Establishing Best Practices for Oral Syringe Compounding


September 2014 - Vol. 11 No. 9 - Page #2

Meeting the unique medication needs of neonates, infants, children, and adults who are unable to swallow solid dosages frequently requires the use of oral medications for syringe administration. And because the necessary medications are not always available in unit doses, extemporaneous compounding often becomes the norm. The manual nature of oral syringe compounding makes it prone to error. In fact, numerous errors continue to occur each year, often resulting in harmful and even fatal errors in patients (see SIDEBAR). Because pediatric facilities provide hundreds of oral syringes daily to their patients, ensuring these medications are prepared safely and in accordance with established policies and procedures is a primary concern.

St. Mary’s Hospital is a 460-bed facility serving West Palm Beach, Florida. The pediatric services include a 146-bed pediatric hospital, a 45-bed NICU, a 14-bed PICU, and a pediatric emergency room. The pharmacy prepares an average of 175 patient-specific oral syringes daily, with an additional 100 oral syringes prepared for storage in the automated dispensing cabinets (ADCs) on the units. Preparation of such a high volume of oral syringes mandates a best practice level of service to ensure patient safety while minimizing waste and cost. 

Guidelines for Improving Safety
ASHP provides a technical assistance bulletin on single unit and unit-dose medications,1 as well as guidelines for repackaging oral solids and liquids in single unit and unit-dose packages.2 Both documents state that syringe-type containers for oral administration should not accept a needle (ie, no Luer lock) and should be labeled For Oral Use Only.

Similarly, ISMP issued goals for this year and 2015, with two of the six best practice suggestions involving oral syringes3:

Best Practice 4: Ensure that all oral liquids that are not commercially available as unit-dose product are dispensed by the pharmacy in an oral syringe. 

The goal of this best practice is to prevent the unintended administration of oral medications via the IV route. ISMP continues to receive reports in which patients are inadvertently administered an oral liquid medication intravenously. As a result, ISMP recommends that only oral syringes marked For Oral Use Only be used by health care providers and that the oral syringes chosen do not connect to any type of parenteral tubing available in the hospital. Use of an auxiliary label marked Oral Use Only also is recommended, as long as it does not obstruct critical information on the syringe or the primary label.

Best Practice 5: Purchase oral liquid dosing devices (oral syringes/cups/droppers) that solely display the metric scale.ISMP has received more than 50 reports—with some involving injuries requiring hospitalization—of mistakes resulting from patients confusing milliliters (mL) with household measures, such as drops and teaspoonfuls. Consequently, if a patient will be taking an oral liquid medication following discharge, staff should supply the patient with oral syringes with metric markings or with a prescription to purchase them from a surgical/drug store. 

In addition, ISMP has listed the following strategies to promote consistent and proper use of oral syringes4

  1. Assess medical equipment connectivity, including all ports on all types of tubing and catheters. Use only parenteral tubing with ports that are completely incompatible with oral syringes and enteral devices that accommodate only oral syringes and catheter tip connectors.
  2. Supply all clinical areas with oral syringes in the appropriate sizes (eg, 1 mL, 5 mL, 10 mL). If possible, such syringes should not resemble parenteral syringes in color, design, or general appearance. 
  3. Whenever possible, dispense oral liquid medications from the pharmacy in patient-specific or unit-of-use oral syringes or commercially available dose cups. 
  4. Nurses and physicians should notify pharmacy of patients who cannot swallow solids so that liquids can be provided in oral syringes or dosing cups.
  5. Reduce tolerance of risk by communicating to all staff the potential dangers of inadvertent IV injection of oral/enteral liquids prepared in parenteral syringes. Include examples of errors and promote the understanding that such errors can happen to them.
  6. Require staff to use oral syringes only when preparing and administering oral/enteral liquids. Staff should prepare and administer all small volume oral/enteral solutions in oral syringes and should avoid placing any non-parenteral products in parenteral syringes and any topical products in oral syringes. 
  7. Apply auxiliary labels that say Oral Use Only on the tip or the plunger of the syringe so that users must remove the label prior to administration.
  8. Label all access lines. Labels should be placed on all distal ports and tubing of access lines, including peripheral and central IV lines and feeding tubes. 
  9. Improve awareness among all health care professionals about the dangers inherent in the use of oral syringes, as well as their connectivity, safety features, and proper handling. 
  10. Establish training programs for all staff members who administer oral liquid medicines and use enteral feeding systems.

