Subject: UW School of Dentistry Comprehensive Medication Policy
Effective Date: December 2014
Revision Dates: June 2015
Purpose
This policy provides all School of Dentistry faculty and employees guidance in the following areas of drug management:
I. Drug Procurement, Distribution, and Control
II. Medication Storage and Security
III. Administration of Medications
IV. Dispensing of Medications
V. Medication Error Reporting
VI. Medications Reference Materials
VII. Responsibility of the Consultant Pharmacist
VIII. Closing a Health Care Entity
General Policy
This policy provides comprehensive guidance on all areas of medications management in the UW School of Dentistry. Adherence to each component is fundamental to patient safety and compliance with Washington State law.
Implementation
I. Drug Procurement, Distribution, and Control
The UWMC department of pharmacy is responsible for the evaluation and appropriateness of all medications distributed to UW School of Dentistry Clinics. The clinics will have a reasonable supply of clinic stock medications as approved by the UW SOD Medication Oversight Committee. Medications approved for clinic stock will be evaluated for patient safety, regulatory and documentation compliance. All clinic stock medications will be cost transferred to the requesting departmental budget. These medications are intended for administration in the clinic.
1. UWMC Pharmacy will fill clinic stock orders from UWSOD Central Purchasing. All medications will be listed in an approved clinic stock requisition. The Associate Dean of Clinical Services will assign a responsible designee to order and maintain the central medication inventory.
2. The pharmacy will only fill items officially printed on the clinic stock requisition form or submitted through the official secure online system. Items that are handwritten in will not be filled.
3. The medications will be delivered via sealed box including a copy of the requisition to UWSOD Central Purchasing. All medications will be received by the responsible designee assigned by the Associate Dean of Clinical Services. Medications received will be checked against the copy of the requisition sent by the pharmacy.
4. Requested medications will be cost transferred to the UWSOD Central Purchasing budget, and subsequently cost transferred to interdepartmental budgets. The clinic and UWMC Pharmacy will maintain a current file with a copy of the purchase request and the invoice provided by pharmacy for a minimum of 2 years.
5. Medications supplied, as clinic stock must only be administered in a UWSOD clinic and documented in the medical record. Patient supplied medications are not to be administered by clinic staff.
6. To request a new medication for clinic stock the following steps will need to occur:
a) The Medication Oversight Committee will determine by majority vote that the medication should be added to the approved UWSOD stock requisition.
b) The UWSOD Central Purchasing clinic manager will request addition or deletion to clinic stock list via the clinic stock email (clincmed@u.washington.edu).
c) UWMC pharmacy will notify the clinic manager that the request has been received.
d) UWMC pharmacy will review the request using one or more of the following criteria for adding or deleting medications from the clinic requisition form, CDM and fee sheet:
• Medication requires no additional pharmaceutical admixing or compounding prior to administration.
• Medication can be stored appropriately in clinic to maintain sterility and stability.
• Medication can be stored securely as outlined in the medication security policy.
• Medication is administered as part of a routine patient-care procedure conducted in clinic and does not require pharmacist order review prior to administration.
• Medications that pose a high allergy risk would require additional safety processes in place before being considered for clinic stock (antibiotics).
• Medications with a high acquisition cost would need to have a specialized process in place to insure appropriate billing and security before being considered for floor stock.
• If the medication is determined to be appropriate for clinic-stock the Pharmacy will contact the Revenue Cycle Management team to update the CDM or charge master and fee sheet.
7. Appropriate medication quantities will be stocked to minimize outdated medication and waste.
8. The consultant pharmacist will review inventory during the monthly unit inspection to ensure appropriate drug storage and control:
a) Drug stock will be rotated as appropriate when new stock is delivered.
b) Expired medications are removed from stock and taken to UWSOD Central Purchasing for quarantine. A representative from UWSOD Central Purchasing will arrange for regular disposal of quarantined drugs by an authorized reverse distributor.
9. Medications not included in the UWSOD stock requisition may be dispensed to patients by a prescription written by an appropriately licensed member of the UWSOD faculty.
II. Medication Storage and Security
To ensure the appropriate storage and security of medications located in the UW School of Dentistry Clinics.
A. Physical Area
1. The area where medications are stored is neat, clean and maintained at the appropriate ambient temperature and protected from light if necessary.
2. Medications are stored in secured areas only. Medications are stored in cabinets or rooms which are locked to prevent access by persons not designated to administer medications.
B. Storage Locations
1. Disinfectants and externals are separated from internals and injectables.
2. Antiseptics and cleaning solutions are stored in the original container; if they are mixed or poured into another container then they must be clearly labeled.
