Pharmacy Practice Part 1: Prescribing and Dispensing Flashcards
Naturopathic Doctors (NDs) have independent prescribing authority, but need a furnishing number to prescribe (typically the ND’s license number preceded by the letters NDF) and are limited to the following:
- Epinephrine to treat anaphylaxis
- Natural and synthetic hormones (must have a DEA # to prescribe controlled substances, including testosterone)
- Vitamins, minerals, amino acids, glutathione, botanicals and their extracts, homeopathic medicines, electrolytes, sugars and diluents, only when such substances are available without a Rx.
They have dependent prescribing authority for all other non-controlled and schedule III-V drugs (does not include schedule II)
Registered pharmacists (RPhs) have dependent authority to prescribe non-controlled and schedule II-V drugs, as well as independent furnishing authority, limited to the following:
- Emergency contraception, self-administered hormonal contraception
- Travel medicine recommended by the CDC, not requiring a diagnosis
- Routine immunizations recommended by the CDC for patients ≥ 3 years old
- Naloxone
- Prescription nicotine replacement products
- Pre-exposure prophylaxis (PrEP), max 60 days every 2 years, future fills must be by PCP
- Post-exposure prophylaxis (PEP)
Providers with dependent prescribing authority limited to non-controlled and schedule II-V drugs include:
- Certified nurse-midwives (CNMs)
- Nurse practitioners (NPs)
- Physician Assistants (PAs)
In California, prescribers can self-prescribe non-controlled substances. They can also prescribe both non-controlled and controlled substances to family members as long as there is
a valid physician/patient relationship
a legitimate medical purpose
and a good faith exam
Prescriptions from deceased prescribers:
If a valid Rx was written when the prescriber was living, the Rx is considered valid until all refills are gone, and no more than…
6 months from the date written for controlled substances and one year for non-controlled substances.
Also, the pharmacist should encourage the patient to look for a new doctor ASAP and not to wait until the Rx is expired or the refills are gone.
If another doctor takes over the deceased prescriber’s practice, the pharmacist should request a new Rx from this prescriber.
A pharmacist can dispense a drug or device pursuant to a written or oral order from a prescriber licensed in another state if the out-of-state prescriber has a license equivalent to that required of a California prescriber. However, the pharmacist may need to first verify…
the prescriber’s license and determine whether he or she is authorized to prescribe.
As a general rule, a pharmacist cannot fill a Rx from another country. The District of Columbia and the U.S. territories are treated the same as U.S. states for filling prescriptions. U.S. territories include:
- Puerto Rico
- the Virgin Islands
- Guam
- American Samoa
Requirements for a valid Rx include:
- Patient name and address
- Drug name and quantity
- Directions for use
- Date of issue
- Prescriber information (rubber-stamped, typed, or printed by hand or typeset): name, business address, and phone number, license classification, DEA # (if CS is prescribed)
- Condition or purpose of prescribed drug, if requested by the patient
- Prescriber signature
Medication orders, or chart orders, are the prescriber’s orders for drugs and other items (such as labs and procedures) for institutionalized patients (in a hospital or long-term care facility). A prescriber can handwrite an order in the patient’s…
a physical paper chart or enter it into the patient’s EMR
Written orders are preferred, but a prescriber can also issue face-to-face verbal and telephone orders for hospital patients. For example, a verbal order can be issued in an emergency where a drug must be administered…
immediately
For example, a nurse could report that a patient is experiencing nausea, and the prescriber could instruct the nurse give ondansetron. The nurse would enter the order, note the prescriber’s name and sign the order. The prescriber has…
48 hours to physically or electronically countersign the order. A copy of the chart order for non-controlled substances must be kept at the hospital for at least 3 years. All orders for controlled substances in a hospital setting must be kept for at least 7 years.
An employee or agent (eg, nurse, secretary), under the supervision of a prescriber, can transmit prescriptions for:
non-controlled and schedule III-V drugs to a pharmacist. The pharmacist must document who is calling in or faxing the Rx on behalf of the prescriber. The agent can also prepare a Rx for the prescriber to sign and date.
A PA’s written drug order (except as a written drug order in a patient’s medical record in
a health facility or medical practice) must include:
- the supervising physician’s name, address and telephone number
- the PA’s name and license number
- PA’s signature.
- If the order is for a controlled medication, it must also include the PA’s DEA registration number.
