21.1 General
1. The pharmaceutical services shall be integrated into the healthcare organization management system. A qualified and credentialed pharmacist director of services shall be responsible for the related administration and coordination of these services within its scope of service.
2. Provision of pharmaceutical services shall meet the needs of the patients’ therapeutic goals by promoting a safe medication use process that ensures optimal use of available resources.
3. There shall be sufficient qualified personnel to meet the pharmaceutical needs of the patient population served. This requirement shall be met by healthcare organization or contracted services.
4. The Pharmacist Director shall be involved in those committees responsible for medication-related policies including consultation and the opioid use committee.
5. The Pharmacist Director shall establish liaison with the medical staff to facilitate clinical pharmacology consultation when indicated.
NOTE 1 Direction of pharmaceutical services may not require continuous on-premise supervision. Depending on the scope of care the supervisory requirement may be accomplished through regularly scheduled visits, in accordance with applicable laws and regulations and accepted professional principles.
21.2 Administration of Medications and Biologicals
1. Medications and biologicals shall be prepared and administered in accordance with the orders of a credentialed medical staff member responsible for the patient’s care and accepted standards of practice.
2. Use of multidose vial medications shall not be allowed in procedure areas where a high potential of viral or other microbial surface contamination of this type of medication container is likely. These areas shall include but are not limited to:
a) operating suites;
b) endoscopy suites;
c) other procedure areas used for cases contaminated by bodily fluids or other infective substances including but not limited to: intensive care areas, disease isolation areas, radiology, emergency department, obstetrical areas, and outpatient procedure facilities.
3. Single dose medication vials and single use syringes loaded and prepared in a clean area (i.e. pharmacy or other suitable clean area), shall be required for patient use in these areas in order to prevent disease transmission. Responsibility for the enforcement of this policy shall be shared by pharmacy and infection control and prevention authority.
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.
4. Proper sterile technique shall be used in preparing IV fluids and any associated adjunct medications to be concomitantly delivered. IV fluids shall be stored and prepared in suitable clean areas. Use of prepared solutions shall be immediate without storage delay. Pharmaceuticals delivered in these solutions shall be prepared and introduced "using single needle, single dose" methodology as referenced in NOTE 1 above.
5. Medications and biologicals shall be administered by, or under supervision of, nursing or other credentialed personnel.
6. If the healthcare organization allows a patient (or his/her caregiver) to self-administer medications, this shall be on order of the responsible physician after an individual patient risk assessment.
7. Medications and biologicals not specifically prescribed as to time or number of doses shall automatically be stopped at a time determined by the medical staff and the pharmacy service.
8. Medications administration errors, adverse drug reactions, and incompatibilities and other errors shall be immediately reported to the attending physician, pharmacy service and become input for quality management review.
21.3 Education, Monitoring and Measuring
1. Training and continuing education on topics regarding medication preparation and administration shall be required for all LIPs ordering or administering medications. These may include but are not limited to:
a) safe handling and preparation;
b) indications, side effects, drug interactions, compatibility, and dose limits;
c) equipment and/or techniques required.
2. The results of training shall be documented as continual medical education (CME).
21.4 Policy and Procedure for Physician Orders
1. All orders for legend or controlled medications and/or biologicals shall be documented and signed by a credentialed medical staff practitioner.
2. All practitioner orders for the administration of medications and biologicals shall include at least the following:
a) name of the patient;
b) name of the prescriber, date and time of the order;
c) medication name;
d) dose, frequency, and route of administration or specific instructions for use;
e) exact strength or concentration, when applicable;
f) quantity, duration and/stop order when applicable;
g) avoidance of dangerous abbreviations;
h) required opioid stop order.
NOTE 1: When well defined clinical scenarios involving medication administration occur on a regular basis, the healthcare organization may adapt policies and procedures that address the conditions and criteria for using:
a) standing orders;
b) order sets;
c) preprinted orders;
d) verbal or telephone orders;
e) orders from non-staff physicians.
3. Verbal orders shall be used infrequently. The healthcare organization shall establish policies for use and criteria defining abuse. It shall have a process for quality review including documentation of findings in the individual’s performance data record.
4. Standing order policies shall include:
a) specific criteria for initiation;
b) documented condition of the patient at onset;
c) inclusion in the medical record at time of onset;
d) signature of the ordering LIP with priority;
e) any modifications duly noted, signed, dated, and timed.
NOTE 2: Standing orders for influenza and pneumococcal polysaccharide vaccines may be excepted by policy.
5. "Resume previous orders" notations shall not be honored.
21.5 Medication Delivery and Schedule of Administration
1. Quantities of medications shall be dispensed in a manner which minimizes diversion and other adverse events.
2. Medication shall be dispensed in the most appropriate available form with respect to patient needs and resources available. This shall include the use of unit doses that have been repackaged by the pharmacy.
