RULES AND REGULATIONS
STATE BOARD OF PHARMACY
[ 49 PA. CODE CH. 27 ]
Revisions Regarding Current Pharmacy Practice
[39 Pa.B. 7205]
[Saturday, December 26, 2009]The State Board of Pharmacy (Board) deletes § 27.3 (relating to location of office) and amends §§ 27.1, 27.2, 27.12, 27.17—27.19, 27.21, 27.25 and 27.31 to read as set forth in Annex A.
Effective Date
The amendments will be effective upon final-form publication in the Pennsylvania Bulletin.
Statutory Authority
The amendments are authorized under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (act) (63 P. S. §§ 390-(4)(j) and 390-6(k)(1) and (9)).
Background and Purpose
The Board undertook a wholesale review of its regulations to determine what provisions were outdated. Through careful review and with input from stakeholders, the Board decided to delete certain regulations and to update others to reflect current pharmacy practice.
Summary of Comments and Responses to Proposed Rulemaking
The Board published notice of proposed rulemaking at 37 Pa.B. 5260 (September 29, 2007), with a 30-day public comment period. The Board received comments from Patricia Clancy Kienle and Jerry Mucheno, J.D., R.Ph. who wrote on behalf of the P-3 class of Wilkes University Nesbitt School of Pharmacy. The Board received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC) as part of their review of proposed rulemaking under the Regulatory Review Act (71 P. S. §§ 745.1—745.12). The Board did not receive any comments from the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC).
§ 27.12. Practice of pharmacy and delegation of duties.
With regard to § 27.12, one commentator offered comment in support of the change that allows pharmacy interns to accept and transcribe oral orders. The commentator and IRRC suggested that the Board affirmatively add that duty to § 27.12(c)(3) in the list of procedures that pharmacy interns are allowed to perform. That list pertains specifically to processing ingredients. The Board believes that with the removal of the prohibition in § 27.12(c)(2), the intent is clear and declines to add this to the list. The Board does not want to go down the road of listing each specific task that a pharmacy intern may perform. Pharmacists may delegate many aspects of the practice of pharmacy to pharmacy interns; therefore so long as an action is not prohibited the intern may perform it.
IRRC asked whether the Board considered adding a specific penalty provision to § 27.12 for the failure of a pharmacist to supervise a pharmacy intern appropriately. Under section 5(a)(6) of the act (63 P. S. § 390-5(a)(6)), the Board has the authority to discipline a pharmacist who has ''violated or knowingly permitted the violation of any provision of this act or regulation of the board.'' Therefore, the Board does not intend to include a specific penalty provision in § 27.12 for failure to supervise a pharmacy intern. A disciplinary matter for failure to supervise a pharmacy intern would be treated as any other violation of a regulation and evaluated on a case-by-case basis.
§ 27.17. Security for Schedule II controlled substances.
One commentator commented that proposed § 27.17(a) does not allow properly trained pharmacy technicians to access or transport controlled substances. The Board notes, as indicated by the brackets, that this language in the current regulation is being removed. The change that was proposed, and remains unchanged in the final-form regulation, is to remove the specific prohibitions on who can have access to controlled substances.
IRRC noted that the changes to § 27.17 appear to be contradictory, first requiring Schedule II controlled substances to be secured in locked cabinets and then permitting them to be dispersed throughout the stock of noncontrolled substances. Another commentator also suggested a change in the wording of § 27.17(a) with regard to storing Schedule II controlled substances to enhance clarity. The Board intended to be consistent with the Drug Enforcement Administration's (DEA) regulations in 21 CFR 1301.75(b) (relating to physical security controls for practitioners) and the Department of Health's (Department) regulations in 28 Pa. Code § 25.63 (relating to security controls for practitioners and research personnel), both of which have been in place for over 30 years, to allow for dispersal as another method of obstructing the theft or diversion of controlled substances. In 1998, the Board had amended § 27.16(b)(3) (relating to construction and equipment requirements) to adopt this change; however, no similar amendment was made to § 27.17 at that time, or anytime since. Therefore, the amendments being made at this time are intended to promote internal consistency within the Board's regulations, not to change a substantive rule. The language has not been amended in response to these comments to be consistent with the regulations of the DEA and the Department relating to security for controlled substances, both of which use nearly identical language to that being adopted by the Board.
