Tech Talk

OTC Medicines - High or Low Risk

In many countries around the globe certain medicines, with a long history of use giving us confidence in the safety and efficacy of the active substance molecule itself, are allowed to be sold ‘over the counter’ (OTC) at certain doses without a prescription. So the safety and efficacy are well known and hence often judged ‘low-risk’.

But wait a minute – this ‘low-risk’ takes no account of the conditions and standards under which the OTC medicine is made, or the security and quality of the supply chain used for its active ingredient(s) and excipients. In the US around 80% of the APIs used in drug products are imported, often from low-cost sources in China and India.

From a public health/patient safety perspective, a contaminated OTC medicine could potentially impact on a larger user population than an Rx medicine. In some countries OTC manufacturers are treated in the same way as other types of drug manufacturers – their products are after all medicines, and are inspected to the same standards and at the same frequencies. In the US, whilst OTC manufacturers must still meet 21 CFR 210 & 211 and current Good Manufacturing Practices (cGMPs), due to resource issues FDA have not always inspected OTC manufacturers to the same frequency.

Remember – the responsibility for the quality of OTC medicines, including the need to comply with cGMP, and to have known supply chains, sits with the firms marketing the OTCs and the manufacturers they choose to use. So is all well then?

Probably not… the situation has become very public recently as consumers see an absence of many well known OTC brands from the shelves. Two very large firms supplying OTCs, previously with reputations for high quality, are now being chastised for their lack of attention to quality and GMPs.

The margins in OTC manufacturing can be small, but that must not be an excuse for OTC firms to be unaware, or ignore, the expectations of cGMP and modern quality management thinking to protect the most important factor – the patient.

To meet this need for all stakeholders, NSF International has developed a new global protocol to assess whether an OTC pharmaceutical or prescription drug manufacturer complies with cGMPs as outlined in the Code of Federal Regulations (21 CFR 210 & 211).

The new protocol, titled NSF P414-201x, Auditing Practices for the Assessment of the Manufacture of Over the Counter Drugs against Established GMP Standards, helps manufacturers understand which requirements must be met in order to produce OTC drugs, including pain relievers, nasal decongestant sprays, cough syrups, antacids and allergy medications. The protocol outlines requirements for personnel, building and facility maintenance, equipment, production/process controls, holding/ distribution, laboratory controls, recordkeeping and packaging and labeling.

Regulators and industry representatives, including the nation’s largest drugstore chain, Walgreens, have championed the development of the NSF protocol. The OTC and prescription drug protocol is intended to be developed into an NSF American National

Standard for OTC and prescription pharmaceuticals by NSF International, an independent organization that writes standards, and tests and certifies products for the food, water, nutritional, health & wellness industries, as well as consumer goods. NSF is currently forming a joint committee to develop the protocol.

“Customers and patients need to have complete trust in the safety of all medicine, whether prescription or over-the-counter,” said Alain Turenne, Director, Product Integrity, at Walgreen Co. “If there are industry gaps of any kind in monitoring, standard setting and quality control, we need to fill them. We are proud to be working with NSF International to continuously elevate our already strong standards for product safety and integrity.”

The new NSF regulatory-based protocol focuses on quality management and provides companies outsourcing manufacturing of drug products, including pharmacy retailers and others, with a means to qualify their pharmaceutical vendors and suppliers. Using a standardized auditing approach, the protocol establishes a grading scheme to ensure OTC manufacturers meet global GMP drug requirements through the inclusion of principles and guidance from ICH and PIC/S, as well as 21 CFR 210 & 211.

The new NSF protocol for OTC and prescription drugs builds on NSF’s significant expertise in pharmaceuticals and dietary supplements and furthers our mission to protect public health. Vendor qualification is a crucial component for pharmacy retailers to ensure they receive high quality OTC and prescription drugs from their vendors and avoid potential recalls. The significant costs involved in a product recall are not only absorbed by the drug manufacturer but the retailer as well.

Since its founding in 1944, NSF International has developed nearly 80 public health and safety standards. These include the American National Standards for foodservice equipment used in restaurants as well as the American National Standards for products coming in contact with drinking water (including water filtration units) which were adopted by the US Environmental Protection Agency (EPA). NSF also developed the American National Standard for dietary supplements (NSF/ANSI Standard 173) and tests supplements to that standard to ensure there are no undeclared ingredients or unsafe levels of contaminants and verify that manufacturers comply with GMPs.

NSF International’s Health Sciences Division offers certification, training, consulting, GMP and GLP testing, R&D and auditing for the pharmaceutical, dietary supplement and medical device industries across the entire product lifecycle. The NSF Health Sciences Division includes: NSF-DBA, which has more than 25 years of pharmaceutical, dietary supplement, and medical devices training expertise; NSF Pharmalytica, a GLP and GMP contract laboratory; NSF Reference Standards and NSF Dietary Supplements Certification Program. NSF International also offers ISO 13485 registration for medical devices and CE Marking delivered through NSF International Strategic Registrations, Ltd (NSF-ISR), as well as drinking water filtration certification through the NSF Water Division. NSF operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America.