Massachusetts Pharmacy Laws

Massachusetts Law: Different Schedules in MA:  In MA, all the drug that are not under schedule 2, 3, 4, or 5, are considered schedule 6. So in MA all prescription drugs are controls. Time valid Max days supply/fill Max refills Oral Prescription 30days (day 30 days (Amphetamines can be given max 60 Not allowed Only for Emergency (obtain HC in 7 1 as the day days supply if for ADD or narcolepsy, There is days, quantity is whatever necessary after) no requirement for the diagnosis to be written. for that situation) for filling Schedule II Or can be 90 days if for infusion pump) Schedule III Fax allowed for hospice or LTCF pts. 6 months 30 days (can be 90 days if for infusion pump) 5 refills Yes, follow up of hard copy via fax or Schedule IV 6 months 180 days 5 refills mail. E-prescription is considered oral Schedule V None, set by store Rx. Schedule VI None, set by store. Refills can not be transferred after 1 year. Yes, no need to obtain hard copy. E-Rx is ok. Schedule II: must be written and signed by MD with MD DEA number written on Rx.  CII inventory has to be done every 10 days  Pharmacy reporting Responsibility:  Every pharmacy that dispense schedule II medication need to transmit to the DPH the following info: Rx number, NABP number, Patient identifier, date dispensed, NDC number,  quantity, days supply and prescriber DEA This info should be transmitted to DPH no later than 15 days following the last day of the  month in which the prescription was dispensed. Rph should require patient to show ID (may be waived under certain circumstances but need to document reason and request patient/agent signature on the back of prescription)   Schedule II, III and IV requires federal transfer label. Schedule III, IV and V are federal controlled substances that do not allow E-prescription. All eprescription is considered oral prescription and must follow up with hard copy that is sent via mail or fax. But for Schedule VI, both oral and E-Rx are ok.  Schedule III, IV and V can only be transferred for a one time base only. But can be transferred back and forth to the maximum refills if sharing a real time online database. Schedule VI can only be transferred within one year of written.  Inventory of Schedule II is done via DEA 222 form and schedule III, IV and V are done via  Only one way to file these prescriptions: schedule II, schedule III/IV/V, Schedule VI invoices. 105 CMR 721: Prescription Format and security in MA  Definition:  Authentication ( 认 证 ): identities of the parties sending and receiving electronic prescription data are duly verified. Content Integrity: electronic prescription data have not been altered during transmission. Electronic signature: only good for schedule 6 in MA because DEA not approved yet.  Technical Non-repudiation ( 拒 绝 ): parties to the generation, transmission, receipt or   1 storage of an electronic prescription can not deny having participated in said activity.  Format Requirement:  A signature line on lower portion of the form. Hospital and clinical forms should have a line below that signature line for the practitioner to print his/her name  Should be a space below the signature line that allows MD to hand write “NO SUBSTITUSTION” which should not be stamped, initialed, pre-printed or checking a box. Below that space should state” interchange is mandated unless the practitioner indicates “no substitution” in accordance with the law.” “Dispense as Written” is not allowed either.  Space for MD to write down: date, registration number, name, dosage, strength and quantity  of drug. Name and address of patient, direction for use and number of refills. Name and address of the practitioner should be clearly written on the prescription.   Can not write multiple prescription on one from. Nurse Midwifes, nurse practitioner, psychiatric nurse and PA shall also contain the name of supervising physician.  Security standards of prescription:  Paper based written prescription must be written and signed by the practitioner  A prescription may be transmitted electronically if: Have security measures to ensure authentication, technical non-repudiation, content 1. integrity and confidentiality. 2.  electronic signature 3. Reasonable and appropriate security measures to invalidate a Rx if signature or record 4. to which it is attached is altered. Meet HIPPA requirement. For schedule III, IV and V, electronic Rx is considered oral Rx, for Schedule VI it is acceptable. 105 CMR 722: Dispensing Procedures:  In MA, exchange of a less expensive reasonably available drug product (either generic or brand) selected from the MA list of interchangeable drugs for a prescribed brand name drug product is required.  Labeling: 1. 