3. All medications including blood and blood products shall be appropriately documented to include:
a) medication name and route of administration;
b) generic variant if applicable;
c) patient name and other identifier;
d) expiration date;
e) conditions for storage if required. The above elements shall be checked by an appropriate authority and confirmed prior to administration to a patient.
4. The pharmacy shall resolve all concerns, issues and/or questions relating to a medication order with the individual prescriber before dispensing.
5. The healthcare organization shall develop documented policies and procedures to determine which medications shall be administered by priority timing (time critical), and those which have a flexible window of administration. Time limits shall be set accordingly.
6. The pharmacy in conjunction with the medical staff shall periodically evaluate the appropriateness and compliance to the medication administration timing policies throughout the healthcare organization.
21.6 Controlled and Non-controlled Medications Security
1. The healthcare organization shall ensure that policies and procedures designed to mitigate or otherwise prevent controlled substance diversion shall be activated and operational at all times. This anti-diversion concept shall be promoted in the patient and staff safety culture and work environment.
2. Current and accurate records shall be kept of the receipt and disposition of all scheduled drugs from the point of entry into the healthcare organization to the point of departure either through administration to the patient, destruction or return to the manufacturer. These shall include:
a) documentation of the distribution, use, disposition and reconciliation of all scheduled medications;
b) these records shall be current, accurate, and trace the movement of scheduled drugs throughout the healthcare organization;
c) this system shall provide a readily retrievable method to facilitate reconciliation.
3. All controlled substances shall be locked within a secure area to ensure their intended use and to safeguard them from tampering and diversion.
4. Non-controlled medications shall be stored within the secure area to ensure their intended use and to safeguard them from tampering and diversion.
NOTE 1 Healthcare organizations are permitted flexibility in the storage of non-controlled medications and biologicals when delivering care to patients, and in the safeguarding of medications and biologicals to prevent tampering or diversion.
5. When a patient care area is not staffed, controlled medications shall meet the requirements of above. In addition, non-controlled substances shall be secured.
6. A secure area shall be defined as an area with entry and exit limited to appropriate staff, patients, and visitors.
7. The requirements 21.6.1. and 21.6.2. shall apply to mobile nursing medication carts, anesthesia carts, epidural carts and other medication carts containing medications or biologicals.
8. Medication automated distribution units with security features, such as logon and password or biometric identification, are considered to be locked. Such units shall be stored in a secure area.
9. Evidence and other data documenting diversion shall be monitored, measured, and analyzed by the pharmacy service and reported to Top management. Additionally, required reports shall be submitted to the Medical Director.
NOTE 2 An area in which staff are actively providing care to patients or preparing to receive patients, i.e., setting up for procedures before the arrival of a patient, would generally be considered a secure area. The operating room is considered secure when the room is staffed, and staff is actively providing patient care. When the room is not in use (e.g., weekends, holidays and after hours), it would not be considered secure. A healthcare organization may choose to lock the entire room, lock non-mobile carts containing medication and biologicals, place mobile carts in a locked room, or otherwise lock medications and biologicals in a secure area. If an individual operating room is not in use, the healthcare organization is expected to lock non-mobile carts, and ensure mobile carts are in a locked room.
21.7 Medication Errors
1. The healthcare organization in concert with the medical staff shall develop policies and procedures to minimize medication errors. (See 4.1.3.–4.1.5).
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) dispensing of high risk medications;
d) opioid oversight use committee recommendations;
e) pharmacist availability on-call when pharmacy does not operate 24 hours a day;
f) separation of look-alike/sound alike medications;
g) expired medications.
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 healthcare organization.
3. Medication error elimination practices shall include but are not limited to the requirements 21.4. as well as the following:
a) policy to sequester look-like and sound-alike medications;
b) the use of facility approved pre-printed order sheets;
c) a voluntary, non-punitive, reporting system to monitor and report adverse drug events (including medication errors and adverse drug reactions);
d) defining hazardous medications preparation, distribution, administration, and their proper disposal;
e) awareness of recall or black labeling;
f) awareness when "weight-based" (BSA) dosing for pediatric populations is required;
g) output from quality management system’s, corrections, and corrective actions.
4. Outdated, expired, mislabeled, or otherwise unusable medications and biologicals including medical gases shall not be available for patient use. They shall be sequestered and labeled as an unusable non-conforming product.
5. Disposal of unused and waste pharmaceuticals shall be in keeping with the requirements of STANDARD 2.6 and 28.5.
6. 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.
7. The healthcare organizations shall ensure that the attending physician is immediately informed of any medication associated error. When the attending physician is unavailable, the covering physician shall be notified.
8. The identified attending physician shall report any medication error to the patient or family. 21 Pharmaceutical Services Module II
- Thêm trang cùng cấp
- Đăng nhập để gửi ý kiến