C. Refrigerated Medications
1. The temperatures of any medication refrigerators are logged daily on a temperature tracking form by clinic staff.
2. The temperature should be maintained between 2 – 6 degrees C (36-46 degrees F).
3. The refrigerators should be clean and free of excessive frost.
4. No food items are stored in medication refrigerators. If a non-medication item (e.g. supply) is stored in a medication refrigerator it must be segregated.
5. If a refrigerator is found to be outside of the required temperature range,
appropriate action must be taken to return the temperature to the required range. In the event that medications are found to be unrefrigerated the consultant pharmacist must be contacted within 24 hours for assessment.
D. Emergency Medications
1. Emergency medications are stored in secure, tamper-proof containers.
2. An additional supply of emergency medications and locks are stored in UWSOD Central Purchasing as immediate replacement stock. To ensure the clinic has a continual supply.
3. The emergency containers are checked monthly by clinic staff.
4. The containers are sealed with a numbered plastic lock obtained from the UWMC Pharmacy. The medications are placed in the container by a licensed employee and sealed, assuring that the contents are complete and within the expiration date.
5. The expiration date of each medication and lock number shall be documented on an emergency checklist outside of the box to assist in assuring that the contents are within date and unadulterated.
E. Controlled Substances
1. Locations where controlled substances are stored require a manual perpetual inventory.
2. The date and time on which the inventory is taken must be indicated on the perpetual inventory log.
3. Controlled substances may be ordered by individual clinics by placing a purchase requisition with UWSOD Central Purchasing. The UW SOD institutional DEA license will be used for purchase of all controlled substances. Medications requiring a DEA 222 form will be authorized and procured using that form with the signature verification of the Associate Dean of Clinical Services or other authorized representative.
4. Controlled substances will be distributed from UWSOD Central Purchasing to individual clinics to be administered only by providers who are legally authorized to administer controlled substances.
5. Controlled substances stocked in clinics must be stored in a secure (locked) location.
6. Any controlled substance theft or loss shall be immediately noted on the inventory log and reported to the Clinic Manager and the Consultant Pharmacist.
7. Wasting of Controlled Substances
a. When a prepared dose is refused by the patient, canceled by the provider or a partial dose is administered, the dose shall be promptly disposed of in a sink. This action is recorded, signed and counter-signed by a second person who witnessed the destruction on the Controlled Substances Inventory Record.
b. When a prepared dose(s) is accidentally destroyed, the person responsible shall record, sign and have a counter-signature by a second person who witnessed the accident on the Controlled Substance Inventory Record.
c. All waste must be documented as witnessed by a second person who has legal authority to administer or dispense controlled substances.
F. Sample Medications:
1. The UW School of Dentistry Clinics will not store or dispense sample medications.
2. Any exception to this policy must receive prior approval from the UWSOD Medication Oversight Committee and follow all regulations pertaining to safe handling and dispensing.
III. Administration of Medications
Drugs shall be administered only upon the order of a practitioner who has been granted clinical privileges to give such orders in accordance with state and federal laws and regulations governing such acts and in accordance with approved UW School of Dentistry policy. (WAC 246-873-090)
A. Safely Administering Medications in the UW School of Dentistry Clinics
1. Allergies of patient must be known before administering any drug. The provider and person administering the medication will verify that the medication is not contraindicated for the patient.
2. Qualified personnel administering the medication should always check the five RIGHTS:
a) Right patient
b) Right medication (including assuring the medication is not expired)
c) Right dose
d) Right route
e) Right time
3. For routine medications, qualified personnel will:
a) Read the medication to be administered
b) Verify the patient name, date of birth, and medical record
c) Ask patient to state name and date of birth
d) Complete the documentation immediately
4. Qualified personnel include: Dentists, dental students, dental assistants, dental hygienists, and dental anesthesia assistants at UW School of Dentistry Clinics
(within their scope of practice, department standard, in accordance with WAC 246-873-090, and WAC 246-817-701 through 246-817-790).
5. Medication Routes of Administration–The actual technique for giving medications via different routes includes: IV, Parenteral, oral, topical, inhaled and sublingual.
6. The UW School of Dentistry Clinics will not store or administer a patient’s private medication. All medication administered will be from a supply source ordered by the clinic.
7. Self-administration of medications shall occur only within approved protocols in accordance with a program of self-care or rehabilitation. Policy and specific written procedures, approved by the appropriate faculty and administration shall be established by the consultant pharmacist.
