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Overview
Complete
28 Jun 2019 / Kate Marcus / SafeDrugs Pharmacy
Pharmacy Audit Checklist
Inspection score
63.04%
Created actions
1
Site
Manila
Site
SafeDrugs Pharmacy
Registered Address
2375 Jones St., Dallas TX 75234
Pharmacy Manager
Kate Marcus
Conducted on

28th Jun, 2019

1:57 PM +08

Actions
1
Pharmacy Audit Checklist
1
63.04%
Prescribing Practices
66.67%
Does the prescription presented for fill appear trustworthy or is the prescriber familiar?
Yes
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Is the prescription written for a legitimate medical purpose within the prescriber’s scope of practice?
Yes
Is a combination of prescriber communication and patient counseling used to confirm the prescription is written for a U.S. Food and Drug Administration (FDA)-labeled or approved compendial indication?
No
Consult State-approved compendial sources, which vary by State and consider prescriptions written for drug classes often associated with inappropriate prescribing practices.
Are Transmucosal immediate-release fentanyl (TIRF) prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?
Yes
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Are buprenorphine-naloxone prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?
No
Ask the ff. questions: What did your prescriber tell you the medication is for? How did your prescriber tell you to take the medication? What did your prescriber tell you to expect? Verify the prescription has been written by a prescriber who is in compliance with the Drug Addiction Treatment Act (DATA) requirements. Contact the prescriber if the drug is used to treat pain or any indication other than opioid dependence maintenance.
Are atypical antipsychotic prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?
Yes
Are pediatric antipsychotic prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled, compendial, or off-label indication?
Yes
Are caregiver counseling procedures examined for pediatric second-generation antipsychotic prescriptions?
Yes
Are Phosphodiesterase inhibitors (PDEI) prescriptions carefully to determine if the patient will use the product for an FDA-labeled or compendial indication?
No
If the drug is being used for erectile dysfunction (ER), explain the exclusion to the patient and offer a self-pay cash option for the prescription.
Are topical retinoid and injectable botulinum toxin prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?
Yes
Are incretin mimetic prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?
Yes
Are amphetamine and cannabinoid prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication.
No
If the drug is being used for an off-label use, such as to enhance academic performance, treat depression, or enhance weight loss, explain the exclusion to the patient and offer a self-pay cash option for the prescription.
Controlled Substances
55.56%
Do hiring procedures include adequate background checks?
No
Conduct a financial and criminal background check after consulting with your State police agency or pharmacy association. Consult your State pharmacy board to determine whether any prior disciplinary action has been taken against the potential employee.
Are there no vulnerabilities for internal diversion?
No
Consider a policy on checking employees’ personal bags. Require boxes be broken down inside the pharmacy. Dispose of all regular pharmacy trash in clear bags and store all waste in secured trash bins. Account for outdated drugs removed from the pharmacy shelf. Use a tamper-evident or resistant receptacle for drugs awaiting transport.
Has the controlled substance inventory management been carefully examined?
Yes
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Has the documentation of a physical inventory that has taken place within the last 2 years been carefully examined?
Yes
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Do all staff members know what to do when a controlled substance loss takes place?
Yes
Has the pharmacist-in-charge (PIC) met all legal and regulatory requirements and responsibilities?
No
Perform a complete controlled substance inventory and complete State-specific requirements, there is an incoming or outgoing PIC.
Is the pharmacy complying with State Prescription Drug Monitoring Program (PDMP) regulations to address vulnerabilities for external diversion by patients?
Yes
Do vulnerabilities exist regarding physical security of the pharmacy?
Yes
Are current procedures communicated with other professionals—prescribers, other pharmacies, law enforcement, and State licensing boards?
No
Document and disseminate information received from prescribers, between pharmacies in and around your local area, by State and local law enforcement, and by State licensing boards. Create a notebook to store external communications received so pharmacy personnel can readily review the communications.
Invoice Management
54.55%
Are amounts of medications that appear on purchased products from wholesale distributors and other applicable company invoices or receipts reviewed?
Yes
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Is there no invoice shortage?
No
In an invoice shortage, payers may suspect you have billed them for: drugs obtained from illegal sources, prescription drug samples, drugs returned to stock, on drugs returned from institutions or patients.
Are all wholesale distributors and other applicable companies with whom the pharmacy does business reputable?
Yes
Do pharmacy staff members know about appropriate procedures with regard to medication samples?