2. If a less expensive generic is given, label should include “interchange”, plus generic name and manufacturer name. IC: Amoxicillin 500mg capsule Teva If a less expensive brand name product is being dispense: “interchange” plus either the generic name and manufacture name or the brand name should appear on the label. IC Trimox 500mg Capsule OR IC Amoxicillin 500 mg capsule Teva 3. If Rx is written in generic and MD writes “NO SUBSTITUTION” then give whatever is legally mandated product that contains such a generic. NO need to indicate interchange on label. If Rx is dispensed as written then no need to indicate interchange. In Medical Emergency, The pharmacist may dispense whatever is available regardless of brand 4.  or generic product. Ok to give generic even though no sub and ok to give brand even though without marking no sub. MD should record on the back of the Rx the date, nature of the emergency and signature of the patient indicating acceptance of this deviation from law. 2  Drug Interchangeability and Midstream Interchange: The first time a drug becomes available for generic, the policy allows a pharmacist up to 90 days to put into effect the requirement for interchange. This affords Rph the time to notify MD or patient according the Rph’s professional judgment. A copy of the notification or a notation that it was provided should be maintained in the pharmacy record. 243 CMR: Physician Self-prescribing / steroid/anorectics  Prohibited from prescribing controlled substances in schedule II, III and IV for own use  Except in an emergency, can’t prescribe a CII to family member.   Prohibited from prescribing anabolic steroids for purpose of enhancing a patient’s athletic ability or performance. Prohibited from prescribing schedule for its anorectic effect. 247 CMR Pharmacist registration: Examination:   > 18 yo, Graduated from ACPE accredited college  1500 intern hours  Good moral character  Pass both law and NAPLEX exam (75% is passing)   Reciprocity:  Has been registered by examination in another state and the license is in good standing.  National Association of Boards of Pharmacy approval  Provide documentation of 1500 hours of practical experience.  Pass law exam.  Notify board for change of name, residence within 10 working days Should carry the license with them at all times  Should not allow displaying his/her license at a place he/she is not employed.  Renewal of Rph license:  License expires on Dec. 31st on even number years.  If forgot to renew for <60 days may renew upon paying late fee and so on   If forgot to renew for > 60days, board may require request for addition CE If forgot to renew for > 2 years then should take law exam again and other requirement by board.  CE is required to renew:  30 credits in 2 years, with 15 hours/year. No carry over of hours from one year to the other.  Out of the 15 hours/year: 2 should be law, no more than 10 can be acquired via home study     Max 8 hours/day Student doesn’t need CE for the year they graduate. Should obtain CE certificate for at least 2 years ACPE number 333-000-95-L01:  L (live offerings) H (Home study) C (offerings which contain both live and home study 3 or mediated components.  01 (drug therapy ), 02 (AIDs therapy ), 03 (Law topic), 04 (General pharmacy topic) Pharmacy registration: In MA, you need to have a DEA (for federal), MA controlled substance registration, MA pharmacy permit from the board, NABP (law), NPI (insurance)  Pharmacy manager of record 2. need to obtain board approval to be a manager can not be manager for more than 1 store 3. Controlled substance inventory every 2 years. 1. 4. 5. 6. The pharmacist’s employer or the pharmacist manager of record shall verify with board to make sure a newly hired Rph’s license is in good standing. If change manager need to notify the board and need to conduct a controlled substance inventory. In the event the outgoing pharmacist manager is unavailable due to death or terminated due to inappropriate handling of drugs, a staff Rph can sign the inventory provided that board is notified.  Required reference or equipment: MA list of interchangeable drugs (orange book, additional list, exceptional list) 1. 2. copy of 247 CMR 4. balance 5. 6.    current copy or electronic version of a compendia 3. equipment label that with name and address of pharmacy 7. sanitary requirements: sick with cold and hot running water 8. bound books for record keeping Minimum square footage required: 300 Patient consultation area with sign Permits: 2. pharmacy permit: expires on Dec. 31st on odd years. MA controlled substance registration: expires on Dec. 31 st on odd years 3. DEA need to renew every 3 years. 1. certificate of fitness ( for compounding using alcohol or selling alcohol ) Security requirement: 4.   