If orally transmitted, the pharmacist who received the Rx is identified by initialing the Rx, and if dispensed…
by another pharmacist, the dispensing pharmacist also initials the Rx
Faxed Rxs can only be received from a prescriber’s office, not from…
the patient
A patient or the patient’s agent can deposit a Rx into a secure container (a drop box) that is…
at the same address as the pharmacy. If the pharmacy choose to use a drop box, the pharmacy is responsible for the security and confidentiality of the Rx placed into it.
The name or initials of the dispensing pharmacist must be documented for each Rx. Commonly, the pharmacist will…
handwrite their initials on the pharmacy’s duplicate copy of the Rx label or use a unique login for an electronic pharmacy workflow software which will electronically document who verified each Rx.
Since 2008, the Federal CMS has required the use of tamper-resistant pads for all Medi-Cal (California Medicaid program) outpatient prescriptions in order to be reimbursed by the government. The tamper-resistant forms must contain three security features in the table below:
- Prevents unauthorized copying of a completed or blank Rx form (the word “void” appears when this Rx is photocopied; forms with watermarks)
- Prevent the erasure or modification of information written on the Rx by the provider (quantity check-off boxes so that the prescriber can indicate the quantity by checking the applicable box; check boxes must be printed on the form so that the prescriber can indicate the number of refills ordered; preprinted test “Rx is void if more than ___ Rxs on paper” on Rx paper)
- Prevent the use of counterfeit Rxs (Each Rx form is serially numbered; certain text or images are printed in thermochromic ink; microprint signature line)
Errors or omissions on a Rx for non-controlled drugs can be revised by the pharmacist if it is minor (eg, misspelling a drug name) or after consultation with the prescriber if it is significant. The pharmacist will need to document the discussion. Alternatively, after verification with the prescriber, the Rx can be re-written as an oral Rx and the original Rx will be voided. The prescriber can also…
resend another Rx via electronic transmission or fax
A patient may prefer to convert a Rx form from a 30-day supply to a 90-day supply to minimize trips to the pharmacy or to save on Rx copays. It is permissible to dispense up to a 90-day supply of a drug when the initial prescription specified a shorter time period (eg, a 30-day supply) as long as the following requirements are met:
- The Rx is not for a controlled substance or a psychiatric drug
- The patient has completed an initial 30-day supply of the drug with no negative effects, or the patient previously received the same medication with a 90-day supply
- The total quantity dispensed (including the refills) does not exceed the amount authorized on the Rx
- The pharmacist notifies the prescriber of the larger quantity dispensed
A pharmacist cannot dispense a greater supply of a drug if:
• The prescriber indicates, either orally or in writing, “No change to quantity,” or other words of similar meaning
• The prescriber indicates that dispensing the prescribed amount is medically necessary.
California expanded patient access to hormonal contraceptives (birth control) by allowing patients…
to pick up an annual supply at one time. Health plans are required to provide coverage for up to a 12-month supply.
For example, if a patient presents a Rx for Sprintec #28 tablets and 11 refills, the patient can request for the entire annual supply to be dispensed at once. The total quantity dispensed (including the refills) cannot exceed the amount authorized on the Rx. So if the prescriber only authorized a Rx for Sprintec #28 tablets and 2 refills, then the pharmacist can only dispense a 3-month supply. However, if the prescriber indicates that there cannot be any change to the quantity or if the prescriber indicates that dispensing the initial amount is medically necessary, the pharmacist must…
dispense the quantity the prescriber has specified (so in this case, it would be only 28)
Refills of prescriptions are permitted as long as the refills were authorized orally, in writing, or electronically by the prescriber. Although there is no refill limit for non-scheduled drugs, refills should not be…
dispensed after one year from the date of issue
All scheduled drug Rxs expire 6 months from the date of issue. There are no refill limits for schedule V drugs, but there…
are restrictions for schedule III and IV drugs.
Refills for schedule II controlled substances…
are prohibited.
PRN (as-needed) refills are acceptable for non-controlled substances according to California law. However, PRN refills should not be refilled after…
one year from the date of issue
If a prescriber writes for a non-scheduled drug for a 30-day supply per fill with “PRN refills,” then…
it can be refilled 11 times before it expires. However, if it is written for a 90-day supply, then the pharmacist can dispense the original fill and 3 refills before the Rx expires.