B. Documentation of Medications Administered
1. All medications should be documented in the patient record immediately after administration.
2. Charting includes the medication name, dosage, route of administration, site, time and date.
C. Multi-dose Vials (MDVs) and Irrigation Solution Containers
1. The multi-dose vial will be inspected prior to each use and discarded if showing signs of contamination. Contamination could include any haze, color change, cloudiness, surface film, particulate matter, gas formation, blood tinged or any other suspicion of contamination. All multi-dose vials must be stored under appropriate conditions at all times before and after they have been opened.
2. When a multi-dose vial is used for the first time, the beyond use date will be written on the vial. The beyond use date is equivalent to the expiration date. The beyond use date is as follows:
• Multi-dose vaccines: The manufacturers expiration date (exception: FluLaval which expires 28 days after initial stopper penetration)
• All other multi-dose vials: 28 days after initial stopper penetration, or the manufacturer’s expiration, whichever is sooner.
• Whenever sterility or stability is questioned or compromised
3. Irrigation Solutions (Sterile Water, Normal Saline) without preservatives must be labeled when opened and discarded 24 hours after opening.
IV. Dispensing of Medications
The practice of dispensing medications to patients directly from the clinics must be approved by UWMC Pharmacy. Medications dispensed to patients directly from the clinic as a take-home medication must be appropriately labeled according to all state and federal statutes. Patients must receive verbal instructions from the appropriately licensed
practitioner prior to dispensing the medication. The practitioner must document the medication dispensed and the instructions provided in the patient’s medical record.
A. Documentation
1. Medications dispensed shall be documented in the patient’s medical record.
2. A log of all medications dispensed to patients will be kept on file in the clinic and reviewed by the consultant pharmacist every month.
B. Patient Verification
1. Verify patient by asking them to state their name and date of birth.
C. Labeling
1. Medications dispensed shall have a fixed label with the following information:
a) name and address of the clinic
b) name of the prescriber
c) the name and strength of the medication
d) prescriber directions
e) name of the patient and date of birth
f) date dispensed
g) expiration date
2. Also included on the label must be the following statement: “Warning: State or federal law prohibits transfer of this drug to any person other than the person for whom it was prescribed.”
3. The information contained on the label shall be supplemented by oral or written information from the prescriber as required by WAC 246-869-220.
D. Instructions to Patients
1. Patients must receive verbal instructions from the appropriately licensed practitioner prior to dispensing the medication.
2. The practitioner must document the instructions provided in the patient’s medical record.
V. Medication Error Reporting
An adverse event may be defined as any event or circumstance not consistent with the normal operations of the UWSOD and its staff, or the routine care of a patient. It may be an occurrence, complication, product failure, accident, or situation which could have or not resulted in injury/harm to a person, property loss or damage, significant patient or visitor dissatisfaction, or interruption in clinical services. Identified medication errors are immediately reported in the electronic (1) Patient Safety Network (PSN) reporting system or (2) UWSOD Incident Report or (3) Online Adverse Reporting System (OARS).
A. Reporting Errors
1. In Case of an Adverse Event in any procedure refer to UW SOD Event Reporting Policy.
a) Immediately notify the senior faculty member or the clinic director in the department.
b) The clinic director will notify Health Sciences Risk Management (598- 6303)
c) The faculty member with Health Sciences Risk Management or clinic director will inform the patient or family of the event as soon as possible.
d) The dental team involved in the event will complete an incident report via UWSOD Incident Report.
2. All medication errors shall be immediately reported to the senior faculty member or the clinic director in the department. They shall be notified of any adverse reaction to the medication and will determine if additional intervention or treatment is required. Medication errors are documented in the Patient Safety Network (PSN) reporting system. The senior faculty member and the Clinic Manager will investigate the situation and review the event with the appropriate personnel. Medication error data is reviewed by the Consultant Pharmacist and the UWSOD Medication Oversight Committee.
C. Reporting of Suspected Adverse Drug Reactions
An adverse drug reaction (ADR) shall be defined as any response to a drug that is noxious and unintended and that occurs at doses used for prophylaxis, diagnosis, or therapy, excluding failure to accomplish the intended purpose.
1. Types of reactions to be reported:
a) Idiosyncrasy – an uncharacteristic response of a patient to a normal dose and route of a drug.
b) Drug-drug interaction.
c) Allergic reaction and hypersensitivities.
d) Side effects – an adverse pharmacologic effect of a drug not associated with the therapeutic purpose for which the drug is given.
e) Unexpected detrimental effects not previously reported in the literature.
f) Drug intolerance – lowered threshold to a normal dose of the drug.