Yes
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Do pharmacy staff members know about appropriate procedures to return medications to stock?
Yes
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Do pharmacy staff members know about appropriate procedures when accepting medications returned from institutions or patients?
Yes
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Do pharmacy staff members know about prescription “shorting” (providing the patient with a quantity less than the prescriber ordered)?
No
Talk to pharmacy staff members. Require the pharmacist who fills any controlled substance or high-dollar prescription and one other person to double count the medication whether manually or robotically and initial the quantity filled and be proactive and alert staff that you monitor inventory.
Are pharmacy practices related to pharmacy sales examined?
Yes
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Do pharmacy staff members know about POS billing parameter manipulation?
No
Talk to pharmacy staff members. Do not dispense a generic drug while submitting a claim to a third-party payer for the brand name drug. Do not submit a claim for a contracted NDC product while dispensing a non-contracted NDC product. Do not split prescriptions into multiple fills within 1 month unless the patient requests to fill only a partial quantity of the amount of drug prescribed.
Do pharmacy staff members know about coordination of benefits billing procedure manipulation?
No
Talk to pharmacy staff members. Do not submit claims to multiple insurance providers without coordination of benefits. Do not list more than one health plan as the primary provider for coordination of benefit claims. Do not submit a claim to a manufacturer’s assistance program as if a patient is uninsured and also submit a claim to a primary insurance provider.
Do pharmacy staff members know about phantom claims?
No
Talk to pharmacy staff members. Establish a procedure to reconcile prescription sales, claims, and inventory receipts for prescription drugs. Verify documentation for prescription claims most commonly associated with fraud. Confirm each prescription claim is supported by corresponding documented verbal prescription order, electronically generated prescription, or prescription hard copy
Billing Practices
71.43%
Are billing procedures discussed with staff to determine if they correctly submit claims for drugs commonly submitted with improper billing units?
Yes
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Are prescription requirements for non-controlled and controlled substances reviewed?
Yes
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Are staff members able to correctly calculate a day’s supply for prescriptions?
No
Multiply the number of doses per day by the number of days of therapy to determine the correct quantity to dispense. Reverse-verify by dividing the quantity dispensed by the number of doses per day to determine the number of days’ supply.
Do pharmacy staff members know about prescriptions written for odd quantities?
Yes
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Do pharmacy staff members know about prescriptions written for doses that exceed FDA labeling?
Yes
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Do pharmacy staff members about prescriptions that include the use-as-directed sig code for dispensed quantities more than one billing unit per month?
No
Talk to pharmacy staff members. Document frequency of use and size of area to be treated for shampoos, creams, and ointments. Document number of headaches treated per month for migraine medications. Document exact regular dosage and maximum daily dosage for any sliding scale directions for insulin. Document maximum use per day for diabetic syringes, test strips, or lancets.
Do pharmacy staff members know about refill practices?
Yes
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Are possible patient-driven inappropriate refill practices?
Yes
Do pharmacy staff members know about overrides at the POS?
Yes
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Do pharmacy staff members know about prescription origin codes?
No
Talk to pharmacy staff members. Do not alter prescription origin codes and verify the prescriber DEA number and office telephone number for all controlled substances prescriptions received by telephone. If the caller or prescriber is unknown, confirm the contact information with a secondary source.
Do pharmacy staff members know about product selection (dispense as written—DAW) codes?
No
Talk to pharmacy staff members. Only use the DAW 1 product selection code when the prescriber has indicated product substitution is not allowed on the prescription and only use the DAW 2 product selection code when the patient has requested to receive the brand name drug rather than the generic equivalent.
Do pharmacy staff members know about partial fill procedures?
Yes
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Do pharmacy staff members know about how they select package sizes when more than one size is available?
Yes
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Do pharmacy staff members know about how they document beneficiary receipt of prescriptions?
Yes
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Completion
1
Additional Observations
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Actions
To do
Follow best practices on questions with “no” as an answer
Pharmacy Manager Name & Signature
Kate Marcus
28th Jun, 2019 3:22 PM +08
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