Errors and Omissions
Part 63 - August 4, 2020 Preparation
Medication Safety – Dr. Cutie
PBR PARTICIPANTS WERE SENT THIS IN A “WORD
DOCUMENT” FORMAT. HERE, I AM USING “POWERPOINT
FORMAT” FOR PRESENTATION PURPOSES ONLY. ITS HAS
MORE IMPACT. PLEASE LISTEN AND TAKE NOTES.
Errors and Omissions - The Presentation Style
On the first day of the Part III examination there are/were 20 points
dedicated to the candidate identifying “Errors and Omissions” on
prescriptions or hospital orders. The NYS Board of Pharmacy usually
provided ten prescriptions each valued at two points each for a total
value of 20 points.
For each of the ten prescriptions you are provided with (1) a copy of
a prescription, (2) the label that was place on the prescription
container and (3) a photograph of the label of the medication bottle
that was used to fill the prescription. On past examinations there is
usually one to two prescriptions that had no errors or omissions
while the other eight or nine prescriptions contain “only one error or
omission per prescription”.
Errors and Omissions - Three Types of Errors The types of errors and omissions on past examination fell into one
of the three following major categories: (1) a therapeutic errors, (2)
a technical errors in terms missing or wrong information on the
prescription or (3) legal errors where there is some violation of NYS
or DEA/DOH regulations and/or ordinances regarding the
dispensing and labeling of non-controlled or controlled substance
prescriptions.
The regulations regarding the “appropriateness prescription blank
itself” may not to be considered as an acceptable answer. For
example they may make a statement on the examination indicating
that, if the DEA numbers are incorrect it should not be considered as
an error for the purpose of this examination.
Be sure to read the preface to these E & O questions very carefully.
Errors and Omissions – Collect you thoughts
The following are some of the more common type errors or
omissions that make appear on the examination.
But be mindful - Start writing
1.
There will be probably no profiles with the prescriptions given.
2.
That the fact that the number of refills is not indicated on the label nor the color of
the tablet is indicated on the label is NOT an omission. These are not required on a
NYS label
3.
Check if it an electronic prescription, written prescription, an oral prescription a
hospital order or a prescription written by a doctor in state other than NYS.
4.
Oral drugs to be swallowed do not have to say by mouth, but drugs that are just not
to be swallowed must indicate chew, under-the-tongue, inhale vaginally, rectally, etc.
must indicate how to use.
Errors and Omissions – Collect your thoughts
5. Drugs that should be taken a certain way but this is not indicated like Nexium 20mg 30
minutes before breakfast or food then the label should indicate that and if it does not it is
an omission. But do not mix this up with drugs that work better at bedtime like Lipitor
and the prescriber just indicates Lipitor 10mg one daily and does not say at bedtime that
is not an omission.
6. Certain drugs must be dispensed in original container and therefore the quantity
prescribed may not match quantity dispensed. This is not an error
7. Drugs dispensed in manufacturer’s original container with label attached must have a
safety closure cap.
8. Drugs that are compounded may need a BUD or the BUD can be wrong.
9. Be cognizant of veterinary labeling requirements.
10.Drugs that have been discontinued and dispensed correctly is an error because you
are dispensing an unapproved drug.
Therapeutic Errors and Omissions: Start Simple
1. The wrong strength of medication is dispensed by
pharmacist (e.g. the doctor wrote for Lipitor 10 mg and the
pharmacist dispensed 80 mg based on the label of the bottle
provided as the source of the drug used to fill the
prescription.)
2. The wrong drug is dispensed or the wrong dosage form
(e.g. like an specially coated tablet and/or special release
product is dispensed when an immediate release product
was prescribed or intended. Enteric coated ibuprofen or
ASA (Ecotrin) being dispensed when the direction to
patient reads every 4 hours when needed fever over 101).
Therapeutic Errors and Omissions:
3. A drug is prescribed or dispensed to a patient that is inappropriate
or potentially dangerous to that gender (e.g. Category X drugs to
child bearing age female (Cipro and other fluoroquinolones to
pediatrics or geriatrics).
