1 Participating Hospital Certification Form ATTENTION: this Certification Form is only applicable for Free Trial Product Units of ABILIFY MAINTENA (aripiprazole). Instructions: The Authorized Representative must perform the following for the Certification Form to be considered complete: Complete all required information marked with an *. Acknowledge all Terms and conditions by initialing in the appropriate box. Print name and title. Sign and date. Completed forms may be sent for processing via fax to 614-652-8810 or email Participating Hospital information: Hospital Name*. Shipping Address Line 1*. Shipping Address Line 2. City*. State*. Zip*. Hospital License Number*. Hospital License Number Expiration Date*. Pharmacy information: Pharmacy License Number*. Pharmacy License Number Expiration Date*. Pharmacist information: Pharmacist License Number*. Pharmacist License Number Expiration Date*. Please see IMPORTANT SAFETY INFORMATION on pages 5 and 6. Page 1 of 6. Affiliated Prescriber information: [If there are more than three (3) prescribers affiliated to a Participating facility, please contact Cardinal Health at 1-844-735-0717 or email HCP First & Last Name*.]
2 HCP License Number*. HCP License Number Expiration Date*. HCP First & Last Name HCP License Number HCP License Number Expiration Date HCP First & Last Name HCP License Number HCP License Number Expiration Date The Hospital Free Trial Program (Program) is intended to provide medication free of charge to a Hospital when a healthcare professional has determined that an adult patient admitted for the maintenance treatment of bipolar I disorder or the treatment of schizophrenia requires onsite treatment with ABILIFY MAINTENA (aripiprazole). The Program will permit designated pharmacists to order, on behalf of Participating hospitals that treat an appropriate patient population, limited quantities of ABILIFY MAINTENA free of charge, and at no cost to the patient or any payor. The Program is available to based facilities, that at the time of enrollment in the Program, do not accept Prescription Drug Marketing Act ( PDMA ) samples. If there is a change to any of the information provided, you are required to notify us immediately.
3 Please see IMPORTANT SAFETY INFORMATION on pages 5 and 6. Page 2 of 6. Program Terms and conditions Acknowledgment Authorized Representative to acknowledge all Terms and conditions below on behalf of Participating Hospital and Participating Hospital employees by initialing in each box below. You can access these rules at any time by logging into your account on They will also be included for your reference on the invoice in each shipment. TERMS ABOUT THE FREE TRIAL PRODUCT: Free trial product (Product) is provided free of charge for administration to appropriate hospitalized patients. Neither the Product, nor any services associated with the administration of the Product, may be billed by any party, to the patient, the patient's insurance carrier, any government healthcare program or any other third party. There is no requirement for subsequent use of ABILIFY MAINTENA (aripiprazole) for any patient receiving a free trial unit. Product received pursuant to this Program may not be sold, traded, bartered, or returned for credit.
4 Participating Hospital must notify relevant payor(s) about the existence of the Program and the fact that the Product is provided under the Program at no charge to the Hospital . Product units are commercially labeled as trade product and not labeled as sample product. The Participating Hospital and its pharmacy must have the ability to track utilization of this Program and Product by each patient and establish adequate controls to ensure that Product received under this Program is appropriately segregated and tracked. Otsuka America Pharmaceutical, Inc. reserves the right to audit these controls. There is a maximum limit of two (2) Product units per patient per calendar year, which should be acknowledged upon receipt of the shipment. Additional quantity limits may apply. Participating Hospital RULES: Available only to appropriate Hospital pharmacies that cannot or will not, at time of enrollment, accept PDMA- compliant samples. Participating hospitals are not permitted to be enrolled in both Otsuka's PDMA sample program, treatNOW, and Otsuka's Hospital free trial program simultaneously.
5 Pharmacy must be able to provide a distinct delivery location (floor, suite, office) for shipment of Product for inpatient use that is separate and distinct from the delivery address of samples, if any, that are also being shipped to the same mailing address for outpatient use. Participating Hospital must be authorized and in good standing to request and receive free trial Product under applicable state and federal laws as well as Otsuka policy. Participating Hospital will adhere to ongoing Program requirements such as timely return of the Acknowledgement of Contents ( AOC(s) ) form and annual re-enrollment form. Failure to complete AOC(s) within ninety (90) days will result in a temporary suspension of the Program for the pharmacist, pharmacy, and Hospital . Repeated failure to meet any of these requirements may result in suspension or termination of Participating Hospital 's enrollment within the Program. There is an employment or contractual relationship between the pharmacist ordering the Product and the Participating Hospital to which the units are sent.
6 For hospitals that do not have an on-site owned and operated pharmacy, the Hospital may receive free trial units for its patients through an off-site pharmacy owned by the Hospital or pharmacy operated by a third party on behalf of the Hospital , if the Hospital designates the pharmacy and the pharmacy provides the required Certification and meets Program requirements. Twice a year, hospitals receiving free trial units from a pharmacy that is not on-site owned and operated by the Hospital will be required to acknowledge their receipt of the free trial units requested by the pharmacy, provide confirmation of a tracking mechanism, confirm only two (2) units were dispensed per patient per year, and confirm compliance with Program requirements. Please see IMPORTANT SAFETY INFORMATION on pages 5 and 6. Page 3 of 6. OTHER PROGRAM RULES: Otsuka has the right to modify the terms and conditions of this Program or terminate the Program, or your enrollment, at any time, for any reason, without notice.
8 Signature Authorized Representative Signature Authorized Representative Printed Name Authorized Representative Title Date For questions regarding the Program call 1-844-735-0717, 7:00 6:00 CST. Please see IMPORTANT SAFETY INFORMATION on pages 5 and 6. Page 4 of 6. INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFY MAINTENA (aripiprazole). INDICATIONS. ABILIFY MAINTENA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults Maintenance monotherapy treatment of bipolar I disorder in adults IMPORTANT SAFETY INFORMATION. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death ( to times) compared to placebo-treated patients. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis. Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.
9 Cerebrovascular Adverse Events, Including Stroke: Increased incidence of cerebrovascular adverse events ( , stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia- related psychosis treated with oral aripiprazole. Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs including ABILIFY MAINTENA. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of ABILIFY MAINTENA, intensive symptomatic treatment, and monitoring. Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible, are believed to increase with duration of treatment and total cumulative dose of antipsychotic drugs.
10 TD can develop after a relatively brief treatment period, even at low doses, or after discontinuation of treatment. Prescribing should be consistent with the need to minimize TD. If antipsychotic treatment is withdrawn, TD may remit, partially or completely. Metabolic Changes: Atypical antipsychotic drugs have caused metabolic changes including: Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics including aripiprazole. Patients with diabetes mellitus should be regularly monitored for worsening of glucose control; those with risk factors for diabetes ( , obesity, family history of diabetes), should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.