anticipation of a prescription” means that community pharmacies may prepare medicines in quantities before receiving a valid prescription or order, provided they can document a history of receiving valid prescriptions or orders that have been generated solely within an established patient-healthcare professional relationship, and provided further that they maintain the prescription on file as required by law;

anticipatory compounding” means preparing a compounded medication before the actual receipt of a prescription or practitioner’s order;

beyond use date” means the date up to which a medicine will retain the strength and other properties which are mentioned on the label which strength and other properties can change after the lapse of time and after which date the medicine shall not be sold to the public or used;

client” means a person who uses the professional services of an authorised prescriber or pharmacist;

client consent” means consent given by the patient after the health care professional informing the patient in a manner understood by a reasonable person of the following:

  1. the presumptive diagnosis; and
  2. the available treatment options and expected prognosis;
  3. an estimate of the expected fees for the rendering of the service chosen by the client;

“commercially available” means a marketed medicine but not if it is discontinued and no longer marketed or it appears on a shortage list;

community pharmacy” means a pharmacy wherein or from which some or all of the services as prescribed under the Pharmacy Act are provided to persons requiring pharmaceutical services, but excludes an institutional pharmacy;

compounding” means to prepare, mix, combine, package, and/or label a non-registered medicine(s), or to mix or combine a registered medicine with a non-registered medicine for dispensing as a result of a prescription for an individual patient by a pharmacist or a veterinarian authorised in terms of the Medicines Act. Compounded medicines are not intended as a replacement for a registered medicine or stock remedy, or for the treatment of a patient for more than 30 consecutive days from the date of compounding. The latter however does not preclude a pharmacist/authorised prescriber from continuing treatment for a period longer than 30 days, provided that a new lot of medicine is compounded for the patient in question every 30 days, except if the stability of the compounded product has been proven by accepted stability trials to extend beyond the 30-day period;

dispensing” means the interpretation and evaluation of a prescription, the selection, manipulation or compounding of the medicine, the labelling and supply of the medicine in an appropriate container according to the Medicines Act and the provision of information and instructions by a pharmacist to ensure the safe and effective use of medicine by the patient and “dispense” has a corresponding meaning;

efficacy and effectiveness” a medication’s efficacy is established in clinical trials and its effectiveness refers to its therapeutic value in the general population;

“essentially a copy” means a compounded medicine is “essentially a copy” of a commercially available medicine if: (1) it has the same active pharmaceutical ingredient (“API”); (2) the APIs have the same, similar or easily substitutable dosage strength; and (3) the commercially available medicine can be used by the same route of administration as the compounded medicine – unless an authorised prescriber determines there is a change, made for an identified individual patient, which produces for that patient a significant difference; 

extemporaneous preparation” means a product which is dispensed immediately after preparation and not kept in stock;

healthcare professional” means a person lawfully entitled under the laws to provide health services in the place in which the services are provided by that person including a pharmacist, dentist, medical practitioner and allied healthcare practitioners;

informed consent” means consent of a patient or authorised agent of the patient or other recipient of services based on the principles of autonomy and privacy. Seven criteria define informed consent:

  • competence to understand and to decide;
  • voluntary decision making;
  • disclosure of material information,
  • recommendation of a plan;
  • comprehension of terms (3) and (4);
  • decision in favour of a plan; and
  • authorization of the plan.

A person gives informed consent only if all of these criteria are met. If the criteria are met except that the person rejects the plan, then that person makes an informed refusal.

in-practice use” means the use of medicine for a bona fide patient of a clinical practice by an authorised prescriber affiliated with the practice.

label”, when used as a verb, means brand, mark or otherwise designate or describe, and when used as a noun, means any brand or mark or any written, pictorial or other descriptive matter appearing on or attached to or packed with and referring to any article or the package containing any article;

manufacture” means all operations including purchasing of raw material, processing, production, packaging, releasing, storage, quality assurance, importation, exportation of medicine and scheduled substances and related control and “manufacturing” has a corresponding meaning;

manufacturing pharmacy” means a pharmacy wherein or from which some or all of the services as prescribed under the Pharmacy Act are provided and which shall sell medicine only to a wholesale pharmacy or a community pharmacy or an institutional pharmacy or to persons who are authorised to purchase medicines in terms of the Medicines Act or to an organ of State;

medicine” means medicine as defined in section 1 of the Medicines and Related Substances, 1965 (Act No. 101 of 1965) and includes a complementary medicine;

over-servicing” means the supply, provision, administration, use or prescription of any treatment or care (including diagnostic and other testing, medicines and devices) which is medically or clinically not indicated, unnecessary or inappropriate under the circumstances or which is not in accordance with current acceptable treatment protocols and procedures by the reasonable authorised prescriber, with due regard to the health and welfare interest of the patient;

patient” means an individual with unique requirements receiving medical treatment distinct from a group and examined and/or treated, operated or consulted on by an authorised prescriber or pharmacist in accordance with a ‘health care professional - client-patient’ relationship;

patient-healthcare professional relationship” means a relationship that can be demonstrated to exist between a patient and a regulated healthcare professional in which a professional service is provided.

