Pharm tech

Brand VS Generic

Generic medications have the same active ingredient as

brand-name medications. They work the same way, but

may appear different and contain different

medication classifications

word stem -astine

-azepam

-caine

-cillin

-conazole

estr-

-glitazone

-micin

-thromycin -olol

-olone

-profen

-prazole

-pril

-sartan

-semide

-setron

sulfa-

-terol

-tidine

-e-triptyline; - amine

classification

antihistamine

anti anxiety

local anesthetic

penicillin

systemic antifungal

estogen

anti-diabetic

aminoglycoside

macrolide

beta - blocker

steroid

anti inflammatory

anti ulcer

ACE inhibitor

angiotensin II receptor antagonist

loop diuretic

serotonin (5-HT3) antagonist

sulfonamide

bronchodilator

H2receptor antagonist

tricylic antidepressant

* above medication

classifications are explained on

next page*

1.1 generic names, brand names and

classifications of medications

Medication classifications explained:

antihistamine - allergic reactions

anti anxiety - anxiety suppresser/can relax muscles

local anesthetic - blocks the nerves from the affected part of your body, so that they cannot transmit pain signals to your brain.

penicillin- utilized for the management and treatment of a diverse spectrum of infections, this medication belongs to the beta-lactam antibiotic category.

estrogen - a steroid hormone linked to the female reproductive system, playing a pivotal role in the development of female sexual traits

anti-diabetic -designed to reduce elevated levels of glucose (sugar) in the bloodstream.

aminoglycoside -Highly effective antibiotics with a wide range of activity, which function by inhibiting protein synthesis. macrolide - A category of medications employed for the management and treatment of diverse bacterial infections.

beta - blocker - Inhibit the release of the stress hormones adrenaline and noradrenaline. It plays a crucial role in the body's fight-or-flight response, and as a medication, norepinephrine is used to raise and maintain blood pressure in specific, urgent medical situations.

steroid - Synthetic compounds, known as hormones, are designed to mimic natural human hormones to reduce inflammation.

anti inflammatory - The characteristic of a substance or therapy that diminishes inflammation or swelling. anti ulcer - Suppresses stomach acid, neutralizing acid, or protecting the gastrointestinal lining from acid damage. ACE inhibitor -Medications that aid in dilating blood vessels, reducing blood pressure.

angiotensin II receptor antagonist - Prescribed for the management of high blood pressure, heart failure, chronic kidney disease, and after a heart attack.

loop diuretic - Medications for fluid overload conditions like heart failure, nephrotic syndrome, cirrhosis, hypertension, and edema management.

serotonin (5-HT3) antagonist - Medications administered before and after chemotherapy to prevent or alleviate nausea and vomiting.

sulfonamide- Crucial synthetic antimicrobial drugs, broadly employed to treat bacterial infections in both humans and animals.

bronchodilator - Medications that ease breathing by relaxing lung muscles and widening airways.

H2receptor antagonist- They work by binding to histamine type 2 receptors on gastric parietal cells, disrupting pathways for acid production and secretion.

tricylic antidepressant - Named "tricyclic" because of their three-ring structure, these drugs work by blocking the reuptake of neurotransmitters like serotonin and norepinephrine, affecting mood, attention, and pain perception.

1.1 generic names, brand names and

classifications of medications

More must know/common medication classifications: Antianginal -Chest pain due to reduced oxygen supply

Anticonvulsant/Antiepileptic - Epilepsy/Seizures

SSRI - Depression

Antipsychotic - Schizophrenia/Bipolar disorder

Anticoagulant- Prevent formation of blood clots

Antineoplastic - Cancer

Antitussive - Cough

Bronchodilators - Asthma

Diuretic - Increase urine output

Hypnotic-Induce sleep

Sedative - Reduce irritability

Biguanide - Diabetes type 2

MAO inhibitors - Depression

PDE5 inhibitors-Erectile dysfunction

Opioids-Pain

Corticosteroids-Inflammation/Airway inflammation/Skin inflammation

Benzodiazepines- Sedation/Anxiety/Seizures/Muscle relaxation

Antiemetics- Nausea/vomiting

Phosphate binder- High blood phosphate levels in patients with renal failure

Immunosuppressant- Overactive immune response/Autoimmune disease/Organ transplant rejection How to Remember Drug Classes:

There are so many ways to remember drugs and what drug class they belong to.

One of the best ways is to examine the suffix of the drug, or the last syllable. Let’s review some of the most common examples:

Beta blockers always end in the suffix-lol

Metoprolol

Bisoprolol

ACE inhibitors always end in the suffix -pril

Ramipril

Perindopril

Lisinopril

Corticosteroids always end in the suffix-one

Hydrocortisone

Prednisolone

Beclomethasone

Benzodiazepines always end in the suffix -am

Diazepam

Midazolam

Nitrazepam

Statins (HMG-CoA reductase inhibitors) always end in the suffix -statin

Atorvastatin

Fluvastatin

Simvastatin

These are just a few of the most common examples, but there are many more that you will come across during your PTCB exam studies.

1.2 Therapeutic Equivalence

A drug is defined as being therapeutically equivalent if the drug:

Contains the same chemical entity

Contains the same quantity of active ingredient

Is the same dosage form

Has the same route of administration

^{1.3 common and life threatening drug interactions andcontradictions (e.g., drug- disease, drug-drug, drug-}dietary supplement, drug-laboratory, drug-nutrient) Drug Interactions & Contradictions

Drug-Drug Interactions: When a medication modifies the effects of another drug, these interactions can manifest as additive,

antagonistic, potentiation, or synergistic effects.

Addition - The cumulative impact of two drugs is equivalent to the total of the effects observed when each drug is administered

independently.

Antagonism - One drug works against the action of another drug

Potentiation - A single drug enhances or extends the impact of another medication, resulting in a combined effect that surpasses the sum of their individual effects.

Synergism - The collaborative action of drugs in which their

combined effect is heightened or prolonged beyond the total of the effects produced by the individual drugs.

^{1.3 common and life threatening drug interactions andcontradictions (e.g., drug- disease, drug-drug, drug-}dietary supplement, drug-laboratory, drug-nutrient)

Drug-Disease Interactions: Numerous medical conditions can impede the absorption, metabolism, and excretion of various medications. For instance, consider the case of using decongestants in patients with hypertension or diabetes.

Drug-Dietary supplement interactions: Many herbal supplements interact with prescription drugs, including vitamins, glucosamine-chondroitin, fish oil, and coenzyme Q, which can interact with Warfarin. About 62% of these supplements show interactions with Warfarin.

Drug-OTC-Drug Interactions: OTC drugs can boost or lessen prescription medication effects. For example, aspirin could enhance warfarin's impact, while antacids might weaken cimetidine's effectiveness.

Drug-Laboratory Interactions: Many modern drugs can impact serum potassium and creatinine levels, prompting additional tests to detect abnormalities.

Drug Nutrient Interactions: Inadequate nutrition can influence the metabolism of different medications. For instance, a case arises when warfarin is taken alongside vitamin K.

Drug-Food Interactions:

Enhanced absorption is observed when the following drugs are taken with a fatty meal: Ketoconazole, nitrofurantoin etc

Low absorption occurs if the following drugs are taken with food:

Tetracycline, ciprofloxacin, etidronate, phenytoin, norfloxacin, zidovudine, levothyroxine and didanosine.

Foods rich in Vitamin K, like romaine lettuce and spinach, can interact with warfarin. Individuals using warfarin should seek guidance from a cardiologist to obtain a list of such foods.

Drug related problems: In drug therapy, this refers to a situation that obstructs or could obstruct the desired outcome. These issues include untreated conditions, wrong drug choice, inadequate dosage, missed administration, excessive dosage, and drug use without a valid indication.

Pregnancy

Categories

When pregnancy serves as a

contraindication or precaution for a drug's

usage, the FDA classifies it into one of five

distinct categories.

Category A: Adequate research conducted on pregnant women has not demonstrated any risk to the fetus during the first trimester, and there is no risk observed in later trimesters as well.

Category B: Research on animal reproduction has not indicated any risk to the fetus, and there is a lack of adequate, well-controlled studies conducted on pregnant women.

Category C: Animal studies show fetal harm, but with limited human data, potential benefits could justify the drug's use in pregnant women despite risks.

Category D: While there is evidence of potential risk to the human fetus, the benefits may outweigh the risks.

Category X: Animal and Human studies have shown fetal abnormalities/toxicity and risk outweighs the benefit

How to remember FDA pregnancy

medication classifications!

A=AbsolutleyUseit B=Better touseit/Benefits>risks

C=Cuttingtooclose/Coulduseit D=Dontuseit

X=X(cross)itout.ItsContraindicated

1.4 strengths/dose, dosage forms, routes of administration, special handling and

administration instructions and duration of drug therapy

Strengths/Dose: Drug strength refers to the active substance amount in a dosage form. It's usually shown right after the drug's name and is measured in milligrams (mg) or micrograms (mcg) for tablets/capsules, milligrams per milliliter (mg/mL) for liquids, and grams (g) for creams and gels. Understanding these units and conversions is vital. For instance, a doctor might prescribe 0.025 mg of levothyroxine, equivalent to 25 mcg on the label.

