Pharmacy & Medicines Management

PHARMACY & MEDICINES MANAGEMENT

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Pharmacy & Medicines Management

Medicines are the highest-volume clinical intervention in any healthcare organisation and one of the largest cost lines. Pharmacy management sits at the intersection of clinical safety, procurement efficiency, and regulatory compliance.

The South African Medicines Regulatory Framework

SAHPRA (South African Health Products Regulatory Authority)

SAHPRA (formerly MCC — Medicines Control Council) regulates medicines, medical devices, and clinical trials under the Medicines and Related Substances Act 101 of 1965 (as amended).

Responsibilities:

Registration of medicines (Schedule 0–8)
Licensing of manufacturers, wholesalers, pharmacies
Post-market surveillance (pharmacovigilance)
Clinical trial authorisation
Scheduling of substances

Scheduling System

Schedule	Category	Examples	Who May Supply
S0	General sale	Paracetamol ≤8 tablets, low-strength antihistamines	Any retail outlet
S1	Pharmacy sale	Standard paracetamol packs, ibuprofen	Pharmacy without prescription
S2	Pharmacist prescription	Stronger analgesics, some antihistamines	Pharmacist may initiate
S3	Prescription (repeat)	Oral contraceptives, statins, amlodipine	Registered prescriber; repeats allowed
S4	Prescription (no repeat without new Rx)	Antibiotics, antihypertensives (most), antidiabetics	Registered prescriber; no automatic repeat
S5	Controlled substance (moderate)	Codeine-containing combinations > threshold	Strict record-keeping; triplicate book
S6	Controlled substance (high)	Morphine, pethidine, oxycodone	S6 register; DEA licence; biannual audit
S7	Prohibited (research only)	MDMA, LSD	Research exemption only
S8	Prohibited	Heroin	No civilian use

Key: S5 and S6 require separate registers, counting, and reconciliation. S6 requires a DEA (Drug Enforcement Authority within SAHPRA) licence. Mismanagement of controlled substances is a criminal offence and grounds for deregistration.

Pharmacy Act 53 of 1974

Governs pharmacy practice:

Only a registered pharmacist may compound, dispense, and supervise the dispensing of medicines
Pharmacist's assistant (post-basic) may dispense under pharmacist supervision
A medical practitioner may dispense from their practice (Section 22C licence) — but this is controversial and increasingly restricted
Community service year is compulsory for pharmacists after internship

Essential Medicines List (EML)

The National EML and Standard Treatment Guidelines (STGs) define the medicines that should be available at each level of care:

Level	Scope	Key Document
PHC / Clinic	~300 medicines	Primary Care STGs
District Hospital	~500 medicines	District Hospital STGs
Regional Hospital	~700 medicines	Regional Hospital STGs
Tertiary/Academic	Full formulary	Tertiary/Academic Hospital STGs

Principle: Prescribe from the EML at the appropriate care level. Off-formulary prescribing requires motivation and approval. Private sector equivalents are the hospital formulary and the medical aid formulary.

Formulary Management in Private Hospitals

Hospital pharmacy formularies:

Closed formulary: Only listed medicines available; must motivate for non-formulary items
Preferred formulary: Listed items are first-line; alternatives available with additional co-payment
Open formulary: Any medicine available; controls via therapeutic interchange and generic substitution

Generic substitution is mandatory in South Africa under the Medicines Act unless the prescriber writes "no substitution" and the patient agrees to pay the price difference.

Medicine Pricing in South Africa

Single Exit Price (SEP)

Introduced in 2004 under the Medicines and Related Substances Amendment Act. All manufacturers and importers must publish a SEP for each medicine. The SEP is the maximum price at which a medicine may be sold to any buyer in South Africa (with the exception of SEP-exempt exports).

Dispensing fee: Pharmacists charge a dispensing fee on top of the SEP. The fee is regulated by the DoH and is tiered based on the SEP of the medicine:

SEP Range	Dispensing Fee (approx.)
R0 – R85.99	R14.00 flat
R86 – R185.99	R16.00
R186+	Sliding scale capped

Exact fee schedule published annually by the DoH.

Medicine Price Register

All registered medicines with their SEP are listed on the Medicine Price Register (MPR), publicly available. This enables price comparison and procurement benchmarking.

Tender Pricing (Public Sector)

National Department of Health negotiates national contracts for high-volume medicines via competitive tender (NDoH Pharmaceutical Contracts). Provincial health departments procure against these contracts. SLA compliance and delivery performance are tracked by the DoH.

Pharmacovigilance

Adverse Drug Reaction (ADR) Reporting

All healthcare professionals have an obligation to report suspected ADRs to SAHPRA via the MedSafety / VigiBase system (South Africa participates in the WHO Programme for International Drug Monitoring).

