Acts

 

1970 federal controlled substance act

• DEA established a closed system of control manufacturing, distributing, and dispensing of controlled substances; The DEA ensures adequate supply of C.S and deter illegal usage of C.S

Poison prevention packing act

• Requires child resistant containers.

Combat methamphetamine epidemic act

• regulate over-the-counter sales of ephedrine, pseudoephedrine.
• If any loss, a return report must file within 15 days using DEA form 106

Ryan Haight online pharmacy protection act of 2008

• Combat unlawful dispense of C.S. by the internet
• Must complete modification of registration for online pharmacies

 

Pharmacy operation

New pharmacy registration

• DEA form 224 (224b is for retail chain pharmacy registration renewal).
• Renew registration every 3 years utilizing DEA form 224a, no more than 60 days before the expiration date. Once expiration passed, a pharmacy cannot handle C.S

Transfer of pharmacy

• the registrant must submit notification to special agent in the area at least 14 days before the proposed transfer

Record keeping

• All E-Rx records and C.S records must maintain for at least 2 years.
• If C.S < 1000 tab, an estimated count is obtained, if the opened bottle appears to contain more than 1000 tabs, an exact count is required. (Hmmm… this is a little against our logic, let’s put it this way: we do not want to estimate count to be less than that of the actual count; A test question loves to play a trick here)
• C.S requires a biennial inventory
• Form 222: copy 1 (supplier), copy 2 (DEA), copy 3 (pharmacy)
  • Unused 222 form and DEA registration must be returned to local DEA when the Rx is closed.
• DEA 41 form: scheduled C-II drugs can be sent to a designated site for disposal. Pharmacy must report to DEA.

Compounding

• date up to 6-mos, or shortest expiration of any ingredient
• Compound sterile inj. From non-sterile ingredient: an ISO class 5 laminar airflow hood that has a positive air pressure, and a barrier isolator (provides ISO class 5 environment)

 

Definitions

• Central fill pharmacy: a pharmacy prepares Rx orders for dispensing at other retail Rx. Can prepare both initial and refill prescriptions. Retail Rx must write the word "central fill" on the original Rx.
• MLP- middle level practitioner: other than MD, dentist, veterinarian such as mid-wife, nurse anesthetist, nurse practitioner
• Readily retrievable: C.S record can easily be separated from other records
• Act: a statutory plan passed by congress or other legislature, which is a "bill" until enacted and becomes law.
• USP - united states pharmacopoeia
• A scientific organization defines standards for Rx, OTC, and supplements.

o   Long term care (LTC)

• A nursing home, retirement care, mental care, which provides extended care to residents. It is not required to register w/ DEA
• A retail pharmacy can register at the site and store C.S in automated dispensing system. An emergency kit w/ C.S. may be placed
• ADS-advance data system records electronically the dispensing records for pharmacy.

o   Online pharmacy

• Apply for a modification of registration to operate as an online pharmacy.
• Ryan Haight online pharmacy consumer protection act is designed to combat the illegal internet website dispensing of C.S.
• Illegal to dispense C.S by internet, except it holds a modification of DEA registration authorization which must be notified 30 days in advance to state board.
• Must submit monthly CS report
• 5 g of PSE per 30 d via mail order (Vs. 9g monthly purchasing limit in store)

o   Skilled nursing facility (SNF)

• Must have policies and procedures on administering meds including biologicals to residents. SNF must have a licensed RPh for consultation who reviews each resident's medication regimen at least once a month.

o   Centralized hospital packaging pharmacy

• Obtain a specialty license from the board, and renew the license annually, which is not transferrable
• May prepare medications within its own acute care hospital, which located within 75 miles of each other

 

Control substance definitions

• S. act: mandates DEA to establish a closed system of control manufacturing, distributing, dispensing of C.S.
• Exemption from DEA registration: Public health service, federal prison, military practitioners., employee of hospital.
• The power of attorney - POA, must be signed by original pharmacy DEA registrant and the new authorized person. (the form does not need to be submitted to DEA, only file with DEA222)
• The renewal POA must be signed by the same person otherwise a new POA needs to be granted when the pharmacy completes a renewal registration.
• DEA Take back program
  • Started in 2009. the purpose is to give customer a safe way to dispose unused meds, NOT C.S.
  • Scheduled drugs must be returned under DEA supervision, to an authorized disposal company that will destroy the drugs.
• Loss/stolen of C.S
  • Notify local DEA and police immediately, a written report filed within 15 days.
  • File DEA form 106 for significant loss of CII
  • To dispose C-II, pharmacy must report to DEA w/ form 41