A drug’s dosage form: Another term for its physical makeup. Drugs exist in varied forms (tablets, capsules, solutions, creams, patches) and sizes (25 mcg, 500 mg, 1 g). An essential form to discuss is suspension, needing shaking for uniform particle dispersion and dosing consistency. Some topical drugs, like betamethasone, are offered as ointments, creams, and emollients.

Common administration routes: includes

inhalation, oral, nasal, rectal, vaginal,

topical, and transdermal routes. Accurate

identification of the intended

administration method is crucial.

Swallowing a capsule instead of rectal

insertion can compromise absorption,

safety, and efficacy. If administration

uncertainty arises, contacting the

prescriber for clarity is recommended.

Special Administration and Handling

Instructions

Certain medications demand specific

storage, administration, and handling

guidelines that patients need to

understand. For instance, suppositories

like promethazine (Phenergan®) should

be refrigerated before use and handled

Duration of Drug Therapy Drug treatment duration hinges on diagnosis and patient factors.

Conditions like depression or diabetes may need ongoing medication, while pain or infections might require shorter

with gloves due to their susceptibility to melting at room temperature or due to body heat. Additionally, suppositories

are often wrapped in foil or hard plastic, necessitating proper unwrapping before rectal insertion, as many patients might not be familiar with correct

administration procedures.

periods. Straying from prescribed duration could cause problems like uncontrolled diabetes or antibiotic resistance. The

prescriber sets treatment duration based on the condition and follow-up needs for chronic cases.

1.5 Common and severe medication side effects, adverse effects, and allergies

Side Effects:

Anticipating side effects is often feasible through an understanding of a drug's mechanism. Nonetheless, as side effects aren't intended therapeutic outcomes, they are regarded as undesirable.

Common side effects:

May involve symptoms like headaches, stomach upset, or dizziness; some fade with time, while others persist during drug use. Onset times vary, with immediate or delayed occurrences. Side effects also differ within the same medication, based on dose, form, and administration.

Adverse Effects:

Are considered more severe than side effects and typically warrant discontinuation of therapy or possibly emergency medical attention based on severity. Adverse events are those that negatively impact a person’s well-being or their disease management. Muscle pain and cramping are common side effects of statin medications used to treat high cholesterol. However, severe unexplained muscle pain accompanied by dark (tea-colored) urine is an adverse effect of statin medications, indicating large muscle breakdown (scientifically known as rhabdomyolysis). This would warrant discontinuation of the specific statin drug completely and a consult with the physician to seek alternative therapy.

Allergies:

While a drug’s most common side effects can often be predicted, allergies are much less predictable because the body’s immune response differs significantly from person to person. Allergic reactions account for just 10% of all drug side effects; however, allergic reactions can be life-threatening. Anaphylaxis is the most serious allergic reaction and can result in hives, swelling of the face or throat, wheezing, and even death. Antibiotics are the most common cause of anaphylactic reactions. It is important to note that some patients are allergic to inactive (non-drug) ingredients, such as gluten or certain dyes; drug compounding allows for medications to be made to suit specific patient needs such as these. When asking a patient about allergies, it is important to also write down the reaction type. Anaphylaxis to a medication is considered a true allergy, while upset stomach is not.

1.6 Indications of medications and dietary supplements

In medical terminology, the term "indication" in reference to a medication signifies its prescribed use in the treatment of a specific medical condition. For instance, insulin is indicated for managing diabetes. This can also be expressed as insulin being recommended for the treatment of diabetes. It's common for medications to have multiple indications, implying that they are employed in the treatment of more than one ailment. In the United States, the Food and Drug Administration (FDA) categorizes drug indications into two groups:

FDA-approved, also known as labeled indications.

Non FDA-approved, also referred to as off-label indications.

In early drug development, pharmaceutical companies identify potential diseases a drug may treat based on its known effects on the body. They conduct FDA-monitored studies on patients with these diseases to confirm efficacy and safety. If successful, they apply for FDA approval for that specific use, known as a "labeled indication."

1) Label Indication

FDA approval allows the inclusion of this indication on the drug's label and enables the manufacturer to promote it for that purpose. Manufacturers cannot market drugs for unapproved uses. FDA approval is pivotal for a drug's financial success, motivating companies to seek approvals that maximize usage and return on investment. Additional indications can be pursued to expand the drug's reach after approval for one labeled indication.

2) Off-label Use

After FDA approval and marketing for a specific purpose, physicians can legally prescribe a drug for alternative uses, such as treating other diseases or conditions, as long as there is credible scientific evidence supporting its efficacy for those uses. These unapproved uses are referred to as off-label indications, indicating that the drug manufacturer has not sought FDA approval for them. While off-label indications often have less comprehensive research behind them compared to labeled indications, it's important to note that this doesn't necessarily imply reduced effectiveness when prescribing the drug for off-label purposes as opposed to FDA approved ones.

My personal suggestion on learning indications

is to study the top 200 drugs and write

indications on each flash card so you’re not

only learning top 200 drugs but the indications

of each of those medications. That’s how it

really stuck with me and how I knew most of

the medications.

1.7 Drug stability (e.g., oral suspensions, insulin, reconstitutables, injectables, vaccinations)

Drug stability

Pharmaceutical solidity is crucially

important to maintain the effectiveness and safe usage of a pharmaceutical

product. Whether it's a vial of insulin or a suspension of antibiotics, proper

handling and storage are essential to

retain the drug's strength and quality.

Medications can degrade, leading to a loss of their therapeutic reliability, and such compromised drugs should not be used due to the compromised potency and

integrity.

Oral suspensions

Oral suspensions are powdered solutions contained in manufacturer's bottles. These products can be stored at room temperature until the expiration date printed on the container. However, before dispensing, the powder needs to be mixed with the specified amount of water to form a suspension. After mixing, the oral suspension should be assigned a beyond-use date according to stability testing data provided by the

manufacturer. For instance, in the case of amoxicillin oral suspension, it should be discarded 14 days after reconstitution, with recommended storage in the refrigerator.

Injectables

Some injectable medications are commercially available and can be dispensed to patients with a valid prescription, while others need to be prepared and administered within a medical facility or under a doctor's supervision. Each injectable has a distinct level of stability and an expiration date determined by the manufacturer's testing data.

Ceftriaxone is an antibiotic employed for the treatment of various infections. Once

reconstituted, it remains effective for 24 hours at room temperature and can be administered intramuscularly.

Dulaglutide is a subcutaneous injectable used to manage type 2 diabetes. It can be stored in the refrigerator until the package's expiration date; however, its stability is limited to two weeks if left unrefrigerated.

Insulin

Prior to use, it's essential to refrigerate all types of insulin, maintaining their stability until the expiration date

indicated on the package. Once insulin is in use, its viability is limited to a specific duration, varying by insulin type. For example, after initiation, rapid-acting insulin like insulin aspart (or NovoLog®) remains stable for around 28 days when stored at room temperature. On the other hand, long-acting insulin like insulin detemir (or Levemir®) retains stability for more than 40 days at room

temperature.

Vaccines

Vaccines are delicate and sensitive, necessitating proper storage to maintain their potency and prevent deterioration. Incorrect storage and handling can result in reduced vaccine efficacy. Both live and

inactivated vaccines generally require refrigeration within the range of 35-46 degrees Fahrenheit, with the exception of Zostavax. Zostavax, being a live

vaccine, should be stored in a freezer until it's ready for administration. Once a vaccine is taken out of the refrigerator or freezer, it should be promptly

administered to the patient to minimize the risk of spoilage.

Reconstitutables

Medications presented as dry powders need to be mixed with a diluent before they can be used. This dry powder format is commonly employed for various formulations to extend their shelf life. Vancomycin, an antibiotic, is an example of a medication available in the form of a dry powder within a vial. Before being added to an intravenous bag, this medication requires reconstitution with the appropriate amount of water. Clindamycin and benzoyl peroxide are topical treatments used for acne. Prior to administration, they need to be combined with the correct quantity of sterile water, after which they are assigned a shelf-life duration of 72 days.

1.8 Narrow Therapeutic Index (NTI) Medications

Narrow therapeutic index (NTI) are characterized by their sensitivity to even slight variations in dosage or blood concentration, potentially causing significant therapeutic failures or adverse reactions that are dependent on the dose and blood concentration. These adverse events are considered serious when they are enduring, irreversible, slowly reversible, or life-threatening, with the potential to lead to hospitalization, disability, or even fatality.

Incompatibilities

Incompatibility occurs when two different drugs are mixed, resulting in an undesirable product due to either physical or chemical interactions. Physical incompatibilities are often visibly noticeable, while chemical

incompatibilities may not always be immediately evident.

Physical incompatibilities

Physical incompatibilities typically result in a visible change that can be observed without the need for magnification. It's important to routinely inspect the physical characteristics of the mixture after compounding to

ensure its stability and compatibility. Several evident indicators of physical incompatibility include:

Unexpected cloudiness

Formation of a precipitate more than one precipitate

Change of original color

Ingredients separation

Physical incompatibilities can sometimes be mitigated by altering solvents, adjusting formulations, using suspending agents, rearranging mixing procedures, and so on. However, certain medications are entirely incompatible and should never be combined. A clear illustration of physical incompatibility is the addition of calcium to ceftriaxone, which leads to a deadly precipitate formation.

