Maryland Pharmacy Law

Compounding: - ANSWER Preparing/mixing a drug as a result of a prescription, and in anticipation of a prescription based on regularly observed prescribing patterns Direct Supervision: - ANSWER A licensed pharmacist is ...

Compounding: - ANSWER Preparing/mixing a drug as a result of a prescription, and in anticipation of a prescription based on regularly observed prescribing patterns Direct Supervision: - ANSWER A licensed pharmacist is physically available on-site in an area where pharmacy services are provided, to supervise the practice of pharmacy Dispensing: - ANSWER Procedure resulting in receipt of a drug by a patient Distribute: - ANSWER Sale or delivery of a drug to another licensee or registrant (NOT to a patient) Pharmaceutical Care - ANSWER Provision of a drug regimen to achieve definite therapeutic outcomes Pharmacy Technician Trainee: - ANSWER Individual engaged in a Board approved technician training program Registered Pharmacy Technician: - ANSWER Technician that is registered with the Board Practice of Pharmacy: - ANSWER Providing pharmaceutical care Compounding and dispensing Monitoring prescriptions and providing information Acting within a Therapeutic Management Contract Administering Vaccinations Providing Drug Therapy Management Pharmacy Intern: - ANSWER Registered with the Board of Pharmacy Must practice under the direct supervision of a pharmacist Dispensing of Prescription Drugs by Physicians, Dentists, or Podiatrists - ANSWER DISCOURAGED Must have dispensing permit from licensing Board Should only be done if a pharmacy is NOT conveniently available to the patient Must label the drug under the rules of the Pharmacy Act Must follow the Poison Prevention Packaging Act Must perform biennial inventory of drugs stocked Board of Pharmacy - ANSWER 2 Consumer Members 10 Ten Pharmacists 2 from chain pharmacy 2 from independent retail pharmacy 2 from acute-care hospitals 1 from long-term care facility 1 from home infusion/home care service 2 pharmacists at large Reciprocity of Pharmacist Licenses - ANSWER Pharmacist in good standing and licensed by examination (NAPLEX) in another jurisdiction may apply for a Maryland pharmacist license without re-taking the NAPLEX exam Applicant must take the Maryland MPJE Pharmacist License Term and Renewal - ANSWER Must complete 30 hours of approved CE within the prior 2 year period Pharmacist license must be renewed every 2 years All ACPE approved programs are approved in Maryland Display of Licenses - ANSWER Pharmacist must conspicuously display license at place of business (employment) Grounds for Discipline - ANSWER Providing professional services while under the influence of controlled substances or alcohol Pays a prescriber to refer patients to the pharmacy (kick back) Provides prescribers with prescription blanks bearing the name or address of the pharmacy Aids in the unauthorized practice of pharmacy Prepares secret/coded prescriptions Fraudulently obtains license Fraudulently collects a fee Fraudulently advertises Accepts employment from a prescriber who owns a pharmacy or joins with a prescriber to own a pharmacy Advertises or claims professional SUPERIORITY Is physically or mentally incompetent or is unable to safely practice pharmacy Discloses confidential patient information without authorization (HIPAA violation) Fails to offer patient counseling or to maintain patient history for new Medicaid prescriptions Discriminates against a patient who is HIV positive Is convicted/pleads guilty/pleads nolo contendre to a: Felony Crime involving dishonesty (moral turpitude) Violation of Pharmacy Act or Board Regulation Discipline by another state Separate Pharmacy Permit for Separate Pharmacies - ANSWER A separate pharmacy permit is required for each separate geographic location Separate permit is NOT needed for multiple pharmacies within one hospital or hospital complex Required Standards/Rules for Operation of a Pharmacy - ANSWER Must be supervised by a Pharmacist at all times it is open AND must have a PIC Must provide complete pharmacy services Not just "fast movers" May NOT interfere with a patient's freedom to choose a pharmacy Must maintain adequate personnel, technology, reference texts and equipment as specified by the Board Must keep all prescription orders for at least 5 years from the date of the last refill If a prescription log is kept which is signed by each patient picking up a prescription, the log must NOT show the patient's social security number, diagnosis, drug, etc. if the log can be viewed by other patients picking up prescriptions Must provide information to patients on how to resolve