State Opioid Prescribing Policy: Florida

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1 State Opiid Prescribing Plicy: Flrida Pain Plicy and Regulatin: Flrida General Plicies f the Flrida Bards f Medicine and Ostepathic Medicine (Bards) The Bards recgnize that "cntrlled substances, including piid analgesics, may be essential in the treatment f acute pain due t trauma r surgery and chrnic pain, whether due t cancer r nn-cancer rigins." The Bards cnsider "prescribing, rdering, administering, r dispensing cntrlled substances fr pain t be fr a legitimate medical purpse if based n accepted scientific knwledge f the treatment f pain r if based n sund clinical grunds. All such prescribing must be based n clear dcumentatin f unrelieved pain and in cmpliance with applicable state r federal laws." The Bards will nt take disciplinary actin against a physician fr failing t adhere strictly t the prvisins f their standards fr the use f cntrlled substances in the treatment f pain "if gd cause is shwn fr such deviatins." The Bards "will judge the validity f prescribing based n the physician's treatment f the patient and n available dcumentatin, rather than n the quantity and chrnicity f prescribing." Definitins Accrding t the Bards Pain: An unpleasant sensry and emtinal experience assciated with actual r ptential tissue damage r described in terms f such damage. Acute pain: The nrmal, predicted physilgic respnse t an adverse chemical, thermal, r mechanical stimulus assciated with surgery, trauma, and acute illness. It is generally time-limited and is respnsive t piid therapy amng ther therapies. Chrnic pain: A pain state which is persistent. Physical dependence: A physilgic state f neuradaptatin that is characterized by the emergence f a withdrawal syndrme if drug use is stpped r decreased abruptly r if an antagnist is administered. Physical dependence is an expected result f piid use. Physical dependence by itself des nt equate with addictin. Tlerance: A physilgic state resulting frm regular use f a drug in which an increased dsage is needed t prduce the same effect, r a reduced effect is

2 bserved with a cnstant dse. Addictin: A neurbehaviral syndrme with genetic and envirnmental influences that results in psychlgical dependence n the use f substances fr their psychic effects and is characterized by cmpulsive use despite harm. Physical dependence and tlerance are nrmal physilgic cnsequences f extended piid therapy fr pain and shuld nt be cnsidered addictin. Pseudaddictin: A pattern f drug-seeking behavir f patients with pain wh are receiving inadequate pain management that can be mistaken fr addictin. Standards fr the Use f Cntrlled Substances fr Pain Accrding t the Bards Evaluatin f the patient Cmplete histry and physical examinatin Dcumented nature and intensity f pain Underlying diseases and cnditins Effect f pain n physical and psychlgical functining Histry f substance abuse Indicatin fr use f cntrlled substances Treatment plan Objectives used t determine treatment success Further diagnstic evaluatins r treatments planned Therapy adjusted t individual patient needs Infrmed cnsent and agreement t treatment Risks and benefits discussed with patient When pssible, patient shuld receive medicatins frm ne physician and ne pharmacy Written agreement if patient is determined t be at high risk:

3 Urine/serum drug level tests Number and frequency f refills Reasns drug therapy may be discntinued (vilatin f agreement) Peridic Review At reasnable intervals Reevaluate need fr piids if gals are nt met Mnitr cmpliance Cnsultatin Refer as necessary Extra care with patients having histry f misuse r living arrangements cnducive t misuse/diversin Addictin medicine cnsult fr patients with a histry f abuse r cmrbid psychiatric disrder Medical recrds Histry and physical examinatin Diagnstic, therapeutic, and labratry results Evaluatins and cnsultatins Treatment bjectives Discussin f risks and benefits Treatments Medicatins (including date, type, dsage, and quantity

4 prescribed) Instructins and agreements Peridic reviews Cmpliance with cntrlled substance laws and regulatins Standards fr Dispensing f Cntrlled Substances fr Pain by the Flrida Bard f Pharmacy Criteria that shuld cause a pharmacist t questin legitimacy f a prescriptin: Frequent lss f cntrlled substance prescriptins Only cntrlled substance medicatins are prescribed fr patient One persn presents cntrlled substance prescriptins with different patient names Same r similar cntrlled substance medicatin prescribed by 2 r mre prescribers at same time Patient always pays cash and always insists n brand name prduct Actin t take when legitimacy f a prescriptin is questined: Require pht identificatin f persn requesting medicatin and phtcpy the identificatin Verify the prescriptin with the prescriber Every pharmacy must maintain recrd f cntrlled substances dispensed Hard cpy recrd must be prvided cvering previus 60 days Must be made available within 72 hurs f law enfrcement request Must include vlume and identity f cntrlled substance

