Traditionally, dedicated operating room (OR) pharmacists and pharmacy activities within the OR setting were viewed as luxury items. In the past, OR drug storage, preparation of intravenous (IV) medications, and narcotic record keeping were performed by nursing personnel and anesthesia staff. However, in recent years, OR pharmacies have become a necessity to facilitate medication handling in large ORs. The driving forces that prompted the creation of on-site OR pharmacies were the need for improved accountability of controlled substances and the reduction of medication errors. Cost containment, reducing waste of unused medications, efficient drug distribution, enhancing accuracy in patient billing, and providing clinical pharmacy information are additional benefits of establishing dedicated OR pharmacies. Automated drug dispensing systems have also become widespread throughout hospitals, reducing both error and personnel dispensing costs, and anesthesia technicians may need to become familiar with their use.
ORs are the most medication-intensive areas in the hospital, and anesthesia technicians should be skilled with medication handling. Anesthesia providers utilize a wide variety of drugs, not all of which can be stored in individual ORs: a provider may not be able to leave an OR to obtain a drug from a pharmacist, and thus, the anesthesia technician is a critical link in a safety chain from the pharmacy to the patient. Developing and maintaining a strong foundation for medication management processes in the OR is largely dependent on multidisciplinary cooperation between OR pharmacists, anesthesiologists, anesthesia technicians, nursing staff, and OR managers. This chapter focuses on safe and efficient medication handling and highlights some of the regulatory issues in this area.
Substance abuse, whether of tobacco, alcohol, or illicit drugs, is widely prevalent in society; medical fields are no exception. Opioids are the most addictive drugs known to mankind, and expansion of access to opioids in the United States has recently resulted in an epidemic of abuse throughout society. Similarly, workplace access to opioids in the perioperative environment has always resulted in diversion and abuse among some anesthesia providers. This risk of abuse is reduced by restricting providers’ personal access to opioids, primarily through strict accounting protocols.
Just as in the wider society, substance abuse among anesthesia personnel is a life-threatening problem. Many addicts’ presenting symptom is death from overdose; colleagues say “we never thought that he….” Anesthesia providers also have a professional obligation to be drug-free for the well-being of their patients. Strict prevention of diversion is thus a way in which we all keep one another safe.
Because of the potential for abuse of certain medications, the U.S. Food and Drug Administration (FDA) has classified them as “controlled substances.” These medications have special regulations for handling and prescribing. Controlled substances play a crucial role in surgery and anesthesia, but because of potential diversion and abuse, their use in the OR falls under strict control and accountability procedures defined by the FDA and state law. Controlled substances are categorized into five distinct schedules:
Hospitals have adopted different methods of dispensing controlled substances in accordance with state and federal regulations. Policy and procedures should be written by the pharmacy department covering the safe handling of controlled substances in the OR. Anesthesia technicians should follow state and federal regulations, as well as institutional policies, when asked to retrieve any medication or assist with the administration of a medication.
Controlled substances must be strictly accounted for to prevent diversion. At the same time, they must be both liberally and promptly available, especially in the OR. Controlled substances are integral to successful perioperative practice, which moves at a very fast pace where minutes and sometimes seconds count. Benzodiazepines may be necessary to ensure on-time arrival in the OR, as it may be inhumane to transport a terrified patient to the OR without relief of anxiety. Opioids and ketamine are often required for induction of anesthesia or to treat acute postsurgical pain. Accounting practices must be followed even when needs are urgent.
The most common methods of dispensing controlled substances to the anesthesia providers are as follows:
1. Manual recording: Manual recording is still used in many facilities and involves signing out a box or specific quantity of controlled substances to an anesthesia provider, who then records the dosages given to a patient. The wastage of controlled substances can be performed at the end of each case by the provider and witnessed by a licensed OR nurse. Documentation of the wastage then needs to be cosigned by the provider and the OR nurse.