4. Remember these are not profiles and answers are solely based on
what you can learn from prescription and user. Directions may say
patient’s daughter should administer Proscar to father at bedtime
by crushed it up in every night orange juice.
5. A drugs having directions “to be used prn” when drug should be
taken on a fixed time regimen. This type of error can be illustrated by
noting directions that say use beclomethasone prn or albuterol
inhaler every four hours for 10 days.
Therapeutic Errors and Omissions:
6. Other inappropriate directions like crush a dosage form that should not
be crushed, chewed or broken or taking a half a tablet of a non-scored
tablet or a half of capsule.
7. The dosage frequency of the medication be wrong for the medication
prescribed.
8. The timing of dosing the medication may be inappropriate.
9. Doing things with drugs like administering a half tablet of Tramadol
50mg by mixing it with cheese to treat pain in a canines.
Here you have a control substance the labeling issues including warning.
Maybe the dose is correct on a milligram per kilogram basis for humans
but not for canines. Half a tablet may not be possible Tramadol 50 mg
tablets if are not scored or are coated. Can you mixing Tramadol with
cheese without having stability issues or incompatibility issues?
Therapeutic Errors and Omissions:
10. Carefully examine prescriptions for patients over 65
(geriatrics) and under 2 or 6 or 12 years of age (pediatrics)
11. The directions may be wrong or insufficient to use the
product safely. May be missing a shake well or refrigerate, or a
controlled auxiliary label.
12. The directions regarding meal sequence or food to be taken
concurrently may be wrong.
13. Prescribing quantities that are impossible to measure or
calculated wrong (suspensions, mEqs, drip rates, mcg per drops
like with fluoride drops, etc.)
Therapeutic Errors and Omissions:
14. Prescribing a chewable, buccal or sublingual tablet instructed to
be swallowed or with no directions how to use it correctly.
15. Prescribing medications that lacks specificity as to site of
administration or application. (e.g. pv, pr, ou, etc.), Also IV products
have to be administered correctly (e.g. IM, IV, SC, IT, etc.) MTX is a
popular drug so remember dosing for JA or RA is one weekly and not
daily. MTX when given as an intrathecal injection never is contains a
preservative). Other MTX routes IV are permitted to have
preservatives.
16. Prescribing a drug with a wrong dosing interval like Tussionex
every four hours for cough.
17. Know your vaccines (dose in mL, needles and syringes, which
have to be patient specific, egg allergies and rescue drugs, age
regulations)
Technical Errors and Omissions: - These are a gifts
1. The address is missing or different on label and the
prescription.
2. The doctor’s name and patient’s name maybe inadvertently
switched or wrong on prescription label.
3. The age of patient may be missing on prescription.
4. The Rx number on the prescription is incorrect or different
on label and the prescription.
5. A label lacking date of filling or refilling.
6. The label indicates wrong dosage form.
Technical Errors and Omissions: - These are a gifts
7. There is more than one prescriptions on a NYS prescription
blank.
8. It is not illegal to fill a prescription having more than one drug
per prescription blank if the prescription is from another state.
9. Remember you can fill prescriptions from other countries
including Canada, Mexico or even countries overseas.
10. You can also fill prescriptions written in NYS having a drug
and device on same blank (e.g. like Lantus insulin and
hypodermics needles and syringes) as long as drug is not a
controlled substance.
Legal Errors and Omissions:
1. Prescriber writing outside their scope of practice (e.g. DDS
writing for Valium 5 mg one hs #30 or DPM writing for Flomax
#30 i qd, etc. or a DMD writing for Lomotil, one bid #20. A
DVM writing for drugs for humans or MD writing for drugs for
animals is also prohibited.
2. Failure to substitute a generic product when required by law.
3. Dispensing quantities of controlled substance for more than
permitted by law (e.g. a 60 day supply or a prescriptions
telephoned in for CII for more than 5 days, etc.).
4. Be up to date on naloxone regulations.
Legal Errors and Omissions:
5. Be sure to be up to date on hospice patients and patients in LTCFs
prescribing regulations for controlled substances.