The HPLC asked for the Board's reasoning for the safety measure of including controlled substances distributed throughout the stock of noncontrolled substances and noted that it did not appear to be an adequate safety measure. As noted, many pharmacies have dispersed their controlled substances throughout the stock of noncontrolled substances for years as the DEA and the Department have had this language in their regulations over 30 years and because similar language has been in § 27.16(b)(3) (relating to construction and equipment requirements) since 1998. See 28 Pa.B. 4532 (September 5, 1998). Dispersing controlled substances throughout the stock is considered to be more secure, as they are not easily identifiable as controlled substances when mixed in with the other stock of the pharmacy. If anyone illegally entered the pharmacy to procure controlled substances they would have to search throughout the stock of the pharmacy to find the controlled substances. Conversely, if all controlled substances were located in one area of the pharmacy, it would be easier to locate them and to procure large quantities of controlled substances illegally in a short period of time.
IRRC further commented that the Board should clarify what a ''substantially constructed cabinet'' is. The Board notes that this language has been in effect over 30 years in the DEA's and the Department's regulations as mentioned, as well as similar language in the Board's existing regulation at § 27.16(b)(3). The Board has not received any inquiries from licensees or inspectors about what would be considered a substantially constructed cabinet. The Board believes the term is clear and is understood by the regulated community. For this reason, the Board has made no amendment to the final-form rulemaking in response to these comments.
IRRC asked how the Board would enforce these storage provisions. The Board will continue to enforce these provisions through routine inspections and investigating complaints. IRRC next asked whether the Board has considered specifying which categories of medical professionals can access Schedule II controlled substances in facilities under the jurisdiction of the Board. The Board discussed this in drafting the proposed regulation and decided to delete the language in § 27.17 that prohibited anyone except a licensed pharmacist or pharmacy intern or, in an institution, a licensed physician or registered nurse from having access to controlled substances. The Board declines to specify who can access Schedule II controlled substances and instead will leave it up to the pharmacy and pharmacist to determine who is authorized to be present in the pharmacy. In a typical retail pharmacy, the only people in the prescription area would normally be the pharmacist, pharmacy technicians and interns and any authorized staff people. In an institution, that list of people would include other medical professionals who are part of the health care team. The Board is comfortable leaving that decision to the discretion of the pharmacist who must still be present and supervising when other authorized personnel are in the pharmacy.
A commentator also commented that ''other persons'' in § 27.17(b) should be clarified. The Board has changed the regulation to specify, ''authorized personnel.'' The commentator also suggested that the Board affirmatively express the ability of a pharmacy technician to assist in the processing of Schedule II prescriptions in this section. The Board declines to state affirmatively that pharmacy technicians may be in an area where controlled substances are stored. As controlled substances may be stored throughout the pharmacy, the Board feels it is unnecessary to make this change. Also, this section applies to more than just pharmacy technicians.
§ 27.18. Standards of practice.
A commentator commented on § 27.18(j), which the Board has amended to provide that prescriptions for Schedule II controlled substances may not be filled more than 6 months from the date of the prescription. The commentator asked the Board to verify that this change is within its purview. The Board feels confident that it is, having previously adopted similar regulations regarding how long prescriptions for Schedule III, IV and V substances are valid. IRRC asked what the Board's statutory authority is for amending § 27.18(j). The Board's authority to regulate the distribution of drugs and devices and the practice of pharmacy is found in section 6(k)(9) of the act. IRRC also asked how the Board determined that 6 months is an appropriate time frame to honor this type of prescription. Similarly, the HPLC asked what the Board's rationale for permitting Schedule II controlled substances to be filled no more than 6 months after the date of the prescription. The Board notes that currently there is no law or regulation that prescribes how long a prescription for a Schedule II controlled substance is valid. Six months is a time frame that other states use, for example Virginia and Arkansas both consider a Schedule II prescription to be valid for 6 months. See Code Ark. R. § 07-04-0004 (relating to time limit on a new Schedule II prescription); and 18 V.A.C. 110-20-290 (relating to dispensing of Schedule II drugs). The Board believes that 6 months is a reasonable time frame during which the Schedule II prescription may be valid.