incorrectly filled prescriptions May post a sign OR May include written notice with the prescription Display and Renewal of Pharmacy Permit - ANSWER expire on May 31st every 2 years Permit must be conspicuously displayed in the pharmacy Sterile Compounding Permits - ANSWER New in 2014 Products must be prepared under USP §797 standards Does not require a patient specific prescription Permit expires on May 31st of the next even-numbered year Pharmacy must be inspected by the Board Permit holder must report adverse events to the Board within 5 calendar days Must also register with the FDA if DISTRIBUTING the compounded product Refusal to Fill or Refill a Prescription - ANSWER A pharmacist may refuse to fill or refill a prescription based upon professional/scientific judgment If a pharmacist refuses to fill or refill a prescription, the pharmacist shall notify the prescriber within 72 hours of the refusal Drug Information and Pricing - ANSWER Only a pharmacist or an intern under the supervision of a pharmacist may provide information to a patient or a health care practitioner concerning drug therapy, side effects, use, etc. If a patient requests, in person or by telephone, the current price for a prescription drug, the pharmacist shall provide the price Dating and Time Limit to Fill Prescriptions - ANSWER Prescriber shall indicate the date of ISSUANCE on all prescriptions A prescription shall not be filled after 120 days of issuance unless the prescriber consents/authorizes Generic Substitution - ANSWER Generic substitution rules apply only if: Prescriber orders the drug by its brand name An FDA approved generic drug is available The prescriber does NOT prohibit substitution The prescription is NOT reimbursed by a third-party payer If substitution rules apply: A pharmacist shall inform the patient of the availability and cost of the generic equivalent drug A pharmacist may substitute an FDA approved generic equivalent drug (Orange Book) that is less expensive than the brand name drug (Purple Book for Biosimilars) The pharmacist shall notify the patient in writing of the substitution The pharmacist shall record on the prescription blank the manufacturer or distributor of the generic drug dispensed Labels of dispensed drugs must contain - ANSWER Date of filling Expiration date of the lesser of 1 year from date of dispensing or manufacturer's expiration date Special handling or storage requirements Name and strength of the drug Must contain same name as used by the prescriber on the prescription (avoid misbranding) If a generic drug is substituted, must also add generic name (to avoid misbranding) and the name of the manufacturer or distributor of the drug Patient alteration of label prohibited - ANSWER So long as any of the original drug remains in the vial/container, the patient is prohibited from altering, defacing, or removing the label of the prescription A pharmacist may refill a prescription without refill authorization IF: - ANSWER The drug is essential to the maintenance of life and to the continuation of therapy in a chronic condition The pharmacist believes it would be detrimental to the patient's health if the drug was not provided The pharmacist attempts to obtain authorization but is unsuccessful The drug is NOT a controlled substance If a pharmacist provides an emergency refill without authorization: - ANSWER Must record date, quantity, and sign or initial the record May provide only 1 refill of a 14-day supply (or unit-of-use) Must notify the prescriber within 72 hours If a state of emergency is declared, a pharmacist may refill without authorization IF: - ANSWER The pharmacist is unable to obtain authorization The drug is not a controlled substance The quantity does not exceed a 14-day supply (or unit-of-use) Pharmacist must notify prescriber within 7 days Drug Information and Records (OBRA 90) requirement - ANSWER Pharmacist or Pharmacist's designee must offer to counsel medical assistance recipients on each new prescription May be done face-to-face OR 2 of the following: Posted sign Note affixed to prescription Note affixed to bag Communication by telephone Only applies to Medicaid patients with new prescriptions (should do for all patients) Pharmacist shall attempt to obtain medical history from the patient Name, address, telephone number, date of birth, and gender History of disease states, allergies, drug reactions, and drugs taken Shall add pharmacist comments Administration of Vaccines - ANSWER A Pharmacist may administer INFLUENZA vaccine to patients at least 9 years of age Pharmacist must report vaccination to the ImmuNet Program If vaccination was administered pursuant