PTCB Federal Requirements

Calculations involved

• since controlled prescriptions have quantity and day supply limitations, it is important to know how to calculate a prescription's days supply -pharmacist ultimately responsible, but tech should know to catch inconsistencies before reaching final check.

• most common opioids and MME conversion factors -- morphine=1 --oxycodone=1.5 --hydrocodone=1 --codeine=0.15

• CDC website is a good resource

Calculations required

calculation relevant to CMEA of 2005:
a patient comes to the pharmacy counter to purchase psuedoephedrine HCl 30 mg(24.6 mg base) tabs. each box consists of 24 tablets. What is the max number of boxes patient can legally buy from pharmacy today?

3.6 gram daily limit = 3.6 grams= 3,600 mg
3600 mg/ 24.6 base mg per tablet = 146 tablets
each box contains 24 tablets, meaning this patient could legally purchase no more than 6 boxes from your pharmacy today.

Controlled Substances

medications that carry a high risk for abuse and misuse

• highly regulated by the DEA and categorized into schedules based on level of potential abuse

• each pharmacy has a designated area (vault or locked cabinet) for certain controlled medications are placed

DEA

comprehensive drug abuse prevention and control act of 1970 (controlled substances act) -- handlers of all controlled substances need to maintain accurate and up to date records and inventory - helps keep pharmacy aligned with federal regulations as well and prevent drug diversion and misuse

• Pharmacies and practitioners must be registered with the DEA for prescribing/dispensing a controlled substance -- each given a unique DEA # -- add first, third and fifth together -- add second, fourth, and sixth together -- multiply the sum in the second step by 2 -- add the total from steps 1 and 3 together -- Verify that the second digit of the sum in step 4 is the same as the last digit in the DEA number

• Prescription monitoring program to keep track of controlled substance history-- helps cut down on polypharmacy doctor shopping and early fills

DEA controlled substance schedules

Schedule I drugs have the highest abuse potential but are not on the market as they are not acceptable medical treatments and lack therapeutic benefit

• Schedule II drugs have the highest abuse potential for medications currently on the market

• the risk for abuse and misuse lessens as the schedule number increases - schedule V drugs have lowest risk

Dispensing

prescription only valid if written for legitimate medical purpose

• medication legally dispensed to the patient or member of household - if controlled substance is dispensed to anyone else, it's called distribution

• federally issued identification is recorded at pharmacy

• no federal quantity limit on controlled prescriptions, but state law typically limits sII dispensing to 30-day supply and sIII-V 90-day supply

• some states limit narcotic sII fills to a 7-day supply for acute pain and 30-day for chronic due to opioid epidemic

example of calculation involving a controlled medication

Oxycodone 5 MG tab 1 tablet by mouth 3x daily as needed for chronic pain#84 tablets Is this prescription valid for dispensing? calculations: 84 tabs total/3 tabs daily = 28 day supply 5 MG x 3 tabs daily= 15 MG of oxycodone daily 15 MG x 1.5 MME factor= 22.5MME

yes, prescription is valid- does not exceed 100 MME/day and 30-day max limit

FDA

responsible for regulating the safety efficacy of medical devices, drugs, and biologics -FDA must approve of each medication before it can be put on market

• regulates the manufacturing, labeling, dispensing, and post-market surveillance.

• requires black box warning --alert healthcare providers and consumers of serious potential adverse affects or life-threatening risks -- i.e. opioid analgesics

• Opioid Analgesic Risk Evaluation and Mitigation (REMS) program that requires adequate training in healthcare professionals

• in 2019, FDA required a label change on opioids to guide providers on dose tapering prior to discontinuation due to reports of harm caused by abrupt discontinuation -MedWatch

Handling and Disposal of Pharmacy Substances and Waste

Extreme caution should always be used - PPE and wear as outlined in SDS

Hazardous materials

any chemical or drug that poses potential harm to the person preparing/coming in contact with

• OSHA has standards to protect employees- PPE SDS- safety data sheets

• should be stored seperately from other materials often in a negative pressure room

• leakproof container labeled hazardous

• in case of accidental exposure, you should be aware of the equipment available and follow all cleanup of hazardous materials -- spill kits for safe cleaning -- report any accidents to supervisor

Labeling

federal regulations for labeling a controlled substance:

• fill date

• pharmacy name and address

• prescription number

• patient name

• prescribing practitioner

• drug name, strength, dosage form, quantity, and number of fills (if CIII-V)

• directions for use and any applicable cautionary verbiage FDA also requires warning to be present on label: "Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"

Loss and Theft

if a sII-V controlled substance is lost/stolen, the DEA and local law enforcement must be notified immediately
- pharmacist then fills out a DEA 106 form that details medications involved in theft
-original is sent, copy is kept
-spilling a small amount of liquid/breaking a few tabs does not need to be reported -- only a significant loss of controlled substances requires DEA 106 form.