2. Password-protected, automated devices such as the Pyxis MedStation dispense controlled substances for each individual patient to a nurse or a physician. Wastage and return of intact vials of controlled substances should be performed via the automated device.
3. Some ORs have dedicated pharmacies to increase control and accountability. Controlled substances are obtained by submitting a controlled substance request form to the pharmacy. The form is patient specific and is filled out by the anesthesiologist. Removal of all controlled substances, return of controlled substances, and wastage of controlled substances are documented in this form. Controlled substance use is audited by comparing the controlled substance request form against the anesthetic records. This procedure allows the OR pharmacist to reconcile the amount of each controlled substance issued to each anesthesiologist with the amounts given to the patient (based on anesthetic records), returned to the pharmacy, or wasted in the pharmacy. Any amount of controlled substances not accounted for in one of these three categories will be flagged as a discrepancy or loss. The anesthesia provider would then be contacted by the pharmacy to reconcile any discrepancies.
Returns of controlled substances that have been drawn into syringes but not used are randomly tested to make sure that there has not been any tampering with the original concentrations of the controlled substance. Use of a refractometer is one of the most common practices for validating the labeled concentration of controlled substances returned to the pharmacy. Any discrepancies that are found are reported to the chairman of the department of anesthesiology or as specified in the institution’s policy and procedures.
In an analysis of critical events during anesthesia, medication-related events (e.g., syringe swaps, drug ampoule swaps, overdoses, and incorrect drug choices) were the most frequent problem. Drug administration errors are estimated to occur in 1 out of every 133 anesthesia cases.
Factors increasing the risk of medication errors during anesthesia include the following:
1. One person responsible for prescribing, preparing, dispensing, and administering the medication
2. The complex environment of the ORs
3. Distractions in the OR
4. Usage of drugs that have a high potential for serious injury or death
5. Lack of standardized protocols for administration of high-risk drugs
6. High volume of drug administration
Standardization of medication preparation by OR pharmacies has been used successfully to reduce medication errors in the OR. Examples of standardized practices in the OR include pharmacy-prefilled syringes, pharmacy-premixed infusion bags, standardized anesthesiology drug trays, and special procedures for the administration of high-risk medications.
Many ORs place each drug in the same location within a drug tray based on the pharmacologic class of the drug. For example, each neuromuscular blocking agent (rocuronium, vecuronium, and cisatracurium) always has a designated spot in the drug tray, and the neuromuscular blocking agents are grouped together. The same principle applies to the placement of antiemetics, reversal agents, antibiotics, and beta-blockers, which are the most commonly used drugs during anesthesia. Some institutions place labels on each bin in the tray identifying the drug for that location. Standardized placement makes it easier for OR personnel to locate drugs; however, if the wrong drug is placed in a tray location, a provider may pull the drug from the bin, all the while thinking it is another drug. The pharmacy must be diligent when restocking trays, but this does not relieve the provider from the responsibility of checking the drug label prior to administration whenever a drug is removed from the tray.
A patient-identifying label can be affixed to the tray during a surgical case so that drugs removed from used trays can be charged to the appropriate patient. Used drug trays must be removed at the end of each case during the room turnover and replaced by a new drug tray. The used drug trays are restocked by pharmacy personnel. The use of a drug tray system in anesthesia carts has proven to be an effective model for the distribution of frequently used medications in the OR.
Several syringes of routinely used medications by anesthesiologists can be prepared by OR pharmacies. Pharmacy departments and anesthesia departments determine which syringes should be prefilled. The goal of prefilling syringes is to reduce errors during drug dilution, standardize drug concentrations after dilution, prolong shelf life, and improve accessibility to emergency drugs. Five drugs that are frequently selected by ORs to be distributed as prefilled syringes include atropine (1 mg/mL 1 mL/syringe), ephedrine (5 mg/mL 10 mL/syringe), succinylcholine (20 mg/mL 10 mL/syringe), lidocaine (20 mg/mL 5 mL/syringe), and phenylephrine (0.1 mg/mL 10 mL/syringe). These syringes are made using a laminar flow hood using an aseptic technique by pharmacy technicians to extend the expiration date. The syringes are made in batches, and a standard color-coded label with the name of the drug, concentration, and expiration date is affixed to each syringe. Each syringe is sealed with a tamper-evident cap. Unused prepared syringes are redispensed until they reach their expiration date if the tamper-evident cap is intact.
