I



I. PURPOSE: To establish policies and procedures for the safe and effective use of medication.

II. APPLICATION: The policies and procedures stated herein apply to all Community Mental Health for Central Michigan programs, contract agencies and vendors.

III. REFERENCES:

A. The Joint Commission Standards MM.1.10-MM.8.10

B. Department of Community Health Administrative Rules, R33.7158

C. Act 258, Public Acts of 1974, as amended, 330.1718, 330.1719

D. PA 368 of 1978 as amended.

IV. DEFINITIONS

| | |

|ADMINISTER |To give the medication by injection, inhalation, derma-patch, suppository or |

| |orally to the consumer. |

| | |

|CASE MANAGER |Staff person responsible for assuring assessment, the Person-Centered Plan, |

| |monitoring, etc., occurs according to agency policy and procedures. |

| | |

|CENTER |Office location for services offered directly by Community Mental Health for |

| |Central Michigan. |

| | |

|DISPENSE |To transfer medication from one container to another for someone else to |

| |administer or take it. |

| | |

|DISTRIBUTE |To give prescriber ordered medication to a person in its original container |

| |dispensed by the pharmacist or supplied by the drug representative. |

| | |

|MEDICATION ERROR |A discrepancy between the medication therapy the individual receives and the |

| |medication therapy the prescriber intended the individual to receive. This |

| |includes: |

| |Administering the wrong medication or dosage: distributing the wrong medication|

| |sample or dosage. |

| |Deliberately charting medications as having been administered or distributed |

| |when this is not the case. |

| |Giving a consumer a medication not ordered for him/her. |

| |Willfully disregarding or changing a prescriber’s order. |

| |Giving a medication outside of the time frame (30 minutes plus or minus). |

| |Administering medication by the wrong route. |

| |Administering medication but not documenting. |

| |Failing to administer ordered medication. |

| |Removal of medication for private use. |

|G. PRESCRIBER |MD, DO or Nurse Practitioner. |

|H. PSYCHOACTIVE MEDICATION |A medication given for the treatment of diagnosed psychiatric disorders and |

| |behavior problems. For the purpose of this guideline the following medication |

| |categories are considered psychoactive medications. |

| |Antipsychotic agents. |

| |Antidepressants. |

| |Lithium. |

| |Anti-anxiety agents. |

| |Sedative/hypnotic agents. |

| |Anticholinergic agents used in treating movement disorders. |

| |Anti-seizure agents used as mood stabilizers. |

| |Stimulant agents. |

| |The following agents when used to treat target symptoms or behaviors: |

| |propranolol, clonidine, cyproheptadine, naltrexone, Benadryl(, Tenex(, |

| |Vistaril(, DDAVP. |

| |Antabuse(. |

| |Other medications when used for specific psychiatric disorders. |

| | |

|I. PSYCHOACTIVE MEDICATION |The use of chemical agents in the treatment or control of mental illness and/or|

|TREATMENT |emotional disorders. |

| | |

| J. PRN |As needed. |

| | |

|K. SCHEDULE IV |Medications in this schedule have low abuse potential and can lead to limited |

| |physical dependency and psychological dependence (such as phenobarbital, |

| |chlordiazepoxide, diazepam, and alprazolam). |

| | |

|SERIOUS ADVERSE MEDICATION EVENT |An adverse medication reaction or medication error which causes sudden and |

| |clinically significant harm to the individual such that, if untreated, major |

| |permanent loss of function or death could result. |

| | |

|M. DAW |Dispense as written. |

V. POLICY: The agency shall establish safe procedures for the prescribing, procuring, storing, preparing, using, dispensing, distributing, retrieving, and disposing of medications.

A. The agency shall establish a plan which assures that:

1. The administration of medications conforms to the guidelines established by the Department of Community Health.

2. The agency’s procedures regarding medications adhere to laws, regulations, licensure and professional standards of practice.

B. The following pharmaceutical plan describes how CMHCM establishes and maintains a pharmaceutical program that provides for the safe and effective use of medication.

1. A prescriber, licensed by the Michigan Department of Licensing and Regulation, will prescribe all psychoactive medications.

2. Procedures are in place for the safe selection and prescription of psychoactive medications.

3. Distribution of sample medications conforms to PA 368 of 1978 as amended.

4. There are established procedures for the distribution of medications to consumers for home visits, outings, and discharge.

