Compliance Corner
By Richard Burton, RPh, Inspector/Compliance Officer
Schedule II Perpetual Inventory
The Board inspectors are finding multiple issues and are being asked
multiple questions as to how the pharmacy should maintain the perpetual inventory.
The Wyoming Controlled Substances Act, Rules and Regulations
Chapter 4, Section 1 (c)(iv) states, in part: “All retail and institutional
pharmacies shall maintain a perpetual inventory for all schedule II controlled
substances. This inventory shall be reconciled no less than once a
quarter.” The rule does not state how the inventory is to be maintained,
which leaves much discretion on the part of each individual pharmacy.
This has led to numerous ways that the perpetual inventory is maintained
within each pharmacy. Some pharmacies keep the inventory electronically
and some keep information by hard copy. Either way is permissible by the
Board. Some pharmacies reconcile quarterly, some reconcile monthly, and
some reconcile with each dispensing of a Schedule II drug. An important
note to remember is that the reconciliation (at least quarterly) should be
documented in whatever format the pharmacy is using (hard copy or
electronically). If a particular Schedule II drug has no activity during the
previous three months, it should be counted and the reconciliation documented
(the rule states “all” Schedule II CS). Discrepancies discovered
during reconciliation should be documented in the inventory with the entry
“inventory adjusted” and the correct quantity entered. Those discrepancies
in the actual inventory count differing by more than five percent from the
recorded inventory shall be reported to the Board within 10 calendar days
by using the DEA Form 106. Documentation in the perpetual inventory
should reflect this action with the entry of “inventory adjustment” and
the correct count entered.
Incomplete Directions on Prescription Labels
The inspectors have noticed during reviews of prescriptions and their
labels that sometimes the directions are not complete. This is a patient
safety issue as well as part of the definition of “unprofessional conduct”
as stated in the Wyoming Pharmacy Act (W.S. 33-24-101): “(iv) ‘Unprofessional
conduct’ means: (A) Dispensing a drug or brand of drug in
filling a prescription which differs from that specified by the prescription,
without authority of the issuer of the prescription, regarding the patient’s
name, drug, strength, quantity, directions or number of authorized refills.”
If the label directions state “take one or two tablets every four hours”
without adding the prescribed “as needed for pain,” the patient may think
this means around the clock, and a possible dangerous overdose could
result. If the prescriber adds notes such as “must last 30 days” or “maximum
of 8 tablets in 24 hours” and those statements are left off the label,
then the communication between the prescriber, patient, and pharmacist is
not complete. The Board has held pharmacists and pharmacy technicians
accountable for such medication safety lapses. Even if good counseling
occurs, the patient or caregiver needs the label to be correct.
Sterile Compounding
The inspectors have found a lot of progress made in compliance with
Chapter 17 of the Wyoming Pharmacy Act Rules and Regulations, which
is based on United States Pharmacopeia Chapter <797>. The Board
members want to thank pharmacists and pharmacy technicians for their
hard work in making the changes to the equipment, environment,
monitoring, and policy/procedures. Your efforts on behalf of the patients
in Wyoming are recognized and appreciated!
By Richard Burton, RPh, Inspector/Compliance Officer
Schedule II Perpetual Inventory
The Board inspectors are finding multiple issues and are being asked
multiple questions as to how the pharmacy should maintain the perpetual inventory.
The Wyoming Controlled Substances Act, Rules and Regulations
Chapter 4, Section 1 (c)(iv) states, in part: “All retail and institutional
pharmacies shall maintain a perpetual inventory for all schedule II controlled
substances. This inventory shall be reconciled no less than once a
quarter.” The rule does not state how the inventory is to be maintained,
which leaves much discretion on the part of each individual pharmacy.
This has led to numerous ways that the perpetual inventory is maintained
within each pharmacy. Some pharmacies keep the inventory electronically
and some keep information by hard copy. Either way is permissible by the
Board. Some pharmacies reconcile quarterly, some reconcile monthly, and
some reconcile with each dispensing of a Schedule II drug. An important
note to remember is that the reconciliation (at least quarterly) should be
documented in whatever format the pharmacy is using (hard copy or
electronically). If a particular Schedule II drug has no activity during the
previous three months, it should be counted and the reconciliation documented
(the rule states “all” Schedule II CS). Discrepancies discovered
during reconciliation should be documented in the inventory with the entry
“inventory adjusted” and the correct quantity entered. Those discrepancies
in the actual inventory count differing by more than five percent from the
recorded inventory shall be reported to the Board within 10 calendar days
by using the DEA Form 106. Documentation in the perpetual inventory
should reflect this action with the entry of “inventory adjustment” and
the correct count entered.
Incomplete Directions on Prescription Labels
The inspectors have noticed during reviews of prescriptions and their
labels that sometimes the directions are not complete. This is a patient
safety issue as well as part of the definition of “unprofessional conduct”
as stated in the Wyoming Pharmacy Act (W.S. 33-24-101): “(iv) ‘Unprofessional
conduct’ means: (A) Dispensing a drug or brand of drug in
filling a prescription which differs from that specified by the prescription,
without authority of the issuer of the prescription, regarding the patient’s
name, drug, strength, quantity, directions or number of authorized refills.”
If the label directions state “take one or two tablets every four hours”
without adding the prescribed “as needed for pain,” the patient may think
this means around the clock, and a possible dangerous overdose could
result. If the prescriber adds notes such as “must last 30 days” or “maximum
of 8 tablets in 24 hours” and those statements are left off the label,
then the communication between the prescriber, patient, and pharmacist is
not complete. The Board has held pharmacists and pharmacy technicians
accountable for such medication safety lapses. Even if good counseling
occurs, the patient or caregiver needs the label to be correct.
Sterile Compounding
The inspectors have found a lot of progress made in compliance with
Chapter 17 of the Wyoming Pharmacy Act Rules and Regulations, which
is based on United States Pharmacopeia Chapter <797>. The Board
members want to thank pharmacists and pharmacy technicians for their
hard work in making the changes to the equipment, environment,
monitoring, and policy/procedures. Your efforts on behalf of the patients
in Wyoming are recognized and appreciated!
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