The practice of prefilling syringes not only saves time for the anesthesia provider but also translates into savings for the hospital. If anesthesiologists mix these routine syringes, the expiration date would only be 24 hours (12 hours for propofol) and they would need to be discarded at the end of each day, whereas the pharmacy-prefilled syringes have longer expiration dates due to the aseptic techniques used during their preparation. All partially used syringes must be discarded after each case.
Collaboration between anesthesiologists, intensivists, and pharmacists should lead to mutual agreement on which infusions are most beneficial to be distributed as a premixed bag. The goals of distribution are essentially the same as those for prefilled syringes. Drugs that are commonly distributed as a premixed 250-mL bag include phenylephrine (200 μg/mL), epinephrine (concentration tends to vary by institution), and vasopressin (1 Unit/mL). Drug concentrations should be standardized within an institution across locations (e.g., the OR, emergency room, and intensive care unit).
High-risk medications have special challenges. Below is a list of documented high-risk medications used in the OR, safety issues, and the recommended practice to decrease risk during administration.
1. Continuous IV insulin infusion
a. Risks
i. Can cause profound hypoglycemia resulting in brain damage. No indication of this will be apparent in a patient under general anesthesia.
ii. Can cause electrolyte derangements and arrhythmias.
iii. Insulin vials are part of the “look-alike/sound-alike” list.
b. Recommendations
i. A standard concentration is used for insulin infusions (1 Unit/mL). Insulin must also be manufactured also for SC injection, at 100 Units/ mL. A vial of insulin should raise a “red flag” in the OR as this is not intended for IV use.
ii. The abbreviation “U” is no longer acceptable. The word “UNITS” must be used.
iii. Insulin vials should not be a floor stock item. All insulin products should be obtained from the pharmacy.
2. Heparin and low molecular weight heparin (LMWH)
a. Risks
i. Increased risk of bleeding.
ii. Both can cause heparin-induced thrombocytopenia (HIT).
iii. Heparin is distributed in a variety of concentrations. Like insulin, heparin is given by multiple routes.
b. Recommendations
i. Premixed heparin bags are removed from the floor stock and automated dispensing devices in the ORs.
ii. Standardized weight-based dosing protocols for both deep vein thrombosis (DVT) and “non-DVT” indications.
iii. Prior to administration, two providers verify the heparin concentration in a vial.
3. Concentrated IV potassium and sodium chloride
a. Risks
i. Potassium chloride can induce fatal arrhythmias.
ii. Concentrated sodium chloride can cause congestive heart failure.
b. Recommendations
i. Undiluted potassium vials are only stored in the pharmacy.
ii. Highly concentrated preparations of sodium chloride (3% premixed hypertonic solutions) are only dispensed by the pharmacy.
4. All medications administered via the intrathecal (within the cerebral spinal fluid) or epidural route of administration
a. Risks
i. Medications not intended for intrathecal or epidural administration can be severely toxic or even lethal when given by these routes.
ii. Medications intended for intrathecal or epidural administration can be toxic or lethal if the wrong dosage is administered.
b. Recommendations
i. Two providers confirm the dosage prior to administration via the intrathecal or epidural route.
ii. Infusion ports and catheters clearly labeled if the catheter or infusion line leads to an intrathecal or epidural route of administration.