5. Medication dosages are monitored.

6. Informed consent is obtained for all psychoactive medications. These consents are to be renewed annually and whenever a dosage is increased above the range indicated on the original consent form.

7. Medications are monitored continuously for their effectiveness, impact on current and future functioning, and side effects.

8. Procedures are in place for the control and storage of medication within the centers. Special procedures are in place for controlled substances.

9. There is a plan in place to retrieve recalled medication and to dispose of unused, outdated, and contaminated medication.

VI. PROCEDURES:

A. Systems and processes are in place for the safe and effective use of medication:

1. A prescriber, licensed by the Michigan Department of Licensing and Regulation, will prescribe all medication.

2. CMHCM does not have an on-site pharmacy; therefore, ordered medications are distributed through the use of samples supplied by drug representatives or dispensed from a community pharmacy.

B. Investigational medications are not used and clinical trials are not conducted at the agency.

C. Policies and procedures support safe prescription and selection of agents:

1. Only presribers licensed by the Michigan Department of Licensing and Regulation prescribe medications.

a. Prescriptions to include consumers name, date, medication, dose, quantity, number of refills, DAW, if appropriate, and prescriber signature.

2. Psychoactive medications are to be prescribed only for those consumers who have demonstrated a need for psychoactive medication treatment. Any medication prescribed must be documented in the consumer's Case record (Consultation/record review – 709b or Progress note- CMHCM-729 or 730, and Medication Record-CMHCM-113A).

3. The medication regimen is to be individually determined by considering the consumer's diagnosis, age, sex, height, weight, physical condition, comorbidities, concurrent illnesses, allergies, current medications, family history, past medication use, drug and alcohol use and abuse, food/drug interactions, relevant laboratory values, pregnancy and lactation status, and any previous adverse reactions to medications.

4. A single psychoactive medication, which offers the most effective treatment for the basic psychiatric disturbance exhibited by the consumer will be selected whenever possible.

5. Additional psychoactive medications for associated symptoms, e.g., insomnia, anxiety, and so forth, for augmentation, or for additional therapeutic benefit will be used only when the primary psychoactive medication is not fully effective. When two or more psychoactive medications are used, the prescriber will document the justification and the rationale for the concomitant use.

6. Medication will not be used as punishment, for the convenience of staff, or as a substitute for other appropriate treatment.

7. Administration of psychoactive medications will be reviewed periodically as set forth in the consumer’s person-centered plan and based on the consumer’s clinical status by a prescriber to determine the appropriate significance of continued use. The Behavior Treatment Committee will review and approve or disapprove all program plans that involve the use of psychoactive medications when they are applied

strictly for behavior control purposes, and where the target behavior is not due to an active psychiatric process. Examples include where the psychoactive medications have been prescribed for unruly, aggressive or otherwise maladaptive behavior. If such medications are used in an emergency, the committee will review their application at its next meeting or sooner. It is the responsibility of the case coordinator to assure that such instances are brought to the committee's attention.

8. If a consumer's medication is changed, a consultation/record review – 709b will be entered to correspond to that change and include the rationale for that change.

9. When a consumer is to receive maintenance anti-psychotic medication for more than three months, the prescriber will weigh the benefits of continued treatment against the risk of long-term use of antipsychotic agents. The prescriber will then document the basis of the decision to either continue or discontinue the medication.

10. Any medical or osteopathic physician/nurse practitioner who is licensed by the State of Michigan and has a prescriber/consumer relationship with an agency consumer may prescribe medications to that person. Each prescriber involved in the consumer’s care should be informed of all medications the person is receiving. The documentation must show evidence of an up to date listing of all of the persons prescribed medications.

11. When a community pharmacist is dispensing a consumer’s medication it is the responsibility of the assigned staff to keep him/her informed of ALL medication the consumer is receiving.

12. The rationale for the concomitant use of anticholinergic agents with antipsychotic agents will be documented in the clinical record. They will be utilized only when symptoms become manifest or if there is a high likelihood of occurrence.

There will be documentation of the possible side effect, including tardive dyskinesia, potential from all prescribed medications. There will be periodic efforts to

reduce/discontinue anticholinergic agents if symptoms are stable and when antipsychotic medication dose are reduced.

13. When PRN orders are written, the prescriber will document the rationale for the PRN order. The written order will include the dose and route of administration. Orders will be specific as to the conditions and behaviors for which the PRN may be

used. Each PRN order will delineate the number of doses that may be given within a 24-hour time period and the time limits between doses. The dosage for psychoactive medications will not exceed the total daily cumulative dosage as designated. PRN

orders for psychoactive medications will be limited as to the prescribed period of time and only renewed with significant justification.