Chemical incompatibilities

Chemical incompatibilities often result in changes in the chemical composition of the compounds, which may not be visible to the naked eye. Some evident indicators of chemical incompatibility include:

The reaction of oxidation-reduction

The obvious change in pH of the drugs

Degradation or/and Decomposition

Hydrolysis

1.8 Narrow Therapeutic Index (NTI) Medications

Warfarin: A vitamin K antagonist employed for the treatment of venous thromboembolism, pulmonary embolism, thromboembolism associated with atrial fibrillation, thromboembolism following cardiac valve replacement, and thromboembolic incidents after myocardial infarction.

Digoxin: A cardiac glycoside utilized for managing mild to moderate heart failure and for controlling ventricular response rates in cases of chronic atrial fibrillation.

Levothyroxine: A synthetic T4 hormone employed to address

hypothyroidism, often utilized in conjunction with surgery and

radioiodine therapy to manage well-differentiated thyroid cancer dependent on thyrotropin.

Phenytoin: An anticonvulsant medication used to prevent and manage various types of seizures.

Digitoxin:A medication derived from cardiac glycosides, employed to address and manage congestive cardiac insufficiency, arrhythmias, and heart failure.

Fosphenytoin: An antiepileptic substance utilized in the management of generalized convulsive status epilepticus and in the prevention and treatment of seizures arising during neurosurgery.

Lithium Carbonate: A therapeutic substance utilized in the treatment of bipolar or manic disorders.

Cyclosporine: A steroid-sparing immunosuppressive agent used in organ and bone marrow transplants, as well as for treating inflammatory conditions like ulcerative colitis, rheumatoid arthritis, and atopic dermatitis.

Procainamide: A pharmaceutical employed to treat life-threatening ventricular arrhythmias.

Theophylline: A xanthine derivative utilized to manage the symptoms associated with asthma, COPD, and other respiratory conditions characterized by reversible airflow obstruction.

1.9 Physical and chemical incompatibilities related to non-sterile compounding and reconstitution

Physical Incompatibilities

observed in non sterile

formulations, can lead to variations

in product consistency, alterations

in smell, changes in taste, or the

creation of an overall unsatisfactory

mixture. An instance frequently

encountered in topical emulsions

like creams or lotions is

immiscibility.

Chemical

Incompatibility

occurs when the

components within

a compounded

formulation

undergo a chemical

reaction, leading to a

reduction in the

potency and

integrity of the

active

pharmaceutical

ingredient.

Preparation of Non sterile compounds

The formulation of non sterile compounds necessitates taking into account potential incompatibilities that have the potential to

impact the stability, effectiveness, and overall safety of the

product.

1.10 Proper storage of medications (e.g., temperature ranges, light sensitivity,

restricted access)

The United States Pharmacopeia (USP) has established terminology related to temperature guidelines for medication storage:

Freezer: A location where the temperature is maintained between -25 and -10°C (-13 and -14°F). Cold: Any temperature not surpassing 8°C (46°F). A refrigerator is maintained between 2 and 8°C. Cool: Any temperature ranging between 8°C and 15°C (46°F and 59°F).

Controlled cold temperature: This refers to a temperature consistently held between 2°C and 8°C (36°F and 46°F), allowing for temperature variations between 0°C and 15°C (32°F and 59°F) that might occur during storage, shipping, and distribution.

Room temperature: The temperature found in a working environment.

Controlled room temperature: A temperature that is thermostatically regulated and encompasses the typical working conditions of 20°C to 25°C (68°F to 77°F).

Warm: Any temperature between 30°C and 40°C (86°F and 104°F).

Excessive heat: A temperature exceeding 40°C (104°F).

Protection from freezing: This term indicates that medications should be safeguarded from freezing conditions, which can cause a decrease in strength, potency, or undesirable alterations in its characteristics. The container's label includes instructions to shield the substance from freezing.

Dry place: The phrase "dry place" signifies an area where the average relative humidity does not surpass 40% at controlled room temperature or the equivalent water vapor pressure at other temperatures.

Restricted Access:

Controlled substances are stored in a designated secure section of the pharmacy, and it's crucial to ensure these drugs are kept out of reach from children, adolescents, and the general public for patients prescribed these substances. Controlled substances falling under the CIII-CV category, such as lorazepam, zolpidem, and buprenorphine, can be integrated into the regular pharmacy inventory. However, some pharmacies may still choose to maintain them in a more restricted area. Medications classified as CII, which carry the highest risk of abuse, must be securely stored, typically in a vault or cage. Examples of CII medications include opioids like oxycodone and fentanyl, as well as ADHD medications like Vyvanse® and Adderall®.

1.10 Proper storage of medications (e.g., temperature ranges, light sensitivity, restricted access)

Investigational drugs come with distinct protocols for receiving, storing, and managing their disposition. Specific storage prerequisites are in place, including the need to secure them in a limited-access area separate from other medications. This designated storage space should be equipped with a backup power source, and a daily temperature log must be meticulously maintained. It's crucial to ensure that study drugs are stored under suitable conditions involving temperature, humidity, and light to preserve their identity, potency, quality, and purity.

The responsibility for securely storing, controlling, administering, and disposing of investigational medications falls upon the site. Acceptable storage conditions, encompassing temperature, storage durations, and reconstitution instructions, are typically determined by the investigational product's sponsor. Moreover, the packaging of study drugs is designed to prevent any potential contamination or deterioration during both transport and storage.

Special storage requirements examples:

Cyclosporine capsules - Light sensitive

Dabigatran - Moisture sensitive

Etanercept - Light sensitive

Nitroglycerin sublingual tablets - Both light and moisture sensitive

Oxcarbazepine oral solution - Light sensitive

Ritonavir capsules - Both light and moisture sensitive

Golimumab - Light sensitive

Dipyridamole - Moisture sensitive

Certain drugs can deteriorate if they are not stored correctly due to their sensitivity

to light, a condition referred to as photosensitivity. Typically, when a prescription is

being dispensed, the pills are counted out from the original container provided by

the manufacturer and then placed into an amber bottle labeled specifically for the

patient. The use of amber bottles is crucial during dispensing because their color is

effective in blocking harmful light rays. However, it's important to note that certain

medications, such as nitroglycerin, come with specific storage instructions and must

_{Amber v}be dispensed in their original manufacturer-provided containers. _ial

Sulfasalazine may cause photosensitivity in an individual if

exposed to direct sunlight.

Packages that have been opened or partially used should be stored appropriately in conditions with limited access. This guideline is outlined in the United States Pharmacopeia 797.

For medications that are considered dangerous or classified as high-alert, it is advised to keep them in a distinct storage area within the pharmacy.

Section 2

Federal Requirements 12.5%

2.1 Federal requirements forhandlinganddisposalof non-hazardous,hazardous,andpharmaceutical substancesandwaste

2.2Federal requirements for controlledsubstance prescriptions (i.e.,new, refill,transfer)andDEA controlledsubstanceschedules

2.3Federal requirements (e.g.,DEA,FDA)for controlled substances (i.e., receiving, storing,ordering,labeling, dispensing, reversedistribution,take-backprograms, andlossor theftof)

2.3Federal requirements for restricteddrugprograms andrelatedmedicationprocessing(e.g.,

pseudoephedrine,RiskEvaluationandMitigation Strategies [REMS])

2.5FDArecall requirements (e.g.,medications,devices, supplies, supplements, classifications

2.1 Federal requirements for handling and disposal of non-hazardous, hazardous, and pharmaceutical substances and waste

The Safe Water Drinking Act

requires disposal of medications

and compliance with

OSHA,EPA,DOT.

Handling of hazardous drugs Hands should be washed both before and after putting on gloves.

Personal Protective Equipment (PPE) must be worn during activities such as receiving, storing, transporting, compounding, cleaning, disinfecting, or managing spills.

Use non-powdered gloves. Change gloves every hour or if they become contaminated. According to OSHA regulations, bags holding contaminated materials must be labeled as "hazard drug waste."

Chemotherapy agents should be prepared in a biological safety cabinet or a vertical flow hood. During this process, it's necessary to wear a gown, goggles, and two pairs of gloves.

Disposal of hazardous drugs

Mark needle containers and fragile hazardous waste items with the

designation "Hazardous Drug Waste Only."

Dispose of correctly labeled, sealed, and covered disposal containers with the assistance of trained and safeguarded personnel.

Dispose of waste associated with hazardous drugs in accordance with EPA, state, and local hazardous

waste regulations.

Handling of

pharmaceutical substance

Non-Hazardous

materials may be

discarded in regular trash bin

All prescription

medications should be stored at right

temperature and

appropriate

conditions.

Hazardous substance include

syringes,needles and toxic medications. Used syringes and needles should be put in a RED plastic sharps CONTAINER.

Toxic Substances (Chemo agents) should be placed in RED biohazard BAGS.

_Br_eakabl_eit_emsli_ke

_ampul_es_,si_ngl_e&

_mult_{i do}s_{e go}i_{n RE}D

_pl_asti_cs_har_ps

_CONTAI_NER.

Handling of hazardous waste

Bags containing

materials

contaminated with hazardous drugs must be labeled

appropriately

Waste should not be moved from one area to another

bags should be sealed when filled

waste containers should be covered

2.2 Federal requirements for controlled substance prescriptions (i.e., new, refill, transfer) and DEA controlled substance schedules

C-2 prescriptions must be sent

electronically from practitioner to

pharmacy or handwritten on a

secure prescription blank

Refills for controlled substances: For C-2 medications refills are NOT permitted. A new

prescription must be issued by prescriber every time.