5. Narcotic/opioid infusions
a. Risks
i. Narcotic overdose can lead to respiratory depression and respiratory arrest.
ii. Drug diversion.
b. Recommendations
i. Standardized premixed narcotic medication bags prepared by the pharmacy
ii. Standardized protocols for narcotic infusion administration (e.g., standardized patient-controlled analgesia order set)
iii. Infusion pumps with standardized medication library
iv. Locked infusion pump systems to prevent access to the medication bag
v. Respiratory monitoring protocol according to patient risk. May include direct observation, pulse oximetry, or exhaled carbon dioxide monitoring
High-risk medication infusions prepared in the pharmacy require a double check and must be documented in an IV compounding logbook. Prior to administration, high-risk medications require a double check at the bedside by two providers. All of the following activities should be documented in the medical record: initiation of administration, bag change, and dose change. All high-risk medications should be confirmed during transfer of care. All high-risk medications should have a red “high-risk” sticker.
To help minimize errors during drug administration, many organizations emphasize the following procedure for all medication administrations characterized by the 5 Rs:
Some organizations have added a sixth “R” to the list—“Read the Label.”
Aseptic technique must be used in all aspects of parenteral administration (routes other than by mouth). Some of the most important guidelines to remember when drawing up medications are as follows:
1. All rubber stoppers of vials should be sanitized with 70% alcohol prior to the introduction of a needle or spike for the removal of product.
2. Always use a sterile syringe and needle when withdrawing medication from a vial.
3. All IV ports should be sanitized with 70% alcohol prior to the introduction of a needle or needleless syringe.
4. Filter needles must be used when withdrawing solution from an ampoule.
5. Use single-dose vials when available.
6. When it is necessary to use a multidose vial, it should be used for a single patient only. This standard is used by many hospitals and medical facilities (and monitored by regulatory agencies). Improper handling of multidose vials can result in transmission of infection.
7. Never use a syringe for more than one patient.
8. Dispose of used needles in an approved sharps container.
9. Medication should be stored and prepared on a clean surface.
10. Always check expiration dates on vials, ampoules, and IV solutions.
11. Keep syringe or needle/cannula in intact packaging until ready for use.
Operating room pharmacies follow international standards to provide the proper level of sterility for medication preparation. A laminar airflow workbench (LAFW) located within a buffer room is used for sterile compounding. Hand washing, donning gowns, gloves, masks, and other personal protective equipment are also used during medication compounding.
A new approach to control medication dispensing is an automated medication system. Some hospitals have opted to utilize this form of technology throughout the institution, including making them available in individual ORs. In general, this dispensing system is designed to maintain inventory for medications and accurately charge patients as medications are removed. At a minimum, the delivery unit is a password-secured system to ensure that only authorized medical personnel have access to remove medications. Some devices also require biometric identification (e.g., fingerprint scan). These machines have the capability to accept returns of unused medication as well as document controlled substances’ wastage. When unused medications are returned, an automatic credit to the patient’s account can be posted. The daily reports generated by the pharmacy department from these machines can provide useful information for restocking needed medication, inventory control, tracking narcotic transactions, and accurate patient billing.
Anesthesia materials and medications are hazardous. The anesthesia provider, with the help of the anesthesia technician, should dispose of medications at the end of every case.
Unused, unopened medications or preprepared infusion bags should not be restocked in a drug tray. Restocking medications in a drug tray runs the risk that the medication vial may be misplaced in the tray. Trays should only be stocked by the pharmacy. Open partially used drug trays should also be returned to the pharmacy. Automated dispensing machines may have a mechanism for return of unused drug vials.
Opened, unused, or partially used drug vials of uncontrolled substances should be discarded into the appropriate waste stream. All syringes should also be emptied into a wastebin and then discarded into the appropriate waste stream (see Chapter 47, Anesthesia Supply and Equipment Contamination, Sanitation, and Waste Management). Many anesthesia medications, most notably neuromuscular blockers, are lethal if injected intravenously in a large dose without anesthesia provider supervision. All are harmless to handle manually, but they should not be left unattended, and should be discarded if found.
