Pharmacy Practice Part 1: Prescribing and Dispensing Flashcards
(129 cards)
1
Q
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:
A
- 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)
2
Q
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:
A
- 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)
3
Q
Providers with dependent prescribing authority limited to non-controlled and schedule II-V drugs include:
A
- Certified nurse-midwives (CNMs)
- Nurse practitioners (NPs)
- Physician Assistants (PAs)
4
Q
In California, prescribers can self-prescribe non-controlled substances. They can also prescribe both non-controlled and controlled substances to family members…
A
as long as there is a valid physician/patient relationship, a legitimate medical purpose, and a good faith exam
5
Q
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…
A
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.
6
Q
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…
A
the prescriber’s license and determine whether he or she is authorized to prescribe.
7
Q
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:
A
- Puerto Rico
- the Virgin Islands
- Guam
- American Samoa
8
Q
Requirements for a valid Rx include:
A
- 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
9
Q
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
a physical paper chart or enter it into the patient’s EMR
10
Q
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…
A
immediately
11
Q
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…
A
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.
12
Q
An employee or agent (eg, nurse, secretary), under the supervision of a prescriber, can transmit prescriptions for:
A
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.
13
Q
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:
A
- 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.
14
Q
If orally transmitted, the pharmacist who received the Rx is identified by initialing the Rx, and if dispensed…
A
by another pharmacist, the dispensing pharmacist also initials the Rx
15
Q
Faxed Rxs can only be received from a prescriber’s office, not from…
A
the patient
16
Q
A patient or the patient’s agent can deposit a Rx into a secure container (a drop box) that is…
A
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.
17
Q
The name or initials of the dispensing pharmacist must be documented for each Rx. Commonly, the pharmacist will…
A
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.
18
Q
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:
A
- 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)
19
Q
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…
A
resend another Rx via electronic transmission or fax
20
Q
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:
A
- 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.
21
Q
California expanded patient access to hormonal contraceptives (birth control) by allowing patients…
A
to pick up an annual supply at one time. Health plans are required to provide coverage for up to a 12-month supply.
22
Q
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…
A
dispense the quantity the prescriber has specified (so in this case, it would be only 28)
23
Q
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…
A
dispensed after one year from the date of issue
24
Q
All scheduled drug Rxs expire 6 months from the date of issue. There are no refill limits for schedule V drugs, but there…
A
are restrictions for schedule III and IV drugs.
25
Refills for schedule II controlled substances...
are prohibited.
26
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
27
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.
28
PRN refills for controlled substances are...
not acceptable
29
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.
30
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.
31
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.
32
Pharmacists cannot dispense an emergency refill for schedule II drugs, but...
an emergency verbal order could potentially be obtained.
33
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.
34
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.
35
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)
36
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)
37
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
38
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
39
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)
40
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.
41
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
42
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.
43
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
44
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.
45
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."
46
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
47
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.
48
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.
49
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.
50
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.
51
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
52
The FDA Amendments Act of 2007 gave the FDA the authority to require a REMS from manufacturers to ensure that the benefits of certain drugs and biologics outweigh the risks. If the FDA feels that the drug has serious safety concerns that would not be sufficiently addressed with the use of boxed warnings and MedGuides, they can mandate the use of a REMS. The manufacturer, also known as the drug's sponsor, develops the REMS and gets FDA approval before implementation. It can be required for a new drug or drug class, or when safety issues arise with an existing drug. There are 4 parts to a REMS:
1. Communication plans
2. Elements to assure safe use
3. Implementation systems
4. MedGuides
53
REMS programs:
* Thalidomide; severe birth defects; a negative pregnancy test is required prior to dispensing each Rx (Thalomid REMS Program)
* Isotretinoin; severe birth defects; iPledge Program; 2 negative pregnancy tests are required before first fill & one negative test prior to dispensing each subsequent Rx
* Clozapine; neutropenia; clozapine REMS program. Monitor the absolute neutrophil count (ANC)
* Phentermine/topiramate (Qsymia). Severe birth defects. MedGuide required, healthcare training program, dispensed only through certified pharmacies
* Opioid analgesics (high abuse potential, life-threatening respiratory depression). Educate providers about treating and monitoring pain by completing REMS-compliant training and taking knowledge assessments. Dispense with MedGuide as required. MedGuide requirements are product specific (i.e. not all opioids require a MedGuide). Educate prescriber and patient on safe use, risks, storage, and disposal.
* Flibanserin (Addyi). Risk of hypotension and syncope due to an interaction with alcohol. Addyi REMS Program. No alcohol use while taking Addyi, all REMS participants must be trained and patients must be properly counseled.