For C-3 to C-5 medications a patient may receive up to 5 refills (if authorized) within 6 months of the date that the prescription was written for

Transfers for controlled substances:Transfers are communicated between pharmacists and the transferring pharmacist is responsible for the following: The word 'VOID' must be written on the face of the script

On reverse side of script must be written the name,address and DEA number of pharmacy to which the RX is being transfered to, date, transfering rph name and name of pharmacist recieving rx info

A new C-2 prescription must have the following: Date of issue

Patients name and address

Practitioners name, address and DEA number Drug name

Drug strength

Quantity prescribed

Number of refills authorized

Manual signature of prescriber

Directions for use

2.2 Federal requirements for controlled substance prescriptions (i.e., new, refill, transfer) and DEA controlled substance schedules

Transferring of Controlled Substance Prescriptions

The following are requirements:

The receiving pharmacist is responsible for the following:

“Transfer” must be written on the face of the transferred prescription. The following information must be recorded:

1) Date of issuance of the original prescription

2) Original number of refills authorized on the original prescription 3) Date of the original dispensing

4) Number of valid refills remaining and dates and locations of previous refills

5) Pharmacy’s name, address, and DEA registration number and prescription number from which the prescription was transferred

6) Name of the pharmacist who transferred the prescription

7) Pharmacy’s name, address, and DEA registration number and prescription number from

which the prescription was originally filled

*The original and transferred prescription(s) must be maintained for a period of 2 years from the date of the last refill*

DE_AFOR_M222 is the

docu_ment for

transfers of schedule

II _medications

2.2 Federal requirements for controlled substance prescriptions (i.e., new, refill, transfer) and DEA controlled substance schedules

DEA controlled substance schedules

Schedule I

are defined as drugs with no current medical use and an extremly high potential for abuse. Examples: heroin, LSD, marijuana,ecstasy etc

Schedule II

Drugs falling into this category are characterized by a significant likelihood for abuse, carrying the potential for severe psychological or physical dependency. These substances are recognized as hazardous. Examples of such drugs include combination products containing less than 15 milligrams of hydrocodone per dosage unit (Vicodin), fentanyl, cocaine, methadone, oxycodone (OxyContin), Adderall, methamphetamine, and others.

Schedule III

are defined as drugs with a moderate to low potential for physical and psychological dependence. The abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Examples: Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone etc

Schedule IV

are defined as drugs with a low potential for abuse and low risk of dependence. Some examples of Schedule IV drugs are: Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, Tramadol

Schedule V

are defined as drugs with lower potential for abuse than Schedule IV. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Examples of Schedule V drugs are: cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica etc

2.3 Federal requirements (e.g., DEA, FDA) for controlled substances (i.e., receiving, storing, ordering, labeling, dispensing, reverse distribution, take-back programs, and loss or theft of)

To dispense controlled substances the pharmacy

registers with the DEA and renew every 3 years by

submitting

DEA FORM 224

Schedule II/C-2 medications are ordered by completing DEA FORM 222. This form is only valid for 60 days. Must be retained for minum of 2 years. DEA FORM 222 is the document for transfer of schedule II medications.

DEA FORM 106 - theft of controls

DEA FORM 41 - destruction of controls

Retention of DEA records

DEA records must be

maintained a

minimu_mof 2 years

Defective forms must

be kept minimu_mof 2

years

Biennial inventory

taken every 2 years

and kept for 2 years

Controls transfer regulation

(DEA)

DEA allows transfer of

original script for schedule

Do you know

what DEA

stands for?

next page for answer

III , IV , V for the purpose of refill dispensing between different pharmacies on one time basis

If pharmacies share

database then script may be transferred up to max # of refills permitted by law

2.3 Federal requirements (e.g., DEA, FDA) for controlled substances (i.e., receiving, storing, ordering, labeling, dispensing, reverse distribution, take-back programs, and loss or theft of)

Receiving a controlled substance: On medication receipt, the number of packages must be recorded on a

retained copy of DEA FORM 222 must be dated and signed by the pharmacist

The packing slip to the completed DEA form 222 must be retained for 2 years in a secure place in the pharmacy

Ordering controlled substances:

Storing a controlled substance: All C-2 medications must be locked in a safe

All C-2 medications requiring refrigeration must be stored in locked fridge

C-3 to C-5 may be dispersed

throughout the pharmacy with other medications

Labeling a controlled substance:

Schedule II medications are ordered by filling out DEA Form 222 or by submitting it electronically.

It must be signed by the individual in whose name the DEA registration is listed.

A DEA Form 222 is valid for only 60 days. A paper DEA Form 222 must be completed with a typewriter, pen, or indelible pencil. Only one item per line, with a maximum of 10 different items per form, is permitted. The number of lines ordered must be totaled on the bottom of the form.

Drugs in Schedules III, IV, and V may be ordered by any method (written, faxed, or verbal).

After receipt, the invoice or packing slip must be dated, signed, stamped with a red C, and retained in a secure location in the pharmacy for a minimum of 2 years.

drug enforcment administration

pharmacy name and address date of initial filing

seriel number

name of patient

name of practicienr issueing prescription

name of medication,

strength,quanity and

directions

Dispensing controlled

substances:

C-2 prescriptions can be sent electronically or be

handwritten or computer generated but must be signed in ink by MD with 0 refills Partial refills of C-2

medications are allowed if remaining quanity is availble to patient in 72 hours

A new script is needed by provider if additional quanities are needed after 72 hours

2.3 Federal requirements (e.g., DEA, FDA) for controlled substances (i.e., receiving, storing, ordering, labeling, dispensing, reverse distribution, take-back programs, and loss or theft of)

Reverse Distribution of controlled substances: when the pharmacy sends outdated/unstable drug prodcuts to

manufactuer.

Unwanted, damaged or outed controlled substances can be destroyed using DEA FORM 41

Retail pharmacy may only submit ONE DEA form 41 per year

Theft of Controlled Substances:

After the discovery of a theft of controlled substances, the pharmacy must notify the nearest DEA diversion office, notify local police, and complete a DEA Form 106. The pharmacy must send the original copy of the DEA Form 106 to the DEA and retain one copy for its records.

Take Back Programs:

The secure and responsible drug disposal act of 2010 says a

person is able to return unused controlled substances to

designed pharmacy's for safe, proper disposal.

2.4 Federal requirements for restricted drug programs and related medication processing (e.g.,

pseudoephedrine, Risk Evaluation and Mitigation Strategies [REMS])

Pseudoephedrine:

The provisions of the Combat Methamphetamine Act of 2005 encompass any non-prescription product containing ephedrine, PPA, or pseudoephedrine. Regulated sellers are obligated to store these products either behind the counter or within a locked cabinet. Additionally, regulated sellers are required to verify the identity of the purchaser and maintain a sales log containing the purchaser's name and address, signature, quantity and type of product sold, date, and time of sale. This sales log must be retained for a period of two years.

Risk Evaluation and Mitigation Strategies (REMS) are structured plans mandated by the FDA for certain drugs deemed to have higher risk profiles, aimed at ensuring that the benefits of these medications outweigh their associated risks. The requirement for REMS was established by the FDA in 2007.

The responsibility of reviewing and approving REMS programs lies with the FDA. REMS can be required both before and after a drug's approval.

A REMS entails various components including a medication guide or patient package insert, communication strategies for healthcare professionals,'Dear Healthcare Professional' letters, supplementary information pertaining to the REMS, and other educational resources.

Some medications subject to REMS include clozapine, fentanyl, buprenorphine, isotretinoin, thalidomide, and pseudoephedrine.

2.5 FDA recall requirements (e.g.

medications, devices, supplies, supplements, classifications

FDA Recall requirements:

Medications: Recalls may be initiated due to factors such as product contamination, incorrect product labeling, the presence of impurities, and adverse effects.

Devices: Recalls are triggered when devices become defective or pose a health hazard. Items like insulin pumps, glucose meters, infusion pumps, glucose test strips, and cardiac pacemakers are examples of products that may undergo recalls.

Supplies: Surgical gloves, syringes, catheters, needles, and other supplies might be subject to recalls either by the FDA or the manufacturer owing to issues with faulty components.

Supplements: Recalls for supplements can stem from reasons such as inaccurate product labeling, contamination, the inclusion of undisclosed ingredients, and misleading claims on product labels.

FOOD AND DRUG ADMINISTRATION Recall Requirements:

The FDA ensures the purity, safety, and effectiveness of all pharmaceutical products. It meticulously reviews the information submitted on MedWatch Forms. If a pharmaceutical product is found to be adulterated or misbranded and hasn't been withdrawn by the drug manufacturer, the FDA issues drug recalls.

Different classes of recalls exist:

Class I recall: This is when there's a substantial likelihood that using or being exposed to a non-compliant product will lead to severe adverse health effects or even death.

Class II recall: This type pertains to situations where using or being exposed to a non-compliant product might result in temporary or medically reversible adverse health effects, or where the likelihood of severe adverse health effects is low. Class III recall: This category is applicable when using or being exposed to a non compliant product is not anticipated to cause adverse health effects.

Post-recall audits are conducted by the FDA to ensure that manufacturers, wholesalers, pharmacists, and customers have been informed and appropriate actions have been taken.