 

Dispensing C.S

 

·Federal law has no qty limit and time limit of filling a C-II

• Prescriber may issue multiple C-II Rx up to a max of 90-day supply: each Rx on a separate blank, each indicate the earliest date it may be filled, all Rx must be signed on the date issued (post-date or pre-sign is not allowed)
• C-II can be transcribed by fax if: LTC, hospice patient, compounding and direct administering to patient by IV, IM, or SQ.
• Verbal C-II for a 72-hr supply, the hard copy must be received w/in 7 days to pharmacy. Must write on face "authorization for emergency dispensing". If not, RPh must notify the w/in 6 days.
• Partial fill for C-II for LTC or terminally ill, the remaining must be supplied within 60 days. RPh must record on the Rx "LTC" or "terminally ill"
• ***Partial fill used to be allowed only w/in 72-hrs for all other patients, but the law has changed in 2016, to allow for the remaining portions of a C-II substance to be dispensed up to 30 daysafter the written date. Additionally, it does not have to be an issue of out of stock, partial dispensing can be requested by either patient or prescriber. However, follow the stricter state law.
• Methadone can't be dispensed by a pharmacy for the treatment of opioid dependence. However, it can be dispensed for the management of pain as long as the prescription says "for pain".
• If Rx is gamma-hydroxybutyric acid, must note medical need.
• The opioid epidemic sweeps the nation, and drug overdose is the leading cause of accidental death in the U.S. Pharmacists, along with prescribers, have responsibility to ensure that controlled substances and other potentially abused medications are prescribed in the usual course of their practice and dispensed for legitimate medical uses.
• Prescription Drug Monitoring Programs – PDMPs, is a tool to help identify potential drug diversion. The purpose of these programs is to reduce prescription drug abuse and diversion. 

• Drug seeking behavior
  • Unusual behavior
  • Assertive personality
  • Unusual appearance (either unkempt or over-dressed)
  • Unusual knowledge of controlled substances
  • Medical history with textbook symptoms, or very vague medical history
  • Claims to have no regular doctor and no health insurance
  • Will request a specific controlled drug and be reluctant to try a different drug
  • Has no interest in diagnosis, follow-up appointments, or referrals
  • Exaggerates medical problems or symptoms
  • Exhibits psychiatric issues such as mood disturbances, suicidal thoughts, etc.
  • Signs of drug abuse such as skin tracks or scars on neck, arms, and feet or ankles
  • Wants to be seen right away
  • Requests an appointment at the end of office hours
  • Calls or comes in after regular hours
  • Claims to be traveling, visiting relatives, etc.
  • Fakes physical problems such as abdominal or back pain, kidney stones, migraines, in order to get a prescription for an opioid
  • Fakes psychological problems such as anxiety, insomnia, etc. to get stimulants or depressants
  • States that non-opioid analgesics are ineffective, or that he or she is allergic to them
  • Claims a prescription has been lost or stolen and requests a replacement
  • Requests refills more than originally prescribed
  • Pressures providers by seeking sympathy, imposing guilt, or direct threats
  • Uses a child or elderly person to get methylphenidate or pain meds

·       Red flag prescribing:

• Pattern prescribing: same drug, quantity
• Prescribing combinations: cocktails of C.S of abuse
• Geographic difference
• Qty and strength in question
• Paying cash
• Patients with the same diagnosis code from same doctor.
• Rx written not consistent w/ the prescribers’ area of specialty

·       Verify DEA number:

• Add 1,3,5th digit
• Add 2,4,6th digit
• Result of step 2 x 2
• Add step 1 with step 3, the last digit is the 7th digit
• Registration with DEA is exempted for Public Health Service or Bureau of Prisons officials and military physicians 

·       Labeling of C-III to C-V

• Labeling is not required in a hospital setting, if less than 34-day supple or 100 units dispensed at one time.

