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Delaware State Profile
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EC PHARMACY UPDATE
Planned Parenthood of Delaware and the Delaware Pharmacists Society are working together to try to improve EC access through pharmacies. Thus far, efforts have focused on educating pharmacists about Plan B. Planned Parenthood recently conducted an updated version of the EC Pharmacy Survey Project (DOC-20K) to determine which pharmacies regularly stock and dispense EC. Results of local findings can be easily viewed at maps.yourgmap.com/v/z_bs_EC_Pharmacy_Survey.html. The next step will be to develop and implement a legislative strategy for direct pharmacy access to EC.
Several years ago, a group, including Planned Parenthood and pharmacists, met to explore the possibility of bringing EC pharmacy access to Delaware. Momentum on this front faded, but Planned Parenthood undertook outreach and educational efforts to increase awareness about EC. These efforts included paid advertising on billboards and radio. Reception to the group’s EC awareness activities on the University of Delaware has been very positive and EC is available at the Campus Health Center.
As a result of Planned Parenthood’s previous survey querying pharmacists about stocking EC they provided EC training to teachers and social workers to increase community-level awareness. Training has not yet expanded to include pharmacists or other health care practitioners.
The State of Delaware makes EC available in family planning clinics.
CONTACTS
Pat Carroll-Grant, R.Ph., CDE
Executive Director
Delaware Pharmacists Society
27 North Main
Smyrna, DE 19977-0454
302-659-3088
Fax: 302-659-3089
Patsgrants@aol.com
Karla Fox
President and CEO
Planned Parenthood of Delaware
625 Shipley Street
Wilmington, DE 19801
302-655-7296
Fax: 302-655-1907
kfox@ppde.org
www.ppdel.org
USEFUL LINKS
Delaware Board of Pharmacy
professionallicensing.state.de.us/boards/pharmacy/index.shtml
Delaware General Assembly
www.legis.state.de.us/Legislature.nsf
Planned Parenthood of Delaware
www.ppdel.org
PROTOCOL ENVIRONMENT
Possible Environment: Revision to Existing Authority Required
This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists. However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community.
Pharmacist initiation of EC would require:
- Revising statute to expand authority to include emergency contraception,
- Modifying the requirement for patient-specific protocols
PHARMACY PRACTICE ACT
Pharmacy Practice Act Regulatory and Statutory Authority
Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003.
DELAWARE
Delaware law does not provide authority for broad collaborative drug therapy management. It does, however, permit pharmacists in any practice setting to administer drugs to a patient or the patients agent, apparently without a written protocol but presumably pursuant to a physicians order for a specific patient. The law does not define administer, but the legislature did not equate it with dispense as that term is used separately, not interchangeably, throughout the statute.
A pharmacist may also administer injectable medications, biologicals, adult immunizations (approved by the FDA or under clinical study) pursuant to a patient-specific prescription or a written protocol, which may cover only the prescribing physicians patient population and those classes of persons and indications approved by a Pharmacy Regulatory Council of the states medical board. To administer injectable medications, the pharmacist must have completed comprehensive, Board-approved appropriate training, be certified in CPR, and take at least 2 hours of continuing education annually. The pharmacist must advise the patient in laymans terms of the contraindications and potential risks, obtain the patients written consent, document each injection in detail, and maintain these records for three years. The Board is authorized to view all patient consent forms and documentation of all injections.
Statutory Authority: Provided in the statutory definition of practice of pharmacy, 24 Del. Code Ann. § 250(2)(l)
Regulatory Authority: Provided in the Board of Pharmacy regulations governing Administration of Injectable Medications, Del. Admin. Code. Title 24, § 2514
DELAWARE STATUTES
Delaware Code
TITLE 24
Professions and Occupations
CHAPTER 25. PHARMACY
Subchapter I. General Provisions; Board of Pharmacy
§ 2502. Definitions as used in this chapter.
(l) Practice of pharmacy means the interpretation and evaluation of an authorized prescriber's order. This process shall include, but not be limited to, the proper compounding, dispensing, labeling, packaging and administering of a drug to the patient or the patient's agent. The practice shall include the application of the pharmacist's knowledge of pharmaceutics, pharmacology, pharmacokinetics, drug and food interactions, drug product selection and patient counseling. It shall also include:
- (1) Maintenance of proper records.
- (2) Proper safe storage of drugs.
- (3) Participation in drug utilization and/or drug regimen review.
- (4) Participation in therapeutic drug selection and substitution of therapeutically equivalent drug products.
- (5) Advisor to the practitioner as well as to the patient regarding the total scope of drug therapy, so as to deliver the best care possible.
- (6) The ability of a pharmacist to recommend over-the-counter products.
- (7) Monitoring drug therapy to determine if there is any potential problem with doses, combinations of medications ordered or noncompliance with the prescriber's orders.