The FDA also oversees the distribution of patient package inserts and the repackaging of medications. It reviews applications for new drugs and investigational new drug applications. The FDA is responsible for initiating "Medicine Take Back Programs" in communities, allowing safe disposal of medications.

Section 3

Patient Safety and Quality Assurance26.25%

3.1 High alert/risk medications and look alike/sound alike

(LASA) medications

3.2 Error prevention strategies (e.g., prescription or

medication order to correct patient, tall man lettering,

separating inventory, leading and trailing zeros, bar code

usage, limit use of error prone abbreviations)

3.3 Issues that require pharmacist intervention (e.g., drug

utilization review (DUR), adverse drug event (ADE), OTC

recommendation, therapeutic substitution, misuse, adherence post immunization follow up , allergies, drug interactions)

3.4 Event reporting procedures (e.g., medication errors,

adverse effects, and product integrity, med watch, near miss,

root cause analysis (RCA)

3.5 Types of presctiption errors (e.g., abnormal doses, early

refill, incorrect quanity, incorrect patient, incorrect drug

3.6 Hygiene and cleaning standards (e.g., hand washing

personal protective equipment (PPE), cleaning counting trays,

countertop, and equipment)

3.1 High-alert/risk medications and look alike/sound-alike [LASA] medications

Look alike/Sound alike

Medications:

accupril - aciphex

actonel - actos

adderall - inderal

Advair - Advicor

allegra - viagra

alprazolam - lorazepam

axert- antivert

bupropion - buspirone

carvedilol- catopril

Celebrex - celexa

celexa - zyprexa

clozaril- cozaril

cozzar-zocor

denavir-indinavir

depakote ER - depakote

diabeta-zebeta

Dilacor XR-pilocar

metronidazole-metformin miralax-mirapex

myleran-leukeran

nuertontin-motin

Neurontin-noroxin

Nexium-nexavar

novolin-humulin

novolog-novolin

paxil-plavix

precose-precare

Prilosec-prozac

provera-proscar

retrovir-ritonavir

risperdal-restoril

Seroquel-seroquel XR sinequan-seroquel

sinequan-singulair

sotalol-sudafed

sumatriptan-zolmitriptan tegretol XR- tegretol tobrex-tobradex

trazodone-tramadol tretinoin-isotretinoin

Specific high Alert/risk medications: Epoprostenol (Flolan), IV

Oxytocin, IV

Methotrexate, oral, non oncologic use

Promethazine, IV

Magnesium sulfate injection Opium tincture

Nitroprusside sodium for injection Vasopressin, IV or intravenous Potassium phosphates injection Potassium chloride for injection concentrate

3.2 Error prevention strategies (e.g., prescription or medication order to correct patient, Tall Man lettering, separating inventory, leading and trailing zeros, bar code usage, limit use of error-prone abbreviations)

ERROR-PRONE ABBREVIATION LIST Numerous pharmacy abbreviations have been misconstrued, leading to medication errors that have caused

harm and, tragically, fatalities among patients. These incidents have been documented and reported to the Institute for Safe Medication Practices (ISMP) via the ISMP National

Medication Errors Reporting Program (ISMP-MERP). The ISMP ardently emphasizes that the utilization of these abbreviations, symbols, and dosage indications should be strictly avoided when conveying medical information, whether through verbal or telephone prescriptions, computer-generated labels, labels for medication storage containers, records for medication administration, or when entering orders in pharmacy and prescriber computer systems.

STRATEGIES FOR AVOIDING ERRORS The Joint Commission (TJC) aids institutions in implementing safety protocols aimed at mitigating medication errors across five distinct domains:

Leadership processes and accountability Ensuring a competent and proficient workforce

Establishing a secure environment for both patients and staff

Enhancing clinical care for patients Advancing quality and safety measures

Bar code scanners:

Mandated by the FDA, the application of bar codes on all human drugs and biological agents is poised to enhance patient and

medication safety. This initiative significantly reduces the potential for errors by ensuring accurate drug administration to the correct

patient, at the correct dose, during the appropriate timeframe, and through the proper route.

WAYS PHARMACY TECHNICIANS CAN REDUCE ERRORS

Always question illegible handwriting.

Question ambiguous orders.

Question the prescription order that uses abbreviations you are not familiar with or that are uncommon.

Do a mental check on dosage appropriateness.

Keep your work area free of clutter.

Always keep the prescription and the label together during the filling process.

Check the drug three times: when removing the medication in the bottle, and before returning medication bottle to the shelf.

• Make sure the label is always compared with the original prescription by at least two people. If an error occurs at this stage, the refills may be filled incorrectly as well.

• Observe and report pertinent OTC purchases

.• Triple check your work.

• Verify your own data entry before processing.

WAYS PHARMACIES CAN REDUCE ERRORS

• Adopt electronic prescribing systems.

• Introduce automation and barcode technology for all dispensing procedures.

• Encourage healthcare professionals to employ standardized language and abbreviations. • Ensure a secure and organized workspace.

• Provide appropriate software applications and hardware for accurate operations.

• Utilize the metric system consistently. Decimal values under 1 must always begin with a leading zero. Mistakes in this regard could lead to dosage errors of at least tenfold.

• Establish proper storage facilities.

• Maintain accurate, current patient profiles that encompass over-the-counter medications, nutritional supplements, and herbal products.

• Verify that prescriptions and orders contain accurate drug names (both brand and generic), correct strength, suitable dosing, quantity or treatment duration, proper dosage form, and administration route. Any missing details should be obtained from the prescribing healthcare provider.

• Refrain from using error-prone abbreviations in internal communications, verbal prescriptions, telephone orders, computer-generated labels, medication storage labels, and administration records.

• Incorporate both brand and generic names on drug labels

. • Configure computer selection screens to prevent consecutive appearance of look-alike drug names. • Utilize barcode scanning for both the prescription label and the UPC code on the medication container. • Designate a separate storage area within the pharmacy for hazardous or high-alert medications. • Recognize common look-alike and sound-alike drugs, and store them separately to avoid confusion.

• Clearly differentiate between different insulin brands.

• Store insulin brands separately from each other.

DRUG NAME WITH TALL MAN LETTERS CONFUSED WITH

ALPRAZolam - LoRazepam

carBAMazepine - OXcarbamazepine ceFAZolin - cefoTEtan, cefOXitin, cefTRIAXone CeleBREX - CeleXA

ePHEDrine - EPINEPHrine

FLUoxetine - DULoxetine, PARoxetine HumaLOG - HumuLIN

ISOtretinoin - tretinoin

KlonoPIN -cloNIDine

metFORMIN - metroNIDAZOLE

NexAVAR - NexIUM

NovoLIN - NovoLOG

OxyCONTIN - OxyCODONE

PriLOSEC - PROzac

QuiNIDine -quiNINE

RisperDAL - rOPINIRole

SandIMMUNE - SandoSTATIN

TEGretol - TRENtal

traMADol -traZODone

Examples from the Food and Drug Administration– Approved List of Generic Drug Names with “Tall Man” Letters DRUG NAMES WITH “TALL MAN” LETTERS

CONFUSED WITH

buPROPion -busPIRone

clomiPHENE -clomiPRAMINE

cycloSERINE - cycloSPORINE

DAUNOrubicin - DOXOrubicin

glyBURIDE - glipiZIDE

hydrALAZINE -hydrOXYzine

medroxyPROGESTERone - methylTESTOSTERone, methylPREDNISolone

NIFEdipine - niCARdipine

prednisoLONE - predniSONE

sulfADIAZINE - sulfiSOXAZOLE

To the left is the Institutes of

Safe Medication Practices list of

drug names with tall man

letters

3.3 Issues that require pharmacist intervention (e.g., drug utilization review [DUR], adverse drug event [ADE], OTC recommendation, therapeutic substitution, misuse,

adherence, post-immunization follow-up, allergies, drug interactions)

Drug utilization evaluation known as DUR:

Enforced through the Omnibus Budget Reconciliation Act of 1990 (OBRA-90), the prescription filling procedure involves cross-referencing prescriptions with all medications listed in the patient's profile. This step is taken to ascertain whether any interactions might occur with other drugs, whether the prescribed medication contradicts any existing medications, or if the patient has any allergies to the prescribed drug. Should the computer detect any potential interactions, it raises an alert in the patient's profile, prompting a warning for the pharmacy technician or

OVER-THE-COUNTER

RECOMMENDATIONS

An over-the-counter (OTC) medication can only be suggested to a patient by a pharmacist, who

assesses the patient's symptoms as well as their existing medication regimen. When a pharmacist provides a recommendation for an OTC medication, they are

exercising their professional expertise within the scope of their practice. It's important to note that pharmacy technicians are not authorized to make professional judgments.

pharmacist to review.

THERAPEUTIC SUBSTITUTION

Therapeutic substitution involves replacing one drug product with another that may have distinct composition but is believed to possess identical or highly comparable pharmacologic and therapeutic effects. The permissibility of therapeutic substitution is contingent upon state regulations and institutional guidelines.

DRUG ADHERENCE

• Determine the duration the

prescriptions should cover by calculating the day's supply (quantity dispensed / quantity taken each day).

