Laws that pertain to pharmacy issues for ALF's and Nursing Homes
Statutes pertaining to ALF's, Nursing Homes, ICF-DD/MR vary. The following chart is a guideline for what is required or permissable by facility type.
| Sevices | Nursing Home | ALF without Pharmacy Permit | ALF with Phrmacy Permit | ICF-DD or MR |
|---|
| Phamacy Permits | Institutional Class I | None required | Special ALF | Institutional Class I |
| Return of Controlled Drugs | Not Permitted | Not Permitted | Not Permitted | Not Permitted |
| Return of Non-Controlled Drugs | Permitted | Not Permitted | Permitted | Permitted |
| Policy and Procedure Manual | Required | Required | Required | Required |
| Consultant RPh Services | Required | Not Required | Required | Required |
| Frequency of Visits by CRPh | At least monthly | Not Required | Monthly | Monthly |
| M.A.R. Review by CRPh | At least monthly | Not Required | Not Required | Monthly |
| Physical Inspection by CRPh | At least quarterly | Not Required | Monthly | At least quarterly |
| Required Reports by CRPh | Monthly irregularities to DON and quarterly summary | Not Required | Monthly report to be filed with facility | Quarterly chart review |
| Emergency Kit | Yes | No | No | Yes |
| Floor Stock OTC's | Yes | No | No | Yes |
| Floor Stock RX Items | No | No | No | No |
| Floor Stock Controls | No | No | No | No |
| Antipsychotic Dose Reductions | q 6 months | MD must review yearly | MD must review yearly | No time frame |
| Anxiolytic Dose Reduction | q 4 months | MD must review yearly | MD must review yearly | No time frame |
Note: See Florida Administrative Code 64B16-28.118 which states that only unit dose medication may be returned and defines what consitutes unit dose. Blister or bubble packs that contain more than one medication are not USP approved unit dose and thus can not be returned.
FAC 64B16-28.118(4) amended July 2002.
ALF's
Q. Are pharmacy permits necessary?
A. Pharmacy permits are not necessary, however the Florida Board of Pharmacy has created a permit for ALF's that wish to return unit dose drugs for credit to the vendor pharmacy. It is call a "Special ALF Pharmacy Permit". Without this permit ALF's are not permitted to return any medications to the pharmacy. Specifically, the Florida Administrative Code 64B16-28.870 reads as follows:
64B16-28.870 Special-ALF.
The Special-ALF permit is an optional facility license for those Assisted
Living Facilities providing a drug delivery system utilizing medicinal
drugs provided in unit dose packaging. All medicinal drugs must be maintained
in individual prescription containers for the individual patient. Medicinal
drugs may not be dispensed on the premises. Medicinal drugs dispensed
to patients of Special-ALF permits may be returned to the dispensing
pharmacy's stock under the provisions of Section 64B16-28.118, F.A.C.
Dispensed controlled substances that have been discontinued shall be
disposed of under the provisions of Section 64B16-28.301, F.A.C. Medicinal
drugs dispensed to the residents of a Special-ALF permit shall meet
the labeling requirements of Sections 64B16-28.502 and 64B16-28.402(1)(h),
F.A.C. Each facility holding a Special-ALF permit shall designate a
consultant pharmacist of record to ensure compliance with the laws and
rules governing the permit. The Board office shall be notified in writing
within 10 days of any change in the consultant pharmacist of record.
The consultant pharmacist of record shall be responsible for the preparation
of the Policy and Procedure Manual required by Section 64B16-28.800(2),
F.A.C. Policy and Procedure Manuals must provide for the appropriate
storage conditions and security of the medicinal drugs stored at the
facility. The consultant pharmacist of record shall inspect the facility
and prepare a written report to be filed at the permitted facility at
least monthly.
Specific Authority 465.022 FS. Law Implemented 465.0196 FS. History-New
2-23-98.
Q. What is the advantage of getting a special ALF pharmacy permit
A. The advantage is that discontinued non-controlled meds can be returned to the pharmacy for credit.
Q. What is the disadvantage of getting a special ALF pharmacy permit
A. The disadvantage is that the facility will have to hire a consultant pharmacist that is required to visit the facility at least once a month. Also keep in mind that all pharmacy permit holders including this special ALF permit, must be inspected by an inspector from the Board of Pharmacy on a yearly basis.
Q. How do I dispose of non-controlled discontinued prescription legend drugs.
A. (1) If the resident is leaving the facility, they should be turned over to the resident, their legal guardian or family member.
(2) If the meds are not taken at discharge they must be stored for at least 15 days. After 15 days the meds are considered abandoned and can be destroyed in accordance with the administrative code.
(3) If the facility has the special ALF pharmacy permit, they may return discontinued in date non-controlled unit dose meds to the pharmacy for credit.
(4) If the facility does not have this permit, disposed of them in accordance with 64B16-28.301, F.A.C.. A document must be completed showing the name and quanity of the drug, strength, dosage form, patients name, prescription number and name of the facility. This documentation, at the time of destruction, shall be witnessed and signed by the administrator and two of her staff members.
Q. How do I dispose of discontinued controlled substance drugs
A. Never return these to the Pharmacy, they must be disposed of in accordance with 64B16-28.301, F.A.C... A document must be completed showing the name and quanity of the drug, strength, dosage form, patients name, prescription number and name of the facility. This documentation, at the time of destruction, shall be witnessed and signed by the administrator and two of her staff members.
