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3751 DEL REY BOULEVARD

LAS CRUCES, NM 88012

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on record review and interview the patient's representative was not afforded the right to make an informed decision regarding medications for 3 (P#s 1, 4, and 5) of 10 adolescent patient records reviewed. LARS (Legally Authorized Representatives) signed consents for multiple psychotropic (medications which affect a patient's mental state) medications which may or may not have been administered during the in-patient stay. The failed practice can result in non-compliance with medication regimen if the patient or LAR do not understand the rationale for taking the medication; fail to adequately recognize side effects which may result from taking multiple medications; and fail to deal with physical and mental symptoms associated with withdrawal from medications when are discontinued.

A. Record review of P#1's MAR (Medication Administation Record- record of drug administration to a patient)dated 04/08/20 (admission) to 04/14/20 (discharge to PHP - partial hospitalization program) revealed no psychotropic medications were administered and no consents were obtained for psychotropic medications.

B. Record review of complaint dated 04/16/20 revealed, "Dr took patient off medications and did not tell LAR that he was doing that" (P#1 was taking multiple medications including Wellbutrin (antidepressant), Lithium (mood stabilizer) and Trileptal (also mood stabilizer) prior to 2nd admission to same facility 04/08/20. Complainant stated the LARs (parents) only received 1 call from facility staff regarding comfort medications such as Tylenol.

C. Record review of P#5's Physician Medication Orders dated 08/19/20 revealed P#5 was prescribed Olanzapine, Risperidone, and Fluoxetine (Prozac) (Medications used to treat certain mood conditions) during admission. A consent form dated 08/20/20 was signed for Quetiapine (antipsychotic medicine that is used to treat schizophrenia), Aripiprazole (Abilify medication used to treat schizophrenia and bipolar disorder), Risperidone (medication used to treat schizophrenia by changing chemicals in the brain), and Olanzapine (medication used to treat schizophrenia and bipolar disorder) by the ordering physician.

D. On 09/11/20 at 2:15 pm during interview, LAR for patient #5 confirmed that no medications were to be given to P#5 until consult obtained with obstetric physician at another facility. LAR also confirmed that after speaking with the facility physician who obtained consent, LAR looked up the medications online and placing a call to the physician due to the side-effects listed for some of the medications which included seizures. LAR stated P#5 has a history of seizures which the physician did not seem to be aware of. LAR confirmed patient is 30 weeks pregnant and any medication given to P#5 may also be given to the baby. LAR reported she did not remember physician speaking with her about Quetiapine and was not aware of the side effects of the medication. LAR also confirmed P#5 is paranoid about taking medications feeling that the medications are "poison" and sometimes she will not take her medications.

E. Record review of MD/PMHNP (Medical Doctor/Psychiatric Mental Health Nurse Practitioner) Progress Note dated 08/20/20 revealed, "Writer called LAR. LAR provided collateral information, agreed with the plan and consented to medications. On 08/21/20 note revealed, "increase risperidone to 0.5 mg (unit of measure), continue to advise patient to take medication, consider bringing up other medications that LAR consented to.

F. Record review of P#4's Physician Medication Orders dated 08/18/20 revealed Risperidone and Lamotrigine (to delay mood episodes in adults with bipolar disorder - manic depression) were prescribed. Consents (for Mood Stabilizers) dated 08/18/20 were signed for 9 different psychotropic medications during the most recent stay at the facility including Divalproex (used to treat bi-polar disorder), Lamotrigine (used to treat bipolar disorder), Risperidone (used to treat schizophrenia), Quetiaprine (used to treat schizophrenia, bipolar disorder and depression), Olanzapine, Aripiprazole (used to treat schizophrenia bipolar disorder and depression), Ziprasidone (used to treat psychosis), Clonidine (used to treat attention deficit disorder), and Prazosin (used to treat PTSD-post traumatic stress disorder)

G. LAR for P#4 confirmed that during a previous admission at the facility, P#4 was taken off Prozac (medication used to treat depression) and after 1 day, LAR was told it was time to pick up P#4. LAR told facility staff it was too soon to determine what side-effects P#4 would be experiencing from the withdrawal of Prozac and confirmed seeing the side-effects of the withdrawal when P#4 was sent home 1 day later. LAR also confirmed physician asked for consent for P#4 to receive numberous medications, but understand that it was understood that any change in dose or type of medication required a phone call for consent. LAR stated that 1 of the medications had been previously prescribed and caused lumps to form in P#4's breasts, but P#4 was again started on Respiradone. LAR stated not knowing a lot about medications and leaving it up to the doctor to decide what was best.

H. Record review of Adverse Effects of Psychotropic Medications published in the Psychiatric Clinical Journal of North America dated 2016 revealed, "Adverse effects (a more appropriate term than side effects) of psychotropic medications are often viewed by clinicians as the unfortunate, unwanted, and perhaps inevitable accompaniments of the benefits of these medications. To the persons taking these medications, however, the distress caused by these adverse effects is as important as that caused by the symptoms of the disorder being treated. Patients are put in the unfortunate position of having to weigh the benefits of the medications against the burden of adverse effects. Given how important adverse effects are to patients, and often to their families, and given the central role they play in nonadherence to medication, it is astonishing how little attention has been paid to the identification and management of these adverse effects. Clinicians need to fully appreciate the extent to which nonadherence is a pervasive problem that vitiates the effectiveness of psychotropic medications.Adverse effects need to be viewed not as a necessary and unavoidable price to be paid for the benefits of treatment but as a major cause of suffering and nonadherence that need to be energetically prevented, reduced, and managed."

I. On 09/11/20 1010 am during interview, Medical Director confirmed it is common practice to obtain consent for multiple psychotropic medications at the same time because it is very difficult to get hold of some of the guardians (LARs). He also confirmed that after the consents are obtained, any of the medications could have been started during hospitalization. MD stated that sometimes patients are in the facility for 3 days and not receiving treatment because facility staff are unable to contact LARs. P#4's LAR answered on the 1st ring when contacted by surveyor. P#5's LAR required 2 phone calls from surveyor for interview, but confirmed if the physician had called her, she would have immediately returned the physician's call.

J. Record review of facility policy Informed Consent for Psychotropic Medication dated 07/19 revealed, "The Practitioner/RN (Registered Nurse) or LPN (Licensed Vocational Nurse) will discuss prescribed medications with the patient (parent and/or guardian in the case of a minor at the time of admission or at the time a new psychotropic medication is ordered: The discussion will include both the benefits, warnings, side effects, alternatives and significant risks involved in taking the medications to obtain informed consent."