54
A pharmacy must keep medication profiles on all patients who have prescriptions filled at the pharmacy except when the pharmacist feels that the patient will not come back to the pharmacy. The following information must be kept on a patient profile:
* The patient's full name and address, telephone #, DOB, and gender
* The prescriber's name, license #, and if needed, the DEA registration #, or other unique identifier
* The date each drug was dispensed or refilled
* The Rx # for each Rx
* Any of the following: allergies, idiosyncrasies, current medications and relevant prior medications, OTC medications, devices, social history, or medical conditions, if provided.
* Any other information which the pharmacist, in his or her professional judgment, feels is appropriate to include.
* The profile must be kept for at least one year from the date when the last Rx was filled.
55
There are 3 types of drug utilization reviews (DURs):
Prospective DUR: evaluation of a patient's medication profile before dispensing. This is performed by the dispensing pharmacist each time a Rx is filled. The clerk at the window asks the patient if they have any new medications or allergies: if so, these will be added to the profile, and the pharmacist will review the current use to determine that the drug is safe to dispense. The purpose is to optimize the patient's therapy by looking for:
* Therapeutic duplication
* Incorrect dose
* Incorrect tx duration
* Contraindications
* Interactions between drugs, disease states or allergies
* Abuse or diversion
56
Retrospective DUR: review of drug therapy after the drug is dispensed. These are often conducted for many patients at once, and are performed by...
the state (according to the Omnibus Budget Reconciliation Act), a medical institution (eg, hospital), or an insurance company.
57
Concurrent DUR: on-going medication during the course of tx. Regulations require hospital pharmacists to obtain a medication profile for each high-risk patient (as determined by the hospital). Technicians or interns...
can obtain the profile if they have received adequate training.
58
Pharmacists must provide counseling (oral consultation) in any of the following situations:
* The Rx drug has not been previously dispensed to the patient
* The refill is being dispensed in a different dosage form, strength, or with a new written Rx
* If the patient requests counseling
* When the pharmacist feels counseling is necessary
59
Patient counseling by the pharmacist must include at least the following items:
* Directions for use and storage
* The importance of compliance with directions
* Precautions and relevant warnings, including common or severe side effects and interactions that can be encountered
60
When the pharmacist feels it is necessary, the patient counseling can also include:
* The name and a description of the drug
* The route of administration
* The dose and/or the dosage form
* The duration of therapy
* Any special directions for use and storage
* Instructions on how to prepare the drug for administration
* Techniques for self-monitoring
* Refill information
* Additional adverse drug reactions or interactions
* What do if a dose if missed
61
Only the pharmacist or intern pharmacist can make the offer to counsel. Although the offer to counsel must be made the patient or patient's caregiver can refuse counseling. The pharmacist must provide...
patient counseling in an area suitable for confidential patient counsulation to protect the patient's health information.
62
If a Rx is mailed or delivered, there must be a written notice that a pharmacist is available for patient consulation, the telephone # the patient can call and the hours of availability. A phamacist must be...
available for consultation for at least 6 days of the week and for at least 40 hours per week
63
Pharmacies often interact with patients with a limited grasp of the English language, and all patients need to know how to use their medications safely. In California, pharmacies are required to...
provide interpretive services in the patient's language during all hours that the pharmacy is open, either in person by the pharmacy staff who can communicate in the patient's language, or by the use of a third-party interpretive service available by the telephone that is at or close to the pharmacy counter. Pharmacists are not required by state law to counsel inpatients; however, a registered nurse, pharmacist or prescriber must provide discharge counseling.
64
The purpose of the Notice to Consumers is to make sure consumers understand that they have certain rights, which includes the requirement to require counseling from a pharmacist, with each new Rx, the type of information that should be provided, and the patient's right to ask questions about their medications. The notice advises the patient that easy-to-read type...
interpreters services and drug prices are available on request. The full-size poster of the Notice to Consumers (see previous page) must be posted in public view where it can be read by the consumer.
65
The poster can be ordered on the board website. Smaller versions can be printed out a legal size paper. The poster can be provided in languages that apply to the pharmacy's customer population. Alternatively, written receipts containing the required information can be provided to patients. This is...
an acceptable option for settings in which the patient does not physically see the pharmacist, such as mail-order or closed-door pharmacies. A pharmacy can also opt to display a PowerPoint presenation of the notice on a video screen.
66
The Health Insurance Portability and Accountability Act (HIPPA) of the 1996 created national standards to protect the privacy of a patient's health information (PHI). Healthcare facilities, insurance companies and pharmacies must...
ensure that patient information is secure and not available to viewers who do not require access, regardless of whether the information is in electronic, verbal or written form.
