CHAPTER 21 STORAGE OF MEDICATIONS

CHAPTER 21 STORAGE OF MEDICATIONS

NURSING HOME

Storage of Medications in the Nursing Home

1. All drugs and non-Rx drugs must be locked

a. Schedule II double locked (standard of practice all controls double locked) b. Key with the charge nurse c. No Aides (C.N.A.'s) in med room unless nurse present d. Drug carts should not be stored in the hall

2. External drugs separate from internal drugs

a. Separate cabinet vs. separate shelf (both acceptable based on facility policy) b. Poisons in a separate and distinct area c. Cabinets clearly labeled d. Med carts: external area and internal area

3. Refrigerated drugs

a. General use vs. medication refrigerator b. Have a thermometer - 36 to 46 degrees F (USP Standard for drug storage) c. Temperature Log d. Handling problematic drugs

a. Flu vaccine b. PPD

4. Outdated drugs

a. Procedures for checking: Rph + nurse b. Cooperation with vendor pharmacist

5. Discontinued drugs

a. Procedure for handling control drugs b. Procedure for handling non-control drugs c. Drugs with resident at discharge d. Drugs brought into the facility with no order

6. Treatment cart storage

a. Where kept b. Clean c. Proper labels d. Expiration dates

7. Inspection forms

8. Storage of medication in a patient's room

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Punch Card Cart

Punch or Bingo Cards

Unit Dose Box Cart

30 Day Box System

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Control Bin with 2nd Lock

Multipak Systems (AutoMed & PacMed)

Treatment Cart

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EXCERPTS FROM THE CDC VACCINE STORAGE AND HANDLING TOOLKIT 2a.vaccines/ed/shtoolkit

Shelf Lives of Reconstituted Vaccines

Vaccine Varicella vaccine

Expiration After Reconstitution 30 minutes (protect from light)

TriHIBit? vaccine (DTaP/Hib)

30 minutes

Menomune? (single-dose vials) MMRV vaccine Zoster vaccine MMR vaccine

ActHIB? vaccine (Hib) Menomune? (multidose vials)

30 minutes 30 minutes (protect from light) 30 minutes (protect from light)

8 hours (protect from light) 24 hours

35 days

Prefilling Syringes

Recommendation

The National Center for Immunization and The National Center for Immunization and

Respiratory Diseases (NCIRD) strongly

Respiratory Diseases (NCIRD), Centers for

recommends that providers draw vaccine only Disease Control and Prevention strongly

at the time of administration.

recommends that providers draw vaccine

only at the time of administration to ensure

that the cold chain is maintained and that vaccine is not inappropriately exposed to light. Do

not predraw doses before they are needed.

Problems Associated with Prefilling Syringes

NCIRD strongly discourages prefilling syringes and has identified the following problems associated with this practice:

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Once vaccine is inside the syringe, it is difficult to tell which vaccine is which; this may lead to administration errors. Prefilling syringes leads to vaccine wastage and increases the risk of vaccine storage under inappropriate conditions. Most syringes are designed for immediate administration and not for vaccine storage. Bacterial contamination and growth can occur in syringes you prefill with vaccines that do not contain bacteriostatic agents, such as the vaccines supplied in single-dose vials. No stability data are available for vaccines stored in plastic syringes. Vaccine components may interact with the plastic syringe components with time and thereby reduce vaccine potency. Finally, prefilling syringes is a violation of medication administration guidelines, which state that an individual should only administer medications he or she has prepared and drawn up. This is a quality control and patient safety problem because if you do not draw up the vaccine yourself you cannot be sure of the composition and sterility of the dose you are administering. ________________________________________________________________________________

INFORMATION FOUND IN THE 2001 P.D.R. UNDER TUBERSOL

Tubersol? is a stabilized solution of Tuberculin PPD. Data indicates that Tubersol? will remain stable for at least four weeks when prefilled into syringes and stored between 2~and 8~C.4 However, in order to avoid possible contamination of the product this practice is not recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solutions and container permit.

This language has been removed from the current package insert. Manufacturers for both Aplisol and Tubersol currently take the position that their product should not be pre-drawn or stored in pre-filled syringes since stability data does not exist for plastic syringes.

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Don't Be Guilty of These Errors in Vaccine Storage and Handling

The following are frequently reported errors in vaccine storage and handling. Some of these errors are much more serious than others, but none of them should occur. Be sure your clinic or practice is not making errors such as these.

Error #1: Designating only one person in the office to be responsible for storage and handling of vaccines, instead of a minimum of two.

It's important to train at least one back-up person to learn proper storage and handling of vaccines. The back-up person should be familiar with all aspects of vaccine storage and handling, including knowing how to handle vaccines when they arrive, how to properly record refrigerator and freezer temperatures, and what to do in case of an equipment problem or power outage.

Error #6: Storing vaccine in the refrigerator in a manner that may inappropriately affect its temperature.

The temperature in the vegetable bins, on the floor, next to the walls, in the door, and near the cold air outlet from the freezer may differ significantly from the temperature in the body of the refrigerator. Always store vaccines in their original packaging in the body of the refrigerator away from these locations. Place vaccine packages in such a way that air can circulate around the compartment. Never overpack a refrigerator compartment.