A commentator suggested that the Board limit the validity of a prescription for a Schedule II drug to no later than 90 days after it was written. The Board declines to make this change. The Board is aware of the provisions of 21 CFR 1306.12(b)(1), which permit practitioners to issue multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of a Schedule II controlled substance, provided certain conditions are met. See 21 CFR 1306.12(b)(1). The Board is not attempting to override the Federal regulation. The final-form regulation would allow some lag time between the issue date of the prescriptions and the dates when they are actually filled. Given that there was no previous time limit as to how long a Schedule II prescription remained valid, the Board is comfortable with enacting the 6-month limitation. In any case, a pharmacist may refuse to fill a prescription if the pharmacist believes in his professional judgment that in the interest of the safety of the patient the prescription should not be filled. See § 27.18(c).
IRRC commented that amended § 27.18(l)(6) is vague and recommended that more specific language is needed in the final-form regulation. The Board has added examples of various types of shipping that could be used to preserve the integrity of the drug. IRRC also asked how the Board would enforce this provision. The Board will enforce it as it does many of the provisions of the act and regulations through routine inspections and investigating any complaints that are filed.
HPLC commented that the Board's use of ''direct supervision'' in § 27.18(n) seemed different than other recently proposed regulations. The Board agrees and has changed § 27.18(n) to specify ''direct, immediate and personal supervision''.
IRRC asked why the Board replaced ''pharmacist or pharmacy'' with the word ''person'' in § 27.18(r)(6). The Board changed the wording to be consistent with use of the term ''person'' in the rest of § 27.18(r). HPLC inquired whether this section would have an impact on physicians offering coupons, specials and samples. This section would have no impact on physicians offering drugs for sale to their own patients. However, advertising to a larger population than just the prescriber's patient population could rise to the level of operating a pharmacy and the Board would be authorized to impose a civil penalty on a practitioner who violates the act.
§ 27.19. Prospective drug review and patient counseling.
IRRC and another commentator thought that amended § 27.19(d) was confusing with two subsections that gave examples of when a PDR is not required. The Board agrees and has amended this section.
§ 27.25. Licensure by reciprocity.
IRRC stated that in § 27.25 there appeared to be abbreviations for licensure exams and asked that the Board define the abbreviations used for the licensure exams. The Board has done so in § 27.1 (relating to definitions).
Other Changes
The Department of Public Welfare (DPW) forwarded comments to the Board after the close of the public comment period. DPW asked the Board to clarify whether a physician is required to date the prescription. The Board's current regulation at § 27.18(b)(1) requires prescriptions on file in the pharmacy to show the date the prescription was issued. The Board only regulates pharmacists and pharmacies and cannot put an affirmative duty on a licensee that it does not regulate. Therefore, so long as the prescription on file in the pharmacy is dated, the Board cannot require that the prescriber must date it. As a practical matter, if a prescription is presented to the pharmacy without a date, the pharmacist may contact the prescriber to confirm the validity of the prescription and enter the date either by hand or a computer-generated label and that becomes the date of the prescription.
DPW also commented that the phrase ''authorized by the prescriber'' in § 27.18 is ambiguous and suggests that the regulation should be clarified to state when the authorization may or must occur. The Board has amended the final-form regulation to specify that refills may be authorized at any time during the 1-year period during which the prescription is valid.
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will have no adverse fiscal impact on the Commonwealth or its political subdivisions and will impose no additional paperwork requirements upon the Commonwealth, political subdivisions or the private sector.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on September 19, 2007, the Board submitted a copy of the notice of proposed rulemaking, published at 37 Pa.B. 5260 to IRRC and the HPLC and the SCP/PLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments received from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on November 18, 2009, the final-form rulemaking was deemed approved by the HPLC and the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on November 19, 2009, and approved the final-form rulemaking.
Additional Information
Persons who require additional information about the final-form rulemaking should submit inquiries to Regulatory Unit Counsel, Department of State, P. O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-7156, or st-pharmacy@state.pa.us.
Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) and regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2 (relating to notice of proposed rulemaking required; and adoption of regulations).
(2) A public comment period was provided as required by law and all comments were considered.
(3) The amendments to this final-form rulemaking do not enlarge the scope of proposed rulemaking published at 37 Pa.B. 5260.
(4) The final-form rulemaking adopted by this order is necessary and appropriate for the administration of the act.
Order
The Board, acting under its authorizing statute, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended, by deleting § 27.3 and by amending §§ 27.1, 27.2, 27.12, 27.17—27.19, 27.21, 27.25 and 27.31, to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Board shall submit this order and Annex A to the Office of Attorney General and the Office of General Counsel for approval as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) The final-form rulemaking shall take effect upon publication in the Pennsylvania Bulletin.