67
HIPAA outlines how protected health information (PHI) can be shared by covered entities and provides the patients the right to access their own information. Covered entities include:
* Healthcare professionals
* Facilities where health care is provided
* Health insurance companies
68
Healthcare professionals must have documented HIPPA training to learn how to protect patient PHI. Violation of HIPPA, either inadvertently or deliberately, can result in fines and imprinsonment. An individual at each facility must be designated to enforce the privacy policy. PHI includes an individually identifiable health information that relates to:
* The patient's past, current, or future physical or mental health (i.e., the medical record)
* The healthcare provided to the patient (eg, lab tests, surgery, medications)
* The past, present or future payment for providing healthcare to the patient (eg, hospital bills)
* When assoicated with health information:
* Name, address, birthdate, social security #
69
It is permissible to share PHI with:
* The patient
* Other healthcare providers caring for the patient
* Entities requiring the information for payment or operational purposes (e.g. care coordination, quality improvement)
* A limited data set can be provided for research, public health or institutional operations
* Law enforcement
* The DEA, FDA, medical board inspectors and pharmacy board inspectors (for a public health purpose or drug abuse concern)
* Organizations related to donation and transplantation of organs and tissues
70
If a release of PHI is not for the purposes listed above, the healthcare provider must receive the patient's written authorization. The authorization must be in plain langauge and include with whom the information will be shared, the purpose, the right to remove authorization, the expiration date and the patient's signature. If the patient is...
is requesting the release, a written authorization is not necessary according to HIPAA, but some facilities will require it.
71
There must be policies, procedures and protocols in place for disclosures (routine, recurring or requests) to ensure that that only the "minimum necessary" information required for the job or request is shared or used. Pharmacists can...
leave voicemails with the minimum necessary information on patients' home machines. Prescriptions can be picked up by family or friends unles the pharmacist has reason to believe that this would be against the wishes of the patient.
72
Incidental disclosures are unavoidable and acceptable under HIPAA. Actions should be taken to minimize disclosure by speaking in a lower volume or speaking in a more private setting whenever possible. Examples of incidental disclosures include when someone overhears:
* Oral coordination of patient care at a nursing station
* A healthcare provider discussing a patient's condition over the phone with another provider, the patient or their family member
* A discussion between providers while on rounds
* A pharmacist discussing a Rx in person or over the phone with a patient or provider
73
To minimize disclosures, healthcare provider must be mindful of the following:
* Avoid discussing patient care in common areas (eg, in elevators, cafeteria)
* Avoid posting any informatoin about patients on social media (eg, summaries of a case, pictures)
* Shred all documents before disposal; redaction (i.e. editing to censor/obscure content) is not an appropriate method of PHI destruction
* Cover patient identifiers on Rx bottles and bags before and during dispensing
* Close electronic medical records on computer screens when not in use and log out of the system
* Only access patient charts that are required for patient care
74
HIPAA requires a site-specific notice on the policies in place to protect PHI and with whom the information can be shared. This should be in simple language, and state the patient's rights to their own information and be specific that any release beyond what is stated in the policy will require the patient's approval. It should...
list the contact for the Department of Health & Human Services if the patient wishes to file a complaint, along with the contact for a person within the pharmacy if the patient wishes to discuss privacy concerns.
75
The HIPAA policy noticed should be placed in a prominent location with the pharmacy and on its website. It must be given to the patient on the first day that services is provided and at any other time it is requested. The pharmacy must make a good faith effort to obtain the patient's written acknowledgment of receiving the notice. The pharmacy must promptly revise and distribute its notice whenever there are changes to any of its privacy practices. A pharmacy can still provide services if the patient refuses to sign. The written acknowledgment must be separate from other signatures; one...
signature cannot be used to acknowledge receipt of the HIPAA privacy notice and to acknowledge another item, such as refusing the right to counsel. The signed HIPAA privacy disclosure forms must be kept for 6 years, and the patient has a right to request all of their privacy disclosures for the past 6 years.
76
The patient has the right to obtain a copy of their records. In California, patients must be able to inspect their medical records within 5 business days of making a written request, and receive copies within 15 business days. The maximum charge for copies is...
$0.25 cents/page, or $0.50 cents/page if the copies are being made from microfilm, plus the addition of reasonable clerical costs incurred in making the records available. The patient can request a copy in the format of their choice (such as a printed copy or an electronic version sent via email).
77
A pharmacist can substitute generic, therapeutically-equivalent drugs for a branded drug using the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) unless the prescriber of patient has requested otherwise. The drug must have...
the same active ingredients with the same strength, quantity and dosage form and the same generic drug name as determined by the United States Adopted Names (USAN), and accepted by the FDA.
78
The purpose of generic substitution is to provide the patient with a lower-cost drug while still providing the same therapeutic benefit. When a substitution is made, the cost savings from the switch must be communicated to the patient. If the generic equivalent is dispensed, the label must contain the generic name, the statement "generic for ______" where the brand name is inserted, and...
the manufacturer name (eg, atorvastatin, generic for Lipitor, MFR: Mylan Pharmaceuticals). If the brand is dispensed, only the brand name is required on the label.