1. a separate working alarm 2. schedule II to V shall be stored within the prescription area Need to notify board for approval if there is change in the configuration, square footage, or location of the pharmacy.  Restricted pharmacy: only to limited users such as union pharmacy that is only for union members.   Nuclear pharmacy: requires extra training to be a pharmacist. Petition to waiver: vet pharmacy will still apply for retail pharmacy but can request for waiver for any 247 CMR terms that do not apply to their pharmacy. Such permit should be filed appropriately. 4 Closing a pharmacy:   Notify board at least 14 days before the intended date with required information Within 10 days of closure should return pharmacy permit and controlled substance registration to the board.  Distribution of controlled substance: transfer from one pharmacy to the other: 1. Complete inventory should be taken and the both pharmacy should keep a copy and also 2. forward a copy to the board notify the board and provide the following information:      name, address and phone of both pharmacies pharmacy permit number, control substance registration of both pahramcies name and pharmacist registration number of the manger of both pharmacists date of transfer intended procedure to ensure secure transfer. Wholesaler:  need to be licensed   Control substance registration (expire yearly on Nov. 30 th) need to meet requirement for storage and handling of drugs Pharmacy Interns and Technicians: need to wear name tag at all times and all can make the offer to counsel patient upon pharmacist approval.  Interns:  2 year of education (become intern during 3rd year)  Complete 1500 hours of board approved pharmacy intern experience (can’t count the work  Can only work max 12 hours /day time before becoming intern as intern hours).   If completed intern hours at other state then need to submit to the MA if want to apply for Pph in MA. May engage in the full range of activities of a Rph as long as is under supervision of a registered pharmacist  Registered Tech:   > 18 years old High school or equivalent  Good moral character  No conviction  Examination (company based)  License expired every 2 years on DOB (if forgot may request for renewal with additional  May request and accept authorization for refills if nothing is changed. Can’t take prescription conditions required by board)  over the phone at all or perform transfer. Registered Tech trainee    Same as tech except haven’t take the exam yet and > 16 yo. They perform the same task as tech under Rph direct supervision Certified tech: 5  Nationally certified.  Can take Rx over the phone or perform transfer if it is schedule 6 drug. Supervisory Ratio:  1:4 (at least 1 certified tech, 1 intern, OR at least 2 certified techs, OR at least 2 interns )  1:3 (at least one of them are either certified tech or intern) Transfer of prescription: (upon patient’s request) a) Can only take place by means of direct communication between two licensed pharmacists or b) interns under supervision of pharmacist. Certified techs can transfer schedule 6 drugs. Schedule III, IV and V can only be transferred for a one time base only. But can be transferred back and forth to the maximum refills if sharing a real time online database. Schedule VI can only be transferred within one year of issuance. Schedule III and IV has limit of max 5 refills and should be transferred within 6 months of issuance. c) Both pharmacists should obtain adequate information required by federal law:   Transfe out Rph: 1. “void” on the face of Rx 2. names, Address, DEA number of pharmacy 3. Pharmacist names(both receiving and transferring) 4. date Tranfer in Rph: 1. write “ transfer” on the face of the transferred Rx 2. written date, original refill #, original fill date, number of refills remaining, 3. name, address, DEA and prescription number of the original filled pharmacy and 4. the previous filled pharmacy name of the pharmacists previous fill date and location Pharmacist advertising:   Should not utilize any false, misleading advertising. May advertise about price of prescription without implication of drug’s safety, effectiveness or indication of use. Such advertisement should include the following: a) Proprietary name, generic name of the drug b) Strength, quantify, dosage from c) Price charged for filling a prescription Dispensing and Refilling of prescriptions: Maintaining patient record/ and DUR/offer to counsel  Rph or designee should make a reasonable effort to obtain and record the following information:   Patient info such as name, address, date of birth, gender, medical condition, allergy, medications and pharmacist’s comment regarding his/her therapy. Such record should be maintained for no less than 1 year from the date of the last entry. 