D. Distribution of sample medications conforms to PA 368 of 1978 as amended:

1. Samples brought into the facility are signed for by a prescriber, entered into a

logbook, and locked in a cabinet immediately.

2. Agency prescibers are the only ones authorized to order the distribution of sample medications.

3. Once the agency prescriber authorizes the dispensing of the sample medication, the presciber may delegate the distribution of the medication to the agency RN.

4. The distribution of samples is documented in the logbook indicating consumer's name, date, quantity distributed, lot number and expiration date of sample.

5. The distribution of samples is also documented in the consumer’s clinical record indicating date, prescription name, dosage, and quantity distributed.

6. Samples are to be distributed in the original manufacturer's packaging with a label or written document containing:

a. Name and address of the facility.

b. Prescriber’s name.

c. Patient’s name.

d. Date distributed.

e. Directions for use.

2. Name, strength and quantity of medication.

3. Expiration date of medication.

7. Samples distributed must be current.

8. No medications are to be removed from the agency clinics by any personnel except when nurses or case managers are delivering prescriber prescribed medications in their original containers to consumers or another agency clinic.

9. Only sample medications provided by the pharmaceutical companies and the consumer’s own medication may be distributed.

E. Distribution of medications to consumers for home visits, outings, and discharge:

1. Only medication in the original manufacturer's packaging or in a prescription container from an outside pharmacy labeled in accordance with Michigan law may be distributed. An exception may be allowed when the consumer leaves the work site or home. This exception applies only when it is not physically possible to carry the medications in the original packaging.

2. Medication that is given to consumers upon leave or discharge from agency service shall be authorized by the agency prescriber and shall be in compliance with state rules and federal regulations pertaining to labeling and packaging.

3. If medication is to be prepared at the clinic for the person to self-administer for a specific amount of time, the designated staff observes while the consumer packages his/her weekly cassette, for self-administration. The medication cannot be packaged into the cassette before the consumer's arrival. The medication will be identified and inspected when brought into the agency and upon distribution into cassettes. The designated staff documents this distribution in the case notes and in the controlled medication inventory if necessary.

F. Dosage of medication:

1. Medication dosages will be monitored at the lowest effective dose.

2. Medication dosages will be maintained as appropriate for the medication, the disorder being treated and the treatment plan. Efforts will be made, as appropriate, to reduce or discontinue anti-psychotics and adjunctive medications targeted to specific symptoms.

G. Administration of medication:

1. Medication will be administered only at the order of a prescriber. This will be

documented on the prescription order. Administered to the correct person by saying their name and them respond and asking for their birth date, which is available in the record.

2. Medication prescribed for a consumer will be given to and used only for that consumer.

3. Allergies/sensitivities are noted on the medication record, health history form, and reviewed.

4. Medication will be administered from the original container. The medication will be checked for expiration date prior to administration, disposed of, if necessary. If preparation needs to occur prior to administration, the area will be clean and free of clutter. The medication to be prepared will be available with careful inspection for particulates or discoloration and disposed of if noted. Pills or capsules are intact without chips or cracks, if irregularities are noted, pill/capsule to be disposed of.

5. Medication will be administered on time, following all training guidelines and procedures.

6. Administration of all medication shall be recorded in the consumer's clinical record.

7. If an individual cannot administer his or her own medication, the medications will be administered only by qualified and trained staff members.

8. In specialized residential settings staff will receive CMHCM/DCH Curriculum medication training.

9. In other settings staff will receive training specific to the needs of the individual consumers.

10. The Agency’s prescribers, nurse, or a CMHCM training staff will provide continuing education for the designated staff members on the use of psychoactive medication treatment.

H. Informed consent:

1. Psychoactive medications shall not be administered to an individual unless the individual consents or the administration is necessary to prevent physical injury to the individual or others.

2. Informed consent will be obtained from the consumer, or parent/guardian, for each psychoactive medication prescribed. The consent will include: name of medication, dosages, frequency, explanation of risks and benefits, major and common side effects, and explanation that consent can be withdrawn at any time. NOTE: The patient instruction sheet will be given to each consumer/ guardian at the time he/she signs the consent (CMHCM-767) to assist in describing risks and major side effects. If a consent is missed, the consent and side effects sheet will be mailed with a return envelope. A note will also be put in the consumers file to document missing consent was mailed.