It is the anesthesia provider’s responsibility to keep controlled substances under his or her control at all times. Syringes or vials containing unused controlled substances should be returned to the pharmacy or wasted according to proper institutional accounting practices. If you find an unattended controlled substance when turning over a room, it is courteous, if possible, to alert the anesthesia provider to their error. This type of unattended syringe in a patient care area is a hazard to others, but is not one of the many discrepancies associated with diversion. (Typically, addicts hold onto their opioids.) If locating the provider right away is not possible, the drug should be returned to the pharmacy immediately.
The complexity and sophistication of medication procedures have increased, expanding the need for specialized OR pharmacies and OR-specific procedures related to medications. Medication administration is the most common form of medical error and routinely is responsible for patient injury. International, national, and local institutions have all placed a high priority on reducing medication errors. Anesthesia technicians should be familiar with narcotic handling, safe medication administration practices, documentation requirements, regulatory requirements, and their local institutional policy and procedures regarding medication handling. This chapter provides an introduction to the core concepts in medication handling for the anesthesia technician.
1. Reducing medication errors in the OR depends on
A) Pharmacy
B) Nursing
C) Anesthesiologists
D) Anesthesia technicians
E) All of the above
Answer: E
All OR personnel are at least peripherally involved with medication administration. Even if not directly administering a medication, an anesthesia technician can be called upon to retrieve medications, set up infusions, or assist with medication delivery.
2. Fentanyl falls under the category of
A) Schedule I
B) Schedule II
C) Schedule III
D) Schedule IV
E) Schedule V
Answer: B
Fentanyl is designated a schedule II drug, which is defined as a controlled substance with a high potential for abuse with an accepted medical use. Other drugs in this schedule include hydromorphone, morphine, and cocaine. Schedule I drugs do not have an accepted medical use.
3. The expiration of propofol drawn up in the OR is
A) 2 hours
B) 4 hours
C) 6 hours
D) 12 hours
E) 24 hours
Answer: D
Even though the propofol on the market today has added preservatives, it is an emulsion and can support bacterial growth. Once it is opened and drawn up, even using aseptic technique, it must be used within 12 hours. Propofol syringes should be properly labeled, including the time and date the drug was prepared.
4. High-risk medications can be treated just like any other medication in the OR setting.
A) True
B) False
Answer: B
High-risk medications have designated special handling instructions to ensure safety. These can range from a “high alert” or “high-risk” sticker attached to having two providers verify the drug and concentration before administration.
5. The five Rs include
A) Right drug, right dose, right route, right concentration, and right pathway
B) Right drug, right patient, right pathway, right dose, and right away
C) Right drug, right dose, right route, right patient, and right time
D) Right drug, right patient, right time, right route, and right concentration
E) None of the above
Answer: C
.
6. Which of the following is a “high-risk” medication?
A) Rocuronium
B) Heparin
C) Propofol
D) Epinephrine
E) Bupivacaine
F) None of the above
Answer: B
High-risk medications have designated special handling instructions to ensure safety. Several, particularly in the OR, are “high risk” because they are commonly given and come in multiple concentrations, and the risk of overdose (or, in the case of heparin and cardiopulmonary bypass, underdose) can be fatal. These include insulin, heparin, potassium, and opioids.
The other medications on this list are certainly associated with significant risks but are not classified as “high-risk” medications by the pharmacy and throughout the hospital. Rocuronium is given in a consistent fashion, setting, and concentration, and only under the supervision of an anesthesiologist. Propofol, too, is given in the context of strict general anesthesia or sedation protocols. Bupivacaine is high risk in the intrathecal space (where all drugs are “high risk” and treated with this protocol) and in settings where its doses are high enough that patients are at risk for LAST (see Chapter 63, Local Anesthetic Toxicity). Epinephrine is given in resuscitation situations that are “high risk” but also as a component of low-risk subcutaneous local anesthetic solutions.
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