MICHAEL A. PODGURSKI, R.Ph.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 39 Pa.B. 6915 (December 5, 2009).)
Fiscal Note: Fiscal Note 16A-5416 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
GENERAL PROVISIONS § 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
ACPE—The Accreditation Council for Pharmacy Education.
* * * * * FDLE—Federal Drug Law Examination.
* * * * * Licensed person—A person holding a license issued by the Board.
* * * * * MPJE—Multistate Pharmacy Jurisprudence Examination.
* * * * * PDR—Prospective drug review performed to assure that a drug dispensed under a prescription is not likely to have an adverse medical result by attempting to identify potential drug therapy problems that might result from therapeutic duplication, drug-drug interactions, incorrect dosage, incorrect duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse.
* * * * * § 27.2. Other definitions.
The definitions contained in the act and also in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101—780-144), including the term ''controlled substances'' and the schedules thereof, apply to this chapter. A requirement contained in this chapter for a controlled substance applies to the lowest schedule of a controlled substance now or subsequently classified as a controlled substance by either the DEA or the Secretary of the Department of Health.
§ 27.3. (Reserved).
STANDARDS § 27.12. Practice of pharmacy and delegation of duties.
* * * * * (c) Pharmacy interns.
(1) A pharmacy intern may work only under the direct, immediate, personal supervision of a pharmacist in accordance with subsection (b)(2).
(2) A pharmacy intern may neither enter nor be in a pharmacy if a pharmacist is not on duty.
(3) A pharmacy intern working under the direct, immediate, personal supervision of a pharmacist may perform procedures which require professional skill and training. Examples of these procedures include: verifying ingredients, weighing ingredients, compounding ingredients and other similar processing of ingredients.
* * * * * § 27.17. Security for Schedule II controlled substances.
(a) Schedule II controlled substances shall be stored in securely locked, substantially constructed cabinets. However, Schedule II controlled substances may be dispersed throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.
(b) The occasional entry of authorized personnel into an area where the controlled substances are accessible to clean, deliver or perform other necessary functions shall be allowed only when a licensed pharmacist is present and supervising.
(c) The pharmacist manager shall be responsible for assuring that licensed persons, employees and others who enter the prescription area know and abide by the standards of security and that the other measures are taken as may be necessary to insure their enforcement.
§ 27.18. Standards of practice.
* * * * * (b) Prescriptions kept on file in the pharmacy must meet the following requirements:
(1) Prescriptions on file must show the name and address of the patient; the name and address or other identifier of the prescriber; the date the prescription was issued, if the prescription is for a controlled substance or if it was written with a PRN or ad lib refill designation; the name and quantity of the drug prescribed; directions for its use; cautions communicated to the ultimate consumer by means of auxiliary labels or other means when dispensed to the ultimate consumer; the date the prescription was compounded and dispensed; and the name or initials of the dispensing pharmacist.
(2) Prescriptions for controlled substances must show the DEA number of the prescriber. Prescriptions for Schedule II controlled substances must be written with ink, indelible pencil, typewriter, word processor or computer printer and must be manually signed by the prescriber. The pharmacist is responsible for compounding and dispensing nonproprietary drugs consistent with the Federal Controlled Substances Act (21 U.S.C.A. §§ 801—904), The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101—780-144) and the regulations promulgated under these acts.
(3) If a prescription for a nonproprietary drug is refilled, a record of the refill must show the date of the refill, the name or initials of the dispensing pharmacist and the quantity dispensed. If the pharmacist dispenses a quantity different from that of the original prescription, the pharmacist shall indicate the changes on the back of the original prescription or must enter the changes in the computerized files of the pharmacy.
(4) Original prescriptions or readily retrievable images of the original prescriptions shall be kept for 2 years from the date of the most recent filling.
(5) In an institution, Schedule II controlled substances which the pharmacy dispensed and which were ultimately received by the patient shall be recorded and the record kept for 2 years.
* * * * * (i) Prescriptions for nonproprietary drugs may be refilled for 1 year from the date of the prescription if refills have been authorized by the prescriber. A nonproprietary drug which is refillable by statute on the basis of designation, such as ad lib, PRN or similar instruction, may be refilled for 1 year from the date of the prescription. Refills may be authorized at any time during the 1-year period.