 

Drug Addiction treatment program - DATA

• To prescribe suboxone for addiction treatment, the prescriber must request a waiver from center substance abuse treatment - CSAT, DEA will issue a DEA number begin with "X".
• DATA 2000 - drug addiction treatment act, opioids addition - Subutex or Suboxone.
• Business activity restrict the physician to treat between 30 to 100 patients.

 

RX drug disposal

• The FDA produces a list of which unused or expired medicines can be flushed down the sink or toilet to help prevent danger to people and pets in the home.
• The best way is to put in a "take back" program or mix with unpalatable substance and placing in a non-descript container before discarding in trash, unless the prescribing info specifically states "flush down to toilet"
• Flush list: Mostly are control substance to help prevent danger to people and pets
  • g: Actiq, Amidone, Demerol, Diastat, Embeda (morphine + naltrexone), methylphenidate patch, Opana, oxycodone, Xyrem (sodium oxybate)

 

Dispensing without a Rx

• RPh can dispense if: no more than 8oz of C.S containing opium, or no more than 4oz to the same purchaser in 48-hr period
• Dispense no more than 48 dose unit containing opium, or no more than 24 units to the same purchaser in 48-hr.
• The purchaser must be 18 years and older.
• the only way a doctor office can receive medications from pharmacy is via invoices (not prescription pad), so they cannot fill a script out where they write 'for office use'. 

 

Recall class

• Class I: reasonable probability exists that the product will lead to serious AE.
• Class II: probability exists that the product will cause AE.
• Class III: product will not cause AE.
• Med Watch: a voluntary program allows healthcare professional to report serious AE. It provides information on safety labeling changes to package insert.
• Manufacturer must file a report w/ FDA if an AE reported.

 

PLLR - pregnancy and lactation labeling final rule

• Rx approved after 2015 will use the new format, the letter system will be replaced with " Pregnancy, Lactation, Females and males of reproductive potential"

 

Clinical trials

• This is an important concept, you need to be familiar with the definition of each stage.
• New drug application-NDA or IND: prove a new drug is safe for human trial
• Phase I: on small group of healthy volunteers to evaluate safety and investigate the SE.
• Phase II: large group (100- 300) to evaluate safety and effective.
• Phase III: large group (1000-3000) to confirm effectiveness. Randomized and blind testing.
• Phase IV: post market surveillance. Collect info on effect and SE of drug.

 

New drug

• Type P (priority): major therapeutic gain for the treatment, may qualify for fast track approval
• Type S (standard): drugs similar to others.
• Chemical classification (FYI)
  • Type 1: new molecular structure and not currently marketed in US
  • Type 2: new derivative of structure currently approved in US
  • Type 3: new formulation
  • Type 4: new combo
  • Type 5: drug manufactured by new company
  • Type 6: new indication

 

Adulterated drugs:

Consists of filthy, putrid or decomposed substance; produced under unsanitary conditions; manufacturing process does not conform to GMP; poisonous/deleterious substance; unsafe color additive; different or lower strength, quantity, purity (unless specified on the label and is as homeopathic products)

 

Misbranded drugs:

False or misleading label; label does not bear name/address of manufacturer; no accurate quantity of active ingredient; lack of accurate monograph for legend drugs.

 

References

• Red book: determine product formulations, suggested retail price and availability
• Orange book: generic equivalency
• Purple book: biologic product and interchangeable
• Physician desk reference - PDR: collection of product package inserts
• National library of medicine: daily med, database of product package inserts
• Pink book: Principles of Immunization.
• Pink sheet: regulatory compliance news that affects the pharmaceutical industry
• Goodman and Gilman's: provide background information on chemical structure and related compounds (the medicine's class) for a prescription medicinal compound
• Foreign drugs: Martindale’s, Micromedex, European Drug Index, USP Dictionary of USAN and International Drug Names
• Compounding:  Remington: The Science and Practice of Pharmacy; Handbook on Extemporaneous Formulations. International Journal of Pharmaceutical Compounding. US Pharmacopoeia National Formulary- (USP 797 is standards for sterile compounding, non-Sterile Compounding- 795). Allen's Compounded Formulations
• Natural products: Natural Medicines Comprehensive Database
• Patient friendly reference: MedlinePlus, Mayo Clinic and WebMD
• Yellow Book - Travelers Health Information