Such precautions are required to ensure the continuous safe use of oral syringes and to avoid harmful or even fatal errors. However, it is also important to note that wrong route errors can expose a hospital to significant financial repercussions. Claims alleging that medication was administered via the incorrect route have the highest average paid indemnity of all medication error claims, averaging $214,240 per case between 1997 and 20075 and $87,500 between 2006 and 2010.6 

Process for Compounding Oral Syringes
Technicians at St. Mary’s spend about six hours each day preparing oral medications. Hiring and retaining experienced technicians to perform this manual, rote work can prove challenging. Once quality technicians are identified, training consists largely of shadowing a technician who is already proficient in the compounding process. 

The process for batch production of scheduled patient medications includes the following steps: 

  • Labeling. Information required for oral syringes prints as a batch on 4-inch x 1-inch perforated labels. Each medication includes a label for the syringe bag (which contains all doses of one medication for one patient), a dispensing record label, and a label for each syringe. 
  • Safety Measures. Each bag and syringe label displays a 72-hour expiration date, and the drug volume is highlighted in yellow. The technician preparing the medication initials the bag and attaches an auxilliary label that states For Oral Use Only. If the medication is for pediatrics or neonates, the technician also affixes a pink DOUBLE CHECK label. [See PHOTO
  • Documentation. The dispensing record label is separated and attached to a record specific for that medication, concentration, lot, and expiration date. The number of doses dispensed is handwritten on the label and initialed. 
  • Preparing the Medication. For safety reasons, only oral syringes are stocked in the oral syringe area. Each medication is drawn up and grouped by patient. Then the label is separated and attached to the oral syringe as a flag, making sure the bar code is not rendered unreadable by a scanner. 
  • Pharmacist Check. The syringes, documentation, and bulk bottles are then placed in a basket for final check by a pharmacist. 
  • Delivery. Each patient’s oral syringes are placed in their own specific bin. If the medication is a controlled substance, the 24-hour count sheet is completed, and a nurse is found to sign the delivery log and the inventory sheet. 
  • Inventory. Finally, the technician takes inventory of what was used and reviews what needs to be ordered or compounded to set up for the next day’s process. 

The pharmacist’s responsibilities include checking non-controlled medications (approximately two hours per day) and controlled substances (about one hour per day). The pharmacist checks the syringes by medication, looking at each label to ensure it is the correct medication in the correct concentration. He or she also views the syringe to verify the volume, which is highlighted, and to ensure that the syringe was filled properly (ie, no bubbles or air pockets). The pharmacist initials each syringe and places it in the patient/medication-specific bag. If the medication is a controlled drug, the pharmacist performs these steps in the vault. The pharmacist then completes and signs a delivery log to accompany each medication.  

We also batch non-unit-dose, commercially available medications for the ADCs in the adult units and stock standard volume emergency medications in the pediatric ER ADCs for first doses and in various outpatient areas for sedation. All of these products receive 90-day expiration dates unless shorter time periods are recommended by the manufacturers. 

If a patient requires a new oral medication or a dose change, the entire process is repeated; if the dose has not left the pharmacy, we alter the syringe volume and labeling. Because we do not have tamperproof caps for the oral syringes, doses that have been delivered to a locked patient bin are not reused.



Looking to the Future
New proposed regulations, USP <800> Hazardous Drugs—Handling in Healthcare Settings, will dictate how hazardous, non-sterile medications will be compounded in the future. The medications that will be affected can be found on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 20127 and the Proposed Additions and Deletions to the NIOSH Hazardous Drug List 2014.8 If the proposed regulation is adopted, medications on the NIOSH list, which previously could be compounded in the oral syringe area, will require mixing in a negative pressure hood in a negative pressure room. Consequently, working with these substances will necessitate an even greater time commitment because of the special garbing required for negative pressure environments and the use of a hood to compound and draw up syringes. Furthermore, additional time will be required annually to educate staff and maintain compliance with the legislation.In the meantime, committing to the investment of the time and resources required to ensure safe practices surrounding oral syringe compounding is necessary in this high-risk environment.