6. Be sure to be up to date on prescriptive powers of CNPs.
Midwives, PAs, Optometrists and pharmacists in their collaborative
practices.
7. Dispensing NTG. In other than full unopened bottles of 25 or 100
tablets. Be mindful of other drugs that must be dispensed in their
original container like Pradaxa.
8. Dispensing controlled prescriptions that fail to comply with
controlled substance labeling.
9. Filling prescriptions that are unsigned or missing other required
information on prescriptions (e.g. MDD).
Legal Errors and Omissions:
10. Filling prescriptions that are unsigned or missing other
required information on prescription or dispensing a
prescription with an incomplete label.
11. Filling prescriptions out of scope for midlevel prescribers
registered physician assistants (RPAs), clinical nurse
practitioners (CNPs), Midwives (L) or (F), Optometrists (O, or
chiropractors (CT). Know their acronyms.
12. Filling prescriptions with products that have expired (“X” on
bottle) or discontinued (Filling discontinued drugs meaning you
are dispensing an unapproved drug.)
Legal Errors and Omissions:
13. Filling prescriptions for a dog with the species missing and/or the
owner’s name missing on the prescription blank and/or label.
14. Filling prescriptions without the MDD on the controlled prescription
may be missing on the prescription label or both.
15. Filling prescriptions without the drug name, the manufacture of drug
or the strength of drug missing or being wrong on the prescription label.
16. Dispensing branded products for Medicaid prescriptions without
prescriber get prior authorization approval numbers.
17. Verify the DEA # if one is given.
Review your Pharmacy law for filling and labeling prescriptions.
Legal issues with E & O
A practitioner may issue a prescription for up to
a three month supply of a controlled substance,
including chorionic gonadotropin, or up to a six
month supply of an anabolic steroid if used in
accordance with the directions for use, provided
that the prescription has been issued for the
treatment of:
(i) panic disorders, designated as code A;
(ii) attention deficit disorder, designated as code B;
(iii) chronic debilitating neurological conditions characterized as
a movement disorder or exhibiting seizure, convulsive or spasm
activity, designated as code C;
(iv) relief of pain in patients suffering from conditions or
diseases known to be chronic or incurable, designated as code
D;
(v) narcolepsy, designated as code E; or
(vi) hormone deficiency states in males, gynecologic conditions
that are responsive to treatment with anabolic steroids or
chorionic gonadotropin, metastatic breast cancer in women,
anemia and angioedema, designated as code F. Day limits: 180
days for steroids; 90 days for HCG
Condition Codes for up to a 3 month supply of a controlled drug or up to a six month
supply of an anabolic steroid or chorionic gonadotropin (HCG)
Code A: Panic Disorder
Code B: Attention Deficit
Disorder.
Code D: Relief of pain in
Code E: Narcolepsy
patients suffering from
diseases known to be chronic
and incurable.
Code C: Chronic debilitating
neurological conditions characterized
as a movement disorder or exhibiting
seizure, convulsive or spasm activity.
Code F: Hormone deficiency
states in males, gynecologic
conditions that are responsive
with anabolic steroids or chorionic
gonadotropin, metastatic breast
cancer in women, anemia and
angioedema.
Expedited Partner Therapy
(EPT) for the Treatment of
Chlamydia trachomatis (Ct)
In New York
What is Expedited Partner Therapy (EPT) in NYS?
Expedited Partner Therapy (EPT) is a strategy for treating the sex
partners of persons diagnosed with Chlamydia trachomatis (Ct).
EPT allows health care providers to provide patients with
medication or a prescription to deliver to his/her sex partner(s)
without a prior medical evaluation or clinical assessment of
those partners.
Is EPT legal for any other sexually transmitted
infections (STIs)?
A: No. EPT was legalized in New York State (NYS) on
January 23, 2009 for Ct infections only.
What is the recommended treatment for Ct using
EPT?
The recommended EPT treatment for Ct is 1gm of Azithromycin
in a single oral dose.
What is Chlamydia?
Ct is the most commonly reported bacterial STI nationwide and in
New York State (NYS). Repeat Ct infections increase the risk of
adverse outcomes such as Pelvic Inflammatory Disease (PID),
infertility, and ectopic pregnancy.
