5122-2-13 Medication practices in regional psychiatric hospitals.

 

 

 

5122-2-13                    Medication practices in behavioral healthcare organizations.

 

 

 

(A)     The purpose of this rule is to ensure safe quality patient care by establishing standards that govern all aspects of medication practices within behavioral healthcare organizations. (BHOs) medication practices shall reaffirm patients' rights to receive appropriate medication treatment and to actively participate in treatment decisions.

 

(B)   This rule applies to all behavioral healthcare organizations (BHO) operated by the Ohio department of mental health. Community support network (CSN) programs operated by a BHO shall meet the requirements established under rule 5122-29-05 of the Administrative Code.

 

(C)  The following definitions shall apply to this rule in addition to those appearing in rule 5122-1-01 of the Administrative Code:

 

(1)   "Administration" means the direct application of a single drug to the body of a patient either by injection, inhalation, ingestion, or any other means.

 

(2)   "Chief clinical officer (CCO)" means the medical director of a BHO as defined in division (K) of section 5122.01 of the Revised Code.

 

(3)   "Department" means the Ohio department of mental health.

 

(4)    "Dispensing" refers to the final association of a medication with a particular patient pursuant to a lawful prescription of a physician, and assuming responsibility for the activities involved in filling the prescription.

 

(5)       "Emergency" means an impending or crisis situation which creates circumstances demanding immediate actions for prevention of injury to the patient person or others. An emergency may be determined by either a licensed physician or registered nurse.

 

(6)     "High risk medication" means medications that have potential side effects which are known or suspected to cause adverse, life-threatening reactions or lasting serious health impairment.

 

(7)   "Informed consent" means a process that requires a physician to give a patient or guardian all information necessary to make an intelligent decision to either undergo or refuse a proposed treatment or medication. Information includes the nature of the treatment or medication; the potential benefits, risks and/or possible side effects or consequences associated with taking or not agreeing to the recommended treatment or medication; and any alternative treatments

 

 

available to the patient. This process presumes that the physician has made an assessment and determined that the patient has the capacity to give informed consent.

(8)      "Medication/drug" means a natural or chemical substance, that exerts a pharmacological effect, intended to be used for the purpose of treatment, prevention, or diagnostic studies of illness.

(9)    "Medication with abuse potential" means a medication, compound, mixture, preparation, or substance included in schedule I, II, III, IV, or V of "the controlled substance act" or other non-controlled medication with recognized potential for abuse.

(10)     "Physician" means a physician who holds a valid and current license to practice medicine in the state of Ohio.

(11)   "Prescribing" means an order for medication(s) issued by a physician.

(12)    "PRN order" means a physician's order for a medication which is given only when a patient manifests a specific clinical condition and consents to take the medication.

(13)    "Prescription drug" means a medication that shall be dispensed only upon a prescription, and/or includes on the manufacturer's label, the wording: "Rx only" or the statement: "Caution: federal law prohibits dispensing without prescription."

(14)   "Psychotropic medication" means medication which has specific and intended effects on the central nervous system functions and which is ordinarily used to alter disorders of thought, perceptions, mood, or behavior.

(15)   "Standing orders" means an established routine or special order prescribed by a physician and approved by the CCO, which is applicable to the general population of a unit/ward as opposed to an individual. Standing orders shall be prohibited.

(16)   "Telephone order" means an order transmitted via the telephone.

(17)   "Verbal order" means an order spoken aloud by a physician in the presence of the person authorized to receive the order.

(D)  Physician/prescribing practices

(1)     Physicians shall prescribe all medications as deemed medically appropriate pursuant to a physical and psychiatric evaluation. Prescribing practices shall be in compliance with state/federal laws, and standards of accrediting/certifying entities.

(2)    All medications shall be prescribed consistent with department policies and policy guidelines. Medications shall not be prescribed or administered in quantities which prevent a patient from participating in treatment.

(3)     Each patient's medication regimen shall be reviewed and evaluated by the attending physician at time intervals established by BHO policies. Documentation of this evaluation shall be made in the patient's medical record.

(4)    When the prescribing of two medications from the same psychotropic class is indicated, the reasons for prescribing more than one medication from the same class shall be documented by the prescribing physician in the patient's record. If the concomitant use of two atypical antipsychotic medications occurs for greater than sixty days three months, a review shall be conducted by the BHO medical director or designee.

(5)      BHO policies and procedures shall address high risk medications and medication with abuse potential.

(6)    Medications may be prescribed on the basis of a physician's telephone order only when received and recorded by a registered nurse or registered pharmacist. All telephone orders must be countersigned, dated and timed, after review by the responsible physician, within seventy two hours, unless a shorter time interval is specified within BHO policy.

(7)    Telephone orders shall be limited to the specific circumstances described in BHO policy.

(8)   Verbal orders may only be used in an emergency situation. Verbal orders shall be signed, dated and timed by the physician within one hour.

(9)    PRN medication orders must be documented in the medical chart when the order is written and after the patient's informed consent has been obtained. PRN orders for a medication may not exceed thirty days.

(10)    PRN orders for injectable psychotropic medications shall be used only under strictly limited circumstances, as described in BHO policies and procedures.

(11)   Standing orders for medications are prohibited.

(12)   Medication orders shall be time limited in accordance with applicable state and federal laws and regulations, but in no case shall medication orders exceed thirty days.

(13)     Upon the patient's discharge, the physician may order up to a fifteen day supply of medication. This must be documented in the patient's medical record.

(E)  Documentation

(1)    The physician shall document in the progress notes of the patient's medical record justification of the use of medications. Documentation shall include, but is not limited to:

(a)      Rationale  for  the  use  of  each  prescribed  medication,  including  the increase/decrease in dose or form of the same medication;

(b)   Rationale for a change to a different medication;

(c)   Rationale for cessation of a given medication; and

(d)   Periodic review and evaluation of the patient's response to the medication regimen.