79
The Orange Book is available in print, online at the FDA website or as a mobile application (Orange Book Express). The Orange Book uses a two-letter code system. The first letter indicates if the drug is therapeutically equivalent to the reference listed drug (RLD) and the second letter provides additional information about the FDA's evaluation (eg, route of administration or formulation.
If the first letter is A, then the drug is therapeutically equivalent to the RLD.
Most states permit brand drugs to be interchanged with AB-generics as a cost-savings measure.
AA, AN (solutions or powder for aerosolization), AO (injectable oil solution), AP (injectable aqueous ad non-aqueous solution) and AT-rated (topical) drugs are therapeutically equivalent to the RLD by meeting in vitro bioequivalence, and they have no known in vivo bioequivalence issues.
80
A substitution cannot be made if the the prescriber has taken any of the following actions:
* Indicates, either orally, in handwriting or electronically "Do not substitute"
* Checks of a box pre-printed with the text "Do not substitute"
* Initials a box pre-printed with the text "Do not substitute"
81
A pharmacist can select a different formulation with the same active ingredients of equivalent strength and duration of therapy as the prescribed drug when the change will improve patient compliance. For example, if a pharmacist receives a Rx for 1/2 of the singe strength sulfamethoxazole/TMP tablets for a child...
the pharmacist may suggest a 5 mL dose of the pediatric suspension to the child's patients. If the prescriber has indicated that no drug substition is allowed, the formulation should not be changed.
82
Substitution is not permitted betwween long-acting and short-acting forms of a medication with the same chemical ingredients. For example, the long-acting form of clonidine that is indicated for ADHD (Kapvay) cannot be interchanged with immediate-release clonidine. Substitution is also not permitted between...
combination drugs products and multiple single agents. For example, a Rx for isosorbide dinitrate/hydralazine (BiDil) cannot be dispensed as the two individual drugs.
83
A biosimilar is considered "highly similar" to an FDA-approved biologic (known as a "reference product") and has no clinically meaningful difference. Biosimilars are not considered therapeutically equivalent to the reference product, so a pharmacist cannot automatically substitute these products for one another. Common biologics with approved biosimilars include:
filgrastim (Neupogen) and the biosimilar filgrastim-sndz (Zarxio), and infliximab (Remicade) with the biosimilar infliximab-dyyb (Inflectra)
84
When approved by the FDA, pharmacists will be able to dispense an interchangeable biosimilar product in place of the prescribed reference product, unless the prescriber indicates otherwise. The dispensed biosimilar product cannot cost more than...
the prescribed biologic product and the substitution must be communicated to the patient. The Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (The Purple Book) lists the reference products, biosimilar products and interchangeable products.
85
A formulary is a preferred drug list that a hospital or other institution, healthcare plan or PBM has chosen for their patient or members. The formulary should include the safest and most effective drugs according to current clinical guidelines/practices while considering cost. When similar drugs exist in a class...
a competitive bidding process is used. Drugs may be removed from the formulary if there is a safety concern (eg, sound-alike or look-alike, abuse potential) or if a less expensive drug is available.
86
The P&T Committee is responsible for all aspects of drug use in a healthcare system, which could be a small hospital or large pharmacy benefit manager (PBM). P&T members include physicians, pharmacists, nurses, administrators, quality improvement manageers and the medication safety orricer. The pharmacy responsibilities of the P&T Committee are to...
create and update the formulary, conduct medication (or drug) use evaluations (MUE/DUE), monitor and report adverse drug events, conduct medication error safety initiatives (which will involve the medication safety officer) and develop clinical care plans and protocols.
87
Healthcare plans have formularies to outline which drugs will be covered in the outpatient or retail setting. These formularies have different tiers, which correlate with different copays. The typical outpatient formulary has 3-5 tiers; the lower the tier, the lower the copay. A copay is an...
out-of-pocket expense that the patient must pay in order to receive services such as doctor visits and Rx drugs. Specialty drugs, including biologics, will be placed on high tier (such as tier 4 or 5), and the insurance plan may require prior authorization to use insurance coverage.
88
In healthcare facilities and some ambulatory care settings, therapeutic interchange protocols developed by the P&T Committee are used by pharmacists to dispense medications that are different, but therapeutically similar to the medication prescribed. Therapeutic interchange protocols are a...
cost-effective strategy, so a more expensive drug can be interchanged with a less costly drug that provides a similar therapeutic benefit.
89
The pharmacist who substitutes one drug for another does not need to discuss the change with a physician as long as the substitution is established in the institution's therapeutic interchange protocol. Drug classes commonly included in therapeutic interchange protocols are:
PPIs, statins, antacids, H2-blockers, hypnotics, ACE inhibitors, ARBs, potassium supplements, antibiotics, insulins, topical steroids, laxatives and stool softeners.