PRN refills for controlled substances are…
not acceptable
California allows emergency refills without the prescriber’s authorization if the prescriber is unavailable to authorize the refill for non-controlled drugs and schedule III-V drugs. A pharmacist must use professional judgment to determine if failure to refill the Rx might interrupt the patient’s outgoing care or if it would have a significant adverse effect on their well-being. The pharmacist must have made a…
reasonable effort to contact the prescriber. The emergency refill must be properly documented and the prescriber must be notified of the emergency refill within a reasonable amount of time.
California does not specify a quantity limit for an emergency refill for non-controlled drugs, so the pharmacist must…
use his or her professional judgment when deciding to dispense a full or partial refill amount.
For schedule III-V drugs, the pharmacist can only provide a reasonable amount to cover the emergency period until the prescriber can be contacted for a refill authorization. For controlled substances, the pharmacist must…
document on the reverse side of the Rx the date and quantity of the refill, that the prescriber was not available, and the reason for refilling without the prescriber’s authorization.
Pharmacists cannot dispense an emergency refill for schedule II drugs, but…
an emergency verbal order could potentially be obtained.
Retail pharmacies can use central fill (or refill) pharmacies to refill new prescriptions and refills. If the two pharmacies use a common electronic file, policies and procedures must be in place to prevent unauthorized disclosures. The originating pharmacy and the refill pharmacy must have a contract outlining the refill arrangement, or…
the pharmacies must have the same owner. In addition to the normal requirements for a Rx label, the name and address of the refilling and/or the originating pharmacy must be included on the label. The patient must be provided with written information, either on the label or on the container that describes which pharmacy to contact for questions. Both pharmacies are responsible for the accuracy of the refills and both need to keep complete records of the refills. The originating pharmacy is responsible for counseling patients, maintaining the medication profiles and performing a drug utilization review before delivery of each Rx.
Prescriptions can be transferred from one pharmacy to another. This must be done by direct communication between two pharmacists or interns. Non-controlled drugs can be transferred as many times as there are refills.
Schedule III-V drugs can only be transferred once, unless a shared database is used.
For prescription transfers, information kept by each pharmacy must at least include:
- Identification of the pharmacists or intern pharmacists involved in transferring information
- Name and identification code (i.e. pharmacy store #) or address of the pharmacy from which the Rx was received or to which the Rx was transferred. Each pharmacy receives the other pharmacy’s information.
- Original date and last dispensing date
- Number of refills and date originally authorized
- Number of refills transferred (remaining refills that have not been dispensed)
Schedule II prescriptions cannot be transferred; written prescriptions should be returned to the patient for filling elsewhere. If a schedule II prescription was sent electronically and has not been filled, the electronic Rx can be…
forwarded to another pharmacy to fill (this is not considered a transfer)
Prescription containers must have all of the following information (including critical elements and less-critical items):
Critical items: • Patient name • Drug name, strength, quantity • Directions for use • Purpose of the drug (if written on the Rx)
Less-critical items: • Prescriber name • Physical description of the drug (including color, shape, and imprint) • Expiration date • Name and address of the dispenser • Serial or Rx number • Date of issue
Prohibitory/caution statement for controlled substances
When a brand name drug is dispensed, the brand name should be listed on the Rx label (eg, Roxicodone). The manufacturer name…
is not required because the brand name can be ued to identify the manufacturer
When a generic drug is dispensed, the label must include:
- the generic name
- the statement “generic for [insert brand name equivalent]
- the generic drug manufacturer (eg, oxycodone, generic for Roxicodone; MFR: Actavis)
The expiration date on the Rx label can be either the manufacturer’s expiration date or…
one year from the date the drug is dispensed (whichever is earlier). The expiration date will usually be notated with a month and year, and the drug is acceptable to use until the end of the month in which it expires. If the drug container does not have an expiration date, it is considered misbranded, is treated as an expired drug and should not be dispensed.
Each of the following items must be compiled in one area of the label that comprises at least 50% of the label. Each item must be printed in at least a 12-point sans serif typeface. For added emphasis, the label must also highlight in bold typeface or color, or use blank space to set off the 4 critical items above:
• Patient name
• Drug name (trade/brand name or generic + “generic for ____” + manufacturer) and strength
** If the brand is not widely used, it can be left off.
• Directions for use
• Condition or purpose for which the drug was prescribed if this was on the Rx
At the request of a patient or patient’s representative, the pharmacist must provide translated directions for use, which must be printed on the Rx container, label, or on a supplemental document. If translated directions for use appear on a Rx container or label (eg, espanol), the English language version of the directions also need to appear on the container or label, whenever possible. When it is not possible for the English language directions for use to appear on the container or label, it should be provided on a…
supplemental document. A pharmacist can use translations made available by the board. A pharmacist is not required to provide translated directions for use beyond the languages that the board has made available in translated form.
