happens if I get pregnant while taking the medications? Tell your medical clinician at once. You will no longer be able to take the medications. Your medical clinician, however, will continue to ask for information on your health throughout your pregnancy and also on the health of your baby after delivery.
Should I take my pills with a meal? Medication can be taken with food.
What happens if I stop taking the medications suddenly? Nothing
Are these medications the only treatment I need for alcohol dependence? No. Counseling and/or participation in mutual-support groups are highly recommended.
If I miss a dose, should I take two doses at once? No. You should not take a double dose of medication. Allow at least 2 hours between doses. If this is not possible, then skip the missed dose.
If I miss a morning dose, should I take the morning dose or the midday dose at midday? If you miss the morning pills, always take them as soon as you remember. Even if it is time for the midday dose, remember to take the four morning pills if at all possible, and then take the remaining doses, with at least 2 hours between doses.
Why are there three extra lines of medication in the blister card for each week? The blister cards have 10 days worth of medication. This includes doses for 7 days (1 week) of medication plus some extras. These extras are provided in the event that you find yourself without medications. For example, if you drop a pill down the sink or are unable to come in for your scheduled session, you may take some of the extra pills.
What should I do if I lose a dose of the medications? If you drop or lose one or more pills, replace them with medication from the corresponding extra set(s) of medications. For example, if you needed to replace a lost morning dose, go down the morning columns (the first four columns of pills) on the blister card to find the first line of extra medication (eighth row of pills) and take those pills.

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Form C–5

Patient Instructions for Managing Side Effects

Most people do not experience side effects from the medication you are taking. Occasionally, some people experience symptoms related to giving up drinking that can be confused with side effects from the medication. These symptoms usually are not serious, and they usually subside within a few days. Do not stop your medication until you have called your medical clinician. If you are concerned about any symptoms you are having, call your medical clinician.

Name of medical clinician: ______________________________________________________

During clinic hours (name): __________________ Phone: __________________

After clinic hours (name): __________________ Phone: __________________

Nausea

Take your medication with food.

Take Pepto-Bismol® according to package instructions or as prescribed by your medical clinician.

Vomiting

Call your medical clinician.

Diarrhea

Take Pepto-Bismol® according to package instructions or as prescribed by your medical clinician.

If diarrhea persists, drink plenty of nonalcoholic fluids and call your medical clinician.

Significant or persistent abdominal pain

Call your medical clinician.

Headache

Use nonprescription headache medications according to package instructions. It is important to avoid alcohol when taking headache medications.

If headache persists, call your medical clinician.

Dizziness, Nervousness, Anxiety, Insomnia

If dizziness, nervousness, anxiety, or insomnia are significant or persistent, call your medical clinician.

Do not start herbal over-the-counter or prescribed medications without first discussing their use with your medical clinician.

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Form C–6

Sample Medical Emergency Card

To Medical Personnel Treating This Person in an Emergency:

This person may be taking an investigational new drug (acamprosate) and/or the oral opioid antagonist naltrexone hydrochloride. If this is a medical emergency and the treating medical staff need to know what medication the person is taking, call the 24-hour emergency number listed on the back of the card.

In an emergency situation for people who are receiving fully blocking doses of naltrexone hydrochloride, a suggested plan of management is regional analgesia, conscious sedation with a benzodiazepine, use of nonopioid analgesics, or general anesthesia.

In a situation requiring opioid analgesia, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged.

A rapidly acting opioid analgesic that minimizes the duration of respiratory depression is preferred. The amount of analgesic administered should be titrated to the needs of this person. Nonreceptor-mediated actions may occur (e.g., facial swelling, itching, generalized erythema, or bronchoconstriction), presumably caused by histamine release.

Irrespective of the drug chosen to reverse naltrexone hydrochloride blockade, this person should be monitored closely by appropriately trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation.

Important information regarding the patient and the practitioner who prescribed medication that may be naltrexone and/or acamprosate:

Patient’s name: _____________________ Phone: _________________________

Patient’s ID #: ______________________ Treatment ID #: ________________

Date treatment began: ___ ___/___ ___/___ ___ ends: ___ ___/___ ___/___ ___

Name of physician: ____________________________________________________________

Pharmacy phone: ______________________________________________________________

24-hour emergency phone: ______________________________________________________

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Form C–7

Name and Location of AA Pamphlet Relevant to Pharmacotherapy

Name: “The AA Member—Medications and Other Drugs”

Location: Available through local AA organization

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Form C–8

Listing of Local Mutual-Support Groups

Provide listing of local meeting times and places for relevant mutual-support groups.