90
In California, a pharmacist can refuse to dispense certain medications if he or she has previously notified his or her employer, in writing of their moral or conscientious objection. A written protocol must be...
established to ensure that the patient has timely access to the prescribed drug or device despite a pharmacist's refusal to dispense the Rx or order. This can mean having another staff pharmacist dispensing the drug or referring the patient to a nearby pharmacy.
91
There are 2 types of internet pharmacies: legitimate mail order pharmacies and rogue internet pharmacists. Internet prescriptions should only be dispensed to patients if the prescriber has performed an examination. In 2008, the Ryan Haight Online Pharmacy Consumer Protection Act was...
signed into law to prevent illegal sales of controlled substances via the internet. In order to legally dispense controlled substances through an online pharmacy, the pharmacy must register with the DEA and report their dispensing activity to the DEA.
92
Remote dispensing sites (ie. telepharmacies) are allowed to operate in underserved locations that do not have an outpatient pharmacy within 10 miles. A remote (telepharmacy) site is...
managed by a supervising pharmacy that is licensed and owns the remote pharmacy. The remote site is not licensed and is considered to be a satellite location of the licensed, supervising pharmacy. The pharmacist supervises all activities in the remote pharmacy (e.g, DUR, filling and counseling) with technology, such as audio-visual equipment.
93
Requirements for a telepharmacy site:
* The supervising pharmacy and the remote site must be within 150 miles of each other
* The pharmacist is not located at the remote site; technicians carry out the work, but can only perform non-discretionary tasks
* Technicians cannot accept new prescriptions, compound medications (which requires direct supervision), or perform other discretionary tasks
* A single pharmacist (off-site) can supervise 2 technicians who are working at the remote site
* A responsible technician will have a key to the remote site
* Counseling for each Rx is required and must be done remotely by the pharmacist
* Drugs are stored at the remote site, including controlled substances, and the PIC at the supervising site retains responsibility for controlled substances at the remote site.
* Controlled substances must be stored separately.
* All management of controlled substances, such as pulling them from the separate area, filling and dispensing, must be captured on video. The video recordings must be kept for at least 120 days.
* The pharmacist must inventory the controlled substances when they are present at the remote site. At this time, the pharmacist should countersign for controlled substance deliveries.
* A pharmacist from the supervising pharmacy must travel to the remote pharmacy and conduct an inspection of the facility at least once monthly.
94
Pharmacy technicians must meet extra requirements in order to practice at a remote dispensing site. In addition to being licensed and certified, a technician must have one of the following:
* Associate's degree in pharmacy technology
* Bachelor's degree in any subject
* Certificate of completion from a board-approved course
95
A pharmacy technician must have...
completed at least 2,000 hours of experience within the 2 years before beginning work at a remote site.
96
A pharmacist can dispense epinephrine auto-injectors (eg, EpiPen) to a pre-hospital emergency medical person (eg, paramedic), lay rescuer, or authorized entity (eg, ambulance company) for first aid purposes. The responder must...
obtain current certification that demonstrates they are trained and qualified to administer the auto-injector.
97
A physician must provide a written order specifying the quantity of epinephrine auto-injectors to be dispensed. A pharmacy can also...
provide auto-injectors for a school district or charter school, based on a physician/surgeon written order.
98
Each epinephrine auto-injector should be dispensed with the manufacturer's product information sheet, and labeled with the following:
* The name of the person to whom the Rx was issued
* The designation "Section 1797.197a responder" and the "First Aid Purposes Only"
* The dosage, use, and expiration
An individual that administers epinephrine in good faith to help someone experiencing anaphylaxis is given immunity from prosecution and no civil damages can be awarded.
99
Hemophilia and Von Willebrand disease are hereditary bleeding disorders. The preferred method of treatment of hemophilia today is intravenous injection, or infusion, or prescription blood clotting products at a federally designated regional hemophilia treatment center. Each provider of blood clotting products for home use must:
* Maintain 24-hour on-call service available every day of the year, screen telephone calls for emergencies and acknowledge all telephone calls within one hour
* Have the ability to obtain all FDA-approved blood clotting products in multiple assay ranges (low, medium and high, as applicable) and vial sizes
* Supply all necessary ancillary infusion equipment and supplies with each Rx, as needed
* Ship the presribed blood clotting products and ancillary infusion equipment and supplies to the patient within 2 business days
100
Pharmacy law requirements can be wavied during declared disasters and emergencies to ensure that patients receive medications. A pharmacist can dispense drugs (controlled and non-controlled) devices in reasonable quantities without a Rx during a federal, state or local emergency. A recording containing the:
* date
* patient's name and address
* the drug or device name
* strength, and quantity dispensed
The pharmacist must make a good faith effort to communicate this information to the patient's healthcare provider as soon as possible.