6  Rph should also perform a DUR every time dispensing a drug to fully evaluate potential DDI, allergy, wrong dose, abuse, duplication, drug disease contraindication and so on.  Designee should be trained to make the offer to counsel for any new prescriptions:  Sign of not less than 11 inches in height by 14 inches in width shall be posted in a conspicuous place stating “Dear patients, you have the right to know about the proper use of your medication and its effects. If you need more information please ask the pharmacist.   If the offer was accepted, the Rph should provide adequate information for the patient to under the proper use of the medication.  If the patient did not pick up the Rx themselves then a toll free number should be provided  for the patient to call. Only pharmacist or intern can counsel on the medication. CQI: MA is the fist state that requires mandatory reporting of medication errors to the board of pharmacy.  Each pharmacy shall establish a CQI program for the purpose of detecting quality related  events QRE discovery and notification:  Notify the patient and/or prescriber Direction for correcting the error  Instruction for minimizing the negative impact of the patient   QRE documentation:     Should be documented on the same date of discovery Should include date of discover, name and time of the person recording the QRE, description of QRE, documentation of the contact with patients or MD. Should maintain 2 years at least from the date of report Data should be analyzed and should inform all pharmacy personal about the recommendations generated by the CQI program. 247 CMR 10. Disciplinary Proceedings:  Adjudicatory hearing: formal administrative hearing held by the board to determine the truth and validity of complains filed against a registrant or license  Complaint: A communication filed with the board or the division of health profession licensure  which the board merits further consideration or action Investigational conference: informal discussion relating to complaint held with the board before hearing.  Order to show cause: order that require the registrant or licensee to appear before the board for a formal adjudicatory hearing.  The board may issue a complaint against its registrant for many different reasons.  Central database so board of different state can see if a hearing is held.  Summary Suspension of a pharmacy:  Closure of the pharmacy: upon receipt by the board of reliable information that a registrant is an imminent and serious threat to the public health or safety. Board agents are authorized to:  Close the registrant’s business Replace all the locks on doors  Display at the entrance of the business that the pharmacy has been suspended  7  Conduct and inventory and audit of the drugs and records. Code of Professional Conduct:  Should not dispense drug, devices or other substances in a manner which is intended to  circumvent the law Should observe the standard of pharmacopoeia   Should not re-dispense any medication which has been dispense before. Rph on duty is responsible for the proper preservation and security of the pharmacy including proper storage of drugs.  Should not enter into an agreement or arrangement with any person for the purpose of dispensing drugs which have been ordered by coded prescriptions  Shall not promise to any person who owns or is an employee of a facility any rebate, discount or commission based upon income received or resulting from the sale.     Should not aid or abet the unlawful practice of pharmacy Should not dispense expired or substandard drugs May dispense by mail or common carrier in a manner consistent with federal and state regulation. Pharmacy connected with or employed by a hospital or clinic should not dispense drugs to any person other than inpatients or outpatients. Or to employees of the hospital or family member of the employees.  Should not provide MD with prescription blank which refer to any pharmacy or pharmacist.  CII inventory every 10 days   Should not limit to whom his/her service should be. Should not refuse to compound customary pharmaceutical preparations except upon extenuating circumstance.  Should be purchase drug samples for the purpose of compounding, reselling or dispending  Comply with the mandatory counseling provision.  Should maintain patient confidentiality at all times. Expiration date of registration:   Rph license: Dec.31st of even numbered years Pharmacy permit from the board and MA controlled substance registration: Dec.31 st of odd numbered year.  Wholesaler controlled substance registration: everyone on Nov. 30th.  Tech license: every 2 years on DOB 8