• If a patient requests a refill ahead of schedule or if the prescription lasts longer than expected, the pharmacy

technician should promptly inform the pharmacist. In cases where the dosing instructions have been altered, it's advisable for the physician to issue a new prescription.

• The pharmacist should approach the situation with empathy and ascertain the underlying reasons for the patient's noncompliance.

ADVERSE DRUG EVENTS

An adverse drug event can be caused by injury resulting from the use of a drug, whether it's within the

prescribed dosage or due to an overdose, as well as any harm arising from the drug's utilization, such as discontinuation of the drug therapy. In case a patient discloses

experiencing an adverse drug event to the pharmacy technician, it's crucial to immediately inform the pharmacist. The pharmacist will then gather details concerning the adverse drug event, contact the prescriber to determine whether the ongoing therapy should be continued, and if deemed necessary, submit a report to the FDA's Adverse Event Reporting System (FAERS, formerly known as AERS).

3.3 Issues that require pharmacist intervention (e.g., drug utilization review [DUR], adverse drug event [ADE], OTC recommendation, therapeutic substitution, misuse,

adherence, post-immunization follow-up, allergies, drug interactions)

POTENTIAL INAPPROPRIATE MEDICATION USAGE IN ELDERLY PATIENTS

Numerous drug categories and specific medications warrant careful

consideration among elderly patients due to their potential adverse effects.

These include:

Anticholinergic drugs: Older individuals should exercise caution with first

generation antihistamines like chlorpheniramine, hydroxyzine,

diphenhydramine, and cyproheptadine due to the likelihood of inducing

confusion, constipation, and dry mouth.

Benzodiazepines like lorazepam can lead to drowsiness

Non benzodiazepine sedatives, such as zolpidem, are associated with

drowsiness.

Androgens, like methyltestosterone, have the potential to trigger cardiac

issues.

Estrogens used with or without progestins might give rise to carcinogenic

effects and should be approached carefully

Insulin: There's a heightened risk of hypoglycemia associated with its use.

Sulfonylureas like glyburide have the potential to induce hypoglycemia.

Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and

naproxen elevate the likelihood of gastrointestinal (GI) bleeding.

Aspirin might amplify the risk of GI bleeding.

Skeletal muscle relaxants like carisoprodol and cyclobenzaprine exhibit

anticholinergic effects

. Oral decongestants such as pseudoephedrine can lead to stimulation of the

central nervous system.

In cases where warnings emerge for elderly patients who might be prescribed

these medications, it's essential to notify the pharmacist. The pharmacist will

then communicate with the prescriber to assess whether an alternative

treatment might be more suitable for the patient.

3.4 Event reporting procedures (e.g., medication errors, adverse effects, and product integrity, MedWatch, near miss, root-cause analysis [RCA])

The tracking of medication errors is carried out by various organizations and agencies, including:

• FDA MedWatch, a voluntary program allowing the reporting of adverse health events and medical issues.

• The ISMP overseeing the MERP.

• FAERS, a database containing information about adverse events and medication error reports submitted to the FDA.

• Institute of Medicine (IOM)

• TJC

• National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP)

• United States Pharmacopoeia (USP): MedMarx, a national database accessible through the internet, utilized by hospitals and healthcare systems to monitor and analyze adverse drug reactions and medication errors.

• The FDA and Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System, a postmarketing safety surveillance initiative collecting data on adverse events occurring after the administration of U.S.-licensed vaccines.

The FDA's Safety Information and Adverse Event Reporting Program offers an Online Voluntary Reporting Form (Form 3500) that serves to report significant adverse events linked to human medical products. This encompasses both potential and actual occurrences of product use errors and instances of product quality issues connected to the utilization of FDA-regulated drugs, biologics (including human cells, tissues, and cellular and tissue-based products), medical devices (including in vitro diagnostics), and specialized nutritional products and cosmetics.

Medical Error Documentation (Incident Reports)

To document accidents and occurrences involving employees, individuals, visitor injuries, property damage, or

occupational illnesses, incident reports are utilized. These reports are completed by the person who witnesses the incident or initially becomes aware of it, and they

are then submitted to the supervising on-duty personnel.

Incident reports typically encompass the following details:

• Pertinent information about the individual implicated in the incident (name, contact details, whether they're an employee, visitor, or patient, and identification data)

• Particulars regarding the incident itself (date, time, location, a comprehensive description of the event, the nature of

the injury sustained, and whether treatment was administered)

• Details about the individual responsible for filing the report or their supervisor (printed name, signature, official title, and date)

It is encouraged for pharmacies to report errors and proactively identify the

It's important to note that the MedWatch system is not employed for reporting vaccine-related events.

underlying causes without the fear of facing punitive actions.

2. MedWatch also supplies safety alerts pertinent to human medical

products such as drugs, biologics, medical devices, specialized nutritional

products, and cosmetics.

Food and Drug Administration Adverse Event Reporting System

The FDA Adverse Event Reporting System (FAERS) is a repository housing data regarding submissions of adverse event and medication error reports to the FDA. This system plays a vital role in supporting the FDA's postmarketing safety surveillance initiative for drug and therapeutic biologic products.

The information collected through FAERS serves the purpose of identifying potential safety issues concerning products that are already on the market. Both healthcare professionals and consumers have the option to voluntarily report adverse events and medication errors to either the FDA or the drug manufacturers.

In instances where drug manufacturers receive a report about an adverse drug event, they are obligated to relay this information to the FDA.

3.5 Types of prescription errors (e.g., abnormal doses, early refill, incorrect quantity, incorrect patient, incorrect drug)

TYPES OF ERRORS

Prescribing errors

- Route of administration not specified

- Patient allergies

- Incorrect strength of medication

- Incomplete medication name

- Quantity and refills omitted

- Additional directions required

Dispensing errors

a. Mechanical: Occurs during preparation and dispensing of a prescription by either a pharmacy technician or pharmacist. Examples of mechanical errors include errors in prescription interpretation, transcription, and performing pharmacy calculations.

b. Judgment: Result of a pharmacist making an incorrect decision during the screening of a patient, during drug utilization evaluation or counseling the patient

Administration errors

- Oral medications given intravenously

- Enteral formulas administered parenterally

- Intravenous medications administered intrathecally

- Intramuscular preparations administered intravenously

- Intravenous syringes used to measure doses of oral medications

- Ear medications being placed in the eye

- Irrigation solutions being administered intravenously

MEDICATIONS ASSOCIATED WITH A HIGH INCIDENCE OF

MEDICATION ERRORS

- Insulin

-Morphine

-Potassium chloride

- Albuterol

- Heparin

-Vancomycin

- Cefazolin

- Acetaminophen

- Warfarin

- Furosemide

3.6 Hygiene and cleaning standards (e.g., hand washing, personal protective equipment [PPE], cleaning counting trays, countertop, and equipment)

Hand Hygiene

Wearing gloves doesn't eliminate the necessity for hand washing

Liquid soap is the preferred choice over bar soap. Hand washing should be conducted in the following situations:

After using the restroom

Before and after interacting with a patient Prior to putting on gloves for tasks in the laminar flow hood

Before consuming food

Whenever hands appear visibly soiled or dirty Alcohol-based preparations (hand rubs) are effective when hands are not visibly unclean and soap and water are unavailable. These antiseptics should be applied to all hand and finger surfaces and allowed to air dry.

Individuals engaged in the preparation of sterile products should cleanse their hands with a suitable antibacterial agent for a predetermined duration and dry them using paper towels. If there's a possibility of contamination, the process should be repeated.

Personal Protective Equipment

Personal protective equipment (PPE) acts as a barrier between employees and specific substances, encompassing items such as latex gloves, masks, goggles, face shields, gowns, laboratory coats, shoe coverings, and head coverings.

Wearing a face shield is imperative when there's a potential for splashes reaching the eyes, nose, or mouth.

Gloves should be swapped out every hour or immediately after any form of contamination. When removing gloves, the process should be

executed to prevent direct contact between the skin and the outer surface of the glove.

It is crucial for employees to be familiar with the correct sequence for donning and doffing gowns, gloves, protective glasses or goggles, shoe covers,

hair covers, and face shields before engaging in sterile compounding.

For individuals allergic to latex, the employer is responsible for supplying hypoallergenic (non latex) gloves and liners.

Hand Washing

Jewelry must not be worn within the hood, and this prohibition extends to artificial nails due to the potential for microbial growth around or beneath them.

Long hair should be secured away from the face by tying it back.

After entering the IV area and prior to accessing the laminar flow hood, hands should be thoroughly washed. Comprehensive hand, wrist, and arm cleaning, up to the elbow, should be performed using antimicrobial soap and hot water, lasting for a minimum of 30 seconds and not exceeding 90 seconds.

Equipment

Counting trays

After each use, it is crucial to cleanse with alcohol to avert potential cross-contamination, as this could lead to an allergic reaction in another patient. Specifically for chemotherapeutic agents, a distinct counting tray should be dedicated for exclusive use.

The laminar flow hood needs to ensure an ISO class 5 clean environment, while the work surface should be sanitized using 70% isopropyl alcohol. Maintenance of the pre filter and HEPA filter is essential to prevent particles larger than 3 microns from entering the sterile zone.