Having an untreated sex partner is an important risk factor for
reinfection, so treating the sex partners of a person diagnosed with
Ct is critical to interrupting the spread of Ct and reinfection.
What are the benefits of EPT?
Randomized controlled trials have found EPT to
decrease rates of Ct reinfection among index patients
and increase the proportion of sex partner’s reported
to be treated for Ct.
What is the prescription format for providing
EPT?
Whenever a health care provider provides EPT using a prescription,
the prescription shall include: (1) name and address of the health
care provider/establishment in which it was written; (2) date the
prescription was issued; (3) name and dosage of the medication; (4)
directions for the use of the drug by the patient; (5) number of refills
(which will be “zero”); (6) the designation "EPT" must be written in
the body of the prescription form above the name of the medication
and dosage for all prescriptions issued;
(7) if the name, address, and date of birth of the sex partner are available at the
time the prescription is written, this should be written in the designated area of
the prescription form; and (8) if the sex partner's name, address, and date of birth
are not available at the time the prescription is written, the written designation
of “EPT” shall be sufficient for the pharmacists fill the prescription; if needed, this
information can be obtained when the patient’s sex partner or designee drops off
or picks up the prescription at the pharmacy.
Is “EPT” sufficient for the pharmacist to fill the
prescription?
According to NYS Public Health Law Section 2312, a pharmacist
can legally fill a prescription with the designation of “EPT” even
when a sex partner’s name, address, and date of birth are not
listed on the prescription. However, if needed, the pharmacist
can request this information when the prescription is dropped
off or picked up at the pharmacy.
Is liability for providers and pharmacists addressed in this
legislation?
A health care provider who reasonably and in good faith renders EPT
in accordance with Public Health Law section 2312 and section 23.4,
and a pharmacist who reasonably and in good faith dispenses drugs
pursuant to a prescription
written in accordance with Public Health Law section 2312 and
section 23.4, shall not be subject to civil or criminal liability or be
deemed to have engaged in unprofessional conduct.
Who will assume the cost for the sex partner’s medication?
Medication costs may be self-pay (paid by the person who picks
up the prescription) or paid by the sex partner’s health
insurance. The health department or some medical offices may
choose to dispense medications to both patients and partners
at no cost instead of writing a prescription.
To whom should medication be billed?
Billing the sex partner’s prescription under the patient’s name
would be considered fraudulent.
If a sex partner is allergic to Azithromycin what are the alternatives?
Other states have been using EPT for approximately 8 years and no adverse
events and/or life threatening allergic reactions have been reported to date. If
the sex partner is known to be allergic to azithromycin, erythromycin,
clarithromycin, or any macrolide or ketolide, azithromycin should not be given
and the partner should be instructed to see a physician for appropriate
treatment. Providers using EPT are required by law to give patients
educational materials to give to his/her sex partner(s). These materials will
address allergic reactions, potential side effects, and contraindications
to taking azithromycin. Patients and their partners should call 311 for more
information.
What if the sex partner is taking a medication that interacts with Azithromycin?
The partner should be referred to a physician or emergency
room for appropriate treatment.
Q: How should pharmacists conduct patient record keeping for
“EPT” prescriptions?
A: EPT prescriptions should be documented/filed like any other
non-controlled substances prescriptions.
What are the educational material requirements for patients provided with EPT?
Each patient provided with antibiotics or a prescription for EPT in accordance with
section 2312 of the Public Health Law must be given informational materials for
the patient to give to his/her sex partner(s). Each patient shall be counseled by
his/her health care provider to inform his/her sex partner(s) that it is important to
read the information contained in the materials prior to the partner’s taking the
medication.
§63.12 Standardized patient-centered data elements to be
used on all drug labels
In accordance with section 6830 of the Education Law, all
prescription medicine dispensed to patients in this State must
include standardized patient-centered data elements as
prescribed by in this section
Definitions. As used in this section:
Critical elements shall consist of:
patient name;
directions for use by the patient, which directions shall be structured in full
sentences; (MDD for controls)
drug name and strength.