Error #2: Recording temperatures only once per day. Temperatures fluctuate throughout the day. Temperatures in the refrigerator and freezer should be checked at the beginning and end of the day to determine if the unit is getting too cold or too warm. Ideally, you should have continuous thermometers that measure and record temperatures all day and all night. A less expensive alternative is to purchase maximum/minimum thermometers. Only certified thermometers should be used for vaccine storage. It's also a good idea to record the room temperature on your temperature log in case there is a problem with the refrigerator or freezer temperature. This information may be helpful to the vaccine company's telephone consultant in ascertaining whether your vaccine can still be used.

Error #3: Recording temperatures for only the refrigerator or freezer.

If your facility administers varicella, zoster (shingles), or live attenuated influenza vaccine, you should have certified thermometers in both the refrigerator and the freezer. Rather than buying cheap thermometers that may not accurately measure the temperature, buy quality thermometers that will last for years.

Error #4: Documenting out-of-range temperatures on vaccine temperature logs and not taking action.

Documenting temperatures is not enough. Acting on the information is even more important! So, what should you do? Notify your supervisor whenever you have an out-of-range temperature. Safeguard your vaccines by moving them to another location and then determine if they are still useable. Check the condition of the unit for problems. Are the seals tight? Is there excessive lint or dust on the coils? After you have made the adjustment, document the date, time, temperature, what the problem was, the action you took, and the results of this action. Recheck the temperature every two hours. Call maintenance or a repair person if the temperature is still out of range.

Error #7: Storing frozen vaccines in a dorm-style refrigerator. Varicella, zoster (shingles), and live attenuated influenza vaccines must be stored in a freezer that has its own external door separate from the refrigerator. No matter how hard you try to adjust the temperature to +5?F in a dorm-style refrigerator's freezer, you won't be able to reach this low temperature in the freezer, and you'll probably freeze the rest of your vaccines in the refrigerator!

Temp Log

Error #8: Inadvertently leaving the refrig-

erator or freezer door open or having inadequate seals. Remind staff to close the unit doors tightly each time they open them. Also, check the seals on the doors on a regular schedule, and if there is any indication the door seal may be cracked or not sealing properly, have it replaced. The cost of replacing a seal is much less than replacing a box of pneumococcal conjugate or varicella vaccine.

Error #9: Discarding multi-dose vials 30 days after they are opened. Don't discard your vaccines prematurely. Almost all multi-dose vials of vaccine contain a preservative and can be used until the expiration date on the vial unless there is visible contamination. However, you must discard multi-dose vials of reconstituted vaccine (e.g., meningococcal, yellow fever) if they are not used within a defined period after reconstitution. Refer to the vaccine package inserts for additional information.

Error #10: Not having emergency plans for a power outage or natural disaster.

Every clinic should have a written Disaster Recovery Plan that identifies a refrigerator with a back-up generator in which to store vaccine in the event of a power outage or natural disaster. Consider contacting a local hospital or similar facility to be your back-up location if you should need it.

Error #5: Throwing away temperature logs at the end of

every month.

Error #11: Storing food and drinks in the vaccine refrigerator.

It's important that you keep your temperature logs for at least three

Frequent opening of the refrigerator door to retrieve food items can

years. As the refrigerator ages, you can track recurring problems. If21.6 adversely affect the internal temperature of the unit and damage

temperatures have been documented out of range, you can

vaccines.

determine how long this has been happening and take appropriate

action. It's also a great way to lobby for a new refrigerator.

REGULATIONS - Federal Survey Manual

483.60 (g)

Storage of drugs and biologicals.

F376 (1) In accordance with State and Federal laws, the facility must store All drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys.

Interpretive Guideline: 483.60(g)(1), Compartments in the context of these Regulations include but are not limited to drawers, cabinets, rooms, refrigerators, carts, and boxes. The provisions for authorized personnel to have access to keys must be determined by the pharmaceutical services committee required by 483.60(c).

F377 (2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.

Interpretive Guideline: 483.60(g)(2). Separately locked means that the key to the separately locked Schedule II drugs is not the same key that is used to gain access to the non-Schedule II drugs.

Survey Procedures and Probes: 483.60(g)(1) and (2). Observe during Environmental Quality Assessment: (Proper drug storage) -- Y = all drugs and biologicals are stored properly (locked and at proper temperature); N = drugs and biologicals not stored properly.

64B16-29.005 Storage. All controlled substances, medicinal drugs or legend drugs shall be stored in a safe place. At a minimum, this shall require that the drugs be kept in a securely locked cabinet within a locked storage room. Schedule II order forms are to be stored under the same conditions. Records of purchases of all controlled substances, medicinal drugs or legend drugs shall be maintained in a separate file from the records of administration. The records of purchases and administration shall be maintained at the location.

Rulemaking Authority 465.005, 828.055 FS. Law Implemented 828.055 FS. History?New 10-17-79, Formerly 21S-14.05, Amended 4-24- 88, Formerly 21S-14.005, 21S-29.005, 61F10-29.005, 59X-29.005, Amended 6-17-13.

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