(j) Prescriptions for Schedule II controlled substances may not be filled more than 6 months from the date of the prescription. Prescriptions for Schedule II controlled substances may not be refilled. A controlled substance in Schedule III, IV or V may not be filled or refilled more than five times in the 6-month period from the date of the prescription.
* * * * * (l) Prescriptions sent through the mail to a pharmacy shall be compounded and dispensed in the following manner:
(1) Prescription medication shall be sent only in first class mail or common carrier, except where the purchaser is advised in advance that a slower means of transportation will be used and agrees thereto.
(2) The mailing of antibiotics which have been reconstituted is prohibited.
(3) The mailing of a medication or prescription drug or device generally accepted and recognized to be subject to significant deterioration of the original content due to heat, cold fermentation or prolonged agitation is permissible if it is shipped in a manner which would preserve the integrity of the drug, such as cold packs or other temperature control devices and sensors that would alert the patient if the integrity of the drug was compromised.
* * * * * (n) A prescription by means of an oral order, telephone or otherwise, shall be received and transcribed by either a registered pharmacist or a pharmacy intern under the direct, immediate and personal supervision of a pharmacist.
(o) Except as provided under the definition of order, an oral prescription shall be reduced to writing immediately by the pharmacist or pharmacy intern and shall be filled by, or under the direction of the pharmacist. An order entered on the chart or medical record of a patient in an institution for the diagnostic care and treatment of a patient on an overnight basis, or on the chart or medical record of a patient under emergency treatment in an institution by or on the order of a practitioner authorized by statute to prescribe drugs or devices, shall be considered to be a prescription if the medication is to be furnished directly to the patient for self-administration. It is the responsibility of the prescriber to see that the chart or medical record contains the information required for a prescription and that it is signed by the prescriber himself at the time the drug is given or if he is not present, then on his next visit to the institution. A registered pharmacist may not compound, prepare, dispense, fill, sell, or give away a drug or device on the basis of a prescription or order in an institution or hospital unless the prescription or order is an original prescription or order or direct copy thereof issued by the authorized prescriber or practitioner who may be using electronic or computerized equipment.
* * * * * (r) The following provisions apply to the advertisement and sale of drugs:
(1) A person may not advertise the filling or refilling of prescriptions for a consumer or patient in this Commonwealth if that person is not licensed under the act or the prescription is not filled or refilled in a pharmacy licensed by the Board.
(2) A person may not promote to the public the sale of any controlled substances.
(3) Advertisements of prescription drugs and devices may not be false or misleading, and must be truthful, reasonable, informative and understandable to the public.
(4) A drug or device misbranded or adulterated in Federal law is misbranded and adulterated in Commonwealth law.
(5) An advertisement of a prescription must be for a commercially reasonable quantity.
(6) A person advertising special prices for prescriptions, dangerous drugs or nonproprietary drugs, preparations or products, devices and appliances, if using a percentage number such as 10% off, 20% off, and the like, as to selected items, shall state or publish a price list from which the percentage prices are derived, so the consumer or patient knows exactly what the retail price is.
(7) The patient has the right to request a copy of an original prescription. The copy must clearly indicate on its face that it is a copy and may not be used to obtain a new prescription or refill. Before a pharmacist provides a copy of a written prescription to a patient or an authorized agent of the patient, the person requesting the copy shall show the pharmacist acceptable authorization and identification, such as a driver's license. The pharmacist shall record in writing the date, to whom and by whom the copy was given.
(8) A violation of the Unfair Trade Practices and Consumer Protection Law (73 P. S. §§ 201-1—201-9.2) is a violation of this chapter.
* * * * * (t) A pharmacist may only refill a prescription at a reasonable time prior to the time when the contents of the prescription shall be consumed according to prescriber's directions.
* * * * * § 27.19. Prospective drug review and patient counseling.
(a) PDR Required. A pharmacist shall perform a PDR before filling, delivering or sending a new prescription or drug order, except when a physician dispenses a drug to a patient being treated in the emergency room. The PDR requires that the pharmacist review a profile of the patient maintained in the pharmacy in accordance with subsection (f) prior to dispensing the medication to the patient or caregiver.
(b) Purpose. The purpose of the PDR is to help assure that a drug dispensed under a prescription is not likely to have an adverse medical result. The PDR accomplishes this by attempting to identify potential drug therapy problems that might result from therapeutic duplication, drug-drug interactions, incorrect dosage, incorrect duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse.