to prescription, pharmacist must attempt to inform prescriber A pharmacist may administer any vaccination listed in the Centers for Disease Control and Prevention Recommended Immunization Schedule The patient must be at least 11 years of age, but under the age of 18 years The patient must have a prescription The pharmacist must inform prescribing physician AND the patient's primary care physician that the vaccine was given The pharmacist must report to the ImmuNet Program A pharmacist may administer to an adult (over 18 years of age) any vaccination listed in the Centers for Disease Control and Prevention Recommended Immunization Schedule or Centers for Disease Control and Prevention's Health Information for International Travel May be administered under a written vaccine specific protocol without a prescription Pharmacist shall report the vaccination to the ImmuNet Program If the vaccine was administered pursuant to a prescription, must attempt to notify the prescriber and the patient's primary care physician Remote Automated Medication Systems - ANSWER Robotic machine located at a nursing home or clinic that does NOT have an on-site pharmacy Pharmacist operates the system remotely using a computer The pharmacist shall review all drug orders before they are entered into the machine A starter dose may be given without a pharmacist's prior review IF the pharmacist does review the order within 24 hours of the delivery of the starter dose The machine must: - ANSWER Have bar-code technology Have electronic reporting capability of all persons accessing the machine and all medication removed from the machine Provide a picture of the drug or a written description of the drug Operate under a quality assurance program with policies and procedures Drug Therapy Management Contracts (Collaborative Care Agreement) - ANSWER Written agreement, initiated by a physician, between a physician, pharmacist, and patient for the pharmacist to manage the patient's drug therapy A contract is NOT required in a hospital setting Pharmacist must have PharmD or other training as approved by the Board The protocol may allow a pharmacist to: Modify or discontinue but NOT INITIATE drug therapy Order laboratory tests Other patient care management Contracts last 1 year unless renewed by all parties Pharmacist technicians must be REGISTERED with the Board - ANSWER Technician trainees do not register Pharmacy students do not register during school or for 10 months after graduation Expiration & Renewal of Technician Registration - ANSWER Registration is valid for 2 years To renew, technician must meet continuing education requirements set by the Board (20 hours every 2 years Qualifications pharmacy technicians : - ANSWER Currently certified by a national program OR Be at least 17 years of age (16 ½ to start training) High school graduate or GED or enrolled in high school Complete a training program At least 160 work hours No longer than 6 months Pass exam approved by the Board Qualifications may be waived by the Board if the applicant will be working or has worked as a pharmacy technician in another state Prohibited Acts/Required Acts of pharmacy technicians - ANSWER Technicians may NOT operate under a drug therapy management contract Technicians may NOT administer influenza vaccine Technicians may NOT delegate a task that was delegated to the technician Technician may not commit an act similar to those prohibited to pharmacists Registration must be displayed at place of business or be available for viewing Must wear ID badge as a registered pharmacy technician Qualifications Pharmacy Intern - ANSWER Must be currently enrolled and completed 1 year of professional education in an accredited pharmacy program Must register with the Board before practicing under the supervision of a pharmacist Must undergo a State criminal history records check Must notify the Board within 7 days of conviction\plea to certain crimes Pharmacist to Intern Ratio - ANSWER A pharmacist may not supervise more than 2 interns at one time Authorized and Prohibited Acts pharmacy intern - ANSWER May not perform a final verification of a prescription May not delegate a pharmacy act May administer vaccinations Must display or have available the registration in the pharmacy where working Prescription Drug Repository Program - ANSWER Program for pharmacies to accept donated prescription drugs for disposal AND dispensing to needy patients If the drugs are donated for dispensing: Must be in original, sealed, tamper-evident unit dose packaging Must have an expiration date equal to or greater than 90 days Must not be adulterated or on a list of unacceptable drugs (