 

Schedule list

• II: codeine, hydrocodone, meperidine (Demerol), opium tincture (Laudanum), pentobarbital (Nembutal, usually used in capture/immobilization of wildlife), secobarbital (Seconal, Tuinal), sufentanil (Sufenta)
• III: anabolic steroids (Body building drugs), testosterone, barbituric acid derivative (barbiturate), buprenorphine (Buprenex, Zubsolv), butalbital (Fiorinal), dornabinol (Marinol), ketamine (Ketaset, special K), opium combination product (Paregoric), Xyrem(sodium oxybate, CIII), Hycotuss (hydromorphone/guaifenesin)
• IV: butorphanol (Stadol), phenobarbital (Luminal, Bellergal-S), tramadol, zolpidem, carisoprodol (Soma), pentazocine (Talwin)
• V: lacosamide (Vimpat), codeine preparations (Robitussin AC, Cheracol)
• Scheduled listed chemical product- SLCP: pseudoephedrine, ephedrine, phenylpropanolamine. Dispensed behind pharmacy counter with restrictions.

 

Common REMS drug

***For a complete list of REMES drug please visit*** https://www.accessdata.fda.gov/scripts/cder/rems/

• Isotretinoin - Ipledge
• All forms of testosterone
• Clozaril (clozapine):
  • fatal agranulocytosis.
  • May only dispense until next blood test 
• Thalomid (thalidomide)
  • STEPS program for prescriber, RPh, and PT - sys. For thalidomide education and prescribing safety
  • Require pregnancy test
  • RX limited to 28-d blister pack
  • No verbal rx or automatic refills
• Tikosyn (dofetilide)
  • TIPS program in retail rx - tikosyn in pharmacy system
  • Risk of induced arrhythmia
  • First 3 days must be in a facility that can monitor CrCl, ECG and cardiac resuscitation
  • Rph must initial, date each rx with a special TIPS stamp
• Tracleer (bosentan)
  • Treat PAH
  • Monitor for liver toxicity
  • Tap program - Tracleer access program
• Xyrem (Na oxybate, also known as GHB)
  • C-III, treat narcolepsy
  • Available only through a single centralized pharmacy
  • Monitor CNS adverse reactions.
  • Prescriber and pts must enroll XYREM REMS program

 

MedGuide required

** Can you guess the reason why they require a MedGuide? This helps a whole lot with knowing the warnings of each drug or drug class.

• Accutane, Advair, antidepressants (suicide warning in children and teenagers), ADHD drugs
• Cordarone (amiodarone)
• Elidel (pimecrolimus), Emsam (selegeline)
• Diabetics: rosiglitazone, Victoza, Symlim (pramitidine)
• HIV/ chemo drugs: Epzicom (abacavir/lamivudine), Ziagen (abacavir), Trizivir (Abacavir/lamivudine/zidovudine), Viramune (vevirapine), Truvada, Tysabri(natalizumab), eculizumab(Soliris), bosentan(Tracleer)
• Forteo (teriparatide), Lariam (mefloquine), Lindane, Lotronex (alosetron)
• Long-acting Narcotics: Palladone (hydromorphone), Xyrem (Na oxybate); longer acting, thus more risk of respiratory depression
• Biologics: Pegasys (peginterferion alfa-2A), PEG-intro (peginterferion alfa-2B), Ribavirin, Roferon-A (interferon alpha-2A), Rebif (Interferion beta-1A), Infergen (Interferon alfacon-1), Avonex (interferon beta-1A)
• Inhalant: Servent (salmeterol)
• Immunosuppressant: Soriatane (Acitretin)
• Strattera(atomoxetine), Tracleer (bosentan), Relivid (lenolidamide), Nolvadex/Soltamox (tamoxifen)
• NSAIDS, Mifepex (mifepristone)
• Anti-addiction med: Suboxone, Subutex, Vivitrol (naltrexone ER inj.)
• Weight loss: phentermine, Topamax

 

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