2. Severity of reactions:
a) Minor reactions: those reactions that do not require drug discontinuation, antidotal, or corrective therapy, or prolonged hospitalization.
b) Moderate reactions: these reactions requiring corrective measures and/or discontinuation of the medication and/or prolonged hospitalization.
c) Severe reactions: those reactions considered potentially life-threatening or fatal.
If any adverse drug reaction occurs, first provide prompt and immediate attention to the patient. Next notify the provider to confirm the reaction and to receive and implement appropriate orders.
3. Adverse drug reactions are reported in the following manner:
a) For all suspected adverse drug reactions, report incident report electronically via Patient Safety Network.
VI. Medications Reference Materials
All medication reference lists and charts distributed in the UW School of Dentistry Clinics shall be reviewed and approved by UWMC Pharmacy before being posted for general use.
A. Reference Material Guidelines for Medical, Nursing and other Clinic Providers.
1. New medication references to be considered for posting shall be sent to the Associate Dean for Clinical Affairs for review.
2. The Associate Dean for Clinical Affairs or designee shall review the reference for applicability, safety and accuracy.
3. The reviewed document shall, after review and approval, have an indicator displayed on the document, which shall identify the date and approval of the reference document.
4. Posted documents shall be reviewed by the consultant pharmacist each year during routine unit inspections.
5. The following references are available:
a) Metric weight and measure conversion charts
b) Poison control center contact information
c) Consultant Pharmacist and Pharmacy Emergency Contact Information
VII. Responsibility of the Consultant Pharmacist
The UWMC Director of Pharmacy will designate a consultant pharmacist to be the pharmacist in charge for the UWSOD. The appointed consultant pharmacist will be employed by UW Medicine – University of Washington Medical Center and must be licensed to practice pharmacy in the state of Washington. The consultant pharmacist shall have the authority and responsibility to assure that the area(s) within the UW School of Dentistry Clinics where drugs are stored, compounded, delivered or dispensed are operated in compliance with all applicable state and federal statutes and regulations. (WAC 246-904-030)
A. Duties and Responsibilities of for the consultant pharmacist or pharmacist in charge of the UW School of Dentistry Clinics.
1. To create and implement policy and procedures relating to:
a) Purchasing, ordering, storing, compounding, delivering, dispensing or administering of controlled substances or legend drugs.
b) Accuracy of inventory records, patient medical records as related to the administration of controlled substances and legend drugs, and any other records required to be kept by state and federal regulations.
c) Adequate security of medications and controlled substances.
d) Controlling access to controlled substances and medications.
2. To assure that the Washington state board of pharmacy is in possession of all current policies and procedures related to medication management for the UWSOD Clinics.
3. To review all requisitions for medications including controlled substances.
4. To verify receipt of all medications including controlled substances ordered by the clinic.
VIII. Closing a Health Care Entity
It is the policy of UW School of Dentistry to notify the pharmacy board when a licensed Health Care Entity ceases to operate and ensure that any remaining medications are safely transferred and accounted for. (WAC 246-869-250 and WAC 246-904-100)
1. Whenever a Health Care Entity (HCE) ceases to operate, the consultant pharmacist shall notify the pharmacy board of the pharmacy’s closing not later than fifteen days prior to the anticipated date of closing. This notice shall be submitted in writing and shall contain all of the following information:
a) The date the Health Care Entity will close.
b) The names and addresses of the individuals who shall have custody of the prescription files and the controlled substances inventory records of the Health Care Entity to be closed.
c) The names and addresses of any individuals who will acquire any of the legend drugs from the Health Care Entity to be closed.
2. Not later than 15 days after the Health Care Entity has closed, the Consultant Pharmacist shall submit to the pharmacy board the following documents:
a) The license of the HCE that closed.
b) A written statement containing the following information.
c) Confirmation that all legend drugs have been transferred to an authorized person (or persons) or destroyed. If the legend drugs were transferred, the names and addresses of the person(s) to whom they were transferred.
d) If controlled substances were transferred, a list of the names and addresses to whom the substances were transferred, the substances transferred, the amount of each substance transferred, and the date on which the transfer took place.
e) Confirmation that the drug enforcement administration (DEA) registration and all unused DEA 222 forms (order forms) were returned to the DEA.
f) Confirmation that all pharmacy labels and blank prescriptions which were in the possession of the HCE were destroyed.
Dean of UW SOD:
Joel Berg
June 19, 2015