101
During a declared federal, state, or local emergency, the board can allow the deployment of a mobile pharmacy in impacted areas in order to ensure the continuity of patient care, if all of the following conditions are met:
* The mobile pharmacy shares common ownership with at least one currently licensed pharmacy in good standing
* The mobile pharmacy retains records of dispensing
* A licensed pharmacist is on-site and managing the mobile pharmacy
* Reasonable security measures are taken to safeguard the drug supply maintained in the mobile pharmacy
* The mobile pharmacy is located within the declared emergency area or affected areas
* The mobile pharmacy ceases activity within 48 hours after the emergency is over
102
California's End of Life Option Act became effective in 2016. The end of life option can be referred to as death with dignity or physician-assisted suicide. The act permits mentally competent, terminally-ill adults to receive and voluntarily self-administer drugs to end their life in a peaceful, humane manner in a place and time of their choosing. Patients who wish to receive an aid-in-dying drug must be:
* ≥ 18 years of age
* A California resident
* Mentally competent (capable of making and communicating healthcare decisions for him/herself)
* Diagnosed with a terminal illness that will lead to death within 6 months (confirmed by 2 physicians)
103
Dispensing Aid-In-Dying Drugs:
The procedure to receive and use the medication is as follows:
1. The patient makes the first oral request to the physician. Patients who do not speak English can use a language interpreter. The physician must discuss the request for medication with the patient (and their interpreter, if applicable) alone to ensure that the request is voluntary.
2. After at least 15 days from the inital oral request, the patient makes a second oral request to the physician.
3. Anytime after the first oral request, a written request is given to the physician (the patient does not need to wait until after the 2nd oral request to make the written request).
4. After the physician receives all 3 requests, the physician can furnish the drugs directly to the patient or send a Rx directly to a pharmacist. If the physician is sending a Rx to a pharmacy, the physician must contact the pharmacy first and inform the pharmacist of the Rx for aid-in-dying drugs. The physician must then personally hand-deliever, mail or electronically send the written Rx to the pharmacist. The patient is never in possession of the Rx.
5. The patient picks up the medication from the pharmacy or has it delivered.
6. The patient can change his/her mind about taking the medication at any time.
7. The patient must complete the final attestation form (to be given to the attending physician) within 48 hours before taking the medication.
104
The schedule II controlled substances secobarbital and pentobarbital are drugs that may be used for this purpose. The patient should be counseled on the importance of keeping the drug secure and out of the reach of children and pets. An anti-emetic should be taken an hour before the drug is taken. Secobarbital comes in capsules and pentobarbital comes in solution. If the contents of the capsules are opened...
the drug can be mixed with juice to mask the bitter taste. A relative or caregiver must properly dispose of any unused drug by the patient. Unused drugs can be taken to a DEA-registered collection receptacle, a law-enforcement sponsered take-back event or any other lawful means. A pharmacist can choose not to furnish the drugs due to conscientious, moral or ethical objection.
105
Automated drug delivery systems (ADDS) are cabinets that are used to store and dispense drugs to patients in skilled nursing and intermediate care facilities, hospital units, and sometimes in other locations, such as medical clinics. An ADDS can also be referred to as...
an automated dispensing system (ADS) or an automated dispensing cabinet (ADC). If the ADDS is used to store and dispense scheduled drugs, a DEA-registered pharmacy must manage the cabinet.
106
For systems located in a skilled or intermediate nursing facillity, the following is required:
* The pharmacy and the nursing facility have policies and procedures to ensure that the drugs are being stored and dispensed properly
* The pharmacist reviews each medication order and the patient's profile before the drug is removed from the ADDS. Use of an override to retrieve a medication before the pharmacist can review the order should be done in emergency situations only.
* When the cabinet is stocked directly in the facility, the stocking is done by a pharmacist.
* If the ADDS uses removable pockets, drawers, or similar technology, the stocking is done outside the facility (i.e. at the pharmacy) and delivered back to the facility. With this type of stocking, the removable pockets or drawers must be transported between the pharmacy and the facility in a secure, tamper-evident container, and once the removable pockets or drawers are brought back to the pharmacy, they are restocked by a pharmacist, an intern pharmacist or a technician working under the supervision of a pharmacist.
The board is also concerned that drugs stored in an ADDS are properly labeled. The drugs must be labeled with at least the following information: drug name, strength, and dosage form, manufacturer, manufacturer's lot, and expiration date.
107
Pharmacies that remotely operate an ADDS must register the ADDS with the board within 30 days of installing the device and annually as part of the license renewal. The pharmacy also has to inform the board in writing if the pharmacy discontinues operating the ADDS. This includes...
pharmacies that remotely operate ADDS in long-term care facilities. Hospitals that operate an ADDS within their own facility do not need to register the ADDS separately with the board.
