Prescription and Compounding Services Policy

1. Purpose and Scope

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This policy governs the submission, evaluation and dispensing of prescriptions, the provision of repeat (chronic) medicine services, and the compounding of medicines by ALEMÈ Health (Pty) Ltd (“ALEMÈ”, “we”, “us”).  All prescription services are provided in accordance with the Medicines and Related Substances Act 101 of 1965 and its General Regulations, the Pharmacy Act 53 of 1974, and the Rules relating to Good Pharmacy Practice (“GPP”) of the South African Pharmacy Council (“SAPC”).

2. Valid Prescriptions

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Medicines in Schedule 3, 4, 5 and 6 are dispensed only against a valid prescription issued by a person authorised to prescribe in South Africa.  A valid prescription must contain, among other things:

• the name, qualification, practice address and practice number of the prescriber, and the prescriber’s signature (or an authenticated electronic signature in the case of a lawful electronic prescription);
• the date of issue;
• the patient’s full name and, where applicable, age or date of birth;
• the approved or proprietary name, strength, dosage form, dose, quantity and directions for use of each medicine; and
• the number of authorised repeats, if any.

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A prescription is valid for dispensing for a period of 30 (thirty) days from the date of issue and, where repeats are authorised, may be repeated at the intervals specified for a total period not exceeding 6 (six) months from the date of issue, unless a shorter period applies by law or by direction of the prescriber.  Schedule 6 medicines may not be repeated on the same prescription; a new prescription is required for each supply, and quantities are limited to a maximum of 30 (thirty) days’ supply as required by law.

3. Submitting Prescriptions

• Prescriptions may be submitted by uploading a clear image or PDF through the Website or by email to info@aleme.co.za, by delivery of the original, or by direct electronic transmission from your prescriber.
• Where an image or copy is submitted, we will require the original paper prescription to be handed to the courier at delivery or otherwise provided to us where the law requires the original to be retained, in particular for Schedule 5 and Schedule 6 medicines. Failure to provide a required original will prevent or delay dispensing.
• Faxed, scanned or electronic prescriptions are accepted only to the extent permitted by the Medicines Act, its regulations and applicable SAHPRA/SAPC directives, and are verified with the prescriber where necessary.
• Prescriptions that are unclear, incomplete, altered or otherwise doubtful, will be verified directly with the prescriber before dispensing, and will be refused for dispensing where authenticity cannot be confirmed. Suspected fraudulent prescriptions are reported to the authorities.
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4. Professional Evaluation and Generic Substitution

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Every prescription is evaluated by a pharmacist, who assesses the prescription’s legality, the appropriateness of the therapy, dosage, interactions, duplications and contraindications on the basis of the information available to us.  The pharmacist may contact you or your prescriber to clarify or resolve any issue, and may decline to dispense where dispensing would be unlawful or contrary to your therapeutic interest.
In accordance with the GPP, our pharmacist will inform you of the benefits of substituting a prescribed medicine with an interchangeable generic medicine and will, unless you refuse, or the prescriber has endorsed the prescription “no substitution”, or substitution is otherwise prohibited, dispense the generic equivalent where its price is lower than that of the prescribed medicine.

5. Repeat and Chronic Medicine Service

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Where your prescription authorises repeats, you may enrol in our repeat management service.  We will prepare each repeat in accordance with the authorised intervals, contact you before dispatch to confirm the delivery details and any changes to your health or medication, and remind you when your prescription is due to expire so that a new prescription can be obtained from your prescriber timeously.  Repeats are not dispensed early except where clinically justified and lawful (for example documented travel), and controlled substances are monitored for over-utilisation.

6. Compounding Services

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ALEMÈ provides compounding services - the preparation of medicine for a specific patient in accordance with a prescription, where a suitable commercially available registered product is not appropriate or available. Our compounding services are provided subject to the following:

• Compounded medicines are prepared only pursuant to a valid prescription for an individual patient, by or under the direct personal supervision of a pharmacist, in accordance with GPP, applicable pharmacopoeial standards and our internal standard operating procedures.
• We do not manufacture medicines in bulk for resale and do not compound copies of commercially available registered medicines except where a legitimate clinical need exists (for example an allergy to an excipient, a required strength or dosage form that is not commercially available, or a supply interruption).
• Compounded medicines are not registered with SAHPRA as individual products; they are prepared under the personal professional responsibility of the compounding pharmacist.  The prescriber remains responsible for the decision to prescribe a compounded preparation.
• Each compounded medicine is labelled with the formula or name of the preparation, directions for use, storage conditions, the date of preparation and the beyond-use date.  Beyond-use dates are typically shorter than the expiry dates of manufactured medicines and must be strictly observed.
• Quotations for compounded items are provided per prescription.  Preparation commences only after pharmacist approval of the prescription and confirmation of payment or medical scheme authorisation, and requires a lead time of [1-3] business days.
• Because compounded medicines are made to your specifications, they are not returnable except where defective, as set out in our Refunds and Returns Policy.
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7. Patient Responsibilities

• Provide true, complete and current information about your health, allergies, other medicines (including complementary medicines) and any pregnancy or breastfeeding, as this information is material to safe dispensing and compounding.
• Use medicines strictly as directed, observe storage instructions and beyond-use dates, and keep all medicines out of reach of children.
• Report any suspected side effect, adverse reaction or quality problem to our pharmacist promptly.

8. Records and Confidentiality

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We retain prescriptions and dispensing records for the periods required by the Medicines Act, the Pharmacy Act and GPP (not less than 5 (five) years).  All patient information is treated as confidential and processed in accordance with our Privacy Policy and the Protection of Personal Information Act 4 of 2013.  Patient records are accessible only to pharmacy personnel who require access to provide our services.