Section 64 dispensing errors trial Dec 2024
Dispensing Errors - when are they not a criminal offence?
In the Context of Criminal Offenses under the Medicines Act 1968
An exploration of dispensing errors and their legal ramifications under the Medicines Act 1968.
To thoroughly examine the responsibilities of pharmacists and the legal implications arising from dispensing errors, aiming to provide insight into how pharmacists can navigate potential legal pitfalls.
Intended Learning Outcomes: to understand:
legislation (Medicines Act 1968) with regards to dispensing errors
elements of the dispensing errors defence introduced in 2018 (and in2022)
see those applied in an imagined court case – to aid understanding
Legislation underpinning dispensing errors
Amending Medicines Act 1968, to modify the defences to offences ofcontravening its sections 63 and 64
The Pharmacy (Preparation and Dispensing Errors – RegisteredPharmacies) Order 2018
The Pharmacy (Preparation and Dispensing Errors – Hospital andOther Pharmacy Services) Order 2022
Condition: Hospital must have a chief pharmacist (role)
Pharmacists, pharmacy technicians, and those they supervise
Remove threat of criminal sanctions for inadvertent dispensing errors in registered pharmacies (2018), hospitals and other pharmacy settings such as prisons (2022)
until 2018 dispensing errors was a criminal offence. stopped be an offense as prevented people owning up to their errors.
protects pharmacist from being criminally prosecuted in courts for dispensing errors, thereby encouraging a culture of transparency and accountability within the profession.
pharmacists and pharmacy techs are protected - as techs are taking more responsibility allowing pharmacists to have a more clinical role.
Legislation on Dispensing Errors Key Legislative Changes: The amendments made to the Medicines Act 1968 that directly pertain to dispensing errors were significant in altering legal frameworks. In 2018, the introduction under the Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order created new defenses that acknowledge inadvertent errors made in good faith. 2022 brought forth the Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order which mandates hospitals to designate a chief pharmacist, elevating accountability and oversight. Impact: These changes effectively remove criminal sanctions for inadvertent dispensing errors across various pharmacy environments, promoting a focus on patient safety and error correction rather than punishment.
In the Kangaroo Crown Court: The Queen vs. Elizabeth White
Section 64 of the Medicines Act 1968
1) No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser
5) Where a medicinal product is sold or supplied in pursuance ofa prescription given by an appropriate practitioner, the preceding provisions of this section shall have effect as if—
in those provisions any reference to sale included a reference to supply and (except as provided by the following paragraph) any reference to the purchaser included a reference to the person (ifany) for whom the product was prescribed by the practitioner, and
In subsection (1) of this section, for the words “demanded by the purchaser”, were substituted the words “specified in the prescription”
Key Provisions: Establishes a criminal offense if a medicinal product sold does not meet the nature or quality demanded by the purchaser. Notably alters the definitions of 'sale' and 'purchaser' when supplying a product based on a prescription – emphasizing that legal references must be interpreted with regard to prescriptions.
Example of Prescribed Medicines Medicinal Products: Actavis Propranolol Tablets: 10mg dosage serves as an example of a prescribed medication commonly dispensed. Prednisolone: A commonly prescribed medication; specifics include 0 28 tablets intended for oral use, indicative reference number 6093 a 2005.
supplied propranolol instead of prednisolone. took medication as trusts pharmacists. drop in BP and collapsed at home. buts and bruises from fall.
Guilty or Not? A thought-provoking question posed to the audience regarding Mrs. White’s potential guilt under Section 64, encouraging engagement and critical analysis. Use of Mentimeter for audience interaction (Code: 8916 7247).
Evidence of Dispensation Confirmation: Clear confirmation that the medicine was dispensed at a registered pharmacy – a critical factor in establishing lawful conduct. Prescription Summary: Instruction detailed: “Take 1 tablet twice a day as needed,” with emphasis on refill protocols requiring authorization.
Definition of "Dispense" Dictionary Definition: To dispense means to distribute, deal out, or prepare and give out medicine, reflecting the foundational understanding of pharmacist duties.
Possible Consequences: If found guilty under Section 64, White may face disciplinary actions, including suspension or revocation of pharmacy license, alongside potential criminal charges. Additionally, a thorough review of the pharmacy's record-keeping practices will be necessary to assess compliance with regulatory standards and to identify any patterns of errors that could inform future training and prevention strategies.
Inquiry into Dispensation A pivotal question directed towards determining whether the medicine was dispensed correctly, examining if Mrs. White holds any guilt in this regard.
Prescription Related Provisions Requirements for Legality: The medicinal product must have been either sold or supplied based on a valid prescription or under an immediate need context, delving into the legal scope surrounding prescription-based dispensing. Legal context surrounding ‘immediate need’ elaborated, elaborating on what qualifies as urgent care.
Circumstances of Supply Inquiry into the specifics of Mrs. Yoo’s situation is reviewed – did it reflect an immediate need for medication considering prescription possibilities?
Awareness of Errors Conditions for Defense: Conditions under which a defendant like Mrs. White may argue a defense include a lack of prior knowledge regarding the product's quality and prompt actions taken to notify patients once aware of any dispensing error.
Actions Taken by Mrs. White An exploration on whether Mrs. White took appropriate and reasonable measures to notify Mrs. Yoo of the dispensing error promptly upon realization.
Professional Standards Registration Requirement: A discussion on whether Mrs. White was acting in accordance with her professional registration, a critical consideration in evaluating her legal and ethical standing.
GPhC Standards for Pharmacy Professionals Key Responsibilities: Provide safe and effective care to patients, prioritizing their best interests. Uphold honesty and transparency when errors occur, including the obligation to apologize, explain, and rectify mistakes whenever possible.
Inquiry on Professional Conduct Reflective question posed: Was Mrs. White acting professionally in this case? A deeper exploration into her ethical implications.
Timeline of Events - Part 1 Thursday Events: Afternoon: Mrs. Yoo contacts the pharmacy requesting medication. 6 PM: Mrs. White dispenses medication on an emergency basis without the benefit of a prescription. 8 PM: Mr. Bigvan collects medication for delivery. 9 PM: Medication is delivered to Mrs. Yoo’s residence.
Timeline of Events - Part 2 Thursday Evening to Friday Morning Events: 9:30 PM: Mrs. White expresses concerns over the medication dispensed. 7 AM Friday: Mrs. Yoo consumes the medication and subsequently collapses. 9 AM: Mrs. Yoo’s daughter returns the medication to the pharmacy. Afternoon: Mrs. White identifies and corrects the error but fails to inform Mr. Yoo about it.
Timeline of Events - Part 3 Subsequent Developments: 14th October: Solicitors begin requesting the Patient Medication Record (PMR) copy for review. 15th October: Documentation provided by Mrs. White to relevant parties. 7th November: During a police interview, Mrs. White admits to the error, which raises additional legal questions about her accountability.
Defense Against Section 64 To establish innocence under Section 64, the following criteria must be addressed: The product dispensed was from a registered pharmacy. The supply occurred under proper prescription or due to an immediate need. The defendant was not previously aware of any quality or nature concerns prior to the charges being initiated. The dispenser functions as a registered professional in compliance with their roles.
Question on Verdict Final query posed to attendees: Is Mrs. White guilty or not guilty based on the established facts and legal context?
Conclusion Closing references and acknowledgments presented at the conclusion of the session, summarizing key points while inviting further discussion on dispensing errors and their legal ramifications.