12.1 General
1. The medication management shall be integrated into the dental organization management system.
2. The dental organization shall designate a qualified individual to appropriately manage and account for pharmaceutical resources.
3. Medication services shall meet the needs of patients’ safety and therapeutic goals by adhering to practices that ensure optimal use of medications relative to dosage, frequency, route, duration, and safe injection techniques.
4. Medication management shall include but may not be limited to:
a) the procuring, dispensing, ordering, distributing, disposition, use, and appropriate safe administration of all medications meeting the needs of the patient;
b) maintenance and calibration of medication related equipment and devices where applicable;
c) provision of medication-related information to dental professionals and patients in order optimize therapeutic outcomes and patient satisfaction.
5. Use of multidose vial medications shall be avoided in favor of single dose preparations to prevent and mitigate potential disease transmission. Alternatively, medication vials and single use syringes loaded and prepared in a clean area (i.e. pharmacy or other suitable clean area using sterile technique), shall be required for patient use.
NOTE 1 The "One and Only One" policy surrounding injection safety can be found at CDC web site at: https://www.cdc.gov/injectionsafety/index.html and https://www.cdc.gov/injectionsafety/ip07_ standardprecaution.html. These recommendations define appropriate use techniques in order to prevent HVC and HIV infectivity in patient via contaminated multidose vials and IV fluid vectors caused by improper handling and methodology.
6. Outdated, expired, mislabeled, or otherwise unusable medications shall not be available for patient use. They shall be sequestered, labeled, and disposed of as an unusable non-conforming product. This disposition shall be in keeping with national law.
12.2 Education, Monitoring, and Measuring
1. Continuing medical education related to preparation and administration of pharmaceuticals shall be required for practicing dental professionals. This education may include but is not limited to the following:
a) safe handling and preparation of authorized medications including appropriate hand hygiene;
b) knowledge of the indications, side effects, drug interactions, compatibility, and dose limits of administered medications;
c) equipment, devices, special procedures, and/or techniques required for safe medication administration.
2. Reference information relating to medication use including interactions, adverse effects, toxicology, dosage, indications for use, and routes of administration shall be readily available to the professional staff.
12.3 Documentation
1. All medications shall be documented in the dental record.
The dental record shall contain at least:
a) name of the patient;
b) name of the prescriber, date, and time of the order;
c) medication name;
d) dose and route of administration;
e) strength or concentration, when applicable;
f) quantity and/or duration, when applicable;
g) patient counseling when applicable ( see 9.2).
12.4 Controlled and Non-controlled Medications Security
1. A secure pharmaceutical/drug storage area shall be designated and administered in accordance with applicable laws, regulations and guidelines governing pharmaceutical services and be consistent with the requirement of standard 18.1.A secure area shall be defined as an area with entry and exit limited to appropriate staff, patient, and visitors.
2. All controlled substances shall be locked within a secure area to ensure their intended use and to safeguard them from tampering and diversion.
3. Non-controlled medications shall be stored within the secure area to ensure their intended use and to safeguard them from tampering and diversion.
4. Current and accurate records shall be kept of the receipt and disposition of all controlled/scheduled drugs. These records shall be maintained as documented information.
5. Supervision of all controlled/scheduled medications shall be maintained as required by national law, regulations, and dental organization policy.
6. The dental organization shall ensure that policies and procedures designed to mitigate or otherwise prevent controlled/scheduled substance diversion shall always be activated and operational. This anti-diversion concept shall be promoted in the patient and staff safety culture and work environment.
7. Evidence and other data documenting diversion shall be monitored, measured, and analyzed by the dental organization. This data shall be reported to the appropriate authority as per national law.
12.5 Medication Errors
1. The dental organization shall develop policies and procedures to minimize medication errors. These policies shall be based on principles relating to standard of care, external alerts, proactive or active review, and adoption of corrections and corrective actions.
2. Policies and procedures to minimize medication errors shall include consideration of: a) dosing limits, administration guidelines, packaging, labeling and storage; b) limiting the variety of medication-related devices and equipment; c) availability of up-to-date medication information; d) labeling recommendations associated with dispensing of high-risk medications; e) awareness of look-alike medications.
3. The dental organization shall monitor, measure, review, and take corrective actions related to all medication errors. These shall include administration errors, adverse drug reactions, incompatibilities, and other errors. This activity shall be documented and maintained as documented information (see 4.1.2.).
NOTE 1 High-risk medications are those medications involved in a high percentage of medication errors and/or sentinel events and medications that carry a higher risk for abuse, errors, or other adverse outcomes. For high risk medications and high-risk patients (pediatric, geriatric or patients with renal or hepatic impairment) there should be systems in place to minimize adverse drug events including but not limited to: checklists, dose limits, pre-printed orders, special packaging, special labeling, double-checks and written guidelines. Examples of high-risk medications may include investigational medications, controlled medications, medications with a narrow therapeutic range, psychotherapeutic medications, and look-alike/sound-alike medications and those new to the market or new to the dental organization
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