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Considerations for Patient Education

According to 201 KAR 9:260, it is the acceptable and prevailing medical practice within the Commonwealth of Kentucky for physicians prescribing or dispensing controlled substances to educate patients receiving controlled substances on the following subjects through verbal or written counseling.

In order to assist physicians, the Board has developed the following outline to either share with patients verbally or in writing.

Proper Use

  1. The patient must carefully following instructions for use, including timing of doses, whether to take the medication with or without food, and any foods or other medications to avoid while taking the medication;
  2. Patients with low or impaired vision should be advised to wear glasses when taking the medication and not take the medication in the dark;
  3. The patient should read the prescription container label each time to confirm the dosage;
  4. The patient should never use the medication after the expiration date;
  5. The patient must never share the medication with others;
  6. The patient must not take the medication with alcohol or other sedatives;
  7. The patient should not take the medication to help them sleep;
  8. The patient should never break, crush or chew the medication;
  9. If appropriate, external heat, fever and exertion can increase the absorption of transdermal products, leading to potentially fatal overdose;
  10. The patient should immediately contact the physician’s office to report any adverse reaction; and,
  11. It is illegal to share, sell or give away controlled substances.

Driving and Work Safety

  1. Caution the patient that the controlled substances may cause sleepiness, clouded thinking, decreased concentration, slower reflexes, or incoordination, all of which may create a danger to the patient and others when driving or operating certain type of machinery;
  2. Encourage the patient to avoid, if possible, driving or engaging in other potentially dangerous work or other activities, for a specific period of time until the initial effects of the controlled substances no longer create such dangers; and,
  3. Caution the patient that ingesting other substances, such as alcohol, benzodiazapines or some cold remedies, at the same time the patient is taking the controlled substances prescribed or dispensed may increase cognitive and motor impairment.

Pregnancy

When a physician determines that prescribing or dispensing controlled substances may be indicated for a medical condition affecting a post-pubescent female patient, the physician should:

  1. Before prescribing or dispensing the controlled substances, counsel the patient about the potential risks and benefits of controlled substance use during pregnancy and encourage the patient not to use controlled substances or only use controlled substances on a minimal basis during pregnancy, unless the benefits of such use outweigh the risks;
  2. Make an individualized and deliberate determination that the benefits of prescribing or dispensing controlled substances sufficiently outweigh the risks for the particular patient, before prescribing or dispensing controlled substances to a pregnant patient;
  3. Obtain written informed consent, after full consultation, from the patient for the prescribing or dispensing of controlled substances during pregnancy before prescribing or dispensing controlled substances to a pregnant patient;
  4. Counsel the pregnant patient about the signs of adverse reaction or side effect, or conditions creating risk of danger to the patient or fetus and the actions to be taken by the patient upon observation of such signs or specific incidents.

Potential for Overdose and Response

  1. Counsel the patient and, if possible, the patient’s family or other caregivers, that the use of controlled substances creates a risk of respiratory depression, which may result in serious harm or death and that the patient and others should be watchful for the following warning signs of overmedication:
    1. intoxicated behavior, such as confusion, slurred speech, or stumbling;
    2. feeling dizzy or faint;
    3. acting very drowsy or groggy;
    4. unusual snoring, gasping, or snorting during sleep; and/or
    5. difficulty waking up from sleep or difficulty in staying awake.
  2. Counsel the patient and other caregivers to immediately call “911” or an emergency service upon observing or experiencing any of the following conditions:
    1. patient cannot be aroused or waken, or patient is unable to talk after being awakened;
    2. patient has shortness or breath, slow or light breathing, or stopped breathing;
    3. gurgling noises coming from the patient’s mouth or throat;
    4. patient’s body is limp, seems lifeless;
    5. patient’s face is pale or clammy;
    6. patient’s fingernails or lips are turning purple or blue; and/or
    7. patient’s heartbeat is slow, unusual or stopped.

Safe Storage of Controlled Substances

  1. Counsel the patient about the potential for partners, family members or others to improperly obtain the patient’s controlled substances if those substances are not stored in a safe manner;
  2. Counsel the patient to maintain the controlled substances prescribed or dispensed in the original container;
  3. Counsel the patient to store controlled substances in a locked cabinet or other secure storage unit, that is cool, dry and out of direct sunlight, such as:
    1. an existing safe;
    2. a cut-proof travel bag;
    3. a portable lock box designed for travel; or,
    4. a locking medical box.
  4. Discourage the patient from storing controlled substances in:
    1. an unlocked medicine cabinet;
    2. in their car; or,
    3. in a refrigerator or freezer unless specifically recommended by the prescriber or pharmacist; and,
  5. Instruct the patient to immediately notify the physician if any controlled substances prescribed or dispensed by the physician are stolen or improperly taken by another individual.

Proper Disposal

  1. Counsel the patient about the importance of safely and appropriately disposing of unused controlled substances that had been prescribed or dispensed by the physician;
  2. Counsel the patient that they should promptly dispose of unused controlled substances after the expiration date of the prescription or after the patient no longer requires the controlled substances to treat the medical condition;
  3. Counsel the patient that, in order to safely dispose of controlled substances, the patient should turn in the unused controlled substances as part of an approved governmental drug take-back program. Due to environmental reasons, patients should not be advised to flush controlled substances down the toilet; and,
  4. Suggest to the patient that the patient should personally remove any identifying information, including the prescription number, from an empty controlled substance container and then properly dispose of the empty container.

The FDA has developed an article on this topic and it is shared here: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm

In addition, the Kentucky Office of Drug Control Policy has a listing of Kentucky Permanent Drug Disposal Locations and the map and listing can be found here: http://www.odcp.ky.gov – click on the Kentucky Prescriptions Drug Drop Map And Locations on the left side of the page.​

Notices

House Bill 1 passed by the 2012 Kentucky General Assembly: