How to Write Pharmacy Repacking Policy?

How to Write Pharmacy Repacking Policy?

Why does Hospital Pharmacy need a pharmacy repacking policy and procedures?

The policy will be extremely efficient in describing all repackaged drug dispensed from outpatient and inpatient pharmacies within the hospital.

How to Write Pharmacy Repacking Policy
How to Write Pharmacy Repacking Policy

Purpose of the pharmacy repacking policy

To set up standards and procedure whereby repackaged drugs are dispensed in a safe and acceptable manner with the greatest consideration towards patient care and safety.

 

Pharmacy repacking policy outlines

  • Repackaged Drugs may be dispensed to Outpatients, discharge patients and emergency room patients.
  • Control records of all repackaged drugs must be kept.
  • Preparation, labeling and checking of all repackaged drugs are the responsibility of a licensed pharmacist.

So, to summarize the repacking policy, it should be maintained by the pharmacy department, and all the repacked medications is going to be dispensed to all patients, regardless of their location or point/level of care. The pharmacy should maintain a log for all the repacked materials to track back any preparations. Labels and packaging should be enforced to maintain the highest levels of patient safety and medication accuracy.

How to use the pharmacy repacking machine?

Pharmacy repacking area

Initial inspection of the repacking area.

Only one drug at a time should be repacked in the repackaging area.

Neither other drugs nor other labels than those for the drug being packaged should be presented in the area. Upon completion of the packaging, all unused stocks of drugs and all finished packages should be removed from the packaging area.

All related equipment should be completely emptied, cleaned and inspected before commencing the next packaging operation.

All unused tools should be removed from the packaging area.

 

Evaluate the original drug

Before beginning a packaging, an organoleptic evaluation (color, odor, appearance and markings) of the drug should be observed.

 

Examine the bulk container

The bulk container should also be examined for evidence of water, damage, contamination or other deleterious effects.

Prepare data beforehand

The Pharmacist should obtain data on the characteristics of all packaging materials used. This information should include data on the chemical composition, light transmission, moisture permeability, and size and storage requirements.

 

Double checking the final package

Repacking should be checked by another pharmacist, other than the packaging operator, and he should verify that:

  • The packaging system is set up correctly.
  • All procedures have been performed properly.

How to keep a log of the pharmacy repacking daily routine?

Daily records of all packaging runs must be kept. These records should include the following information:

  • Complete description of the product, i.e., name, strength, dosage form, generic name, etc.
  • The products manufacturer.
  • Control or manufacturer batch number.
  • The Pharmacy batch number.
  • Expiration dates of the original container and the repackaged product.
  • The number of units packaged and the date (s) they were packaged.
  • The number of repackages.
  • Initials of the operator and checker.
  • A sample of the label and, if feasible, a sample of the finished packaged.
  • Which should not be discarded until after the expiration date and which should be examined periodically for signs of deterioration.

How to set the expiry dates for the pharmacy repacking products?

Pharmacist is responsible for determining the expiration date of repacked drug and should not be beyond that of the original package. Also, pharmacist should take in to account the nature of the drug repacked and the characteristics of the package.

What to consider when writing the expiry date for pharmacy repacking containers?

The following expiration guidelines will be applied for prepackaged drugs:

  • One year for opened used drug container for solid dosage form (tablets and capsules) and six months for effervescent and sublingual tablets in original packing after opening.
  • Six months for non-unit dose packed oral solid powder and liquid form.
  • Three months for loose repacking solid dosage form (tablets/sublingual, capsules and powders) i.e., not in the original packing.
  • Six months for all antiseptic/chemicals like (alcohol 70%, hydrogen peroxide 6% and others) after opening in the pharmacy.
  • For all repacked antiseptic/chemicals like (alcohol 70%, hydrogen peroxide 6% and others) issued to other departments.
    • To be expired after 1 week after repacking.
    • To be expired after 1 month if it is opened and kept in the same original container.
  • Manufacturer’s expiration date will be used if pre-packed item is strip-packed (by manufacturer) and was simply pre-packed in small bags or packages, or cut in individual doses, without removing the tablets/capsules from strip-packing.
  • Individual doses (tablets/capsules) if separated from unit-dose packed strips (without exposing the drug dose wrapper) must have a label indicating the drug name, strength, LOT number expiration as the following example.

NOTE: This policy does not apply to antibiotic, which are known to have stability problems that preclude them from being repackaged.

How to label pharmacy repacking containers?

The computer should be used (free text label program) to generate self-adhering labels for the repackaged products. The label must bear the following information:

  • Complete description of the product, i.e., name, strength, dosage form, generic name, etc.
  • The products manufacturer.
  • The manufacturer batch number.
  • The manufacturer’s expiration date.
  • Expiration dates of the repackaged product.
  • Number of units packaged and the date they were packaged.
  • Repackaged unit and selling price.
  • Initials of the operator and checker.

How to determine the batch number for the pharmacy repacking container?

Pharmacy batch number (consist of 10 characters)

Example: T2802-05Xi

Indicating:

  • The dosage form – T for tablet and C for Capsule, etc…
  • 28 – indicating the day of repackaging the product.
  • 02 – indicating the month of repackaging the product.
  • 05 – indicating the serial number of the repackaged product on the Pharmacy repackaging log.
  • X – indicating the location of pharmacy within the hospital.
  • I – indicating the Pharmacy section like inpatient or outpatient.

How to store pharmacy repacking containers?

All drugs should be packaged and stored in a temperature and humidity-controlled environment to minimize degradation caused by heat and moisture. A relative humidity of 75% at 18-25 C should not be exceeded.

Packaging materials should be stored in accordance with the manufacturer’s instructions and any applicable regulations


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