Movement

movement of controlled substances from manufacturer to pharmacy, then pharmacy to patient - highly regulated by DEA
-each step in the life cycle of a controlled substance must be traceable

New prescriptions

schedule II prescriptions must be sent electronically from the practitioner to the pharmacy or handwritten on a secure prescription blank

• Faxes are only acceptable for hospice/long-term care patients

• telephonic emergency schedule II prescriptions must be followed up with an electronic or hard copy per DEA regulations

• To combat current opioid crisis, some states limit days supplu and amount that can be prescribed to 100 MME per day -Nothing on a schedule II prescription can be altered, even with confirmation from practitioner

• Expiration date is based on state's regulations-- typically within 90 days of the written date

• pharmacies must follow both federal and state laws- when each is different (i.e., expiration of a schedule II prescription) the stricter of the 2 must be followed. -Schedule III-V prescriptions can be handwritten, electronically sent, faxed, and even taken over the phone

Non-hazardous materials

handled with care, even though PPE is not required
- may pose a risk to the environment if not disposed of correctly
-keep out of waterways (don't dump down drain)
-can range from materials used to prepare a compounded product to products that have passed their intended expiration date

Ordering

sII: use DEA form 222- 3 copies for consistency- top for supplier, middle for DEA, and bottom is for purchaser. valid for 60 days - max of 10 different meds can be ordered on one- signed by registrant pharmacist

• Controlled substance ordering system (CSOS) in place of DEA 222 form-- as long as pharmacy meets electronic requirements

• October 2019- single copy DEA 222 form to replace triplicate format sIII-V - no special requirements

Other regulations for controlled substances

DEA- Drug Enforcement Agency
FDA- Food and Drug Administration

Pharmaceutical Substances

-any substance used for therapeutic treatment - medications or the ingredients used to make them

• Hazardous: warfarin, tretinoin, finasteride, methotrexate

• Non-hazardous: amoxicillin, diphenhydramine, ranitidine, atorvastatin

• expired pharm subs can be sent back to manufacturer

• vaccines, syringes, and needles disposed in sharps container.

Pseudoephedrine

Combat Methamphetamine Epidemic Act of 2005 (CMEA) has restrictions on sale, storage, and record requirements for products containing ephedrine, pseudoephedrine, and phenylpropanolamine

• the max amount that can be bought by an individual customer is 3.6 grams/day and 9 grams in a 30-day period -- base chemical

• act also requires that any products containing ephedrine, pseudoephedrine, and phenylpropanolamine be kept behind pharmacy counter to make sure all required documentation is completed with the sale and to prevent theft -electronic/written logbook must be kept detailing info about person purchasing product-- quantity, strength, date, and time of product sale

Recall Classifications

• Class I is the most severe, involves medication that is likely to cause severe adverse effects or even death, or when one drug is labeled as another

• Class II occurs when medication can cause temporary adverse health effects, small risk of serious effects

• Class III is the least severe, not likely to cause adverse effects

Recall targets

FDA can request recall of any medical product available on market - pharmaceutical manufacturer as well -- recalls sent to distribution wholesalers, then pharmacies who purchase and supply to public. If recall is severe enough, Class I, pharmacy is required to personally reach out to anyone affected

Recalled Devices

can become defective or a health hazard -- insulin pumps, glucose meters, infusion pumps, glucose test strips, cardiac pacemakers, etc.

Recalled Medications

most common reasons for medication recall include product contamination, presence of impurities, product of mislabeling, and adverse effects.

Recalled supplements

common reasons for supplement recall: contamination, presence of undeclared ingredients, super/subpotency, product mislabeling, misleading product label claims, etc.

Recalled supplies

supplies recalled due to faulty components -- needles, syringes, surgical gloves, sterile saline and water solutions, catheters, etc.

Recalls

pharmacy must comply with recall and keep accurate records to aid in the safety of patients

• BOP and Joint Comission's recommendations must be followed

• pharmacist needs to contact all patients who may have been affected

• all records should be maintained

Receiving

sII: verify and document date received on 3rd copy. copy 3 of each order form must be maintained in the pharmacy for at least 2 years
sIII-V: no special requirements

Refills

-Schedule II prescriptions are not permitted to be written with any refills
- Controlled substances cannot be filled early

Regulation Categories

Receiving
Storing
Ordering
Labeling
Dispensing
Reverse distribution
Take back programs
Loss and theft

Restricted Drug Programs

certain potentially harmful medications have specific criteria that must be met before the prescription can be filled - certain OTC meds (pseudoephedrine) have strict quantity limits to cut down potential for illegal misuse

Reverse Distribution

occurs when a pharmacy sends outdated, unusable drug product back to manufacturer for processing or disposal -- returned by patients or expired

• outdated, damaged, or unwanted controlled substances may be destroyed under authorization of DEA- using DEA 41 form. must contain: -- dates, location, method of destruction --NDC, name, strength, dosage form, and quantity being destroyed -- signatures of 2 witnesses of the destruction (employees)

Risk Evaluation and Mitigation Strategies (REMS)

a plan to minimize drug-induced harm
- each drug has different criteria that must be met--patient education, elements for safe use, communication plan between healthcare providers and patient, laboratory tests, etc.
Example: isotretinoin- can be very teratogenic if given to a pregnant woman - Isostretinoin Safety and Risk Management Act outlines requirements to prevent disastrous effects -- requires patients to have a blood test and be counseled on safe use before being given a prescription - also, 7 day time frame to fill prescription and only given a 30day supply

Storing

sII: must be kept under lock and key in own designated vault w/cameras
sIII-V: in own area of locked vault- cameras positioned on them as well- preference of pharmacist

Take Back Programs

unwanted medications are voluntarily donated and disposed of correctly - controlled or not
- makes community safer since meds are not ending up in local waterways or wrong hands

Transfer of prescription

-schedule II medications cannot be transferred from one pharmacy to another

• schedule III-Vs can be transferred between pharmacies one time only

• all transfers must occur between 2 pharmacists -schedule III-V transfers are indicated by law for refill purposes only (non-transferable)

• following needs to be included when transferring a prescription: -- original prescription date and dispensing date -- number of refills remaining --the name of the transferring pharmacist --the DEA number, name, and address of the transferring phar