References

  1. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on single unit and unit dose packages of drugs. Am J Hosp Pharm. 1985;42(2):378-379. 
  2. American Society of Hospital Pharmacists. ASHP guidelines for repackaging oral solids and liquids in single unit and unit dose packages. Am J Hosp Pharm. 1979;36(2):223-224.
  3. 2014-15 Targeted Medication Safety Best Practices for Hospitals. http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed July 24, 2014.
  4. Oral syringes: A crucial and economical risk-reduction strategy that has not been fully utilized. Acute Care ISMP Medication Safety Alert. http://www.ismp.org/newsletters/acutecare/articles/20091022.asp. Accessed July 24, 2014.
  5. CNA Insurance Companies, Nurses Service Organization. CNA HealthPro nurse claims study: an analysis of claims with risk management recommendations 1997-2007. https://www.nso.com/pdfs/db/rnclaimstudy.pdf?fileName=rnclaimstudy.pdf&folder=pdfs/db&isLiveStr=Y&refID=rnstudynsna. Accessed July 24, 2014.
  6. CNA Insurance Companies, Nurses Service Organization. Understanding nurse liability, 2006-2010: a three-part approach. http://www.nso.com/pdfs/db/RN-2010-CNA-Claims-Study.pdf?fileName=RN-2010-CNA-Claims-Study.pdf&folder=pdfs/db&isLiveStr=Y. Accessed July 24, 2014.
  7. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012. http://www.cdc.gov/niosh/docs/2012-150/. Accessed July 24, 2014.
  8. Proposed Additions and Deletions to the NIOSH Hazardous Drug List 2014. http://www.cdc.gov/niosh/docket/review/docket233/pdf/FRN_HD_LIST_2014.pdf. Accessed July 24, 2014.

Carla J. Maslakowski, MS, MEd, RPh, is the director of pharmacy implementations in the applied clinical informatics department at Tenet Healthcare Corporation. She received her bachelor of science degree in pharmacy from Creighton University in Omaha and her masters degree in education and computer science from Plymouth State University, Plymouth, New Hampshire. Carla also completed an ASHP hospital pharmacy residency and an MS in hospital pharmacy from the University of Kansas.

Colette A. Isner, BS Pharm, PharmD, is the informatics pharmacist at St. Mary’s Medical Center in West Palm Beach, Florida. She received her BS Pharm from West Virginia University in Morgantown, West Virginia and her PharmD from Nova Southeastern University in North Miami Beach, Florida. 

 


The Case for Caution 
The practice of administering oral medications via syringe is fraught with the potential for error. Even though recommendations for the safe use of oral syringes have existed since 1979, mistakes continue to occur. 

In one recent instance, a nurse administered oral lorazepam intravenously to a combative patient going through alcohol withdrawal.1 The nurse inadvertently retrieved an oral lorazepam syringe from an ADC refrigerator, brought it to the bedside, removed the large red cap, and handed the syringe to another nurse, who expressed frustration with the pharmacy for providing the medication in a syringe that would not connect to the IV cannula’s needleless connector. That nurse then expelled the oral lorazepam into an IV syringe, attached it to an IV port, and administered the medication. The mistake was discovered 12 hours later when the controlled drug count was found to be incorrect. 

In another instance, a graduate nurse, who received an order for IV morphine, retrieved an oral syringe of morphine liquid from an ADC, expelled the liquid into a dosing cup, diluted it with saline, drew it up into a parenteral syringe, and administered it intravenously. Fortunately, no adverse effects were reported in either incident. 

A third instance describes a newborn infant who died after an intermittent feeding prepared in a parenteral syringe was administered intravenously instead of via a nasogastric tube.2

In another case, a graduate nurse prepared yogurt—intended to be given via an enteral tube to treat diarrhea—in a parenteral syringe and then administered it to an adult patient intravenously through a PICC line.2 The nurse then flushed the line with water. The distal ends of the enteral and PICC lines, all unlabeled, looked similar. The error was not reported.

In yet another case, a patient required sedation with 500 mg chloral hydrate for an MRI.2 Because the patient would not drink from a pharmacy-dispensed unit-dose cup, a nurse withdrew the medication into a parenteral syringe and administered it orally. Once in the radiology department, the patient required additional sedation, so the nurse was called to send another dose of chloral hydrate. The nurse was uncomfortable sending a parenteral syringe to radiology, but no oral syringes were available, so she repeated the process she conducted earlier, leaving the syringe uncapped and without a needle, and including the tear-off label from the unit-dose cup for reference. The physician in radiology, however, did not notice the label and began administering the medication intravenously. He stopped when the patient began screaming. Fortunately, the patient was uninjured.

  1. Avoiding inadvertent IV injection of oral liquids. Acute Care ISMP Medication Safety Alert. http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=29. Accessed July 29, 2014. 
  2. Oral syringes: A crucial and economical risk-reduction strategy that has not been fully utilized. Acute Care ISMP Medication Safety Alert. http://www.ismp.org/newsletters/acutecare/articles/20091022.asp. Accessed July 24, 2014.

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