3. Consents are to be obtained by a physician, physician's assistant, nurse practitioner or registered nurse. Prior to dispensing/ administrating there will be documentation of consents placed in the case record.

4. The assigned clinical staff will assure that the consumer/guardian receives information on specific food and medication interactions including but not limited to the adverse effects of alcohol with psychoactive medications, the need to maintain adequate sodium and fluid levels when taking lithium, a tyramine free diet with patients on MAO inhibitors and dietary considerations with Antabuse(.

5. Administration of psychoactive medications will be reviewed periodically as set forth in the consumer's individual plan of service and based upon the consumer's clinical status by a prescriber to determine the appropriateness of continued use.

I. Monitoring medication effects:

1. Consumers will be checked and routinely monitored for the presence of any condition affecting therapy by the assigned clinical staff and these conditions will be reported to the prescriber.

2. All consumers who are on psychoactive medications should have appropriate laboratory studies ordered by the prescriber.

3. The prescriber reviews the laboratory results for any medication related problems.

4. If serum levels exceed or are below the therapeutic range, the medical rationale for either continuing or modifying the medication regimen will be documented in the progress notes.

5. Consumers in need of specific medical care are to be advised of appropriate resources by the agency prescriber.

6. All psychoactive medications are to be reviewed by the prescriber at least every six months or more often at his or her discretion. The review is to address medical history, laboratory test results if appropriate, Tardive Dyskinesia assessment results, allergies, medication history, purpose and effects of prescribed medications.

7. A clinical plan for assessing Tardive Dyskinesia will be done by the prescriber or nurse at least every six months or more often at his or her discretion. The prescriber or the nurse will document the presence or absence of Tardive Dyskinesia. The National Institute of Mental Health AIM scale is to be used. In those groups considered at risk of Tardive Dyskinesia (elderly, especially female) there will be periodic evaluations of the need for continuous use of anti-psychotic agents. (See Appendix A).

8. The effects of the medication on the consumer's behavior and on the target symptoms will be recorded in the clinical record. The prescriber, nurse, residential staff, and case manager will record medication effects.

9. Case coordinators and direct care staff who provide service to consumers on medication are to be familiar with possible side effects and toxic reactions so that they can assist in monitoring effects of the medication.

10. Consumers on medication and parent/guardians are to be advised of side effects and toxic reactions of medications to further monitor side effects. Serious adverse medication events must be reported to the consumer’s prescriber immediately, who in turn is responsible for the further assessment and care of the consumer. In an emergency situation, the consumer should be taken to the local hospital emergency room and his/her prescriber notified. Documentation is required in the case record, including how the reaction was manifested. Other findings of medication errors and medication reactions may be reported to the nurse or case manager who in turn will follow up and do the required documentation. The staff member discovering the error must complete an incident report on that medication error.

J. Control of medication within the centers:

1. Nurses, registered by Michigan State Board of Nursing, will monitor monthly to ensure proper storage, control, distribution and administration of medications within each center.

2. A nurse taking a phone or verbal order for medication must write down the complete order or enter it into a computer, then read it back, and receive confirmation from the individual who gave the order. Voice mail orders are not acceptable. When an order is not received directly, the nurse or pharmacist must call the prescriber back to get the order directly, including a “read back”.

3. The prescriber or the RN will call telephone orders for new and refill orders for medications directly to a pharmacy. The prescriber should write the orders for new medication as soon as possible. Telephone orders for new medication and refills must be recorded in the consumer’s case record.

4. Medications ordered in the agency clinics are prescribed on the agency's prescription pad and signed by the prescriber. These orders will be legible and will not contain unacceptable symbols or dangerous abbreviations. If the name of the medication prescribed can be easily confused with another medication, the reason the medication is being prescribed will also be included.

a. A list of abbreviations, symbols, acronyms, and dose designations that are unacceptable because of their propensity for misinterpretation and error will be posted in medication preparation areas.

b. Only medication prescribed by a licensed prescriber and samples provided by pharmaceutical companies will be stored in any agency medication storage location.

c. A copy of the prescription order is to be placed in the consumer's case record.

d. All consumer medication brought into agency clinics will be delivered immediately to an agency Registered Nurse to be logged in and immediately locked in a cabinet.

e. Orders for medication will be effective either for a specific number of days, or until the order is changed or terminated, as indicated by the prescriber. Blanket reinstatement of previous orders for medication are not acceptable.

f. Automatic stop orders are enforced for antibiotics and narcotics in the event the agency prescriber prescribes them.