- (8) The teaching of pharmacy, the practice in an industrial setting which is directly related to the practice of pharmacy and the activities of licensed pharmacists who are involved with administrative duties, which are directly related to the practice of pharmacy.
- (9) A pharmacist may administer injectable medications, biologicals and adult immunizations pursuant to a valid prescription or physician-approved protocol. The scope of the protocol or valid prescription must be limited to that physician's patient population. A Pharmacy Regulatory Council of the Board of Medical Practice shall establish requirements and regulations that pharmacists must meet in order to administer injectable adult immunizations, biologicals and medications. Those regulations shall include a list of those classes of and the indications for the biologicals, medications and adult immunizations that are appropriate to be administered by pharmacists who have been so authorized. The Pharmacy Regulatory Council shall consist of 7 members as follows:
- a. The Board of Pharmacy shall appoint 1 public member and 4 pharmacists.
- b. The Board of Medical Practice shall appoint 2 physicians, 1 of whom shall serve as Chair of the Pharmacy Regulatory Council.
- (10) A pharmacist may perform capillary blood tests and interpret the results as a means to screen for or monitor disease risk factors and facilitate patient education. The pharmacist shall report results obtained from such blood tests to the patient's health care practitioner. Pharmacists must comply with all state and federal laboratory regulations.
DELAWARE REGULATIONS
14.0 Administration of Injectable Medications
The purpose of this regulation is to implement provisions relating to the training, administration, and documentation of injectable medications, biologicals, and adult immunizations by pharmacists, pursuant to Chapter 25, Title 24 of the Delaware Code relating to Pharmacy.
14.1 Educational Requirements
- 14.1.1 In order to administer injectable medications, biologicals, and adult immunizations a licensed pharmacist shall provide proof that the following requirements have been satisfied:
- 14.1.1.1 The satisfactory completion of an academic and practical curriculum approved by the Board of Pharmacy which includes, but is not limited to, disease epidemiology, vaccine characteristics, injection technique, emergency response to adverse events, and related topics.
- 14.1.1.2 A current Cardio-Pulmonary Resuscitation (CPR) certificate acceptable to the Board of Pharmacy.
- 14.1.2 A registered pharmacist may only administer injections consistent with public health and safety and in a competent manner consistent with the academic curriculum and training completed.
- 14.1.3 Continued competency shall be maintained. A minimum of two hours (0.2 C.E.U.) of the thirty hour requirement for continuing education, every licensure period, must be dedicated to this area of practice.
- 14.1.4 Documentation of the satisfactory completion of the proper academic and practical training requirements shall be listed in a policy and procedures manual available for inspection by the Board of Pharmacy. Maintaining such a policy and procedures manual shall be the responsibility of each registered pharmacist administering injections.
14.2 Practice Requirements
- 14.2.1 The pharmacist must maintain a manual with policies consistent with OSHA (Occupational Exposure to Bloodborne Pathogens) and procedures for dealing with acute adverse events.
- 14.2.2 Prescriptions and/or physician-approved written protocols will be maintained and available for inspection by the Board of Pharmacy.
- 14.2.3 The pharmacist, before administering an injectable medication, biological, or immunization, must counsel the patient and/or the patient's representative about contraindications and inform them in writing in specific and readily understood terms about the risks and benefits. A signed copy of the patient's consent shall be filed and available for inspection by the Board of Pharmacy.
- 14.2.4 The pharmacist must document all injections made and have such documentation available for inspection by the Board of Pharmacy. Documentation shall include:
- 14.2.4.1 Patient's name, address, phone number, date of birth, and gender.
- 14.2.4.2 Medication or vaccine administered, expiration date, lot number, site of administration, dose administered.
- 14.2.4.3 Date of original order and the date of administration(s).
- 14.2.4.4 The name of the prescribing practitioner and the pharmacist administering the dose.
- 14.2.5 The pharmacist must document fully and report all clinically significant adverse events to the primary-care provider and to the Vaccine Adverse Event Reporting System (VAERS) when appropriate.
- 14.2.6 The pharmacist shall provide documentation to each person receiving immunizations and when appropriate to the Immunization Section of the Department of Health and Social Services so the names of those individuals can be added to the Vaccination Registry.
- 14.2.7 All documentation and records required by this Regulation must be maintained for a period of not less than three years.
14.3 Classes and Indications of Approved Medications. Classes of medications shall include injectable medications, immunizations, and biologicals contained in the list of Approved Drug Products with Therapeutic Equivalence Evaluations or drugs under clinical study when administered in accordance with indications approved by the Food & Drug Administration.
14.4 Authorization. Only those registered pharmacists meeting the requirements of this Regulation shall administer injectable medications, biologicals, and adult immunizations. The Board of Pharmacy shall maintain a current list of those pharmacists so authorized. It is the responsibility of each registered pharmacist to maintain his or her current status on such list.
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