Pharmacist Registration: Regulations & Ethics

• Key controls of the Pharmacist Registration Act include registration, practice, education (CPE), training, accreditation, disciplinary proceedings, and fitness to practice.

• Examples of misbehavior include fraudulent registration, wrongful use of titles/qualifications or advertising, convictions not reported, false CPE submissions, professional incompetence, and failure to report unfit practice.

• Pharmacists' Registration Regulations govern pharmacy practice to ensure competency through continual learning (CPE), which is compulsory for renewing practicing certificates.

• The Code of Ethics guides pharmacists and is composed of 10 principles under Inter-Professional relationships, Professional qualities, and Practices & responsibilities.

• Misuse of approved titles and qualifications goes against both the PRA and the COE principles of honesty and integrity.

Pharmacist Registration

• Registration types include full, conditional, temporary, and specialist registration.
• The requirements are an NUS pharmacy degree, 12 months of pre-registration, and passing forensic and pharmacist competency examinations.

Disciplinary and Health Inquiries

• Complaints can arise from improper conduct that disreputes the profession or convictions related to various acts.
• The acts include the PRA, Health Products Act 2007, Medicines Act 1975, Medicines (Advertisement and Sale) Act 1955, Misuse of Drugs Act 1973, and Poisons Act 1938.
• Complaints can also arise from offenses involving fraud/dishonesty or physical/mental unfitness to practice.
• Public complaints must be written and supported by a statutory declaration, while public or council officers do not need to include it.

Complaint Process

• Complaints are referred to the chairperson, and those involving fraud or dishonesty are sent to the disciplinary committee.
• The Complaints Committee consists of a chairperson (council member), two registered pharmacists (one not a council member), and a lay person.
• The Complaints Committee can issue a letter of advice/warning, dismiss the complaint, or order a formal inquiry.

Disciplinary and Health Committee

• Inquiries may be held by either the health committee or a disciplinary committee
• The Disciplinary Committee consists of at least 3 registered pharmacists (10+ years standing, 2+ SPC members).
• The disciplinary committee investigates findings related to conviction, fraud, or abuse of title.

Disciplinary Committee Recommendations

• Recommendations can include removal from the register, suspension, practice restrictions, fines, advice/warning letters, abstinence from improper action, or other appropriate orders.
• The Health Committee consists of at least 3 council members deal with the health of pharmacists/ability to practice.

Actions Against Unfit Pharmacists

• Actions include ordering the pharmacist to cover inquiry costs, suspending registration, or imposing restricted registration to meet specific requirements.
• Recommendations can include removing the registered pharmacist's name from the register.

Training Framework

• NUS pharmacy graduates undergo pre-registration training with supervised hands-on experience, observation, participation, reflection, and assessments.
• Foreign pharmacists must graduate from an SPC-recognized university, have 3 months of supervised training by a registered pharmacist in Singapore, and pass forensic and competency exams.

CPE Requirements

• Fully registered pharmacists must complete mandatory continuing professional education (CPE) to maintain their practicing certificate.
• It consists of achieving 50 CPE points over 2 years to renew it

Practices & Ethics

• Pharmacy practice combines knowledge, skills, intuition, ethics, experience, also upholding law and code of ethics
• Ideal practice integrates medical aims for disease prevention, cure, life prolongation, and palliation through medication management
• Pharmacists should collaborate with healthcare professionals and participate in research.

Specialist Pharmacists

• Specialist Accreditation Board determines specialist qualifications and accredits training programs.
• The specialist accreditation Board certifies qualified individuals and advises the council on specialist registration matters.
• Specialist accreditation Board consists of a chairperson, alongside at least 6 registered pharmacists (each appointed by the minister).
• Appointees serve terms of up to 3 years and can be re-appointed. A quorum of 3 board members is required for meetings, with the chairperson or a designated member presiding, and the chairperson holds a casting vote in case of ties.

Specialist Accreditation Eligibility

• Applicants must be fully registered with the Singapore Pharmacy Council, possess a valid practicing certificate, and practice in Singapore.
• They must have a valid specialty certification from the Pharmacy Specialists Accreditation Board (PSAB), relevant postgraduate education, and completed a year of full-time broad-based pharmacotherapy residency, along with a year of specialty residency training.
• Furthermore, applicants need a year of specialty practice experience following residency, meet competency standards, and fulfill the necessary PSAB criteria.

Residency Programs

• Full-time residency training in broad-based pharmacotherapy and a year of specialty residency are necessary.
• These correspond to National Pharmacy Residency Programs (R1 + R2).

Drug Controls

• The Health Products Act and its regulations include controls for psychotropic drugs/certain opioid drugs.
• Regulations place additional controls on psychotropic and certain opioid drugs beyond those for regular therapeutic products.
• Provisions for psychotropic drug controls are outlined in health products (therapeutic products) regulations.
• The import of therapeutic products containing psychotropic substances requires HSA approval (R6).
• Import for personal use without a license is not allowed (R521a) and HSA approval for exportation (R8) is necessary.
• Import restrictions on codeine/dextromethorphan-containing products, requiring HSA approval for exportation (R9), and adhering to specified supply limits (240mL liquid or 355mg codeine base with counseling).

Misuse of Drugs Act

• It is Enforced by MHA and CNB
• Controlled substances are specified and categorized into four schedules based on abuse potential and therapeutic value.
• The Schedules are I, II, III, IV - IV has the highest potential for abuse but little therapeutic value

Traffic Definitions

• "Traffic/trafficking" includes various activities such as selling, giving, administering, transporting, sending, delivering, and distributing controlled substances
• It excludes consumption, manufacture, import/export and possession

Manufacture and Supply

• Manufacture: Requires a CD license specifying the allowed CD, but practitioners and pharmacists can compound specified CD in Schedules I, II, or III
• A CD license is needed for wholesale supply & supply is restricted to supply of practitioner, pharmacists, nurses, scientist etc
• Administration by instruction: Provisions include lawful administration by DR/dentist (S2/3) and persons acting under their instructions, with any person allowed to administer CD in S1

Regulations

• Possession of CD requires a CD license, with specific exceptions for those authorized to supply CD, ship masters for medical supplies, transportation, laboratory personnel etc .
• For administration according to instructions, provided CD were not obtained from more than one practitioner concurrently by fraud or any person can have in his possession CD in S1

Wholesale requirements

• Wholesale supply) requires a requisition order signed by the recipient, including their name, address, profession, purpose, and total quantity.
• Ink is a requirement.
• Prescriptions must be in ink, include the prescriber's name, address, signature, and date, and specify patient details, dosage instructions, and preparation details; no repeats allowed for CD prescriptions
• They cannot be dispensed before date or 30 days

CD Register

• CD register needs to record movements, chronology, type, strength etc
• Must not cancel, obliterate, alter entries, keep separate register and ink transactions
• Kept for three years

Labelling and Storage

• It includes labeling requirements for CD containers (excluding S1 CDs or those dispensed by practitioners), and instructions for amount and dosage units in the container.
• The labelling include amounts, percentages and units of measure.

Storage and Safe keeping

• Storage requires lock and key, and disposal must be witnessed and documented by a CD inspector.
• S2/4 requires destruction only in presence of and in accordance with directions given by CD inspector and CD inspector endorse entry in CD register documenting date of destruction and quantity of CD destroyed