The Poison Prevention Packaging Act (PPA) required the use of child-resistant (CR) containers for many OTC products, most oral Rx drugs, and dangerous household containers. At least 90% of adults should be able to open the container. The PPA mandates that a new plastic container and closure (eg, bottle and cap) must be used for each Rx dispensed. If a glass container is used, only the top closure needs to be replaced. Exemptions to CR packaging include:
- Sublingual nitroglycerin
- Oral contraceptives
- Hormone replacement therapy
- Powdered unflavored aspirin
- Effervescent aspirtin
- Powdered iron preparations
- Effervescent acetaminophen
The patient or prescriber can request “easy-open,” non-C-R containers. The prescriber can waive the use of a C-R container for a single Rx. The patient can provide a…
blanket waiver for all prescriptions. The pharmacist must document the waiver request with the patient’s signature.
C-R-packaging is not required for drugs administered by a healthcare provider. For the people who might have trouble opening C-R containers, the PPPA allows manufacturers to…
package one size of OTC drugs in a non-C-R (easy-open) container as long as the same product is also available in a C-R container. The package must have the warning, “This package is for households wihout young children” or “Package Not Child-Resistant.”
There are 4 types of written information that can be provided to the patient:
- Consumer Medication Information (CMI) leaflets
- Patient Package Inserts (PPIs)
- Medication Guides (MedGuides)
- Instructions for Use
The FDA mandates that useful written patient information be provided to patients with each new Rx. CMI handouts are the paper leaflets of drug information that are…
put inside the Rx bag or stapled to the outside. These are not reviewed or approved by the FDA. The information should be simplified for patients to understand and should reflect the FDA-approved package insert. They should explain how to use the drug, received benefit and avoid harm.
In the 1970s, the FDA required that all oral contraceptives be dispensed with the FDA-approved patient package insert (PPI) in order for the patient be fully informed of the benefits and risks involved with the use of these drugs. For oral contraceptives, the PPI must be…
given each time the drug is dispensed in the outpatient or retail setting, with both the initial fill and with refills.
In an institutional setting such as a hospital or long-term care facility, the PPI must be…
provided to the patients before the administration of the first dose and every 30 days thereafter. If the PPI is not provided as required by law, it is considered misbranding.
MedGuides are FDA-approved patient handouts for many Rx medicines that may have a serious and significant health concern. The FDA required that MedGuides be issued with drugs or biologics that require education about how to prevent serious side effects, the risks of side effects (to guide decision-making) or if adherence to specific instructions is essential to effectiveness. The manufacturer must…
supply the MedGuides to the dispenser by providing the physical handouts or the electronic file so the pharmacy can print them out for the patient.
There are over 300 medications that required MedGuides. The full list can be found on the FDA website. Select drugs that require MedGuides are:
- Antidepressants (bupropion, citalopram, doxepin, duloxetine, escitalopram, fluoxetine, imipramine, mirtazapine, nortriptyline, paroxetine, sertraline, trazodone, venlafaxine)
- NSAIDS (celecoxib, diclofenac, diclofenac/misoprostol, etodolac, ibuprofen, ibuprofen/hydrocodone, indomethacin, ketorolac, meloxicam, nabumetone, naproxen, oxaprozin)
- Insomnia (eszopiclone, ramelteon, temazepam, triazolam, zaleplon, zolpidem)
- LABAs- arformoterol, formoterol, formoterol/budesonide, salmeterol, salmeterol/fluticasone
- ADHD drugs- atomoxetine, dexmethylphenidate, dextroamphetamine, dextroamphetamine/amphetamine, lisdexamfetamine, methylphenidate
- Diabetes- exenatide, pioglitazone, pioglitazone/metformin, rosiglitazone, rosigliazone/metformin, canagliflozin
- Antipsychotics- aripiprazole, olanzapine, quetiapine
- Antiarrhythmics- amiodarone
- Retinoids- acitretin, isotretinoin
- Others: anticoagulants, alendronate/bisphosphonates, monoclonal antibodies, quinolone antibiotics, etanercept, ESAs, fentanyl, pimecrolimus, raloxifene, tacrolimus, tamoxifen, teriparatide, testosterone, varenicline