Q. Under what conditions does the Florida Board of Pharmacy require a consultant pharmacist and how often to visit my facility
If the ALF facility does not have a special permit, a consultant pharmacist is not required. If the facility has a special ALF pharmacy permit, then the consultant pharmacist must inspect and prepare a written report at least monthly.
Q. CE's are offered by Pharmacy Care for your staff. What are the CE requirements for your staff?
A. Staff providing Personal Care:
(1) must have 1 hour CE in Infection Control (including Universal Precautions)
(2) must have 3 hours of training within 30 days of employment on resident behaviors, assistance with ADL's etc.
(3) Must have 2 hours CE on HIV within 6 months of hire.
(4) 1 hour of additional CE every 2 years.
For Facilities providing Special Services(i.e. Alzheimers Disease)
(1) must have 4 hours of additional training in Alzheimer's Disease within 3 months of hiring.
(2) if employee is involved in direct care - must have 4 more hours of training with 9 months of hire in Alzheimer's disease.
Note: these were the requirements in 2002. Please refer to your statutes for changes and updates
Nursing Homes's
Q. Are pharmacy permits necessary?
A. Yes, An Institutional Class I permit is required. (64B-16.28.501)
Q. How do I dispose of discontinued non-controlled prescription legend drugs.
A. If unit dose and within date, the facility may return them to the pharmacy for credit. If the patient is being discharged, they may take them with them with a doctor's order. If they need to be disposed of the consultant pharmacist along with DON and a designee of the administrator as witnesses may destroy the meds.
Q. How do I dispose of discontinued controlled substance drugs?
A. In accordance with:
64B16-28.301 Destruction of Controlled Substances - Class I Institutional Pharmacies - Nursing Homes.
(1) Controlled substances that have been dispensed and not used by the patient shall not be returned to the pharmacy and shall be securely stored by the nursing home until destroyed.
(2) A document must be completed showing the name and quanity of the drug, strength and dosage form, patients name, prescription number and name of the nursing home. This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the nursing home administrator or his designee excluding the above.
Specific Authority 465.022FS. Law Implemented 465.019 FA History-New 4-21-87. Formerly 21S-19.001. Amended 7-31-91. Formerly 21S-28.301. 61F10.28.301. Amended 1-30-96. Formerly 59X-28.301
Q. Under what conditions does ACHA require a consultant pharmacist and how often to visit my facility
A. The consultant pharmacist must Inspect and provide a written report at least monthly. Other Responsibilities of the consultant pharmacist include monitoring Drug Therapy which is:
MONITORING DRUG THERAPY IN THE NURSING HOME (THE DRUG REGIMEN REVIEW)
MONITORING DRUG THERAPY IN THE NURSING HOME
I. The drug therapy of each resident MUST be monitored
monthly
II. The Consultant must sign and date each Resident's chart monthly
and either :
1. Document any areas of concern in a written note
2. If there are no concerns the Consultant must document "No Irregularities
Noted"
III. The key areas of the chart reviewed by the Consultant
Pharmacist
1. The Physician Order Sheet (P.O.S.)
2. The Telephone Orders written since the last review
3. The Medication Administration Record (M.A.R.)
4. The Nursing Notes
5. Lab reports taken since the last review
6. The M.D.S.
7. The resident's Care Plan
IV. Minimum Standards set for the review process
1. The Federal Indicators
2. The Unnecessary Drug Regs
3. The Quality Indicators
V. What are we looking for?
1. All drugs orders being signed monthly
2. Telephone Orders being signed in a timely manner
3. Match meds ordered against meds being administered (see MAR)
4. Review new orders to rule out the possibility of treating an unidentified
adverse effect
5. Review nursing notes to rule out unidentified adverse drug reactions
6. Make sure that all doses are within normal geriatric range
7. Make sure duration of therapy is appropriate
8. Make sure that dosage reductions are attempted on the anxiolytic
and antipsychotic drugs
9. Make sure there is a supporting diagnosis for each order
10. Review PRN drug usage to ensure they are not becoming routine orders
11. Review Lab values to identify sub-therapeutic or toxic levels or
irregularities caused by current therapy
VI. Required Documentation of the Drug Regimen Review
1. sign and date every chart
2. prepare individual comments for every concern or irregularity
3. prepare a monthly report that summarizes the entire D.R.R. for the
D.O.N. and Medical Director
4. Follow up on previous recommendations to ensure that every Prescriber
has responded
5. Prepare a quarterly report that summarizes what has happened during
the past 3 months of Drug Regimen Reviews
ICF-DD or MR facilities
Q. Are pharmacy permits necessary?
A. Yes, an Institutional Class I permit is required.
How do I dispose of discontinued prescription legend drugs.
Q. How do I dispose of discontinued controlled substance drugs
A. A document must be completed showing the name and quanity of the drug, strength and dosage form, patients name, prescription number and name of the facility. This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the facility's administrator or his designee excluding the above.
Q. Under what conditions does the Board of Pharmacy require a consultant pharmacist and how often to visit my facility
A. A consultant pharmacist must inspect and provide a written report at least monthly.
(c) 2002 - Pharmacy Care Specialists, Inc. - All Rights Reserved