K. Storage of medication:

1. All medications are stored according to manufacturer’s recommendations.

2. All medications administered or distributed in agency programs will be kept in locked cabinets accessible only to the agency prescribers and RNs; in agency residential facilities accessible only to trained direct care staff; and in contract worksites accessible only to designated staff members.

3. The internal medications are to be stored in a separate locked cabinet from the external medications.

4. Medication cabinets are to be kept locked except for when restocking, dispensing, distributing, counting, checking or disposing of medications.

5. Medication stored in the locked cabinet may include:

a. Medication for administering to the consumer with a current prescriber’s order to do so.

b. Consumer medication brought to the facility for the purpose of repackaging by the consumer into weekly cassettes. Medications are brought in and stored in the original package, whether it is from the manufacturer or outside pharmacy.

c. Medication obtained from the medication manufacturers for the indigent programs.

d. Unused, outdated, contaminated medication will be kept separate from all other medications. The nurse, will destroy the unused, outdated, contaminated medication with a witness present, at the center site. This will be documented.

5. Storage of controlled substances conforms to law and standards of good practice.

a. A list of controlled substances will be maintained at each clinic.

b. All controlled substances will be counted when brought into the facility and counted each business day thereafter. Upon receipt of controlled substances, the amount received will be verified by two RNs or RN and supervisor.

c. All controlled medication will be double locked.

d. The assigned clinical staff will inspect and remove all expired medications at least monthly.

e. Controlled substance/medication counts will be periodically reconciled by someone independent of responsible staff. Controlled substances will be reconciled quarterly by an RN and supervisor.

L. Recall of medication:

1. Samples brought into the Agency are logged in with the lot number.

2. Documentation of medications distributed to consumers includes the lot number.

3. In case of a recall, the clinic nurse will immediately notify the consumers who received the medications to return the medication to the clinic.

M. Disposal of medication:

1. All consumer returned, outdated, contaminated, expired, and recalled medications are disposed of by returning to the pharmacy, or disposal by the designated staff and witness with documentation as to the method used in the logbook.

The following procedures are to be followed when disposing of medications:

a. Check with local pharmacy to see if they have a “take back program”. Keep the medication in their original container, scratch out, or use permanent marker to make personal information unreadable. If NO “take back program”, keep the medication in the original container, scratch out, or use permanent marker to make personal information unreadable.

b. To reduce the opportunity for misuse, prepare the drugs for disposal by:

1) For solid medications, such as pills or capsules: add a small amount of water to at least partially dissolve them. Seal the container with duct or other opaque tape.

2) For liquid medications: add enough table salt, flour, charcoal, or nontoxic powdered spice to make a pungent, unsightly mixture that discourages anyone from eating it. Seal the container with duct or other opaque tape to prevent leaks or breakage.

3) For blister packs: wrap the blister packages containing pills in multiple layers of duct or opaque tape.

c. Double bag the contained drugs in a closable bag, or put it in another container with the lid taped closed and put it in the trash. This helps prevent immediate identification that the package contains drugs and helps contain any leaks if the container breaks during the disposal process, e.g., when plastic garbage bags tear, the trash can tips over, etc. Avoid putting drugs into any material or food that might be attractive to pets or wildlife.* (*From Michigan Department of Environmental Quality)

2. Medications must be disposed of so that animals or humans cannot retrieve them.

3. Controlled substances must be disposed of by the RN (with a witness) or by a pharmacist.

This policy shall be reviewed at least annually and more often if needed with input from the medical director, staff psychiatrist, clinical staff and administration.

Date Approved: 8/27/02

Revised: 3/26/03

Revised: 1/09/04

Revised: 9/12/06

Revised: 11/25/08

Revised: 12/22/08

Revised: 3/16/09

Revised: 5/11/10

Revised: 8/12/10

APPENDIX A

Antipsychotic Medications

Requiring Periodic Assessment for

Tardive Dyskinesia (AIMS)

Abilify( Prolixin (

Clozaril( Risperdal(

Fanapt( Saphris(

Geodon( Serentil(

Haldol( Seroquel(

Invega( Stelazine(

Loxitane( Thorazine(

Mellaril( Trilafon(

Moban( Zyprexa(

Navane(

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download