108
Drugs can be pre-counted or poured (repackaged) from a bulk stock container into smaller quantities suitable for dispensing. This is often done for frequently used drugs so that the commonly dispensed drugs can be filled and dispensed quickly once the Rx is received. It may also be done for drugs that are not available at a reasonable cost in smaller quantities, or for drugs that are needed as unit-dose for a hospital or other type of instuitional setting. The repackaging should be done according to....
the Current Good Manufacturing Practices (CGMPs), and the drugs must be properly labeled with at least the following information: drug, name, strength, dosage form, manufacturer's name, lot #, expiration date and quantity per repackaged unit. If the approved labeling contains instructions for handling or storage of the product, the repackaging will need to be done in accordance with those instructions. A lot must be kept for drugs pre-packed for future dispensing.
109
The board has created a specialty licensed for a hospital pharmacy that perfoms centralized packaging for the pharmacy's hospital and one or more general acute care hospitals under common ownership and located within a 75-mile readious of each other. The centralized pharmacy can prepare and store a limited quantity of unit-dose drugs in advance of a patient-specific Rx in amounts necessary to ensure continuity of care. Drugs packaged as single units or "unit-doses" can help to reduce drug diversion, drug waste and medication errors. The unit-dose container...
is a non-reusable container designed to hold a quantity of drug intended for direct, oral administration as a single dose. Unit-dose packaging can be performed by the drug company or prepared from bulk containers in the pharmacy.
110
Barcoding is essential for medication safety since it helps to verify that the right drug is given to the patient. The nurse administering the drug scans the barcode on the unit-dose medication and then scans the barcode on the patient's wristband to verify that it is the right drug, dose, and route for the correct patient. Any unit-dose medication...
produced by a centralized hospital packaging hospital must be barcoded to be machine-readable at the inpatient's bedside using barcode medication administration software. The software must read the barcode and compare the information retrieved to the electronic medical record of the inpatient.
111
The label for each unit-dose medication produced by a centralized hospital packaging pharmacy must contain all of the following:
* Date that the medication was produced
* Beyond-use date
* Name of the drug
* Quantity of each active ingredient
* Special storage or handling requirements
* Lot/control # assigned by the packaging pharmacy
* A pharmacist must be able to retrieve the following information with the lot/control #: the components in each container and the expiration date and NDC of each drug component
* Name of the packaging pharmacy
112
According to United States Pharmacopeia (USP) guidelines, the beyond-use date (BUD) for unit-containers is not later than either of the following:
* 6 months from the date the drug is repackaged
| * Expiration date on manufacturer's container
113
Drugs previously dispensed can be repackaged at the patient's request into a package that is more convenient for the patient. This type of packaging is referred to as a "medication blister pack" or "bubble blister pack" or "medication pill card." This can be done when a patient has a complicated drug regimen and/or lives in a long-term facility. Repackaging a patient's drugs into a bubble pack could increase compliance and reduce medication errors. An pharmacy providing repackaging services must have policies and procedures for the repackaging process, and must label the repackaged drugs with the following:
* All the information required for a Rx label
* The name and address of the pharmacy that initially dispensed the drugs to the patient, and the name and address of the pharmacy repackaging the drugs, if different.
114
Pharmacies engaged in compounding must comply with the United States Pharmacopeia (USP) compounding standards..
in addition to any regulation set by the California Board of Pharmacy.
115
Compounding is the process of combining or altering ingredients to create a medication. A traditional compounded drug is prepared by a pharmacist for an individual patient based on a Rx. Compounded drugs meet unique needs and are not FDA-approved. The dose or formulation cannot be commerically available. Traditional compounding is used for this purpose and is defined under section 503A of the Drug Quality and Security Act (DQSA). Traditional compounding includes any of the following:
* Altering the dosage form or delivery system
* Altering the strength
* Combining components or active ingredients
* Preparing a drug product from chemicals or bulk drug substances
These activites are not defined as compounding:
• Reconstituting a drug, according the manufacturer's directions
• Splitting tablets
• Adding flavors agents to an existing drug product in order the enhance palatability
116
Drugs made with traditional compounding methods have 3 exemptions from requirements that otherwise apply to Rx drugs:
* Complying with the FDA's Current Good Manufacturing Practices (CGMPs)
* Labeling with adequate directions for use
* The need to complete a New Drug Application (NDA) in order to have the end product FDA-approved
117
Section 503A permits pharmacists to prepare small batches of a compounded preparation in advance if the dispensing history of the pharmacy supports the need. If a pharmacist in a medical building prepares...
3-4 Rxs of the same strength of a progesterone cream each day, the pharmacy can prepare a few days' supply of the cream so it is is ready when the prescriptions are received. These preparations will need to be labeled with the appropriate BUD.