(c) Scope.
(1) The PDR is required for prescriptions and drug orders.
(2) The following are examples of situations in which a PDR is required:
(i) A patient visits a physician in the physician's office and receives a prescription. The patient has the prescription filled in a retail pharmacy.
(ii) A pharmacist fills a prescription for a patient who lives in a personal care home.
(iii) A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employee.
(iv) A patient is treated on a nonemergency basis in an outpatient clinic of a hospital and is given a prescription. The patient has the prescription filled either in the hospital pharmacy or in a retail pharmacy.
(v) A pharmacist fills a prescription for a patient in a nursing home.
(vi) A pharmacist in a hospital dispenses a drug which will be administered to a patient in the hospital.
(3) The following are examples of situations in which a PDR is not required:
(i) A physician dispenses a drug to a patient being treated in the emergency room.
(ii) A pharmacist dispenses a radiopharmaceutical to a physician who will administer it to a patient.
(iii) A medical practitioner dispenses a drug.
(iv) A pharmacist dispenses a drug to a medical practitioner which the practitioner will administer to a patient.
(d) Offer to counsel.
(1) An offer to counsel shall be made to each patient or caregiver when the pharmacist fills, delivers or sends a new retail or outpatient prescription.
(2) The pharmacist or designee of the pharmacist shall orally make the offer in person if a patient or caregiver comes to the pharmacy. If the pharmacist in the exercise of professional judgment in the interest of a patient believes that an oral offer would be less effective than a written offer, the pharmacist may substitute a written offer. The following are examples of situations in which a pharmacist might substitute a written offer:
(i) The patient or caregiver is hearing impaired.
(ii) The patient or caregiver is not an English speaker.
(3) If neither the patient nor caregiver comes to the pharmacy, the offer to counsel shall be made in one of the following ways:
(i) The pharmacist or designee may telephone the patient or caregiver.
(ii) The pharmacy delivery person may orally make the offer to the patient or caregiver.
(iii) The pharmacist may send a written offer to counsel together with the filled prescription which is delivered or sent to the patient.
(4) A written offer to counsel must include the telephone number of the pharmacy.
(5) A pharmacy shall provide toll-free telephone service if its primary patient population is beyond the local or toll-free exchange.
(6) A mail order pharmacy shall make the offer to counsel either by telephone or by sending a written offer together with the filled prescription. The written offer must include a toll-free telephone number of the pharmacy which a patient or caregiver may use to obtain counselling.
(7) The obligation to make an offer to counsel will be fulfilled by making one offer in accordance with this subsection.
(e) Counselling.
(1) Only a pharmacist may counsel.
(2) If a patient or caregiver who comes to the pharmacy indicates that he wants counselling, the pharmacist shall counsel the patient or caregiver in person, or, at the discretion of the patient or caregiver, by telephone.
(3) If the filled prescription is sent or delivered to the patient or caregiver, counselling shall be by telephone.
(4) The following are examples of matters which a pharmacist in the exercise of professional judgment might deem significant and discuss with the patient or caregiver:
(i) The name and description of the medication.
(ii) The route of administration, dosage form and duration of drug therapy.
(iii) Special directions and precautions for preparation, administration and use by the patient.
(iv) Common severe side effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur.
(v) Techniques for self-monitoring drug therapy.
(vi) Proper storage.
(vii) Prescription refill information.
(viii) Action to be taken in the event of a missed dose.
(5) If a pharmacist discovers a specific problem with a medication during the course of a PDR, the pharmacist shall intervene to attempt to resolve the problem.
(f) Patient profile.
(1) The pharmacist or designee of the pharmacist shall make a reasonable effort to obtain, record and maintain the following information about each patient:
(i) The name, address, telephone number, date of birth (or age) and gender.
(ii) Individual history, if significant, including known allergies and drug reactions, and a list of medications and relevant devices, as provided by the patient or caregiver.
(iii) Pharmacist comments relative to the individual's drug therapy.
(2) The patient profile may be maintained electronically or manually.
(3) The pharmacist or designee of the pharmacist shall begin a patient profile when the pharmacist fills a prescription for a new patient or for a current patient for whom a profile had not previously been maintained.
(4) The patient profile shall be maintained for at least 2 years after the last entry.