Important elements shall consist of:
name, address and telephone number of the pharmacy;
patient’s address;
name of prescriber;
the date of filling or refilling of the prescription; and
the prescription number or other identifying number assigned to the
prescription.
All prescription drug labels shall contain all of the critical elements
and all of the important elements.
Critical elements of each prescription label shall be:
emphasized by being highlighted in color, in bold type, or both: and
printed in a minimum of a 12-point font.
Important elements of each prescription label and any other information
contained on the label shall not be highlighted in color or in bold type, shall
be legible and shall not be presented in a fashion that undermines the
emphasis on the critical elements.
Medication
Assisted
Treatment
Acronyms
DATA - Drug Addiction Treatment Act of 2000
CARA – Comprehensive Addiction & Recovery Act of 2016
OTP - Opioid Treatment Program
NTP - Narcotic Treatment Program
MMTP Methadone Maintenance Treatment Program
MAT – Medication-Assisted Treatment
OASAS – Office of Alcoholism and Substance Abuse Services
SAMHSA – Substance Abuse and Mental Health Services
Administration
40
FDA Approved Medications for Opioid Use Disorder
❑ Methadone- given in clinics, necessary to contact medical
director/opioid treatment program, withdrawal is not required to
start, stringent requirements for admission
❑ Buprenorphine- office based opioid treatment, requires
“X” DEA number, DATA 2000, CARA
❑ Naltrexone- anyone licensed to prescribe in NYS can
prescribe, must be abstinent from narcotics for 7 to 10 days
41
Federal Health and Human Services (HHS)
Buprenorphine Final Rule
❑ Effective February 2017, Nurse Practitioners (NPs) and
Physician Assistants (PAs) became able to prescribe
buprenorphine, a medication typically used to treat SUD.
❑ This program currently has a “sunset date” of 5 years.
❑ NPs and PAs must complete 24 hours of required training
to prescribe the SUD treatment, buprenorphine.
❑ Once training requirements are met, NPs and PAs can
apply for a waiver to treat up to 30 patients.
42
FDA Approved Medications for Opioid Use Disorder
❑ Methadone- given in clinics, necessary to contact medical
director/opioid treatment program, withdrawal is not required to
start, stringent requirements for admission
❑ Buprenorphine- office based opioid treatment,
requires “X” DEA number, DATA 2000, CARA
❑ Naltrexone- anyone licensed to prescribe in NYS can
prescribe, must be abstinent from narcotics for 7 to 10 days
43
buprenorphine
›
PHARMACIST LABELING of C/S under the ORANGE LABEL LAW
allow the choice of:
a.
ORANGE label & 2 caution labels (1 federal & 1 state caution label)
b.
ORANGE tape over white label & 2 caution labels
c.
Your standard label with 2 ORANGE caution labels using black lettering on the caution labels
Federal Caution Label or (FEDERAL) TRANSFER CAUTION LABEL
(for CII, CIII, and CIV only) READS:
“CAUTION: Federal law prohibits the transfer of this drug to
any person other than the patient for whom it was intended”
State Caution Label for ALL C/S dispensed in NEW YORK STATE
READS:
“CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED
AS DIRECTED”
Errors and
Omissions
The following are some practice examples with having either no error
or multiple errors. The answers to these questions are found in the
back of the booklet. Remember on the NYS Board part 3
examination there is either no errors or one error per prescription.
These are past examples so please to not pay attention to expiration
dates on manufacturer’s label.
#2
21
These are easy points to get – Predictable
Final tips on test taking in this section:
1. If you are asked how many tablets can be dispensed based on a
prescription written incorrectly in multiple choice questions the
answer will be “0”
2. Review GlobalRPh and click on IV products. There may be 50 of
them and be familiar with their use and with any unusual
infusion rates, techniques or do not dos.
3. Review orders for controlled substances in hospitals (e.g.
standing orders, routine orders, etc.)
4. Be familiar with hospital orders for controls substances
(residents, foreign trained, etc., prescribing using hospital DEA
numbers with suffixes.