5 dispensed by specific prescriber t specific patient A pharmacist with reasn t believe that a prescriber is invlved with diversin must reprt the prescriber t the Flrida Department f Health Federal Cntrlled Substance Rules That Are Enfrceable in Flrida General rules All cntrlled substance prescriptins must be issued fr a "legitimate medical purpse" and in the "usual curse f prfessinal practice" This is primarily the practitiner's respnsibility Pharmacists have a crrespnding respnsibility t assure that this requirement has been met Transfers f cntrlled substances by a pharmacy t a physician r clinic fr ffice use must be dne in the same way that cntrlled substances are acquired frm a whlesaler r manufacturer. Fr C-II drugs, use either a paper frm 222 r an electrnic frm 222 Fr C-III, C-IV, and C-V drugs, use an invice retained n file Prescriptins issued withut a specific patient name "fr ffice use" cannt be filled Under federal law, C-III and C-IV prescriptins may be authrized fr refilling up t 5 times in 6 mnths fllwing issuance. Flrida law impses this requirement fr C-V prescriptins als. All cntrlled substance prescriptins must be dated n the date f issuance. There is n maximum dse, maximum quantity, r maximum duratin f therapy with cntrlled substance medicatins under federal

6 law r Flrida law. Specific rules fr C-II prescriptins Under federal law there is n time limit within which a C-II prescriptin must be filled. In Flrida, every prescriptin must be filled within 1 year f issuance, s that basic rule cvers C-II prescriptins. C-II prescriptins may nt be refilled. Perid. End f stry. Never use the wrd "refill" with reference t the issuance f a cntinuing supply f C-II medicatin pursuant t a new prescriptin. Multiple C-II prescriptins may be issued n the same day fr up t a 90-day cntinuing supply t be acquired peridically thrugh new prescriptins that cntain "d nt fill until [m-day-year]" instructins fr the pharmacist. Under certain circumstances, federal law permits a faxed prescriptin t serve as the riginal, and Flrida law specifically defers t federal law n this matter. This applies under 3 circumstances: The prescriptin is fr infusin treatment (narctic C-II prescriptins nly) The prescriptin is fr a resident f a lng-term care facility (LTCF) (any C-II prescriptin) The prescriptin is fr a patient enrlled in hspice care (narctic C-II prescriptins nly) A pharmacist may partially fill a C-II prescriptin if the pharmacist is unable t fill the prescriptin fr the full amunt The balance must be dispensed within 72 hurs r nt at all If the balance is nt dispensed within 72 hurs, the prescriber must be ntified A pharmacist may partially fill a C-II prescriptin ver a perid f 60 days, in peridic amunts up t the ttal amunt prescribed, if the patient is either terminally ill r a lng-term care patient.

7 The pharmacist must write either "terminally ill" r "LTCF patient" n the prescriptin Fr each partial filling, the date the prescriptin was partially filled, the quantity dispensed, the remaining quantify, and the identificatin f the dispensing pharmacist must be dcumented In an emergency situatin, a prescriber may verbally authrize a pharmacist t dispense a supply f C-II medicatin. Several rules apply t this prcess: The amunt f medicatin dispensed is limited t that necessary t treat the patient during the emergency perid The verbal rder must be immediately reduced t writing by the pharmacist If the prescriber is nt knwn t the pharmacist, the pharmacist must make a reasnable effrt t verify the validity f the prescriptin, such as by calling the prescriber at a number listed in the telephne bk Within 7 days fllwing verbal authrizatin t dispense an emergency supply f C-II medicatin, the prescriber must furnish t the pharmacist a hard prescriptin that reflects the emergency rder N special Drug Enfrcement Agency (DEA) registratin is required t prescribe methadne fr pain, and n special restrictins exist fr the prescribing f methadne fr pain. Hwever, it is a gd practice t write "fr pain" n a methadne prescriptin issued t treat pain. Infrmal DEA Advice Frm the DEA Web site The fllwing is a list f infrmatin that must be included n a cntrlled substance prescriptin under federal law. Flrida law als requires that all prescriptins be either legibly printed r typed, that the quantity f drug prescribed appear in bth textual and numeric frmats, and the date be written ut

8 in textual letters. Date f issue Patient's name and address Practitiner's name, address, and DEA registratin number Drug name Drug strength Dsage frm Directins fr use Number f refills (if any) authrized Pharmacists may make sme changes t a cntrlled substance prescriptin, including a C-II prescriptin, after cnsultatin with and agreement f the prescriber: Dsage frm Drug strength Drug quantity Directins fr use Issue date (t the crrect date if there has been an errr) Patients may return cntrlled substances t the registrant wh supplied them nly under 2 circumstances: The cntrlled substance was dispensed in errr The cntrlled substance is the subject f a US Fd and Drug Administratin supervised recall

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