Reportable events:

All ADRs to newly registered medicines (< 5 years post-registration)
Serious ADRs to any medicine (hospitalisation, disability, death, congenital abnormality)
Unexpected ADRs not described in the package insert
ADRs in special populations (children, pregnant women, elderly)

Naranjo Algorithm — assesses causality of suspected ADR:

Score ≥ 9:   Definite ADR
Score 5–8:   Probable ADR
Score 1–4:   Possible ADR
Score ≤ 0:   Doubtful ADR

Drug-Drug Interactions (DDIs)

High-risk interaction pairs common in SA context:

Drug A	Drug B	Risk	Management
Warfarin	Fluconazole	Major — INR ↑↑	Avoid / reduce warfarin dose / monitor INR
Rifampicin	ARVs (PIs, NNRTIs)	Major — induces CYP3A4	Use rifabutin / switch ARV regimen
Metformin	IV contrast media	Major — lactic acidosis risk	Hold metformin 48h peri-procedure
TMP-SMX	ACE inhibitor	Moderate — hyperkalaemia	Monitor K⁺; avoid in renal impairment
Clopidogrel	Omeprazole	Moderate — reduced antiplatelet effect	Use pantoprazole instead
Clozapine	Ciprofloxacin	Major — clozapine levels ↑	Avoid; monitor clozapine levels

Hospital Pharmacy Operations

Medicine Supply Chain

NDoH/Provincial Tender → Primary Depot (NDOH Depot / Provincial Depot)
                             ↓
                     Secondary Depot (District)
                             ↓
                     Facility Pharmacy (Hospital)
                             ↓
                     Ward Dispensing / Satellite Pharmacy
                             ↓
                     Patient / Bedside Administration

Stockout prevention:

Maintain min/max par levels based on 6-month consumption data
Buffer stock: 2–4 weeks for essential medicines; 4–8 weeks for ARVs
Daily review of ward requisitions vs stock on hand
Alert system for medicines approaching reorder level
National Drug Action Committee (NDAC) stockout reporting

Dispensing Systems

System	Description	Best For
Traditional dispensing	Pharmacist-checked individual patient packs	Small facilities; outpatient
Ward stock (floor stock)	Medicines stocked in ward, nurses administer	Routine ward medicines
Unit dose dispensing	24-hour supply per patient, individually labelled	ICU, high-dependency, reducing medication errors
Automated dispensing cabinets (ADCs)	Pyxis, Omnicell — controlled electronic dispensing	Theatre, ED, ICU — high-value/controlled substances

Medication Error Prevention

WHO High-Alert Medicines (require double-checks at administration):

Concentrated electrolytes (KCl, hypertonic saline) — never on wards
Insulin — independent double-check before administration
Chemotherapy — pharmacist verification + second nurse check
Anticoagulants (heparin, warfarin, LMWHs)
Neuromuscular blocking agents — must be labelled; never stored with other injectables
Opioids — S6 register + double-check

Look-alike / sound-alike (LASA) medicines: Physical separation, different-coloured labels, TALL man lettering (e.g., DOBUTamine vs DOPamine).

ARV (Antiretroviral) Medicines Management

South Africa runs the world's largest ARV programme (approximately 5.5 million people on treatment). ARV supply chain management is a national priority.

Current First-Line Regimen (Adults)

Per SA ARV Treatment Guidelines (2023):

TLD: Tenofovir (TDF) 300mg + Lamivudine (3TC) 300mg + Dolutegravir (DTG) 50mg — one tablet daily

ARV-Specific Management Requirements

2-month dispensing intervals (stable patients) to reduce facility visits — Adherence Clubs and CCMDD (Central Chronic Medicines Dispensing and Distribution)
CCMDD: pick-up points in the community (spaza shops, community sites) for chronic stable patients
DTG in pregnancy: safe (early concern about NTDs resolved with folic acid supplementation)
Viral load monitoring: 6-monthly for stable patients; monthly if unsuppressed
Resistance testing (genotyping): on treatment failure before switching regimen

TB-ARV Co-treatment Drug Interactions

Rifampicin (TB treatment backbone) is a potent CYP3A4 inducer:

Rifampicin + DTG: DTG dose doubled to 50mg twice daily
Rifampicin + PI-based regimens: not recommended (use rifabutin instead, or switch to EFV-based)
Standard approach: use TLD with DTG 50mg BD during rifampicin-containing TB treatment; revert to once-daily DTG after TB treatment completes

Pharmacy Metrics

KPI	Benchmark	Notes
Stockout rate (tracer medicines)	< 2%	Monitor monthly; report to NDAC
Prescription turnaround time (outpatient)	< 30 minutes	Patient satisfaction driver
Dispensing error rate	< 0.1%	Near-miss captures important
Generic dispensing rate	> 80%	Cost reduction; SAHPRA encourages
ADR reporting rate	> 0.5/100 beds/year	Underreporting is systemic
Controlled substance discrepancy rate	0%	Any discrepancy triggers investigation
Medicine expenditure as % of total facility spend	15–25% private; 25–35% public	Varies by case mix