pharmacist” means a person registered as such under the Pharmacy Act, 1974;

practice use” means possessing in a clinical practice of reasonable and sufficient quantities of compounded medicines to service the immediate needs of patients in the practice setting based on historic usage and delivery periods and for emergency treatment;

prescription” means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs (medicines) specified therein be dispensed for the person/patient named in the order;

public” includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or a Scheduled substance;

re-dispensing” means the dispensing of a medicine, stocked in the pharmacy or the dispensary of a clinical practice, which was previously dispensed by a pharmacist of a community pharmacy to an authorised prescriber of a clinical practice, by an authorised prescriber affiliated with the clinical practice to a bona fide patient of the practice.

registered facility” means a pharmacy or clinic facility which complies with the minimum standards as applicable to the category of service rendered there, and is registered with a Professional Council;

“regularly or in inordinate amounts” means if a medicine is compounded more frequently than needed to address unanticipated, emergency circumstances or in more than the small quantities needed to address unanticipated, emergency circumstances.  As examples:

  • Compounding copies of more than a small number of prescriptions;
  • The compounder routinely substitutes compounds that are essentially copies;
  • The compounder offers pre-printed prescription pads that a prescriber may complete without making a “significant difference” determination;
  • The drug is not compounded on an “as needed basis”, but on a routine or pre-set schedule. 

re-packaging” means the removing of a medicine from its original container and placing it into a patient ready pack and “pre-packaging” have corresponding meanings;

“same API” means a compounded medicine with the same API to be “essentially a copy” unless a prescriber determines there is a change between the compounded and manufactured medicine that will produce a significant difference for the patient for whom it is prescribed;

“same route of administration” (i.e., topical, intravenous, oral) –  a product with the same API and similar/substitutable strengths to be essentially copies if they have different routes of administration.  However, if the compound and manufactured medicines have the same API and same/substitutable strengths, and the commercially available medicine can be used regardless of how it is labelled by the route of administration prescribed for the compound, the compound medicine is considered to be a copy of a commercially available medicine;

“same, similar or easily substitutable strength” – two medicines will have similar dosage strength if the strength of the compound is within 10% of the commercial product.  Dosages are easily substitutable if a patient could take, for example two 25mg manufactured doses, instead of one 50 milligram compounded dose; 

scheduled substance” means any medicine or other substance prescribed by the Minister under section 22A of the Medicines Act;

scope of practice” means the scope of work which a pharmacist, authorised prescriber may perform by law or chooses to restrict himself/herself to, and defines the minimum standards of the facility that will be registered for that purpose;

sell” means sell by wholesale or retail and includes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale or prepare or possess for purposes of sale, and barter or exchange or supply or dispose of to any person whether for a consideration or otherwise; and “sale” and “sold” have corresponding meanings;

statement of significant difference” means any determination of a significant difference in the compounded preparation from the commercially available product should be documented on the prescription.

third party” means any individual, organization, or company outside of a patient-healthcare professional or valid authorised prescriber – client - patient - pharmacist relationship.

valid authorised prescriber-patient-pharmacist relationship” means a valid APPR exists when these conditions apply:

  1. The patient has given the responsibility of medical care to the authorised prescriber and has agreed to follow the instructions of the authorised prescriber, and;
  2. the authorised prescriber has assumed the responsibility of the patient for making a clinical judgement regarding the health of the patient, the need for medical treatment, and for ensuring the provision of ongoing medical care for the patient;
  3. the authorised prescriber has sufficient knowledge of the health status of the patient and the care received or to be received. The knowledge has been obtained through a recent examination of the patient or through a history of medically appropriate and timely examinations and interventions, and;
  4. the authorised prescriber is readily available, or has made the necessary arrangements with another authorised prescriber, for the ongoing medical care of adverse reactions or therapy failure;

wholesale pharmacy” means a pharmacy wherein or from which some or all of the services as prescribed under the Pharmacy Act are provided and who shall sell medicine only to a wholesale pharmacy or a community pharmacy or an institutional pharmacy or to persons who are authorised to purchase medicines in terms of the Medicines Act or to an organ of State;

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