(F)   Pharmacy/dispensing practices

(1)    The pharmacy is responsible for procurement, distribution and drug control within the BHO. Pharmacy operations shall comply with the state and federal drug laws, regulations, and standards of accrediting or certifying entities. The pharmacy shall maintain an up-to-date policy and procedure manual.

(2)   The pharmacy shall receive medication orders in accordance with the Ohio drug laws. Procedures for receipt of medication orders shall be specified in BHO policies. The pharmacy shall dispense medications only upon the order of a physician.

(3)     The pharmacy shall maintain a medication profile for each patient and a pharmacist must clinically review this profile prior to dispensing medication. Medication profiles will be in accordance with Ohio drug laws, BHO policies, and standards of accrediting or certifying entities. When deemed necessary, the pharmacy shall notify the appropriate clinician(s) of problems existing within a medication regimen. This notification shall be documented.

(4)    The pharmacy may have semiprofessional or clerical assistance in activities which do not require professional judgement. These activities must be supervised by a licensed pharmacist.

(5)     Patient specific prescription drugs will be dispensed, packaged, stored, and labeled as required by Ohio drug laws. Prescription drugs that are emergency supplies or floor stock must be accompanied by appropriate accountability records, and shall be issued, stored, and secured in accordance with Ohio drug laws. Prescription drugs issued as floor stock shall not be in excessive quantities and shall be periodically reconciled with the corresponding accountability sheets.

(6)     Pharmacies that provide a contingency drug cabinet/automated dispensing machine (ADM) shall maintain the cabinet/(ADM) in a secure area other than the pharmacy. BHO policy shall specify personnel who may access the contingency supply and address accountability of the medications.

(7)   The pharmacy is responsible for the safe and secure storage of all medication. All areas within the BHO where medications are stored will be inspected on a monthly basis by a pharmacist. Inspections will be documented and discrepancies identified, communicated, and corrected. Medications must be properly stored in all areas of the BHO with respect to appropriate space, temperature, light, moisture, segregation, and security.

(8)      The pharmacy will dispense medications in compliance with department policies, directives, guidelines, or protocols.

(G)  Record keeping

The pharmacy will maintain appropriate and current licenses with the Ohio board of pharmacy and the U.S. drug enforcement administration and maintain records as required by Ohio and federal drug laws to ensure a complete audit trail of accountability.

(H)  Clinical responsibilities

(1)    BHO pharmacists shall participate in clinical activities regarding medications. BHO policies and procedures shall define these clinical activities.

(2)     A BHO may establish additional policies which outline clinical pharmacy practices consistent with the Revised Code and under the supervision of the CCO or designee.

(I)  Administration practices

(1)     All medication orders shall have the authority of a privileged and licensed physician's signature or other means of order authentication when computerized physician order entry is used..

(2)   Medication may be administered to patients only with a documented informed consent, except: in emergency situations or as authorized by a court. Medications shall be administered by a registered nurse, a licensed practical nurse, or a licensed physician.

(a) In emergency situations; or

(b) When administering over the counter medications; or

(c) As authorized by a court.

Medications  shall  be  administered  by  a  registered  nurse,  licensed practical nurse, or a licensed physician.

(3)       Sound and prudent professional judgement shall be exercised in the administration of medications.

(4)    Physicians' telephone orders may only be received by a registered nurse or registered pharmacist.

(5)      Medication must always be verified with the physician's order prior to transcription and administration.

(6)    Self administration of medication by a patient shall be permitted only when a special order is written by the patient's physician and as specified by BHO policy.

(7)        Medication shall be administered by the established standard drug administration  schedule  of  the  BHO  unless  otherwise  specified  by  the

physician.

(8)   All medication errors and/or adverse drug reactions (ADR) shall be immediately reported to the patient's physician and documented per department policy.

(J)   Education/competency/performance improvement

(1)     Physicians, nurses, and pharmacists shall hold current, valid, professional licenses and be in good standing with their licensing boards. All of these disciplines shall assist in educating direct care personnel regarding appropriate medication practices. The content of this rule shall be a part of employee orientation. Physicians, nurses, and pharmacists shall provide education and information relating to medication to staff, patients, and family.

(2)    The competency of each physician, nurse, and pharmacist shall be monitored, evaluated and documented on an ongoing basis as part of the BHO performance improvement program and consistent with BHO policies, procedures, and competency plans.

(3)   As part of the BHO performance improvement program, physicians, nurses and pharmacists shall identify, develop and implement indicators that address significant areas of medication standards of practice.

(K)Quality Assurance/Performance Improvement

(1) BHOs  shall  establish  mechanisms  that  make  patient  safety  in  the  area  of medication use a high priority.

(2) BHOs shall establish mechanisms to encourage a culture of safety that includes:

(a) Reporting of near miss errors and all medication errors and adverse drug reactions as specified in ODMH policy MD-03.

(b) Analysis  of  medication  use  processes  through  failure  mode  effects analysis to reduce or eliminate potential errors.

(3) BHOs shall establish mechanisms in coordination with the IBHS pharmacy and therapeutics committee to disseminate to clinicians current information on prevention of errors and improvement potentials.

(K)(L) Implementation

(1) The chief executive officer of each BHO shall be responsible for prescribing guidelines for implementation of this rule.

Replaces:                                 former 5122-2-13 and 5122-3-02

Effective:                                12/09/2002

CERTIFIED ELECTRONICALLY

Certification

11/29/2002

Date

Promulgated Under:   111.15

Statutory Authority:   5119.07, 5119.01

Rule Amplifies:           5119.01, 5119.07 Prior Effective Dates: 7/1/80, 2/10/90, 9/1/00