(5) The Board will consider a single request for information for a patient profile made to a patient or caregiver a reasonable effort to obtain the information outlined in this subsection.
(g) Refusal to accept counselling or to provide information.
(1) A pharmacist is not required to provide counselling or obtain information for the patient profile if the patient or caregiver refuses the offer to counsel or refuses to divulge information for the patient profile. If a patient or caregiver fails to respond to an offer to counsel or a request for information, the failure to respond will be deemed a refusal.
(2) The pharmacist or designee shall document the refusal of a patient or caregiver to accept counselling or provide information. The documentation must include the name or initials of the pharmacist or designee noting the refusal. The following kinds of documentation are acceptable:
(i) A notation made by the pharmacist or designee on the prescription or patient profile or the electronic records of the pharmacy.
(ii) A writing signed by the patient or caregiver.
(h) Confidentiality.
(1) Information gained by a pharmacist, pharmacy or employee of a pharmacy about a patient under this section shall be regarded as confidential. The information shall be maintained in accordance with section 8(10) of the act (63 P. S. § 390-8(10)).
(2) The pharmacist or pharmacy may reveal the information if one of the following circumstances occurs:
(i) The patient consents to the disclosure.
(ii) The Board or its authorized agents require the information for any proceeding under the act.
(iii) State or Federal law or regulations require or authorize the disclosure.
(iv) A court orders the disclosure.
PHARMACISTS § 27.21. Application for examination and licensure.
(a) A candidate for licensure to practice pharmacy by examination applying to take the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE) shall obtain an application for licensure from the Board, complete the application and file the application with the Board.
(b) The applicant shall include in the application proof of graduation with a B.S. or advanced degree in pharmacy granted by an ACPE accredited school or college; affidavits of all internship experience gained prior to submitting the application; and the application fee.
(c) The applicant shall also complete and submit the examination fees and examination registration forms to the test administrator.
(d) Affidavits of internship experience shall be filed before authorization to take the exam is given.
§ 27.25. Licensure by reciprocity.
(a) An applicant for licensure by reciprocity shall comply with section 3(g) of the act (63 P. S. § 390-3(g)).
(b) Except as provided in subsection (c), an applicant for licensure by reciprocity who received a license to practice pharmacy in any other state, territory or possession of the United States, after January 26, 1983, shall be required to demonstrate that the applicant passed the FDLE.
(c) If an applicant licensed after January 26, 1983, cannot demonstrate that the applicant passed the FDLE, the applicant shall be required to demonstrate that the applicant passed the Pennsylvania MPJE.
RENEWAL OF PHARMACIST LICENSE AND PHARMACY PERMIT § 27.31. Biennial renewal.
(a) A holder of a pharmacy permit shall renew the permit every 2 years, in odd-number years. Renewal requires completion of a form mailed to the holder by the Board in advance of the renewal period, and payment of the specified fee.
(b) A licensed pharmacist shall renew the license every 2 years, in even-numbered years. Renewal requires completion of a form mailed to the pharmacist by the Board in advance of the renewal period or completion of an online electronic form, and payment of the specified fee. A pharmacist shall also submit proof of compliance with the continuing education requirements of § 27.32 (relating to continuing education).
(c) A pharmacist or holder of a pharmacy permit who fails to timely renew shall cease practice or operation until the license or permit is renewed. The holder may be subject to disciplinary action, and will be assessed an additional fee of $5 for each month or part of month after which renewal occurs beyond the date specified by the Board. Notice of lapsed pharmacy permits shall be forwarded to other Commonwealth agencies, including the Department of Health, the Department of Public Welfare and the Department of Aging.
(d) A pharmacist allowing the license to lapse may so notify the Board on the renewal form. Reasons shall be briefly stated, and the pharmacist's pocket license and display license shall be surrendered to the Board with the renewal form. A pharmacist who has had a lapsed license for 1 year or more, and who then seeks to reactivate the license, will be required to show current proficiency to practice pharmacy. The full-time practice of pharmacy in another state, during the period of lapsed licensure in this Commonwealth, will be evidence of current proficiency. A holder of a lapsed license who engaged in activities outside the profession of pharmacy during the lapsed period shall complete hours of continuing education equivalent to the hours which he would have been required to take had he held an active license.
[Pa.B. Doc. No. 09-2369. Filed for public inspection December 24, 2009, 9:00 a.m.]
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