*Running hot and cold water must be available in every pharmacy. When cleaning instruments used in extemporaneous compounding, a mild detergent can be utilized. For cleaning all countertops within the pharmacy, 70% isopropyl alcohol should be used. Additionally, all pharmacy equipment needs to be maintained in good condition and kept clean.*

section 4

order entry and processing 21.25%

4.1 Procedures to compound non-sterile products (e.g., ointments, mixtures, liquid, emulsions, suppositories, enemas)

4.2 Formulas, calculations, ratios, proportions, allegation's, conversions, sig codes (e.g., b.i.d., t.i.d., Roman numerals), abbreviations, medical terminology, and symbols for days supply, quantity, dose, concentration, dilutions)

4.3 Equipment/supplies required for drug administration (e.g., package size, unit dose, diabetic supplies, spacers, oral and injectable syringes)

4.4 Lot numbers, expiration dates, national drug code (NDC) numbers

4.5 Procedures for identifying and returning dispensable, non dispensable, and expired medications and supplies (e.g., credit return, return to stock, reverse distribution)

4.1 Procedures to compound non-sterile products (e.g., ointments, mixtures, liquids, emulsions, suppositories, enemas)

Procedure for Preparing an Emulsion Using the Wet Gum Method

Creating the Initial Emulsion:

Begin by grinding one part of gum with two parts of water until a mucilage is formed.

Slowly introduce four parts of oil while triturating. Incorporate any extra components as needed.

Continental Method (Dry Gum) for Making Emulsions: The primary emulsion is generated by combining four parts of oil, two parts of water, and one part of gum (specifically acacia, which acts as an emulsifier).

In a Wedgwood or porcelain mortar, the gum and oil are mixed thoroughly.

Gradually include water and continue the trituration process. Once the primary emulsion forms, supplementary ingredients can be integrated, maintaining the original volume with the external phase.

Steps for Crafting Emulsions via the Beaker Approach: Separate containers are employed to blend water-soluble and oil soluble components.

Both phases are heated to 70°C and then removed from the heat source.

The internal phase is introduced into the external phase. The end product is cooled down to room temperature while being consistently stirred.

Procedures for Preparing Ointments and Creams

Important: Selection of ointment bases depends on their attributes for effective drug delivery

Measure the amounts of all components and position them on an ointment slab or parchment paper.

Follow these steps:

Fusion Mold Procedure for Preparing Suppositories

• Active components are dispersed or dissolved within a molten base.

• Measure out amounts of both the base and active ingredients.

• Gently heat the suppository base to a low temperature and dissolve the medication in it. The mixture is then poured, allowing it to overflow slightly, into a specialized suppository mold made of metal, plastic, or rubber. Subsequently, it is left to solidify.

• Excess material from the upper part of the mold is trimmed away.

Compression Molding Technique for Formulating Suppositories:

• Measure out quantities of the base and active ingredient.

• Blend the suppository base with the drug components.

• Compel the amalgam into a distinct

compression mold..

Procedure for Preparing a Liquid Drug in a Liquid Vehicle

Quantify the volumes of individual liquids using a graduated cylinder. Introduce the medication into the carrier fluid at a gradual pace, followed by shaking and stirring.

Utilize geometric dilution along with two spatulas to thoroughly combine the ingredients.

Employ a spatula to transfer the resultant mixture into an ointment jar.

Remove any trapped air within the ointment by carefully using a spatula.

Ensure even distribution within the container by spreading uniformly.

Steps for Dissolving Solid Medication in a Liquid Carrier:

• Determine the weight of the solid substance and gauge the quantity of the solvent. • If necessary, grind the drug and dissolve it in the solvent.

• Apply mild heat, gentle stirring, or soft shaking if required.

4.2 Formulas, calculations, ratios, proportions, alligations, conversions, Sig codes (e.g., b.i.d., t.i.d., Roman numerals), abbreviations, medical terminology, and symbols for days supply, quantity, dose, concentration, dilutions

Liquid and Solid Dilutions:

We can NOT change strength or concentration of a prepartation by simply adding more of it. Instead we have to add some type of diluent, solvent or inactive ingredient to accomplish this. Adding diluent results in liquid solution or solid medication with lower percent strength. These are dilution problems. This means were ADDING diluent/solvent. NOT SUBTRACTING.

Formulas for dilutions are:

1) Initial volume x initial strength = final volume x final strength

V1 x S1 = V2 x S2

V1/S2 = V2/S1

2) Initial quantity x Initial Strength = final quanity x final strength

Q1 x S1 = Q2 x S2

Q1/S2 = Q2/S1

These volumes/quantities to have same units: L, mL, g, mg etc.

When using dilution formulas, we are allowed to input the % strength as whole numbers.

Concentration and Dilution:

Equation: IV x IS = FV x FS

Hints:

IS must be greater FS

IV must be lower FV

FV -IV = amount of diluent to be added to make final volume

FORMULAS:

Temperature Conversions:

9C = 5F - 160

F = (Cx1.8) + 32

C = F-32/1.8

Compounding:

FS - Final Strength

FV - Final Volume

IS - Intitial strength IV- Intitial volume

IW - Initial weight

FW - Final Weight

Dilutions

C1 x V1 = C2 x V2

C - Concentration

V- Volume

Clarks Rule (weight)- Adult Dose X (Weight/ 150) = Child Dose Youngs Rule (age) - Adult Dose X (Age/(age+12)) = Childs Dose

A proportion expresses the equality of two ratios.Setting up a proportion helps to find the missing value in the equivalent expressions. Proportions can be seen in different ways, which include:

a:b = c:d

a/b = c/d

a:b :: c:d

Allegation:

Another common calculation method is alligation, used to create a solution with a specific concentration from two solutions containing the same ingredients but at different strengths. You'll need one solution stronger and one weaker than your target concentration. By considering the differences in their percentage strengths, you can determine the proportions of each solution needed, and then calculate the volume of each proportion based on the desired total volume of the final product. There are different ways to solve these problems, my favorite is the box method. Look up online the different ways and see what works best for you :)

Medical Terminology:

Medical terminology is crucial in healthcare and pharmacy, facilitating effective communication. Pharmacy technicians must grasp these terms for seamless interactions. Differentiating between conditions like hypertension and hyperlipidemia helps identify the right medications and enhances communication with patients and colleagues. Building a list of essential medical terms through online research is recommended.

IV Calculations:

IV Infusion Set Calculations:

IV Infusion sets are pre

calibrated to how many drops

per mL (gtt/mL) of a solution

they give to a patient. this is

NOT to be confused with drops

per minute (gtt/min)

Calculating RATE OF FLOW:

Vol/Time = Rate

Flow Rate(gtt/min) -

(Volume [mL]) x drop factor

(gtt/mL)

Basic formula: Volume(mL)/min x drop factor = flow rate (gtt/mL) (gtt/min)

*drop factor - (gtt/mL) calibrated to deliver drops per mL *flow rate - (gtt/min) nurse set up so many drops per min

IV Calculations - Rate : Volume/Time = Rate ex) Patient is prescribed 3.6L of mixture over 6 hours. 3,600ml/6 hrs = 600mL/hr

600mL/hr /60 (min/hr)= 10mL/minute

IV Calculations - Volume: Rate x Time = Volume ex) For example: The patient is prescribed 300ml/Hr for 4 hours.

300ml X 4Hr = 1200ml

1.2L will be needed (volume)

IV Calculations - Time: Volume / Rate = Time

For example: The patient is prescribed

1.5L of a solution at a rate of 150ml/Hr

1500ml ÷ 150ml/Hr = 10 Hours

The solution will last for 10 Hours (Time)

Drip (flow) rates:

Common IV set: 10 drops/mL, 15 drops/mL and 60 drops/mL (mini drip set)

Time of infusion = volume of fluid

(or amount of drug)/time of infusion

Rate of infusion = volume of fluid

(or amount of drug)/ Time of infusion

Infusion Rate = Drops/min

= (number of mL/hr) x ( number of drops/mL)/ 60min/hr

IV Drip Rates example problems:

1) IV drip rate 2L over 8 hours 20 gtt/mL.How many gtt/min?

2L/8H (1h/60min)(1000ml/L)(20gtt/mL) = 83 gtt/min

2) IV drip rate patient weight = 80kg. 3mg/kg/H. 5g of drug in 1L. How many gtt/min? 3mg/kg/H = 3mg/kgXH ( USE THIS EQUATION)

3mg/kg X H (80kg)(100mL/5000mg)(20gtt/mL)(1H/60min)=16 gtt/min

Common Conversions:

1 kg = 2.2 lbs

1 kg = 1000g

1 g = 1000mg

1mg = 100mcg

1 oz = 30mL

1 grain = 64.8mg

1 tsp = 5mL

1 TBSP = 15mL

1 gallon = 3,840 mL

1 lb = 454g

473 mL = 1 pint

8 pints = 1 gallon

1 L = 1000mL

1 ml = 20 drops

1 pint = 480 mL

1 g = 15.4 gr

gallons to quarts to pints to cups to mcg to mg to g

Essential Conversions:_{‘mEq’ is amount of active}

30 mL = 1 oz = 30 g 5mL = 1 tsp

15 mL = 1 TBSP 1 pint = 16 0z = 1 lb 1 kg = 2.2 lb

ingredients of chemical element (compound) equal to 1/1000 of a gram

equivalent weight of a compound

Roman numerals:

V or v = 5

X or x = 10 L or l = 50

C or c = 100 D or d = 500 M or m = 1000

Common Calculations: Day supply - Quantity/Dose x Frequency

Quantity Dispensed - Dose x Frequency x Day supply

Common SIG Codes/Abbreviations:

Q = Every

QH = Every Hour

QAM = Every Morning QPM = Every Evening QHS = Every Bedtime QD = EveryDay

QOD = Every other day QWK = Every week QMO= Every Month Q_H = Every _ Hours BID= Twice Daily

TID = Three times daily QID = Four times daily X_D = times _ days TDS = 3 times a day NTE = not to exceed STAT = immediately PO = by mouth/oral C = with

S = without

AC = before a meal PC = after a meal

HS = at bedtime

PRN = as needed

UD = as directed

TAD = take as directed UAD = Use as directed AA = Equal parts

QS = quantity sufficient SS = half

OD = Right eye

OS = Left eye

OU = Both eyes

AD = right ear

AS = left ear

AU = Both Ears

SL = sublingual

BUCCAL = cheek/gum PR = rectally

PV = Vaginally

SUPP = Suppository TAB = Tablet

CAP = capsule

SYR = syrup

SUSP = Suspension Oint/UNG = Ointment INH = Inhaler

SQ = subcutaneous IV = intravenous

ID = intra dermal

IN - Intra nasal

INJ - Injection

IM - Intra muscular

AAA - apply to affected area AP - Apply

SOB - shortness of breath

BP - blood pressure

PCHS - after meals and at bedtime ACHS - before meals and at bedtime DAW - dispense as written

Preop/Postop - before surgery/after surgery

d/c - discontinue

D5W- dextrose 5% water

GTT(s) - drop (s)

TBSP - tablespoon

TSP - teaspoon

OZ - ounce

KG - kilogram

GM - gram

MG - miligram

LB -pound

ML - milliliter

L - Litter

G - Gallon

4.3 Equipment/supplies required for drug administration (e.g., package size, unit dose, diabetic supplies, spacers, oral and injectable syringes)

Package Size

Some drugs are supplied by manufacturers in unit-of use containers due to factors like stability, light sensitivity, and moisture control. For example, Aggrenox is found in 60-tablet unit-of-use bottles and should not be repackaged. Similarly, sublingual nitroglycerin tablets are kept in small amber vials to protect against light and maintain stability. Keeping these tablets in their original containers until needed is vital due to light sensitivity and stability concerns.

Unit Dose

In a hospital or inpatient environment, medications are individually packaged into small unit doses. This simplifies administration, considering patients' brief stays in such settings. As these stays are usually short, only a few days' worth of medication is required, avoiding the use of entire bottles. In retail settings, certain pharmacies might provide blister packaging or pouches, aiding medication management and adherence. These services are particularly advantageous for caregivers or individuals with memory issues who struggle with organizing their pill regimens.

Spacers

Spacers are used on the end of an inhaler to create a chamber between the

inhaler and a patient’s mouth. This facilitates a better inhalation technique as

it holds the medication until the patient breathes in. Spacers also increase the

amount of medication that reaches the lungs. When a spacer is not used, there

is a greater chance of improper technique, which results in the majority of

medication reaching the back of the throat only with limited amounts

reaching the lungs.

Diabetic Supplies

Diabetic supplies encompass preloaded insulin pens and calibrated insulin syringes employed for administering insulin to patients. These pens can be adjusted to the required insulin units for subcutaneous injection, and a disposable pen needle is attached for single use before being disposed of in a sharps container.

When using insulin syringes to draw and administer insulin from a vial, they are calibrated in units instead of milliliters, as insulin is measured in units. Some patients utilize insulin pumps that deliver short-acting insulin at a personalized rate, suited to well-controlled diabetes and strict dietary management.

Diabetic supplies also include tools for blood sugar measurement. A lancet device and associated lancet are used to prick the patient's finger for a blood sample. A glucose meter, along with a corresponding test strip, assesses glucose levels in the blood sample. Typically, diabetics test their blood sugar before meals.

Numerous meter, test strip, and lancet varieties exist in the market. It's essential for patients to receive lancets that match their device and test strips compatible with their glucose meter. Additionally, using a control solution periodically on the glucose meter ensures its accuracy.

Oral and Injectable Syringes

An injectable syringe consists of three main components: the plunger, barrel, and needle. The plunger is responsible for propelling medication through the barrel and the needle tip. The interior of the plunger must remain sterile and should not be touched while handling the product. All needles should be disposed of in a sharps container to ensure safety. Injectable syringes are available in various standardized sizes, including 1 mL, 3 mL, 5 mL, 10 mL, 20 mL, 40 mL, and 60 mL. The barrel of the syringe features calibrated markings for precise measurement of solutions. When choosing a syringe for drawing up or administering medication, it's important to select one that is roughly double the required volume. This prevents the plunger from extending completely, reducing the risk of contamination. For instance, if you need to draw up 1 mL of cyanocobalamin for a patient, a 3 mL syringe would be appropriate.

An oral syringe shares the same structure as an injectable syringe but lacks a needle. Oral syringes are employed to accurately administer oral solutions or liquids. Typically, they are used to facilitate the administration of liquids to infants, children, and individuals under hospice care.

4.4 Lot numbers, expiration dates, and National Drug Code (NDC) numbers

NUMBERS (BATCH NUMBERS)

Lot numbers are assigned by the drug manufacturer to identify a given batch of medication.

EXPIRATION DATES

Manufacturers assign expiration dates to guarantee the purity, safety, and effectiveness of a product for patient use. The expiration date corresponds to the final day of a specific month within a particular year. In drug recalls, whether initiated by the manufacturer or the Food and Drug Administration (FDA), both the lot number and expiration date play crucial roles.

NATIONAL DRUG CODES NUMBERS (NDC)

An individual drug is allocated a distinct 11-digit code for identification purposes. The initial five digits pertain to the manufacturer, the ensuing four digits pertain to the drug product, and the final two digits symbolize the package size and packaging. In the event of a medication reformulation, a fresh National Drug Code (NDC) number will be assigned. Similarly, if a drug company acquires another, the NDC number will undergo modification.

4.5 Procedures for identifying and returning dispensable, non-dispensable, and expired medications and supplies (e.g., credit return, return to stock, reverse distribution)

Identifying Medications to Return

The process of identifying medications for return from your pharmacy stock may appear challenging. However, it can be simplified by focusing on a few key factors. Medications that show sluggish movement and remain on the shelf are prime candidates for credit returns. Typically, a usage report can be generated to display a medication's month-to-date and year-to date usage, along with its last dispensed date. This data offers valuable insights into whether the product should be returned. Medications with moderate to low usage that are 3 to 6 months away from their listed expiration date are also suitable for credit returns. Performing monthly shelf checks is vital for the pharmacy. Items nearing expiration within the current year are tagged with their expiration month. This strategy ensures that products with the nearest expiration dates are used first and simplifies the process of identifying medications eligible for return before it becomes urgent. Expired medications must also be returned, but not for credit or refund. Instead, they are returned for proper disposal.

Recalled medication is returned to manufacturer for credit.

The terms outlined in agreements with wholesalers and manufacturers dictate the possibility of returning products for either partial or complete credit. Effective inventory management

techniques can potentially negate the need for manufacturer returns when products are

appropriately rotated.

Controlled substances are eligible for return solely by institutions holding a DEA number. As an illustration, long-term care facilities lack a DEA number, therefore they are unable to return

controlled substances to pharmacies.

Dispensable vs. Non-Dispensable Medications and Supplies

Medications and supplies eligible for return align with the criteria mentioned earlier, designating them as "good candidates" for such action. In essence, these items are unopened, well-maintained, and possess ample time before their indicated expiration date. These items are considered dispensable, indicating their suitability for patient dispensing as per prescriptions. Dispensable medications and supplies can be returned for credit, likely to be sold to another pharmacy and eventually dispensed to patients. On the other hand, non-dispensable medications are unlikely to be dispensed to patients and may not qualify for manufacturer or wholesaler return credit.

Expired Medications: Expired medications are those that have met or exceeded their specified expiration date. Every medication bottle from manufacturers bears an expiration date. When prescriptions are filled, the label's expiration date is typically set a year from the filling date, unless the manufacturer's bottle specifies an earlier date. Expired medications are not eligible for credit returns; however, they must be returned to a reverse distributor for proper disposal, often through incineration.

Destinations of Returns: Once a medication is identified as returnable, its destination depends on its origin and type. Even expired medications must be returned and then appropriately disposed of.

Credit Return: Pharmacies can return unopened, untampered medication bottles to their drug wholesaler or manufacturer, given the return date is well before the indicated expiration date and the items are in good condition (free of patient labeling residue or markings). Such returns usually involve a restocking fee, deducting 10-20% off the product's return value. If the return date is too close to the product's expiration, the item might not be eligible for return, as reselling it before it expires could be challenging.

Return to Stock: Retail pharmacies typically reintegrate medications into their stock if patients fail to pick up prescriptions within two weeks. Since these medications never left the pharmacy, they can be safely returned to stock for future prescriptions. However, if a patient returns a prescription drug, it cannot be restocked; it must be held in a designated area for disposal or return to the drug manufacturer.

Reverse Distribution: Reverse distribution involves sending outdated or unusable drug products back to the drug manufacturer or authorized distributor for processing or disposal. This procedure applies when drugs are returned by patients or when drugs have expired.