§ 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.

Source

   The provisions of this §  27.19 adopted March 4, 1994, effective March 5, 1994, 24 Pa.B. 1180; amended December 24, 2009, effective December 26, 2009, 39 Pa.B. 7205. Immediately preceding text appears at serial pages (345064), (247939) to (247940) and (319647) to (319648).

Cross References

   This section cited in 49 Pa. Code §  27.203 (relating to centralized prescription processing).



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