118
Pharmacists can sell a reasonable quantity of compounded preparations to prescribers for administration or application to patients (human and animal) in the prescriber's office. Prescribers cannot purchase compounded preparations from pharmacies to furnish/dispense to human patients. The prescriber's office...
will need to send a purchase order or other documentation to the pharmacy that lists the patients requiring the preparation. The quantity needed for each patient should be specified. The preparations are delivered to the prescriber's office and signed for by the prescriber or their agent.
119
Veterinarians can also purchase compounded preparations from a pharmacy for the purpose of furnishing/dispensing up to a 120-hour supply of compounded preparations to their patients (i.e. animals). This means a veterinarian can administer...
the compounded preparation to the animal in the office and/or provide a take-home supply. When veterinarians order compounded preparations from the pharmacy, the veterinarians must indicate how many veterinary patients they anticipate needing the compound for and must also indicate how much they anticipate using their veterinary patient (for office-use and for furnishing).
120
Pharmacists can also compound patient-specific parenteral therapy for other pharmacies. For example, one pharmacy receives the Rx/order and dispenses the preparation but contracts with another pharmacy to prepare the compound. Compounding can only...
begin after receiving a patient-specific Rx/order. The label on the dispensed compound must include the name of both the compounding pharmacy and the dispensing pharmacy.
121
In 2012, contaminated methylprednisolone injections prepared by the New English Compounding Center (NECC) caused a fungal meningitis outbreak. The vials of compounded methylprednisolone was contaminated due to...
unsanitary conditions and poor aseptic technique. Adequate regulations and oversight of compounding pharmacists were not in place to proactively identify the problem. As a result, the FDA revised the Drug Quality and Security Act, dividing compounding pharmacies into 2 groups: 503A and 503B facilities.
122
Section 503B permits specially licensed compounding facilities to operate as outsourcing facilities. These facilities can prepare bulk medications without patient-specific Rxs as long as the...
facility meets certain requirements. This is especially important in the event of drug shortages. To register as an outsourcing facility under 503B, the facility needs to be compounding sterile drugs for humans.
123
Facilities can operate as an outsourcing facility if the following requirements are met:
* The drugs must be compounded in compliance with CGMPs.
* The facility is licensed as an outsourcing facility by the FDA and the California Board of Pharmacy
* It cannot be licensed as a sterile compounding pharmacy at the same time
* It cannot perform functions of a pharmacy, such as dispensing patient-specific prescriptions.
* It it subject to inspection by the FDA and the California Board of Pharmacy
* The preparations must be made by or under the supervision of a licensed pharmacist
* The facility must meet certain labeling requirements, drug reporting requirements, and AEs reporting requirements
124
Manufacturing:
* Regulation: FDA
* Standards: FDA drug approval; USP; CGMPs
* Individual Rx Required: No
* Interstate Distribution: Yes
125
Traditional (503A) Compounding:
* Regulation: State board
* Standards: 503A; USP
* Individual Rx Required: Yes
* Interstate Distribution: Up to 5% of total sales (the "5% rule")
126
Outsourcing (503B) Compounding:
* Regulation: FDA, state board
* Standards: 503B, USP, CGMPs
* Individual Rx Required: No
* Interstate Distribution: Yes
127
The National Institute for Occupational Safety and Health (NIOSH) issues a list of hazardous drugs (HDs) that require special precautions in order to prevent work-related injury and illness. HDs can cause:
harm to healthcare staff who handle them, including pharmacists, techs, nurses, and cleaning staff. Common HDs include: antineoplastics (chemotherapy drugs), teratogenic drugs, hormones, and transplant drugs. The standard for handling drugs on the NIOSH lists are set by USP in Chapter 800. The California Board of Pharamcy has implemented regulations that closely mirror the USP 800 standards.
128
Minimally, a pharmacy or other setting handling HDs must have the following:
* Engineering controls, such as closed-system transfer devices and negative pressure ventilated cabinets (eg, hood or biological safety cabinets)
* The hood externally vents the drug's toxic fumes, with a negative air pressure inside the hood (air moves away the staff near the hood)
* Personal protective equipment (eg, chemotherapy drugs, respiratory protection, goggles, 2 pairs of shoe covers, chemotherapy gloves)
* HDs will require either single or double gloves when handling. Sterile HD compounding requires double gloves. The outer pair must be sterile. Per USP 800, gloves for all HD compounding should be powder-free because the powder can contain HD residue
* Safe work practices, spill kits and disposal requirements
129
Nuclear pharmacists compound and dispense radioactive drugs for diagnostic purposes or treatment. Due to the inherent danger of radioactive drugs must be competent in the preparation, storage, and dispensing of radioactive drugs. A pharmacist qualified in radioactive drug management must be...
in the pharmacy whenever radioactive drugs are being provided to medical staff. All personnel involved in the furnishing of radioactive drugs must be under the immediate and direct supervision of a qualified nuclear pharmacist. Pharmacies that compound nuclear drugs must have a sterile compounding permit from the board.
